Dexcel Cholesterol Lowering 10mg Tablets

(Simvastatin)

Please read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

This medicine is available without prescription. Nevertheless you still need to use Dexcel Cholesterol Lowering 10mgTablets carefully to get the best results from it.

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

-    Ask your pharmacist if you need more information or advice.

-    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.

In this leaflet:

1.    What Dexcel Cholesterol Lowering 10mg Tablets are and what they are used for

2.    Before you take Dexcel Cholesterol Lowering 10mg Tablets

3.    How to take Dexcel Cholesterol Lowering 10mg Tablets

4.    Possible side effects

5.    How to store Dexcel Cholesterol Lowering 10mg Tablets

6.    Further information

1.    WHAT DEXCEL CHOLESTEROL LOWERING 10mg TABLETS ARE AND WHAT THEY ARE USED FOR

The active ingredient in Dexcel Cholesterol Lowering 10mg Tablets is simvastatin which belongs to a group of medicines known as 'statins'. These significantly reduce the amount of cholesterol in your blood.

Dexcel Cholesterol Lowering 10mg Tablets reduce the level of LDL "bad" cholesterol and fatty substances called triglycerides in your blood. LDL cholesterol is called "bad" because it is the cholesterol that clogs your coronary arteries. These tablets also raise the HDL "good" cholesterol. HDL is called "good" cholesterol because it helps to protect against heart disease. Too much cholesterol in your blood builds up in the walls of the coronary arteries causing plaques to form. This leads to a narrowing of the coronary arteries, just like hard water furs up a water pipe. Heart attacks can then happen when a blood clot forms in a narrowed coronary artery.

Taking these tablets can significantly reduce cholesterol levels and help to reduce build up of artery-narrowing plaques. In order to get the maximum benefit from treatment, these tablets should be taken regularly on a long-term basis. The risk of heart attacks increases as you age because of the build up of plaques. Reducing this risk with these tablets and changes to your lifestyle needs to be a lifelong effort.

Section 6 includes information on what you can do to help reduce your risk of heart attack.

Dexcel Cholesterol Lowering 10mg Tablets reduces the levels of "bad" cholesterol in the blood by around 27%. Studies show that reducing cholesterol by this much can reduce the risk of first heart attack by about one third after 3 years of treatment.

Dexcel Cholesterol Lowering 10mg tablets can reduce the risk of a first heart attack in people who have a moderate risk of coronary heart disease (heart disease because of build up of plaques in the coronary arteries). Moderate risk means your chances of having a heart attack in the next 10 years are at least 1 in 10.

This medicine is for use by adults only.

You are likely to be at moderate risk of coronary heart disease if you are:

•    a man aged 55 or over.

•    a man aged between 45 and 54 or a woman aged 55 or over and answers yes to one or more of the questions below:

-    Do you have a parent, brother or sister who suffered a heart attack younger than 55 for men or 65 for women?

-    Do you smoke or have you smoked within the past 5 years?

-    Are you overweight? This means you have a body mass index over 25 kg/m2 (your weight in kilos divided by your height in meters squared), or your waist is greater than 40 inches or 102 cm (for men), or 35 inches or 88 cm (for women). Your pharmacist can help you answer this question.

-    Are you of South Asian origin, i.e. from the Indian subcontinent that includes India, Bangladesh, Pakistan or Sri Lanka?

If, in addition, you take no physical exercise other than normal daily activities, your risk of a heart attack is further increased.

2.    BEFORE YOU TAKE DEXCEL CHOLESTEROL LOWERING 10mg TABLETS

Do not take this medicine if:

•    you have ever had an allergic reaction to simvastatin or similar medicines or to any of the other ingredients in this medicine;

•    you know you have liver disease or you have been told you have abnormal liver function blood tests;

•    you are pregnant or breast-feeding;

•    you are already taking prescription drugs to lower your cholesterol (such as gemfibrozil, bezafibrate);

•    you have had muscle problems in the past after taking a cholesterol lowering medicine;

•    you are taking one of the following medicines:

-    oral antifungal medicines (drugs taken by mouth which are used to treat fungal infections such as itraconazole, ketoconazole, posaconazole or voriconazole).

-    antibiotics called erythromycin, telithromycin or clarithromycin.

-    medicines for HIV infections called protease inhibitors such as indinavir, nelfinavir, ritonavir or saquinavir.

