How does it work?

Zocor heart-pro tablets contain the active ingredientsimvastatin, which is a type of medicine called a statin. It works by reducingthe production of cholesterol by the liver.

For the sake of simplicity, there are two sorts of cholesterol;a 'bad' sort called low density lipoprotein (LDL) and a 'good' sort called highdensity lipoprotein (HDL). LDL is deposited in the arteries and increases therisk of heart disease by clogging and narrowing the arteries (atherosclerosis),while HDL actually protects the arteries against this.

Simvastatin decreases the production of LDL cholesterol byblocking the action of the enzyme in the liver (called HMG-CoA reductase) thatis responsible for its production. This decreases the amount of cholesterol inthe liver cells, which causes them to take up LDL cholesterol from the blood.The decreased cholesterol production and increased removal of LDL cholesterolfrom the blood ultimately results in lowered blood cholesterol levels.

The body produces most cholesterol at night, so simvastatin ismore effective when taken in the evening.

Simvastatin also causes a small decrease in the production ofother 'bad fats' in the blood called triglycerides, and a small increase in thelevel of HDL cholesterol. This results in lowered levels of 'bad fats' andraised levels of 'good fats' in the blood.

Statins have an important role in the prevention of coronaryheart disease because they reduce the risk of excess cholesterol beingdeposited in the major blood vessels of the heart. Any blockage in the bloodvessels limits the amount of blood and therefore oxygen being carried to theheart muscle. This can cause angina (chest pain), and in severe cases canresult in a heart attack (myocardial infarction).

Statins are normally prescribed by doctors to reduce the risk ofheart attacks in people who are at high risk of having a heart attack due tovarious risk factors, or who already have coronary heart disease (angina or apast heart attack). Zocor heart-pro, however, contains a lower dose of statinthan that normally prescribed, and can be bought without a prescription frompharmacies. It is licensed to be sold to people considered to be at moderaterisk of a heart attack. Remember that the risk of a heart attack can be loweredthroughstopping smoking,eating healthily,losing weight and takingregular exercise. This medicine can be used in additionto lifestyle changes to further lower heart attack risk, but you shouldremember that for it to be effective it will need to be taken long term.

What is it used for?

Reducing the risk of a heart attack in people at moderate risk of coronary heart disease. Moderate risk is defined as people who have a 10 to 15 per cent chance of having a heart attack in the next 10 years. Men aged 55 years and over fall into this category, as do men aged 45 to 55 years and women aged 55 years and over who have one or more of the following risk factors:

• family history of coronary heart disease in a parent, brother or sister
• currently a smoker or has been in the last five years
• overweight (body mass index higher than 25kg/m² or waist measurement larger than 40 inches in men or 35 inches in women)
• South Asian ethnic origin (ie, from the Indian subcontinent that includes India, Bangladesh, Pakistan or Sri Lanka).

Your pharmacist can help you assess whether this medicine might be of benefit to you.

Warning!

• Before selling you this medicine your pharmacist will need to establish whether it is safe and appropriate for you to take it. You can expect to be asked questions about your age, lifestyle, medical history, family history of heart disease and any medicines you are currently taking.
• It is recommended that you avoid drinking excessive amounts of alcohol while taking this medicine.
• You should avoid drinking grapefruit juice while taking this medicine. This is because grapefruit juice can affect the metabolism of simvastatin and could increase the amount of the medicine in your blood, thus increasing the risk of side effects.
• This medicine can sometimes cause liver problems. For this reason, you should stop taking this medicine and consult your doctor promptly if you develop unexplained itching, yellowing of the skin or eyes, unusually dark urine, nausea and vomiting, abdominal pains, loss of appetite or flu-like symptoms while taking this medicine.
• This medicine may occasionally have side effects on the muscles. For this reason, you should inform your doctor immediately if you experience any unexplained muscular symptoms, such as pain, tenderness, cramps or weakness, while taking this medicine. Your doctor may need to check for side effects on the muscles by taking a blood test to measure the level of a compound called creatine kinase (CK) in your blood. If this is the case, the test should not be done following strenuous exercise.
• Statins may very rarely be associated with a type of lung disease. For this reason, you should consult your doctor if you experience shortness of breath or difficulty breathing, a non-productive cough and deterioration in your general health (eg weight loss, fever, fatigue) while taking this medicine.

Use with caution in

• High blood pressure.
• Decreased kidney function.
• Underactive thyroid gland (hypothyroidism).
• Personal or family history of hereditary muscle disorders.
• People over 70 years of age.
• History of liver disease.
• People who drink large amounts of alcohol.
• Hereditary blood disorders called porphyrias.

