What is simvastatin used for

Simvastatin AL 40mg film-coated tablets

Patient information for Simvastatin AL 40mg film-coated tablets

1.What is Simvastatin AL 40mg film-coated tablets and what it is used for?

1.1 What are the properties of the medicinal product?

Simvastatin AL 40mg film-coated tablets contains the active ingredient simvastatin, a drug from the group of so-called statins, which in turn belong to the class of cholesterol synthesis enzyme inhibitors (CSE inhibitors).

Statins are used to treat increased levels of fat in the blood. They reduce the formation of cholesterol in the liver; they also lead to a decrease in so-called LDL cholesterol (cholesterol-charged lipoproteins of low density) and other blood fats (triglycerides) and to an increase in HDL cholesterol (cholesterol-charged lipoproteins of high density). These effects mean that less cholesterol is deposited in the walls of the blood vessels; Overall, the risk of suffering a heart attack or stroke is reduced and life expectancy is increased in patients with an increased coronary risk.

Simvastatin has been shown to lower the risk of having a heart attack or stroke in patients at high risk of coronary heart disease.

Simvastatin requires a prescription and should only be used on medical advice.

1.2 What strengths and dosage forms are there?

Simvastatin is usually available as

- Film-coated tablets containing 5 mg, 10 mg, 20 mg, 30 mg, 40 mg, 60 mg or 80 mg simvastatin.

Your doctor will determine which strength and dosage form are suitable for your treatment.

1.3 Simvastatin is used for

- high levels of cholesterol in the blood (primary hypercholesterolaemia) or high levels of fat in the blood (mixed hyperlipidaemia),

- a hereditary disease (homozygous familial hypercholesterolaemia) which leads to high cholesterol levels in the blood. You may receive further treatments,

- Heterozygous familial hypercholesterolemia in children and adolescents from 10 years of age (boys: Tanner stage II and above. Girls: at least 1 year after menarche).

- a cardiovascular disease (CHD - coronary artery disease) or a high risk of cardiovascular disease (because you have diabetes, have had a stroke or any other vascular disease). Simvastatin can extend life by reducing the risk of cardiovascular complications, regardless of the level of cholesterol in your blood.

Simvastatin is used in addition to a low-cholesterol diet.

2. What should you know before you take Simvastatin AL 40 mg film-coated tablets?

2.1 Simvastatin AL 40 mg film-coated tablets must not be taken

- if you are hypersensitive (allergic) to the active substance simvastatin or any of the other ingredients of this medicine,

- if you currently have liver disease

- if you are pregnant or breastfeeding,

- if you are taking one or more of the following medicines at the same time as Simvastatin AL 40 mg film-coated tablets:

- itraconazole, ketoconazole or posaconazole (medicines used to treat fungal infections)

- erythromycin, clarithromycin, or telithromycin (antibiotics used to treat infections)

- HIV protease inhibitors such as indinavir, nelfinavir, ritonavir and saquinavir (HIV protease inhibitors are used to treat HIV infection)

- nefazodone (medicine used to treat depression).

2.2 Special care is required when taking Simvastatin AL 40 mg film-coated tablets

Tell your doctor:

- about all your health problems and about allergies.

- if you consume a large amount of alcohol.

- if you have a history of liver disease. Simvastatin AL 40mg film-coated tablets may not be suitable for you.

- if you are about to have an operation, as it may be necessary to temporarily interrupt treatment with Simvastatin AL 40 mg film-coated tablets.

Your doctor should do blood tests before starting treatment, but also while you are taking Simvastatin AL 40 mg film-coated tablets, to check your liver function if you have any signs of liver problems. Your doctor may also do blood tests during treatment to continue monitoring your liver function.

During treatment with Simvastatin AL 40 mg film-coated tablets, your doctor will closely monitor you if you have blood sugar problems (diabetes mellitus) or if you are at risk of developing blood sugar problems. The risk of developing blood sugar disorder is if you have high levels of sugar and fat in the blood, are overweight and have high blood pressure.

Talk to your doctor or pharmacist before treatment with Simvastatin AL 40 mg film-coated tablets if you have severe breathing problems.

If you notice any unexplained muscle pain, tenderness or weakness of the muscles, please contact your doctor immediately. This is necessary because diseases of the muscles can in rare cases be serious, which can lead to the breakdown of skeletal muscle cells with subsequent kidney failure; there were also very few deaths.

