PACKAGE LEAFLET: INFORMATION FOR THE USER. Lovastatin STADA 10 mg, 20 mg and 40 mg tablets Active substance: lovastatin

Transcription

1 PACKAGE LEAFLET: INFORMATION FOR THE USER Lovastatin STADA 10 mg, 20 mg and 40 mg tablets Active substance: lovastatin 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 Lovastatin STADA is and what it is used for 2. Before you take Lovastatin STADA 3. How to take Lovastatin STADA 4. Possible side effects 5. How to store Lovastatin STADA 6. Further information 1. What Lovastatin STADA is and what it is used for Lovastatin belongs to a group of medicines called HMG CoA reductase inhibitors (serum lipid reducing agents). It is a cholesterol-lowering medicine for people who cannot reduce their cholesterol levels by diet alone. Lovastatin STADA is used to: treat severe cases of high cholesterol levels (hypercholesterolaemia) 2. Before you take Lovastatin STADA DO NOT take Lovastatin STADA If you are allergic (hypersensitive) to lovastatin or to any of the other ingredients of the Lovastatin tablets (see 6. Further information at the end of the leaflet) If you suffer from any of the following diseases: a liver disease or if your liver function tests are abnormal cholestasis (blockage of the flow of bile from the liver) myopathy (a muscle disease) If you are taking any medicine which inhibits the liver enzyme CYP3A4, such as: mibefradil (to treat high blood pressure) itraconazole or ketoconazole (antifungal medicines)

2 certain medicines used to treat AIDS, such as HIV protease inhibitors delavirdine (a reverse transcriptase inhibitor) the antibiotics erythromycin, clarithromycin or telithromycin nefazodone (an antidepressant) amiodarone (to treat irregular heart rate) If you are pregnant or breast-feeding (see Pregnancy and breast-feeding ) If you suffer from alcoholism Take special care with Lovastatin STADA If any of the conditions or illnesses listed below applies to you, or if you have suffered from any of them in the past. Please ask your doctor before you start to take Lovastatin. Check with your doctor or pharmacist before taking Lovastatin STADA: If you have or have had any of the following diseases: hypothyroidism (if your thyroid is not working well) a liver disease Lovastatin can cause an increase in your liver enzymes. Therefore, your doctor will test your blood to monitor your liver function before and during treatment. muscle diseases (myopathy or rhabdomyolysis) Lovastatin may rarely cause serious muscle diseases, especially when taken together with certain other medicines (see section Taking other medicines ). If you start to have muscle pain, muscle weakness or cramps while you are taking Lovastatin, you must tell you doctor immediately. In this case, your doctor may decide to stop or change your treatment. Also tell your doctor if any member of your close family has a history of muscle disorders. kidney failure, a severe kidney impairment or if you have any condition that can increase the risk of kidney failure, such as: a serious acute infection low blood pressure (hypotension) major surgery injury (trauma) severe disorder of the metabolism or of the hormone household severe disturbances of the chemicals in your body uncontrolled epilepsy homozygotic familial hypercholersteraemia (a rare hereditary disease) Lovastatin may not be effective if you suffer from this disease. severe respiratory failure. If you drink too much alcohol If you are more than 70 years old

3 If you are taking any of the medicines listed under Taking other medicines. 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. Taking other medicines Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. You must take special care if you are also taking any of the following medicines: gemfibrozil and other fibrates (other lipid-lowering medicines) niacin (nicotinic acid), a lipid regulating medicine, at doses of 1 g per day or more amiodarone (to treat irregular heart beat) coumarin anticoagulants (medicines used to thin the blood) medicines which inhibit the liver enzyme CYP3A4. Your doctor will know which medicines these are. They include, for example: cyclosporin (an immunosuppressant) mibefradil or verapamil (medicines to treat high blood pressure) itraconazole or ketoconazole (to treat mycoses) erythromycin or clarithromycin (antibiotics) HIV protease inhibitors to treat AIDS nefazodone (an antidepressant) Taking Lovastatin with food and drink Excessive alcohol intake increases the risk of myopathy (a muscle disease). Therefore, you should not drink alcohol during treatment. Grapefruit may increase the concentration of Lovastatin in your blood. Therefore, you should not eat grapefruit or drink grapefruit juice during treatment. Usually, Lovastatin STADA should be taken as a single daily dose together with the evening meal. Children and adolescents Lovastatin is not recommended for the treatment of children and adolescents. Pregnancy and breast-feeding Ask your doctor or pharmacist for advice before taking any medicine. Lovastatin may harm the unborn child. Therefore, you must not take Lovastatin if you are pregnant or trying to become pregnant. If you become pregnant while you are taking Lovastatin, you must stop taking the tablets immediately and tell your doctor. If you are of child-bearing age, you must use a suitable method of contraception during treatment. Talk to your doctor if you are unsure of what method to use.

