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Package leaflet: Information for the user

Simvastatin 10 mg film-coated tablets Simvastatin 20 mg film-coated tablets Simvastatin 40 mg film-coated tablets Simvastatin 80 mg film-coated tablets

(Simvastatin)

What is in this leaflet:

1.    What Simvastatin is and what it is used for

2.    What you need to know before you take Simvastatin

3.    How to take Simvastatin

4.    Possible side effects

5.    How to store Simvastatin

6.    Contents of the pack and other information

1. What Simvastatin is and what it is used for

Simvastatin is a medicine used to lower levels of total cholesterol, “bad” cholesterol (LDL cholesterol) and fatty substances called triglycerides in the blood. In addition Simvastatin raises levels of “good” cholesterol (HDL cholesterol). You should stay on a cholesterol-lowering diet while taking this medicine. Simvastatin is member of the class of drugs called statins.

Simvastatin 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 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 goals with your doctor.

2. What you need to know before you take Simvastatin

DO NOT use Simvastatin

•    if you are allergic to simvastatin or any of the other ingredients of this medicine (listed in section 6).

•    if you currently have a liver problems

•    if you are pregnant or breast-feeding

•    if you are taking one or more of the following medicinal products at the same time:

-    itraconazole, ketoconazole, or posaconazole (medicines for fungal infections)

-    erythromycin, clarithromycin or telithromycin, (antibiotics for infections)

-    HIV protease inhibitors such as indinavir, nelfinavir, ritonavir, and saquinavir (HIV protease inhibitors are used for HIV infections)

-    nefazodone (a medicine for depression).

Warnings and precautions

Talk to your doctor or pharmacist before taking Simvastatin

•    Tell your doctor about all your medical conditions including allergies.

•    Tell your doctor if you drink large amounts of alcohol

•    Tell your doctor if you have ever had liver disease. Simvastatin may not be right for you.

•    Tell your doctor if you are due to have an operation. You may need to stop taking Simvastatin tablets for a short time.

•    Your doctor should do a blood test before you start taking Simvastatin. This is to check how well your liver is working.

•    Your doctor may also want you to have blood tests to check how well your liver is working after you start taking Simvastatin.

•    Tell your doctor if you have severe lung disease.

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.

Contact your doctor immediately if you experience unexplained muscle pain, tenderness, or weakness. This is because on rare occasions, muscle problems can be serious, including muscle breakdown resulting in kidney damage; and very rare deaths have occurred.

The risk of muscle breakdown is greater at higher doses of Simvastatin and is greater in certain patients.

Talk with your doctor if any of the following applies:

•    you consume large amounts of alcohol

•    you have kidney problems

•    you have thyroid problems

•    you are 65 years or older

•    you are female

•    you have ever had muscle problems during treatment with cholesterollowering medicines called “statins” or fibrates

•    you or a close family member have a hereditary muscle disorder.

Other medicines and Simvastatin

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including those obtained without a prescription. Taking Simvastatin 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.”)

•    ciclosporin (a medicine often used in organ transplant patients)

•    danazol (a man-made hormone used (to treat endometriosis)

•    medicines like itraconazole, ketoconazole, fluconazole or posaconazole (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 for an irregular heartbeat)

•    verapamil , diltiazem, or amlodipine (medicines for high blood pressure, chest pain associated with heart disease, or other heart conditions)

•    colchicine (a medicine used to treat gout)

In particular, tell your doctor if you are taking any of the following:

•    medicines to prevent blood clots, such as warfarin phenprocoumon or acenocoumarol (anticoagulants).

•    fenofibrate (another medicine for lowering cholesterol).

•    niacin (another medicine for lowering cholesterol).

•    rifampicin (a medicine used to treat tuberculosis)

Also tell your doctor if you are taking niacin (nicotinic acid) or a niacin-containing product and are Chinese.

Simvastatin with food and drink

Grapefruit juice contains one or more components that alter how the body uses some medicinal products, including Simvastatin. Consuming grapefruit juice should be avoided.

Pregnancy and breastfeeding

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 Simvastatin if you are pregnant, trying to get pregnant or think you may be pregnant. If you get pregnant while taking Simvastatin, stop taking it immediately and contact your doctor.

Do not take Simvastatin if you are breast-feeding, because it is not known if the medicine is passed into breast milk.

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

Children

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”). Simvastatin has not been studied in children under the age of 10 years. For more information, talk to your doctor.

Driving and using machines

Simvastatin is not expected to interfere with your ability to drive or to use machinery. However, it should be taken into account that some people get dizzy after taking Simvastatin.

Simvastatin contains lactose

Simvastatin tablet contain sugar called 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.

3. How to take Simvastatin

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

You should stay on a cholesterol-lowering diet while taking Simvastatin.

