Product Details

What you need to know before you take Ciclosporin Soft Capsules

 If you are taking Ciclosporin soft gel capsules following a transplant it will only be prescribed for you by a doctor with experience in transplants and/or autoimmune diseases. Page 2 of 11 The advice in this leaflet may vary depending on whether you are taking the medicine for a transplant or for an autoimmune disease. Follow all your doctor’s instructions carefully. They may differ from the general information contained in this leaflet. Do not take Ciclosporin soft gel capsules: – if you are allergic to ciclosporin, or any of the other ingredients of this medicine (listed in section 6). – with products containing Hypericum perforatum (St John´s Wort). – with products containing dabigatran etexilate (used to avoid blood clots after surgery) or bosentan and aliskiren (used to reduce high blood pressure). Do not take Ciclosporin soft capsules and tell your doctor if the above applies to you. If you are not sure, talk to your doctor before taking Ciclosporin soft capsules.

Warnings and precautions Talk to your doctor or pharmacist before and while taking Ciclosporin Soft Capsules• if you have any signs of infection, such as fever or a sore throat. Ciclosporin soft capsules suppresses the immune system and may also affect your body’s ability to fight against infection. • if you have liver problems. • if you have kidney problems. Your doctor will carry out regular blood tests and may change your dose if necessary. • if you develop high blood pressure. Your doctor will check your blood pressure regularly and may give you a medicine to lower blood pressure if necessary. • if you have low levels of magnesium in your body. Your doctor may give you magnesium supplements to take, especially just after your operation if you have had a transplant. • if you have high levels of potassium in your blood. • if you have gout. • if you need to have a vaccination. • if you have hepatitis C. Your liver function may change with treatment of hepatitis C and this may affect the levels of ciclosporin in your blood. Your doctor may need to closely monitor ciclosporin blood levels and make adjustments to the dose after you start treatment for hepatitis C. If any of the above applies to you before or during treatment with Ciclosporin soft capsules, tell your doctor straight away. Sunlight and sun protection Ciclosporin soft gel capsules suppresses your immune system. This increases your risk of developing cancers, particularly of the skin and lymphoid system. You should limit your exposure to sunlight and UV light by: • Wearing appropriate protective clothing. • Often applying a sunscreen with a high protection factor. Talk to your doctor before taking Ciclosporin soft capsules: • if you have or have had alcohol-related problems.

• if you have epilepsy. • if you have any liver problems. • if you are pregnant. • if you are breast-feeding. • if this medicine is being prescribed for a child. If any of the above apply to you (or you are not sure), tell your doctor before taking Ciclosporin soft capsules. This is because this medicine contains alcohol (see section below “Ciclosporin soft capsules contains ethanol”). Monitoring during your treatment with Ciclosporin soft capsules Your doctor will check: • the levels of ciclosporin in your blood, especially if you have had a transplant, • your blood pressure before the start of your treatment and regularly during treatment, • how well your liver and kidneys are working, • your blood lipids (fats). If you have any questions about how Ciclosporin soft capsules works or why this medicine has been prescribed for you, ask your doctor. In addition, if you are taking Ciclosporin soft capsules for a non-transplant disease (intermediary or posterior uveitis and Behçet’s uveitis, atopic dermatitis, severe rheumatoid arthritis or nephrotic syndrome), do not take Ciclosporin soft capsules: • if you have kidney problems (except for nephrotic syndrome). • if you have an infection which is not under control with medication. • if you have any type of cancer. • if you have high blood pressure (hypertension) which is not under control with medication. If you get high blood pressure during treatment and it cannot be controlled, Ciclosporin soft capsules should be stopped by your doctor.

Do not take Ciclosporin soft capsules if any of the above applies to you. If you are not sure, talk to your doctor or pharmacist before taking Ciclosporin soft capsules. If you are being treated for Behçet`s uveitis, your doctor will monitor you particularly carefully if you have neurological symptoms (for example: increased forgetfulness, personality changes noticed over time, psychiatric or mood disorders, burning sensation in limbs, decreased sensation in limbs, tingling sensation in limbs, weakness of limbs, walking disturbances, headache with or without nausea and vomiting, vision disturbances including restricted movement of eyeball). Your doctor will closely monitor you if you are elderly and are being treated for psoriasis or atopic dermatitis. If you have been prescribed Ciclosporin soft capsules to treat your psoriasis or atopic dermatitis, you must not be exposed to any UVB-rays or phototherapy during treatment. Children and adolescents Ciclosporin soft capsules should not be given to children for a non-transplant disease, except for treatment of nephrotic syndrome.

