PACKAGE LEAFLET: INFORMATION FOR THE USER

Transcription

1 PACKAGE LEAFLET: INFORMATION FOR THE USER Simvastatin Bluefish 10 mg film-coated tablets Simvastatin Bluefish 20 mg film-coated tablets Simvastatin Bluefish 40 mg film-coated tablets Simvastatin Bluefish 80 mg film-coated tablets (Simvastatin) Read all of this leaflet carefully before you start taking this medicine. 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. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. In this leaflet: 1. What Simvastatin Bluefish is and what it is used for 2. Before you take Simvastatin Bluefish 3. How to take Simvastatin Bluefish 4. Possible side effects 5. How to store Simvastatin Bluefish 6. Further information 1. WHAT SIMVASTATIN BLUEFISH IS AND WHAT IT IS USED FOR Simvastatin Bluefish is a medicine used to lower levels of cholesterol, bad cholesterol (LDL cholesterol) and fatty substances called triglycerides in the blood. In addition Simvastatin Bluefish raises levels of good cholesterol (HDL cholesterol). You should stay on a cholesterol-lowering diet while taking this medicine. Simvastatin Bluefish is used along with diet if you have: a raised cholesterol level in your blood (primary hypercholesterolaemia) or elevated fat levels in your blood (mixed hyperlipidaemia) a hereditary illness (homozygous familial hypercholesterolaemia) that increases the cholesterol level in your blood. You may also receive other treatments. coronary heart disease (CHD) or are at high risk of CHD (because you have diabetes, history of stroke, or other blood vessel disease). Simvastatin Bluefish may prolong your life by reducing the risk of heart disease problems, regardless of the amount of cholesterol in your blood. In most people, there are no immediate symptoms of high cholesterol. Your doctor can measure your cholesterol with a simple blood test. Visit your doctor regularly, keep track of your cholesterol, and discuss your goal with your doctor. 2. BEFORE YOU TAKE SIMVASTATIN BLUEFISH DO NOT use Simvastatin Bluefish if you are allergic (hypersensitive) to simvastatin or any of the other ingredients of Simvastatin Bluefish if you currently have a liver disorder if you are pregnant or breast-feeding if you are using at the same time one or more than one of the following drugs, which strongly inhibit a specific liver enzyme (CYP3A4): - the antifungal agents itraconazole and ketoconazole - the drugs erythromycin, clarithromycin or telithromycin, which are used to prevent/fight against certain infections

2 - HIV drugs (see Using other medicines) - the antidepressant drug, nefazodone. Take special care with Simvastatin Bluefish if you have kidney problems if you have uncontrolled thyroid problems (hypothyroidism) if you have or ever had muscle pain,tenderness or weakness when using a statin (a group of cholesterol-lowering drugs) or when using fibrates (drugs that lower the lipid content of the blood) if you or close family member have a hereditary muscle disorder or previous history of muscle problems if you drink or have drunk large amounts of alcohol (alcohol abuse) tell your doctor if you are due to have an operation. You may need to stop taking Simvastatin Bluefish tablets for a short time. if you ever had liver problems if you are over 70 years of age Your doctor may want to do simple blood tests to check your liver function before and during your treatment with simvastatin. The dose of 80 mg is only recommended for patients with a severely raised cholesterol level in the blood (hypercholesterolaemia) and a high risk of cardiovascular complications. If you develop unexplained muscle pain, hypersensitive muscles, muscle weakness or muscle cramp, contact your doctor immediately. Rarely during the use of simvastatin, muscle tissue breakdown (rhabdomyolysis) occurs, accompanied by pain, sensitivity, weakness or cramp in the muscles, fever, and reddish brown urine (see Possible side effects ). The risk of muscle problems can be increased by the simultaneous use of certain drugs (see Using other medicines ). Consult your doctor if any of the above warnings is applicable to you or has been applicable to you in the past. Using other medicines It is particularly important to tell your doctor if you are taking any of the following medicinal products. Taking Simvastatin Bluefish with any of these medicinal products can increase the risk of muscle problems (some of these have already been listed in the above section Do not take Simvastatin Bluefish. ) cyclosporin (a medicine often used in organ transplant patients) danazol (an anti-hormonal medicine that is used in the treatment of the development of uterine mucous membrane outside the uterus (endometriosis) and the treatment of painful or sensitive breasts) medicines like itraconazole or ketoconazole (medicines for fungal infections) fibrates like gemfibrozil and bezafibrate (medicines for lowering cholesterol) erythromycin, Clarithromycin, telithromycin or fusidic acid (medicines for bacterial infections) HIV protease inhibitors such as indinavir, nelfinavir, ritonavir and saquinavir (medicines for AIDS). nefazodone (a medicine for depression) amiodarone (a medicine used for an irregular heart beat) verapamil or diltiazem (medicines for high blood pressure, chest pain associated with heart disease, or other heart conditions) As well as medicines listed above, tell your doctor or pharmacist if you are taking or have recently taken any medicines, including those obtained without a prescription. In particular, tell your doctor if you are taking any of the following:

3 medicines to prevent blood clots, such as warfarin phenprocoumon or acenocoumarol (anticoagulants). fenofibrate (another medicine for lowering cholesterol). large amounts (at least 1 g each day) of niacin or nicotinic acid (medicines for lowering cholesterol). Using Simvastatin Bluefish with food and drink Grapefruit juice contains one or more components that alter the transformation of other medicines, such as Simvastatin Bluefish. Consumption of grapefruit juice must therefore be avoided. Pregnancy and breast-feeding Do not take Simvastatin Bluefish if you are pregnant, trying to become pregnant or think you may be pregnant. If you get pregnant while taking Simvastatin Bluefish, stop taking it immediately and contact your doctor. Do not take Simvastatin Bluefish if you are breast-feeding, because it is not known if the medicine is passed into breast milk. Ask your doctor or pharmacist for advice before taking any medicine. Driving and using machines Simvastatin Bluefish is not expected to affect your ability to drive and use machines. However, when driving vehicles or using machines, it should be borne in mind that dizziness has been rarely reported. Important information about some of the ingredients of Simvastatin Bluefish Simvastatin Bluefish contain lactose monohydrate (milk sugar); If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product. 3. HOW TO USE SIMVASTATIN BLUEFISH Always take Simvastatin Bluefish exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure. Method of administration: Simvastatin Bluefish tablets should be taken with water. It can be taken with or with out food. Dosage The dose is 5-80 mg simvastatin once daily in the evening. Your doctor may adjust your dose to a maximum of 80 mg per day, given as a single dose in the evening atleast for 4 weeks. The 80 mg dose is only recommended in patients with severely raised cholesterol level (hypercholesterolaemia) and high risk cardiovascular complications. Dosage for high cholesterol levels in blood (Hypercholesterolaemia): You should follow a cholesterol-lowering standard diet before starting the treatment and continue this diet during treatment with simvastatin. The usual starting dose is 10 mg or 20 mg simvastatin once daily in the evening. If cholesterol has to be lowered by a large amount, your doctor may prescribe an initial dose of 20 mg or 40 mg once daily in the evening.

4 If necessary your doctor will adjust the dose as described under Dosage. Dosage for homozygous familial hypercholesterolaemia (hereditary high blood cholesterol): The recommended dose is 40 mg/day in the evening, or 80 mg/day (to be taken in three doses of 20 mg, 20 mg and 40 mg in the evening). Simvastatin Bluefish tablets should be used in addition to other lipid-lowering treatments (e.g. LDL-apheresis) or if such supplementary treatments are not available. Dosage for prevention of cardiovascular disease: The usual dose is 20 mg or 40 mg once a day in the evening in patients at a high risk of coronary artery disease (with or without high blood lipids). Treatment can be started with diet and exercise. If necessary your doctor will adjust the dose as described in Dosage. Dosage for concomitant therapy with other medicines: If Simvastatin Bluefish is taken with other drugs (e.g. colestipol and colestyramine) to reduce cholesterol levels, it should be taken two hours before or four hours after taking these drugs. If you are using cyclosporin (drug that suppresses the defence) or certain other cholesterollowering medicines (gemfibrozil, other fibrates (except fenofibrate)) or niacin (in doses of more than 1 g/day) with simvastatin, the simvastatin dose must not be higher than 10 mg/day. If you are using amiodarone or verapamil (medicines for heart disorders) together with simvastatin, the simvastatin dose should be no higher than 20 mg/day (see Take special care with Simvastatin Bluefish ). Dosage for decreased renal function: If your kidney function is severely impaired, your doctor may prescribe a lower initial dose. Dosage for children under 18 years: The use of simvastatin is not recommended in children, because its safety and efficacy have not yet been established. Dosage for elderly patients: There is no need of dosage adjustment. Duration of treatment: You will have to take simvastatin for a fairly long-time. Your doctor will tell you how long to take simvastatin for. If you take more Simvastatin Bluefish than you should If you take more Simvastatin Bluefish tablets than you should, talk to your doctor or pharmacist or contact with the nearest hospital. If you forget to take Simvastatin Bluefish If you forget to take Simvastatin Bluefish, just continue with your normal dose. Do not take a double dose to make up for a forgotten dose. Simply continue the treatment as usual the next day. If you stop taking Simvastatin Bluefish

