What ZOCOR is used for

ZOCOR helps to lower high cholesterol and triglyceride levels.

Everyone has cholesterol and triglycerides in their blood. They are types of blood fat needed by the body for many things.

Cholesterol

Some of the reasons cholesterol is needed by the body include; building cell walls, making bile acids (which help to digest food) and certain hormones. However, too much cholesterol can be a problem.

Your body makes cholesterol, but it also comes from food.

Normally the body balances the cholesterol it makes with the cholesterol it gets from food. This means if more cholesterol comes from food, less is made by the body. However, if you eat a diet high in fat, your body may not keep this balance and your cholesterol levels rise.

High cholesterol is more likely to occur with certain diseases or if you have a family history of high cholesterol.

When you have high levels of cholesterol, it may 'stick' to the inside of your blood vessels instead of being carried to the parts of the body where it is needed. Over time, this can form hard areas, called plaque, on the walls of blood vessels, making it more difficult for the blood to flow. This blocking of your blood vessels can lead to coronary heart disease (such as heart attack and angina), and stroke.

In patients with coronary heart disease (CHD) accompanied by high cholesterol levels, ZOCOR may slow down the hardening of blood vessels and may reduce the development of new plaques.

If you have CHD your doctor has prescribed ZOCOR to help prolong your life and to lessen the risk of a heart attack or a stroke, or mini-stroke. ZOCOR may also decrease the risk of needing an operation to increase the blood flow to your heart.

There are different types of cholesterol, called LDL and HDL cholesterol. LDL cholesterol is the 'bad' cholesterol that can block your blood vessels. HDL cholesterol, on the other hand, is the 'good' cholesterol that is thought to remove the bad cholesterol from the blood vessels.

Triglycerides

Triglycerides are an energy source for the body. However, as with cholesterol, too much triglycerides can be a problem.

How ZOCOR Works

ZOCOR belongs to a group of medicines known as HMG-CoA reductase inhibitors. It works by reducing the amount of cholesterol made by the liver. In terms of good and bad cholesterol, in most patients, ZOCOR reduces the bad cholesterol and can actually raise the good cholesterol.

ZOCOR does not reduce the cholesterol that comes from fat in food. Therefore, when you are taking ZOCOR, you also need to follow a low fat diet and other measures, such as exercise and weight control.

In most people, there are no symptoms of high cholesterol. Your doctor can measure your cholesterol with a simple blood test.

ZOCOR is not recommended for use in children, as there have been no studies of its effects in children.

Your doctor may have prescribed ZOCOR for another reason. Ask your doctor if you have any questions about why ZOCOR has been prescribed for you.

ZOCOR is not addictive.

Before you take ZOCOR

When you must not take it

Do not take ZOCOR if:

you have an allergy to ZOCOR or Lipex* (which is another brand of simvastatin, Australia only), or to any of the ingredients listed at the end of this leaflet

Symptoms of an allergic reaction may include skin rash, itchiness, shortness of breath, swelling of the tongue or face, or painful joints.

you are pregnant or breast-feeding

Your baby may absorb this medicine in the womb or from breast milk and therefore there is a possibility of harm to the baby.

you have liver disease

you have had muscle pain, tenderness or weakness from other medicines used to treat high cholesterol or triglycerides

the packaging is torn or shows signs of tampering

the expiry date on the pack has passed.

If you take this medicine after the expiry date has passed, it may not work.

If you are not sure whether you should start taking ZOCOR, talk to your doctor.

Before you start to take it

Tell your doctor if:

you intend to become pregnant or plan to breast feed

ZOCOR should not be used during pregnancy or while breast-feeding.

you have ever had liver disease

Your doctor will do a blood test to make sure you have no problems with your liver.

you have kidney disease or any other medical problems

you drink alcohol regularly

you have any allergies to any other medicines or any other substances, such as foods, preservatives or dyes.

If you have not told your doctor about any of the above, tell them before you take any ZOCOR.

Taking other medicines

Tell your doctor if you are taking any other medicines, including medicines that you buy without a prescription from your pharmacy, supermarket or health food shop.

