Product Details

What you need to know before you take Naltrexone 50 mg film-coated tablets

Do not take Naltrexone 50 mg film-coated tablets – if you are allergic to Naltrexone hydrochloride or any of the other ingredients of this medicine (listed in section 6) – if you are taking opioid-containing drugs – if you are opioid-addicted (without successful withdrawal) – if you experience acute symptoms of opioid withdrawal – if your urine test is positive for opioids – if you experience withdrawal symptoms after a naloxone injection – if you have severe liver problems or acute hepatitis (inflammation of the liver) – if you have severe kidney problems Warnings and precautions – Your treatment should be started and supervised by a physician experienced in treatment of alcohol addiction. – You must inform every doctor treating you that you are taking Naltrexone 50 mg film-coated tablets. – Naltrexone 50 mg film-coated tablets may cause life-threatening withdrawal symptoms to opioidaddicted patients – Please inform your doctor if you are suffering from liver or kidney diseases. Liver function tests should be conducted before and during therapy. 3 – If you go for any blood tests, inform your doctor that you are taking Naltrexone 50 mg film-coated tablets as these tablets can affect the results of liver function tests. – During treatment with Naltrexone 50 mg film-coated tablets painful conditions should not be treated with opioids. – After treatment with Naltrexone 50 mg film-coated tablets you might be more sensitive to opioid containing medicines. (e.g. opioid containing cough medication, opioid containing medication for symptomatic treatment of common cold or opioid containing medication for diarrhea etc.). – Please inform your doctor if you become pregnant. – For patients with additional opioid-addiction: Do not take opioids after use of Naltrexone 50 mg film-coated tablets. Although Naltrexone 50 mg film-coated tablets inhibit the opioid-effect there might be opioids in your body when efficacy of Naltrexone 50 mg film-coated tablets has already decreased. Accidentally overdoes might have severe or fatal consequences (respiratory depression). Other medicines and Naltrexone 50 mg film-coated tablets Tell your doctor or pharmacist if you are taking/using, have recently taken/used or might take/use any other medicines. During treatment with Naltrexone 50 mg film-coated tablets opioid containing medicines should be avoided as the effect might be decreased. Please inform your doctor if you take drugs against cough, common cold, diarrhoea or pain. He will prescribe non-opioid containing medicines. If you need opioid analgesia in emergency situations the dose needed may be higher than normal. In this situation a close attention by an experienced physician is strictly required because respiratory depression, circulatory disturbance and other symptoms (itching and other skin manifestations) might be stronger and longer lasting. 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. The doctor has to decide whether Naltrexone 50 mg film-coated tablets can be taken during pregnancy and lactation considering the risk for mother and child. Driving and using machines Driving vehicles should be avoided. Do not use any tools or machines since Naltrexone 50 mg film-coated tablets may impair the mental and physical abilities. Naltrexone 50 mg film-coated tablets contain lactose. If you have been told by your doctor that you have intolerance to some sugars, please contact your doctor before taking this medicinal product.