The dose is 1 Simvastatin 5-mg, 10 mg, 20 mg, 40 mg, or 80 mg tablet by mouth once a day.

Use in children and adolescents

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.

The 80 mg dose is only recommended for adult patients with very high cholesterol levels and at high risk of heart disease problems who have not reached their cholesterol goal on lower doses.

Your doctor will determine the appropriate tablet strength for you, depending on your condition, your current treatment and your personal risk status.

Take Simvastatin in the evening. You can take it with or without food. The usual starting dose is 10, 20 or , in some cases, 40 mg a day. Your doctor may adjust your dose after at least 4 weeks to a maximum of 80 mg a day. Do not take more than 80 mg a day. Your doctor may prescribe lower doses, particularly if you are taking certain medicinal products listed above or have certain kidney conditions. Keep taking Simvastatin unless your doctor tells you to stop.

If your doctor has prescribed Simvastatin along with any bile acid sequestrant (medicines for lowering cholesterol), you should take Simvastatin at least 2 hours before or 4 hours after takingthe bile acid sequestrant.

If you take more Simvastatin than you should

•    please contact your doctor or pharmacist.

If you forget to take Simvastatin

Do not take an extra dose, just take your normal amount of Simvastatin at the usual time the next day. Do not take a double dose to make up for a forgotten tablet.

If you stop taking Simvastatin

•    your cholesterol may rise again.

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.

The following rare (may effect up to 1 in 1000 users) 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 (may effect up to 1 in 1000 users):

•    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

•    trouble sleeping (very rare)

•    poor memory (very rare)

The following side effects have also been reported but the frequency cannot be estimated from the available information (frequency not known):

•    erectile dysfunction

•    depression

•    inflammation of the    lungs causing    breathing problems including

persistent cough and/or shortness of breath or fever

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 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, Website: www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Simvastatin

Keep this medicine out of the sight and reach of children.

This medicinal product does not require any special storage conditions.

Do not use this medicine 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.

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.

-    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 (E 464), hydroxy propyl cellulose (E 463), 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 tablets look like and contents of the pack

Film-coated tablets

Simvastatin 10 mg film-coated tablets:

Light pink, round [diameter 6.1 mm], and biconvex with the inscription “A” on one side and “01” on the other.

Simvastatin 20 mg film-coated tablets:

Light pink, round [diameter 8.1 mm], and biconvex with the inscription “A” on one side and “02” on the other.

Simvastatin 40 mg film-coated tablets:

Pink, round [diameter 10.1 mm], and biconvex with the inscription “A” on one side and “03” on the other.

Simvastatin 80 mg film-coated tablets:

Pink, capsule-shaped and biconvex with the inscription “A” on one side and “04” on the other. The size is 18.8 mm x 8.8 mm

Simvastatin 10, 20 and 40 mg film-coated tablets are available in blister packs containing 10, 14, 20, 28, 30, 50, 56, 60, 84, 90, 98 and 100 tablets.

Simvastatin 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.

Marketing Authorisation Holder

Aurobindo Pharma Limited,

Ares, Odyssey Business Park,

West End Road,

South Ruislip HA4 6QD,

United Kingdom.

Tel: ++ 44 20 8845 8811 Fax: ++ 44 20 8845 8795

Manufacturer

Milpharm Limited,

Ares, Odyssey Business Park,

West End Road,

South Ruislip HA4 6QD,

United Kingdom.

or

APL Swift Services (Malta) Limited HF26, Hal Far Industrial Estate, Hal Far,

Birzebbugia, BBG 3000.

Malta

This medicinal product is authorised in the Member States of the EEA under the following names:

SIMVASTATINE AUROBINDO 10 /20 /40 mg, comprimes pellicules

Simvastatin Aurobindo 5 /10 /20 /40 /80 mg Filmtabletten

Simvastatin Aurobindo 10 /20 /40 /80 mg film-coated tablets

Simvastatina Aurobindo 10 /20 /40 mg compresse rivestite con film

Simvastatin Aurobindo 40 /80 mg apvalkotas tabletes

Simvastatin Aurobindo 10 /20 /40 /80 mg plevele dengtos tabletes

Simvastatin Aurobindo 10 /20 /40 /80 mg tabletter, filmdrasjerte Simvastatin Aurobindo Simvastatina Aurobindo

Simvastatin Aurobindo 10 /20 /40 mg comprimat filmat

Simvastatina Aurobindo 10 /20 /40 mg comprimidos recubiertos con pelfcula Simvastatine Aurobindo 5 /10 /20 /40 /80 mg filmomhulde tabletten

Simvastatin 10 /20 /40 /80 mg film-coated tablets

This leaflet was last revised in 08/2014.

6. Contents of the pack and other information

What Simvastatin tablets contain