Some medicines and ZOCOR may interfere with each other. These include:-

other medicines to lower cholesterol levels, for example, gemfibrozil or nicotinic acid (also known as niacin)

warfarin, a medicine used to prevent blood clots

erythromycin and clarithromycin, antibiotics used to treat infections

ketoconazole and itraconazole, medicines used to treat certain fungal infections

cyclosporin, a medicine used to suppress the immune system

nefazodone, a medicine used to treat depression

protease inhibitors, used to treat HIV infection, including indinavir, nelfinavir, ritonavir, saquinavir

These medicines may be affected by ZOCOR, or may affect how well it works. You may need different amounts of your medicine, or you may need to take different medicines.

Your doctor or pharmacist has more information on medicines to be careful with or avoid while taking ZOCOR.

How to take ZOCOR

How much to take

Take ZOCOR only when prescribed by your doctor.

Your doctor will tell you how many tablets you need to take each day. This depends on your cholesterol level and other factors, such as kidney disease.

The usual starting dose is 10mg or 20 mg per day, which may need to be increased up to 80mg daily to have the best effect.

Swallow ZOCOR with a glass of water.

Follow all directions given to you by your doctor and pharmacist carefully.

They may differ from the information contained in this leaflet.

If you do not understand the instructions on the box, ask your doctor or pharmacist for help.

When to take it

Take ZOCOR once a day in the evening.

The liver produces its greatest amount of cholesterol when the body is at rest and when there is no dietary intake. For most people this is at night when asleep. Therefore, ZOCOR is more effective when taken in the evening. A good time would be after your evening meal. However, it does not matter whether you take it before or after food.

Take ZOCOR at about the same time each evening.

Taking your tablet(s) at the same time each evening will have the best effect. It will also help you remember when to take the tablets.

How long to take it

ZOCOR helps lower your cholesterol. It does not cure your condition. Therefore, you must continue to take it as directed by your doctor if you expect to lower your cholesterol and keep it down. You may have to take cholesterol-lowering medicine for the rest of your life. If you stop taking ZOCOR, your cholesterol levels may rise again.

If you forget to take it

If it is almost time for your next dose, skip the dose you missed and take your next dose when you are meant to. Otherwise, take it as soon as you remember, and then go back to taking your tablet(s) as you would normally.

If you are not sure whether to skip the dose, talk to your doctor or pharmacist.

Do not take a double dose to make up for the dose that you missed.

If you have trouble remembering to take your tablets, ask your pharmacist for some hints.

If you take too much (overdose)

Immediately telephone your doctor or the National Poisons Information Centre (New Zealand 03 4747000), or go to casualty at your nearest hospital, if you think that you or anyone else may have taken too much ZOCOR. Do this even if there are no signs of discomfort or poisoning.

While you are using ZOCOR

Things you must do

If you become pregnant while you are taking ZOCOR, stop taking it and contact your doctor immediately.

Have your blood fats checked when your doctor says, to make sure ZOCOR is working.

If you are about to be started on any new medicine tell your doctor and pharmacist that you are taking ZOCOR.

If you are about to have elective surgery, tell your doctor that you are taking ZOCOR.

Your doctor may suggest stopping the tablets a few days before surgery.

Things you must not do

Do not give ZOCOR to anyone else, even if they have the same condition as you.

Things to be careful of

Avoid drinking large quantities of alcohol.

Drinking large quantities of alcohol may increase your chance of ZOCOR causing liver problems.

Be careful driving or operating machinery until you know how ZOCOR affects you.

ZOCOR generally does not cause any problems with your ability to drive a car or operate machinery. However, as with many other medicines, ZOCOR may cause dizziness in some people. Make sure you know how you react to ZOCOR before you drive a car or operate machinery.

Changes to lifestyle that may help reduce the chance of coronary heart disease

Lowering high cholesterol can help reduce your chances of having coronary heart disease (CHD). However, your chances of having CHD may be increased by several other factors including high blood pressure, cigarette smoking, diabetes, excess weight, family history of CHD, being a male and being a woman who has reached menopause.

Some self help measures suggested below may help your condition and help reduce your chances of having CHD. Talk to your doctor, pharmacist, or dietician about these measures and for more information.

Diet - continue the low fat diet recommended by your doctor, dietician or pharmacist.

Weight - your doctor may advise you to lose weight if you are overweight.

