Package leaflet: Information for the patient. Tramadol HCl/Paracetamol CF 37,5 mg / 325 mg, filmomhulde tabletten

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1 Package leaflet: Information for the patient Tramadol HCl/Paracetamol CF 37,5 mg / 325 mg, filmomhulde tabletten Tramadol hydrochloride 37.5 mg Paracetamol 325 mg Read all of this leaflet carefully before you start taking this medicine because it contains important information for you. - 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 only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. - If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. What is in this leaflet 1. What Tramadol HCl/Paracetamol CF is and what it is used for 2. What you need to know before you take Tramadol HCl/Paracetamol CF 3. How to take Tramadol HCl/Paracetamol CF 4. Possible side effects 5. How to store Tramadol HCl/Paracetamol CF 6. Contents of the pack and other information 1. What Tramadol HCl/Paracetamol CF is and what it is used for Tramadol HCl/Paracetamol CF is a combination of the two analgesics tramadol hydrochloride and paracetamol. Tramadol HCl/Paracetamol CF is used for the treatment of moderate to severe pain. Your doctor will prescribe you this medicine if he decides that a combination of tramadol hydrochloride and paracetamol is recommended. Tramadol HCl/Paracetamol CF should only be taken by adults and adolescents over 12 years. 2. What you need to know before you take Tramadol HCl/Paracetamol CF DO NOT take Tramadol HCl/Paracetamol CF If you are allergic to tramadol, paracetamol or any of the other ingredients of this medicine (listed in section 6). In case of acute alcohol poisoning. If you are taking sleeping pills, pain relievers or medicines that affect mood and emotions. If you are also taking medicines called monoamine oxidase inhibitors (MAOIs) or within two weeks after you have stopped the treatment. MAOIs are used in the treatment of depression or Parkinson s disease. If you suffer from severe liver disease. If you suffer from epilepsy that is not adequately controlled by your current medicine. Warnings and precautions Talk to your doctor or pharmacist before taking Tramadol HCl/Paracetamol CF: If you take other medicines containing paracetamol or tramadol. If you have severe kidney problems. In this case the use of Tramadol HCl/Paracetamol CF is not recommended. In cases of moderate kidney problems, the interval between doses should be increased to 12 hours. If you have liver problems or disease as your eyes and skin may turn yellow, which may suggest jaundice. 1

2 If you have severe difficulties in breathing, for example asthma or severe lung problems. If you are dependent on any medicine (for example morphine). If you have recently suffered from a head injury, shock or severe headaches associated with vomiting (being sick). If you have epilepsy or have already experienced fits or seizures. If you are in a reduced consciousness for unknown reasons. If you are going to have an anaesthetic. Tell your doctor or dentist that you are taking Tramadol HCl/Paracetamol CF In all cases described above, this medicine should only be used with caution. Tramadol must not be taken as a substitute therapy in opioid-dependent patients, since it does not suppress morphine withdrawal symptoms. Tramadol can cause convulsions even at the recommended doses. Epileptic patients controlled by a treatment, or those susceptible to fits or seizures should therefore not be treated with Tramadol HCl/Paracetamol CF unless absolutely necessary. Children Treatment with Tramadol HCl/Paracetamol CF is not recommended in children under the age of 12 years. The efficacy and safety of use in children has not been established. Abuse Even at therapeutic doses, tolerance and withdrawal symptoms may develop. Rarely, cases of physical and/or psychological dependence and abuse have been reported. Other medicines and Tramadol HCl/Paracetamol CF Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. Important: This medicine contains paracetamol and tramadol. Tell your doctor if you are taking any other medicine containing paracetamol or tramadol, so that you do not exceed the maximum daily doses. Tramadol HCl/Paracetamol CF must not be taken in combination with: MAO inhibitors (used in the treatment of depression or Parkinson s disease), since there is a risk of getting serotoninergic syndrome. Symptoms of serotoninergic syndrome include diarrhoea, increased heartbeat, sweating, tremor, confusion and even coma. In case of recent treatment with MAO inhibitors, you have to maintain a delay of two weeks before you start the treatment with tramadol. Tramadol HCl/Paracetamol CF should not be taken in combination with: Carbamazepine (a medicine used to treat epilepsy or some types of pain). If you take these medicines simultaneously the efficacy and the duration of effect of tramadol will be reduced. Painkillers (buprenorphine, nalbuphine, pentazocine). If you take these medicines simultaneously the pain-relieving effect of Tramadol HCl/Paracetamol CF is reduced, with the risk of occurrence of withdrawal syndrome. The risk of side effects increases if you are taking medicines which may cause convulsions (fits), such as certain antidepressants or antipsychotics. The risk having a fit may increase if you take Tramadol HCl/Paracetamol CF at the same time. Your doctor will tell you whether Tramadol HCl/Paracetamol CF is suitable for you. if you are taking certain antidepressants. Tramadol HCl/Paracetamol CF may interact with these medicines and you may experience symptoms such as involuntary, rhythmic contractions of muscles, including the muscles that control movement of the eye, 2

