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PACKAGE LEAFLET: INFORMATION FOR THE USER STATIN 10mg, 20mg AND 40mg FILM-COATED TABLETS

In this leaflet:

1.    What Simvastatin is and what it is used for

2.    Before you take Simvastatin

3.    How to take Simvastatin

4.    Possible side effects

5.    How to store Simvastatin

6.    Further information

1. WHAT SIMVASTATIN IS AND WHAT IT IS USED FOR

The name of your medicine is Simvastatin. Each Simvastatin tablet contains 10 mg, 20 mg or 40 mg of the active ingredient simvastatin. Simvastatin belongs to a group of medicines called HMG-CoA reductase inhibitors. They work by reducing the level of cholesterol and fats (triglycerides) in your blood.

•    Higher than normal levels of fats in the blood (hyperlipidaemia)

•    An inherited condition causing high levels of cholesterol in the blood (homozygous familial hypercholesterolaemia)

Having too much cholesterol in your blood can lead to coronary heart disease. It can clog blood vessels, leading to hardening of the arteries (atherosclerosis). Hardened arteries are less able to carry blood to the heart and around the body. This can lead to chest pain (angina) and heart attacks. Simvastatin can both prevent hardening of the arteries and slow it down.

If you have high levels of cholesterol you are more likely to get heart disease if you also:

•    Have high blood pressure (hypertension) or high blood sugar (diabetes)

•    Take little exercise

•    Smoke

•    Are overweight or eat a high fat diet

Ask your doctor or pharmacist if you would like advice about any of the above factors.

2. BEFORE YOU TAKE SIMVASTATIN

Do not take Simvastatin:

•    If you are allergic (hypersensitive) to simvastatin or any of the other ingredients of Simvastatin (see Section 6: Further Information)

•    If you have liver problems

•    If you are pregnant or breast-feeding (see the section “Pregnancy and Breast-feeding” below)

•    If you are a woman of child bearing age and you are not using a reliable method of contraception (see the section on pregnancy below)

•    If you are taking one or more of the following medicines at the same time: antifungal medicines (itraconazole, posaconazole and ketoconazole), anti-HIV medicines, and/or specific types of antibiotics (erythromycin, clarithromycin and telithromycin) (see Section 2: Taking other medicines).

•    If you have a rare inherited disease called porphyria.

•    If you have a creatinine kinase blood test result greater than five times normal

Take special care and check with your doctor or pharmacist before taking Simvastatin:

•    If you have severe respiratory failure

•    If you regularly drink a large amount of alcohol

•    If you have had liver problems in the past

•    If you have kidney problems

•    If you have an underactive thyroid for which you are not being treated

•    If you have or have had muscle problems in the past

•    If you are an alcoholic

•    If you are elderly (aged 70 years or older)

•    If you are taking one or more of the following medicines at the same time: a medicine to treat endometriosis, a condition affecting a woman's reproductive system (danazol), medicines to treat high blood pressure or heart problems (verapamil and diltiazem)

Taking other medicines 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.

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. If you take Simvastatin at the same time as some other medicines, it may change the way that Simvastatin or the other medicine works. Please check with your doctor if you are taking any of the following as taking any of these medicines with simvastatin may increase the risk of muscle problems:

•    Ciclosporin (a medicine that suppresses the immune system)

•    Other medicines to lower cholesterol known as fibrates (such as bezafibrate, ezetimibe, fenofibrate or gemfibrozil)

•    Itraconazole, posaconazole, or ketoconazole (medicines for fungal infections)

•    Large amounts of niacin or nicotinic acid (that is, more than 1 gram a day)

•    Erythromycin, telithromycin, fusidic acid, rifampicin or clarithromycin (antibiotics)

•    Medicines to treat HIV infections (such as indinavir, nelfinavir, ritonavir, efavirenz, or saquinavir)

•    Digoxin or amiodarone (medicines for your heart)

•    Bosentan (a medicine to treat high blood pressure)

•    Cytotoxics (drugs used to treat cancer by chemotherapy)

•    St. John's Wort (a herb to treat depression)

It is also important to tell your doctor if you are taking warfarin (a medicine to thin the blood).

Taking Simvastatin with food and drink

You should not drink grapefruit juice when you are taking Simvastatin. It may increase the amount of simvastatin in your blood and could increase the risk of muscle problems.

Pregnancy and Breast-feeding Do not take Simvastatin if:

•    You are pregnant or planning to get pregnant

•    You are breast-feeding

If you get pregnant while taking Simvastatin, stop taking it and see your doctor straight away.

You should stop taking Simvastatin 1 month before trying to get pregnant. If there is a chance that you may get pregnant when taking Simvastatin, talk to your doctor.

Driving and using machines

There are no indications that Simvastatin negatively affects the ability to react. Simvastatin may cause dizziness in rare cases. If you feel dizzy, then do not drive or operate any machines.

Important information about some of the ingredients of Simvastatin tablets

Simvastatin tablets contain lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

Blood tests

Your doctor may want you to have some simple blood tests to check your liver both before you start taking Simvastatin and during your treatment.

