PACKAGE LEAFLET: INFORMATION FOR THE USER

Transcription

1 CO-CODAMOL 8 mg/500 mg TABLETS PACKAGE LEAFLET: INFORMATION FOR THE USER Read all of this leaflet carefully before you start taking this medicine. Keep this leaflet. You may need to read it again. If you have any further questions, ask your doctor or pharmacist. 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 get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. IN THIS LEAFLET: 1. What Co-Codamol is and what it is used for 2. Before you take Co-Codamol 3. How to take Co-Codamol 4. Possible side effects 5. How to store Co-Codamol 6. Further information 1. WHAT CO-CODAMOL IS AND WHAT IT IS USED FOR Your tablets are called Co-Codamol Tablets. They are a mixture of two drugs paracetamol, which relieves pain and fever and codeine phosphate, a pain killer belong to a group of medicine called opoid analgesics. Co-Codamol is used in children over 12 years of age to treat pain, including muscular and rheumatic pains, headache, migraine, neuralgia, toothache, sore throat, period pains, aches and pains, discomfort associated with flu, feverishness and feverish colds. 2. BEFORE YOU TAKE CO-CODAMOL Codeine is transformed to morphine in the liver by an enzyme. Morphine is the substance that produces pain relief. Some people have a variation of this enzyme and this can affect people in different ways. In some people, morphine is not produced or produced in very small quantities, and it will not provide enough pain relief. Other people are more likely to get serious side effects because a very high amount of morphine is produced. If you notice any of the following side effects, you must stop taking this medicine and seek immediate medical advice: slow or shallow breathing, confusion, sleepiness, small pupils, feeling or being sick, constipation, lack of appetite. DO NOT take Co-Codamol if you: are allergic (hypersensitive) to paracetamol, codeine or any other opioid analgesics, or any of the other ingredients of this medicine listed in section 6, Further Information are taking any other products containing paracetamol, such as over-the-counter cold remedies have recently suffered a head injury or have suffered a serious illness or accident which resulted in increased pressure in the brain

2 suffer from alcoholism suffer from any disorder which may cause fits have breathing problems that are caused by bronchitis or asthma. are having an asthma attack have diarrhoea caused by poisoning or severe bloody diarrhoea (pseudomembranous colitis) are children and adolescents (0-18 years of age) and taking it for pain relief after removal of tonsils or adenoids due to obstructive sleep apnoea syndrome children know that you metabolise codeine very rapidly into morphine. are breastfeeding. Children and adolescents Use in children and adolescents after surgery Codeine should not be used for pain relief in children and adolescents after removal of their tonsils or adenoids due to Obstructive Sleep Apnoea Syndrome. Use in children with breathing problems Codeine is not recommended in children with breathing problems, since the symptoms of morphine toxicity may be worse in these children. Take special care with Co-Codamol Do not take for longer than directed by your prescriber. Taking codeine regularly for a long time can lead to addiction, which might cause you to feel restless and irritable when you stop taking the tablets. Taking a painkiller for headaches too often or for too long can make them worse. Your doctor will review your treatment with this medicine regularly to assess that the benefits of continued treatment outweigh any risks to you. Tell your doctor before you start to take this medicine if you: have any problems with your kidneys or liver suffer from an underactive thyroid gland, underactive adrenal glands or an enlarged prostate gland and have difficulty urinating and are male have low blood pressure have bowel problems have myasthenia gravis (muscle weakness) are suffering from shock suffer from allergies, for example to food, cosmetics, dust or drugs diseased adrenal glands (Addison s disease) or high blood pressure caused by a tumour near a kidney (phaeochromocytoma) gall bladder disease or gall stones recently had surgery on your gastro-intestinal tract or urinary system

