Patient Leaflet Updated 06-Dec-2023 | SANOFI
Zimovane 7.5mg & Zimovane LS 3.75mg film-coated tablets
PACKAGE LEAFLET: INFORMATION FOR THE USER
Zimovane 7.5 mg film-coated tablets
Zimovane LS 3.75 mg film-coated tablets
zopiclone
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Read all of this leaflet carefully before you start taking this medicine because it contains important information for you
What is in this leaflet
1. What Zimovane is and what it is used for
2. What you need to know before you take Zimovane
3. How to take Zimovane
4. Possible side effects
5. How to store Zimovane
6. Contents of the pack and other 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 for short term treatment of sleep problems (insomnia) in patients over 18 years of age, such as:
Do not take Zimovane as long-term treatment. Treatment should be as short as possible, because the risk of dependence increases with the duration of treatment.
Ask your doctor for advice if you are unsure.
2. What you need to know before you take Zimovane
Do not take Zimovane if:
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.
Warnings and precautions
Talk to your doctor or pharmacist before taking Zimovane if:
Risk of abuse and dependence
Use of Zimovane may lead to the development of abuse and/or physical and psychological dependence. The risk of dependence increases with dose and duration of treatment and is greater when Zimovane is used for longer than 4 weeks, and in patients with a history of mental disorders and/or alcohol, illicit substance or drug abuse.
Zimovane and mental health
Some people being treated with Zimovane can experience mental health problems such as irrational thoughts (delusions), seeing or hearing things that are not there (hallucinations), feeling confused or disorientated (delirium), feeling angry, irritable, restless or depressed.
Additionally, some studies have shown an increased risk of suicidal ideation, suicide attempt and suicide in patients taking certain sedatives and hypnotics, including this medicine. However, it has not been established whether this is caused by the medicine or if there may be other reasons.
If you have suicidal thoughts, contact your doctor as soon as possible for further medical advice.
Zimovane and unusual behaviour
Zimovane may cause sleepwalking or other unusual behaviour (such as driving, eating, making a phone call, or having sex etc.) while not being fully awake. The next morning, you may not remember that you did anything during the night. These activities may occur whether or not you drink alcohol or take other medicines that make you drowsy with Zimovane. If you experience any of the above, stop the treatment with Zimovane immediately and contact your doctor or healthcare provider.
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.
Other medicines and Zimovane
Tell your doctor or pharmacist if you are taking, have recently taken or might take 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:
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:
The following medicines can make Zimovane work less well:
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, breast-feeding and fertility
Pregnancy
Use of Zimovane is not recommended during pregnancy. If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.
If used during pregnancy there is a risk that the baby is affected. Some studies have shown that there may be an increased risk of cleft lip and palate (sometimes called “harelip”) in the newborn baby.
Reduced fetal movement and fetal heart rate variability may occur after taking Zimovane during the second and/or third trimester of pregnancy.
If Zimovane is taken at the end of pregnancy or during labour, your baby may show muscle weakness, a drop in body temperature, difficulty feeding and breathing problems (respiratory depression).
If this medicine is taken regularly in late pregnancy, your baby may develop physical dependence and may be at risk of developing withdrawal symptoms such as agitation or shaking. In this case the newborn should be closely monitored during the postnatal period.
Breast-feeding
Do not take Zimovane if you are breast-feeding or planning to breast-feed.
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
Like other medicines used for sleep problems, Zimovane can cause slowing of your normal brain function (central nervous system depression). The risk of psychomotor impairment including driving ability, is increased if:
Do not engage in hazardous activities requiring complete mental alertness such as driving or operating machinery after taking Zimovane, and in particular during the 12 hours after taking your medicine.
For more information about possible side effects which could affect your driving see section 4 of this leaflet.
Zimovane contains
3. How to take Zimovane
Treatment should be as short as possible and should not exceed four weeks including period of tapering off. Your doctor will give you the lowest effective dose.
Always take Zimovane exactly as your doctor or pharmacist has told you. You should check with your doctor or pharmacist if you are not sure.
Taking this medicine
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.
Use in 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
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:
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:
In rare cases fits (seizures) may also occur.
If you have any further questions on the use of the medicine, ask your doctor or pharmacist.
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:
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)
Not known (frequency cannot be estimated from available data)
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)
Uncommon (affects 1 to 10 users in 1,000)
Rare (affects 1 to 10 users in 10,000)
Not known (frequency cannot be estimated from available data)
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 or search for MHRA Yellow Card in the Google Play or Apple App Store.
By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store Zimovane
Keep this medicine out of the sight and reach of children.
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.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
6. Contents of the pack and other information
What Zimovane and Zimovane LS contain
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
Manufacturer
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 January 2022
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