Zimovane Ls 3.75mg Film-Coated Tablets
Out of date information, search anotherzopiclone
PACKAGE LEAFLET: INFORMATION FOR THE USER
Zimovane 7.5 mg film-coated tablets Zimovane LS 3.75 mg film-coated tablets
SANOFlO
Is this leaflet hard to see or read? Phone 08453727101 for help
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.
In this leaflet:
1. What Zimovane is and what it is used for
2. Before you take Zimovane
3. How to take Zimovane
4. Possible side effects
5. How to store Zimovane
6. Further information
1. What Zimovane is and what it is used for
The name of your medicine is Zimovane tablets or Zimovane LS tablets (both called Zimovane in this leaflet). Zimovane contains a medicine called zopiclone. This belongs to a group of medicines called hypnotics. It works by acting on your brain to help you sleep.
Zimovane is used to treat sleep problems in adults such as:
• Difficulty falling asleep
• Waking in the middle of the night
• Waking too early
• Severe or upsetting sleep problems that are caused by your mood or mental health problems
Zimovane can be used for both temporary and longer lasting sleep problems. However, Zimovane is not meant to be used every day for long periods of time or to treat depression.
-1 - R774050
Ask your doctor for advice if you are unsure.
2. Before you take Zimovane
Do not take this medicine and tell your doctor if:
X You are allergic (hypersensitive) to zopiclone or any of the other ingredients of Zimovane (listed in Section 6 below)
Signs of an allergic reaction include: a rash, swallowing or breathing problems, swelling of your lips, face, throat or tongue
X You have a problem that causes severe muscle weakness (myasthenia gravis)
X Your lungs do not work properly (respiratory failure)
X You have a problem where you stop breathing for short periods at night (sleep apnoea)
X You have severe liver problems X You are under the age of 18. The safety and efficacy of Zimovane in children and adolescents aged less than 18 years have not been established.
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 Zimovane.
I
0Take special care with Zimovane
Check with your doctor or pharmacist before taking your medicine if:
▲ You have any liver problems (see also ‘Do not take this medicine and tell your doctor if:’ section above). Your doctor may need to give you a lower dose of Zimovane ▲ You have any kidney problems. Your doctor may need to give you a lower dose of Zimovane ▲ You suffer from mild breathing problems, your doctor will decide if you should receive Zimovane (see also ‘Do not take this medicine and tell your doctor if:’ section above).
▲ You have a history of alcohol or drug abuse
▲ You have been told by a doctor that you have a personality disorder ▲ You have recently taken Zimovane or other similar medicines for more than four weeks
▲ You do not feel you will ever be able to stop taking Zimovane or other medicines used to treat sleep problems
Before taking Zimovane, it is important to make sure that you can have at least 7 to 8 hours of uninterrupted sleep to help reduce the risk of some side effects (see section 4 - Possible side effects).
If you are not sure if any of the above applies to you, talk to your doctor or pharmacist before taking Zimovane.
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 Zimovane can affect the way some other medicines work. Also some medicines can affect the way Zimovane works.
Tell your doctor if you are taking any of the following medicines.
Zimovane may increase the effect of the following medicines:
• 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
The following medicines can increase the chance of you getting side effects when taken with Zimovane. To make this less likely, your doctor may decide to lower your dose of Zimovane:
• Some antibiotics such as clarithromycin or erythromycin
• Some medicines for fungal infections such as ketaconazole and itraconazole
• Ritonavir (a protease inhibitor) - for HIV infections
The following medicines can make Zimovane work less well:
• Some medicines for epilepsy such as carbamazepine, phenobarbital or phenytoin
• Rifampicin (an antibiotic) - for infections
• St John’s Wort (a herbal medicine) -for mood swings and depression
Taking Zimovane with food and drink
• Do not drink alcohol while you are taking Zimovane. Alcohol can increase the effects of Zimovane 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 Zimovane during the last 3 months of pregnancy or during labour because it may be harmful to your baby
• Do not breast-feed if you are taking Zimovane. This is because small amounts may pass into mother’s milk. If you are breast-feeding or planning to breast-feed, talk to your doctor or pharmacist before taking any medicine
Ask your doctor or pharmacist for advice before taking any medicine if you are pregnant or breast-feeding.
Driving and using machines
On the day after taking Zimovane, do not drive or use machinery or tools if you feel sleepy, dizzy or confused.
For more information about possible side effects which could affect your driving see section 4 of this leaflet. Important information about some of the ingredients of Zimovane Zimovane contains:
• Lactose. This is a type of sugar. If you have been told by your doctor that you cannot tolerate some sugars (have an intolerance to some sugars), talk to your doctor before taking this medicine.
• Wheat starch. People with wheat allergy should not take this medicine. Wheat allergy is not the same as Coeliac disease. Zimovane can be taken by people with Coeliac disease.
3. How to take Zimovane
Treatment should be as short as possible and should not exceed four weeks including period of tapering off
Always take Zimovane exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.
Taking this medicine
• Take this medicine by mouth
• Swallow the tablet with a drink of water
• Do not crush or chew your tablets
• Take just before bedtime
• The usual length of treatment is 2 days to 3 weeks
Adults
The usual dose is one Zimovane tablet (7.5 mg) just before bedtime.
Elderly
The usual starting dose is one Zimovane LS tablet (3.75 mg) just before bedtime. Your doctor may decide to increase your dose to one Zimovane tablet (7.5 mg) if needed.