The risk of skeletal muscle cell disintegration increases with the dose of Simvastatin AL 40 mg film-coated tablets, especially with the 80 mg dose. In addition, there is this increased risk in patients:

- who consume a large amount of alcohol

- with kidney problems

- with thyroid disease

- over 65 years

- of female gender

- who have ever had a muscle disorder under treatment with cholesterol-lowering medicines called statins or fibrates

- if you have a hereditary muscle disorder or have an inherited muscle disorder in the family.

Please talk to your doctor if one or more of the diseases or circumstances mentioned apply to you.

Note on other ingredients: Oral medicinal products may contain different types of sugar. Therefore, please only take this after consulting your doctor if you know that you suffer from an intolerance to certain sugars.

2.2.a) Children and young people

The safety and effectiveness of simvastatin have been studied in boys aged 10 to 17 and in girls who had their first menstrual period at least 1 year ago. Simvastatin has not been studied in children under 10 years of age. Your doctor will give you further information on this.

2.2.b) Elderly people

No dose adjustment is required for elderly patients. Treatment with Simvastatin AL 40 mg film-coated tablets should be carried out with caution and under medical supervision if you are older than 70 years.

2.2.c) Pregnancy

Simvastatin AL 40 mg film-coated tablets must not be taken during pregnancy. Simvastatin AL 40 mg film-coated tablets must not be taken by women who are pregnant, planning to become pregnant or suspect that they may be pregnant. If a woman being treated with Simvastatin AL 40 mg film-coated tablets becomes pregnant, she must interrupt the treatment and contact her doctor immediately.

2.2.d) Breastfeeding

Since it is not known whether simvastatin, the active ingredient in Simvastatin AL 40 mg film-coated tablets, is excreted in breast milk, Simvastatin AL 40 mg film-coated tablets must not be used during breastfeeding.

2.2.e) Ability to drive and use machines

Simvastatin AL 40 mg film-coated tablets have no or negligible effects on the ability to drive and use machines. However, when driving or using machines, you should take into account that dizziness has rarely been reported after taking Simvastatin AL 40 mg film-coated tablets.

2.3 When taking Simvastatin AL 40 mg film-coated tablets with other medicinal products

- Medicines to suppress the immune system (immunosuppressants) with the active ingredient cyclosporine, which are often used after organ transplants

- Medicines to treat growths of the lining of the womb (endometriosis) with the active substance danazol

- Medicines to treat fungal infections with active substances such as itraconazole, ketoconazole, fluconazole or posaconazole

- Medicines to lower cholesterol with substances from the class of fibrates such as gemfibrozil and bezafibrate

- Medicines to treat bacterial infections with the active substances erythromycin, clarithromycin, telithromycin or fusidic acid

- Medicines for the treatment of the immunodeficiency AIDS from the class of active substances called HIV protease inhibitors such as indinavir, nelfinavir, ritonavir and saquinavir

- Medicines to treat hepatitis C virus infections with the active substances boceprevir or telaprevir

- Medicines used to treat depression containing the active substance nefazodone

- Medicines to treat irregular heartbeats with the active substance amiodarone

- Medicines to treat high blood pressure, chest pain with heart disease or other heart diseases with the active substances verapamil, diltiazem or amlodipine

- Medicines used to treat gout containing the active substance colchicine.

In particular, please tell your doctor if you are taking or using any of the following medicines:

- Medicines to prevent blood clotting with active substances such as warfarin, phenprocoumon or acenocoumarol (anticoagulants)

- Another medicine for lowering cholesterol from the group of fibrates with the active ingredient fenofibrate

- another medicine used to lower cholesterol called niacin

- Medicines to treat tuberculosis with the active substance rifampicin.

Chinese patients should inform their doctor if they are taking niacin (nicotinic acid) or a drug containing niacin (e.g. to lower cholesterol).

If you are prescribing a new medicine, tell your doctor that you are taking Simvastatin AL 40 mg film-coated tablets.

Simvastatin is effective alone or together with anion exchangers. Simvastatin should be taken at least 2 hours before or at least 4 hours after taking an anion exchanger.

2.4 When taking Simvastatin AL 40 mg film-coated tablets with food and drink

Let your doctor know if you consume large amounts of alcohol.

