Loprazolam 1mg Tablets
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LOPRAZOLAM 1mg Tablets (loprazolam mesilate)
Patient Information Leaflet
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 pharmacist.
This medicine has been prescribed 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 gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Your doctor may have given you this medicine before from another company. It may have looked slightly different. However, either brand will have the same effect.
In this leaflet:
1. What loprazolam is and what it is used for
2. Before you take loprazolam
3. How to take loprazolam
4. Possible side effects
5. How to store loprazolam
6. Further information
1. What Loprazolam is and what it is used for
The name of your medicine is Loprazolam 1mg Tablets (called loprazolam throughout this leaflet). Loprazolam contains a medicine called loprazolam mesilate.
This belongs to a group of medicines called hypnotics.
It works by acting on your brain to help you sleep.
Loprazolam is used to treat sleep problems such as:
• Difficulty falling asleep
• Waking often during the night
Loprazolam is used for short term sleep problems.
Loprazolam is not meant to be used every day for long periods of time. Ask your doctor for advice if you are unsure.
2. Before you take Loprazolam Do not take this medicine and tell your doctor if:
• You are allergic (hypersensitive) to loprazolam mesilate or any of the other ingredients of this medicine (listed in Section 6 overleaf)
Signs of an allergic reaction include: a rash, swallowing or breathing problems, swelling of your lips, face, throat or tongue
• You are allergic (hypersensitive) to other benzodiazepines such as nitrazepam or temazepam
• You have a problem that causes severe muscle weakness (myasthenia gravis)
• Your lungs do not work properly
• You have heart problems
• You suffer from depression, anxiety or mental problems including phobias and obsessive disorders
• You have ever been addicted to alcohol
• You have a problem where you stop breathing for short periods at night (sleep apnoea)
Do not take this medicine if any of the above applies to you. If you are not sure, talk to your doctor or pharmacist before taking loprazolam.
Take special care and check with your doctor or pharmacist before taking loprazolam if:
• You have any liver problems
• You have any kidney problems
• You have a history of drug abuse
• You have been told by your doctor that you have had or are likely to have a stroke
• You have been told by a doctor that you have a personality disorder
• You have recently taken loprazolam or other similar medicines for more than four weeks
• You do not feel you will ever be able to stop taking loprazolam or other medicines used to treat sleep problems
If you are not sure if any of the above applies to you, talk to your doctor or pharmacist before taking loprazolam.
Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines. This includes medicines you buy without a prescription, including herbal medicines. This is because loprazolam can affect the way some other medicines work. Also some medicines can affect the way loprazolam works.
Tell your doctor if you are taking any of the following:
• Medicines to treat stomach problems such as cisapride
• Medicines which relax muscles (neuromuscular depressants). These are often used during operations or in Intensive Care Units.
• Medicines for mental problems (antipsychotics)
• Medicines for depression
• Medicines for epilepsy (anticonvulsants)
• Medicines used in surgery (anaesthetics)
• Medicines to calm or reduce anxiety or for sleep problems (hypnotics)
• Medicines for hay fever, rashes or other allergies that can make you sleepy (sedative antihistamines) such as chlorphenamine or promethazine
• Some medicines for moderate to severe pain (narcotic analgesics) such as codeine, methadone, morphine, oxycodone, pethidine or tramadol
Taking loprazolam with food and drink
• Do not drink alcohol while you are taking loprazolam.
• Alcohol can increase the effects of loprazolam and make you sleep very deeply so that you do not breathe properly or have difficulty waking.
Pregnancy and breast-feeding
• Talk to your doctor before taking this medicine if you are pregnant, might become pregnant, or think you may be pregnant.
• Do not take loprazolam if you are in the last 3 months of pregnancy or during labour because it may be harmful to your baby. However, in some cases your doctor may feel it is absolutely necessary for you to take this medicine during this time. Taking it during this time means your baby may be born with breathing difficulties, limp or weak muscles, a low body temperature (hypothermia) and may have withdrawal symptoms.
• Do not take loprazolam if you are breast-feeding or planning to breast-feed. This is because small amounts may pass into mother's milk.
Ask your doctor or pharmacist for advice before taking any medicine if you are pregnant or breast-feeding. Driving and using machines
This medicine may cause drowsiness, lack of concentration, muscle weakness and memory loss. If this happens do not drive or use any tools or machines.
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:
• 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.
Important information about some of the ingredients of loprazolam
Lactose: This is a type of sugar. If you have been told by your doctor that you cannot tolerate some sugars, talk to your doctor before having this medicine.
