Simvastatin 5 Mg Film-Coated Tablets
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Simvastatin 5 mg Film-coated Tablets Simvastatin 10 mg Film-coated Tablets Simvastatin 20 mg Film-coated Tablets Simvastatin 40 mg Film-coated Tablets
simvastatin
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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 side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
What is in this leaflet
1. What Simvastatin Tablets are and what they are used for
2. What you need to know before you take Simvastatin Tablets
3. Howto take Simvastatin Tablets
4. Possible side effects
5. Howto store Simvastatin Tablets
6. Contents of the pack and other information
Simvastatin Tablets are a medicinal product to lower elevated cholesterol levels in blood.
Simvastatin Tablets are used:
• in elevated blood lipid values
Treatment of elevated blood lipid values which are not attributable to another disease (primary hypercholesterolaemia or mixed hyperlipidaemia), additionally to diet when response to diet and other non-pharmacological measures (e.g. physical exercise, weight reduction) are not sufficient.
Treatment of hereditary elevated blood lipid values (homozygous familial hypercholesterolaemia). Simvastatin Tablets are used as an adjunct to diet and other lipid-lowering measures or if such measures are not appropriate.
• to prevent cardiovascular events
Reduction in the frequency of cardiovascular-induced deaths and events in patients with manifest atherosclerotic heart disease or diabetes mellitus whose cholesterol values are normal or elevated. As an adjunct to correct other risk factors and cardioprotective therapy.
Do not take Simvastatin Tablets
• if you are allergic to simvastatin or to any of the other ingredients of this medicine (listed in section 6)
• if you have an active liver disease or suffer from an unexplained, persistent elevation of certain liver enzymes in blood (transaminases)
• if you are pregnant or breast-feeding
• if you concomitantly take medicinal products which inhibit the enzyme cytochrome P450 3A4 (e.g. itraconazole, ketoconazole, posaconazole [medicinal products against pathogenic fungi], HIV protease inhibitors [medicinal products in HIV infection, e.g. nelfinavir], boceprevir, telaprevirs, erythromycin, clarithromycin, telithromycin [antibiotics], nefazodone [antidepressant]), gemfibrozil, ciclosporin or danazol (see section "Other medicines and simvastatin”).
Warnings and precautions
Talk to your doctor or pharmacist before taking Simvastatin tablets
• if you experience muscle pain, weakness or cramps during therapy with Simvastatin Tablets, please inform your doctor immediately. Simvastatin occasionally causes a disease of skeletal muscles (myopathy). In rare cases Simvastatin can cause severe muscle problems that can produce renal impairment (rhabdomyolysis). The risk of a muscle disease/decomposition of muscle cells is higher in patients who take high doses of Simvastatin Tablets or who take Simvastatin Tablets with certain medicines, (see section “Other medicines and simvastatin”).
• if you are older than 65 years, if you are female, if you experience renal dysfunction, untreated thyroid hypofunction, if you have familial history or have previously suffered from muscular disorders or if you regularly consume alcohol, since these factors can increase the risk of muscle disorders.
• if you have had some liver disease. Moderate increases of transaminase levels are likely to occur and usually return to baseline without discontinuing simvastatin treatment. Persistent increases in serum transaminases usually fall slowly to pre-treatment levels when simvastatin is discontinued or interrupted.
• if you have a scheduled surgery. It is advisable to stop taking Simvastatin Tablets at least a few days prior to surgery.
• if you have severe respiratory failure.
Your doctor may want to carry out blood/liver function tests to check that liver and muscles are working properly before and during treatment with Simvastatin Tablets.
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.
Other medicines and simvastatin
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
The following medicines can interact with Simvastatin Tablets and can increase the risk of muscle adverse reactions. In these cases dosage adjustment or discontinuation of simvastatin can be necessary:
• itraconazole, ketoconazole, posaconazole, erythromycin, clarithromycin, telithromycin, HIV protease inhibitors (e.g. nelfinavir), boceprevir, telaprevir (hepatitis C treatment) and nefazodone. These medicinal products must therefore not be taken concomitantly with Simvastatin Tablets (see “Do not take Simvastatin Tablets”)
• fibrates (other cholesterol-lowering medicines)
• niacin or nicotinic acid (cholesterol-lowering medicines) in large doses (> 1 g/day)
• ciclosporin (medicine to prevent transplant rejection)
• verapamil, diltiazem, amlodipine (medicinal products to treat high blood pressure or chest tightness) and amiodarone (medicinal product to treat arrhythmias)
• fusidic acid (medicine for bacterial infections)
• danazol (synthetic hormone, gonadotropin inhibitor)
• colchicine (medicinal product to treat gout)
Tell your doctor if you are taking any of these.