3 epilepsy or suffered head injury or raised pressure in the skull (may cause painful eyes, changes in vision or headache behind the eyes) suffered from alcoholism, drug abuse or dependence or mental illness. Taking other medicines Talk to your doctor if you are taking any of the following: other pain killers which contain codeine monoamine oxidase inhibitors (e.g. phenelzine, moclobemide, for treatment of depression), or if you have stopped taking these within the last two weeks other medicines which depress the nervous system such as antidepressants (e.g. fluoxetine, amitriptyline), phenothiazines (e.g. chlorpromazine), hypnotics (e.g. temazepam) or sedatives (sleeping tablets, e.g. diazepam) anticoagulants e.g. warfarin (to stop your blood clotting) medicines for diarrhoea e.g. loperamide or kaolin medicines for muscle spasm e.g. dicyclomine or propantheline cholestyramine (to lower cholesterol) metoclopramide, cisapride or domperidone, cyclizine,(to stop you feeling or being sick) quinidine or mexiletine (for irregular heart rhythm) cimetidine (to reduce stomach acid) ciprofloxacin (antibacterial medicine) oral contraceptives (the pill ) guanethidine or diuretics ( water tablets ) e.g. spironolactone, furosemide (to treat high blood pressure) selegiline (for Parkinson s disease) phenytoin (to treat epilepsy) atropine or hyoscine (anticholinergic medicines) medicines which affect the liver (e.g. primidone and rifampicin) muscle relaxants barbiturates (e.g. phenobarbital) anaesthetics opioid antagonists (buprenorphine, naltrexone, naloxone) Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. Tell your doctor you are taking Co-Codamol if you are due to have an operation or any treatment which requires an anaesthetic. Diet If your diet is poor or you have a low protein intake, you may be at a higher risk of serious paracetamol poisoning when taking Co-codamol.

4 Taking Co-Codamol with food and drink Do not drink alcohol while you are taking Co-Codamol. Pregnancy and breast-feeding If you are pregnant, planning to become pregnant or are breast-feeding, ask your doctor for advice before taking this medicine. Do not take Co-codamol during pregnancy, unless advised by your doctor. Do not take codeine while breastfeeding. Codeine and morphine passes into breast milk. Regular use during pregnancy may cause withdrawal symptoms in the newborn. Driving and using machines Co-Codamol may cause dizziness or drowsiness, blurred vision or the inability to think clearly. If you are affected, do not drive or operate machinery. The medicine can affect your ability to drive as it may make you sleepy or dizzy. Do not drive while taking this medicine until you know how it affects you. It is an offence to drive if this medicine affects your ability to drive. However, you would not be committing an offence if: The medicine has been prescribed to treat a medical or dental problem and You have taken it according to the instructions given by the prescriber or in the information provided with the medicine and It was not affecting your ability to drive safely Talk to your doctor or pharmacist if you are not sure whether it is safe for you to drive while taking this medicine. 3. HOW TO TAKE CO-CODAMOL Always take Co-Codamol exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure. The tablets should be swallowed with a drink of water. You should leave at least four hours between doses and you should not take more than four doses in 24 hours. The usual dose is: Adults 1-2 tablets taken with a drink of water. The dose may be repeated every 4-6 hours, with a maximum of 8 tablets in 24 hours. Elderly

