Temazepam Oral Solution
PACKAGE LEAFLET: INFORMATION FOR THE USER
Temazepam Oral Solution BP
• Read all of this leaflet carefully before you start taking this medicine.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or your pharmacist.
• This medicine has been prescribed only for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
In this leaflet:
1. What is Temazepam Oral Solution and what is it used or?
2. 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. Further information
1. What is Temazepam Oral Solution and what is it used for?
Temazepam belongs to a group of medicines known as Hypnotics. These are medicines which are used to help sleep. It may also be used in a hospital as pre-medication before minor surgery or other procedures.
2. Before you take Temazepam Oral Solution
Do not take Temazepam Oral Solution and tell your doctor if:
• You have a severe respiratory ailment
• You have ever had an unusual reaction to benzodiazepines (e.g. Diazepam, Temazepam) or to any of the ingredients listed in section 6 ‘Further information’
• You have liver problems
• You have been told that you have a condition where you tend to stop breathing temporarily while you are asleep (sleep apnoea)
• You have long term fatigue and muscle weakness
• You have any long term mental illness such as obsessions or phobias (irrational fears)
• You suffer from anxiety with or without depression, as temazepam may cause you to think about suicide
• You suffer from glaucoma.
This medicine should not be given to children under 18.
Before you take temazepam tell your doctor if:
• You have a personality disorder (e.g. schizophrenia)
• You have an addiction to alcohol or drugs
• You have kidney problems
• You have recently suffered a loss or bereavement as the medicine may affect the way you react to this.
Taking other medicines
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.
In particular tell your doctor if you are taking any of the following medicines:
• Narcotic painkillers (e.g. codeine, morphine)
• Anti-depressants
• Medicines to treat epilepsy
• Medicines that help you relax and sleep
• Anti-histamines (used to treat allergy) that cause drowsiness
• Monoamine oxidase inhibitors (used to treat depression such as phenelzine)
• Medicines to treat viral infections (including HIV, for example, ritonavir or zidovudine)
• Medicines to treat high blood pressure (for example, moxonidine)
• Disulfiram (used to treat alcoholism)
• Lofexidine (used to treat drug dependence)
• Nabilone (used to treat nausea and vomiting)
• Medicines to treat mental illness (for example, clozapine)
• Medicines that help you sleep
• Medicines that relax your muscles (for example, baclofen or tizanidine)
• Medicines used to treat Parkinson’s disease (for example, levodopa).
If you are having a general anaesthetic you should tell the doctor that you are taking temazepam.
If you are to receive this medicine as a pre-medication before surgery or investigative procedures, you should ensure that someone is with you to accompany you home.
At high doses taken for a long period of time, it is possible that you may become dependent on the medication. If this occurs you might experience withdrawal symptoms if the treatment stops too suddenly. If this is the case your doctor will advise you to cut down gradually.
You may develop tolerance to the effects of temazepam, this means you may notice that your medicine is less effective at relieving your symptoms.
If you take Temazepam for a long period of time, it may cause blood disorders and affect your liver. Your doctor may want to perform tests on your blood and liver function.
Taking Temazepam with food and drink
You should not drink alcohol while taking Temazepam. This is because alcohol can change the way Temazepam works.
Pregnancy and breast-feeding
Do not take this medicine if you are pregnant, might become pregnant or are breast-feeding.
If your doctor has decided that you should receive this medicine during late pregnancy or during labour, your baby might have a low body temperature, floppiness and breathing and feeding difficulties. If this medicine is taken regularly in late pregnancy, your baby may develop withdrawal symptoms.
Driving and using machines
Temazepam can cause side effects such as sleepiness, dizziness, confusion, reduced alertness, poor muscle coordination and blurring of vision. If you do get any of these side effects do not drive or use machinery.
The 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:
o The medicine has been prescribed to treat a medical or dental problem and o You have taken it according to the instructions given by the prescriber or in the information provided with the medicine and o 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.
Important information about what is in Temazepam Oral Solution
This medicines contains:
• This product contains sorbitol. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
• This product also contains 10% ethanol (alcohol), i.e. up to 440mg per dose, equivalent to 10ml of beer, 4ml of wine per dose. Speak to your doctor before taking this medicine if you have an addiction to alcohol, liver disease, epilepsy, you are pregnant or breast-feeding.