4 Do not use Lovastatin if you are breast-feeding. Driving and using machines Lovastatin has no or negligible influence on the ability to drive and use machines. Important information about some of the ingredients of Lovastatin STADA This medicine contains lactose (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 take Lovastatin STADA Always take Lovastatin exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure. You should continue on your standard cholesterol-lowering diet during treatment with Lovastatin. Dosage: The usual starting dose is 20 mg per day, taken as a single dose with the evening meal. In some cases, the starting dose can be reduced to 10 mg per day. Changes in dose should be usually made at intervals of at least 4 weeks. Your dose might be adjusted depending on how your cholesterol responds to treatment. The maximum dose is 80 mg per day. This can be taken either as a single dose with the evening meal, or divided into 2 doses taken with breakfast and the evening meal. Patients taking other medicines: If you are also taking cyclosporin, fibrates or nicotinic acid, your maximum dose should not exceed 20 mg per day. In addition, please pay attention to the infomations given in section 2 ("DO NOT take Lovastatin STADA" and "Taking other medicines"). Patients with impaired kidney function: If you have a moderate kidney function impairment you can take the normal dose. If you suffer from severe kidney failure your maximum daily dose should not exceed 20 mg. If higher doses should be necessary, your doctor will closely monitor you. Children and adolescents Lovastatin is not recommended for the treatment of children and adolescents. Elderly patients: If you are over the age of 60 you can usually take the same doses as younger patients. Method of administration Lovastatin tablets should be swallowed with a glass of water together with the evening meal.

5 Duration of treatment Cholesterol-lowering therapy is usually long-term. If you take more Lovastatin STADA than you should If you accidentally take too many tablets, contact your doctor or nearest hospital emergency department immediately for advice. If you forget to take Lovastatin STADA If you forget to take a dose of Lovastatin, just take the next dose at the usual time. Do not take a double dose to make up for a forgotten dose. If you stop using Lovastatin STADA Do not stop or change your treatment before talking to your doctor. If you have any further questions on the use of this product, ask your doctor or pharmacist. 4. Possible side effects Like all medicines, Lovastatin STADA can cause side effects although not everybody gets them. The evaluation of the side effects is based on the following frequencies: Very common Common Uncommon Rare Very rare Not known in more than 1 in 10 patients treated in less than 1 in 10, but more than 1 in 100 patients treated in less than 1 in 100, but more than 1 in 1000 patients treated in less than 1 in 1000, but more than 1 in patients treated in less than 1 in patients treated frequency cannot be estimated from the available data Most of the side effects observed with Lovastatin are mild and stop within a short time. They include: Common: Wind (flatulence) Diarrhoea Constipation Nausea Indigestion Feeling of spinning (vertigo) Blurred vision Headache Muscle cramps Muscle pain

6 Rash Abdominal pain Uncommon: Rare: Tiredness Itching (pruritus) Dry mouth Sleeplessness (insomnia) Sleeping difficulties Altered tastes Myopathy (a muscle disease with symptoms such as muscle pain, muscle weakness or cramps) Rhabdomyolysis (a muscle disease caused by the breakdown of muscle cells) Difficulty with erection Allergic (hypersensitivity) syndrome that includes one or more of the following symptoms: Anaphylaxis (severe allergic reaction) Angiooedema (swelling of the skin, lips or tongue) Lupus-like syndrome (an autoimmune disease that can affect the skin, joints, heart, lungs, kidneys and brain) Polymyalgia rheumatica (a rheumatic disease with pain in the shoulder and hip) Vasculitis (inflammation of the blood vessels) Thrombocytopenia (low number of blood platelets) Leukopenia (low number of white blood cells) Eosinophilia (high number of a certain type of white blood cells called eosinophils) Haemolytic anaemia (anaemia caused by an abnormal breakdown of red blood cells) Positive anti-nuclear antibodies (when the body attacks itself) Increased sedimentation rate (a blood test that measures inflammation) Arthritis (inflammation of the joints) and arthralgia (joint pains) Hives (urticaria) Weakness (asthenia) Sensitivity to sunlight Fever Flushing Shivering Shortness of breath Indisposition (generally feeling ill). The following blood tests might show increased results during treatment with Lovastatin:

7 Blood tests for liver function: increase in serum transaminase, alkaline phosphatase or bilirubin levels Blood tests for muscle disease: increase in creatine kinase levels. The following adverse reactions have been reported since the product has been in widespread use: Inflammation of the liver (hepatitis) Cholestatic jaundice (yellowing of the skin and the whites of the because of a blockage of the flow of bile from the liver) Vomiting Loss of appetite (anorexia) Feeling of pins and needles (paraesthesiae) Peripheral polyneuropathy (a disorder of the peripheral nerves; in particular if used for a long period of time) Mental disorders such as anxiety Hair loss (alopecia) Toxic epidermal necrolysis (a very serious skin disorder that causes the loss of large areas of skin) Erythema multiforme (a skin condition with red blotches) Stevens-Johnson syndrome (a severe skin disorder characterised by peeling of the skin). Possible side effects: Sleep disturbances, including nightmares Memory loss 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. 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 Lovastatin STADA Keep out of the reach and sight of children. Do not use Lovastatin STADA tablets after the expiry date, which is stated on the carton and blister pack. The expiry date refers to the last day of that month. This medicinal product does not require any special storage conditions. Medicines should not be disposed of in wastewater or in the household waste. Ask your pharmacist how to dispose of medicines that are no longer required. These measures will

8 help to protect the environment. 6. Further information What Lovastatin STADA contains The active substance is lovastatin. Lovastatin STADA 10 mg tablets 1 tablet contains 10 mg lovastatin. Lovastatin STADA 20 mg tablets 1 tablet contains 20 mg lovastatin. Lovastatin STADA 40 mg tablets 1 tablet contains 40 mg lovastatin. The other ingredients are: lactose monohydrate pregelatinised maize starch microcrystalline cellulose magnesium stearate butylated hydroxyanisole maize starch. Lovastatin 10 mg tablets also contain the colourant allura red (E129). Lovastatin 20 mg tablets also contain the colourant patent blue (E131). Lovastatin 40 mg tablets also contain the colourants patent blue (E131) and quinoline yellow (E104). What Lovastatin STADA looks like and contents of the pack Lovastatin STADA 10 mg tablets are round, slightly biconvex, pale pink tablets with a bevelled edge. Lovastatin STADA 20 mg tablets are round, slightly biconvex, pale blue tablets with a bevelled edge and one side scored. Lovastatin STADA 40 mg tablets are round, slightly biconvex, pale green tablets with a bevelled edge and one side scored. Lovastatin STADA is available in packs containing 20, 28, 30, 40, 50, 56, 60, 84, 98, 100, 112, 120 or 500 tablets in PVC/PVDC/Al blisters. Marketing authorisation holder STADA Arzneimittel AG, Stadastraße 2 18, Bad Vilbel, Germany Telefon: , Telefax: , Internet: Manufacturer:

9 STADA Arzneimittel AG, Stadastraße 2 18, Bad Vilbel, Germany This medicinal product is authorised in the Member States of the EEA under the following names: 10 mg: Austria: Denmark: Germany: Lovastatin Stada 10 mg - Tabletten Lovastatin STADA Lovastatin STADA 10 mg Tabletten 20 mg: Austria: Denmark: Finland: Germany: Portugal: 40 mg: Austria: Denmark: Finland: Germany: Portugal: Lovastatin Stada 20 mg - Tabletten Lovastatin STADA Lovastatin Stada 20 mg Lovastatin STADA 20mg Tabletten Lovastatina Stada 20 mg Lovastatin Stada 40 mg - Tabletten Lovastatin STADA Lovastatin Stada 40 mg Lovastatin STADA 40mg Tabletten Lovastatina Stada 40 mg This leaflet was last approved in.