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Zopiclone Tablets 3.75mg, 7.5mg

Last Updated on eMC 22-Oct-2014 View changes  | Actavis UK Ltd Contact details

The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine. It is written for patients and gives information about taking or using a medicine. It is possible that the leaflet in your medicine pack may differ from this version because it may have been updated since your medicine was packaged.

Please click on the link to the left to view the PIL in PDF format.

Text only version for the visually impaired
Below is a text only representation of the Patient Information leaflet. The original may contain images or tables and can be viewed in PDF format using the link to the left. This PIL may be available from the RNIB in large print, Braille or audio CD. For further information please call the RNIB Medicine Leaflet line on 0800 198 5000. The product code(s) for this leaflet is/are: PL 00142/0449, PL 00142/0434.



Zopiclone Tablets 3.75mg, 7.5mg

PATIENT INFORMATION LEAFLET

Zopiclone 3.75mg and 7.5mg Tablets

Please read all of this leaflet carefully before you start to take this medicine.

  • Keep this leaflet. You may need to read it again.
  • If you have any further questions, ask your pharmacist or doctor.
  • 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 Zopiclone tablets are and what they are used for
2. Before you take Zopiclone tablets
3. How to take Zopiclone tablets
4. Possible side effects
5. How to store Zopiclone tablets
6. Further information

1. What Zopiclone tablets are and what they are used for

Zopiclone tablets are sleeping pills (hypnotics) which work by acting on the brain to cause sleepiness.

They may be used for short term treatment of difficulties in falling asleep, waking up at night or early in the morning or difficulty in sleeping caused by events, situations or mental illness, which is severe, disabling or causing great distress.

2. Before you take Zopiclone tablets

Do not take Zopiclone tablets and tell your doctor if you:

  • are allergic (hypersensitive) to zopiclone or any of the other ingredients in the tablet (see section 6). An allergic reaction may include a rash, itching, difficulty breathing or swelling of the face, lips, throat or tongue.
  • have severe liver problems
  • suffer from breathing problems whilst sleeping (Sleep Apnoea Syndrome)
  • suffer from severe muscle weakness (myasthenia gravis)
  • have severe breathing problems
  • these tablets are not recommended for use in children.

Check with your doctor or pharmacist before taking Zopiclone tablets if you:

  • have any kidney or liver problems.
  • have a history of mental illness
  • have or have ever had a history of or tendency to alcohol or drug abuse or personality disorders. The risk of dependence to Zopiclone tablets (physical or mental effects produced by a compulsion to keep taking the medicine) increases in these patients, and with dose and length of treatment.

Please tell your doctor if you have any of the conditions listed above.

Other considerations

  • Habituation – if after a few weeks you notice that the tablets are not working as well as they did when first starting treatment, you should go and see your doctor as an adjustment to your dosage may be required.
  • Dependence – when taking this type of medicine there is a risk of dependence, which increases with dose and length of treatment. There is a greater risk in patients with a history of alcohol or drug abuse or personality disorders.
  • Withdrawal – treatment should be gradually withdrawn. A transient syndrome whereby the symptoms that led to treatment with Zopiclone tablets recur in an enhanced form, may occur on withdrawal. It may be accompanied by other reactions including mood changes, anxiety and restlessness.
  • Amnesia – Zopiclone tablets can cause memory loss. To reduce this risk you should ensure that you are able to have a full night of uninterrupted sleep.

Taking other medicines

Tell your doctor or pharmacist if you are taking or have recently taken any other medicine including medicines obtained without a prescription. Zopiclone tablets may influence the effect and/or side effects of other medicines. If you see another doctor or go into hospital, particularly if you are having an operation under anaesthesia, tell the doctor which medicines you use.

The following medicines may increase the sedating effect of Zopiclone tablets:

  • medicines to treat mental illness (antipsychotics)
  • medicines to treat depression
  • other sleeping pills
  • medicines to treat anxiety and other tranquillizers
  • narcotics (strong pain killers) e.g. codeine, morphine
  • medicines used to treat epilepsy
  • anaesthetics (used during surgery)
  • antihistamine medicines which cause sleepiness
  • medicines inhibiting liver enzymes e.g. cimetidine, allopurinol, propranolol. Ask your doctor or pharmacist which medicines have this effect.
  • erythromycin ( an antibiotic to treat infections).

Taking Zopiclone with alcohol

Alcohol should not be consumed when taking Zopiclone tablets, as the sedating effect may be increased.

Pregnancy and breast-feeding

Zopiclone tablets should not be taken during pregnancy. If for urgent medical reasons, Zopiclone tablets are taken during late pregnancy or during labour the baby may have low body temperature or breathing difficulties and show withdrawal symptoms after birth because of physical dependence.

If you are planning to become pregnant or suspect you may already be pregnant, do not take Zopiclone tablets and contact your doctor as soon as possible for advice.

Zopiclone will appear in breast milk in small amounts, therefore breast-feeding mothers should not take this medicine.

