Zocor Heart- Pro
1 What the medicine is for
Zocor Heart-Pro is a medicine which is used to reduce the risk of a first heart attack in people who have a moderate risk of coronary heart disease (heart disease caused by a build up of plaques in the coronary arteries). Moderate risk means that your chances of having a heart attack in the next 10 years are at least 1 in 10 (10%). The tablets contain simvastatin, which belongs to a group of medicines known as statins. Statins significantly reduce the amount of cholesterol in your blood.
You will need to take these tablets regularly for a long period of time to get the maximum benefit from them.
Who is at moderate risk of coronary heart disease?
■ You are likely to be at moderate risk if you are a man aged 55 or over.
■ You are also likely to be at moderate risk if you are a man aged between 45 and 54 or a woman aged 55 or over and you answer 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 last 5 years?
■ Are you overweight?
This means you have a body mass index (BMI) over 25kg/m2 (this is your weight in kilos divided by your height in metres squared), OR
■ Men – your waist is greater than 40 inches or 102cm OR
■ Women -your waist is greater than 35 inches or 88cm
Your pharmacist can help you answer this question if you are in any doubt.
■ Are you of South Asian origin (from the Indian subcontinent that includes Bangladesh, India, Pakistan or Sri Lanka)?
■ In addition, if you take no physical exercise other than normal daily activities, your risk of heart attack is further increased.
How does the medicine work?
Zocor Heart-Pro works by reducing the level of LDL (bad) cholesterol and fatty substances called triglycerides in your blood and raises HDL (good) cholesterol.
LDL (bad) cholesterol clogs your coronary arteries.
HDL (good) cholesterol helps to protect against heart disease.
How LDL (bad) Cholesterol can cause a heart attack
If too much cholesterol in your blood builds up in the walls of the coronary arteries, then plaques will form. This leads to 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.
How this medicine can help reduce the likelihood of a heart attack
By taking these tablets you can significantly reduce LDL (bad) cholesterol levels and help reduce the build up of artery-narrowing plaques.
2 Before taking this medicine
This medicine is suitable for most adults, but a few people should not use it. If you are in any doubt, talk to your doctor or pharmacist.
Do not use this medicine.
■ If you have ever had a bad reaction to statins or any of the ingredients in this medicine.
■ If you have liver disease or have been told that you have abnormal liver function blood tests.
■ If you are already taking prescription drugs to lower your cholesterol (such as gemfibrozil, bezafibrate).
■ If you are pregnant, planning to become pregnant or think you may be pregnant, or if you are breast-feeding.
■ If you discover you are pregnant while taking Zocor Heart-Pro. In this case you should stop taking the tablets immediately and contact your doctor.
■ If you have had muscle problems in the past after taking a cholesterol lowering medicine.
■ If you are taking any of the following medicines:
■ Oral antifungal medicines (drugs taken by mouth which are used to treat fungal infections such as itraconazole or ketoconazole).
Erythromyrin, Telithromycin and Clarithromyrin (these are a type of antibiotic medicine).
■ Protease inhibitors (drugs used to treat HIV infections such as indinavir, nelfinavir, ritonavir or saquinavir). Nefazodone (a drug used to treat depression).
If any of these apply to you, get advice from a doctor or pharmacist without using Zocor Heart-Pro.
Talk to your doctor or pharmacist before taking this medicine.
■ If you have an under active thyroid gland (hypothyroidism).
■ If you have kidney problems.
■ If you have a family history of muscle disorders.
■ If you already have angina or have had a heart attack.
■ If you have diabetes.
■ If you have had a stroke.
■ If you have disease of the arteries of your legs or neck (peripheral vascular disease).
■ If you have inherited very high blood cholesterol levels.
■ If you have high blood pressure.
■ If you are aged over 70.
■ If you drink more than 4 units of alcohol a day (for men) or 3 units a day (for women). One unit is Yi pint of lager, a small glass of wine or one short.
■ If you eat grapefruit or drink grapefruit juice.
■ If you are taking any other medicines, including:
■ Anti-coagulants (drugs that thin the blood, such as warfarin).
■ High doses of niacin or nicotinic acid (more than 1000 mg a day) for poor blood flow to the hands and feet.
■ Cidosporin (an immunosuppressant medicine).
■ Danazol (a steroid often used to treat endometriosis).
■ Fusidic acid (an antibiotic used to treat bacterial infections).
If you are not sure about any of the medicines you are taking, show the bottle or pack to your pharmacist.
■ If your doctor prescribes a new medicine while you are taking this medicine, you should mention that you are taking Zocor Heart-Pro.
If any of these bullets apply to you now or in the past, talk to a doctor or pharmacist.
If 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 Zocor Heart-Pro to reduce your cholesterol levels.
If you are pregnant or breast-feeding
■ Do not take this medicine if you are pregnant, think you may be pregnant, trying to become pregnant or breast-feeding.
