Package leaflet: Information for the patient

SIMVASTATIN 10 mg, 20 mg and 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 only. Do not pass it on to others. It may harm them, even if their signs of illness 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.

What is in this leaflet

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

2.    What you need to know before you take Simvastatin Tablets

3.    How to take Simvastatin Tablets

4.    Possible side effects

5.    How to store Simvastatin Tablets

6.    Contents of the pack and other information

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

Simvastatin Tablets are used to lower levels of total cholesterol, “bad” cholesterol (LDL cholesterol), and fatty substances called triglycerides in the blood. In addition, Simvastatin Tablets raise levels of “good” cholesterol (HDL cholesterol). You should stay on a cholesterol-lowering diet while taking this medicine. Simvastatin is a member of the class of drugs called statins.

Cholesterol is one of several fatty substances found in the bloodstream. 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 clocking 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 Tablets are used in addition to your cholesterol-lowering diet if you have:

•    a raised cholesterol level in your blood (primary hypercholesterolaemia) or elevated fat levels in your blood (mixed hyperlipidaemia)

•    a hereditary illness (homozygous familial hypercholesterolaemia) that increases the cholesterol level in your blood. You may also receive other treatments.

•    coronary heart disease (CHD) or at high risk of CHD (because you have diabetes, history of stroke, or other blood vessel disease).

Simvastatin Tablets may prolong your life by reducing the risk of heart disease and blood vessels 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 Tablets Do not take Simvastatin Tablets:

•    If you are allergic (hypersensitive) to simvastatin, to similar medicines or to any of the other ingredients of Simvastatin Tablets (see section 6 "Contents of the pack and other information");

•    If you currently have liver problems;

•    If you are pregnant, plan to become pregnant or are breastfeeding;

•    If you are taking medicine(s) with one or more than one of the following active ingredients:

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

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

-    HIV protease inhibitors such as indinavir, nelfinavir, ritonavir and saquinavir (HIV protease inhibitors are used for HIV infections)

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

-    nefazodone (used to treat depression)

-    gemfibrozil (used to lower cholesterol)

-    ciclosporin (used in organ transplant patients)

-    danazol (a man-made hormone used to treat endometriosis, a condition in which the lining of the uterus grows outside the uterus and for breast cysts in women)

•    if you are taking or, in the last 7 days, have taken or been given a medicine called fusidic acid (used to treat bacterial infection)

If you think any of these apply to you, do not take the tablets, go and talk to your doctor first and follow the advice given.

Warnings and precautions:

Tell your doctor:

•    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 for you;

•    If you are due to have an operation. You may need to stop taking Simvastatin Tablets for a short time.

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

Your doctor should do a blood test before you start taking Simvastatin Tablets and if you have any symptoms or liver problems while you take 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.

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.

Take your doctor if you have severe lung disease.

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 doctor may perform a blood test to check the condition of your muscles before and after starting treatment.

Also tell your doctor 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 Tablets, particularly the 80-mg dose. 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 thyroid problems;

•    You are 65 years of age or older;

•    You are a 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.

Other medicines and Simvastatin Tablets

It is particularly important to tell your doctor if you are taking medicine(s) with any of the following active ingredients. Taking Simvastatin Tablets with any of these medicines can increase the risk of muscle problems. Some of these have already been listed in the above section “Do not take Simvastatin Tablets”).

-    ciclosporin (often used in organ transplant patients)

-    danazol (a man-made hormone used to treat endometriosis, a condition in which the lining of the uterus grows outside the uterus and for breast cysts in women)

-    medicines with an active ingredient like itraconazole, ketoconazole, fluconazole, posaconazole or voriconazole (used to treat fungal infections)

-    fibrates with an active ingredient like gemfibrozil and bezafibrate (used to lower cholesterol)

-    erythromycin, clarithromycin, telithromycin or fusidic acid (used to treat bacterial infections). Do not take fusidic acid while using this medicine. Also see section 4 of this leaflet.

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

-    boceprevir or telaprevir (medicines for hepatitis C virus infection)

-    nefazodone (used to treat depression)

-    amiodarone (used to treat an irregular heart beat)

-    verapamil, diltiazem or amlodipine (used to treat high blood pressure, chest pain associated with heart disease, or other heart conditions)

-    colchicine (used to treat gout).

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 medicine(s) with any of the following active ingredients:

-    medicines with an active ingredient to prevent blood clots, such as warfarin, phenprocoumon or

-    acenocoumarol (anticoagulants)

-    fenofibrate (also used to lower cholesterol)

-    niacin (also used to lower cholesterol)

-    rifampicin (used to treat tuberculosis).

You should also tell any doctor who is prescribing a new medicine for you that you are taking Simvastatin Tablets.

Simvastatin Tablets with food, drink and alcohol Grapefruit juice contains one or more components that alter how the body uses some medicinal products, including Simvastatin Tablets. Consuming grapefruit juice should be avoided.

Alcohol can affect the action of simvastatin and your doctor should have advised you to always keep your alcohol intake to a minimum while you are on these tablets. If you are concerned about how much alcohol you may drink while taking simvastatin, discuss this with your doctor.

