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What you need to know before you take ANTALGEX T CAPSULES

Do not take ANTALGEX T CAPSULES • if you are allergic to tramadol hydrochloride, paracetamol or any of the other ingredients of this medicine (listed in section 6) • in cases 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 have taken MAOIs in the last 14 days before treatment with ANTALGEX T CAPSULES. 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 Talk to your doctor before taking ANTALGEX T CAPSULES • if you take other medicines containing paracetamol or tramadol • if you have liver problems or disease as your eyes and skin may turn yellow, which may suggest jaundice • if you have kidney problems • if you have severe difficulties in breathing, for example asthma or severe lung problems • if you have epilepsy or have already experienced fits or seizures • if you suffer from depression and you are taking antidepressants as some of them may interact with tramadol (see “Other medicines and ANTALGEX T CAPSULES”); • if you have recently suffered from a head injury, shock or severe headaches associated with vomiting (being sick) • if you are dependent on any medicine (for example morphine) • if you take other medicines to treat pain that contain buprenorphine, nalbuphine or pentazocine • if you are going to have an anaesthetic (tell your doctor or dentist that you are taking ANTALGEX T CAPSULES). Sleep-related breathing disorders ANTALGEX T CAPSULES contains an active substance that belongs to the group of opioids. Opioids can cause sleeprelated breathing disorders, for example central sleep apnea (shallow/pause of breathing during sleep) and sleep-related hypoxemia (low level of oxygen in the blood). The risk of experiencing central sleep apnea is dependent on the dose of opioids. Your doctor may consider decreasing your total opioid dosage if you experience central sleep apnea. There is a small risk that you may experience a so-called serotonin syndrome that can occur after having taken tramadol in combination with certain antidepressants or tramadol alone. Seek medical advice immediately if you have any of the symptoms related to this serious syndrome (see section 4 “Possible side effects”). Tramadol is transformed in the liver by an enzyme. Some people have a variation of this enzyme and this can affect people in different ways. In some people, they may not get enough pain relief but other people are more likely to get serious side effects. 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. If any of the above-mentioned points applied to you in the past or applies to you while you are taking ANTALGEX T CAPSULES, please make sure your doctor knows. He/she can then decide whether you should continue to use this medicine. Children and adolescents Use in children with breathing problems: Tramadol is not recommended in children with breathing problems, since the symptoms of tramadol toxicity may be worse in these children. Talk to your doctor if you experience any of the following symptoms while taking ANTALGEX T CAPSULES: Extreme fatigue, lack of appetite, severe abdominal pain, nausea, vomiting or low blood pressure. This may indicate that you have adrenal insufficiency (low cortisol levels). If you have these symptoms, contact your doctor, who will decide if you need to take hormone supplement. Other medicines and ANTALGEX T CAPSULES Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. Do not exceed the maximum daily doses of paracetamol or tramadol from this or other medicines. Do not take ANTALGEX T CAPSULES with MAOIs (see section ‘Do not take ANTALGEX T CAPSULES’). ANTALGEX T CAPSULES is not recommended to be taken with the following: • carbamazepine (a medicine used to treat epilepsy or some types of pain) • buprenorphine, nalbuphine or pentazocine (opioid-type pain relievers). Please inform your doctor or pharmacist if you are taking: • flucloxacillin (antibiotic), due to a serious risk of blood and fluid abnormality (high anion gap metabolic acidosis which occurs when there is an increase in blood plasma acidity) that must have urgent treatment and which may occur particularly in case of severe kidney or liver impairment, sepsis (when bacteria and their toxins circulate in the blood leading to organ damage), malnutrition, chronic alcoholism, and if the maximum daily doses of paracetamol are used, especially if you take the maximum daily dose of paracetamol for longer time. High anion gap metabolic acidosis is a serious disease that must have urgent treatment. The risk of side effects increases: • if you are taking triptans (used for migraine) or selective serotonin re-uptake inhibitors (SSRIs, used for depression). Check with your doctor if you experience confusion, restlessness, fever, sweating, uncoordinated movement of limbs or eyes, uncontrollable jerking of muscles or diarrhoea. • if you are taking 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 feel faint. Concomitant use of ANTALGEX T CAPSULES and sedative medicines such as benzodiazepines or related drugs increases the risk of drowsiness, difficulties in breathing (respiratory depression), coma and may be lifethreatening. Because of this, concomitant use should only be considered when other treatment options are not possible. However if your doctor prescribes ANTALGEX T CAPSULES together with sedative medicines the dose and duration of concomitant treatment should be limited by your doctor. Please tell your doctor about all sedative medicines you are taking, and follow your doctor’s dose recommendation closely. It could be helpful to inform friends or relatives to be aware of the signs and symptoms stated above. Contact your doctor when experiencing such symptoms. • 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 ANTALGEX T CAPSULES at the same time. Your doctor will tell you whether ANTALGEX T CAPSULES is suitable for you. • if you are taking certain antidepressants. ANTALGEX T CAPSULES may interact with these medicines and you may experience serotonin syndrome (see section 4 “Possible side effects”). • if you are taking warfarin or phenprocoumon (for blood thinning). The effectiveness of such medicines may be altered and bleeding may occur (see section 4). The effectiveness of ANTALGEX T CAPSULES may be altered if you also take: • metoclopramide, domperidone or ondansetron (medicines used to treat nausea and vomiting/being sick) • cholestyramine (medicine used to reduce cholesterol in the blood) ANTALGEX T CAPSULES with food and alcohol Do not drink alcohol while you are taking ANTALGEX T CAPSULES, as you may feel drowsier. Pregnancy, breast-feeding and fertility 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. Do not take ANTALGEX T CAPSULES while you are pregnant or breast-feeding. Check with your doctor if you become pregnant during treatment with ANTALGEX T CAPSULES and before taking any further tablets. Breast-feeding Tramadol is excreted into breast milk. For this reason, you should not take ANTALGEX T CAPSULES more than once during breast-feeding, or alternatively, if you take ANTALGEX T CAPSULES more than once, you should stop breastfeeding. Based on human experience tramadol is suggested not to influence female or male fertility. No data on the influence of the combination of tramadol and paracetamol on fertility are available. Ask your doctor or pharmacist for advice before taking any medicine. Driving and using machines If you feel drowsy while taking ANTALGEX T CAPSULES, do not drive, use tools or use 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. ANTALGEX T CAPSULES contains lactose Lactose is an ingredient in these tablets. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product. ANTALGEX T CAPSULES contains sodium This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free’