Simvastatin 10mg Tablets

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Document: leaflet MAH GENERIC_PL 08215-0040 change

CP.SIM.JNT.T.V4P2

PATIENT INFORMATION LEAFLET

SIMVASTATIN 10mg, 20mg AND 40mg TABLETS

Read all of this leaflet carefully before you start taking simvastatin tablets because it contains important information for you.

• Keep this leaflet. You may need to read it again.

• If you have further questions, please ask your doctor or your pharmacist.

• This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.

• If any of the side effects gets serious, or you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

• Your doctor may have given you this medicine before from another company and it may have looked slightly different. Either brand will have the same effect.

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

■ WHAT SIMVASTATIN IS AND WHAT IT IS USED FOR

The name of your medicine is simvastatin. Each simvastatin tablet contains 10mg, 20mg or 40mg 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.

It is used to treat:

• Raised cholesterol level in the blood (primary hypercholesterolaemia)

• Elevated levels of fats in the blood (hyperlipidaemia)

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

• Coronary heart disease (CHD) or those at risk of developing CHD

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 . 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 (see Section 6: Contents of the pack and other 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 “Pregnancy and breast-feeding” below)

• If you are taking one or more of the following medicines at the same time:

-antifungal medicines (itraconazole, posaconazole, ketoconazole or voriconazole)

-anti-HIV medicines (indinavir, nelfinavir, ritonavir, saquinavir)

-specific types of antibiotics (erythromycin, clarithromycin and telithromycin)

-boceprevir or telaprevir (medicines for hepatitis C virus infection) specific types of antidepressants (nefazodone)

-cobicistat

-cholesterol lowering medicine (gemfibrozil)

-medicines used in organ transplant patients (ciclosporin)

-danazol (a man-made hormone used to treat endometriosis, a condition in which the lining of the uterus grows outside the uterus (see the section “Taking other medicines”).

• If you are taking or have taken (in the past 7 days) fusidic acid (used to treat bacterial infection)

Do not take more than 40 mg Simvastatin if you are taking lomitapide (used to treat a serious and rare genetic cholesterol condition)

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 rarely deaths have occurred.

Also tell your doctor or pharmacist if you have a muscle weakness that is constant. Additional tests and medicines may be needed to diagnose and treat this.

The risk of muscle breakdown is greater at higher doses of simvastatin, particularly the 80mg dose.

Warnings and precautions

Talk to your doctor before taking simvastatin:

• If you regularly drink a large amount of alcohol

• If you have had liver problems in the past

• If you have impaired kidney function

• If you have previously experienced problems with your muscles as a result of the use of statins or fibrates (medicines to reduce fat levels in the blood)

• If you or your family members suffer from hereditary muscle disorders

• If you are more than 65 years old

• If you are female

• If you have a thyroid problem which is not being treated.

• If you go into hospital for an operation, tell the doctor that you are taking Simvastatin.

• If you have severe lung disease.

• If you are Asian, because a different dose may be applicable to you.

Check with your doctor or pharmacist before taking Simvastatin if you:

• Have had severe respiratory failure

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

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 (some of these have already been listed in the above section “Do not take Simvastatin”):

• Ciclosporin (a medicine that suppresses the immune system)

• Danazol (a synthetic steroid used to treat endometriosis and breast cysts in women)

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

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

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

• Nefazodone (a medicine to treat depression)

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

• boceprevir or teleprevir (medicines for hepatits C virus infection)

• Amiodarone (medicine for your heart)

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

• Colchicine (a medicine used to treat gout)

• Lomitapide (used to treat serious and rare genetic cholesterol condition)

• Medicines with the active ingredient cobicistat.

It is also important to tell your doctor if you are taking or have recently taken:

• Anticoagulants - Medicines to thin the blood in order to prevent blood clots, such as warfarin, phenprocoumon or acenocoumarol

• 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.

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 immediately and contact your doctor.

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. Do not take simvastatin if you are breastfeeding, because it is not known if the medicine is passed into breast milk. Ask your doctor or pharmacist for advice before taking any medicine.