5 Your doctor will probably tell you to take a lower dose than the one normally recommended for adults Children 12 to 18 years old 1-2 tablets should not be repeated more frequently than every 6 hours and not more than 4 doses should be taken in any 24-hour period. Co-codamol should not be taken for more than 3 days. If pain does not improve after 3 days, talk to your doctor for advise. Children under 12 years old Co-Codamol is not recommended for use in Children under 12 years old due to risk of severe breathing problem. You may become tolerant to the effects of Co-Codamol if you need to take it for a long period of time. If you notice that the tablets are not working as well as they did when you first started taking them, you should go and see your doctor as an adjustment to your dose may be necessary. Do not take a higher dose or more often than the doctor has told you. If you take more Co-Codamol than you should If you (or someone else) take too many tablets all together, or if you think a child has accidentally swallowed any of the tablets, contact your nearest hospital casualty department or your doctor immediately, even if you feel well, because of the risk of delayed serious liver damage. An overdose is likely to cause feeling or being sick, loss of appetite, abdominal pain, irregular heartbeat, or pin-point-pupils. Please take this leaflet, any remaining tablets and the container with you to the hospital or doctor so that they know which tablets were consumed. If you forget to take Co-Codamol If you forget to take a tablet, take one as soon as you remember, unless it is nearly time to take the next one. Do not take a double dose to make up for a forgotten dose. If you stop taking Co-Codamol Do not stop taking your medicine without talking to your doctor first even if you feel better. Symptoms of restlessness and irritability may result when treatment is stopped after regular use. If you stop taking the tablets you may develop the following withdrawal symptoms tremor, difficulty sleeping, feeling or being sick, sweating and increased heart rate, breathing or blood pressure. If you have any further questions on the use of this product, ask your doctor or pharmacist. 4. POSSIBLE SIDE EFFECTS Like all medicines, Co-Codamol can cause side effects, although not everybody gets them.

6 Stop taking the tablets and tell your doctor immediately or go to the casualty department at your nearest hospital if the following happens: an allergic reaction causing swelling of the lips, face or neck leading to severe difficulty in breathing, or severe skin rash or hives. This is a very serious but rare side effect. You may need urgent medical attention or hospitalisation. Tell your doctor if you experience any of the following effects: fever or chills, sore throat, ulcers in you mouth or throat, unusual tiredness or weakness, unusual bleeding or unexplained bruising, if you have an increase in number of nose bleeds. you seem to be getting more infections than usual severe pain in the abdomen or back, usually accompanied by sickness, diarrhoea or fever. Tell your doctor if you notice any of the following side effects or notice any other effects not listed: Allergic Reactions - increased sweating, mucosal lesions (such as mouth ulcers), drug fever Gastrointestinal system - stomach irritation (mild stomach pain, heartburn and feeling sick), constipation, feeling or being sick, loss of appetite, dry mouth, difficulty in the passage of food through guts, abdominal pain (may be caused by spasm of the bile ducts) and inflammation of the liver or pancreas Heart - slow heart rate, palpitations, low blood pressure which causes light-headedness or fainting, inflammation of the heart muscle Blood - anaemia, changes in numbers and types of blood cells. Urinary system - pain and difficulty in passing urine and a less frequent need to do so, kidney problems. Nervous system - confusion, drowsiness, dizziness, spinning sensation, mood changes, depression, hallucinations (seeing or hearing things that are not real), restlessness, excitation, fits, increased pressure in the skull (painful eyes, changes in vision or headache behind the eyes), headache, difficulty sleeping, nightmares, reduced alertness, tolerance (medicine has less effect) or dependence (suffer from withdrawal symptoms e.g. tremor, sweating, increased heart rate, increased breathing rate, raised blood pressure and feeling or being sick if the medicine is stopped too quickly) Eyes - blurred or double vision, extremely small pupils Others - trembling, unusual tiredness or weakness, malaise, low body temperature, facial flushing, anxiety

7 If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. 5. HOW TO STORE CO-CODAMOL Keep out of the reach and sight of children. Store in a cool dry place. Do not use Co-Codamol after the expiry date that is stated on the outer 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 Co-Codamol Tablets contain: The active ingredients are codeine phosphate 8 mg and paracetamol 500 mg The other ingredients are maize starch, pregelatinised maize starch, povidone, hydroxybenzoate esters, sodium starch glycolate and magnesium stearate. What Co-Codamol Tablets look like and contents of the pack: Co-Codamol Tablets are white, coded CO-COD with a breakline on one side and a twin triangle logo on the reverse side. Co-Codamol Tablets are available in packs of 100 and 500 tablets. Not all pack sizes may be marketed. Marketing Authorisation Holder and Manufacturer Marketing Authorisation holder and company responsible for manufacture: TEVA UK Ltd, Eastbourne, BN22 9AG This leaflet was last revised: September 2014 PL 00289/1426