Turn
Over
Children and adolescents
Zimovane should not be used in children and adolescents less than 18 years.
The safety and efficacy of Zimovane in children and adolescents aged less than 18 years have not been established. Patients with liver, respiratory or kidney problems The usual starting dose is one Zimovane LS tablet (3.75 mg) just before bedtime.
Blood Tests
• Zimovane can change the levels of liver enzymes shown up in blood tests. This can mean that your liver is not working properly
• If you are going to have a blood test, it is important to tell your doctor that you are taking Zimovane
If you take more Zimovane than you should
If you take more Zimovane 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. Taking too much Zimovane can be very dangerous. The following effects may happen:
• Feeling drowsy, confused, sleeping deeply and possibly falling in to a coma
• Floppy muscles (hypotonia)
• Feeling dizzy, light headed or faint. These effects are due to low blood pressure
• Falling over or losing your balance (ataxia)
• Shallow breathing or difficulty breathing (respiratory depression)
If you forget to take Zimovane
Zimovane 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 Zimovane
Keep taking Zimovane until your doctor tells you to stop. Do not stop taking Zimovane 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 Zimovane 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, shaky, irritable, agitated, confused or having panic attacks
• Sweating
• Headache
• Faster heartbeat or uneven heartbeat (palpitations)
• A lower level of awareness and problems with focusing or concentrating
• Nightmares, seeing or hearing things that are not real (hallucinations)
• Being more sensitive to light, noise and touch than normal
• Relaxed grip on reality
• Numbness and tingling in your hands and feet
• Aching muscles
• Stomach problems
In rare cases fits (seizures) may also occu r.
Turn
Over
4. Possible side effects
Like all medicines, Zimovane can cause side effects, although not everybody gets them.
Stop taking Zimovane and see a doctor or go to a hospital straight away if:
• You have an allergic reaction. The signs may include: a rash, swallowing or breathing problems, swelling of your lips, face, throat or tongue
Tell your doctor as soon as possible if you have any of the following side effects:
Rare (affects 1 to 10 users in 10,000)
• Poor memory since taking Zimovane (amnesia). By having 7-8 hours of uninterrupted sleep after taking Zimovane, this is less likely to cause you a problem.
• Seeing or hearing things that are not real (hallucinations)
• Falling, especially in the elderly Not known (frequency cannot be estimated from available data)
• Thinking things that are not true (delusions)
• Feeling low or sad (depressed mood)
Tell your doctor or pharmacist if any of the following side effects get serious or lasts longer than a few days:
Common (affects 1 to 10 users in 100)
• A mild bitter or metallic taste in your mouth or a dry mouth
• Feeling drowsy or sleepy
• Dry mouth
Uncommon (affects 1 to 10 users in 1,000)
• Feeling sick (nausea) or being sick (vomiting)
• Feeling dizzy or sleepy
• Headache
• Nightmares
• Feeling physically or mentally tired
• Agitation
Rare (affects 1 to 10 users in 10,000)
• Feeling confused
• Itchy, lumpy rash (urticaria)
• Feeling irritable or aggressive
• Reduced sex drive
• Difficulty breathing or being short of breath
Not known (frequency cannot be estimated from available data)
• Feeling restless or angry
• Feeling light headed or having problems with your coordination
• Double vision
• Moving unsteadily or staggering
• Muscular weakness
• Indigestion
• Becoming dependent on Zimovane
• Slower breathing (respiratory depression)
• Unusual skin sensations such as numbness, tingling, pricking, burning or creeping on the skin (paraesthesia)
Sleep-Driving and other strange behaviour
There have been some reports of people doing things while asleep that they do not remember when waking up after taking a sleep medicine.
This includes sleep-driving and sleep walking. Alcohol and some medicines for depression or anxiety can increase the chance that this serious effect will happen.
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. m h ra.gov. uk/yell owca rd
By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store Zimovane
Keep this medicine in a safe place where children cannot see or reach it. Do not use Zimovane after the expiry date which is stated on the carton after EXP. The expiry date refers to the last day of that month.
Store below 30°C. Keep the blister in the outer carton in order to protect from light and moisture.
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 Zimovane and Zimovane LS contain
• Each tablet of Zimovane contains 7.5 mg of the active substance zopiclone
• Each tablet of Zimovane LS contains 3.75 mg of the active substance zopiclone
Other ingredients are lactose monohydrate, calcium hydrogen phosphate dihydrate, wheat starch, sodium starch glycollate, magnesium stearate, hypromellose, titanium dioxide and macrogol 6000.
What Zimovane looks like and contents of the pack
Zimovane is a white, elliptical (oval), biconvex shaped film-coated tablet with a score line on one side contained within PVC/aluminium foil blisters containing 56, 28, 14, 7 or 3 tablets, and in a starter pack containing 3 tablets.
Zimovane LS is a white, round, biconvex shaped film-coated tablet within PVC/aluminium foil blisters containing 112, 56, 28, 14, 10, 7 or 3 tablets, and in a starter pack containing 3 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder Sanofi,
One Onslow Street, Guildford,
Surrey, GU1 4YS Tel: 08453727101 email:
uk-medicalinformation@sanofi.com
Manufacturer
Sanofi Winthrop Industrie,
56, route de Choisy-au-Bac,
60205 Compiegne,
France.
This leaflet does not contain all the information about your medicine. If you have any questions or are not sure about anything, ask your doctor or pharmacist.
This leaflet was last revised in 01/2015.
© sanofi, 1993 - 2015
- 6 - R774050