Product Details

What you need to know before you take Neotigason

Do not take Neotigason if you are allergic to: • Acitretin or any of the other ingredients of Neotigason (listed in Section 7). • Other ‘retinoid’ medicines. These include isotretinoin and tazarotene. Do not take Neotigason if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before taking Neotigason. Do not take Neotigason if: • You are pregnant or breast-feeding. • there is any chance you could become pregnant, you must follow the precautions under ”Pregnancy and prevention programme”, see section on ”Warnings and precautions”. • You have liver or kidney problems. • You have very high levels of fat in your blood (also known as ‘hyperlipidaemia’). • You are taking an antibiotic called tetracycline (for an infection) or a medicine called methotrexate (for skin problems, arthritis or cancer). See the section on ‘Taking other medicines’. • You are taking other retinoid medicines or medicines, vitamin supplements or foods that contain Vitamin A. See the section on ‘Taking other medicines’. Do not take Neotigason if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before taking Neotigason. Warnings and precautions Talk to your doctor or pharmacist before taking Neotigason if: • You have diabetes. You will need to check your blood sugar levels more often when you start taking Neotigason. • You have high levels of fat in your blood, you are obese, drink a lot of alcohol or at risk of heart problems. Your doctor may need to do blood tests while you are taking Neotigason to check the amount of fat and/or sugar in your blood and check your blood pressure. • You are going out in strong sunlight or you are going to use a sun bed. Neotigason can make the e‑ects of UV light on the skin stronger. Before going out into strong sunlight apply a sunblock to exposed skin. • You have ever had any mental health problems including depression, aggressive tendencies or mood changes. This is because taking Neotigason may a‑ect your mood. Advice for all patients: Acitretin commonly increase blood fats, such as cholesterol or triglycerides which have been associated with pancreatitis. Tell your doctor if you experience severe pain in the abdomen and back (these can be signs of inammation of the pancreas). Mental health problems You may not notice some changes in your mood and behaviour and so it is very important that you tell your friends and family that this medicine could a‑ect your mood and behaviour. They may notice these changes and help you identify any problems that you need to talk to your doctor about. A serious condition which causes the small blood vessels (capillaries) to leak has been reported very rarely (Capillary Leak Syndrome/Retinoic Acid Syndrome). This can lead to severe hypotension (low blood pressure), oedema (build up of uid leading to swelling) and shock (collapse). Patient Information Leaet UK Neotigason 10mg and 25mg Capsules Acitretin WARNING CAN SERIOUSLY HARM AN UNBORN BABY Women must use e‑ective contraception Do not use if you are pregnant or you think you may be pregnant A serious skin reaction with symptoms such as rash, blistering or peeling of the skin (Exfoliative dermatitis) has been reported very rarely. Neotigason may a‑ect your liver function. Your doctor may need to do blood tests whilst you are taking this medicine to check your liver function. Neotigason may cause increased pressure in the head. You should tell your doctor if you experience severe headaches, feeling or being sick or changes in sight. Your doctor may carry out further checks. Neotigason may cause changes in bone growth. You should tell your doctor if you feel pain in your muscles or bones. Your doctor may carry out further checks. High doses of Neotigason can cause mood changes such as irritability, aggression, depression. Hair loss is a very common side e‑ect of Neotigason. If any of the above apply to you, or if you are not sure, talk to your doctor or pharmacist before you take Neotigason. Pregnancy prevention programme Women who are pregnant must not take Neotigason This medicine can seriously harm an unborn baby (the medicine is said to be ‘teratogenic’) – it can cause serious abnormalities of the unborn baby’s brain, face, ear, eye, heart and certain glands (thymus gland and parathyroid gland). It also makes a miscarriage more likely. This may happen even if Neotigason is taken only for a short time during pregnancy. • You must not take Neotigason if you are pregnant or if you think you might be pregnant. • You must not take Neotigason if you are breastfeeding. The medicine is likely to pass into your milk and may harm your baby. • You must not take Neotigason if you could get pregnant during treatment. • You must not get pregnant for 3 years after stopping this treatment because some medicine may still be left in your body. Women who could get pregnant are prescribed Neotigason under strict rules. This is because of the risk of serious