Grapefruit juice contains one or more ingredients that change the metabolism of some medications, including Simvastatin AL 40mg film-coated tablets, and thus increase the risk of muscle diseases. You should avoid grapefruit juice during treatment with Simvastatin AL 40 mg film-coated tablets.

3. How should Simvastatin AL 40 mg film-coated tablets be taken?

Always take Simvastatin AL 40 mg film-coated tablets exactly as your doctor has told you. Please ask your doctor or pharmacist if you are not sure.

3.1 Type of application

Take the film-coated tablet with a glass of water in the evening (as the body's own cholesterol production in the liver mainly takes place at night). It can be taken independently of food intake.

An appropriate cholesterol-lowering diet should be started before starting treatment and should be continued during treatment.

If your doctor has prescribed Simvastatin Aurobindo for you to take with an anion exchanger (a medicine used to lower cholesterol), take simvastatin at least 2 hours before or at least 4 hours after the anion exchanger. When taking Simvastatin AL 40 mg film-coated tablets, it is usually a long-term treatment; Your doctor will determine the duration of the treatment.

3.2 Unless otherwise prescribed by the doctor, the usual dose is

The dose range of simvastatin is from 5 mg per day to 80 mg per day. The 80 mg dose of simvastatin is only recommended for adult patients with severely elevated cholesterol and at high risk of complications related to heart disease who have not reached their target cholesterol levels with a lower dose.

Do not take more than 80 mg simvastatin per day.

The following recommendations apply:

3.2.a) To lower blood lipid levels

Starting dose: 10 to 20 mg simvastatin, once a day as a single dose in the evening.

If your blood lipid levels have to be reduced significantly, a starting dose of 20 to 40 mg simvastatin per day can be prescribed.

Your doctor may increase the dose to a maximum of 80 mg simvastatin per day after at least 4 weeks.

3.2.b) Patients with homozygous familial hypercholesterolemia

Starting dose: usually 40 mg simvastatin per day, once a day as a single dose in the evening.

As far as possible, simvastatin should be used in these patients concomitantly with other lipid-lowering measures (e.g. LDL apheresis).

3.2.c) For the prevention of cardiovascular diseases

20 to 40 mg simvastatin, once a day in the evening.

Treatment with the medicine can be started at the same time as diet and exercise.

3.2.d) Joint treatment with other medicinal products

If your doctor has prescribed simvastatin to take with colestyramine (an anion exchanger) or another anion exchanger, take simvastatin at least 2 hours before or at least 4 hours after the anion exchanger.

If you are being treated concomitantly with ciclosporin (medicine to suppress the immune system), a dose of 10 mg simvastatin per day should not be exceeded.

If you are taking gemfibrozil, other fibrates (except fenofibrate), or lipid-lowering doses (more than 1 g / day) of niacin (nicotinic acid), a dose of 10 mg simvastatin per day should not be exceeded.

If you are taking amiodarone or verapamil (medicines used to treat various cardiovascular diseases), a dose of 20 mg simvastatin per day should not be exceeded.

3.2.e) Use in children and adolescents (heterozygous familial hypercholesterolemia)

The usual recommended dose in children and adolescents (boys; Tanner stage II and above, girls: at least 1 year after menarche, between the ages of 10 and 17 years) with heterozygous familial hypercholesterolaemia is 10 mg per day as a single starting treatment -Dose in the evening. Before starting therapy with simvastatin, children and adolescents should follow a cholesterol-lowering diet, which should also be continued during therapy with simvastatin.

The recommended dose range is 10 to 40 mg simvastatin per day; the maximum recommended dose is 40 mg per day. The respective dose must be individually adjusted to the recommended therapeutic goal in accordance with the recommendations for treating children. Dose adjustments should be made at intervals of at least 4 weeks.

3.2.f) Use in renal dysfunction

If you have moderate renal impairment, no dose adjustment is usually necessary. If you have severe renal impairment, doses greater than 10 mg simvastatin per day should be carefully considered and, if necessary, prescribed with caution by your doctor.

3.3 If you take more Simvastatin AL 40 mg film-coated tablets than you should

If you have taken more tablets than prescribed, please contact your doctor immediately.

3.4 If you forget to take Simvastatin AL 40 mg film-coated tablets

If you forget a dose, take the prescribed dose the evening of the following day. Do not take any extra tablets.

3.5 Effects if treatment with Simvastatin AL 40 mg film-coated tablets is interrupted or ended prematurely

Take Simvastatin AL 40 mg film-coated tablets for as long as your doctor has prescribed. If you stop treatment, your cholesterol may rise again.

