Temazepam 10mg/5ml Oral Solution
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Package leaflet: Information for the user
Temazepam 10mg/5ml Oral Solution
Read all of this leaflet carefully before you start taking this medicine because it contains important
information for you.
■ Keep this leaflet. You may need to read it again.
■ If you have any further questions, ask your doctor or pharmacist.
■ This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
■ If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
What is in this leaflet
1. What Temazepam Oral Solution is and what it is 3. How to take Temazepam Oral Solution
used for 4. Possible side effects
2. What you need to know before you take 5. How to store Temazepam Oral Solution
Temazepam Oral Solution 6. Contents of the pack and other information
1. What Temazepam Oral Solution is and what it is used for
The name of your medicine is Temazepam Oral Solution. This belongs to a group of medicines called benzodiazepines. (T)
Page 1
52mm x 100mm
Temazepam 10mg/5ml Oral Solution
Sugar Free
Each 5mI contains 10mg Temazepam,
The product also includes ethanol, propylene glycol (E1520), glycerol (E422) and sorbitol solution (E420). See leaflet for further information.
Administration: For oral use. Read the package leaflet before use.
This medicine can make you feel sleepy. Do not drive while taking this medicine until you know how it makes you feel. See the leaflet inside for more information. Storage: Store between 4°C and 25°C and protect from light. Use within 3 months of opening. Keep out of the sight and reach of children.
Manufactured by the MA holder:
Rosemont Pharmaceuticals Ltd., Leeds, LS11 9XE, UK.
Distributed by: Focus Pharmaceuticals Ltd,, Capital House, ,-.
85 King William Street, London EC4N 7BL, United kingdom, |POM| CD PL 0427/0089 __ ■■ ■
300ml L1549 II II I
Base Page 52mm x 144mm
* Temazepam 10mg/5ml Oral Solution
| Sugar Free
! Each 5ml contains 10mg Temazepam.
i The product also includes ethanol, propylene glycol (E1520), glycerol (E422) and j sorbitol solution (E420). See leaflet for further information. i Administration: For oral use. Read the package leaflet before use.
I This medicine can make you feel sleepy. Do not drive while taking this medicine I until you know how it makes you feel. See the leaflet inside for more information. j Storage: Store between 4°C and 25°C and protect from light. Use within 3 months of ! opening. Keep out of the sight and reach of children. j Manufactured by the MA holder:
; Rosemont Pharmaceuticals Ltd., Leeds, LS11 9XE, UK. i Distributed by: Focus Pharmaceuticals Ltd.,Capital House, i 85 King William Street, London EC4N 7BL, United kingdom. j PL 0427/0089
300ml
■M CD
Temazepam can be used:
■ to help you sleep and re-set your sleep patterns when you have been having difficulty sleeping
■ as a medicine that you should take before you have an operation or a test.
2. What you need to know before you take Temazepam Oral Solution
Do not take Temazepam if:
■ you are allergic to temazepam, to other benzodiazapines or any other ingredients of this medicine (listed in section 6). The signs of an allergic reaction can include a rash, itching, difficulty breathing or swallowing or swelling of the face, lips, throat or tongue
■ you have sudden or severe breathing problems
■ you have severe liver problems
■ you have ‘myasthenia gravis’. The signs of this may be long term tiredness (fatigue) and muscle weakness
■ you suffer from a condition where you stop breathing whilst asleep (sleep apnoea)
■ you have an eye problem called “glaucoma”
■ you have a severe mental health problem called “chronic psychosis” or a “phobic or obsessional state”
■ you have anxiety problems with or without depression. Temazepam may cause you to think about killing yourself (suicide) more often
■ you are breast-feeding.
Do not take this medicine if any of the above apply to you. If you are not sure, talk to your doctor or
pharmacist before taking temazepam.
Warnings and precautions
Talk to your doctor or pharmacist before taking temazepam if:
■ you have any long-term kidney or liver problems
■ you have or have ever had a history of alcohol or drug abuse (see “Dependence” below)
■ you have a personality disorder such as schizophrenia
■ you have recently suffered a loss or bereavement as the medicine may affect the way you react and adjust to this
■ you are elderly or frail. If you get up at night, take care as there is an increased risk of falling and consequently of hip fractures due to the muscle relaxant effect of temazepam
■ you have a history of breathing problems. Whilst taking temazepam your breathing may become less forceful
■ you suffer from or have history of depression
■ you suffer from muscle weakness
■ you are or suspect that you are pregnant.
If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before taking temazepam. Other considerations:
Tolerance - if after a few weeks you notice that temazepam is not working as well as it did when first starting treatment, you should go and see your doctor as an adjustment to your dosage may be required. Dependence - when taking this type of medicine there is a risk of dependence, which increases with dose and length of treatment. There is a greater risk in patients with a history of alcohol or drug abuse. (3)
Temazepam can be habit forming. This medicine should only be used for the shortest time possible Withdrawal - treatment should be gradually withdrawn. Withdrawal symptoms occur with temazepam even when normal doses are given for short periods of time. (See section 3 “If you stop taking Temazepam Oral solution”)
Memory loss - may be experienced several hours after taking temazepam. If possible, to reduce the risk allow 7-8 hours of uninterrupted sleep after taking temazepam.
Psychiatric and “paradoxical” reactions - Temazepam can cause behavioural side effects such as restlessness, agitation, irritability, aggressiveness, delusions (false beliefs), rage, nightmares, hallucinations, psychoses, sleepwalking, inappropriate behaviour, increased insomnia and other adverse behavioural effects. Minor surgery - if you have been given temazepam as a sedative prior to minor surgery you should make arrangements to be accompanied home.
Sleep behaviour - complex sleep behaviour-related events such as “sleep driving” (driving while not fully awake with no memory of the event) have been reported in patients taking temazepam. The risk of these behaviours increases when alcohol is consumed. Tell your doctor immediately if you suffer from any sleep behaviour-related events as your medicine may need to be changed.
Other medicines and Temazepam
Tell your doctor or pharmacist if you are taking or have recently taken any other medicines. This includes medicines bought without a prescription, including herbal medicines. This is because Temazepam Oral Solution can affect the way some other medicines work. Also, some medicines can affect the way Temazepam Oral Solution works.
©
Do not take temazepam in combination with:
■ Sodium oxybate, used to treat narcolepsy with cataplexy - sleep disorders with sudden or transient loss of muscle tone. Temazepam increases the effect of Sodium oxybate
Take care when taking temazepam in combination with:
■ medicines to treat severe mental illness such as chlorpromazine, olanzapine or schizophrenia such as clozapine
■ medicines used for depression or anxiety including amitriptyline, fluoxetine, fluvoxamine and Monoamine Oxidase Inhibitors (MAOIs) such as phenelzine or other tranquillisers
■ medicines that calm your emotions or help you sleep such as diazepam and zolpidem
■ narcotic painkillers such as codeine and morphine or other painkillers
■ lofexidine, used to treat drug problems (dependence)
■ disulfiram, used for alcohol problems (alcoholism)
■ medicines used to treat epilepsy such as phenytoin, barbiturates, hydantoins, carbamazepine or sodium valproate
■ anaesthetics (used during surgery)
■ antihistamines used to treat allergies that make you drowsy, such as chlorphenamine
■ theophylline, used to treat asthma
■ medicines used to treat high blood pressure such as moxonidine or doxazosin
■ medicines used to treat HIV infection such as zidovudine and ritonavir
■ medicines used to treat Parkinsons disease such as levodopa
■ medicines that help the muscles relax in multiple sclerosis or spine injuries such as baclofen or tizanidine
■ nabilone, used to treat sickness caused by chemotherapy
■ cimetidine, used to treat stomach ulcers (5)
■ rifampicin, used to treat bacterial infections.
Temazepam Oral Solution with food and drink
Do not drink alcohol whilst taking this medicine. This medicine can make you sleepy and drinking alcohol when you are taking this medicine can make you even more sleepy.
Pregnancy and breast-feeding
■ do not take this medicine if you are pregnant, likely to become pregnant or are breast-feeding.
■ if your doctor has decided that you should take this medicine during late pregnancy or during labour, your baby may have a low body temperature, floppiness (hypotonia) and breathing or feeding difficulties.
■ if this medicine is taken regularly in late pregnancy, your baby may develop withdrawal symptoms.