3 agitation, excessive sweating, tremor, exaggeration of reflexes, increased muscle tension, body temperature above 38 C. Furthermore Tramadol HCl/Paracetamol CF should not be taken in combination with: Triptans used for migraine. Tramadol HCl/Paracetamol CF may interact with these medicines and you may experience symptoms such as involuntary, rhythmic contractions of muscles, including the muscles that control movement of the eye, agitation, excessive sweating, tremor, exaggeration of reflexes, increased muscle tension, body temperature above 38 C. Other opioid derivatives (including cough medicines and substitutive treatments), barbiturates and benzodiazepines (sedatives). If you take these medicines simultaneously the risk of respiratory depression can increase, which can be fatal in cases of overdose. Other central nervous system depressants, anxiolytics (used to lower fear), hypnotics, sedative antidepressants, sedative anti-histamines (used to treat allergies), neuroleptics (used to treat psychosis), centrally-acting antihypertensive medicines (used to lower blood pressure), thalidomide (a sedative) and baclofen (a muscle relaxant). These medicines may cause worsening of central depression. The effect on alertness may make driving vehicles and using machines dangerous. Warfarin-like medicines (used for blood thinning). Your doctor might have to evaluate prothrombin time regularly. Other medicines known to inhibit the liver enzyme CYP3A4, such as ketoconazole and erythromycin. Metoclopramide or domperidone (medicines used to treat nausea and vomiting/being sick). The absorption of paracetamol may be increased if you take these medicines simultaneously. Cholestyramine (medicine used to reduce cholesterol in the blood), since the absorption of Tramadol HCl/Paracetamol CF may be reduced. If you have taken ondansetron (used to treat nausea) the effectiveness of Tramadol HCl/Paracetamol CF may be altered. Tramadol HCl/Paracetamol CF with food, drink and alcohol Tramadol HCl/Paracetamol CF can be taken with or without food. You should not drink any alcohol during the treatment, since alcohol increases the sedative effect of Tramadol HCl/Paracetamol CF. Pregnancy and breast-feeding If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. Pregnancy You should not use this medicine during pregnancy. The long-term treatment during pregnancy may result in withdrawal symptoms in the newborn, as a consequence of habituation. Breast-feeding This medicine is excreted into human breast milk. You should not take this medicine while you are breast-feeding, as small amounts of tramadol may pass into the breast-milk. Driving and using machines This medicine may cause drowsiness or dizziness, which may be enhanced by alcohol or other depressants, which react with the central nervous system. If you feel drowsy or dizzy you should not drive or use machines. 3. How to take Tramadol HCl/Paracetamol CF Always take this medicine exactly as your doctor has told you. Check with your doctor or 3