harm to the unborn baby These are the rules: • Your doctor must explain the risk of harm to the unborn baby – you must understand why you must not get pregnant and what you need to do to prevent getting pregnant. • You must have talked about contraception (birth control) with your doctor. The doctor will give you information on how not to get pregnant. The doctor may send you to a specialist for contraception advice. • Before you start treatment, your doctor will ask you to take a pregnancy test. The test must show that you are not pregnant when starting treatment with Neotigason. Women must use e‑ective contraception before, during and after taking Neotigason • You must agree to use at least one very reliable method of contraception (for example an intra uterine device or contraceptive implant) or, two e‑ective methods that work in di‑erent ways (for example a hormonal contraceptive pill and a condom). Discuss with your doctor which methods would be suitable for you. • You must use contraception for a month before taking Neotigason, during treatment and for 3 years afterwards. • You must use contraception even if you do not have periods or you are not sexually active (unless your doctor decides this is not necessary). Women must agree to pregnancy testing before, during and after taking Neotigason • You must agree to regular follow-up visits, ideally every month. • You must agree to have regular pregnancy tests, ideally every month during treatment and, because some medicine may still be left in your body, every 1 to 3 months for 3 years after stopping Neotigason (unless your doctor decides this is not necessary in your case). • You must agree to extra pregnancy tests if your doctor asks you. • You must not get pregnant during treatment or for 3 years afterwards because some medicine may still be left in your body. • Your doctor will discuss all these points with you, using a checklist and will ask you (or a parent/guardian) to sign it. This form con­rms that you have been told about the risks and that you will follow the rules above. If you get pregnant while taking Neotigason, stop taking the medicine straight away, and contact your doctor. Your doctor may send you to a specialist for advice. Also if you become pregnant within 3 years after you stop taking Neotigason, you should contact your doctor. Your doctor may send you to a specialist for advice. Advice for men The levels of oral retinoid in the semen of men taking Neotigason are too low to harm their partners’ unborn baby. However, you must never share your medication with anyone. Additional precautions You should never give this medicinal product to another person. Please take any unused capsules to your pharmacist at the end of treatment. You should not donate blood during treatment with this medicine and for 3 years after stopping Neotigason because an unborn baby could be harmed if a pregnant patient receives your blood. Children Neotigason should not be given to children. Neotigason may cause changes in bone growth in children. Other medicines and Neotigason Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This includes medicines that you buy without a prescription and herbal medicines. This is because Neotigason can a‑ect the way some other medicines work. Also some other medicines can a‑ect the way Neotigason works. Talk to your doctor or pharmacist, if you are taking any of the following: • An antibiotic called tetracycline (for an infection). • A medicine called methotrexate (for skin problems, arthritis or cancer). • Other retinoid medicines, such as isotretinoin or tazarotene. • Medicines or vitamin supplements that contain Vitamin A. Tell your doctor or pharmacist if you are taking the following medicine: • Phenytoin (used to treat epilepsy). • Low dose progesterone only contraceptives (‘minipills’). Neotigason with food and alcohol Women of childbearing potential should not consume alcohol (in drinks, food or medicines) during treatment with Neotigason and for 2 months after cessation of therapy. Concurrent ingestion of Neotigason and alcohol may result in formation of a compound (etretinate), which may be harmful to an unborn child, and if formed takes some time for it to be totally removed from the body. Pregnancy, breast-feeding and fertility For more information on pregnancy and contraception, see section 2 “Pregnancy and prevention programme”. Driving and using machines Your vision may be a‑ected, particularly at night time, while you are taking Neotigason. Be careful if you are driving or using any tools or machines. Important information about some of the ingredients of Neotigason This medicine contains glucose, which is a type of sugar. If you have been told by your doctor that you cannot tolerate or digest some sugars (have an intolerance to some sugars), talk to your doctor before taking this medicine. This medicine contains less than 1 mmol sodium (23mg) per tablet, that is to say essentially ‘sodium-free’