Some of the ingredients can cause problems
■ This product contains lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
Special warnings about this medicine
■ This medicine can cause dizziness. If affected, do not drive or operate machinery.
■ Do not drink grapefruit juice while you are taking these tablets.
3 How to take this medicine
Check the table below to see how much medicine to take.
■ For oral use only.
■ Do not use more than the stated dose shown in the table.
■ Do not give to children.
■ Swallow the tablet whole with a drink of water.
■ Zocor Heart-Pro should betaken regularly and on a long term basis in order to gain the full benefits of treatment.
Children (under 18 years):
This medicine is not recommended for children under 18 years of age.
Adults and the elderly:
|Adults and the elderly. Take one tablet in the evening.|
|■ Do not take more than one tablet in any 24 hour period.■ Ask your doctor or pharmacist if you are not sure about anything.|
Special warnings whilst taking Zocor Heart-Pro
■ Very rarely these tablets can affect the muscles. Symptoms of this are generalised muscle pain, tenderness or weakness unless clearly related to the flu, unaccustomed exercise or recent injury or strains. If you develop these symptoms you should stop taking your tablets immediately and contact your doctor.
■ The chances of getting the muscle disorder mentioned above are greater if you drink grapefruit juice, have kidney problems or are taking tidosporin, danazol or prescription drugs to lower your cholesterol. If you are in any doubt whether to take the medicine or whether any symptoms you have are related to the medicine you should talk to your doctor or pharmacist.
■ if you are going into hospital for major surgery, you should tell your doctor you are taking these tablets, as you will need to stop taking them a few days beforehand.
■ if your cholesterol is checked whilst you are taking these tablets and your fasting LDL-cholesterol is above 5.5 mmol/lyou should talk to your doctor as it may mean that you need more than 10 mg of Zocor Heart-Pro to reduce your cholesterol.
If anyone has too much of the medicine
If anyone has taken too many Zocor Heart-Pro tablets, contact a doctor or your nearest Accident and Emergency Department (Casualty) taking this post and pack with you.
If you forget to take the medicine
You should only take this medicine as required following the dosage instructions above carefully. If you forget to take a dose, take one tablet the next evening you remember. Do not take a double dose to make up.
4 Possible side-effects
Zocor Heart-Pro tablets can have side-effects, like all medicines, although these don’t affect everyone and are usually mild.
If you experience any of the following, stop using the medicine and seek immediate medical help:
■ Allergic reactions such as swelling of the face or neck, muscle and joint pains, joint and blood vessel inflammation, itchy, lumpy rash (hives, nettle rash), a high temperature, sensitivity to light, flushing, difficulty in breathing or tiredness.
■ Muscle aches and pains, cramps, tenderness or weakness which can be severe (see section 3 Special warnings while you are taking Zocor Heart-Pro).
■ Yellowing of the skin or the whites of the eyes, dark coloured urine. This may mean you have a problem with your liver.
■ Abdominal pain felt just behind the ribs and spreading through to your back which may be due to pancreatitis (inflammation of the pancreas).
If you experience any of the following stop using the medicine and talk to your doctor:
■ Tiredness, faintness or breathlessness that may be due to anaemia (not enough red blood cells).
■ Tingling and numbness, dizziness, painful heavy pins and needles.
■ Rash, itching, hair loss.
■ Abnormal blood test results for liver or muscle function.
Other effects which occur are listed below:
■ Commonly stomach pain, wind, constipation, weakness, indigestion and headache.
■ Diarrhoea, feeling sick or being sick.
If you experience any side-effects not included in this leaflet or are not sure about anything, talk to your doctor or pharmacist.
5 Storing this medicine
Keep the product out of the reach and sight of children.
Do not store above 30°C.
Do not put them in another container as they might get mixed up.
Do not use your medicine if the pack is damaged, or after the expiry date on the packaging.
6 Further information
What’s in this medicine?
The active ingredient in Zocor Heart-Pro is: 10 mg simvastatin.
Other ingredients are: Ascorbic acid (E300), Butylated hydroxyanisole (E320), Citric acid monohydrate (E330), Lactose,
Magnesium stearate (E572), Microcrystalline cellulose (E460), Pregelatinised maize starch, Hydroxypropylcellulose (E463),
Methylhydroxy-propylcellulose (E464), Talc (E553b), Titanium dioxide (E171), Red iron oxide (E172), Yellow iron oxide (E172).
What the medicine looks like
Zocor Heart-Pro are peach coloured, oval shaped film coated tablets marked “MSD-735″. They are available in packs of
7 What you can do to help reduce your risk of heart attack
At the same time as taking Zocor Heart-Pro 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 – this 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, increase your risk of developing diabetes and increase the risk of developing heart disease due to high cholesterol levels. Try to 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 do 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 gardening.
If you would like to receive other advice and information on a healthy lifestyle and reducing your risk of a heart attack, register on the Healthy Heart Programme. This is a free on line service designed to help you understand your heart attack risk, lower it and keep it low.