Zopiclone 7.5mg Tablets
Assessed against UK PIL dated April 2006
Assessed against UK PIL dated April 2006
APPROVED
By Nafisa Potrick at 2:37 pm, Jun 26, 2007
Mock up
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.
Patient Information Leaflet
Your medicine is available using the above name, but will be referred to as Zimovane throughout this leaflet.
Please read this leaflet carefully BEFORE you start to take your Zimovane 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 Zimovane tablets?
Each tablet contains 7.5mg of the active ingredient zopiclone.
The other (inactive) ingredients are: lactose monohydrate, calcium hydrogen phosphate, maize starch, sodium starch glycollate, magnesium stearate, hypromellose and titanium dioxide (E171).
This product contains lactose monohydrate. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product
Zimovane tablets are white, elliptical, film-coated tablets, with a scoreline on one side and plain on the reverse. They are available in blister packs containing 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.
Zimovane is manufactured by: Aventis Pharma S.A., Alcorcon, Madrid, 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: 08929/0408
Why have you been prescribed Zimovane 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 painkillers such as codeine, morphine or diamorphine, sedative antihistamines (to treat 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 tablets.
Special Warnings
Important information about some of the ingredients in Zimovane:
• Alcohol can affect the way Zimovane works, you should not drink alcohol while taking these tablets.
• You should not drive if you drink alcohol while 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 dependent on 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
How to take your medicine
Your doctor will have told you how much to take. The number of tablets you need to take will depend on your condition. The usual adult dosage is one Zimovane 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 small 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 tablets or a child swallows any tablets, contact your nearest hospital casualty department or tell your doctor immediately.
Do Zimovane 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 Zimovane 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 coordination
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 - 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 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
Do not use your tablets after the expiry date printed on the carton and blister labels. This 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 tablets
Your tablets should be stored in the pack in which you are given them.
Do not store above 30°C.
Store in a dry place.
Protect from light.
Keep out of the reach and sight of children.
If your doctor decides to stop the treatment, return any tablets left over to the pharmacist. Only keep them if your doctor tells you to.
If your tablets appear to be discoloured or show any other signs of deterioration, please return to your pharmacist who will advise you.
REMEMBER: This medicine has been prescribed for you personally. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
Leaflet revision & issue date (ref): 07.06.07 TM
Zimovane is a trademark of May & Baker.
Mock up
Zopiclone 7.5mg Tablets
Patient Information Leaflet
Your medicine is available using the above name, but will be referred to as Zopiclone throughout this leaflet.
Please read this leaflet carefully BEFORE you start to take your Zopiclone 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 tablets?
Each tablet contains 7.5mg of the active ingredient zopiclone.
The other (inactive) ingredients are: lactose monohydrate, calcium hydrogen phosphate, maize starch, sodium starch glycollate, magnesium stearate, hypromellose and titanium dioxide (E171).
This product contains lactose monohydrate. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product
Zopiclone tablets are white, elliptical, film-coated tablets, with a scoreline on one side and plain on the reverse. They are available in blister packs containing 30 tablets.
Zopiclone is one of a group of medicines called hypnotics. It should help you to sleep, without leaving you feeling drowsy the next day.
Zopiclone is manufactured by: Aventis Pharma S.A., Madrid, 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: 08929/0408
Why have you been prescribed Zopiclone 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 painkillers such as codeine, morphine or diamorphine, sedative antihistamines (to treat 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 tablets.
Special Warnings
Important information about some of the ingredients in Zopiclone:
• Alcohol can affect the way Zopiclone works, you should not drink alcohol while taking these tablets.
• You should not drive if you drink alcohol while taking Zopiclone
• 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 dependent on them. However, with Zopiclone this possibility is small
• If your doctor has prescribed Zopiclone 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
• When you stop taking Zopiclone 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 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 of tablets you need to take will depend on your condition. The usual adult dosage is one Zopiclone 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 small 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 tablets or a child swallows any tablets, contact your nearest hospital casualty department or tell your doctor immediately.
Do Zopiclone 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 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 coordination
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 - 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 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
Do not use your tablets after the expiry date printed on the carton and blister labels. This 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 tablets
Your tablets should be stored in the pack in which you are given them.
Do not store above 30°C.
Store in a dry place.
Protect from light.
Keep out of the reach and sight of children.
If your doctor decides to stop the treatment, return any tablets left over to the pharmacist. Only keep them if your doctor tells you to.
If your tablets appear to be discoloured or show any other signs of deterioration, please return to your pharmacist who will advise you.
