Text of the patient insert Patient information leaflet

Zopiclone tablets 3.75 mg and 7.5 mg

Please read this leaflet carefully before you start to take your tablets.

It contains important information.

If you are not sure about anything, or you want to know more, ask your doctor or a pharmacist.

Keep this leaflet safe, as you may want to read it again.

1    About your tablets

Your tablets are called Zoplicone tablets.

They are part of a group of drugs known as hypnotics and sedatives.

2    What is in your tablets

Each tablet contains:

-    zopiclone (active ingredient); and

-    lactose, calcium hydrogen phosphate, maize starch, carmellose sodium, magnesium stearate, titanium dioxide and hypromellose (inactive ingredients).

Zopiclone 3.75 mg tablets also contain iron oxide yellow (E172) and iron oxide red (E172)

Zopiclone tablets come in packs of 10, 14, 28, 30, 56 and 60 tablets.

3 Who makes your tablets

Your tablets are made by Synthon BV, Microweg 22, 6545 CM Nijmegen, The Netherlands or

Synthon Hispania S.L., Poligono Las Salinas, 08830 Sant Boi de Llobregat, Spain.

The product licence holder is Synthon BV, Microweg 22, 6545 CM Nijmegen, The Netherlands.

4 What your tablets do

Zopiclone tablets are prescribed for the treatment of insomnia/sleeplessness which disrupts normal functioning or which causes extreme suffering. Zopiclone tablets make you fall asleep more quickly.

5 Before you take your tablets

Please tell your doctor before you start to take your tablets if you:

-    are pregnant, may become pregnant or are breast-feeding;

-    have ever had a bad reaction to any of the ingredients listed in the 'What is in your tablets' section;

-    are taking other medicines including ones that you have bought for yourself without a prescription;

-    have ever had any problems with your kidneys, liver or lungs;

-    are taking anti-depressants or drugs that act on the nervous system (for example tranquillizers);

-    have been addicted to drugs before: or

-    have any difficulties with your breathing;

-    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 may make you feel drowsy. Do not drive or use machinery as it may be dangerous.

If you see another doctor or visit a hospital, remember to tell them what medicines you are already taking.

6 How to take your tablets

You must take your tablets as your doctor has told you to. The label will tell you how many to take and how often to take them. The number of tablets you take is called the 'dose'. The most common adult dose for these tablets is 7.5 mg 30 to 60 minutes before you go to bed.

Swallow the tablets whole with a glass of water.

Children should not take Zopiclone tablets.

If you are elderly, your doctor may tell you to take 3.75 mg a day at first, and then gradually increase this dose to 7.5 mg.

If you have a problem with your kidneys or liver, the dose will be kept as low as possible. If you have mild kidney or liver problems you should not take more than 7.5 mg of Zopiclone tablets a day. If the problems are more serious, you should not take more than 3.75 mg of Zopiclone tablets a day.

Your doctor will tell you how many tablets to take.

If you forget to take a dose at the right time, take it as soon as you remember. Do not take two doses together. If it is almost time to take the next dose, wait until then and then carry on as before.

It can be dangerous to stop taking your tablets without your doctor's advice.

7 What to do if you take too many tablets

It is important not to take too many tablets.

Contact your nearest hospital casualty department or a doctor for advice if you have swallowed too many tablets or if you think a child has swallowed any.

Take this leaflet, and any tablets that you still have to show the doctor.

If you take too many tablets you may feel tired or sleepy and have jerking movements.

8    After taking your tablets

You may have some side effects while you are taking your tablets.

Tell your doctor if you suffer from any of the following for more than a few days.

-    Drowsiness in the morning or lack of co-ordination.

-    Headache, feeling dizzy, a dry mouth, a strange taste in you mouth or blurred vision.

-    Feeling irritable, depressed or nervous.

-    Feeling and being sick, loss of memory, sleep walking, feeling confused, suffering from nightmares and feeling like you have a hangover.

If you are allergic to the tablets, you may get a skin rash.

The use of Zopiclone tablets may lead to physical and mental dependence. When physical dependence has developed abrupt termination of treatment will be accompanied by withdrawal symptoms. If this affects you, the withdrawal symptoms may be similar to the symptoms you were originally given the tablets for. To reduce the risk of these symptoms the treatment with Zopiclone tablets should not be terminated abruptly but gradually tapered off. The risk of dependence increases with dose and duration of treatment.

In order to avoid above mentioned symptoms the use of Zopiclone tablets will normally not exceed two weeks with a maximum, including the tapering-off, of four weeks.

If you feel unwell in any other way, tell your doctor as soon as you can.

9 Looking after your tablets

Keep your tablets in a safe place where children cannot see or reach them. Do not store your tablets above 25°C.

Store in the original package. Keep the tablets in the pack they came in.

Do not take the tablets after the 'use by' date shown on the blister and the carton.

You should take any tablets that are out of date or which you no longer need back to your pharmacist.

These tablets are only for you. Only a doctor can prescribe them for you. Never give them to anyone else.

PL number 14048/0003 (Zopiclone Tablets 3.75 mg)

PL number 14048/0004 (Zopiclone Tablets 7.5 mg)

This leaflet was written in February 2007.