Elderly population (65 years of age and older) There is limited experience with Ciclosporin soft capsules in elderly patients. Your doctor should monitor how well your kidneys work. If you are over 65 and have psoriasis or atopic dermatitis, you should only be treated with Ciclosporin soft capsules if your condition is particularly severe. Other medicines and Ciclosporin soft capsules Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. In particular, tell your doctor or pharmacist if you are taking any of the following medicines before or during Ciclosporin soft capsules treatment: – Medicines that may affect your potassium levels. These include medicines which contain potassium, potassium supplements, water tablets (diuretics) called potassium-sparing diuretics and some medicines which lower your blood pressure. – Methotrexate. This is used to treat tumours, severe psoriasis and severe rheumatoid arthritis. – Medicines which may increase or decrease the level of ciclosporin (the active substance of Ciclosporin soft capsules) in your blood. Your doctor might check the level of ciclosporin in your blood when starting or stopping treatment with other medicines. – Medicines which may increase the level of ciclosporin in your blood include: antibiotics (such as erythromycin or azythromycin), anti-fungals (voriconazole, itraconazole), medicines used for heart problems or high blood pressure (diltiazem, nicardipine, verapamil, amiodarone), metoclopramide (used to stop sickness), oral contraceptives, danazol (used to treat menstrual problems), medicines used to treat gout (allopurinol), cholic acid and derivatives (used to treat gallstones), protease inhibitors used to treat HIV, imatinib (used to treat leukaemia or tumours), colchicine, telaprevir (used to treat hepatitis C), cannabidiol (uses amongst others include treatment of seizures).

Medicines which may decrease the level of ciclosporin in your blood include: barbiturates (used to help you to sleep), some anti-convulsant medicines (such as carbamazepine or phenytoine), octreotide (used to treat acromegaly or neuroendocrine tumours in the gut), anti-bacterial medicines used to treat tuberculosis, orlistat (used to help weight loss), herbal medicines containing St. John’s wort, ticlopidine (used after a stroke), certain medicines which lower blood pressure (bosentan), and terbinafine (an anti-fungal medicine used to treat infections of the toes and nails). – Medicines which may affect your kidneys. These include: anti-bacterial medicines (gentamycin, tobramycin, ciprofloxacin), anti-fungal medicines which contain amphotericin B, medicines used for urinary tract infections which contain trimethoprim, medicines for cancer which contain melphalan, medicines used to lower the amount of acid in your stomach (acid secretion inhibitors of the H2-receptor antagonist type), tacrolimus, pain Page 5 of 11 killers (non-steroid anti-inflammatory medicines such as diclofenac), fibric acid medicines (used to lower the amount of fat in the blood). – Nifedipine. This is used to treat high blood pressure and heart pain. You might get swollen gums that might grow over your teeth if you are taking nifedipine during your treatment with ciclosporin.

Digoxin (used to treat heart problems), medicines which lower cholesterol (HMG-CoA reductase inhibitors also called statins), prednisolone, etoposide (used to treat cancer), repaglinide (oral anti-diabetic medicine), immunosuppressives (everolimus, sirolimus), ambrisentan and specific anti-cancer medicines called anthracyclines (such as doxorubicin). – Mycophenolate sodium or mycophenolate mofetil (an immunosuppressant) and eltrombopag (used to treat bleeding disorders). If any of the above applies to you (or you are not sure), talk to your doctor or pharmacist before taking Ciclosporin soft capsules. Ciclosporin soft gel capsules with food and drink Do not take Ciclosporin soft capsules with grapefruit or grapefruit juice. This is because these can affect how Ciclosporin soft capsules work. 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 • Tell your doctor if you are pregnant or intend to become pregnant. Experience with Ciclosporin soft capsules in pregnancy is limited. In general, Ciclosporin soft capsules should not be taken during pregnancy. If it is necessary for you to take this medicine, your doctor will discuss with you the benefits and potential risks of taking it during pregnancy. • Tell your doctor if you are breast-feeding. Breast-feeding is not recommended during treatment with Ciclosporin soft capsules. This is because ciclosporin, the active substance, passes into breast milk. This may affect your baby. Driving and using machines You may feel sleepy, disoriented, or have blurred vision after taking Ciclosporin soft capsules. Be careful driving or operating machinery while you are taking Ciclosporin soft capsules until you know how it affects you. Ciclosporin soft capsules contains alcohol (ethanol)

Ciclosporin soft capsules 25 mg capsules contain 25 mg of alcohol (ethanol) in each capsule. The amount in each capsule is equivalent to less than 1 ml of beer or 1 ml of wine. Ciclosporin soft capsules 50 mg capsules contain 50 mg of alcohol (ethanol) in each capsule. The amount in each capsule is equivalent to less than 2 ml of beer or 1 ml of wine. Page 6 of 11 Ciclosporin soft capsules 100 mg capsules contain 100 mg of alcohol (ethanol) in each capsule. The amount in each capsule is equivalent to less than 3 ml of beer or equivalent to 1 ml of wine. The small amount of alcohol in this medicine will not have any noticeable effects. Ciclosporin soft capsules contains propylene glycol Ciclosporin soft capsules 25 mg capsules contain 26 mg propylene glycol in each capsule. Ciclosporin soft capsules 50 mg capsules contain 43 mg propylene glycol in each capsule. Ciclosporin soft capsules 100 mg capsules contain 70 mg propylene glycol in each capsule. Ciclosporin soft capsules contains macrogolglycerol hydroxystearate This medicine contains macrogolglycerol hydroxystearate which may cause stomach upset and diarrhoea