PACKAGE LEAFLET: INFORMATION FOR THE USER

SIMVASTATIN 5 mg, 10 mg, 20 mg & 40 mg TABLETS

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 or 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 you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet see section 4.

What is in the 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 belongs to a group of medicines called HMG-CoA reductase inhibitors, also known as 'statins', which work by lowering the levels of total cholesterol, bad cholesterol (LDL cholesterol) and fatty substances (triglycerides) in your blood. In addition, Simvastatin raises levels of good cholesterol (HDL cholesterol).

Cholesterol is one of several fatty substances found in the blood stream. Your total cholesterol is made up mainly of LDL and HDL cholesterol.

LDL cholesterol is often called bad cholesterol because it can build up in the walls of your arteries forming plaque. Eventually this plaque build-up can lead to a narrowing of the arteries. This narrowing can slow or block blood flow to vital organs such as the heart and brain. This blocking of blood flow can result in a heart attack or stroke.

HDL cholesterol is often called "good" cholesterol because it helps keep the bad cholesterol from building up in the arteries and protects against heart disease.

Triglycerides are another form of fat in your blood that may increase your risk for heart disease.

You should stay on a cholesterol-lowering diet while taking this medicine.

Simvastatin is used in addition to your cholesterol-lowering diet while taking this medicine to:

•    treat raised levels of cholesterol (primary hypercholesterolaemia) or triglycerides (mixed hyperlipidaemia) in your blood.

•    treat hereditary illness that increased levels of cholesterol in your blood (homozygous familial hypercholesterolaemia), together with dieting and other treatments (e.g. LDL-apheresis), or when such treatments are not appropriate. You may also receive other treatments.

•    prevent 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 and tell your doctor if you:

•    are allergic (hypersensitive) to Simvastatin or any of the other ingredients in these tablets (listed in section 6)

•    have liver problems

•    are pregnant or breast-feeding (see the section 'Pregnancy and Breast-feeding' below)

•    are taking medicines, with one or more than one of the following active ingredients (also see the section 'Taking other medicines' below)

-    itraconazole, ketoconazole, voriconazole or posaconazole (used to treat fungal infections)

-    HIV-protease inhibitors such as ritonavir, indinavir, saquinavir or nelfinavir (used to treat HIV infections)

-    boceprevir or telaprevir (used to treat hepatitis C virus infection).

-    cobicistat

-    gemfibrozil (used to lower cholesterol)

-    ciclosporin (used in organ transplant patients)

-    danazol (used to treat endometriosis, a condition in which the lining of the uterus grows outside the uterus)

-    erythromycin, clarithromycin or telithromycin (used to treat infections)

-    nefazodone (used to treat depression)

-    taking lomitapide (used to treat a serious and rare genetic cholesterol condition)

If you are not sure, talk to your doctor or pharmacist before taking Simvastatin.

Warnings and Precautions

Tell your doctor:

•    about all your medical conditions including allergies

•    if you consume large amounts of alcohol.

•    if you have ever had liver disease. Simvastatin may not be right for you.

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

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.

Tell your doctor if you have severe lung disease.

Contact your doctor immediately if you experience unexplained muscle pain, tenderness or muscle weakness while being treated with Simvastatin. This is because on rare occasions, muscle problems can be serious, including muscle breakdown resulting in kidney damage; and very rare deaths have occurred.

Simvastatin may cause muscle breakdown (see section 4). The risk of muscle breakdown is greater at higher doses, particularly the 80 mg dose. This risk of muscle breakdown is also greater in certain patients. Talk with your doctor if you:

•    regularly consume large amounts of alcohol

•    have kidney problems

•    are female

•    have ever had problems with your muscles while using statins or fibrates (medicines to reduce fat levels in the blood)

•    or a close family members suffer from hereditary muscle disorders

•    are 65 years or older

•    have thyroid problems which are not being treated

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.

Operations and tests

If you are going to have an operation, tell the doctor, dentist or nurse that you are taking Simvastatin. You may need to stop taking Simvastatin tablets for a short time.

Taking Simvastatin may affect the results of some clinical tests. If you are going to have a test, it is important to tell your doctor or nurse that you are taking Simvastatin.