It is also important to tell your doctor if you are taking or have within the last 4 weeks taken:
• Medicinal products for oral intake which inhibit blood coagulation (oral anticoagulants), since the anticoagulant effect is increased if they are taken with Simvastatin Tablets.
• Rifampicin (medicine for bacterial infections), since the cholesterol-lowering effect of simvastatin may be diminished by rifampicin
Simvastatin Tablets with food, drink and alcohol
Grapefruit juice can increase the concentration of simvastatin in blood. Avoid consumption of grapefruit juice during therapy with Simvastatin Tablets.
Alcohol: Inform your doctor if you consume larger quantities of alcohol.
Elderly patients
No dose adjustment is necessary for elderly patients.
Use in children and adolescents (10-17 years of age)
Safety and effectiveness have been studied in 10-17 year old boys and in girls who had started their menstrual period at least one year before (see “How to take Simvastatin Tablets”). Simvastatin Tablets have not been studied in children under the age of 10 years. For more information, talk to your doctor.
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.
If you become pregnant while using Simvastatin Tablets, you must stop taking the tablets immediately and contact your doctor (see “Do not take Simvastatin Tablets”).
No data on the passage of the active substance of Simvastatin Tablets in breast milk are available. On account of the risk of serious adverse reactions in infants, Simvastatin Tablets must not be used in the breast-feeding period. If therapy is indispensable, breast-feeding must be stopped.
Driving and using machines
You are allowed to drive and use machines. Simvastatin Tablets have no or only negligible influence on the ability to drive and to operate machines. However, when driving or operating machines, it should be taken into account that dizziness has rarely been reported in the post-marketing period.
Simvastatin tablets contains lactose
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
Take the tablets with sufficient liquid (a glass of water) as single dose in the evening. You may take Simvastatin Tablets irrespective of meals. The tablet can be divided into equal doses.
You should stay on a cholesterol-lowering diet while taking Simvastatin Tablets.
The recommended dose is: See table below. 00000000
Maximum dose: 80 mg simvastatin once daily. 853)
Your attending doctor will increase the dose - if required - at intervals of at least 4 weeks. The 80 mg dose is only recommended in adult patients with very high cholesterol levels and at high risk of heart disease problems.
|
Usual initial dose |
Patients who require a large starting dose | |
|
In case of elevated blood lipid values |
10 mg to 20 mg simvastatin once daily. |
20 mg to 40 mg simvastatin once daily. |
|
In case of hereditary elevated blood lipid values (homozygous familial hypercholesterolaemia) |
40 mg simvastatin once daily in the evening. | |
|
To prevent cardiovascular events |
20 mg to 40 mg simvastatin once daily. |
Concomitant administration with other medicinal products
Simvastatin tablets are effective alone or together with anion exchangers such as colestyramine and colestipol. Simvastatin tablets should be taken at least 2 hours before or at least 4 hours after intake of anion exchangers.
In patients taking fibrates (except fenofibrate or gemfibrozil) concomitantly with Simvastatin Tablets, a dose of 10 mg simvastatin a day should not be exceeded. In patients taking amiodarone, amlodipine, diltiazem or verapamil concomitantly with Simvastatin Tablets, a dose of 20 mg simvastatin a day should not be exceeded.
Elderly patients
No dose adjustment is necessary for elderly patients.
Use in children and adolescents (10-17years of age)
For children (10-17 years old), the recommended usual starting dose is 10 mg a day in the evening. The maximum recommended dose is 40 mg a day.
Use in renal dysfunction
No dose adjustment is usually necessary in patients with moderate renal dysfunction. In patients with severe renal dysfunction (creatinine clearance below 30 ml/min), doses above 10 mg simvastatin a day should be carefully considered and, if necessary, prescribed with caution.
Intake of Simvastatin Tablets is long-term therapy. The attending doctor decides on the duration of treatment.
Please talk to your doctor if you have the impression that the effect of Simvastatin Tablets is too strong or too weak.