3. How to take Loprazolam
Always take loprazolam exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.
Taking this medicine
• Swallow the tablet whole with a drink of water
• Take just before bedtime
• You should not normally take loprazolam for more than 4 weeks.
Adults
The usual dose is one tablet (1mg)just before bedtime.
This dose may be increased by your doctor to one and a half tablets or 2 tablets (2mg).
Elderly or frail people
The starting dose is half a 1 mg tablet just before bedtime. This dose may be increased by your doctor to one whole tablet.
Children
Do not give this medicine to children.
If you take more loprazolam than you should
If you take more loprazolam than you should, tell a doctor or go to a hospital casualty department straight away. Take the medicine pack with you. This is so the doctor knows what you have taken.
If you forget to take loprazolam
Loprazolam must only be taken at bedtime. If you forget to take your tablet at bedtime, then you should not take it at any other time, otherwise you may feel drowsy, dizzy and confused during the day.
Do not take a double dose to make up for a forgotten tablet.
If you stop taking loprazolam
Keep taking loprazolam until your doctor tells you to stop.
Do not stop taking loprazolam suddenly, but tell your doctor if you want to stop. Your doctor will need to lower your dose and stop your tablets over a period of time.
If you stop taking loprazolam suddenly, your sleep problems may come back and you may get a ‘withdrawal effect'. If this happens you may get some of the effects listed below.
See a doctor straight away if you get any of the following effects:
• Feeling anxious, irritable, confused or restless
• Changes in your behaviour
• Depression (low mood)
• Sleep problems
• Headaches
4. Possible side effects
Like all medicines, loprazolam can cause side effects, although not everybody gets them.
Stop taking loprazolam and see a doctor or go to a hospital straight away if:
• You get swelling of the hands, feet, ankles, face, lips or throat which may cause difficulty in swallowing or breathing. You could also notice an itchy, lumpy rash (hives) or nettle rash (urticaria). This may mean you are having an allergic reaction to loprazolam tablets.
Tell your doctor straightaway if you have any of the following side effects:
• Poor memory since taking loprazolam (amnesia)
• Thoughts of harming or killing yourself, depression (low mood)
• Limp or weak muscles
• Behavioural changes. This might include angry outbursts or feeling very excited
• Liver problems that may cause the eyes or skin to go yellow (jaundice)
Tell your doctor or pharmacist if any of the following side effects get serious or lasts longer than a few days:
• Skin rash
• Difficulty passing water (urine)
• Feeling unsteady or clumsy
• Feeling sick (nausea), stomach problems
• If you have recently suffered a bereavement you may find it more difficult to cope
• Feeling dizzy, sleepy or confused
• Headache
• Problems with your eyesight such as blurred vision
• Changes in your sex drive
• Feeling dizzy, light headed or faint. These effects are due to low blood pressure
• You get infections or bruise more easily than usual.
This could be because of a blood problem (such as agranulocytosis, neutropenia or thrombocytopenia)
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. 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 Loprazolam
• There are no special storage conditions for Loprazolam 1mg tablets.
• Do not use after the expiry date printed on the carton label or blister strip. The expiry date refers to the last day of that month.
• KEEP ALL MEDICINES OUT OF THE SIGHT AND REACH OF CHILDREN.
• If your doctor tells you to stop taking the tablets, please take them back to the pharmacist for safe disposal. Only keep the tablets if your doctor tells you to.
• If the tablets become discoloured or show any other signs of deterioration, you should consult your pharmacist who will advise you what to do.
• 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
Your medicine is called Loprazolam 1mg tablets. Each tablet contains 1mg of the active ingredient, loprazolam (as the mesilate) in a pale yellow, biconvex tablet with a scoreline on one side, and plain on the reverse.
Loprazolam 1mg tablets also contain the following inactive ingredients:
lactose, magnesium stearate, microcrystalline cellulose, povidone, colloidal silicon dioxide and maize starch.
Loprazolam 1mg tablets are available as blister packs of 30 tablets.
POM
PL No: 6464/2136
This product is manufactured by Teofarma S.r.l., Via F.Iii Cervi 8, 27010 Valle Salimbene (PV) Italy and is procured from within the EU and repackaged by the Product Licence holder:
Waymade plc, Miles Gray Road, Basildon, Essex SS14 3FR
Leaflet revision and issue date (Ref.) 24.02.2014
000-0000D
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