Exercise - make exercise a part of your routine - walking is good. Ask your doctor for advice before starting exercise.

Smoking - your doctor may advise you to stop smoking or at least cut down.

Adverse Effects

Tell your doctor or pharmacist as soon as possible if you do not feel well while you are taking ZOCOR.

ZOCOR helps most people with high cholesterol, but it may have unwanted adverse effects in a few people. All medicines can have adverse effects. Sometimes they are serious, most of the time they are not. You may need medical treatment if you get some of the adverse effects.

Ask your doctor or pharmacist to answer any questions you may have.

Tell your doctor if you notice any of the following and they worry you:

constipation, diarrhoea, wind

stomach upset or pain, feeling sick (nausea)

headache

dizziness

These are the more common adverse effects of ZOCOR. For the most part these have been mild and short-lived.

Tell your doctor immediately if you notice any of the following:

aching muscles, muscle tenderness or weakness, not caused by exercise

tingling in the hands or feet

yellowing of the skin and/or eyes, also called jaundice

signs of anaemia, such as tiredness, being short of breath, and looking pale

fever, generally feeling unwell

skin rash, itchiness

pinkish, itchy swellings on the skin, also called hives or nettlerash

painful, swollen joints

bruising more easily than normal

larger breasts than normal in men.

These may be serious adverse effects of ZOCOR. Some of these may be symptoms of an allergic reaction to ZOCOR. You may need urgent medical attention. Serious adverse effects are rare.

Tell your doctor immediately or go to accident and emergency at your nearest hospital if you notice any of the following:

swelling of the face, lips, mouth, throat or tongue which may cause difficulty in swallowing or breathing

shortness of breath.

These are serious adverse effects. If you have them, you may have had a serious allergic reaction to ZOCOR. You may need urgent medical attention or hospitalisation. Serious adverse effects are rare.

Also, tell your doctor if you notice:

hair loss

muscle cramps

These are other adverse effects that have been reported with ZOCOR.

Liver problems can also occur and may be serious. Your doctor will do blood tests to check your liver.

Other adverse effects not listed above may also occur in some patients. Tell your doctor if you notice any other effects.

Do not be alarmed by this list of possible adverse effects. You may not experience any of them.

After using ZOCOR

Storage

Keep your tablets in the blister pack until it is time to take them.

If you take the tablets out of the blister pack they may not keep well.

Keep ZOCOR in a cool dry place where the temperature stays below 30°C. Do not store it or any other medicine in the bathroom or near a sink.

Do not leave it in the car or on window sills.

Heat and dampness can destroy some medicines.

Keep it where children cannot reach it.

A locked cupboard at least one-and-a-half metres above the ground is a good place to store medicines.

Disposal

If your doctor tells you to stop taking ZOCOR or the tablets have passed their expiry date, ask your pharmacist what to do with any that are left over.

Product description

What it looks like

ZOCOR comes in four types of tablets:

ZOCOR 5 mg - buff coloured, oval-shaped tablet with "MSD 726" marked on one side

ZOCOR 10 mg - peach coloured, oval-shaped tablet with "MSD 735" marked on one side

ZOCOR 20 mg - tan coloured, oval-shaped tablet with "MSD 740" marked on one side

ZOCOR 40 mg - brick-red coloured, oval-shaped tablet with "MSD 749" marked on one side

A box of ZOCOR contains 30 tablets.

Ingredients

Active ingredient:

ZOCOR 5 mg - 5 mg simvastatin per tablet

ZOCOR 10 mg - 10 mg simvastatin per tablet

ZOCOR 20 mg - 20 mg simvastatin per tablet

ZOCOR 40 mg - 40 mg simvastatin per tablet

Inactive ingredients:

butylated hydroxyanisole

ascorbic acid

citric acid monohydrate

cellulose

starch - pregelatinised maize

magnesium stearate

lactose

hypromellose

hydroxypropylcellulose

titanium dioxide

talc

iron oxide yellow CI77492 (5 mg, 10 mg and 20 mg tablets)

iron oxide red CI77491 (10 mg, 20 mg and 40 mg tablets)

ZOCOR does not contain gluten, sucrose, tartrazine or any other azo dyes.