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Lipicure belongs to a group of medicines known as statins, which are lipid (fat) regulating medicines. Lipicure is used to lower lipids known as cholesterol and triglycerides in the blood when a low fat diet and life style changes on their own have failed. If you are at an increased risk of heart disease, Lipicure can also be used to reduce such risk even if your cholesterol levels are normal. You should maintain a standard cholesterol lowering diet during treatment. How to use Before starting treatment, your doctor will place you on a low-cholesterol diet, which you should maintain also during therapy with Lipicure. The usual starting dose of Lipicure is 10 mg once a day in adults and children aged 10 years or older. This may be increased if necessary by your doctor until you are taking the amount you need. Your doctor will adapt the dose at intervals of 4 weeks or more. The maximum dose of Lipicure is 80 mg once daily for adults and 20 mg once daily for children. Lipicure tablets should be swallowed whole with a drink of water, and can be taken at any time of day, with or without food. However, try to take your tablet at the same time every day. Always take Lipicure exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure. Warnings and precautions Do not take Lipicure If you are hypersensitive (allergic) to Lipicure or to any similar medicines used to lower blood lipids or to any of the other ingredients of the medicine – see Section 6 for details. If you have or have ever had a disease which affects the liver. If you have had any unexplained abnormal blood tests for liver function. If you are a woman able to have children and not using reliable contraception. If you are pregnant or trying to become pregnant. If you are breast-feeding. Take special care with Lipicure The following are reasons why Lipicure may not be suitable for you: If you have had a previous stroke with bleeding into the brain, or have small pockets of fluid in the brain from previous strokes. If you have kidney problems. If you have an under-active thyroid gland (hypothyroidism). If you have had repeated or unexplained muscle aches or pains, a personal history or family history of muscle problems. If you have had previous muscular problems during treatment with other lipidlowering medicines (e.g. other ‘-statin’ or ‘-fibrate’ medicines). If you regularly drink a large amount of alcohol. If you have a history of liver disease. If you are older than 70 years. Side Effects If you experience any of the following serious side effects, stop taking your tablets and tell your doctor immediately or go to the nearest hospital accident and emergency department. Rare: affects 1 to 10 users in 10,000: Visual disturbance. Unexpected bleeding or bruising. Cholestasis (yellowing of the skin and whites of the eyes). Tendon injury. Serious allergic reaction which causes swelling of the face, tongue and throat that can cause great difficulty in breathing. Serious illness with severe peeling and swelling of the skin, blistering of the skin, mouth, eyes genitals and fever. Skin rash with pink-red blotches especially on palms of hands or soles of feet which may blister. Other possible side effects with Lipicure: Common side effects (affects 1 to 10 users in 100) include: Inflammation of the nasal passages, pain in the throat, nose bleed. Allergic reactions. Increases in blood sugar levels (if you have diabetes continue careful monitoring of your blood sugar levels), increase in blood creatine kinase. Headache. Nausea, constipation, wind, indigestion, diarrhea. Joint pain, muscle pain and back pain. Storage Information Store below 30°C. This medicine does not require any special storage conditions. Drug Interactions 1. Medicines used to alter the way your immune system works, e.g. ciclosporin. Certain antibiotics or antifungal medicines, e.g. erythromycin, clarithromycin, telithromycin, ketoconazole, itraconazole, voriconazole, fluconazole, posaconazole, rifampin, fusidic acid. 2. Other medicines to regulate lipid levels, e.g. gemfibrozil, other fibrates, colestipol 3. Some calcium channel blockers used for angina or high blood pressure, e.g. amlodipine, diltiazem,; medicines to regulate your heart rhythm e.g. digoxin, verapamil, amiodarone 4. Medicines used in the treatment of HIV e.g. ritonavir, lopinavir, atazanavir, indinavir, darunavir, etc. 5. Other medicines known to interact with Lipicure include ezetimibe (which lowers cholesterol), warfarin (which reduces blood clotting), oral contraceptives, stiripentol (an anti-convulsant for epilepsy), cimetidine (used for heartburn and peptic ulcers), phenazone (a painkiller) and antacids (indigestion products containing aluminium or magnesium). 6. Medicines obtained without a prescription: St John’s Wort. 7. Colchicine: Cases of myopathy, including rhabdomyolysis, have been reported with atorvastatin co-administered with colchicine, and caution should be exercised when prescribing atorvastatin with colchicine Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. Ingredients The active substance is atorvastatin.
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