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The eMC  

Last Updated 08 Aug 2013

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Zopiclone 3.75mg tablets

Zopiclone (Zop-pee-kloan) is a medicine which is used in difficulty sleeping.

The information in this Medicine Guide for Zopiclone varies according to the condition being treated and the particular preparation used.

There are 2 preparations of Zopiclone available. If Zopiclone 3.75mg tablets is not the preparation you are looking for, please select from the drop down list below.

Select your preparation (type) of Zopiclone

Zopiclone 3.75mg tablets

Information specific to Zopiclone 3.75mg tablets when used in difficulty sleeping

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Your medicine

Zopiclone is a medicine which is used to treat sleeping problems.

Zopiclone should only be used at the lowest possible dose and for a maximum of up to four weeks. This will reduce the chance of tolerance, dependence and withdrawal symptoms. Reducing the dose of Zopiclone gradually over time may reduce the chances of having these problems.

It is essential to get a full night of continuous and uninterrupted sleep after taking Zopiclone. If your sleep is disturbed before this time has passed, Zopiclone may cause you to have some memory problems. You may have no memory of what happened from the time your sleep was interrupted until the time when the effects of this medicine have worn off.

Furthermore, it is important to be aware that sleeping problems can be a symptom of a psychiatric condition, particularly when the sleeping problems have been going on for some time. Some people, in the course of taking Zopiclone for a sleeping problem, may find that an undiagnosed psychiatric condition, such as depression, becomes apparent. People who have a psychiatric condition and who are taking Zopiclone may experience some changes in behaviour.

Do not share your medicine with other people. It may not be suitable for them and may harm them.

The pharmacy label on your medicine tells you how much medicine you should take. It also tells you how often you should take your medicine. This is the dose that you and your prescriber have agreed you should take. You should not change the dose of your medicine unless you are told to do so by your prescriber.

If you feel that the medicine is making you unwell or you do not think it is working, then talk to your prescriber.

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When to take your medicine

Some medicines work best if they are taken at a specific time of day. Getting the most benefit from your medicine can also be affected by what you eat, when you eat and the times at which you take other medicines.

Specific information on when to take Zopiclone can be found in the Patient Information Leaflet that comes with this medicine or on the medicine label. You can also ask your doctor or pharmacist for information about when to take your medicine.

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How to take your medicine

Some medicines have specific instructions about how to take them. This is because they work better when taken correctly. These instructions can include getting the right dose and special instructions for preparing the medicine.

Specific information on how to take Zopiclone can be found in the Patient Information Leaflet that comes with this medicine or on the medicine label. Alternatively, you can request information about how to take your medicine from your doctor or pharmacist.

If you are having problems taking this form of Zopiclone, you should talk to your prescriber or pharmacist. They may be able to give you advice on other ways to take your medicine or other preparations that are easier for you to take.

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Taking too much of your medicine

Taking extra doses of some medicines can be harmful. In some cases even one extra dose can cause you problems. If you take extra doses of your medicine, you must get medical advice immediately. You may need a test to assess the effect of taking extra doses. This is because the effects of taking too much medicine are very complex so it is very important that you seek medical advice.

Contact your prescriber, pharmacist, specialist clinic or call 111 for advice.

Make sure you take all of your medicine containers with you if you are advised to go to hospital.

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Stopping your medicine

If you are not having any problems taking this medicine then do not stop taking it, even if you feel better, unless advised to do so by your prescriber. If, however, you find that this medicine is causing you problems then you should talk to your prescriber about your concerns.

If your medical team decides that it is best that you do not take this medicine any more, they may advise that you do not stop Zopiclone abruptly. This is because, in some instances, stopping Zopiclone abruptly can cause withdrawal symptoms or cause your original condition to return. In these instances, reducing the dose of Zopiclone gradually over time may reduce the chances of having these problems.

If you are in any doubt, contact your prescriber, pharmacist, specialist clinic or call 111.

