Zopiclone 7.5mg Tablets
APPROVED
By austino at 2:37 pm, 10/22/07
Assessed against UK PIL dated April 2006 Final Draft Mock up
Zimovane™ 7.5mg Tablets
(zopiclone)
Patient Information Leaflet
Your medicine is called Zimovane 7.5mg Tablets but will be referred to as Zimovane throughout this leaflet.
Please read this leaflet carefully BEFORE you start to take Zimovane.
This leaflet is a summary of the important information about your medicine. Keep it in a safe place, you may want to refer to it again. If you have any questions or are not sure about anything to do with your treatment, ask your doctor or pharmacist for more information.
WHAT IS IN ZIMOVANE?
Each film-coated tablet contains 7.5mg of the active ingredient zopiclone. Your tablets contain the following ingredients: Lactose, calcium hydrogen phosphate, maize starch, sodium starch glycollate, magnesium stearate, hypromellose and titanium dioxide (E 171).
Zimovane are white, elliptical film-coated tablets with a score line on one side and plain on the reverse.
Zimovane are available in blister pack of 30 tablets.
Zimovane is one of a group of medicines called hypnotics. It should help you to sleep, without leaving you feeling drowsy the next day.
Manufactured by: Aventis Pharma S.A., Alcorcon, Spain Procured from within the EU and repackaged by: Doncaster Pharmaceuticals Group Ltd, Kirk Sandall, Doncaster, DN3 1QR.
Product Licence holder: BR Lewis Pharmaceuticals Ltd, Kirk Sandall, Doncaster, DN3 1QR.
|POM| PL No: 08929/0450
WHY HAVE YOU BEEN PRESCRIBED ZIMOVANE?
These tablets are normally used for the short term treatment of severe sleeping difficulties.
If you need any further information on your condition, please ask your doctor.
BEFORE TAKING YOUR MEDICINE
Tell your doctor or pharmacist if any of the following apply:
• If you are sensitive to or allergic to zopiclone or any of the inactive ingredients
• If you suffer from myasthenia gravis (a condition where the muscles easily tire and become weak)
• If you have any breathing problems, especially during sleep
• If you have any liver or kidney problems
• If you are pregnant or, think you might be pregnant
• If the patient is under 12 years of age
• If you are breast feeding
• If you have a personality disorder
• If you have ever been treated for drug or alcohol abuse
• If you are taking any other medicines. Some medicines may change the way these tablets work e.g. any other treatment to help you sleep, any treatment for schizophrenia and psychotic disorders, any other treatment for anxiety or depression, any treatment for epilepsy, any strong pain killers such as codeine, morphine, or diamorphine, sedative antihistamines (to treat skin allergies, skin irritation or vomiting) or erythromycin (an antibiotic to treat infections) and itraconazole (for treating fungal infections).
If you have to go to a doctor, dentist or hospital for any reason, tell them that you are taking Zimovane.
SPECIAL WARNINGS
Important information about some of the ingredients of Zimovane:
• If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
• Alcohol can affect the way Zimovane works, you should not drink alcohol whilst taking these tablets.
• You should not drive if you drink alcohol whilst taking Zimovane.
• Rarely the tablets may cause daytime drowsiness. You should not drive or operate machinery unless you are sure that you are not affected.
• Do not break the tablets.
• If you are taking any medicines belonging to the hypnotic group there is a possibility that you may become dependant upon them.
However, with Zimovane this possibility is small.
• If your doctor has prescribed Zimovane during the later stages of pregnancy, then there may be some effects on the baby when it is born. Tell your doctor or midwife that you have taken Zimovane.
When you stop taking Zimovane you may experience symptoms such as anxiety, sweating, shaking, palpitations, nightmares, muscle cramps, stomach upsets and difficulty sleeping. This is more likely to happen if you stop taking Zimovane after you have taken it for a long time.
HOW TO TAKE YOUR MEDICINE
Your doctor will have told you how much to take. The number or tablets you need to take will depend on your condition. The usual adult dosage is one Zimovane. Your treatment will usually be for less than four weeks, and the doctor may reduce your dose near the end of your course.
The tablets should be swallowed whole with a glass of water shortly before retiring. These tablets are not recommended for children.
WHAT IF YOU FORGET TO TAKE YOUR MEDICINE?
Do not worry, just take your next tablet at the usual time, then go on as before. Do not try and catch up on the doses you have missed.
WHAT IF YOU OR A CHILD TAKES TOO MUCH?
If you accidentally take too many or a child swallows any tablets, contact your nearest hospital casualty department or tell your doctor immediately.
