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Simvastatin 40mg Film Coated Tablets

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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)

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, pharmacist or nurse.

• 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, pharmacist or nurse. This includes any possible side effects not listed in this leaflet.

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 take Simvastatin

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

• if you currently have liver problems

• if you are pregnant or breast-feeding

• if you are taking one or more of the following drugs 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

• 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 cholesterol-lowering medicines called “statins” or fibrates

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

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.

Other medicines and Simvastatin

It is particularly important to tell your doctor if you are taking any of the following drugs. Taking Simvastatin with any of these drugs 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)

As well as the medicines listed above, tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including those obtained without a prescription. 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 and alcohol

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 Breast-feeding and fertility

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.

Ask your doctor or pharmacist for advice before taking any medicine.

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 tablets contain a 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 or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

You should stay on follow 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.

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 taking the 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.

If you stop taking simvastatin

• your cholesterol may rise again.

If you have any further questions on the use of thismedicine, ask your doctor, pharmacist or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

The following terms are used to describe how often side effects have been reported:

Rare (occurring in 1 or more of 10,000 and less than 1 of 1000 patients treated)

Very rare (occurring in less than 1 of 10,000 patients treated)

Frequency not known

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

• 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

• tendon injury

• 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.

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any side effects not listed in this leaflet.

- 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 (E464)

Hydroxypropyl cellulose (E463)

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 looks like and contents of the pack

Film-coated tablets

Simvastatin 10 mg Film-coated Tablets:

Light pink coloured, round shaped, biconvex, film coated tablets, debossed with' CS ' on one side and plain on the other side Simvastatin 20 mg Film-coated Tablets:

Light pink coloured, round shaped, biconvex, film coated tablets, debossed with' CT ' on one side and plain on the other side Simvastatin 40 mg Film-coated Tablets:

Pink coloured, round shaped, biconvex, film coated tablets, debossed with' CU ' on one side and plain on the other side Simvastatin 80 mg Film-coated Tablets:

Pink coloured, capsule shaped, biconvex, film coated tablets, debossed with' CV ' on one side and plain on the other side

Simvastatin 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.

Marketing Authorisation Holder and Manufacturer

Accord Healthcare Limited, Sage house, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF, United Kingdom

This leaflet was last revised in 05/2012

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.

6. Contents of the pack and other information

What Simvastatin tablets contain

- The active substance is simvastatin (10mg, 20mg, 40mg and 80mg).

Each Film-coated simvastatin.	Tablet	contains	10	mg
Each Film-coated simvastatin.	Tablet	contains	20	mg
Each Film-coated simvastatin.	Tablet	contains	40	mg
Each Film-coated simvastatin.	Tablet	contains	80	mg