Package leaflet: Information for the user Trampalgin 37.5 mg/325 mg tablets tramadol hydrochloride/paracetamol 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 or nurse. • 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 or nurse. This includes any possible side effects not listed in this leaflet. See section 4. What is in this leaflet: 1. What Trampalgin is and what it is used for 2. What you need to know before you take Trampalgin 3. How to take Trampalgin 4. Possible side effects 5. How to store Trampalgin 6. Contents of the pack and other information 1. What Trampalgin is and what it is used for Trampalgin is composed of two pain relieving active substances, tramadol and paracetamol. Trampalgin is used to treat moderate to severe pain when your doctor recommends that a combination of tramadol and paracetamol is needed. Trampalgin is intended for adults, adolescents and children over 12 years of age. 2. What you need to know before you take Trampalgin Do not take Trampalgin • if you are allergic (hypersensitive) to the active substances tramadol and paracetamol or any of the other ingredients of Trampalgin • in cases of acute poisoning with alcohol, sleeping pills, pain relievers or psychotropic drugs (that affect mood, emotions and state of mind). • if you are also taking medicines called monoamine oxidase inhibitors (MAOIs) or have taken MAOIs in the last 14 days before treatment with Trampalgin. MAOIs are used in the treatment of depression or Parkinson’s disease. • if you have a severe liver disorder. • if you have epilepsy that is not adequately controlled by your current medicine. Warnings and precautions Take special care with Trampalgin if you 1/ 7 • take other medicines containing also active substances paracetamol or tramadol. • have liver disease as your eyes and skin may turn yellow, which may suggest jaundice. • have kidney problems. • have severe difficulties in breathing, for example asthma or severe lung problems. • have epilepsy or have already experienced fits or seizures. • have recently suffered from a head injury, shock or severe headaches associated with vomiting (being sick). • think you are addicted to other analgesics, for example morphine. • take other medicines to treat pain that contain buprenorphine, nalbuphine or pentazocine. • are going to have an anaesthetic (tell your doctor or dentist that you are taking Trampalgin). Should any of these problems occur during the treatment with Trampalgin or has it occurred in the past, inform your doctor. Please, pay attention to the fact that the active substance tramadol may induce physical or psychic dependence. The effect of tramadol may diminish with long-term use (the development of tolerance) and an increase in dosage may be needed. A treatment by Trampalgin of patients with drug-abusing tendencies or drug-dependent patients should be only for a short term under strict medical supervision. Children Trampalgin is not recommended in children under 12 years of age. Other medicines and Trampalgin Please inform your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. Trampalgin contains paracetamol and tramadol. Tell your doctor if you take any other medicine containing also paracetamol or tramadol. Do not exceed the total maximum daily doses of paracetamol or tramadol from this or other medicines. Do not take Trampalgin with MAOIs (see section Do not take Trampalgin). Trampalgin is not recommended with the following medicines: • carbamazepine (a medicine used to treat epilepsy or some types of pain) • buprenorphine, nalbuphine or pentazocine (opioid type pain relievers). Their pain relieving effect my be decreased. Trampalgin may increase the risk of side effects if you also take the following medicines: • medicines which may cause convulsions (fits), such as certain antidepressants,antipsycotics or bupropion. The risk of having a fit may increase if you take Trampalgin at the same time. Your doctor will tell you whether Trampalgin is suitable for you. • certain antidepressants such as selective serotonin re-uptake inhibitors (SSRIs) or triptans (used for migraine) . Trampalgin may interact with these medicines and you may experience symptoms such as involuntary, rhytmic contractions of muscles, including the muscles that control movement of the eye, agitation, excessive sweating, tremor, exaggeration of reflexes, increased muscle tension or body temperature above 38oC. 2/ 7 • tranquilizers, sleeping pills, other pain relievers such as morphine and codeine (also as cough medicine), baclofen (a muscle relaxant), medicines used to lower blood pressure, antidepressants or medicines to treat allergies. Check with your doctor if you feel drowsy or feel faint. • warfarin or phenprocoumon (for blood thinning). The effectiveness of such medicines may be altered and bleeding may occur (see section 4). Inform your doctor about any prolonged or unexpected bleeding. The effectiveness of Trampalgin may also be altered if you take the following medicines concomitantly: • metoclopramide, domperidone or ondansetron (medicines used to treat nausea and vomiting/being sick) • cholestyramine (medicine used to reduce cholesterol in the blood) • ketoconazole or erythromycin (medicines used against infections). Trampalgin with food and drink Do not drink alcohol while you are taking Trampalgin. Pregnancy, breast-feeding and fertility If you are pregnant or think you may be pregant, or if you are breast-feeding, ask your doctor for advice before taking any medicine. Do not take Trampalgin while you are pregnant. Inform your doctor if you become pregnant during treatment with Trampalgin. Trampalgin is not recommended while you are breastfeeding, as small amounts of tramadol may pass into the breast-milk. Driving and using machines If you feel drowsy while taking Trampalgin, do not drive, use tools or use machinery. 3. How to take Trampalgin Always take Trampalgin exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure. The dosage should be adjusted to the intensity of the pain and your individual pain sensitivity. In general the lowest pain-relieving dose should be taken. Take Trampalgin for as short a time as possible and no longer than your doctor has told you. Use in adults, adolescents and children over 12 years of age The recommended dosage is to start with 2 tablets, unless otherwise prescribed by your doctor. If required, further doses may be taken, as instructed by your doctor. The shortest time between doses must be at least 6 hours. Do not take more than 2 tablets in a single dose or 8 tablets per day. Your doctor may increase the time between doses: • if you are older than 75 years. 3/ 7 • if you have kidney problems. • if you have liver problems. Swallow the tablets whole with sufficient liquid. If you think that the effect of Trampalgin is too strong (you feel very drowsy or have difficulty breathing) or too weak (you do not have enough pain relief), contact your doctor. Use in children under 12 years of age Trampalgin is not recommended in children under 12 yers of age. Use in 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. Use in severe liver or kidney disease (insufficiency) patients Patients with severe liver and/or kidney insufficiency should not take Trampalgin. If in your case the insufficiency is mild or moderate, your doctor may recommend prolonging the dosage interval. If you take more Trampalgin than you should In case of overdose or accidentally taking this medicine by children seek immediately your doctor or the nearest hospital and tell them precisely what amount of this medicine was taken. Take all the remaining tablets and this package leaflet to your doctor. Overdose by paracetamol may cause serious impairment up to failure of liver function that may lead to death. If you forget to take Trampalgin If you forget to take the tablets, pain is likely to return. Do not take a double dose to make up for forgotten individual doses; simply continue taking the tablets as before. If you stop taking Trampalgin If you discontinue or abruptly interrupt the treatment with Trampalgin, the pain is likely to reappear. If you wish to discontinue the treatment due to the unpleasant side effects of the product, consult your doctor. The discontinuation of treatment with Trampalgin is not usually followed by withdrawal symptoms. After a discontinuation of long-term treatment, however, symptoms such as restlessness, anxiety, nervousness, panic attacks, hallucinations, unusual sensory sensations (itching, tingling, loss of sensation), tinnitus, insomnia, tremors or gastrointestinal symptoms may occur in some patients. Please contact your doctor, should any of these symptoms occur following the discontinuation of Trampalgin. If you have any further questions on the use of this product, ask your doctor or pharmacist. 4. Possible side effects Like all medicines, Trampalgin can have side effects although not everybody gets them. Some side effect could be serious.