Driving and using machines
Temazepam may make you feel drowsy or affect your concentration, vision, memory or muscle function.
This feeling may persist the next day or be even worse when you sleep for less than 7 to 8 hours after taking your medication.
This medicine can affect your ability to drive as it may make you sleepy or dizzy.
■ Do not drive while taking this medicine until you know how it affects you.
■ It is an offence to drive if this medicine affects your ability to drive.
■ However, you would not be committing an offence if:
- The medicine has been prescribed to treat a medical or dental problem and
- You have taken it according to the instructions given by the prescriber or in the information provided
with the medicine and (6)
- It was not affecting your ability to drive safely
Talk to your doctor or pharmacist if you are not sure whether it is safe for you to drive while taking this medicine. Temazepam Oral Solution contains liquid sorbitol and ethanol:
■ liquid sorbitol (a type of sugar). If your doctor has told you that you cannot tolerate some sugars, talk to your doctor before taking this medicine.
■ ethanol (alcohol). Each 5ml spoonful contains 10%v/v ethanol which is equal to 10ml of beer or 4ml of wine. Speak to your doctor before taking this medicine if you have an addiction to alcohol, liver disease, epilepsy, brain injury or disease, you are pregnant or if this medicine has been prescribed for a child.
3. How to take Temazepam Oral Solution
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
■ this medicine contains 10mg of temazepam in each 5ml
■ take this medicine by mouth
■ long term use of this medicine is not recommended.
Adults
For sleeping problems:
• the usual dose is 5ml to 20ml each day before going to bed
• this should only be taken for up to 4 weeks at a time ^
• your doctor may advise you to take this only when necessary. (Z)
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• the usual dose is 10 to 20ml, half to one hour before your surgery or test
• make sure that you have someone to take you home after the procedure.
Older people and people with disease of the blood vessels
• the usual dose is 2.5ml to 7.5ml
• take this each day before going to bed.
Children and adolescents
For sleeping problems:
• this medicine should not be used to help children sleep.
As a pre-medication:
• the usual dose is 0.5ml per kilogram of body weight before surgery or test
• the doctor will work out the correct dose for your child.
If you take more Temazepam Oral Solution than you should
If you take more of this medicine than you should, talk to a doctor or go to your nearest hospital straight away. Do not go unaccompanied to seek medical help. Take the medicine pack with you.
If you take too much the following effects may happen:
■ having trouble with your co-ordination or muscle tension
■ slurred speech
■ feeling confused
■ feeling tired, light-headed and possibly fainting (all due to low blood pressure)
■ breathing problems
■ falling into a coma.
If you forget to take Temazepam Oral Solution
■ if you forget a dose, take it as soon as you remember it. However, if it is nearly time for the next dose, skip the missed dose
■ do not take a double dose (two doses at the same time) to make up for a forgotten dose.
If you stop taking Temazepam Oral Solution
Do not stop taking this medicine unless your doctor tells you to. Do not stop it abruptly.
If the medicine is stopped quickly, the following effects may happen:
■ feeling nervous, irritable, confused, being unable to sleep, finding it hard to concentrate
■ feeling depressed, loss of appetite, having a headache, ringing in your ears (tinnitus), feeling dizzy, feeling detached from yourself or your surroundings (toxic psychosis)
■ tingling hands or feet, sweating, being more sensitive to light, noise or touch than usual, fits and shaking, heart or blood pressure disturbances
■ feeling or being sick, stomach cramps and diarrhoea.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Stop taking this medicine and see a doctor straight away if you have any of the following: (9)
■ an allergic reaction.
The signs of an allergic reaction may include:
• swelling of your face, lips, tongue or throat or difficulty breathing or swallowing
• severe itching of your skin with raised lumps.
■ A rare reaction that affects behaviour (affects more than 1 in 10,000 people)
The signs of this may include:
• feeling depressed and suicidal
• feeling excited, restless, agitated, irritable and confused
• aggressive outbursts or rages
• nightmares
• hallucinations (seeing or hearing things that are not there)
• delusions (thinking things are true that are not really true)
• feeling detached from yourself or your surroundings (psychosis)
• inappropriate behaviour
• sleepwalking (mainly in the elderly patients).
Tell your doctor if you get any of these side effects:
Common (affects more than 1 in 100 people):
■ feeling drowsy, sleepy, extremely tired or unable to sleep
■ double vision
■ feeling unsteady or dizzy
■ feeling less alert to your surroundings
■ numbed emotions
■ lack of co-ordination or muscle weakness
■ slurred speech
■ shallow breathing
■ memory loss
■ light headedness
■ confusion
■ fatigue.
These side effects are more likely to occur at the start of treatment, if alcohol is taken with this medicine or if you are an older person.
Rare (affects more than 1 in 10,000 people):
■ low blood pressure
■ stomach upset (indigestion, diarrhoea, constipations)
■ change in sexual desire
■ headache
■ jaundice (yellowing of the skin and whites of the eyes)
■ difficulty passing water, reduce urine output
■ skin reactions
■ sight problems
■ hangover
■ shaking Ql)
■ feeling dizzy or like you are spinning (vertigo)
■ difficulty pronouncing your words, dry mouth or making more saliva than usual
■ loss of control of your bladder or bowels (incontinence)
■ impaired muscular function
■ vivid dreams
■ palpitations (abnormal heart beat)
■ sedation.
You may have changes to your blood cells. The signs you may notice of this are feeling weak, sore throat, unexplained bruises or bleeding, getting more infections and sores or ulcers in your mouth.
You may develop tolerance to the effects of temazepam. This means you may notice that your medicine is not working as well to relieve your symptoms. If this happens, speak to your doctor.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store Temazepam Oral Solution
■ Keep this medicine out of the sight and reach of children.
■ Store between 4°C and 25°C and protect from light.
■ Take back to the pharmacy 3 months after you first open it.
■ Do not use after the expiry date (month, year) stated on the label and carton. The expiry date refers to the last day of that month.
■ If it is out of date or you no longer want it, take it back to the pharmacy.
■ Do not use Temazepam Oral Solution if you notice anything wrong with the medicine. Talk to your pharmacist.
■ Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
6. Contents of the pack and other information
What Temazepam Oral Solution contains
■ The active substance is temazepam. This medicine contains 10mg of temazepam in each 5ml of solution.
■ The other ingredients are ethanol, propylene glycol (E1520), peppermint oil, caramel E150, trometamol, citric acid, colour E131, glycerol (E422), sorbitol solution 70% non-crystallising (E420) and purified water.
What Temazepam Oral Solution looks like and contents of the pack
A clear green liquid with an odour of peppermint. It comes in a brown glass bottle holding 300ml of solution. Marketing Authorisation Holder and Manufacturer
Rosemont Pharmaceuticals Ltd, Yorkdale Industrial Park, Braithwaite Street, Leeds, LS11 9XE, UK. Distributed by: Focus Pharmaceuticals Ltd., Capital House, 85 King William Street,
London EC4N 7BL, United kingdom.
This leaflet was last revised in 07/2016. Of)
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Product: |
Temazepam 10mg/5ml Oral Solution | ||
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L1549 | ||
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Date:
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Rosemont Pharmaceuticals Ltd. Printed Packaging Origination and Approval
Third Party Approval Required YES Q NO Q applicable
|
Product: |
Temazepam 10mg/5ml Oral Solution | ||
|
Strength: |
10mg/5ml | ||
|
New Item Code: |
L1549 | ||
|
Previous Item Code: |
L1444 | ||
|
Design Icon: |
- |
Sugar-Free: |
YES |
|
Cutter Ref: |
- |
Pack Size |
300ml |
|
Dimensions: |
Base Label: 52x144mm Leaflet Page 1: 52x100mm Right hand opening Core Size: 76.2mm Max dia of reel: 800 labels ✓ Left hand opening | ||
|
Number of Colours: |
2 + Varnish ■ 213 ■ 302 | ||
Date:
Proof Number:
Page:
New Pharmacode:
18.07.16
Name:
FIVE
1 of 3
460
Barcode:
□ Keyline
Braille
Signature:
Date:
7—7
Authority Approval Supplied
Name:
Signature:
Date:
7-/-
Artwork produced by:
Package leaflet: Information for the user
Temazepam 10mg/5ml Oral Solution
Read all of this leaflet carefully before you start taking this medicine because it contains important
information for you.