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. This is to check how well your liver is working.

Other medicines and Simvastatin

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines bought without a prescription.

In particular, tell your doctor or pharmacist if you are taking any of the following medicines:

•    medicines to treat irregular heart beat, such as amiodarone

•    medicines to treat bacterial infections such as clarithromycin, erythromycin, telithromycin or fusidic acid. Do not take fusidic acid while using this medicine. Also see section 4.

•    medicines to treat fungal infections such as fluconazole, itraconazole, ketoconazole, voriconazole or posaconazole

•    HIV protease inhibitors used to treat AIDS, such as indinavir, nelfinavir, ritonavir or saquinavir

•    medicines to treat hepatitis C infections such as boceprevir or telaprevir

•    medicines with the active ingredient cobicistat.

•    medicines to treat high blood pressure or chest pain associated with heart disease or other heart conditions, such as diltiazem, verapamil or amlodipine

•    medicines used to thin the blood and stop blood clots from forming, such as warfarin, phenprocoumon or acenocoumarol

•    other cholesterol-lowering medicines known as fibrates, such as bezafibrate and gemfibrozil

•    niacin or nicotinic acid also to lower cholesterol (in doses greater than 1 gram a day)

•    ciclosporin, often used in organ transplant patients.

•    colchicine to treat gout

•    danazol to treat endometriosis and breast cysts in women

•    nefazodone to treat depression

•    rifampicin, an antibiotic used to treat tuberculosis

•    fenofibrate, used to lower cholesterol

•    lomitapide, used to treat a serious and rare genetic cholesterol condition

Taking Simvastatin with food and drink

You should not drink grapefruit juice whilst you are being treated with 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 trying to become pregnant or think you may be pregnant.

You should stop taking Simvastatin before trying to get pregnant. If you become pregnant while taking Simvastatin, stop taking it and see your doctor straight away.

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.

Children and adolescents

Safety and effectiveness have been studied in 10-17 year old boys and in girls who had started their menstrual period (menstruation) at least one year before (see 'section 4' below).

Simvastatin has not been studied in children under the age of 10 years. For more information, talk to your doctor.

Driving and using machines

Simvastatin is not expected to interfere with your ability to drive or to use machinery. Simvastatin may cause dizziness in rare cases. If you feel dizzy, then do not drive or operate any machines.

Simvastatin tablets contain lactose

This medicine contains lactose. If you have been told by your doctor that you have an intolerance to lactose or other sugars, contact your doctor before taking this medicine.

3. How to take Simvastatin

Your doctor will determine the appropriate tablet strength for you, depending on your condition, your current treatment and your personal risk status. Always take Simvastatin exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

Swallow the tablets with water. Simvastatin tablets may be taken with or without food. Remember to keep to a low-fat diet and exercise while taking Simvastatin.

Dosage:

The recommended dose is Simvastatin 10 mg, 20 mg, 40 mg or 80 mg by mouth once a day.

Adults:

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 certain kidney conditions. The 80 mg dose is only recommended for adult patients with very high cholesterol levels and at high risk of heart disease problems.

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

Your doctor may ask you to take a bile acid sequestrant (another type of medicine for lowering cholesterol, such as cholestyramine) at the same time as taking Simvastatin. 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 the bile acid sequestrant.

Patients with severe kidney problems:

Your doctor may prescribe a lower dose, which will usually not be more than 10 mg per day.

Children and adolescents:

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.

Method of administration:

Take Simvastatin in the evening. You can take it with or without food. Keep taking Simvastatin unless your doctor tells you to stop.

If you take more Simvastatin than you should

If you (or someone else) take too many tablets, contact your doctor or the nearest hospital casualty department immediately. Take this leaflet and the package with you so they know what has been taken.

If you forget to take Simvastatin

If you forget to take a dose, take it as soon as you remember. However, if it is nearly time for the next dose, skip the missed dose and take the next dose when it is due. Do not take a double dose (two doses at the same time) to make up for a forgotten dose.

If you stop taking Simvastatin

If you suddenly stop taking Simvastatin, your blood cholesterol levels may rise again. Do not stop taking this medicine without consulting your doctor beforehand. Your doctor will advise you on how best to do this.