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Looking after your medicine

The instructions on how you should keep your medicine are on the pharmacy label. It is a good idea to keep your medicine in the original container. This will help to keep your medicine in the best condition and also allow you to check the instructions. Do not take the medicine if the packaging appears to have been tampered with or if the medicine shows any signs of damage. Make sure that the medicine is out of the sight and reach of children.

Specific information on how to look after Zopiclone can be found in the Patient Information Leaflet that comes with this medicine or on the medicine label. Alternatively, you can request information about how to look after your medicine from your doctor or pharmacist.

You must not take the medicine after the expiry date shown on the packaging. If you have any unused medicine, return it to your pharmacist who will dispose of it safely.

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Whether this medicine is suitable for you

Zopiclone is not suitable for everyone and some people should never use it. Other people should only use it with special care. It is important that the person prescribing this medicine knows your full medical history.

Your prescriber may only prescribe this medicine with special care or may not prescribe it at all if you:

Furthermore the prescriber may only prescribe this medicine with special care or may not prescribe it at all for someone under the age of 18 years.

As part of the process of assessing suitability to take this medicine a prescriber may also arrange tests:

  • to check that this medicine is not having any undesired effects

Over time it is possible that Zopiclone can become unsuitable for some people, or they may become unsuitable for it. If at any time it appears that Zopiclone has become unsuitable, it is important that the prescriber is contacted immediately.

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Side-effects

A medicine is only made available to the public if the clinical trials have shown that the benefits of taking the medicine outweigh the risks.

Once a medicine has been licensed, information on the medicine's effects, both intended and unintended, is continuously recorded and updated.

Some side-effects may be serious while others may only be a mild inconvenience.

Everyone's reaction to a medicine is different. It is difficult to predict which side-effects you will have from taking a particular medicine, or whether you will have any side-effects at all. The important thing is to tell your prescriber or pharmacist if you are having problems with your medicine.

Common: More than 1 in 100 people who take Zopiclone:

  • dry mouth
  • sleepiness
  • taste changes

Uncommon: More than 1 in 1000 people who take Zopiclone:

  • feeling dizzy
  • feeling drowsy
  • headaches
  • nausea
  • psychological problems and behavioural changes including restlessness, agitation, irritability, aggression, delusion, anger, nightmares or hallucinations - seek medical advice if you experience psychological or behavioural changes
  • tiredness
  • vomiting

Rare: More than 1 in 10,000 people who take Zopiclone:

Very rare: Fewer than 1 in 10,000 people who take Zopiclone:

The frequency of these side-effects is unknown:

  • balance or coordination problems
  • coordination problems
  • depression
  • dose tolerance
  • double vision
  • feeling light-headed
  • hiding symptoms of depression - this may lead to precipitation of suicide
  • indigestion
  • muscle weakness
  • physical and psychological dependence that may lead to drug abuse
  • rebound insomnia - this may be accompanied by mood changes, anxiety and restlessness
  • sleep walking
  • withdrawal symptoms can occur when this medicine is stopped abruptly. These include headaches, muscle pain, extreme anxiety, tension, restlessness, confusion, irritability, rebound insomnia, tremor, sweating, agitation, palpitations, faster hear rate, delirium, nightmares, panic attacks, muscle cramps and gastrointestinal problems. If withdrawal is severe the following may occur: derealisation, depersonalisation, numbness and tingling of the extremities, hypersensitivity to light, noise and physical contact, hallucinations or seizures
  • Zopiclone dependence

If you feel unwell or if you have concerns about a side-effect, you will need to seek advice. If you feel very ill, get medical help straight away. Contact your prescriber, pharmacist, nurse or call 111.

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Taking other medicines

If you are taking more than one medicine they may interact with each other. At times your prescriber may decide to use medicines that interact, in other cases this may not be appropriate.

The decision to use medicines that interact depends on your specific circumstances. Your prescriber may decide to use medicines that interact, if it is believed that the benefits of taking the medicines together outweigh the risks. In such cases, it may be necessary to alter your dose or monitor you more closely.