DOES ZIMOVANE HAVE SIDE EFFECTS?
As well as benefits, all medicines may occasionally have unwanted effects in some patients. These are called side effects.
Minor side effects of Zimovane that are well known are mild bitter or metallic taste in the mouth, stomach discomfort, nausea or vomiting, dizziness, headache, drowsiness, dry mouth, light-headedness, and loss of co-ordination.
You do not need to worry about them unless they become troublesome - in which case, you should contact your doctor.
Some side effects may be more serious and you should tell your doctor immediately if you have any of the following
• Difficulty in breathing
• Mood changes such as irritability or aggressiveness
• Confusion
• Depression
• Loss of memory
• Hallucinations or nightmares
• Skin rashes, with or without itching
• Swelling of the lips, face and neck.
Very rarely there may also be an increase in liver enzymes in your blood. Do not be alarmed by this list of possible events. Most people take Zimovane without any problems.
All medicines may have unwanted effects which are not mentioned in the product leaflet. If you notice any other changes in your health whilst taking this medicine, tell your doctor immediately.
EXPIRY DATE
You must not take these tablets after the expiry date. This is given in two places:
• on the carton
• on the blisters
In both places it is given as ‘EXP’ followed by the month and year. The tablets should not be used after the end of that month. If you are not sure when this is, check with your doctor or pharmacist.
STORAGE OF YOUR ZIMOVANE
• Do not store above 30°C.
• Store in a dry place.
• Protect from sunlight.
• Keep out of the reach and sight of children.
• Do not keep the tablets if your doctor decides to stop treatment.
• Return them to your pharmacist who will arrange for their safe
• destruction.
• If your tablets are out of date, take them to your pharmacist who will get rid of them safely.
• If your tablets become discoloured or show any sign of deterioration, take them back to your pharmacist who will tell you what to.
REMEMBER: These tablets are for you. Only a doctor may prescribe them for you. Never give your tablets to other people. They may harm other people
even if their symptoms appear to be the same as yours.
Leaflet revision and issue date: 22.10.07 Zimovane™ is a trademark of May & Baker Ltd.
Assessed against UK PIL dated April 2006
Final Draft Mock lip
Zopiclone 7.5mg Tablets
(zopiclone)
Patient Information Leaflet
Please read this leaflet carefully BEFORE you start to take Zopiclone 7.5mg Tablets.
This leaflet is a summary of the important information about your medicine. Keep it in a safe place, you may want to refer to it again. If you have any questions or are not sure about anything to do with your treatment, ask your doctor or pharmacist for more information.
WHAT IS IN ZOPICLONE 7.5MG TABLETS?
Each film-coated tablet contains 7.5mg of the active ingredient zopiclone. Your tablets contain the following ingredients: Lactose, calcium hydrogen phosphate, maize starch, sodium starch glycollate, magnesium stearate, hypromellose and titanium dioxide (E 171).
Zopiclone 7.5mg Tablets are white, elliptical film-coated tablets with a score line on one side and plain on the reverse.
Zopiclone 7.5mg Tablets are available in blister packs containing 30 tablets.
Zopiclone 7.5mg Tablets is one of a group of medicines called hypnotics. It should help you to sleep, without leaving you feeling drowsy the next day.
Manufactured by: Aventis Pharma S.A., Alcorcon, Spain Procured from within the EU and repackaged by: Doncaster Pharmaceuticals Group Ltd, Kirk Sandall, Doncaster, DN3 1QR.
Product Licence holder: BR Lewis Pharmaceuticals Ltd, Kirk Sandall, Doncaster, DN3 1QR.
|POM| PL No: 08929/0450
WHY HAVE YOU BEEN PRESCRIBED ZOPICLONE 7.5MG TABLETS?
These tablets are normally used for the short term treatment of severe sleeping difficulties.
If you need any further information on your condition, please ask your doctor.
BEFORE TAKING YOUR MEDICINE
Tell your doctor or pharmacist if any of the following apply:
• If you are sensitive to or allergic to zopiclone or any of the inactive
• ingredients
• If you suffer from myasthenia gravis (a condition where the
• muscles easily tire and become weak)
• If you have any breathing problems, especially during sleep
• If you have any liver or kidney problems
• If you are pregnant or, think you might be pregnant
• If the patient is under 12 years of age
• If you are breast feeding
• If you have a personality disorder
• If you have ever been treated for drug or alcohol abuse
• If you are taking any other medicines. Some medicines may change the way these tablets work e.g. any other treatment to help you sleep, any treatment for schizophrenia and psychotic disorders, any other treatment for anxiety or depression, any treatment for epilepsy, any strong pain killers such as codeine, morphine, or diamorphine, sedative antihistamines (to treat skin allergies, skin irritation or vomiting) or erythromycin (an antibiotic to treat infections) and itraconazole (for treating fungal infections).
