Package leaflet: information for the user Tramadol/Paracetamol Xantis 75 mg/650 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. - 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/Paracetamol Xantis 75 mg/650 mg is and what it is used for 2. What you need to know before you take Tramadol/Paracetamol Xantis 75 mg/650 mg 3. How to take Tramadol/Paracetamol Xantis 75 mg/650 mg 4. Possible side effects 5. How to store Tramadol/Paracetamol Xantis 75 mg/650 mg 6. Contents of the pack and other information 1. What Tramadol/Paracetamol Xantis 75 mg/650 mg is and what it is used for Tramadol/Paracetamol Xantis 75 mg/650 mg is composed of two pain relieving active substances, tramadol and paracetamol. Tramadol/Paracetamol Xantis 75 mg/650 mg is used to treat moderate to severe pain when your doctor recommends that a combination of tramadol and paracetamol is needed. Tramadol/Paracetamol Xantis 75 mg/650 mg is indicated for adults, adolescents and children over 12 years of age. 2. What you need to know before you take Tramadol/Paracetamol Xantis 75 mg/650 mg Do not take Tramadol/Paracetamol Xantis 75 mg/650 mg • if you are allergic to tramadol, paracetamol or any of the other ingredients of this medicine (listed in section 6) • 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 taking medicines called monoamine oxidase inhibitors (MAOIs) or have taken MAOIs in the last 14 days before treatment with Tramadol/Paracetamol Xantis 75 mg/650 mg (MAOIs are used to treat 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 Talk to your doctor before taking Tramadol/Paracetamol Xantis 75 mg/650 mg - if you take other medicines containing also active substances paracetamol or tramadol - if you have liver disease, or your eyes and skin turn yellow, which may suggest jaundice - if you have kidney problems - if you have severe difficulties with breathing, for example asthma or severe lung problems - if you have epilepsy or have already experienced fits or seizures - if you have recently suffered from a head injury, shock or severe headaches associated with vomiting (being sick) - if you think you are addicted to other analgesics, for example morphine 1 - if you take other medicines to treat pain that contain buprenorphine, nalbuphine or pentazocine - if you are going to have an anaesthetic administered (tell your doctor or dentist that you are taking Tramadol/Paracetamol Xantis 75 mg/650 mg) Should any of these problems occur during the treatment with Tramadol/Paracetamol Xantis 75 mg/650 mg 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 Tramadol/Paracetamol Xantis 75 mg/650 mg of patients with drug-abusing tendencies or drug-dependent patients should be only for a short term under strict medical supervision. Children Tramadol/Paracetamol Xantis 75 mg/650 mg is not recommended for children under 12 years. Other medicines and Tramadol/Paracetamol Xantis 75 mg/650 mg Tell your doctor if you are taking, have recently taken or might take any other medicines. Tramadol/Paracetamol Xantis 75 mg/650 mg 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 (see section 3). Do not take Tramadol/Paracetamol Xantis 75 mg/650 mg with MAOIs (see section Do not take Tramadol/Paracetamol Xantis 75 mg/650 mg). Tramadol/Paracetamol Xantis 75 mg/650 mg 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 may be decreased Tramadol/Paracetamol Xantis 75 mg/650 mg may increase the risk of side effects if you also take the following medicines - certain antidepressants (such as selective serotonin re-uptake inhibitors, SSRIs) and triptans (used for migraine). Tramadol/Paracetamol Xantis 75 mg/650 mg 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. - 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 or medicines to treat allergies. Check with your doctor if you feel drowsy or faint. - medicines which may cause convulsions (fits), such as certain antidepressants or antipsychotics (medicine affecting your state of mind) or bupropion (medicine used to stop smoking). The risk of having a fit may increase if you take Tramadol/Paracetamol Xantis 75 mg/650 mg at the same time. Your doctor will tell you whether Tramadol/Paracetamol Xantis 75 mg/650 mg is suitable for you. - 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 Tramadol/Paracetamol Xantis 75 mg/650 mg may be also altered if you take concomitantly the following medicines - 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). 2 Tramadol/Paracetamol Xantis 75 mg/650 mg with food, drink and alcohol Do not drink alcohol while you are taking Tramadol/Paracetamol Xantis 75 mg/650 mg because you can feel sleepy. 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. Tramadol/Paracetamol Xantis 75 mg/650 mg should not be taken during pregnancy or breast-feeding. Driving and using machines Tramadol/Paracetamool Xantis 75 mg/650 mg may make you feel sleepy. If you feel drowsy while taking Tramadol/Paracetamol Xantis 75 mg/650 mg, do not drive, use tools or use machinery. 3. How to take Tramadol/Paracetamol Xantis 75 mg/650 mg Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure. Take Tramadol/Paracetamol Xantis 75 mg/650 mg for as short time period as possible and no longer than your doctor has told you. 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. Adults, adolescents and children over 12 years of age - The recommended dose is 1 tablet, unless otherwise prescribed by your doctor. If required, further doses may be taken, as instructed by your doctor. - Tablet can be divided into equal doses. - Swallow the tablets with sufficient liquid. - The shortest time between doses must be at least 6 hours. - Do not take more than 4 tablets per day. If you think that the effect of Tramadol/Paracetamol Xantis 75 mg/650 mg 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 Tramadol/Paracetamol Xantis 75 mg/650 mg is not recommended in children under 12 years of age. Elderly In elderly (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/Paracetamol Xantis 75 mg/650 mg. If in your case the insufficiency is mild or moderate, your doctor may recommend prolonging the dosage interval. If you take more Tramadol/Paracetamol Xantis 75 mg/650 mg than you should In case of overdose or accidental taking this medicine by children see 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 with paracetamol may cause serious impairment progressing to failure of liver function that may lead to death. If you forget to take Tramadol/Paracetamol Xantis 75 mg/650 mg If you forget to take the tablets, pain is likely to return. Do not take a double dose to make up for a forgotten dose, simply continue taking the tablets as before. 3 If you stop taking Tramadol/Paracetamol Xantis 75 mg/650 mg If you discontinue or abruptly interrupt the treatment with Tramadol/Paracetamol Xantis 75 mg/650 mg, the pain is likely to reappear.