4. What are the possible side effects?

Like all medicines, Simvastatin AL 40 mg film-coated tablets can cause side effects, although not everybody gets them.

When evaluating side effects, the following frequencies are used as a basis:

- very common: more than 1 in 10 people

- common: less than 1 in 10, but more than 1 in 100 patients

- uncommon: less than 1 in 100, but more than 1 in 1,000 patients

- rarely: less than 1 in 1,000 but more than 1 in 10,000 people treated

- very rare: less than 1 in 10,000 patients, including isolated cases

- Frequency not known: frequency cannot be calculated from the available data

4.1 Which side effects can occur in detail?

4.1.a) Possible side effects that have been reported with some statins (medicines of the same type)

Sleep disorders such as insomnia and nightmares, memory loss, sexual function disorders, depression, breathing problems including persistent cough and / or shortness of breath or fever, blood sugar disorder (diabetes). The risk of developing blood sugar problems increases if you have high levels of sugar and fat in the blood, are overweight and have high blood pressure. Your doctor will monitor you while you are taking Pravastatin.

4.1.b) Rarely

4.1.b.1.Serious side effects

If any of the following serious side effects occur, stop taking this medicine and contact your doctor immediately or go to the nearest hospital emergency room.

Muscle disease with pain, tenderness, weakness or muscle cramps. Muscular disorders can in rare cases be serious, which can lead to the breakdown of skeletal muscle cells with subsequent kidney failure; there were also very few deaths.

Hypersensitivity (allergic) reactions with: swelling of the face, tongue and throat which can cause difficulty breathing or swallowing, severe muscle pain usually in the shoulders and pelvic area, rash with weakness of the limbs and neck muscles, joint pain or inflammation ( Polymyalgia rheumatica), inflammation of the blood vessels (vasculitis), unusual bruising, rashes and swelling of the skin (dermatomyositis), oozing, itchy rash (hives), sensitivity of the skin to light, fever, facial redness, difficulty breathing (dyspnoea) and malaise with skin rash, disease , Joint diseases and changes in the blood count (lupus-like symptoms).

Inflammation of the liver or jaundice with the following symptoms: yellowing of the skin and eyes, itching, dark urine or light-colored stools, feeling tired or weak, loss of appetite

Inflammation of the pancreas, often with severe abdominal pain.

In very rare cases, immune-mediated necrotizing myopathy (IMNM) can occur during treatment with CSE inhibitors. The clinical signs are persistent proximal muscle weakness and elevated serum creatine kinase values ​​that persist despite discontinuation of statin treatment. If muscle weakness persists, inform your doctor.

4.1.b.2.Other rare side effects

Low number of red blood cells (anemia or anemia), numbness or weakness in the arms and legs, headache, abnormal sensations, dizziness, indigestion (abdominal pain, constipation, gas, indigestion, diarrhea, nausea, vomiting), rash, itching, hair loss, Weakness.

4.1.b) Very rare

Liver failure, insomnia, memory impairment, memory loss, confusion.

4.1.c) Frequency not known

Erectile dysfunction, depression, inflammation of the lungs causing breathing problems including prolonged coughing and / or shortness of breath or fever, tendon disease, sometimes leading to a tear.

Laboratory values: Elevations in some liver values ​​and high levels of a muscle enzyme (creatine phosphokinase) have been noted.

4.2 What measures should be taken if side effects occur?

Tell your doctor or pharmacist if you notice any side effects not listed here or in the package insert.

You can also report side effects directly to the Federal Institute for Drugs and Medical Devices, Dept. Pharmacovigilance Kurt-Georg-Kiesinger Allee 3, D-53175 Bonn (website: www.bfarm.de). By reporting side effects you can help provide more information on the safety of this medicine.

5. How should Simvastatin AL 40 mg film-coated tablets be stored?

Store Simvastatin AL 40 mg film-coated tablets at normal room temperature and keep the medicine in the original packaging, away from light and moisture.

Medicines should generally be kept out of the reach of children.

Do not use the medicine after the expiry date stated on the pack.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer need. This measure helps to protect the environment.

6. Source and processing status

Information from the SCHOLZ database based on the data approved by the Federal Office for Drugs and Medical Devices

Copyright by ePrax GmbH, Munich; March 2015 (10)