-    the antidepressant nefazodone.

-    ciclosporin an immunosuppressant medicine (used in organ transplant patients)

-    danazol (a steroid often used to treat endometriosis, a condition in which the lining of the uterus grows outside the uterus and for breast cysts in women.

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

-    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)

Take special care with this medicine if:

•    you have severe respiratory failure.

•    you have an under active thyroid gland

(hypothyroidism).

•    you have kidney problems.

•    You have ever had liver disease. Dexcel Cholesterol Lowering 10mg Tablets may not be right for you.

•    you have a family or personal history of muscle disorders.

•    your doctor has told you that you have high blood pressure, check with your doctor before taking.

•    you are aged over 65.

•    you are female.

•    If you drink more than 4 units of alcohol a day (for men) or 3 units a day (for women). One unit is 1/2 pint of lager, a small glass of wine or one short.

•    you have your cholesterol levels checked and you find that you have a fasting LDL cholesterol measurement greater than 5.5 mmol/l, you should talk to your doctor because you may need more than these tablets to reduce your cholesterol levels.

•    you go into hospital for surgery, you should tell your doctor you are taking Dexcel Cholesterol Lowering 10mg Tablets as you will need to stop taking it a few days beforehand.

Your doctor should do a blood test before you start taking Dexcel Cholesterol Lowering 10mg Tablets and if you have any symptoms of liver problems while you take Dexcel Cholesterol Lowering 10mg 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.

Tell your doctor if you have severe lung disease.

Tell your doctor immediately if you experience symptoms such as muscle pain, tenderness or weakness, unless it is clearly the result of flu, unaccustomed exercise or recent strain or injury. This is because on rare occasions, there is a risk of muscle problems which may be severe, including muscle breakdown which can result in kidney damage; and very rarely, deaths have occurred. The doctor may perform a blood test to check the condition of your muscles before and after starting treatment.

You are at a higher risk of coronary heart disease if you are in one of the groups below. You should discuss your condition with your doctor since you are likely to need more than these tablets to reduce your risk.

•    You already have angina or have had a heart attack.

•    You have diabetes.

•    You have had a stroke.

•    You have disease of the arteries of your legs or neck (peripheral vascular disease).

•    You have inherited (it runs in the family) very high blood cholesterol levels.

If you think any of these apply to you or you are unsure that you have one of these conditions, go and talk to your pharmacist or doctor first.

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.

Taking other medicines

•    Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. Your pharmacist may advise you to check with your doctor before taking Dexcel Cholesterol Lowering 10mg Tablets. If your doctor prescribes a new medicine for you while you are taking this product (for example, if you develop an infection and your doctor decides to give you a course of antibiotics), you should mention that you are taking these tablets.

•    Take special care if you are taking medicines for thinning the blood, such as warfarin, phenprocoumon or acenocoumarol, as they may cause problems when you take them with these tablets.

•    In addition to the medicines listed in the section 'Do not take these tablets if', this medicine can react with the following drugs to cause muscle problems:

-    Fluconazole (a medicine used to treat fungal infections).

-    Lipid-lowering medicines (such as fenofibrate, high doses of niacin or nicotinic acid (more than 1000mg/day)).

-    Amiodarone (a medicine used for irregular heart beat).

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

-    Colchicine (a medicine used to treat gout).

-    Rifampicin (a medicine used to treat tuberculosis).

If you are taking any of these or any other medicines talk to your pharmacist or doctor

before taking Dexcel Cholesterol Lowering 10mg Tablets.

Taking tablets with food and drink:

Grapefruit juice contains one or more components that alter the metabolism of some medications, including Dexcel Cholesterol Lowering 10mg Tablets. Do not drink grapefruit juice while you are taking Dexcel Cholesterol Lowering 10mg Tablets as it increases the chance of muscle damage (see above under ‘Take special care' and section 4 ‘Possible side effects').

Pregnancy and Breast-feeding Do not take if:

•    you could become pregnant, are pregnant, are planning to become pregnant or are breastfeeding;

•    discover you are pregnant while taking these tablets. In this case, you should stop taking these tablets immediately and contact your doctor.

Driving and using machines:

Dexcel Cholesterol Lowering 10mg Tablets can cause dizziness. If affected, do not drive or operate machinery.