4 pharmacist if you are not sure. The dosage should be adjusted to the intensity of your pain and your individual pain sensitivity. In general the lowest pain-relieving dose should be taken. The recommended dose is: Adults and adolescents (aged 12 years or over): A starting dose of 1 tablet in the morning and 1 tablet in the evening is recommended. The interval between two administrations should not be less than 6 hours. If necessary, you can take more tablets per day, but you should not exceed the maximum daily dose of 8 tablets (equivalent to 300 mg of tramadol and 2600 mg of paracetamol) and you should not take other medicines containing paracetamol or tramadol hydrochloride in order to avoid overdose. Elderly Patients: In elderly patients (above 75 years) the excretion of tramadol may be delayed. If this applies to you, your doctor may recommend prolonging the dosage interval. Severe liver or kidney disease (insufficiency)/dialysis patients: Patients with severe liver and/or kidney insufficiency should not take Tramadol HCl/Paracetamol CF. If in your case the insufficiency is mild or moderate, your doctor may recommend prolonging the dosage interval. Method of administration You have to take the tablets orally. You should swallow the tablets whole, with a sufficient quantity of liquid (e.g. a 200 ml glass of water). The tablets should not be broken or chewed. Duration of treatment You should not take this medicine for longer than strictly necessary. If repeated or prolonged treatment with this medicine is required (owing to the nature and severity of the disorder), careful, regular monitoring should be carried out to assess whether the treatment needs to be continued. Whenever possible, breaks in the treatment should be included during long-term treatment. If you take more Tramadol HCl/Paracetamol CF than you should If you have taken more tablets than you should, you must contact your doctor or the nearest emergency department immediately. In case of an overdose, you may experience nausea (feeling sick), miosis (pupil constriction), vomiting (being sick), anorexia (less appetite), abdominal pain, cardiovascular collapse, consciousness disorders including coma, convulsions and respiratory depression which can cause respiratory arrest. Liver damage may appear 12 or 48 hours after ingestion. In severe poisoning, liver failure may lead to severe brain disease (encephalopathy), coma and death. Acute kidney failure with tubular necrosis (cell destruction) may develop, even in the absence of severe liver damage. Cardiac arrhythmias (irregular heartbeat) and pancreatitis (inflammation of the pancreas) have also been reported. If you forget to take Tramadol HCl/Paracetamol CF If you forget to take this medicine you can skip the missed dose and continue the treatment as normal, or you can take the missed tablet but have to keep a 6 hour interval to the next intake. Do not take a double dose to make up for a forgotten tablet. If you stop taking Tramadol HCl/Paracetamol CF Do not stop taking this medicine without consulting your doctor. 4

5 If therapy is no longer necessary the treatment should be stopped by gradually reducing the dose to prevent withdrawal symptoms. If you have any further questions on the use of this medicine, ask your doctor or pharmacist. 4. Possible side effects Like all medicines, this medicine can cause side effects, although not everybody gets them. Very common: may affect more than 1 in 10 people dizziness, somnolence, feeling sick. Common: may affect up to 1 in 10 people confusion, mood changes (anxiety, nervousness, elation), sleep disorders, headache, shiver, vomiting (being sick), constipation, dry mouth, diarrhoea, abdominal pain, indigestion, flatulence, sweating, itching. Uncommon: may affect up to 1 in 100 people depression, hallucinations, nightmares, memory loss, involuntary muscular contractions, tingling or numbness, ringing in the ears, high blood pressure, palpitations, fast heartbeat, irregular heartbeat, laboured breathing, difficulty in swallowing, blood stained stools, elevated transaminase (a liver enzyme) levels, skin reactions (e.g. rash, urticaria), albuminuria (albumin (a protein) in the urine), urination disorders (dysuria, urinary retention), shivers, hot flushes, chest pain. Rare: may affect up to 1 in 1,000 people drug dependence, lack of coordination, fits (seizures), fainting, blurred vision. Not known: frequency cannot be estimated from the available data decrease in blood sugar level (hypoglycaemia). Very rare: may affect up to 1 in 10,000 people abuse. The following are recognised side effects which have been reported by people using medicines that contain only tramadol or only paracetamol. However, if you experience any of these while taking Tramadol HCl/Paracetamol CF, you should tell your doctor: Very rare cases of serious skin reactions have been reported. worsening of asthma. feeling faint when getting up from a lying or sitting position, slow heart rate, fainting, changes in appetite, muscle weakness, slower or weaker breathing, mood changes, changes in activity, changes in perception In some rare cases a skin rash, indicating an allergic reaction, may develop with sudden swelling of the face and neck, difficulties breathing or drop of blood pressure and fainting. 5