Driving and using machines

Zopiclone tablets may affect your ability to drive or operate machinery. Make sure you are not affected before driving or operating machinery, especially if taken with alcohol.

Important information about some of the ingredients of Zopiclone tablets

If you have been told you have an intolerance to some sugars, tell your doctor or pharmacist before taking Zopiclone tablets as this medicine contains lactose.

3. How to take Zopiclone tablets

Always take Zopiclone tablets exactly as your doctor has told you. You should check with your doctor or pharmacist when you are not sure.

The tablet should be taken together with liquid immediately before going to bed.

The usual dose is:

  • Adults: 7.5mg before going to bed.
  • Elderly: A lower dose of 3.75mg may be used initially. This dose may be increased to 7.5mg.
  • Patients with liver disease: Usually a lower dose of 3.75mg at night. Up to 7.5mg can be given.
  • Patients with kidney disease: Treatment should be started with a dose of 3.75mg.
  • Children: not recommended.

How long should you take Zopiclone tablets?

Treatment should be as short as possible. In general, it should not exceed 4 weeks including the withdrawal period. Your doctor will choose a withdrawal regime based on your individual needs.

If you take more Zopiclone tablets than you should

If you, (or someone else) swallow a lot of the tablets at the same time, or if you think a child has swallowed any of the tablets, contact your nearest hospital casualty department or your doctor immediately. Do not go unaccompanied to seek medical help. If an overdose has been taken, you may become increasingly drowsy very quickly, with high doses probably leading to a coma.

If you forget to take Zopiclone tablets

If you forget to take a tablet, take one as soon as you remember, unless it is nearly time to take the next one. Never take two doses together. Take the remaining doses at the correct time.

If you stop taking Zopiclone tablets

  • Treatment should be gradually withdrawn as the symptoms you are treated for will return more intense than before (rebound insomnia), also anxiety, restlessness and mood changes may occur. These effects will disappear in time.
  • If you have become physically dependent to Zopiclone tablets, sudden withdrawal of treatment will lead to side effects such as headaches, muscle pain, extreme anxiety, tension, restlessness, confusion, irritability. In severe cases other effects may appear, such as hypersensitivity to light, noise and physical contact, abnormally acute hearing and painful sensitivity to sound, hallucinations, numbness and tingling of the extremities, derealisation (feeling the world around you is not real), depersonalisation (feeling your mind is becoming separated from your body) or epileptic seizures (violent fitting or shaking).

4. Possible side effects

Like all medicines, Zopiclone tablets can cause unwanted side effects, although not everybody gets them.

If you experience the following rare, but very serious side effect, stop taking Zopiclone tablets and tell your doctor immediately or contact the casualty department at your nearest hospital:

  • an allergic reaction: skin rash, swelling of the face, lips, tongue or throat, or difficulty breathing or swallowing or light headedness, lack of co-ordination.

Tell your doctor or pharmacist if any of the following side effects occur or worsen:

  • Effects on the gastrointestinal system: a bitter or metallic taste in the mouth, dry mouth and feeling sick or being sick.
  • Effects on the nervous system: headache, dizziness, drowsiness, irritability, aggressiveness, confusion, depression, amnesia, hallucinations or nightmares.
  • Other: sometimes sleeplessness has occurred on stopping the tablets, usually following prolonged use.

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

By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Zopiclone tablets

Keep out of the reach and sight of children.

Store below 25°C in a dry place and protected from light.

Do not use Zopiclone after the expiry date which is stated on the product packaging. The expiry date refers to the last day of that month.

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 Zopiclone tablets contain

  • The active substance (the ingredient that makes the medicine work) is zopiclone. Each tablet contains either 3.75mg or 7.5mg of the active ingredient.
  • The tablets also contain lactose monohydrate, calcium hydrogen phosphate, maize starch, croscarmellose sodium, magnesium stearate, hypromellose, titanium dioxide and macrogol. The 3.75mg tablets also contain iron oxide yellow and iron oxide red.

Contents of the pack

Pack size: 28

Marketing authorisation holder

Actavis
Barnstaple
EX32 8NS
UK

Manufacturer

Synthon Hispania SL
C/ Castelló
1- Poligono Las Salinas
08830 SanBoi De Llobraegat
Barcelona

Date of last Revision: September 2014

Actavis
Barnstaple
EX32 8NS
UK

AAAH2185 50822731

Company contact details

Actavis UK Ltd

Company image
Address

Whiddon Valley, Barnstaple, Devon, EX32 8NS, UK

Fax

+44 (0)1271 346 106

Medical Information e-mail
Telephone

+44 (0)1271 311 200

Medical Information Direct Line

+44 (0)1271 311 257

Before you contact this company: often several companies will market medicines with the same active ingredient. Please check that this is the correct company before contacting them. Why?

Active ingredients

zopiclone

Legal categories

POM - Prescription Only Medicine

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