■ Keep this leaflet. You may need to read it again.
■ If you have any further questions, ask your doctor or pharmacist.
■ This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
■ If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
What is in this leaflet
1. What Temazepam Oral Solution is and what it is 3. How to take Temazepam Oral Solution
used for 4. Possible side effects
2. What you need to know before you take 5. How to store Temazepam Oral Solution
Temazepam Oral Solution 6. Contents of the pack and other information
1. What Temazepam Oral Solution is and what it is used for
The name of your medicine is Temazepam Oral Solution. This belongs to a group of medicines called benzodiazepines. (T)
Page 1
52mm x 100mm
Temazepam 10mg/5ml Oral Solution
• •
Temazepam can be used:
■ to help you sleep and re-set your sleep patterns when you have been having difficulty sleeping
■ as a medicine that you should take before you have an operation or a test.
2. What you need to know before you take Temazepam Oral Solution
Do not take Temazepam if:
■ you are allergic to temazepam, to other benzodiazapines or any other ingredients of this medicine (listed in section 6). The signs of an allergic reaction can include a rash, itching, difficulty breathing or swallowing or swelling of the face, lips, throat or tongue
■ you have sudden or severe breathing problems
■ you have severe liver problems
■ you have ‘myasthenia gravis’. The signs of this may be long term tiredness (fatigue) and muscle weakness
■ you suffer from a condition where you stop breathing whilst asleep (sleep apnoea)
■ you have an eye problem called “glaucoma”
■ you have a severe mental health problem called “chronic psychosis” or a “phobic or obsessional state”
■ you have anxiety problems with or without depression. Temazepam may cause you to think about killing yourself (suicide) more often
■ you are breast-feeding.
Do not take this medicine if any of the above apply to you. If you are not sure, talk to your doctor or
pharmacist before taking temazepam.
Warnings and precautions
Talk to your doctor or pharmacist before taking temazepam if:
■ you have any long-term kidney or liver problems
■ you have or have ever had a history of alcohol or drug abuse (see “Dependence” below)
■ you have a personality disorder such as schizophrenia
■ you have recently suffered a loss or bereavement as the medicine may affect the way you react and adjust to this
■ you are elderly or frail. If you get up at night, take care as there is an increased risk of falling and consequently of hip fractures due to the muscle relaxant effect of temazepam
■ you have a history of breathing problems. Whilst taking temazepam your breathing may become less forceful
■ you suffer from or have history of depression
■ you suffer from muscle weakness
■ you are or suspect that you are pregnant.
If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before taking temazepam. Other considerations:
Tolerance - if after a few weeks you notice that temazepam is not working as well as it did when first starting treatment, you should go and see your doctor as an adjustment to your dosage may be required. Dependence - when taking this type of medicine there is a risk of dependence, which increases with dose and length of treatment. There is a greater risk in patients with a history of alcohol or drug abuse. (3)
Temazepam can be habit forming. This medicine should only be used for the shortest time possible Withdrawal - treatment should be gradually withdrawn. Withdrawal symptoms occur with temazepam even when normal doses are given for short periods of time. (See section 3 “If you stop taking Temazepam Oral solution”)
Memory loss - may be experienced several hours after taking temazepam. If possible, to reduce the risk allow 7-8 hours of uninterrupted sleep after taking temazepam.
Psychiatric and “paradoxical” reactions - Temazepam can cause behavioural side effects such as restlessness, agitation, irritability, aggressiveness, delusions (false beliefs), rage, nightmares, hallucinations, psychoses, sleepwalking, inappropriate behaviour, increased insomnia and other adverse behavioural effects. Minor surgery - if you have been given temazepam as a sedative prior to minor surgery you should make arrangements to be accompanied home.
Sleep behaviour - complex sleep behaviour-related events such as “sleep driving” (driving while not fully awake with no memory of the event) have been reported in patients taking temazepam. The risk of these behaviours increases when alcohol is consumed. Tell your doctor immediately if you suffer from any sleep behaviour-related events as your medicine may need to be changed.
Other medicines and Temazepam
Tell your doctor or pharmacist if you are taking or have recently taken any other medicines. This includes medicines bought without a prescription, including herbal medicines. This is because Temazepam Oral Solution can affect the way some other medicines work. Also, some medicines can affect the way Temazepam Oral Solution works.
©
Do not take temazepam in combination with:
■ Sodium oxybate, used to treat narcolepsy with cataplexy - sleep disorders with sudden or transient loss of muscle tone. Temazepam increases the effect of Sodium oxybate
Take care when taking temazepam in combination with:
■ medicines to treat severe mental illness such as chlorpromazine, olanzapine or schizophrenia such as clozapine
■ medicines used for depression or anxiety including amitriptyline, fluoxetine, fluvoxamine and Monoamine Oxidase Inhibitors (MAOIs) such as phenelzine or other tranquillisers
■ medicines that calm your emotions or help you sleep such as diazepam and zolpidem
■ narcotic painkillers such as codeine and morphine or other painkillers
■ lofexidine, used to treat drug problems (dependence)
■ disulfiram, used for alcohol problems (alcoholism)
■ medicines used to treat epilepsy such as phenytoin, barbiturates, hydantoins, carbamazepine or sodium valproate
■ anaesthetics (used during surgery)
■ antihistamines used to treat allergies that make you drowsy, such as chlorphenamine
■ theophylline, used to treat asthma
■ medicines used to treat high blood pressure such as moxonidine or doxazosin
■ medicines used to treat HIV infection such as zidovudine and ritonavir
■ medicines used to treat Parkinsons disease such as levodopa
■ medicines that help the muscles relax in multiple sclerosis or spine injuries such as baclofen or tizanidine
■ nabilone, used to treat sickness caused by chemotherapy
■ cimetidine, used to treat stomach ulcers (5)
■ rifampicin, used to treat bacterial infections.
Temazepam Oral Solution with food and drink
Do not drink alcohol whilst taking this medicine. This medicine can make you sleepy and drinking alcohol when you are taking this medicine can make you even more sleepy.
Pregnancy and breast-feeding
■ do not take this medicine if you are pregnant, likely to become pregnant or are breast-feeding.
■ if your doctor has decided that you should take this medicine during late pregnancy or during labour, your baby may have a low body temperature, floppiness (hypotonia) and breathing or feeding difficulties.
■ if this medicine is taken regularly in late pregnancy, your baby may develop withdrawal symptoms.
Driving and using machines
Temazepam may make you feel drowsy or affect your concentration, vision, memory or muscle function.
This feeling may persist the next day or be even worse when you sleep for less than 7 to 8 hours after taking your medication.
This medicine can affect your ability to drive as it may make you sleepy or dizzy.
■ Do not drive while taking this medicine until you know how it affects you.
■ It is an offence to drive if this medicine affects your ability to drive.
■ However, you would not be committing an offence if:
- The medicine has been prescribed to treat a medical or dental problem and
- You have taken it according to the instructions given by the prescriber or in the information provided
with the medicine and (6)
- It was not affecting your ability to drive safely
Talk to your doctor or pharmacist if you are not sure whether it is safe for you to drive while taking this medicine. Temazepam Oral Solution contains liquid sorbitol and ethanol:
■ liquid sorbitol (a type of sugar). If your doctor has told you that you cannot tolerate some sugars, talk to your doctor before taking this medicine.
■ ethanol (alcohol). Each 5ml spoonful contains 10%v/v ethanol which is equal to 10ml of beer or 4ml of wine. Speak to your doctor before taking this medicine if you have an addiction to alcohol, liver disease, epilepsy, brain injury or disease, you are pregnant or if this medicine has been prescribed for a child.
3. How to take Temazepam Oral Solution
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
■ this medicine contains 10mg of temazepam in each 5ml
■ take this medicine by mouth
■ long term use of this medicine is not recommended.
Adults
For sleeping problems:
• the usual dose is 5ml to 20ml each day before going to bed
• this should only be taken for up to 4 weeks at a time ^
• your doctor may advise you to take this only when necessary. (Z)
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EaC#i#hl covins 10mg Temazejam, • •
The^product also#ncludes ethanol, propylene glycol (E1520), glycerol (E422) and sorbitol solution (E420). See leaflet for further information.