Customer: MK/FL/IS Originated by: Kent Pharm (Ath) Product: Simvastatin 10mg, 20mg & 40mg Tablets Dimensions: 210mm x 330mm Item Code: CP.SIMJNT.T.V4P2 Proof No and Date: 6 01/05/14

Revision:

ARTWORK FOR SUBMISSION Supersedes:

Colours

Pantone Blue 280 C

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

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.

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

• Dark coloured urine or pale coloured stool, liver failure (very rare)

• You experience severe abdominal pain which may be caused by an inflamed pancreas (pancreatitis)

• Lupus-like disease

Rare side effects (may affect up to 1 in 1,000 people)

Constipation

Numbness

Weakness

Feeling sick (nausea) or being sick (vomiting)

Diarrhoea

Pins and needles

Dizziness

• Stomach pain

• Wind (flatulence)

• Headache

• Indigestion

• Skin rash or itching

• Hair loss

• Pain

• Trouble sleeping (very rare)

• Memory loss (very rare)

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

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

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.

Remember to keep to a low-fat diet and exercise while taking simvastatin.

The usual doses are:

Adults:

People with coronary heart disease (CHD)

20 to 40mg a day, taken in the evening. The maximum dose is 80mg a day.

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

• Erectile dysfunction

• Depression

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

• Tendon (joins muscle to bone) injury, sometimes complicated by rupture (complete tear) in a tendon

• Muscle weakness that is constant

People with high levels of blood fats (Hyperlipidaemia)

The starting dose is 10mg a day, taken in the evening. The maximum dose is 80mg a day.

People with inherited high cholesterol levels (Homozygous familial hypercholesterolaemia)

40mg a day, taken in the evening. The doctor may ask you to take a higher dose of 80mg each day, taken in three doses through the day (20mg, 20mg and a 40mg dose taken in the evening).

Children:

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.

The 80mg 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 strength for you, depending on your current treatment, your personal risks and on your condition.

Your doctor may ask you to take a lower dose, particularly if you are taking ciclosporin, danazol, other fibrates or niacin, 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.

Taking another medicine for lowering your cholesterol at the same time as simvastatin

Your doctor may ask you to take another medicine for lowering your cholesterol at the same time as taking simvastatin. This includes medicines such as cholestyramine (a resin-type medicine).

This type of medicine can change the way simvastatin works. You should take simvastatin at least two hours before, or at least four hours after taking a resin-type medicine.

If you take more Simvastatin than you should

If you 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.

Other side effects:

• Sleep disturbances, including insomnia and nightmares

• 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 any of the side effects get 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.

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.

Do not use Simvastatin after the expiry date which is stated on the packaging after '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 this medicine above 30°C. Store in the original container. 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.

■ CONTENTS OF THE PACK AND OTHER INFORMATION

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, such as swollen face, tongue or throat, difficulty breathing and swallowing or hives

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

• Inflammation of the blood vessels

• Unusual bruising, swelling, skin sensitivity to the sun

• You get a lumpy rash or flushing of the skin

What Simvastatin contains

• The active substance is simvastatin.

• The other ingredients are: Lactose monohydrate, microcrystalline cellulose, pregelatinised starch, butylated hydroxyanisole (E320), ascorbic acid, citric acid, colloidal anhydrous silica, talc, magnesium stearate, hypromellose, red iron oxide (E172), yellow iron oxide (E172), triethyl citrate, titanium dioxide (E171), povidone.

What Simvastatin looks like and contents of the pack

Simvastatin 10mg Tablets are peach-coloured, oval-shaped, biconvex, film-coated scored tablets.

Simvastatin 20mg Tablets are tan-coloured, oval-shaped, biconvex, film-coated tablets.

Simvastatin 40mg Tablets are brick-red-coloured, oval-shaped, biconvex, film-coated tablets.

They are supplied in blister packs of 28 tablets.

PL Holder

Kent Pharmaceuticals Ltd., Wotton Road, Ashford, Kent, TN23 6LL, U.K. Distributor

Kent Pharmaceuticals Limited, Repton Road, Measham, DE12 7DT, U.K.

Company responsible for release of this medicine

Kent Pharmaceuticals Limited, Crowbridge Road, Ashford, Kent,

TN24 0GR, U.K.