Important information about some of the ingredients

This medicine contains a 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 DEXCEL CHOLESTEROL LOWERING 10mg TABLETS

Adults and the elderly:

Take one tablet every evening. Swallow the tablet with a drink of water.

The evening is the best time because it means that your medicine will be working when your body is producing the most cholesterol. Tablets should be taken regularly and on a long-term basis in order to gain the full benefits of treatment. Never take more than one tablet each day. If you have any further questions on the use of this product, ask your doctor or pharmacist.

Children (under 18 years):

This medicine is not recommended for children under 18 years of age.

If you take more Dexcel Cholesterol Lowering 10mg Tablets than you should:

If anyone has taken too many Dexcel Cholesterol Lowering 10mg Tablets, contact a doctor or your nearest Accident and Emergency Department (Casualty) taking this leaflet and pack with you.

If you forget to take Dexcel Cholesterol Lowering 10mg Tablets:

You should only take this medicine as required following the dosage instructions above carefully. If you forget a dose, just take one dose the next evening you remember. Do not take an extra one to make up for a forgotten tablet.

If you stop taking Dexcel Cholesterol Lowering 10mg Tablets:

Your cholesterol may rise again.

Checking Your Cholesterol:

If you have a moderate risk of heart disease, reducing the level of cholesterol in your blood will reduce your risk. Your pharmacist can arrange to check your cholesterol level, but it is not necessary to know this before you start using Dexcel Cholesterol Lowering 10mg Tablets. Checking your cholesterol can provide additional information and can be helpful to show your progress while taking Dexcel Cholesterol Lowering 10mg Tablets. If your fasting LDL-cholesterol measurement is above 5.5 mmol/l, you should talk to your doctor as it may mean that you need more than Dexcel Cholesterol Lowering 10mg Tablets to reduce your cholesterol.

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

4.    POSSIBLE SIDE EFFECTS

Like all medicines, these 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, cramps, tenderness or weakness. 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).

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.

If you experience any side effects not included in this leaflet or are not sure about anything, talk to your doctor or pharmacist.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects 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.    STORING DEXCEL CHOLESTEROL LOWERING 10mg TABLETS

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

Do not use after the expiry date stated on the label.

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

If your doctor tells you to stop taking the tablets, please take them back to the pharmacist.

6.    FURTHER INFORMATION

What else can I do to reduce my risk of a heart attack?

At the same time as taking the tablets, try to reduce your risk of coronary heart disease by doing the following:

•    Stop smoking - there is strong evidence to link cigarette smoking with heart disease. The risks increase with the number of cigarettes you smoke each day, but risks still exist even if you smoke as little as five a day. It is better to stop smoking altogether rather than just cut down on how much you smoke. Your pharmacist can advise you on a suitable programme to help you stop smoking.

•    Eat a healthy diet - a healthy diet will not only help towards preventing coronary heart disease, but has also been shown to reduce the risk of stroke and a number of cancers. Try to increase the amount of fruit and vegetables in your diet and reduce the amount of sugar, salt and fat.

•    Lose weight - being overweight can cause a rise in your blood pressure, increases your risk of developing diabetes and increases the risk of developing heart disease due to high cholesterol levels. Change your diet as described above and take more exercise.

•    Exercise - a brisk walk to the shops can help. Swimming is a good all round exercise that you could consider doing, as it is something you can gradually build up without overdoing it to start with. You could try adding the following to your daily routine: vigorous housework, walk upstairs more often (and don't take the lift or escalator when you are out), and gardening.

Your pharmacist can provide details of a Healthy Heart Programme to help you.

What Dexcel Cholesterol Lowering 10mg Tablets contain:

Each film-coated tablet contains 10mg simvastatin as the active ingredient.

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 Dexcel Cholesterol Lowering 10mg Tablets look like:

Dexcel Cholesterol Lowering 10mg Tablets can be identified as peach coloured, film coated, oval shaped tablets.

Content of the pack:

Dexcel Cholesterol Lowering 10mg Tablets come in calendar packs containing 28 film coated tablets.

Marketing Authorization Holder/Manufacturer:

Dexcel- Pharma Laboratories Limited Ashacres House, Ashacres Industrial Part, Draycott in the Clay, Ashbourne,

Derbyshire, DE6 5GX, UK

This leaflet was last revised in July 2014.