5 Keep taking Simvastatin Bluefish unless your doctor tells you to stop. If you stop taking Simvastatin Bluefish your cholesterol levels may increase again. If you have any further questions on the use of this product, ask your doctor or pharmacist. 4. Possible side effects Like all medicines, Simvastatin Bluefish can cause side effects, although not everybody gets them. The following term is used to describe how often side effects have been reported: Rare: affecting more than 1 out of patients and less than 1 out of 1000 patients treated Very rare: affecting less than 1 out of patients The following rare serious side effects were reported. If any of these serious side effects happen, stop taking the medicine and tell your doctor immediately or go to the emergency room at your nearest hospital. muscle pain, tenderness, weakness, or cramps. On rare occasions, these muscle problems can be serious, including muscle breakdown resulting in kidney damage; and very rare deaths have occurred. hypersensitivity (allergic) reactions including: swelling of the face, tongue and throat which may cause difficulty in breathing severe muscle pain usually in the shoulders and hips rash with weakness of limbs and neck muscles pain or inflammation of the joints inflammation of the blood vessels unusual bruising, skin eruptions and swelling, hives, skin sensitivity to the sun, fever, flushing shortness of breath and feeling unwell lupus-like disease picture (including rash, joint disorders, and effects on blood cells) inflammation of the liver with yellowing of the skin and eyes, itching, dark-coloured urine or pale-coloured stool, liver failure (very rare) inflammation of the pancreas often with severe abdominal pain. The following side effects have also been reported rarely: low red blood cell count (anaemia) numbness or weakness of the arms and legs headache, tingling sensation, dizziness digestive disturbances (abdominal pain, constipation, flatulence, indigestion, diarrhoea, nausea, vomiting) rash, itching, hair loss weakness. Laboratory values Elevations in some laboratory blood tests of liver function and a muscle enzyme (creatine kinase) have been observed. If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. 5. HOW TO STORE SIMVASTATIN BLUEFISH Keep out of the reach and sight of children. This medicinal product does not require any special storage conditions.

6 Do not use Simvastatin Bluefish tablets after the expiry date which is stated on the blister and carton after EXP. The expiry date refers to the last day of that month. Medicines should not be disposed off via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment. 6. FURTHER INFORMATION What Simvastatin Bluefish tablets contain - The active ingredient is simvastatin. Each film-coated tablet contains 10 mg simvastatin. Each film-coated tablet contains 20 mg simvastatin. Each film-coated tablet contains 40 mg simvastatin. Each film-coated tablet contains 80 mg simvastatin. - The other ingredients are: Tablet core: Butylated hydroxyanisole (E320) Ascorbic acid (E300) Citric acid monohydrate (E330) Microcrystalline cellulose (E460a) Pregelatinised maize starch Lactose monohydrate Magnesium stearate (E470B) Film coating: Hypromellose Hydroxypropyl cellulose (E464) Titanium dioxide (E171) Talc (E553b). Iron oxide yellow (E 172) - For 10 and 20 mg Iron oxide red (E 172) For 10, 20, 40 and 80 mg What Simvastatin Bluefish tablets look like and contents of the pack Film-coated tablets Simvastatin Bluefish 10 mg film-coated tablets: Light pink, round, and biconvex with the inscription A on one side and 01 on the other. Simvastatin Bluefish 20 mg film-coated tablets: Light pink, round, and biconvex with the inscription A on one side and 02 on the other. Simvastatin Bluefish 40 mg film-coated tablets: Pink, round, and biconvex with the inscription A on one side and 03 on the other. Simvastatin Bluefish 80 mg film-coated tablets: Pink, capsule-shaped and biconvex with the inscription A on one side and 04 on the other. Simvastatin Bluefish 10, 20, 40 and 80 mg film-coated tablets are available in blister packs containing 10, 14, 28, 30, 50, 56, 84, 98 and 100 tablets. Not all pack sizes may be marketed.

7 Marketing Authorisation Holder [To be completed nationally] Manufacturer [To be completed nationally] This medicinal product is authorised in the Member States of the EEA under the following names: Austria: Simvastatin Bluefish 10 /20 /40 mg Filmtabletten Czech Republic: Simvastatin Bluefish 10/20 /40 mg potahované tablety Denmark: Simvastatin Bluefish Finland: Simvastatin Bluefish 10 /20 /40 /80 mg tabletti, kalvopäällysteinen France: SIMVASTATINE BLUEFISH 10 /20 /40 mg, comprimés pelliculés Germany: Simvastatin Bluefish 10 /20 /40/80 mg Filmtabletten Hungary: Simvastatin Bluefish 10 /20 /40 mg filmtabletta Ireland: Simvastatin Bluefish 10 /20 /40 mg film-coated tablets Italy: Simvastatina Bluefish 10 /20 /40 mg compresse rivestite con film Norway: Simvastatin Bluefish 10 /20 /40 mg tabletter, filmdrasjerte Poland: Simvastatin Bluefish Portugal: Simvastatina Bluefish Romania: Simvastatin Bluefish 10 /20 /40 mg comprimate filmate Slovakia: Simvastatine Bluefish 10 /20 /40 mg filmom obalené tablety Spain: Simvastatina Bluefish 10 /20 /40 mg comprimidos recubiertos con película Sweden: Simvastatin Bluefish 10 /20 /40 /80 mg filmdragerade tabletter The Netherlands: Simvastatine Bluefish 10 /20 /40/80 mg filmomhulde tabletten This leaflet was last approved in {MM/YYYY}. [To be completed nationally]