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

4. Possible side effects

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

If you get any of the following side effects, STOP TAKING Simvastatin and tell your doctor immediately or go to the nearest hospital emergency department:

•    an allergic reaction to Simvastatin

You experience some of the following symptoms;

-    swelling of the face, tongue or throat which may cause difficulty breathing

-    Lupus-like syndrome (an inflammatory disease which causes joint pain, skin rashes and fever)

-    severe muscle pain and stiffness usually in the shoulders and hips

-    rash with weakness of the limbs and neck muscles

-    inflammation of the blood vessels

-    increased incidents of bleeding or bruising

-    stiffness, pain or inflammation of the joints

-    skin eruptions and swelling (dermatomyositis), red, raised lumps (hives), skin sensitivity to the sun, fever, flushing, unusal bruising

-    shortness of breath, feeling unwell

•    Muscle pain, tenderness, weakness or cramps. On rare occasions, these muscle problems can be serious, including muscle breakdown resulting in kidney damage.

If you get the following rare side effects, see a doctor straight away:

•    inflammation of the liver, (hepatitis), which may cause yellowing of the skin or whites of the eyes (jaundice), darker urine or paler stools, feeling tired or weak, loss of appetite; liver failure (very rare)

•    inflammation of the pancreas (pancreatitis), which causes severe pain in the abdomen and back

Tell your doctor or pharmacist if you get any of these side effects:

Rare side effects (may affect up to 1 in 1000 people):

•    low levels of red blood cells, (anaemia), which can make your skin pale and cause tiredness and breathlessness

•    constipation, stomach pain, wind (flatulence), indigestion, diarrhoea, feeling sick or being sick (nausea or vomiting)

•    weakness

•    headache, tingling or 'pins and needles', dizziness, a disorder of the nerves which can cause weakness or numbness of the arms and legs

•    rash, itching, hair loss

Very rare side effects (may affect up to 1 in 10,000 people):

•    liver failure

•    trouble sleeping, nighmares

•    poor memory, memory loss, confusion

Not Known (frequency cannot be estimated from the available data):

•    Muscle weakness that is constant, sometimes complicated by rupture of tendon.

•    depression

•    breathing problems including a persistent cough and/or shortness of breath

•    impotence

Additional possible side-effects reported with some statins:

•    sleep disturbances, including sleeplessness 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.

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 Yellow card Scheme at: 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 the tablets after the expiry date stated on the label [EXP]. The expiry date refers to the last day of that month.

Do not store above 25°C. Store the tablets in the original package.

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. Each tablet contains 5 mg or 10 mg or 20 mg or 40 mg of the active substance.

The other ingredients are: lactose anhydrous, microcrystalline cellulose (E460), pregelatinised maize starch, butylhydroxyanisole (E320), talc (E553b), magnesium stearate (E572), hydroxypropylcellulose (E463), hypromellose (E464) and titanium dioxide (E171).

The 5 mg tablets also contain yellow iron oxide (E172).

What Simvastatin tablets look like and contents of the pack

Simvastatin 5 mg Tablets are yellow, oblong, scored film-coated tablets, with 'SVT' on one side and '5' on the other.

Simvastatin 10 mg Tablets are white, oblong, biconvex film-coated tablets, scored on one side, embossed with '10' on the scored side and with "SVT" and logo on the other side.

Simvastatin 20 mg Tablets are white, oblong, biconvex film-coated tablets, scored on one side, embossed with "20" on the scored side and with "SVT" and logo on the other side.

Simvastatin 40 mg Tablets are white, oblong, biconvex film-coated tablets, scored on one side, embossed with "40" on the scored side and with "SVT" and logo on the other side.

Simvastatin tablets are available in blister packs of 28 tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Chelonia Healthcare Limited

Boumpoulinas 11, 3rd Floor, Nicosia, P.C. 1060, Cyprus

Manufacturer

DDSA Pharmaceuticals Limited,

310 Old Brompton Road, London, SW5 9JQ

For more information about this product, please contact the Marketing Authorisation Holder.

This leaflet was last approved in 06/2016

CL0101-0102-0103-0104/0/PIL/G2