Admirfistrflion: Foftral use. t^ ^ckag£leafleebefoi#u^ • • •
This medicine can make you feel sleepy. Do flbt drive white taking this medicine• untH you know how it makes you feel. See th#le!Het intfdt for more information#
within 3 months of
ing. Keep oiW of thesight and reachof Children. w • • • ••
MaoyractiRdbytheMfholder: * ** ••• ••
mont Pharmaceutica
ght. Use within ^m^ths oj
laoufactiRdby the MA holder:
Ro^monffharmaceutlcals Ltd., Letds, LS11 9xE, UK.® • •
Distributed by: Focus Pharmaceuticals Ltd,, Capital House, ,-.
85 King William Street, London EC4N 7BL, United kingdom, |POM| CD PL 0427/0089
300ml
L1549
Base Page 52mm x 144mm
* Temazepam 10mg/5ml Oral Solution
| Sugar Free
! Each 5ml contains 10mg Temazepam.
i The product also includes ethanol, propylene glycol (E1520), glycerol (E422) and j sorbitol solution (E420). See leaflet for further information. i Administration: For oral use. Read the package leaflet before use.
I This medicine can make you feel sleepy. Do not drive while taking this medicine I until you know how it makes you feel. See the leaflet inside for more information. j Storage: Store between 4°C and 25°C and protect from light. Use within 3 months of ! opening. Keep out of the sight and reach of children. j Manufactured by the MA holder:
; Rosemont Pharmaceuticals Ltd., Leeds, LS11 9XE, UK. i Distributed by: Focus Pharmaceuticals Ltd.,Capital House, i 85 King William Street, London EC4N 7BL, United kingdom. j PL 0427/0089
300ml
■M CD
• the usual dose is 10 to 20ml, half to one hour before your surgery or test
• make sure that you have someone to take you home after the procedure.
Older people and people with disease of the blood vessels
• the usual dose is 2.5ml to 7.5ml
• take this each day before going to bed.
Children and adolescents
For sleeping problems:
• this medicine should not be used to help children sleep.
As a pre-medication:
• the usual dose is 0.5ml per kilogram of body weight before surgery or test
• the doctor will work out the correct dose for your child.
If you take more Temazepam Oral Solution than you should
If you take more of this medicine than you should, talk to a doctor or go to your nearest hospital straight away. Do not go unaccompanied to seek medical help. Take the medicine pack with you.
If you take too much the following effects may happen:
■ having trouble with your co-ordination or muscle tension
■ slurred speech
■ feeling confused
■ feeling tired, light-headed and possibly fainting (all due to low blood pressure)
■ breathing problems
■ falling into a coma.
If you forget to take Temazepam Oral Solution
■ if you forget a dose, take it as soon as you remember it. However, if it is nearly time for the next dose, skip the missed dose
■ do not take a double dose (two doses at the same time) to make up for a forgotten dose.
If you stop taking Temazepam Oral Solution
Do not stop taking this medicine unless your doctor tells you to. Do not stop it abruptly.
If the medicine is stopped quickly, the following effects may happen:
■ feeling nervous, irritable, confused, being unable to sleep, finding it hard to concentrate
■ feeling depressed, loss of appetite, having a headache, ringing in your ears (tinnitus), feeling dizzy, feeling detached from yourself or your surroundings (toxic psychosis)
■ tingling hands or feet, sweating, being more sensitive to light, noise or touch than usual, fits and shaking, heart or blood pressure disturbances
■ feeling or being sick, stomach cramps and diarrhoea.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Stop taking this medicine and see a doctor straight away if you have any of the following: (9)
■ an allergic reaction.
The signs of an allergic reaction may include:
• swelling of your face, lips, tongue or throat or difficulty breathing or swallowing
• severe itching of your skin with raised lumps.
■ A rare reaction that affects behaviour (affects more than 1 in 10,000 people)
The signs of this may include:
• feeling depressed and suicidal
• feeling excited, restless, agitated, irritable and confused
• aggressive outbursts or rages
• nightmares
• hallucinations (seeing or hearing things that are not there)
• delusions (thinking things are true that are not really true)
• feeling detached from yourself or your surroundings (psychosis)
• inappropriate behaviour
• sleepwalking (mainly in the elderly patients).
Tell your doctor if you get any of these side effects:
Common (affects more than 1 in 100 people):
■ feeling drowsy, sleepy, extremely tired or unable to sleep
■ double vision
■ feeling unsteady or dizzy
■ feeling less alert to your surroundings
■ numbed emotions
■ lack of co-ordination or muscle weakness
■ slurred speech
■ shallow breathing
■ memory loss
■ light headedness
■ confusion
■ fatigue.
These side effects are more likely to occur at the start of treatment, if alcohol is taken with this medicine or if you are an older person.
Rare (affects more than 1 in 10,000 people):
■ low blood pressure
■ stomach upset (indigestion, diarrhoea, constipations)
■ change in sexual desire
■ headache
■ jaundice (yellowing of the skin and whites of the eyes)
■ difficulty passing water, reduce urine output
■ skin reactions
■ sight problems
■ hangover
■ shaking Ql)
■ feeling dizzy or like you are spinning (vertigo)
■ difficulty pronouncing your words, dry mouth or making more saliva than usual
■ loss of control of your bladder or bowels (incontinence)
■ impaired muscular function
■ vivid dreams
■ palpitations (abnormal heart beat)
■ sedation.
You may have changes to your blood cells. The signs you may notice of this are feeling weak, sore throat, unexplained bruises or bleeding, getting more infections and sores or ulcers in your mouth.
You may develop tolerance to the effects of temazepam. This means you may notice that your medicine is not working as well to relieve your symptoms. If this happens, speak to your doctor.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store Temazepam Oral Solution
■ Keep this medicine out of the sight and reach of children.
■ Store between 4°C and 25°C and protect from light.
■ Take back to the pharmacy 3 months after you first open it.
■ Do not use after the expiry date (month, year) stated on the label and carton. The expiry date refers to the last day of that month.
■ If it is out of date or you no longer want it, take it back to the pharmacy.
■ Do not use Temazepam Oral Solution if you notice anything wrong with the medicine. Talk to your pharmacist.
■ Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
6. Contents of the pack and other information
What Temazepam Oral Solution contains
■ The active substance is temazepam. This medicine contains 10mg of temazepam in each 5ml of solution.
■ The other ingredients are ethanol, propylene glycol (E1520), peppermint oil, caramel E150, trometamol, citric acid, colour E131, glycerol (E422), sorbitol solution 70% non-crystallising (E420) and purified water.
What Temazepam Oral Solution looks like and contents of the pack
A clear green liquid with an odour of peppermint. It comes in a brown glass bottle holding 300ml of solution. Marketing Authorisation Holder and Manufacturer
Rosemont Pharmaceuticals Ltd, Yorkdale Industrial Park, Braithwaite Street, Leeds, LS11 9XE, UK. Distributed by: Focus Pharmaceuticals Ltd., Capital House, 85 King William Street,
London EC4N 7BL, United kingdom.
This leaflet was last revised in 07/2016. Of)
|
Product: |
Temazepam 10mg/5ml Oral Solution | ||
|
Strength: |
10mg/5ml | ||
|
New Item Code: |
L1549 | ||
|
Previous Item Code: |
L1444 | ||
|
Design Icon: |
- |
Sugar-Free: |
YES |
|
Cutter Ref: |
- |
Pack Size |
300ml |
|
Dimensions: |
Base Label: 52x144mm Leaflet Page 1: 52x100mm Right hand opening Core Size: 76.2mm Max dia of reel: 800 labels ✓ Left hand opening | ||
|
Number of Colours: |
2 + Varnish ■ 213 ■ 302 | ||
Date:
18.07.16
Name:
Proof Number:
Page:
New Pharmacode:
Barcode:
FIVE
1 of 3
460
□ Keyline
Braille
Signature:
Date:
Name:
Signature:
Date:
V—/-
Artwork produced by:
Rasemont4]
► Package
leaflet Information for the user
Temazepam 10mg/5ml Oral Solution
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
What is in this leaflet
1. What Temazepam Oral Solution is and what it is used for
2. What you need to know before you take Temazepam Oral Solution
3. How to take Temazepam Oral Solution
4. Possible side effects
5. How to store Temazepam Oral Solution
6. Contents of the pack and other information
1. What Temazepam Oral Solution is and what it is used for
The name of your medicine is Temazepam Oral Solution. This belongs to a group of medicines called benzodiazepines.
