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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.

if you are not sure if any of the above apply to you, talk to your doctor or pharmacist before taking simvastatin.

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 Oral Suspension).

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

Other medicines and Simvastatin Oral Suspension

It is particularly important to teii your doctor if you are taking any of the following medicines. Taking simvastatin 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'):

■    ciciosporin, used to dampen the immune system

■    danazoi, a steroid used to treat endometriosis and breast cysts in women

■    medicines to treat fungal infections such as itraconazole, ketoconazoie, fluconazole, posaconazoie or voriconazole

■    medicines to lower cholesterol called fibrates (such as gemfibrozil or bezafibrate)

■    antibiotics, such as erythromycin, clarithromycin, telithromycin or fusidic acid. Do not take fusidic acid while using this medicine

■    medicines to treat HIV infections such as indinavir, nelfinavir, ritonavir or saquinavir

■    boceprevir or telaprevir, used to treat hepatitis C virus infection

■    nefazodone, used to treat depression

■    amiodarone, used to treat irregular heart beats

■    verapamil, diltiazem or amlodipine, used to treat heart conditions

■    colchicines, 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. This includes medicines bought without a prescription, including herbal medicines.

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

■    medicines that stop blood clots from forming such as warfarin

■    fenofibrate (another medicine for lowering cholesterol)

■    niacin (nicotinic acid, another medicine for lowering cholesterol)

■    medicines to lower cholesterol called bile acid sequestrants such as colestyramine. Take simvastatin at least 2 hours before or 4 hours after taking the bile acid sequestrant

■    rifamapicin (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.

Having operations and tests

If you are going to have an operation, tell the doctor that you are taking simvastatin as it should be stopped a few days before.

Simvastatin Oral Suspension with food and drink

You must not drink grapefruit juice while taking this medicine as it could increase your risk of muscle damage.

Pregnancy and Breast-feeding

Do not use simvastatin if you are pregnant or planning to become pregnant. If you become pregnant while on this medicine, stop taking it and talk to your doctor straight away.

Do not use simvastatin if you are breast-feeding.

Driving and using machines

This medicine should not affect your ability to drive or operate machinery. However, this medicine may cause dizziness. If you feel this, take extra care when driving or using tools or machines.

Simvastatin 40mg/5mI Oral Suspension contains methyl parahydroxybenzoate, ethyl parahydroxybenzoate and propyl parahydroxybenzoate:

■    Methyl, ethyl and propyl parahydroxybenzoates. These may cause an allergic reaction. This allergy may happen some time after starting the medicine.

Treatment of high cholesterol levels:

■    The usual starting dose is 10mg (1.25ml) to 20mg (2.5ml) each day. This may be increased gradually by your doctor up to 40mg (5ml) each day

■    Take this dose in the evening.

Treatment of high cholesterol levels if you have a family history of this:

■    The usual dose is 40mg (5ml) in the evening, or

■    20mg (2.5ml) in the morning, 20mg (2.5ml) at lunch time and 40mg (5ml) in the evening.

Prevention of coronary heart disease (CHD):

■    The usual dose is 20mg (2.5ml) to 40mg (5ml) each day

■    Take this dose in the evening.

People with kidney problems

■    The doctor will start you on a lower dose and gradually increase it

Children (10 -17 years old)

■    The recommended usual starting dose is 10mg (1.25ml) a day in the evening

■    The maximum recommended dose is 40mg (5ml) a day.

If you take more Simvastatin Oral Suspension than you should

If you take more of this medicine than you should, talk to your doctor or go to your nearest hospital straight away. Take the medicine pack with you.

If you forget to take Simvastatin Oral Suspension

■    If you forget a dose, take it as soon as you remember. However, if it is nearly time for the next dose, skip the missed dose

■    Do not take a double dose (two doses at the same time) to make up for a forgotten dose. If you stop taking Simvastatin Oral Suspension

Do not stop taking Simvastatin Oral Suspension unless your doctor tells you to. It may make your cholesterol levels rise again.

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

4. Possible side effects

3. How to take Simvastatin 40mg/5ml Oral Suspension

Take this medicine as your doctor or pharmacist has told you. Look on the label and ask the doctor or pharmacist if you are not sure.

Taking this medicine

■    This medicine contains 40mg of simvastatin in each 5ml

■    Take this medicine by mouth

■    Always shake the bottle before using it

■    If you feel that the effect of your medicine is too strong or too weak, do not change the dose yourself, but talk to your doctor or pharmacist.

The usual doses are given below. Your doctor may change these.

Adults including older people

The usual dose range is 5mg to 80mg each day. The 80mg dose is only recommended in patients with very high cholesterol levels and at high risk of heart disease problems who have not reached their cholesterol goal on lower doses. The dose will be decided by your doctor depending upon what you are being treated for.

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

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

■    Rare (occurring in 1 or more of 10,000 and less than 1 of 1000 patients treated)

■    Very rare (occurring in less than 1 of 10,000 patients treated).

■    Frequency not known

The following rare serious side effects were reported.

If any of these serious side effects happen, stop taking simvastatin and tell your doctor immediately or go to the emergency room at your nearest hospital:

■    muscle pain, tenderness, weakness or cramps. On rare occasions, muscle problems can be serious, including muscle breakdown resulting in kidney damage; and very rare, deaths have occurred.

■    an allergic reaction 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

-    inflammation of the blood vessels

-    unusual bruising, skin eruptions and swelling, hives, 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 skin and eyes, itching, dark-coloured urine or pale-coloured stools, liver failure (very rare)

■    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, feeling dizzy

■    feeling sick (nausea) or being sick (vomiting)

■    stomach upset including constipation, diarrhoea, wind, heartburn and stomach pain

■    rash, itching, hair loss

■    feeling weak

■    trouble sleeping (very rare)

■    poor memory (very rare).

Side effects where the frequency is not known (cannot be estimated from the available data):

■    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.

Continued overleaf

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