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Artw#rl< • • Creative Desians	Artwork No.		210712/1			Colours Used
	Customer		Relonchem		■	Balck
	Description		Simvastatin 10/20/40mg leaflet
	Market		UK
	Language		English
	Size		155 x 290 mm
	Min. Font Size		8 pt
	Page No.		1 of 2
e-mail : artworkcd@yahoo.com Ph : +91-09845609386	Version No.		6
	Date		25-10-12
	Software		Illustrator 10
Packaging Development		QualityAssurance (QA)		Quality Control (QC)		Production

Simvastatin 10, 20 and 40mg Tablets    Rc/Olt " \CH1

Simvastatin

PACKAGE LEAFLET: INFORMATION FOR THE USER

Read all of this leaflet carefully before you start taking

this medicine.

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

« If you have any further questions, ask your doctor or pharmacist.

« This medicine has been prescribed foryou. 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 get serious, or if you notice any side effects not listed in the leaflet, please tell your doctor or pharmacist.

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.    Howto store Simvastatin Tablets

6.    Further information

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

What Simvastatin Tablets are

Simvastatin is one of a group of medicines known as statins or “HMG-CoA reductase inhibitors”. They work by reducing cholesterol and fatty substances, called triglycerides, in the blood. Cholesterol is vital for the body to function. Sometimes cholesterol can build up in the blood stream and become deposited on the walls of the arteries. There it forms plaques which will eventually blockthe blood vessels (similar to scale furring up of a water pipe).

We have a small amount of cholesterol in our diet but nearly all our cholesterol is made by our liver. High cholesterol in your blood adds to your risk of heart disease. Other factors such as existing heart disease, high blood pressure, high blood sugar (diabetes), increased weight, lack of exercise, smoking and a diet high in fat increase your risk further to the development of heart disease.

Cholesterol may cause coronary heart disease by obstructing the blood vessels that carry oxygen and nutrients to the heart. This obstruction or hardening of arteries is called atherosclerosis. Atherosclerosis may cause chest pain (called angina) and heart attack.

What Simvastatin Tablets are used for

If you suffer from coronary heart disease, your doctor may have prescribed Simvastatin tablets to reduce the risk of heart disease and prolong your life. Simvastatin may also decrease the risk of having to undergo surgery in order to increase blood flow to the heart. Simvastatin can also delay the progression of atherosclerosis and reduces the development of new atherosclerosis.

2. Before you take Simvastatin Tablets

Do not take Simvastatin Tablets:

•    If you are hypersensitive (allergic) to any of the ingredients.

•    If you have active liver disease.

•    If you are taking mibefradil, a drug for the treatment of hypertension and angina.

•    If you have a rare inherited disease called porphyria.

•    If you are pregnant or breastfeeding. See Pregnancy and Breastfeeding section.

•    If you had severe respiratory failure.

•    If you are takingany of the below medicines:

•    Itraconazole, Ketoconazole (medicines for fungal infections).

•    Erythromycin,clarithromycin, telithromycin(antibiotics for infections).

•    Nefazodone (a medicine for depression)

•    If you are taking HIV protease inhibitors such as indinavir, nelfinavir, ritonavir, and saquinavir (HIV protease inhibitors are used for HIV infections).

Take special care with Simvastatin Tablets

Tell your doctor before you start takingthese tablets:

•    About all your medical conditions including allergies.

•    If you drink large amounts of alcohol.

•    If you have ever had liver disease. Simvastatin tablets may not be right foryou.

•    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 tablets. 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 tablets.

•    If you have severe lung disease.

•    If you have high blood pressure or high levels of fats and sugars in your blood or if you have a body mass index of more than 30kg/m2. You may be more at risk of developing diabetes. Your doctor will monitor you closely if this applies to you.

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 tablets. The risk of muscle breakdown is also 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 thyroid¹ 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.

Simvastatin is not recommended for children.

Safety and effectiveness have been studied in 10-17year old boys and in girls who had started their menstrual period at least one year before (see HOWTO TAKE SIMVASTATIN). Simvastatin has not been studied in children underthe age of 10 years. For more information, talkto your doctor.

Taking other medicines

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

•    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)

•    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 oracenocoumarol (anticoagulants)

•    fenofibrate (another medicine for lowering cholesterol)

•    niacin (another medicine for lowering cholesterol)

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

Taking Simvastatin Tablets with food and drink

Grapefruit juice has one or more components that alter the metabolism of some medications including Simvastatin. Large volumes of grapefruit juice (more than I litre) may have adverse effects however typical consumption (one 250 ml glass daily) is unlikely to cause problems. If you are unsure ask your doctor for advice.

Your doctor will have told you to keep alcohol to a minimum. If you are concerned about how much alcohol you can drink you should discuss this with yourdoctor.

Pregnancy and Breastfeeding

Tell your doctor if you are, you think you might be or are planning to become pregnant, or if you are breast feeding.

•    If you are planning to become pregnant. You should stop taking Simvastatin at least one month before trying to become pregnant.

