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Atorvastatin 10 mg, 20 mg, 40 mg and 80 mg Film-Coated Tablets
What is in this leaflet:
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you. Keep this leaflet. You may need to read it again. If you have any further questions, ask your doctor or pharmacist. This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. If you get any of the side effects talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
1. What Atorvastatin is and what it is used for 2. What you need to know before you take Atorvastatin 3. How to take Atorvastatin 4. Possible side effects 5. How to store Atorvastatin 6. Contents of the pack and other information What Atorvastatin is and what it is used for
Atorvastatin belongs to a group of medicines known as statins, which are lipid (fat) regulating medicines. Atorvastatin is used to lower lipids known as cholesterol and triglycerides in the blood when a low fat diet and lifestyle changes on their own have failed. If you are at an increased risk of heart disease, Atorvastatin 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. What you need to know before you take Atorvastatin
Do not take Atorvastatin If you are allergic to atorvastatin or to any similar medicines used to lower blood lipids or to any of the other ingredients of this medicine (listed in section 6) If you have or have ever had a disease that 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. Warnings and precautions Talk to your doctor or pharmacist before taking Atorvastatin. If you are taking or have taken in the last 7 days a medicine called fusidic acid, (a medicine for bacterial infection) orally or by injection. The combination of fusidic acid and Atorvastatin can lead to serious muscle problems (rhabdomyolysis). 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 lipid-lowering 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. While you are on this medicine your doctor will monitor you closely if you have diabetes or are at risk of developing diabetes. You are likely to be at risk of developing diabetes if you have high levels of sugars and fats in your blood, are overweight and have high blood pressure. Talk to your doctor or pharmacist before taking Atorvastatin If you have severe respiratory failure. If any of these apply to you, your doctor will need to carry out a blood test before and possibly during your Atorvastatin treatment to predict your risk of muscle-related side effects. The risk of muscle-related side effects e.g rhabdomyolysis is known to increase if certain medicines are taken at the same time as atorvastatin (see section 2 "Other medicines and Atorvastatin"). Also tell your doctor or pharmacist if you have a muscle weakness that is constant. Additional tests and medicines may be needed to diagnose and treat this. Other medicines and Atorvastatin Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. There are some medicines that may change the effect of Atorvastatin, or their effect may be changed by Atorvastatin. This type of interaction could make one or both of the medicines less effective. Alternatively it could
increase the risk or severity of side effects, including the important muscle-wasting condition known as rhabdomyolysis described in section 4: If you need to take oral fusidic acid to treat a bacterial infection you will need to temporarily stop using this medicine. Your doctor will tell you when it is safe to restart Atorvastatin. Taking Atorvastatin with fusidic acid may rarely lead to muscle weakness, tenderness or pain (rhabdomyolysis). See more information regarding rhabdomyolysis in section 4. Medicines used to alter the way your immune system works, e.g. ciclosporin Other antibiotics (medicines for bacterial infections) or antifungal medicines, e.g. erythromycin, clarithromycin, telithromycin, ketoconazole, itraconazole, voriconazole, fluconazole, posaconazole, rifampicin Other medicines to regulate lipid levels, e.g. gemfibrozil, other fibrates, colestipol 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 Medicines used in the treatment of HIV, e.g. ritonavir, lopinavir, atazanavir, indinavir, darunavir, etc. Other medicines known to interact with atorvastatin 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) Medicines obtained without a prescription: St. John's wort. Atorvastatin with food, drink and alcohol See section 3 for instructions on how to take Atorvastatin. Please note the following: Grapefruit juice Do not take more than one or two small glasses of grapefruit juice per day because large quantities of grapefruit juice can change the effects of Atorvastatin. Alcohol Avoid drinking too much alcohol while taking this medicine. See section 2 "Warnings and precautions" for details. 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. Do not take Atorvastatin if you are pregnant, or if you are trying to become pregnant. Do not take Atorvastatin if you are able to become pregnant unless you use reliable contraceptive measures. Do not take Atorvastatin if you are breast-feeding. The safety of Atorvastatin during pregnancy and breast-feeding has not yet been proven. Ask your doctor or pharmacist for advice before taking any medicine. Driving and using machines Normally this medicine does not affect your ability to drive or operate machines. However, do not drive if this medicine affects your ability to drive. Do not use any tools or machines if your ability to use them is affected by this medicine. How to take Atorvastatin
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. Before starting treatment, your doctor will place you on a low-cholesterol diet, which you should maintain also during therapy with Atorvastatin. The recommended starting dose of Atorvastatin is 10 mg once a day in adults. This may be increased if necessary by your doctor until you are taking the amount you need. Your doctor will adapt the dosage at intervals of 4 weeks or more. The maximum dose of Atorvastatin is 80 mg once daily for adults. Use in children and adolescents The recommended starting dose is 10 mg once a day in children aged 10 years or older. The dose may be increased by a doctor to a maximum dose of 20 mg once daily. The use of Atorvastatin is not recommended in children below 10 years of age. Atorvastatin 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. The duration of treatment with Atorvastatin is determined by your doctor. Please ask your doctor if you think that the effect of Atorvastatin is too strong or too weak. If you take more Atorvastatin than you should If you accidentaly take too many Atorvastatin tablets (more than your usual daily dose), contact your doctor or nearest hospital for advice. If you forget to take Atorvastatin If you forget to take a dose, just take your next scheduled dose at the correct time.