If you take more Simvastatin Tablets than you should
Please consult your doctor without delay. In case of overdose, your doctor should take symptomatic and supportive measures.
If you forget to take Simvastatin Tablets
Do not take a double dose to make up for a forgotten dose, but continue treatment with the dose prescribed.
If you stop taking Simvastatin Tablets
The blood lipid values can rise again.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Stop taking the medicine and tell your doctor immediately or go to the emergency room at your nearest hospital if you experience any of the following serious side effects:
• 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 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:
Rare (may affect up to 1 in 1,000 people):
• 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.
Very rare (may affect up to 1 in 10,000 people):
• trouble sleeping
• poor memory.
Not known (frequency cannot be estimated from the available data):
• erectile dysfunction
• depression
• inflammation of the lungs causing breathing problems including persistent cough and/or shortness of breath or fever
• pain in tendon, sometimes complicated by rupture.
Additional possible side effects reported with some statins:
• sleep disturbances, including nightmares
• memory loss
• sexual difficulties
• 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.
Laboratory Values
Elevations in some laboratory blood tests of liver function and a muscle enzyme (creatine kinase) have been observed.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme (www.mhra.gov.uk/yellowcard). By reporting side effects you can help provide more information on the safety of this medicine.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the blister and on the carton after “Exp”. The expiry date refers to the last day of that month.
Do not store above 30°C. Keep the blister in the outer carton, in order to protect from light. Store in the original container, in order to protect from light.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. The measures will help protect the environment.
What Simvastatin Tablet contains
• The active substance is simvastatin. One film-coated tablet contains 5 mg, 10 mg, 20 mg or 40 mg simvastatin
• The other ingredients are:
Tablet core for 5 mg and 10 mg: pregelatinized starch, lactose monohydrate, cellulose microcrystalline, butylhydroxyanisole (E320), ascorbic acid (E300), citric acid monohydrate (E330), magnesium stearate.
Tablet core for 20 mg and 40 mg: pregelatinized starch, lactose monohydrate, cellulose microcrystalline, butylhydroxyanisole (E320), citric acid monohydrate (E330), magnesium stearate.
Film-coating for 5 mg: hypromellose, talc, titanium dioxide (E171), ferric oxide, yellow (E172).
Film-coating for 10 mg and 20 mg: hypromellose, talc, titanium dioxide (E171), ferric oxide, yellow (E172), ferric oxide, red (E172). Film-coating for 40 mg: hypromellose, talc, titanium dioxide (E171), ferric oxide, red (E172).
What Simvastatin Tablets look like and contents of the pack
Simvastatin 5 mg film-coated Tablet is a yellow coated, oval, scored, convex tablet coded ‘SIM 5’ on one side.
Simvastatin 10 mg film-coated Tablet is a pale pink coated, oval, scored, convex tablet coded ‘SIM 10’ on one side.
Simvastatin 20 mg film-coated Tablet is an orange coated, oval, biconvex tablet with score line on both sides coded ‘20’ on one side.
Simvastatin 40 mg film-coated Tablet is a red brown coated, oval, biconvex tablet with score line on both sides coded ‘40’ on one side.
Tablets are available in the following packs:
Blister (Aluminium/PVC)
Pack size: 10, 20, 28, 30, 40, 49, 50, 50x1, (60, 84 and 90 not 5mg), 98 and 100 film-coated tablets.
Polyethylene tablet container with screw cap
Pack size 10, 20, 28, 30, 40, 50, (84 and 90 not 5mg), 100 and 250 film-coated tablets.
Simvastatin 5 mg, 10 mg , 20 mg and 40 mg film-coated tablets can be divided into equal halves along the score line.
Not all pack sizes or pack types may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder: Sandoz Ltd, Frimley Business Park, Frimley, Camberley, Surrey, GU16 7SR, UK.
Manufacturer: Salutas Pharma GmbH, Otto-von-Guericke-Alle 1, D-39179 Barleben, Germany orS.C. Sandoz S.R.L., Str. Livezeni nr. 7A, 540472 Targu Mures, Jud. Mures, Romania or Salutas Pharma GmbH, Dieselstr. 5, D-70839 Gerlingen, Germany or LEK S.A., ul. Domaniewska 50 C, 02-672 Warszawa, Poland or Lek Pharmaceuticals d.d., Verovskova 57, 1526 Ljubljana, Slovenia.
This leaflet was last revised in 06/2014.
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