6 If this happens to you, stop treatment and see a doctor immediately. You must not take the medicine again. In rare cases, using a medicine of the type of tramadol may make you become dependent on it, making it hard to stop taking it. On rare occasions, people who have been taking tramadol for some time may feel unwell if they stop treatment abruptly. They may feel agitated, anxious, nervous or shaky. They may be hyperactive, have difficulty sleeping and have stomach or bowel disorders. Very few people may also get panic attacks, hallucinations, unusual perceptions such as itching, tingling and numbness, and noise in the ears (tinnitus). If you experience any of these complaints after stopping Tramadol HCl/Paracetamol CF, please consult your doctor. In exceptional cases blood tests may reveal certain abnormalities, for instance, low counts of blood platelets, which may result in nose bleeds or bleeding gums. Use of Tramadol HCl/Paracetamol CF together with medicines used to thin the blood (e.g. phenprocoumon, warfarin) may increase the bleeding risk. Any prolonged or unexpected bleeding should be reported to your doctor immediately. Reporting of side effects If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine. 5. How to store Tramadol HCl/Paracetamol CF Keep this medicine out of the sight and reach of children. Do not use this medicine after the expiry date which is stated on the blister pack and on the carton. The expiry date refers to the last day of that month. This medicinal product does not require any special storage conditions. Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment. 6. Contents of the pack and other information What Tramadol HCl/Paracetamol CF contains The active substances are: 37.5 mg tramadol hydrochloride and 325 mg paracetamol. The other ingredients are: Film-coated tablet core: Pre-gelatinised Starch Maize Starch Sodium Starch Glycolate (Type A) Microcrystalline cellulose (Avicel PH 102) Magnesium stearate Film-coating: Opadry yellow 03K82345 (Hypromellose 6 cps (E464), Titanium dioxide (E171), Triacetin, Iron oxide yellow (E172)) 6

7 What Tramadol HCl/Paracetamol CF looks like and contents of the pack Light yellow, oblong, biconvex, film-coated tablet. Cartons containing 2, 10, 20, 30, 40, 50, 60, 70, 80, 90 or 100 tablets. Not all pack sizes may be marketed. Marketing Authorisation Holder and Manufacturer Marketing Authorisation Holder: Centrafarm B.V. Nieuwe Donk AC Etten-Leur Nederland Manufacturer: Laboratoires BTT Zone lndustrielle de Krafft Erstein Frankrijk Medis International a.s. vyrobni závod Bolatice, Prumyslová 961/ Bolatice Tsjechië STADA Arzneimittel AG Stadastrasse Bad Vilbel Duitsland In het register ingeschreven onder Tramadol HCl/Paracetamol CF 37,5 mg / 325 mg, filmomhulde tabletten RVG This medicinal product is authorised in the Member States of the EEA under the following names: België: Tramadol/Paracetamol EG 37,5/325 mg filmomhulde tabletten Duitsland: Tramadolhydrochlorid/Paracetamol STADA 37,5 mg/325 mg Filmtabletten Ierland: Xymel Comp 37.5 mg/325 mg film-coated tablets Luxemburg: Tramadol/Paracetamol EG 37,5/ 325mg comprimés pelliculés Nederland: Tramadol HCl/Paracetamol CF 37,5 mg / 325 mg, filmomhulde tabletten Portugal: Tramadol+Paracetamol Ciclum 37,5 mg mg comprimidos revestidos por pelicula Spanje: Tramadol/Paracetamol STADA 37,5 mg/325 mg comprimidos recubiertos con pelicula Tsjechië: DIALGON 37,5 mg/325 mg Deze bijsluiter is voor het laatst goedgekeurd in april