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What you need to know before you take Toctino

Do not take Toctino • If you are pregnant or breast-feeding • If there is any chance you could become pregnant, you must follow the precautions under “Pregnancy and prevention programme”, see section on “Warnings and precautions”. • If you have liver disease. • If you have severe kidney disease. • If you have high blood fats (such as high cholesterol or raised triglycerides). • If you have untreated thyroid disease. • If you have very high levels of vitamin A in your body (hypervitaminosis A). • If you are allergic to alitretinoin, to other retinoids (such as isotretinoin), to peanut or soya or any of the other ingredients of this medicine (listed in section 6). • If you are taking tetracycline (a type of antibiotic). Ø If any of these apply to you, go back to your doctor. You must not take Toctino. Warnings and precautions Talk to your doctor before taking Toctino: • If you have ever had any kind of mental health problems. This includes depression, aggressive tendencies or mood changes. It also includes thoughts about hurting yourself or ending your life. This is because your mood may be affected while taking Toctino. • If you have kidney disease. Toctino is not recommended for people with moderate kidney disease. If you have kidney disease – check with your doctor that Toctino is suitable for you. • If you have high blood fats, you may need blood tests more often. Toctino commonly increases blood fats, such as cholesterol or triglycerides. If your blood fats stay high, your doctor may lower your dose, or take you off Toctino. • If you have high blood sugar (diabetes), your blood sugar levels may need to be checked more often and your doctor may start you on a lower dose of Toctino. • If you have been suffering from thyroid disease. Toctino may lower your thyroid hormone levels. If your thyroid hormone level is low, your doctor may prescribe supplements. You need to take care during treatment: • If you experience any problems with your sight, tell your doctor immediately. Toctino may need to be stopped and your sight monitored. • If you get a persistent headache, nausea or vomiting (feeling or being sick) and blurred vision, these may be signs of a condition called benign intracranial hypertension. Stop the capsules immediately and contact your doctor as soon as possible. • If you have bloody diarrhoea stop the capsules immediately and contact your doctor as soon as possible. • Minimise your exposure to sunlight and avoid sun lamps. Your skin may become more sensitive to sunlight. Before you go out in the sun, use a sun protection product with a high protection factor (SPF 15 or higher). If you get dry skin and lips during treatment, use a moisturising ointment or cream and a lip balm. • Cut down on intensive physical exercise: alitretinoin can cause muscle and joint pain. • If you develop dry eyes, lubricating eye ointment or tear replacement drops can help. If you wear contact lenses, you may need to wear glasses during alitretinoin treatment. Dry eyes and sight problems normally return to normal once treatment is stopped. • Toctino may increase liver enzyme levels. Your doctor will do blood tests during treatment to check these levels. If they stay high, your doctor may lower your dose or take you off of Toctino. Mental health problems • You may notice some changes in your mood and behaviour and so it is very important that you tell your friends and family that you are taking this medicine. They may notice these changes and help you quickly identify any problems that you need to talk to your doctor about. • If you develop any mental health problems including depression, aggressive tendencies, mood changes, thoughts about hurting yourself or ending your life, you must stop taking Toctino immediately and contact your doctor as soon as possible. Children and adolescents Toctino is not recommended for people aged under 18 years old. It is not known how well it works in this age group. Other medicines and Toctino Do not take other retinoid medicines (e.g. isotretinoin), vitamin A supplements or tetracyclines (a type of antibiotic) while taking Toctino. This increases the risk of side effects. Tell your doctor or pharmacist if: Ø you are taking amiodarone (a medicine that helps to regulate heart rate). Amiodarone is not recommended to be taken together with Toctino. Ø you are taking ketoconazole, fluconazole, miconazole (medicines used to treat infections). Your doctor may decide to reduce your dose of Toctino. Ø you are taking simvastatin (a medicine used to lower cholesterol). Toctino may decrease the amount of this medicine in your body. Ø you are taking gemfibrozil (another medicine used to lower cholesterol) or oxandrolone (an anabolic steroid). Your doctor may decide to reduce your dose of Toctino. Ø you are taking paclitaxel (used to treat cancer), rosiglitazone or repaglinide (used to treat diabetes). Toctino may increase the amount of these medicines in your body. Tell your doctor or a pharmacist if you are taking, or have recently taken or might take any other medicines. This includes medicines obtained without a prescription, and herbal medicines. Pregnancy Prevention Programme Women who are pregnant must not take Toctino 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 Toctino is taken only for a short time during pregnancy. • You must not take Toctino if you are pregnant or if you think you might be pregnant. • You must not take Toctino if you are breast-feeding. The medicine is likely to pass into your milk and may harm your baby. • You must not take Toctino if you could get pregnant during treatment • You must not get pregnant for one month after stopping this treatment because some medicine may still be left in your body. Women who could get pregnant are prescribed Toctino under strict rules. This is because of the risk of serious harm to the unborn baby These are the rules: • Your doctor must have explained 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 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 Toctino. Women must use effective contraception before, during and after taking Toctino • You must agree to use at least one very reliable method of contraception (for example an intra uterine device or contraceptive implant) or two effective methods that work in different ways (for example a hormonal contraceptive pill and a condom). Discuss with your doctor which method would be suitable for you. • You must use contraception for a month before taking Toctino, during treatment and for a month 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 Toctino • 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, 1 month after stopping Toctino, (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 a month 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 confirms that you have been told about the risks, and that you will follow the rules above. Ø If you get pregnant while taking Toctino, 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 one month after you stop taking Toctino, you should contact your doctor. Your doctor may send you to a specialist for advice. Your doctor will provide you written information on pregnancy. If you have not seen this information, ask your doctor. Advice for men The levels of oral retinoid in the semen of men taking Toctino 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 the treatment. You should not donate blood during treatment with this medicine and for 1 month after stopping Toctino because an unborn baby could be harmed if a pregnant patient receives your blood. Pregnancy and breast-feeding Do not take Toctino if you are breast-feeding • The medicine is likely to pass into your milk and may harm your baby. Do not take Toctino if you are pregnant Toctino is likely to cause severe birth defects (in medical language it is teratogenic). It also increases the risk of miscarriage. • You must not take Toctino when you are pregnant. • You must not get pregnant during treatment with Toctino, or during the month after treatment. For more information on pregnancy and contraception, see section 2 “Pregnancy and prevention programme”. Driving and using machines You may not see as well at night during your treatment. If this happens to you, you should not drive or operate machinery. Toctino contains soya oil and sorbitol If you are allergic to peanut or soya, do not use this medicinal product. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking Toctino. Each 10 mg capsule of Toctino contains 20.08 mg sorbitol. Each 30 mg capsule of Toctino contains 25.66 mg sorbitol.