3. HOW TO TAKE SIMVASTATIN

Always take Simvastatin exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure. You should stay on a cholesterol lowering diet and exercise while taking simvastatin.    xxxxxx/x

The usual doses are:

People with coronary heart disease (CHD)

The usual dose is 20 to 40mg a day, taken in the evening. The maximum dose is 80mg a day, taken in the evening. People with high levels of blood fats (Hyperlipidaemia)

The usual starting dose is 10 mg a day, taken in the evening. The maximum dose is 80mg a day, taken in the evening. Your doctor may ask you to take a lower dose, particularly if you are taking ciclosporin, fibrates, danazol, nicotinic acid, amiodarone, verapamil or diltiazem or if you have kidney problems.

Keep taking the medicine until your doctor tells you to stop.

Always swallow the tablets with plenty of water.

Children

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 in for adult patients with very high cholesterol levels and at high risk of heart disease problems.

If you take more Simvastatin than you should

If take more Simvastatin than you should, tell your doctor or go to your nearest hospital straight away. Take the carton and any Simvastatin tablets left with you so that the doctors know what you have taken.

If you forget to take Simvastatin

If you forget to take a dose, take it as soon as you remember, unless it is time for your next dose.

Do not take a double dose.

If you stop taking Simvastatin

Continue taking simvastatin, unless your doctor tells you to stop. Your blood cholesterol levels may rise again once you stop taking simvastatin.

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

4. POSSIBLE SIDE EFFECTS

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

Stop taking Simvastatin and see a doctor or go to a hospital straight away if:

•    You experience symptoms of angioedema, or anaphylaxis such as swollen face, tongue or throat, difficulty in breathing and swallowing and hives

•    You get unexplained pain, tenderness or weakness in the muscles or pain in your joints, high temperature or tiredness

•    You get a lumpy rash or flushing of the skin

•    You get liver problems, such as yellowing of the skin or eyes (jaundice/hepatitis)

Most common side effects

•    Stomach pain

•    Constipation

•    Wind (flatulence)

•    Weakness

•    Headache

•    Feeling sick or being sick (nausea or vomiting)

•    Diarrhoea

•    Skin rash or itching

•    Serious skin conditions (severe rash/or swelling), including Stevens-Johnson syndrome (symptoms of which include fever, rash, sore mouth and eyes, joint and muscle pains)

•    Pins and needles

•    Indigestion or severe abdominal pain (possibly caused by an inflamed pancreas)

•    Feeling breathless and very tired. This could mean you have low levels of red blood cells (anaemia).

•    Infection. This could mean you have low levels of white blood cells (leucopenia)

•    Hair loss

•    Dizziness

•    Muscle cramps, unexplained pain, swelling, tenderness or weakness in the muscles

•    Pain

Other possible side effects

•    Sleep disturbances, including insomnia and nightmares

•    Memory loss

•    Disturbed thinking patterns

•    Sexual difficulties

•    Depression

•    Red or purple discolorations on the skin

•    Muscle breakdown, accompanied by kidney failure

•    Feeling light-headed or faint, caused by low blood pressure

•    Breathing problems including persistent cough and/or shortness of breath or fever.

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. Do not be alarmed by this list - most people take Simvastatin without any problems.

5. HOW TO STORE SIMVASTATIN

Keep out of the reach and sight of children.

Do not use Simvastatin after the expiry date which is stated on the packaging behind 'EXP'.

The first two digits indicate the month and the last four digits indicate the year. The expiry date refers to the last day of the month. Do not store above 30°C.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. FURTHER INFORMATION

What Simvastatin contains

•    The active substance is simvastatin.

•    The other ingredients are: lactose monohydrate, microcrystalline cellulose (E460), pregelatinised starch, butylated hydroxyanisole (E320), ascorbic acid (E300), anhydrous citric acid (E330), colloidal anhydrous silica, talc (E553b) magnesium stearate (E572), hypromellose (hydroxypropyl methyl cellulose) (E464), red iron oxide (E172), yellow iron oxide (E172)) triethylcitrate (E1505), titanium dioxide (E171) and povidone K-30 (E1201).

What Simvastatin looks like and content of the pack

Simvastatin 10 mg Tablets are oval-shaped, biconvex, peach-coloured tablets of 8.5mm length, with a scoreline on one side.

The scoreline is only to facilitate breaking for ease of swallowing and not to divide into equal doses.

Simvastatin 20 mg Tablets are oval-shaped, biconvex, tan-coloured tablets of 11mm length.

Simvastatin 40 mg Tablets are oval-shaped, biconvex, brick-red-coloured tablets of 14mm length.

They are supplied in blister packs of 28 tablets.

Marketing Authorisation Holder and Manufacturer

The Marketing Authorisation Holder is: Wockharrdt UK Limited, Ash Road North, Wrexham, LL13 9UF, UK.

The Manufacturer is: CP Pharmaceuticals Limited, Ash Road North, Wrexham, LL13 9UF, UK.

Other formats:

To listen to or request a copy of this leaflet in Braille, large print or audio please call, free of charge: 0800 198 5000 (UK Only)

This leaflet was last revised in October 2013.

This leaflet does not contain all the information about your medicine. If you have any questions or you are not sure about anything ask your doctor or pharmacist.

WOCKHARDT    XXXXXX/X