3. How to take Temazepam Oral Solution
Take this medicine as your doctor or pharmacist has told you. Look on the label and ask the 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.
The usual doses are given below. These may be changed by your doctor.
Adults
Insomnia
• 5 - 20ml before going to bed.
Pre-medication
• 10 - 15ml half an hour to one hour before surgery or other procedures.
Elderly or patients with disease of the blood vessels i.e. hardening of the arteries
• 5 - 10ml.
The medicine should only be taken for a maximum of 4 weeks at a time.
Your doctor may advise you to take this medicine only when necessary.
If you take more Temazepam Oral Solution than you should
Talk to your doctor or go to your nearest hospital straight away. Common symptoms of Temazepam overdose are drowsiness, loss of coordination of movement, confusion and slurred speech. Occasionally low blood pressure (symptoms such as tiredness, light-headedness and fainting), breathing problems and coma may occur.
If you forget to take Temazepam Oral Solution
Do not take a double dose (two doses at the same time) to make up for the forgotten dose. Wait until the next dose is due and then take only that dose.
If you stop taking Temazepam Oral Solution
You should only stop taking this medicine when the doctor tells you. Do not stop it abruptly. If the medicine is stopped quickly the following symptoms may occur: nervousness, sleeplessness, depression, irritability, sweating, shaking, vomiting, confusion, psychosis, fits, headaches, muscle pain, restlessness, anxiety, tension, tingling in the hands or feet, hallucinations, an increased sensitivity to light, noise or physical contact, feeling detached from yourself or your surroundings.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. Possible side effects
Along with its wanted effects, a medicine can cause some side effects. The following have been reported with Temazepam:
If you have any of the following side effects, contact your doctor immediately or go to hospital straight away and stop taking this medicine.
• Thoughts of suicide or other behavioural side effects that may include aggressive outbursts, excitement, confusion, depression, restlessness, agitation, irritability, hallucinations, delusions, mental disorders or inappropriate behaviour.
• Severe allergic reactions that may include a red and lumpy skin rash, difficulty breathing, swelling of the face, mouth, lips and eyelids. If the swelling affects your throat and makes breathing and swallowing difficult, go to hospital straight away.
• Jaundice which may include yellowing of the skin or whites of the eyes.
Common side effects are drowsiness, sleepiness, blurring of vision, unsteadiness, numbed emotions, reduced alertness, dizziness, muscle weakness, slurred speech, difficulty in breathing, poor muscle coordination and fatigue. These side effects are more likely to occur if alcohol is taken with this medicine or if you are elderly.
Rarely the following side effects may occur: mental disorders, dry mouth, restless sleep, nightmares, increase in saliva, finding it hard to speak, incontinence and unusual shaking. In such cases your doctor will stop or change your treatment.
Other side effects that may occur are low blood pressure, stomach upsets, changes in vision, skin rashes, headache, difficulty in passing urine, a feeling of dizziness or “spinning” and changes in sexual desire. Loss of memory may occur and in cases of loss or bereavement there may be a difficulty in adjusting psychologically, whilst taking this medicine.
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 via 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 out of the reach and sight of children.
• The product should be stored at or below 25°C and protected from light.
• The label on the bottle contains an expiry date (month, year). Do not use this product after that date.
• 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 something wrong with the medicine. Talk to your pharmacist.
• Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
6. Further information
What Temazepam Oral Solution contains
• The active substance is Temazepam.
• The other ingredients are povidone 25, polyethylene glycol 400, ethanol, glycerol, sodium phosphate, anhydrous citric acid, chlorophyll, sorbitol solution 70%, peppermint oil, lemon flavour and purified water.
What Temazepam Oral Solution looks like and contents of the pack
Temazepam Oral Solution is a clear green lemon and mint flavoured liquid.
It comes in a brown glass bottle holding 300ml of solution.
Marketing Authorisation Holder
Focus Pharmaceuticals Limited, Capital House, 85 King William Street, London EC4N 7BL, UK.
Tel: 01283 495 280 Fax: 01283 495 290 Email: medinfo@focuspharmaceuticals.co.uk
Manufacturer
Penn Pharmaceutical Services Ltd, Tredegar, Gwent, NP22 3AA.
For any information about this medicinal product, please contact the Marketing Authorisation Holder, details provided above.