•    If you discover you are pregnant while taking Simvastatin you should stop taking Simvastatin immediately.

Artw#rl< • • Creative Desians	Artwork No.		210712/1			Colours Used
	Customer		Relonchem		■	Balck
	Description		Simvastatin 10/20/40mg leaflet
	Market		UK
	Language		English
	Size		155 x 290 mm
	Min. Font Size		8 pt
	Page No.		2of2
e-mail : artworkcd@yahoo.com Ph : +91-09845609386	Version No.		6
	Date		25-10-12
	Software		Illustrator 10
Packaging Development		QualityAssurance (QA)		Quality Control (QC)		Production

• If you are a woman who could bear children unless you are using a reliable form of contraception other than the pill (you may want to discuss this with your doctor).

Driving and using machines

Simvastatin tablets are 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 tablets.

Important information about some of the ingredients of Simvastatin Tablets

These 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.

3. Howto take Simvastatin Tablets

Always take Simvastatin Tablets 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 while taking simvastatin.

Usual Dose:

To betaken orally, whole with aglass of water:

•    10 mg daily for high cholesterol levels.

•    20 mg daily for coronary heart disease, taken as a single dose in the evening.

•    Some patients with mild to moderate hypercholesterolaemia may be treated with an initial dose of 5 mg of Simvastatin.

Children (I0-I7years old):

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

The maximum recommended dose is40 mg a day.

Your doctor may adjust the dose to a maximum daily dose of 80 mg, taken as a single dose in the evening. Your doctor may prescribe lower doses, especially if you are taking ciclosporin or suffer from certain kidney disorders. Continue taking Simvastatin until your doctor tells you to stop treatment.

If you take more Simvastatin Tablets than you should

If you swallow too many tablets or someone else accidentally takes your medicine, contact your doctor, pharmacist or nearest hospital straight away.

If you forget to take Simvastatin Tablets

Try to take Simvastatin Tablets daily as prescribed. However, if you miss a dose wait until the next dose is due then continue as before. Do not take a double dose to make up forthe forgotten one.

If you stop taking Simvastatin Tablets If you stop taking Simvastatin your cholesterol levels may rise again. Do not stop taking Simvastatin Tablets without first discussing it with your doctor.

If you have any further questions on the use of Simvastatin Tablets askyour doctor or pharmacist.

4. Possible Side Effects

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

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

Rare (less than I of f000 users)

Very rare (occurring in less than I of 10,000 users). 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.

•    Pancreatitis (inflammation of the pancreas) often with severe abdominal pain.

•    Inflammation of the liver with yellowing of the eyes and/or skin, itchiness of the skin, dark-coloured urine or pale-coloured stools, liver failure (very rare, may affect up to I in 10,000 people).

•    Pancreatitis (inflammation of the pancreas) often with severe abdominal pain.

The following side effects have also been reported rarely:

•    Diabetes. This is more likely if you have high blood pressure, high levels of sugar or fats in your blood or if you have abody mass index of more than 30kg/m2. Your doctor will monitor you more closely if these factors apply to you

•    Anaemia (a condition in which the body does not have enough healthy red blood cells) which can lead to pale skin and cause weakness or breathlessness

•    Headache, dizziness, numbness or weakness in the arms and legs, tingling sensation (pins and needles)

•    Sickness, vomiting, constipation, diarrhoea, flatulence, indigestion and abdominal pain

•    Rasn, 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

Laboratory values

Elevations in some laboratory blood tests of liver function and a muscle enzyme (creatine kinase) have been observed. Your doctor may want to do simple blood tests to check your muscle enzyme levels and if your liver is working properly before and during your treatment with Simvastatin Tablets.

If any of the side effects get serious, or ifyou notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

5. Howto store Simvastatin Tablets

Keep out of the reach and sight of children

Store in the original packaging Do not store above 30C

Do not use after the expiry date stated on the carton. The expiry date refers to the last day of that month.

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 protect the environment.

6. Further information

What Simvastatin Tablets contain

The active substance in this medicine is simvastatin which is available in 3 strengths, 10,20 and 40mg pertablet.

The other ingredients are lactose monohydrate, microcrystalline cellulose, pregelatinised starch, butylated hydroxyanisole (E320), ascorbic acid, anhydrous citric acid, colloidal anhyarous silica, talc, magnesium stearate, hypromellose, red iron oxide (EI72),yellow iron oxide (E172), triethylcitrate, titanium dioxide (EI7I), povidone.

What Simvastatin Tablets look like and contents of the pack

10mgtablets are peach coloured oval shaped.

20mgtablets are tan coloured oval shaped.

40mg tablets are brick red coloured.

•    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 ofthejoints

■    Inflammation ofthe blood vessels

■    Unusual bruising, skin eruptions and swelling, hives,itchiness, 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 eyes

and/or skin, itchiness ofthe skin, dark-coloured urine or

pale-coloured stools, liver failure (very rare, may affect

up to I in 10,000 people).

PL20395/0004    I POM

PL20395/0005

PL20395/0006

This leaflet was last revised in October 2012