PATIENT INFORMATION LEAFLET Patients with liver or kidney problems Very Rare (may affect up to 1 in 10,000 The usual starting dose is 3.75mg (½ a tablet). people) ZOPICLONE 7.5mg TABLETS • Change in blood tests (increase of liver Patients with Respiratory Insufficiency enzymes in the blood) Read this leaflet carefully BEFORE you start taking Zopiclone Tablets because it A reduced dosage is recommended (frequency cannot be estimated contains important information for you. Not known Pharmacode location from the available data) • Keep this leaflet. You may need to read it again. Use in Children and adolescents • Restlessness • If you have further questions, please ask your doctor or your pharmacist. Zopiclone Tablets are NOT recommended for • Delusion • This medicine has been prescribed for you only. Do not pass it on to others. It may harm children. • Anger them, even if their signs of illness are the same as yours. • Muscular weakness • If you get any of the side effects talk to your doctor or pharmacist. This includes any Your treatment will usually be for less than 4 • Loss of co-ordination possible side effects not listed in this leaflet. See section 4 weeks, and the doctor may reduce your dose near the end of your course. If you take • Loss of memory WHAT IS IN THIS LEAFLET Zopiclone longer than this, the medicine may • Double vision 1. What Zopiclone Tablets are and what they are used for not work as well, you may become dependent • Unusual skin sensations such as numbness, 2. What you need to know before you take Zopiclone Tablets and you may have withdrawal symptoms when burning, tingling or prickling (paraesthesia) 3. How to take Zopiclone Tablets you stop. • Difficulty concentrating or paying attention 4. Possible side effects If you have the impression that the effect of • Disrupted normal speech 5. How to store Zopiclone Tablets Zopiclone Tablets is too strong or too weak talk • Indigestion 6. Contents of the pack and other information to your doctor or pharmacist. • Becoming dependent • Sleepwalking allergies, skin irritation or vomiting) such as If you take more of this medicine than you Sleep-driving and other strange behaviour WHAT ZOPICLONE TABLETS ARE chlorpheniramine or promethazine should AND WHAT THEY ARE USED FOR There have been some reports of people doing 1. • rifampicin, clarithromycin or erythromycin If you have taken more Zopiclone Tablets than things while asleep that they do not remember (antibiotics to treat infections) you should, or a child swallows any tablets, go when waking up after taking a sleep medicine. Zopiclone is one of a group of medicines called • some medicines for fungal infections such as to your nearest casualty department hypnotics (sleeping tablets). These tablets can This includes sleep-driving and sleepwalking. ketoconazole and itraconazole immediately. Take the medicine pack with you Alcohol and some medicines for depression or be used for both temporary and longer lasting • St. John’s Wort (a herbal medicine) for mood so the doctor knows what you have taken. sleep problems (insomnia). It should help you to anxiety can increase the chance that this swings and depression Taking too much Zopiclone can be very serious effect will happen. sleep, without leaving you drowsy the next day. • ritonavir (a protease inhibitor) for HIV dangerous. The symptoms of overdose include However, Zopiclone is not meant to be used infections feeling drowsy, shallow breathing or difficulties Reporting of side effects every day for long periods of time. If you need • medicines used in surgery (anaesthetics) breathing and difficulty in controlling If you get any side effects, talk to your doctor or any further information on your condition, please • treatment for pain, cough, diarrhoea and movements. pharmacist. This includes any possible side ask your doctor. shortness of breath (opioids) effects not listed in this leaflet. You can also If you forget to take your medicine report side effects directly via the Yellow Card WHAT YOU NEED TO KNOW BEFORE If you have to go to a doctor, dentist or hospital, Zopiclone must only be taken before going to Scheme at: www.mhra.gov.uk/yellowcard or 2. YOU TAKE ZOPICLONE TABLETS for any reason, tell them that you are taking bed. If you forget to take a dose just take the search for MHRA Yellow Card in the Google Zopiclone Tablets. next tablet at the usual time. DO NOT take two Play or Apple App Store. By reporting side Do not take Zopiclone if: Zopiclone with alcohol doses at the same time. effects, you can help provide more information • You are allergic to Zopiclone or any Do not drink alcohol while you are taking this on the safety of this medicine. of the other ingredients of this medicine If you stop taking this medicine medicine. Alcohol can increase the effects of (listed in section 6). Signs of an allergic It is important to continue taking the tablets