REMEMBER: This medicine has been prescribed for you personally. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
Leaflet revision & issue date (ref): 07.06.07
Patient Information Leaflet
Your medicine is available using the above name, but will be referred to as Zimovane throughout this leaflet.
Please read this leaflet carefully BEFORE you start to take your Zimovane 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 Zimovane tablets?
Each tablet contains 7.5mg of the active ingredient zopiclone.
The other (inactive) ingredients are: lactose monohydrate, calcium hydrogen phosphate, maize starch, sodium starch glycollate, magnesium stearate, hypromellose and titanium dioxide (E171).
This product contains lactose monohydrate. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product
Zimovane tablets are white, elliptical, film-coated tablets, with a scoreline on one side and plain on the reverse. They are available in blister packs containing 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.
Zimovane is manufactured by: Aventis Pharma S.A., Alcorcon, Madrid, 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: 08929/0408
Why have you been prescribed Zimovane 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 painkillers such as codeine, morphine or diamorphine, sedative antihistamines (to treat 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 tablets.
Special Warnings
Important information about some of the ingredients in Zimovane:
• Alcohol can affect the way Zimovane works, you should not drink alcohol while taking these tablets.
• You should not drive if you drink alcohol while 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 dependent on 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
Final Draft
• 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 of tablets you need to take will depend on your condition. The usual adult dosage is one Zimovane 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 small 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 tablets or a child swallows any tablets, contact your nearest hospital casualty department or tell your doctor immediately.
Do Zimovane 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 Zimovane 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 coordination
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 - 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 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
Do not use your tablets after the expiry date printed on the carton and blister labels. This 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 tablets
Your tablets should be stored in the pack in which you are given them.
Do not store above 30°C.
Store in a dry place.
Protect from light.
Keep out of the reach and sight of children.
If your doctor decides to stop the treatment, return any tablets left over to the pharmacist. Only keep them if your doctor tells you to.
If your tablets appear to be discoloured or show any other signs of deterioration, please return to your pharmacist who will advise you.
REMEMBER: This medicine has been prescribed for you personally. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
Leaflet revision & issue date (ref): 07.06.07 TM
Zimovane is a trademark of May & Baker.
Zopiclone 7.5mg Tablets
Patient Information Leaflet
Your medicine is available using the above name, but will be referred to as Zopiclone throughout this leaflet.
Please read this leaflet carefully BEFORE you start to take your Zopiclone 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 tablets?
Each tablet contains 7.5mg of the active ingredient zopiclone.
The other (inactive) ingredients are: lactose monohydrate, calcium hydrogen phosphate, maize starch, sodium starch glycollate, magnesium stearate, hypromellose and titanium dioxide (E171).
This product contains lactose monohydrate. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product
Zopiclone tablets are white, elliptical, film-coated tablets, with a scoreline on one side and plain on the reverse. They are available in blister packs containing 30 tablets.
Zopiclone is one of a group of medicines called hypnotics. It should help you to sleep, without leaving you feeling drowsy the next day.
Zopiclone is manufactured by: Aventis Pharma S.A., Madrid, 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: 08929/0408
Why have you been prescribed Zopiclone 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 painkillers such as codeine, morphine or diamorphine, sedative antihistamines (to treat 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 tablets.
Special Warnings
Important information about some of the ingredients in Zopiclone:
• Alcohol can affect the way Zopiclone works, you should not drink alcohol while taking these tablets.
• You should not drive if you drink alcohol while taking Zopiclone
• 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 dependent on them. However, with Zopiclone this possibility is small
• If your doctor has prescribed Zopiclone 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
• When you stop taking Zopiclone you may experience symptoms such as anxiety, sweating, shaking, palpitations, nightmares,
Final Draft
muscle cramps, stomach upsets and difficulty sleeping. This is more likely to happen if you stop taking Zopiclone 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 of tablets you need to take will depend on your condition. The usual adult dosage is one Zopiclone 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 small 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 tablets or a child swallows any tablets, contact your nearest hospital casualty department or tell your doctor immediately.
Do Zopiclone 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 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 coordination
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 - 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 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
Do not use your tablets after the expiry date printed on the carton and blister labels. This 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 tablets
Your tablets should be stored in the pack in which you are given them.
Do not store above 30°C.
Store in a dry place.
Protect from light.
Keep out of the reach and sight of children.
If your doctor decides to stop the treatment, return any tablets left over to the pharmacist. Only keep them if your doctor tells you to.
If your tablets appear to be discoloured or show any other signs of deterioration, please return to your pharmacist who will advise you.
REMEMBER: This medicine has been prescribed for you personally. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
Leaflet revision & issue date (ref): 07.06.07