Tell your prescriber the names of all the medicines that you are taking so that they can consider all possible interactions. This includes all the medicines which have been prescribed by your GP, hospital doctor, dentist, nurse, health visitor, midwife or pharmacist. You must also tell your prescriber about medicines which you have bought over the counter without prescriptions.

The following medicines may interact with Zopiclone:

The following types of medicine may interact with Zopiclone:

If you are taking Zopiclone and one of the above medicines or types of medicines, make sure your prescriber knows about it.

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Complementary preparations and vitamins

Medicines can interact with complementary preparations and vitamins.

Make sure you tell your prescriber the names of all the complementary preparations and vitamins that you are taking or are planning to take.

Your prescriber can then decide whether it is appropriate for you to take combinations that are known to interact.

In the case of Zopiclone:

If you have been prescribed Zopiclone you should only take something on the above list on the specific advice of your prescriber or pharmacist.

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Driving and operating machinery

When taking any medicine you should be aware that it might interfere with your ability to drive or operate machinery safely.

In the case of Zopiclone:

  • this medicine could affect your ability to drive or operate machinery

You should see how this medicine affects you before you judge whether you are safe to drive or operate machinery. If you are in any doubt about whether you should drive or operate machinery, talk to your prescriber.

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Diet

Medicines can interact with certain foods. In some cases, this may be harmful and your prescriber may advise you to avoid certain foods.

In the case of Zopiclone:

  • there are no specific foods that you must exclude from your diet when taking Zopiclone
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Alcohol

Alcohol can interact with certain medicines.

In the case of Zopiclone:

  • alcohol increases the sedative effects of Zopiclone

You must not drink any alcohol if you are taking this medicine.

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Family planning and pregnancy

Most medicines, in some way, can affect the development of a baby in the womb. The effect on the baby differs between medicines and also depends on the stage of pregnancy that you have reached when you take the medicine.

In the case of Zopiclone:

  • if you become pregnant, or think you have become pregnant while taking Zopiclone, you must contact your prescriber
  • if you take this medicine during the late stages of pregnancy or during labour, your baby may have some problems immediately after birth
  • if you repeatedly take this medicine during the late stages of pregnancy your baby may become physically dependent on Zopiclone. This may lead to your baby having withdrawal symptoms from Zopiclone after birth
  • the use of this medicine during pregnancy is not recommended. You should only take this medicine during pregnancy if your doctor thinks that you need it

You need to discuss your specific circumstances with your doctor to weigh up the overall risks and benefits of taking this medicine. You and your doctor can make a decision about whether you are going to take this medicine during pregnancy.

If the decision is that you should not have Zopiclone, then you should discuss whether there is an alternative medicine that you could take during pregnancy.

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Breast-feeding

Certain medicines can pass into breast milk and may reach your baby through breast-feeding.

In the case of Zopiclone:

  • women who are breast-feeding should not take this medicine

Before you have your baby you should discuss breast-feeding with your doctor or midwife. They will help you decide what is best for you and your baby based on the benefits and risks associated with this medicine. If you wish to breast-feed you should discuss with your prescriber whether there are any other medicines you could take which would also allow you to breast-feed. You should not stop this medicine without taking advice from your doctor.

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Ingredients of your medicine

Medicines contain active ingredients. They may also contain other, additional ingredients that help ensure the stability, safety and effectiveness of the medicine. They are also added to improve the medicine's taste and appearance and to make it easier to take. Some may be used to prolong the life of the medicine.

This medicine contains zopiclone.

We are unable to list all of the ingredients for your medicine here. For a full list, you should refer to the patient information leaflet that comes with this medicine. You should check that you are able to take the ingredients of your medicine, especially if you have any allergies. You should also check whether any of these ingredients are known to have side-effects.

If you are not able to take any of the ingredients in your medicine, talk to your prescriber or pharmacist to see if they can suggest an alternative medicine. If you have reacted badly to Zopiclone before, do not take Zopiclone. Talk to your prescriber, pharmacist or nurse as soon as possible.

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Zopiclone, Version 8, last updated 08 Aug 2013