PAGE 1
52mm x 100mm
Each 5ml contains 10mg Temazepam.
The product also contains ethanol, propylene glycol (E1520), glycerol (E422) and sorbitol solution (E420).
See leaflet for further information.
Administration:
For oral use. Read the package leaflet before use.
This medicine can make you feel sleepy. Do not drive while taking this medicine until you know how it makes you feel. See the leaflet inside for more information.
Storage: Store between 4°C and 25°C and protect from light. Use within 3 months of opening.
Keep out of the sight and reach of children.
Manufactured by the MA Holder.
Rosemont Pharmaceuticals Ltd.,
Leeds LS11 9XE, UK PL 0427/0089 LXXXX
Temazepam can be used:
• to help you sleep and re-set your sleep patterns when you have been having difficulty sleeping as a medicine that you should take before you have an operation or a test.
2. What you need to know before you take Temazepam Oral Solution
Do not take Temazepam if:
• you are allergic to temazepam, to other benzodiazapines or any other ingredients of this medicine (listed in section 6). The signs of an allergic reaction can include a rash, itching, difficulty breathing or swallowing or swelling of the face, lips, throat or tongue
• you have sudden or severe breathing problems
• you have severe liver problems
• you have 'myasthenia gravis'. The signs of this may be long term tiredness (fatigue) and muscle weakness
• you suffer from a condition where you stop breathing whilst asleep (sleep apnoea)
• you have an eye problem called "glaucoma"
• you have a severe mental health problem called "chronic psychosis" or a "phobic or obsessional state"
• you have anxiety problems with or without depression. Temazepam may cause you to think about killing yourself (suicide) more often
• you are breast-feeding.
Do not take this medicine if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before taking temazepam.
©
Warnings and precautions
Talk to your doctor or pharmacist before taking temazepam if:
• you have any long-term kidney or liver problems
• you have or have ever had a history of alcohol or drug abuse (see "Dependence" below)
• you have a personality disorder such as schizophrenia
• you have recently suffered a loss or bereavement as the medicine may affect the way you react and adjust to this
• you are elderly or frail. If you get up at night, take care as there is an increased risk of falling and consequently of hip fractures due to the muscle relaxant effect of temazepam
• you have a history of breathing problems. Whilst taking temazepam your breathing may become less forceful
• you suffer from or have history of depression
• you suffer from muscle weakness
• you are or suspect that you are pregnant.
If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before taking temazepam. Other considerations:
Tolerance - if after a few weeks you notice that temazepam is not working as well as it did when first starting treatment, you should go and see your doctor as an adjustment to your dosage may be required. Dependence - when taking this type of medicine there is a risk of dependence, which increases with dose and length of treatment. There is a greater risk in patients with a history of alcohol or drug abuse. Temazepam can be habit forming. This medicine should only be used for the shortest time possible
Withdrawal - treatment should be gradually withdrawn. Withdrawal symptoms occur with temazepam even when normal doses are given for short periods of time. (See section 3 "If you stop taking Temazepam Oral solution")
Memory loss - may be experienced several hours after taking temazepam. If possible, to reduce the risk allow 7-8 hours of uninterrupted sleep after taking temazepam.
Psychiatric and “paradoxical” reactions - Temazepam can cause behavioural side effects such as restlessness, agitation, irritability, aggressiveness, delusions (false beliefs), rage, nightmares, hallucinations, psychoses, sleepwalking, inappropriate behaviour, increased insomnia and other adverse behavioural effects. Minor surgery - if you have been given temazepam as a sedative prior to minor surgery you should make arrangements to be accompanied home.
Sleep behaviour - complex sleep behaviour-related events such as "sleep driving" (driving while not fully awake with no memory of the event) have been reported in patients taking temazepam. The risk of these behaviours increases when alcohol is consumed. Tell your doctor immediately if you suffer from any sleep behaviour-related events as your medicine may need to be changed.
Other medicines and Temazepam
Tell your doctor or pharmacist if you are taking or have recently taken any other medicines. This includes medicines bought without a prescription, including herbal medicines. This is because Temazepam Oral Solution can affect the way some other medicines work. Also, some medicines can affect the way Temazepam Oral Solution works.
Do not take temazepam in combination with:
• Sodium oxybate, used to treat narcolepsy with cataplexy - sleep disorders with sudden or transient loss of muscle tone. Temazepam increases the effect of Sodium oxybate
Take care when taking temazepam in combination with:
• medicines to treat severe mental illness such as chlorpromazine, olanzapine or schizophrenia such as clozapine
• medicines used for depression or anxiety including amitriptyline, fluoxetine, fluvoxamine and Monoamine Oxidase Inhibitors (MAOIs) such as phenelzine or other tranquillisers
• medicines that calm your emotions or help you sleep such as diazepam and zolpidem
• narcotic painkillers such as codeine and morphine or other painkillers
• lofexidine, used to treat drug problems (dependence)
• disulfiram, used for alcohol problems (alcoholism)
• medicines used to treat epilepsy such as phenytoin, barbiturates, hydantoins, carbamazepine or sodium valproate
• anaesthetics (used during surgery)
• antihistamines used to treat allergies that make you drowsy, such as chlorphenamine
• theophylline, used to treat asthma
• medicines used to treat high blood pressure such as moxonidine or doxazosin
• medicines used to treat HIV infection such as zidovudine and ritonavir
• medicines used to treat Parkinsons disease such as levodopa
• medicines that help the muscles relax in multiple sclerosis or spine injuries such as baclofen or tizanidine
nabilone, used to treat sickness caused by chemotherapy
• cimetidine, used to treat stomach ulcers
• rifampicin, used to treat bacterial infections.
Temazepam Oral Solution with food and drink
Do not drink alcohol whilst taking this medicine. This medicine can make you sleepy and drinking alcohol when you are taking this medicine can make you even more sleepy.
Pregnancy and breast-feeding
• do not take this medicine if you are pregnant, likely to become pregnant or are breast-feeding.
• if yo ur doctor has decided that you should take this medicine during late pregnancy or during labour, your baby may have a low body temperature, floppiness (hypotonia) and breathing or feeding difficulties.
• if this medicine is taken regularly in late pregnancy, your baby may develop withdrawal symptoms.
Driving and using machines
Temazepam may make you feel drowsy or affect your concentration, vision, memory or muscle function.
This feeling may persist the next day or be even worse when you sleep for less than 7 to 8 hours after taking your medication. This medicine can affect your ability to drive as it may make you sleepy or dizzy.
• Do not drive while taking this medicine until you know how it affects you.
• It is an offence to drive if this medicine affects your ability to drive.
• However, you would not be committing an offence if:
- The medicine has been prescribed to treat a medical or dental problem and
- You have taken it according to the instructions given by the prescriber or in the information (
provided with the medicine and
- It was not affecting your ability to drive safely
Talk to your doctor or pharmacist if you are not sure whether it is safe for you to drive while taking this medicine. Temazepam Oral Solution contains liquid sorbitol and ethanol:
• liquid sorbitol (a type of sugar). If your doctor has told you that you cannot tolerate some sugars, talk to your doctor before taking this medicine.
• ethanol (alcohol). Each 5ml spoonful contains 10%v/v ethanol which is equal to 10ml of beer or 4ml of wine. Speak to your doctor before taking this medicine if you have an addiction to alcohol, liver disease, epilepsy, brain injury or disease, you are pregnant or if this medicine has been prescribed for a child.
am Oral Solution
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
Taking this medicine
• this medicine contains 10mg of temazepam in each 5ml
• take this medicine by mouth
• long term use of this medicine is not recommended.
Adults
For sleepin g problems:
• the usua l dose is 5ml to 20ml each day before going to bed
• this should only be taken for up to 4 weeks at a time _
• your doctor may advise you to take this only when necessary. continued overleaf (Z)
PAGE 9 52mm x 97mm
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PAGE 11 52mm x 95mm
PAGE 12 52mm x 95mm
PAGE 13 52mm x 96mm
PAGE 14 52mm x 95mm
POM CD
Rosemont*
|
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% | |
|
'// |
ZZ |
BASE PAGE 52mm x 144mm
As a pre-medication:
• the usual dose is 10 to 20ml, half to one hour before your surgery or test
• make sure that you have someone to take you home after the procedure.