Not to be used in

• Children.
• People already taking prescription cholesterol lowering medicines.
• People taking the antifungals itraconazole or ketoconazole, the antibiotics erythromycin, clarithromycin or telithromycin, a protease inhibitor for HIV infection, or the antidepressant nefazodone.
• History of muscular side effects during previous treatment with a statin or fibrate medicine.
• Active liver disease.
• People with unexplained raised results in liver function tests.
• Pregnancy.
• Breastfeeding.
• Rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption (Zocor heart-pro tablets contain lactose).
• If you have previously had a heart attack or stroke, or have angina, peripheral vascular disease (eg poor blood flow to the legs), a cholesterol level of 5.5mmol/l or greater, high cholesterol levels due to a genetic condition called familial hypercholesterolaemia, or diabetes, this non-prescription medicine will not be suitable for you. These conditions carry a higher risk of heart disease and should be treated by a doctor.

This medicine should not be used if you are allergic to any of its ingredients. Please inform your doctor or pharmacist if you havepreviously experienced such an allergy.

If you feel you have experienced an allergic reaction, stopusing this medicine and inform your doctor or pharmacist immediately.

Pregnancy and breastfeeding

Certain medicines should not be used during pregnancy orbreastfeeding. However, other medicines may be safely used in pregnancy orbreastfeeding providing the benefits to the mother outweigh the risks to theunborn baby. Always inform your doctor if you are pregnant or planning apregnancy, before using any medicine.

• This medicine should not used by women who are pregnant, trying to get pregnant, or suspect they could be pregnant. Seek further medical advice from your doctor.
• It is not known if this medicine passes into breast milk. For this reason, the manufacturer states that it should not be used by breastfeeding women. Seek medical advice from your doctor.

Side effects

Medicines and their possible side effects can affect individualpeople in different ways. Just because a side effect is stated here, it doesnot mean that all people using this medicine will experience that or any sideeffect. The following are some of the side effects that are known to beassociated with this medicine.

Rare (affect between 1 in 1000 and 1 in 10,000 people)

• Anaemia.
• Pins and needles (paraesthesia).
• Headache.
• Dizziness.
• Feeling of weakness.
• Disturbances of the gut, such as constipation, abdominal pain, flatulence, indigestion, diarrhoea, nausea and vomiting.
• Hepatitis (inflammation of the liver).
• Muscle breakdown (rhabdomyolysis).
• Inflammation of the muscles (myositis).
• Skin reactions such as rash or itching.
• Hair loss (alopecia).

Very rare (affect less than 1 in 10,000 people)

• Inflammation of the pancreas (pancreatitis).
• Memory loss.
• Difficulty sleeping (insomnia).

Unknown frequency

• Interstitial lung disease.
• Depression.
• Sleep disturbances.
• Sexual problems.

The side effects listed above may not include all of the sideeffects reported by the medicine's manufacturer.

For more information about any other possible risks associatedwith this medicine, please read the information provided with the medicine orconsult your doctor or pharmacist.

How can this medicine affect other medicines?

It is important to tell your pharmacist what medicines you arealready taking, including those bought without a prescription and herbalmedicines, before you start treatment with this medicine. Similarly, check withyour doctor or pharmacist before taking any new medicines while taking thisone, to ensure that thecombination is safe. If your doctor prescribes you anynew medicines make sure he knows that you are taking this one.

This medicine should not be taken by people who are alreadytaking any of the following medicines:

• clarithromycin
• erythromycin
• itraconazole
• ketoconazole
• nefazadone
• prescription cholesterol-lowering medicines, eg statins, fibrates, nicotinic acid (niacin), ezetimibe
• protease inhibitors for HIV infection, eg nelfinavir
• telithromycin.

If you get an infection that your doctor thinks should be treated with the antifungals itraconazole or ketoconazole, or the antibioticserythromycin, clarithromycin or telithromycin, you should stop taking Zocorheart-pro during the course of treatment.

There may be an increased risk of side effects on the muscles(myopathy) if simvastatin is taken with the following medicines (if you aretaking any of these you should consult your doctor before taking Zocorheart-pro):

• amiodarone
• ciclosporin
• danazol
• diltiazem
• fusidic acid
• nicotinic acid or niacin
• verapamil.

The anti-blood-clotting effect of anticoagulants such aswarfarin may be increased by simvastatin. For this reason, if you are taking ananticoagulant you should consult your doctor before taking this medicine. Yourdoctor may want to check your blood-clotting time when you start or stoptreatment with simvastatin.

The following medicines may reduce the amount of simvastatin in your blood and could make it less effective:

• efavirenz
• rifampicin
• the herbal remedy St John's wort (Hypericum perforatum).

Other medicines containing the same active ingredient

Prescription-only simvastatin tablets are also available withouta brand name, ie as thegeneric medicine.