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PACKAGE LEAFLET: INFORMATION FOR THE USER Simvastatin 10mg Tablets Simvastatin 20mg Tablets Simvastatin 40mg Tablets

(simvastatin)

In this leaflet:

1.    What Simvastatin Tablets are and what they are used for

2.    Before you take Simvastatin Tablets

3.    How to take Simvastatin Tablets

4.    Possible side effects

5.    How to store Simvastatin Tablets

6.    Further information

Simvastatin belongs to a group of medicines called ‘HMG-CoA reductase inhibitors’ which reduce the amount of cholesterol and fatty substances called triglycerides in the blood. Cholesterol is vital to the normal functioning of the body but if levels in the bloodstream are too high, it can be deposited on the walls of the arteries and build up to form plaques which can eventually block the blood vessel.

Simvastatin Tablets are used to:

lower levels of cholesterol (and triglycerides) in the blood, thereby reducing the risk of heart disease

slow or reduce the progression of:

o atherosclerosis (clogging of blood vessels by cholesterol) which can lead to angina (chest pain) and heart attack.

o coronary heart disease (CHD) - Simvastatin Tablets can help to lessen the risk of a heart attack.

DO NOT take Simvastatin Tablets if you:

are allergic (hypersensitive) to simvastatin or any of the other ingredients in the product (see Section 6 and end of section 2)

have liver problems or continual raised transaminase levels (liver enzymes) in your blood are taking any of the following medicines: itraconazole, ketoconazole, HIV protease inhibitors, erythromycin, clarithromycin, telithromycin or nefazodone (see ‘Taking other

medicines')

are pregnant or breast-feeding Take special care with Simvastatin Tablets

When taking this medicine, it is important that you tell your doctor if you have persistent muscle aches or pain.

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.

Your doctor will monitor your blood levels for the enzyme creatine kinase before, during and after taking these tablets especially if you: are over 70 years have problems with your kidneys. have uncontrolled thyroid problems

have repeated or unexplained muscle aches or pains (either personal or family history of muscle problems)

have a history of muscle problems when taking other cholesterol lowering medicines You regularly drink large amounts of alcohol.

Tell your doctor if you have severe lung disease

It is important to stay on a low-fat diet as well as taking this medicine.

Taking other medicines

Please tell your doctor if you are taking or have recently taken any other medicines, including those obtained without a prescription.

You must not take any of the following medicines with Simvastatin Tablets. If you need to take any of these medicines, treatment with Simvastatin Tablets must be stopped: itraconazole, ketoconazole - for the treatment of fungal infection

HIV protease inhibitors (indinavir, nelfinavir, ritonavir or saquinavir) for the treatment of HIV infection

erythromycin, clarithromycin, telithromycin - antibiotics nefazodone - for the treatment of depression.

Simvastatin Tablets may occasionally interact with the following medicines: digoxin (for heart conditions) warfarin (for thinning the blood)

two other kinds of lipid-lowering agents: fibric acid derivatives (e.g. benzafibrate, fenofibrate, gemfibrozil) and large doses of niacin or nicotinic acid, ciclosporin (an immunosuppressant medicine) amiodarone, verapamil or diltiazem (heart drugs).

Taking Simvastatin Tablets with food and drink

Do not drink grapefruit juice while you are taking this medicine as it can increase the level of simvastatin in your blood.

Also avoid alcoholic drinks as too much alcohol during treatment with simvastatin can increase your cholesterol level.

Pregnancy and breastfeeding

Do not take Simvastatin Tablets if you are pregnant, planning to become pregnant or are breastfeeding.

Ask your doctor for advice before taking any 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 Section 3 How to take Simvastatin Tablets). Simvastatin has not been studied in children under the age of 10 years. For more information, please talk to your doctor.

Driving and use of machines

Although Simvastatin Tablets are not expected to affect your ability to drive or operate machinery, dizziness has been reported rarely. If you feel dizzy after taking these tablets, do not drive or operate machinery.

Important information about some of the ingredients of Simvastatin Tablets

Lactose - if you know you have an intolerance to some sugars, consult your doctor before taking this medicine.

Always take Simvastatin Tablets exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

It is important you should stay on a low-fat diet as well as taking simvastatin tablets.

The dose is one simvastatin 5mg, 10mg, 20mg, 40mg or 80mg Tablet by mouth once a day.

For children (10-17 years old), the recommended usual starting dose is 10mg a day in the evening. The maximum recommended dose is 40mg a day.

For high cholesterol levels: the usual starting dose is 10-20mg per day.

For coronary heart disease: the usual starting dose is 20-40mg per day, given as a single dose in the evening.

Your doctor may adjust your dose (maximum 80mg) in order to have the best effect. The 80mg dose is only recommended for adult patients with very high cholesterol levels and at high risk of heart disease problems.

Keep taking Simvastatin Tablets for as long as your doctor has told you to.

If you notice muscle pain, weakness or cramps whilst taking these tablets, tell your doctor immediately so that your blood levels can be monitored. Your doctor may decide to stop the treatment and re-introduce the tablets at a lower dose with close monitoring. Always speak to your doctor before stopping any medication.

If you have need to have surgery

If you are going to hospital for an operation, please tell the doctor as Simvastatin Tablets should be temporarily stopped a few days before the operation. Your doctor will advise you when to stop and restart taking them.

If you take more Simvastatin Tablets than you should

If you or someone else swallows several of these tablets together, contact your doctor or nearest hospital emergency department immediately (taking any remaining tablets as well as the box with you if possible).

If you forget to take Simvastatin Tablets

If you miss a dose, take one as soon as you can then carry on as before. Do not take an extra dose to make up for a forgotten dose.

If you stop taking Simvastatin Tablets

Talk to your doctor if you want to stop taking these tablets. Your cholesterol levels might increase again if you stop taking them.

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

Like all medicines, Simavastatin Tablets can cause side effects, although not everybody gets them. If any of the following side effects come on soon after taking these tablets, stop the tablets and tell your doctor immediately:

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)

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

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.

Other possible side effects:

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.

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.

Keep out of the reach and sight of children.

This medicinal product does not require any special storage conditions. Do not use the tablets after the expiry date stated on the label.

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.

What Simvastatin Tablets contain

The active substance is simvastatin, 10mg, 20mg or 40mg.

The other ingredients are lactose anhydrous, microcrystalline cellulose, pregelatinised maize starch, butylhydroxyanisole, magnesium stearate, talc, hydroxypropylcellulose, hydroxypropyl methylcellulose and titanium dioxide (E171).(See also end of Section 2 ‘Important information about some of the ingredients of Simvastatin Tablets ’).

What Simvastatin Tablets look like and contents of the pack

Simvastatin Tablets are white, oblong, biconvex film-coated, scored/embossed tablets.

They are available in blister packs of 2x 14 tablets of 10mg, 20mg or 40mg strength.

Marketing Authorisation Holder :

Medley Pharma Limited

Unit 2A, Olympic Way

Sefton Business Park

Liverpool

L30 IRD

UK

Distributed by:

Zanza Laboratories Limited, Liverpool, U.K.

This leaflet was revised : October 2014