Older people and people with disease of the blood vessels
• the usual dose is 2.5ml to 7.5ml
• take this each day before going to bed.
Children and adolescents
For sleeping^ problems:
• this medicine should not be used to help children sleep.
As a pre-medication:
• the usual dose is 0.5ml per kilogram of body weight before surgery or test
• the doctor will work out the correct dose for your child.
If you take more Temazepam Oral Solution than you should
If you take more of this medicine than you should, talk to a doctor or go to your nearest hospital straight away. Do not go unaccompanied to seek medical help. Take the medicine pack with you.
If you take too much the following effects may happen:
• having trouble with your co-ordination or muscle tension
• slurred speech
• feeling confused
• feeling tired, light-headed and possibly fainting (all due to low blood pressure)
|
?/, |
% | |
|
YZ. |
ZZ |
• breathing problems
• falling into a coma.
If you forget to take Temazepam Oral Solution
• if you forget a dose, take it as soon as you remember it. However, if it is nearly time for the next dose, skip the missed dose
• do not take a double dose (two doses at the same time) to make up for a forgotten dose.
If you stop taking Temazepam Oral Solution
Do not stop taking this medicine unless your doctor tells you to. Do not stop it abruptly.
If the medicine is stopped quickly, the following effects may happen:
• feeling nervous, irritable, confused, being unable to sleep, finding it hard to concentrate
• feeling depressed, loss of appetite, having a headache, ringing in your ears (tinnitus), feeling dizzy, feeling detached from yourself or your surroundings (toxic psychosis)
• tingling hands or feet, sweating, being more sensitive to light, noise or touch than usual, fits and shaking, heart or blood pressure disturbances
• feeling or being sick, stomach cramps and diarrhoea.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them. Stop taking this medicine and see a doctor straight away if you have any of the following:
®
• an allergic reaction.
The signs of an allergic reaction may include:
• swelling of your face, lips, tongue or throat or difficulty breathing or swallowing
• severe itching of your skin with raised lumps.
• A rare reaction that affects behaviour (affects more than 1 in 10,000 people)
The signs of this may include:
• feeling depressed and suicidal
• feeling excited, restless, agitated, irritable and confused
• aggressive outbursts or rages
• nightmares
• hallucinations (seeing or hearing things that are not there)
• delusions (thinking things are true that are not really true)
• feeling detached from yourself or your surroundings (psychosis)
• inappropriate behaviour
• sleepwalking (mainly in the elderly patients).
Tell your doctor if you get any of these side effects:
Common (affects more than 1 in 100 people):
• feeling drowsy, sleepy, extremely tired or unable to sleep
• double vision
• feeling unsteady or dizzy
• feeling less alert to your surroundings
• numbed emotions
• lack of co-ordination or muscle weakness
• slurred speech
• shallow breathing
• memory loss
• light headedness
• confusion
• fatigue.
These side effects are more likely to occur at the start of treatment, if alcohol is taken with this medicine or if you are an older person.
Rare (affects more than 1 in 10,000 people):
• low blood pressure
• stomach upset (indigestion, diarrhoea, constipations)
• change in sexual desire
• headache
• jaundice (yellowing of the skin and whites of the eyes)
• difficulty passing water, reduce urine output
• skin reactions
• sight problems
• hangover
• shaking /*pj\
• feeling dizzy or like you are spinning (vertigo)
• difficulty pronouncing your words, dry mouth or making more saliva than usual
• loss of control of your bladder or bowels (incontinence)
• impaired muscular function
• vivid dreams
• palpitations (abnormal heart beat)
• sedation.
You may have changes to your blood cells. The signs you may notice of this are feeling weak, sore throat, unexplained bruises or bleeding, getting more infections and sores or ulcers in your mouth.
You may develop tolerance to the effects of temazepam. This means you may notice that your medicine is not working as well to relieve your symptoms. If this happens, speak to your doctor.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store Temazepam Oral Solution
• Keep this medicine out of the sight and reach of children.
• Store between 4°C and 25°C and protect from light.
• Take back to the pharmacy 3 months after you first open it.
• Do not use after the expiry date (month, year) stated on the label and carton. The expiry date refers to the last day of that month.
• If it is out of date or you no longer want it, take it back to the pharmacy.
• Do not use Temazepam Oral Solution if you notice anything wrong with the medicine. Talk to your pharmacist.
• Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
6. Contents of the pack and other information
What Temazepam Oral Solution contains
• The active substance is temazepam. This medicine contains 10mg of temazepam in each 5ml of solution.
• The other ingredients are ethanol, propylene glycol (E1520), peppermint oil, caramel E150, trometamol, citric acid, colour E131, glycerol (E422), sorbitol solution 70% non-crystallising (E420) and purified water.
What Temazepam Oral Solution looks like and contents of the pack
A clear green liquid with an odour of peppermint. It comes in a brown glass bottle holding 300ml of solution.
Marketing Authorisation Holder and Manufacturer
Rosemont Pharmaceuticals Ltd, Yorkdale Industrial Park, Braithwaite Street, Leeds, LS11 9XE, UK.
This leaflet was last revised in 05/2016.
Each 5ml contains 10mg Temazepam.
The product also contains ethanol, propylene glycol (E1520), glycerol (E422) and sorbitol solution (E420).
See leaflet for further information.
Administration:
For oral use. Read the package leaflet before use.
This medicine can make you feel sleepy. Do not drive while taking this medicine until you know how it makes you feel.
See the leaflet inside for more information.
Storage: Store between 4°C and 25°C and protect from light.
Use within 3 months of opening.
Keep out of the sight and reach of children.
Manufactured by the MA Holder.
Rosemont Pharmaceuticals Ltd.,
Leeds LS11 9XE, UK
PL 0427/0089
POM CD
|
77 | |
LXXXX
Tick
applicable
box
O
On
□
>4-
|
Product: |
Temazepam 10mg/5ml Oral Solution | ||
|
Strength: |
10mg/5ml | ||
|
New Item Code: |
SPC Updates | ||
|
Previous Item Code: |
TMG Drug Driving | ||
|
Design Icon: |
CNS |
Sugar-Free: |
YES |
|
Cutter Ref: |
- |
Pack Size |
300ml |
|
Dimensions: |
Base Label: 52x144mm Leaflet Page 1: 52x100mm Right hand opening Core Size: 76.2mm Max dia of reel: 800 labels ✓ Left hand opening | ||
|
Number of Colours: |
3 + Varnish H Black | 7474 | 193 | ||
Date:
24.05.16
Name:
Proof Number:
Page:
New Pharmacode:
Barcode:
FIVE
1 of 3
TBC
5 "016119"! 24099" >
□ Keyline
Braille
Signature:
Date:
Name:
Signature:
Date:
Artwork produced by:
PAGE 1
52mm x 100mm
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First bar
First bar
Pharmacode position
Please ensure a minimum of 6mm quiet zone either side of pharmacodes
Rosemont Pharmaceuticals Ltd. Printed Packaging Origination and Approval
|
Product: |
Temazepam 10mg/5ml Oral Solution | ||
|
Strength: |
10mg/5ml | ||
|
New Item Code: |
SPC Updates | ||
|
Previous Item Code: |
TMG Drug Driving | ||
|
Design Icon: |
CNS |
Sugar-Free: |
YES |
|
Cutter Ref: |
- |
Pack Size |
300ml |
|
Dimensions: |
Base Label: 52x144mm Leaflet Page 1: 52x100mm Right hand opening Core Size: 76.2mm Max dia of reel: 800 labels □ Left hand opening | ||
|
Number of Colours: |
3 + Varnish | Black B 7474 | 193 | ||
Date:
Proof Number:
Page:
New Pharmacode:
Barcode:
24.05.16
FIVE
2 of 3
TBC
5 "016119"124099" >
□ Keyline
Braille
Third Party Approval Required YES [] NO [] applicable
Name:
Signature:
Date:
Authority Approval Supplied
Name:
Signature:
Date:
V—/-
Artwork produced by:
Rasemont4]
► Package
leaflet Information for the user
Temazepam 10mg/5ml Oral Solution
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
What is in this leaflet
1. What Temazepam Oral Solution is and what it is used for
2. What you need to know before you take Temazepam Oral Solution
3. How to take Temazepam Oral Solution
4. Possible side effects
5. How to store Temazepam Oral Solution
6. Contents of the pack and other information
1. What Temazepam Oral Solution is and what it is used for
The name of your medicine is Temazepam Oral Solution. This belongs to a group of medicines called benzodiazepines.