Pregnancy and breast-feeding

Do not use Simvastatin Tablets if you are pregnant, trying to become pregnant or think you may be pregnant.

If you become pregnant while taking Simvastatin Tablets, stop taking them immediately and contact your doctor.

Do not take Simvastatin Tablets 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.

Children and adolescents

Safety and effectiveness of Simvastatin tablets have been studied in 1017 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 Tablets has not been studied in children under the age of 10 years. For more information, talk to 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.

Simvastatin Tablets contain a milk sugar called lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

3. How to take Simvastatin Tablets

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 Tablets exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

You should stay on a cholesterol-lowering diet while taking Simvastatin Tablets.

Dosage:

The recommended dose is 1 Simvastatin 10mg, 20mg, 40mg, or 80mg Tablet by mouth once a day.

Adults:

The usual starting dose is 10, 20 or, in some cases, 40mg a day. Your doctor may adjust your dose after at least 4 weeks to a maximum of 80mg per day Do not take more than 80mg a day.

Your doctor may prescribe lower doses, particularly if you are taking certain medicinal products listed above or have certain kidney conditions.

The 80mg dose is only recommended for adult patients with very high cholesterol levels and at high risk of heart and blood vessels disease problems who have not reached their cholesterol goal on lower doses.

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.

Method and duration of administration:

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

If your doctor has prescribed Simvastatin Tablets along with another medicine for lowering cholesterol containing any bile acid sequestrant, you should take Simvastatin Tablets at least 2 hours before or 4 hours after taking the bile-acid sequestrant.

If you take more Simvastatin Tablets than you should

If you ever take too much, go to the nearest hospital casualty department or tell your doctor immediately.

If you forget to take Simvastatin Tablets

Do not take an extra dose; just take the normal amount of Simvastatin Tablets at the usual time the next day.

If you stop taking Simvastatin Tablets

Talk to your doctor or pharmacist because your cholesterol may rise again.

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

4. Possible side effects

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

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

Rare (may affect up to 1 of 1000 patients)

Very rare (may affect up to 1 of 10,000 patients)

Not known (frequency cannot be estimated from the available data)

The following serious side effects were reported.

If any of these serious side effects happen, stop taking the tablets and contact 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.

•    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 (polymyalgia rheumatic)

-    inflammation of the blood vessels (vasculitis)

-    unusual bruising, skin eruptions and swelling (dermatomyositis), hives, itchiness, skin sensitivity to the sun

-    fever, flushing

-    shortness of breath (dyspnoea) and feeling unwell

-    lupus-like disease picture (including rash, joint disorders, and effects on blood cells)

•    Inflammation of the liver with the following symptoms: yellowing of the eyes and/or skin, itching, dark-coloured urine or pale-coloured stool, feeling tired or weak, loss of appetite, liver failure (very rare).

•    Pancreatitis (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 (pins and needles), dizziness

•    Digestive disturbances (abdominal pain, constipation, flatulence, indigestion, diarrhoea, nausea, vomiting)

•    Rash, itching, hair loss

•    Weakness

•    Trouble sleeping (very rare)

•    Poor memory (very rare), memory loss, confusion

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

•    Tendon problems, sometimes complicated by rupture of the tendon.

•    Bursitis (inflammation of the fluid filled sacs around different joints. You might feel pain, tenderness, redness, warmth, swelling and/or stiffness near the affected area).

•    Muscle weakness that is constant

Additional possible side effects reported with some statins:

•    Sleep disturbances, including nightmares

•    Sexual difficulties

•    Diabetes. This is more likely if you have high blood pressure, high levels of sugar or fats in your blood or if you are overweight (have a body mass index of more than 30kg/m²). 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 effectgs directly via the 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 Tablets

Keep this medicine out of the sight and reach of children.

Do not use Simvastatin Tablets after the expiry date which is stated on the label.

Do not store above 25^oC. Store 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.    Content of the pack and other information

What Simvastatin Tablets contain

Simvastatin 10, 20 & 40mg Film-coated Tablets contain the active substance simvastatin 10mg, 20mg or 40mg.

The other ingredients are: lactose monohydrate, pregelatinised maize starch, ascorbic acid (E300), citric acid monohydrate (E330), microcrystalline cellulose (E460(i)), butylhydroxyanisole (E320), croscarmellose sodium, magnesium stearate (E572).

The film coating materials contain hydroxypropylcellulose (E463), hypromellose 15cP (E464), titanium dioxide (E171), talc (E553(b)), iron oxide yellow (E172), iron oxide red (E172) and iron oxide black (E172).

What Simvastatin Tablets look like and contents of the pack

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

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

Simvastatin 40mg Tablets are salmon-pink coloured, film coated, oval shaped tablets.

Simvastatin Tablets are available in calendar packs containing 28 tablets in a carton.

Marketing Authorization Holder and Manufacturer

Dexcel® - Pharma Ltd., 7 Sopwith Way, Drayton Fields, Daventry, Northamptonshire, NN11 8PB, UK.

This leaflet was last revised in February 2015.