for Zopiclone and make you sleep very deeply so HOW TO STORE ZOPICLONE reaction include: a rash, swallowing or as long as your doctor tells you to. You should that you do not breathe properly or have TABLETS breathing problems, swelling of your lips, not stop taking your tablets suddenly without difficulty waking. advice from your doctor. Do not change the face, throat or tongue. KEEP THIS MEDICINE OUT OF THE SIGHT • You suffer from myasthenia gravis (a dose of your medicine unless you have spoken Pregnancy and breast-feeding AND REACH OF CHILDREN. condition where the muscles easily tire and with your doctor. If you are pregnant or breast-feeding, think you become weak) Your doctor will need to lower your dose before Do not use this medicine after the expiry date may be pregnant or are planning to have a • You suffer from sleep apnoea stopping your treatment to help prevent any printed on the blister and carton. The expiry baby, ask your doctor or pharmacist for advice • You suffer from respiratory failure (your lungs withdrawal effects and to help prevent return of date refers to the last day of that month. before taking this medicine. If used during do not work properly) your sleep problems (rebound insomnia). Do not store above 25°C. Store in the original pregnancy there is a risk that the baby is • You have severe liver problems Stopping treatment with Zopiclone Tablets is package. affected. Some studies have shown that there • You are under 18 years of age unlikely to be associated with withdrawal effects Do not keep the tablets if your doctor decides to may be an increased risk of cleft lip and palate Do not take this medicine if any of the above when duration of treatment is limited to 4 weeks. stop treatment. (sometimes called “harelip”) in the newborn applies to you. If you are not sure, talk to your Do not throw away any medicines via baby. Withdrawal symptoms doctor or pharmacist before taking Zopiclone. wastewater or household waste. Ask your Reduced fetal movement and fetal heart rate Some patients may experience withdrawal pharmacist how to throw away medicines you Warnings and precautions variability may occur after taking Zopiclone symptoms when they stop taking this medicine. no longer use. These measures will help protect Talk to your doctor or pharmacist before during the second and/or third trimester of See a doctor immediately if you get any of the the environment. taking Zopiclone if you: pregnancy. following symptoms: • Headaches • have a personality disorder Do not take this medicine during the last 3 CONTENTS OF PACK AND OTHER • Muscle pain • have ever been, or are currently being months of pregnancy or during labour because INFORMATION treated for drug or alcohol abuse it may be harmful to your baby. If taken in late • Sweating • Stomach problems • have any kidney or liver problems - your pregnancy, the baby may have muscle What your medicine contains doctor may need to give you a lower dose weakness, low body temperature, difficulty • Relaxed grip on reality The active ingredient is zopiclone. Each tablet • feel you will not be able to stop taking feeding, breathing difficulties and show • Faster or uneven heartbeat contains 7.5mg of zopiclone. Zopiclone or any medication used to treat withdrawal symptoms such as agitation or • Numbness and tingling sensation in hands The inactive ingredients are calcium hydrogen your sleep problems shaking after birth because of physical and feet phosphate dihydrate, lactose monohydrate, • have recently taken Zopiclone or other similar dependence. In this case the newborn should • Increased sensitivity to light, noise and maize starch, sodium starch, glycollate type A, medication for more than 4 weeks be closely monitored during the postnatal physical contact magnesium stearate, hydroxypropylmethyl- • are elderly as there may be a greater risk of period. • Feeling of watching yourself cellulose, propylene glycol, titanium dioxide and side effects (Depersonalization) talc. • have or have ever had depression or any Breast-feeding • A lower level of awareness and problems with other mental illness Do not take Zopiclone if you are breast-feeding focusing or concentrating What your medicine looks like and contents • suffer from mild breathing problems (your or planning to breast-feed. This is because • Nightmares, seeing or hearing things that are of the pack doctor will decide if you should take small amounts may pass into mother’s milk. If not real (hallucinations) Zopiclone 7.5mg Tablets are white coloured, Zopiclone) you are breast-feeding or planning to • Feeling anxious, shaky, irritable, agitated, circular, film-coated tablets with a score line on Before taking Zopiclone Tablets, ensure that you breast-feed, talk to your doctor or pharmacist confused or having panic attacks one side. can have an uninterrupted sleep of 7 to 8 hours, before taking any medicine.