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Each 5ml contains 10mg Temazepam.
The product also contains ethanol, propylene glycol (E1520), glycerol (E422) and sorbitol solution (E420).
See leaflet for further information.
Administration:
For oral use. Read the package leaflet before use.
This medicine can make you feel sleepy. Do not drive while troin7this medicine until you know how it makes you feel. See the leaflet inside for more information.
Storage: Store between 4°c and 25°C anJ prote*t from light. Use within 3 months of opening.
Keep out of the sight and reach of children.
Manufactured by the MA Holder.
Rosemont Pharmaceuticals Ltd.,
Leeds lOLe,UK_ _ • • • _ • _ 8oS
PL 0427/0089 LXXXX
• • •
Temazepam can be used:
• to help you sleep and re-set your sleep patterns when you have been having difficulty sleeping as a medicine that you should take before you have an operation or a test.
2. What you need to know before you take Temazepam Oral Solution
Do not take Temazepam if:
• you are allergic to temazepam, to other benzodiazapines or any other ingredients of this medicine (listed in section 6). The signs of an allergic reaction can include a rash, itching, difficulty breathing or swallowing or swelling of the face, lips, throat or tongue
• you have sudden or severe breathing problems
• you have severe liver problems
• you have 'myasthenia gravis'. The signs of this may be long term tiredness (fatigue) and muscle weakness
• you suffer from a condition where you stop breathing whilst asleep (sleep apnoea)
• you have an eye problem called "glaucoma"
• you have a severe mental health problem called "chronic psychosis" or a "phobic or obsessional state"
• you have anxiety problems with or without depression. Temazepam may cause you to think about killing yourself (suicide) more often
• you are breast-feeding.
Do not take this medicine if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before taking temazepam.
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Warnings and precautions
Talk to your doctor or pharmacist before taking temazepam if:
• you have any long-term kidney or liver problems
• you have or have ever had a history of alcohol or drug abuse (see "Dependence" below)
• you have a personality disorder such as schizophrenia
• you have recently suffered a loss or bereavement as the medicine may affect the way you react and adjust to this
• you are elderly or frail. If you get up at night, take care as there is an increased risk of falling and consequently of hip fractures due to the muscle relaxant effect of temazepam
• you have a history of breathing problems. Whilst taking temazepam your breathing may become less forceful
• you suffer from or have history of depression
• you suffer from muscle weakness
• you are or suspect that you are pregnant.
If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before taking temazepam. Other considerations:
Tolerance - if after a few weeks you notice that temazepam is not working as well as it did when first starting treatment, you should go and see your doctor as an adjustment to your dosage may be required. Dependence - when taking this type of medicine there is a risk of dependence, which increases with dose and length of treatment. There is a greater risk in patients with a history of alcohol or drug abuse. Temazepam can be habit forming. This medicine should only be used for the shortest time possible
Withdrawal - treatment should be gradually withdrawn. Withdrawal symptoms occur with temazepam even when normal doses are given for short periods of time. (See section 3 "If you stop taking Temazepam Oral solution")
Memory loss - may be experienced several hours after taking temazepam. If possible, to reduce the risk allow 7-8 hours of uninterrupted sleep after taking temazepam.
Psychiatric and “paradoxical” reactions - Temazepam can cause behavioural side effects such as restlessness, agitation, irritability, aggressiveness, delusions (false beliefs), rage, nightmares, hallucinations, psychoses, sleepwalking, inappropriate behaviour, increased insomnia and other adverse behavioural effects. Minor surgery - if you have been given temazepam as a sedative prior to minor surgery you should make arrangements to be accompanied home.
Sleep behaviour - complex sleep behaviour-related events such as "sleep driving" (driving while not fully awake with no memory of the event) have been reported in patients taking temazepam. The risk of these behaviours increases when alcohol is consumed. Tell your doctor immediately if you suffer from any sleep behaviour-related events as your medicine may need to be changed.
Other medicines and Temazepam
Tell your doctor or pharmacist if you are taking or have recently taken any other medicines. This includes medicines bought without a prescription, including herbal medicines. This is because Temazepam Oral Solution can affect the way some other medicines work. Also, some medicines can affect the way Temazepam Oral Solution works.
Do not take temazepam in combination with:
• Sodium oxybate, used to treat narcolepsy with cataplexy - sleep disorders with sudden or transient loss of muscle tone. Temazepam increases the effect of Sodium oxybate
Take care when taking temazepam in combination with:
• medicines to treat severe mental illness such as chlorpromazine, olanzapine or schizophrenia such as clozapine
• medicines used for depression or anxiety including amitriptyline, fluoxetine, fluvoxamine and Monoamine Oxidase Inhibitors (MAOIs) such as phenelzine or other tranquillisers
• medicines that calm your emotions or help you sleep such as diazepam and zolpidem
• narcotic painkillers such as codeine and morphine or other painkillers
• lofexidine, used to treat drug problems (dependence)
• disulfiram, used for alcohol problems (alcoholism)
• medicines used to treat epilepsy such as phenytoin, barbiturates, hydantoins, carbamazepine or sodium valproate
• anaesthetics (used during surgery)
• antihistamines used to treat allergies that make you drowsy, such as chlorphenamine
• theophylline, used to treat asthma
• medicines used to treat high blood pressure such as moxonidine or doxazosin
• medicines used to treat HIV infection such as zidovudine and ritonavir
• medicines used to treat Parkinsons disease such as levodopa
• medicines that help the muscles relax in multiple sclerosis or spine injuries such as baclofen or tizanidine
nabilone, used to treat sickness caused by chemotherapy
• cimetidine, used to treat stomach ulcers
• rifampicin, used to treat bacterial infections.
Temazepam Oral Solution with food and drink
Do not drink alcohol whilst taking this medicine. This medicine can make you sleepy and drinking alcohol when you are taking this medicine can make you even more sleepy.
Pregnancy and breast-feeding
• do not take this medicine if you are pregnant, likely to become pregnant or are breast-feeding.
• if yo ur doctor has decided that you should take this medicine during late pregnancy or during labour, your baby may have a low body temperature, floppiness (hypotonia) and breathing or feeding difficulties.
• if this medicine is taken regularly in late pregnancy, your baby may develop withdrawal symptoms.
Driving and using machines
Temazepam may make you feel drowsy or affect your concentration, vision, memory or muscle function.
This feeling may persist the next day or be even worse when you sleep for less than 7 to 8 hours after taking your medication. This medicine can affect your ability to drive as it may make you sleepy or dizzy.
• Do not drive while taking this medicine until you know how it affects you.
• It is an offence to drive if this medicine affects your ability to drive.
• However, you would not be committing an offence if:
- The medicine has been prescribed to treat a medical or dental problem and
- You have taken it according to the instructions given by the prescriber or in the information (
provided with the medicine and
- It was not affecting your ability to drive safely
Talk to your doctor or pharmacist if you are not sure whether it is safe for you to drive while taking this medicine. Temazepam Oral Solution contains liquid sorbitol and ethanol:
• liquid sorbitol (a type of sugar). If your doctor has told you that you cannot tolerate some sugars, talk to your doctor before taking this medicine.
• ethanol (alcohol). Each 5ml spoonful contains 10%v/v ethanol which is equal to 10ml of beer or 4ml of wine. Speak to your doctor before taking this medicine if you have an addiction to alcohol, liver disease, epilepsy, brain injury or disease, you are pregnant or if this medicine has been prescribed for a child.
am Oral Solution
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
Taking this medicine
• this medicine contains 10mg of temazepam in each 5ml
• take this medicine by mouth
• long term use of this medicine is not recommended.
Adults
For sleepin g problems:
• the usua l dose is 5ml to 20ml each day before going to bed
• this should only be taken for up to 4 weeks at a time _
• your doctor may advise you to take this only when necessary. continued overleaf (Z)
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As a pre-medication:
• the usual dose is 10 to 20ml, half to one hour before your surgery or test
• make sure that you have someone to take you home after the procedure.