Do not take a double dose to make up for a forgotten dose. If you stop taking Atorvastatin If you have any further questions on the use of this medicine or wish to stop your treatment, ask your doctor or pharmacist. If you have any further questions on the use of this medicine, ask your doctor or pharmacist. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them. 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: may affect up to 1 in 1,000 people 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. Muscle weakness, tenderness or pain (rhabdomyolysis) and particularly, if at the same time, you feel unwell or have a high temperature it may be caused by an abnormal muscle breakdown which can be life-threatening and lead to kidney problems. Very rare: may affect up to 1 in 10,000 people If you experience problems with unexpected or unusual bleeding or bruising, this may be suggestive of a liver complaint. You should consult your doctor as soon as possible. Other possible side effects with Atorvastatin Common: may affect up to 1 in 10 people 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, diarrhoea joint pain, muscle pain and back pain blood test results that show your liver function can become abnormal Uncommon : may affect up to 1 in 100 people anorexia (loss of appetite), weight gain, decreases in blood sugar levels (if you have diabetes you should continue careful monitoring of your blood sugar levels) having nightmares, insomnia dizziness, numbness or tingling in the fingers and toes, reductions of sensation to pain or touch, change in sense of taste, loss of memory blurred vision ringing in the ears and/or head vomiting, belching, abdominal pain upper and lower, pancreatitis (inflammation of the pancreas leading to stomach pain) hepatitis (liver inflammation) rash, skin rash and itching, hives, hair loss neck pain, muscle fatigue fatigue, feeling unwell, weakness, chest pain, swelling especially in the ankles (oedema), raised temperature urine tests that are positive for white blood cells Rare : may affect up to 1 in 1,000 people visual disturbance unexpected bleeding or bruising cholestasis (yellowing of the skin and whites of the eyes) tendon injury Very rare : may affect up to 1 in 10,000 people an allergic reaction - symptoms may include sudden wheezing and chest pain or tightness, swelling of the eyelids, face, lips, mouth, tongue or throat, difficulty breathing, collapse hearing loss gynecomastia (breast enlargement in men and women). Not known (frequency cannot be estimated from the available data) include: muscle weakness that is constant Possible side effects reported with some statins (medicines of the same type): Sexual difficulties Depression Breathing problems including persistent cough and/or shortness of breath or fever Diabetes. This is more likely if you have high levels of sugars and fats in your blood, are overweight and have high blood pressure. Your doctor will monitor you while you are taking this medicine. Reporting of side effects If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard By reporting side effects you can help provide more information on the safety of this medicine.
How to store Atorvastatin:
Keep out of the sight and reach of children. Store below 30°C. Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiry date refers to the last day of that month. Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use . These measures will help protect the environment. Contents of the pack and other information
What Atorvastatin contains The active substance is atorvastatin Each 10 mg tablet contains 10 mg of atorvastatin as atorvastatin calcium Each 20 mg tablet contains 20 mg of atorvastatin as atorvastatin calcium Each 40 mg tablet contains 40 mg of atorvastatin as atorvastatin calcium Each 80 mg tablet contains 80 mg of atorvastatin as atorvastatin calcium The other ingredients in the tablet core are microcrystalline cellulose, sodium carbonate anhydrous, maltose, croscarmellose sodium and magnesium stearate. The other ingredients in the film-coating are hypromellose (E464), hydroxypropylcellulose, triethyl citrate (E1505), polysorbate 80 and titanium dioxide (E171). What Atorvastatin looks like and the contents of the pack 10 mg: Atorvastatin Film-Coated Tablets are white to off-white, elliptic, biconvex and smooth film-coated tablets. The dimensions of each tablet are approximately 9.7 mm x 5.2 mm. 20 mg: Atorvastatin Film-Coated Tablets are white to off-white, elliptic, biconvex and smooth film-coated tablets. The dimensions of each tablet are approximately 12.5 mm x 6.6 mm. 40 mg: Atorvastatin Film-Coated Tablets are white to off-white, elliptic, biconvex and smooth film-coated tablets. The dimensions of each tablet are approximately 15.6 mm x 8.3 mm. 80 mg: Atorvastatin Film-Coated Tablets are white to off-white, elliptic, biconvex and smooth film-coated tablets. The dimensions of each tablet are approximately 18.8 mm x 10.3 mm. Atorvastatin is available in aluminium-aluminium blisters containing 7, 10, 14, 15, 20, 28, 30, 50, 50x1, 56, 60, 84, 90, 98, 100 or 200 tablets and in high density polyethylene bottle containing 50 or 100 tablets and as multipack containing 100 tablets (2 bottles of 50 tablets). Not all pack sizes may be marketed. Marketing Authorisation Holder and Manufacturer Marketing Authorisation Holder TEVA UK Limited, Eastbourne, BN22 9AG Manufacturer BELMAC, S.A. 50016 Zaragoza. SPAIN This leaflet was last revised in November 2015. PL 00289/1289 - 1292
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