If you have to go to a doctor, dentist or hospital for any reason, tell them that you are taking Zopiclone 7.5mg Tablets.
SPECIAL WARNINGS
Important information about some of the ingredients of Zopiclone 7.5mg Tablets:
• If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
• Alcohol can affect the way Zopiclone 7.5mg Tablets work, you should not drink alcohol whilst taking these tablets.
• You should not drive if you drink alcohol whilst taking Zopiclone 7.5mg Tablets.
• Rarely the tablets may cause daytime drowsiness. You should not drive or operate machinery unless you are sure that you are not affected.
• Do not break the tablets.
• If you are taking any medicines belonging to the hypnotic group there is a possibility that you may become dependant upon them.
However, with Zopiclone 7.5mg Tablets this possibility is small.
• If your doctor has prescribed Zopiclone 7.5mg Tablets during the later stages of pregnancy, then there may be some effects on the baby when it is born. Tell your doctor or midwife that you have taken Zopiclone 7.5mg Tablets. When you stop taking Zopiclone 7.5mg Tablets you may experience symptoms such as anxiety, sweating, shaking, palpitations, nightmares, muscle cramps, stomach upsets and difficulty sleeping. This is more likely to happen if you stop taking Zopiclone 7.5mg Tablets after you have taken it for a long time.
HOW TO TAKE YOUR MEDICINE
Your doctor will have told you how much to take. The number or tablets you need to take will depend on your condition. The usual adult dosage is one Zopiclone 7.5mg Tablet. Your treatment will usually be for less than four weeks, and the doctor may reduce your dose near the end of your course.
The tablets should be swallowed whole with a glass of water shortly before retiring. These tablets are not recommended for children.
WHAT IF YOU FORGET TO TAKE YOUR MEDICINE?
Do not worry, just take your next tablet at the usual time, then go on as before. Do not try and catch up on the doses you have missed.
WHAT IF YOU OR A CHILD TAKES TOO MUCH?
If you accidentally take too many or a child swallows any tablets, contact your nearest hospital casualty department or tell your doctor immediately.
DO ZOPICLONE 7.5MG TABLETS HAVE SIDE EFFECTS?
As well as benefits, all medicines may occasionally have unwanted effects in some patients. These are called side effects.
Minor side effects of Zopiclone 7.5mg Tablets that are well known are mild bitter or metallic taste in the mouth, stomach discomfort, nausea or vomiting, dizziness, headache, drowsiness, dry mouth, light-headedness, and loss of co-ordination.
You do not need to worry about them unless they become troublesome - in which case, you should contact your doctor.
Some side effects may be more serious and you should tell your doctor immediately if you have any of the following
• Difficulty in breathing
• Mood changes such as irritability or aggressiveness
• Confusion
• Depression
• Loss of memory
• Hallucinations or nightmares
• Skin rashes, with or without itching
• Swelling of the lips, face and neck.
Very rarely there may also be an increase in liver enzymes in your blood. Do not be alarmed by this list of possible events. Most people take Zopiclone 7.5mg Tablets without any problems.
All medicines may have unwanted effects which are not mentioned in the product leaflet. If you notice any other changes in your health whilst taking this medicine, tell your doctor immediately.
EXPIRY DATE
You must not take these tablets after the expiry date. This is given in two places:
• on the carton
• on the blister
In both places it is given as ‘EXP’ followed by the month and year. The tablets should not be used after the end of that month. If you are not sure when this is, check with your doctor or pharmacist.
STORAGE OF YOUR ZOPICLONE 7.5MG TABLETS
• Do not store above 30°C.
• Store in a dry place.
• Protect from sunlight.
• Keep out of the reach and sight of children.
• Do not keep the tablets if your doctor decides to stop treatment.
• Return them to your pharmacist who will arrange for their safe destruction.
• If your tablets are out of date, take them to your pharmacist who will get rid of them safely.
• If your tablets become discoloured or show any sign of deterioration, take them back to your pharmacist who will tell you what to.
REMEMBER: These tablets are for you. Only a doctor may prescribe them for you. Never give your tablets to other people. They may harm other people
even if their symptoms appear to be the same as yours.
Leaflet revision and issue date: 22.10.07