Older people and people with disease of the blood vessels
• the usual dose is 2.5ml to 7.5ml
• take this each day before going to bed.
Children and adolescents
For sleeping^ problems:
• this medicine should not be used to help children sleep.
As a pre-medication:
• the usual dose is 0.5ml per kilogram of body weight before surgery or test
• the doctor will work out the correct dose for your child.
If you take more Temazepam Oral Solution than you should
If you take more of this medicine than you should, talk to a doctor or go to your nearest hospital straight away. Do not go unaccompanied to seek medical help. Take the medicine pack with you.
If you take too much the following effects may happen:
• having trouble with your co-ordination or muscle tension
• slurred speech
• feeling confused
• feeling tired, light-headed and possibly fainting (all due to low blood pressure)
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• breathing problems
• falling into a coma.
Oral Solution
If you forget to take Tem
• if you forget a dose, take it as soon as you remember it. However, if it is nearly time for the next dose, skip the missed dose
• do not take a double dose (two doses at the same time) to make up for a forgotten dose.
If you stop taking Temazepam Oral Solution
Do not stop taking this medicine unless your doctor tells you to. Do not stop it abruptly.
If the medicine is stopped quickly, the following effects may happen:
• feeling nervous, irritable, confused, being unable to sleep, finding it hard to concentrate
• feeling depressed, loss of appetite, having a headache, ringing in your ears (tinnitus), feeling dizzy, feeling detached from yourself or your surroundings (toxic psychosis)
• tingling hands or feet, sweating, being more sensitive to light, noise or touch than usual, fits and shaking, heart or blood pressure disturbances
• feeling or being sick, stomach cramps and diarrhoea.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them. Stop taking this medicine and see a doctor straight away if you have any of the following:
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• an allergic reaction.
The signs of an allergic reaction may include:
• swelling of your face, lips, tongue or throat or difficulty breathing or swallowing
• severe itching of your skin with raised lumps.
• A rare reaction that affects behaviour (affects more than 1 in 10,000 people)
The signs of this may include:
• feeling depressed and suicidal
• feeling excited, restless, agitated, irritable and confused
• aggressive outbursts or rages
• nightmares
• hallucinations (seeing or hearing things that are not there)
• delusions (thinking things are true that are not really true)
• feeling detached from yourself or your surroundings (psychosis)
• inappropriate behaviour
• sleepwalking (mainly in the elderly patients).
Tell your doctor if you get any of these side effects:
Common (affects more than 1 in 100 people):
• feeling drowsy, sleepy, extremely tired or unable to sleep
• double vision
• feeling unsteady or dizzy
• feeling less alert to your surroundings
• numbed emotions
• lack of co-ordination or muscle weakness
• slurred speech
• shallow breathing
• memory loss
• light headedness
• confusion
• fatigue.
These side effects are more likely to occur at the start of treatment, if alcohol is taken with this medicine or if you are an older person.
Rare (affects more than 1 in 10,000 people):
• low blood pressure
• stomach upset (indigestion, diarrhoea, constipations)
• change in sexual desire
• headache
• jaundice (yellowing of the skin and whites of the eyes)
• difficulty passing water, reduce urine output
• skin reactions
• sight problems
• hangover
• shaking /*pj\
• feeling dizzy or like you are spinning (vertigo)
• difficulty pronouncing your words, dry mouth or making more saliva than usual
• loss of control of your bladder or bowels (incontinence)
• impaired muscular function
• vivid dreams
• palpitations (abnormal heart beat)
• sedation.
You may have changes to your blood cells. The signs you may notice of this are feeling weak, sore throat, unexplained bruises or bleeding, getting more infections and sores or ulcers in your mouth.
You may develop tolerance to the effects of temazepam. This means you may notice that your medicine is not working as well to relieve your symptoms. If this happens, speak to your doctor.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store Temazepam Oral Solution
• Keep this medicine out of the sight and reach of children.
• Store between 4°C and 25°C and protect from light.
• Take back to the pharmacy 3 months after you first open it.
• Do not use after the expiry date (month, year) stated on the label and carton. The expiry date refers to the last day of that month.
• If it is out of date or you no longer want it, take it back to the pharmacy.
• Do not use Temazepam Oral Solution if you notice anything wrong with the medicine. Talk to your pharmacist.
• Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
6. Contents of the pack and other information
What Temazepam Oral Solution contains
• The active substance is temazepam. This medicine contains 10mg of temazepam in each 5ml of solution.
• The other ingredients are ethanol, propylene glycol (E1520), peppermint oil, caramel E150, trometamol, citric acid, colour E131, glycerol (E422), sorbitol solution 70% non-crystallising (E420) and purified water.
What Temazepam Oral Solution looks like and contents of the pack
A clear green liquid with an odour of peppermint. It comes in a brown glass bottle holding 300ml of solution.
Marketing Authorisation Holder and Manufacturer
Rosemont Pharmaceuticals Ltd, Yorkdale Industrial Park, Braithwaite Street, Leeds, LS11 9XE, UK.
This leaflet was last revised in 05/2016.
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Each 5ml contains 10mg Temazepam.
The product also contains ethanol, propylene glycol (E1520), glycerol (E422) and sorbitol solution (E420). See leaflet for further information.
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□
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r\J
Administration:
For oral use. Read the package leaflet before use.
This medicine can make you feel sleepy. Do not drive while taking this medicine until you know how it makes you feel.
See the leaflet inside for more information.
Storage: Store between 4°C and 25°C and protect from light.
Use within 3 months of opening.
Keep out of the sight and reach of children.
Manufactured by the MA Holder.
Rosemont Pharmaceuticals Ltd.,
Leeds LS11 9XE, UK
PL 0427/0089
RosEmanf
LXXXX
Q)
TO
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applicable
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Temazepam 10mg/5ml Oral Solution | ||
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10mg/5ml | ||
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300ml |
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Base Label: 52x144mm Leaflet Page 1: 52x100mm Right hand opening Core Size: 76.2mm Max dia of reel: 800 labels ✓ Left hand opening | ||
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3 + Varnish H Black | 7474 | 193 | ||
Date:
24.05.16
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■ A rare reaction that affects behaviour (affects more than 1 in 10,000 people)
The signs of this may include:
• feeling depressed and suicidal
• feeling excited, restless, agitated, irritable and confused
• aggressive outbursts or rages
• nightmares
• hallucinations (seeing or hearing things that are not there)
• delusions (thinking things are true that are not really true)
• feeling detached from yourself or your surroundings (psychosis)
• inappropriate behaviour
• sleepwalking (mainly in the elderly patients).
Temazepam 10mg/5ml Oral Solution
Tell your doctor if you get any of these side effects: Common (affects more than 1 in 100 people):
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feeling drowsy, sleepy, |
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lack of co-ordination or |
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extremely tired or unable |
muscle weakness | ||
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to sleep |
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slurred speech | |
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double vision |
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shallow breathing |
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feeling unsteady or dizzy |
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memory loss |
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feeling less alert to your |
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light headedness |
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surroundings |
■ |
confusion | |
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numbed emotions |
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fatigue. |
These side effects are more likely to occur at the start of treatment, if alcohol is taken with this medicine or if you are an older person.
Rare (affects more than 1 in 10,000 people):
■ low blood pressure
■ stomach upset (indigestion, diarrhoea, constipations)
■ change in sexual desire
■ headache
■ jaundice (yellowing of the skin and whites of the eyes)
■ difficulty passing water, reduce urine output
■ skin reactions
■ sight problems
■ hangover
■ shaking
■ feeling dizzy or like you are spinning (vertigo)
■ difficulty pronouncing your words, dry mouth or making more saliva than usual
■ loss of control of your bladder or bowels (incontinence)
■ impaired muscular function
■ vivid dreams
■ palpitations (abnormal heart beat)
■ sedation.
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
■ Keep this leaflet. You may need to read it again.
■ If you have any further questions, ask your doctor or pharmacist.
■ This medicine has been prescribed for you only. Do not
|
pass it on to others. It may harm them, even if their signs | ||
|
DUMMY |
of illness are the same as yours. |
DUMMY |