Simvastatin Winthrop

Simvastatin Winthrop^®

simvastatin

Consumer Medicine Information (CMI)

This leaflet answers some common questions about Simvastatin Winthrop. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist.

All medicines have risks and benefits. Your doctor has weighed the risk of you taking this medicine against the benefits it is expected to have for you.

If you have any concerns about taking this medicine, ask your doctor or pharmacist.

Keep this leaflet with the medicine.

You may need to read it again.

Simvastatin Winthrop is used to lower high cholesterol and triglyceride levels. It is used in people who have Coronary Heart Disease (CHD) or who are at high risk of CHD, for example if they have diabetes, a history of stroke or other blood vessel disease. Simvastatin Winthrop may be used in these people, regardless of their cholesterol level, to help prolong life by reducing the risk of a heart attack, to reduce the risk of stroke, to reduce the need for surgery to increase blood flow to the heart or to reduce the need for hospitalisation due to angina.

Everyone has cholesterol in their blood. It’s a type of blood fat needed by the body for many things, such as building cell walls, making bile acids (which help to digest food) and some hormones.

Cholesterol is present in many foods and is also made in your body by the liver. If your body does not balance the amount of cholesterol it needs with the amount of cholesterol eaten, then your cholesterol levels become too high.

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 your 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.

If you have Coronary Heart Disease, your doctor has prescribed Simvastatin Winthrop to help prolong your life and to lessen the risk of a heart attack or further attacks or stroke. This medicine may also decrease the risk of needing an operation to increase the blood flow to your heart.

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

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

As there are mostly no symptoms of high cholesterol or triglycerides, you may not realize you have increased levels. See your doctor if you are uncertain, as your cholesterol and triglycerides can be measured with a simple blood test.

Simvastatin Winthrop belongs to a group of medicines called HMG-CoA reductase inhibitors.

It works by reducing the amount of cholesterol made by the liver.

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

Simvastatin Winthrop reduces the ‘bad’ cholesterol and raises the ‘good’ cholesterol. In patients with CHD accompanied by high cholesterol levels, Simvastatin Winthrop may slow down the hardening of blood vessels and reduces the risk of new plaque development.

Simvastatin Winthrop affects only the cholesterol and triglycerides made by the liver in your body. It has no effect on cholesterol and triglycerides that come from fats in food. Therefore, Simvastatin Winthrop treatment should be accompanied by a diet that is low in fat and the used fats should be preferably unsaturated and of vegetable origin.

There is no evidence that Simvastatin Winthrop is addictive.

Ask your doctor if you have any questions about why this medicine was prescribed for you.

Your doctor may have prescribed it for another reason.

This medicine is available only with a doctor’s prescription.

Simvastatin Winthrop is not recommended for use in children, as there have been no studies of its effect in children.

Do not take Simvastatin Winthrop if:

you have liver disease.

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

Do not take Simvastatin Winthrop if you are allergic to it or any of the ingredients listed at the end of this leaflet.

Some symptoms of an allergic reaction include skin rash, itching, shortness of breath or swelling of the face, lips or tongue, which may cause difficulty in swallowing or breathing.

Do not give Simvastatin Winthrop to a child or adolescent.

There is no experience with its use in children or adolescents under 18 years old.

Do not take Simvastatin Winthrop if you are pregnant or intend to become pregnant.

It may affect your developing baby if you take it during pregnancy.

Do not take Simvastatin Winthrop it if you are breastfeeding or planning to breastfeed.

It is not known if the active ingredient of Simvastatin Winthrop passes into breast milk. For safety reasons, it is not recommended to breastfeed your baby if you are taking Simvastatin Winthrop.

Do not take Simvastatin Winthrop after the expiry date (EXP) printed on the pack.

If you take it after the expiry date has passed, it may not work as well.

Do not take it if the packaging is damaged or shows signs of tampering.

Tell your doctor if you have allergies to:

any of the ingredients listed at the end of this leaflet

any other medicines including any other substances, such as foods, preservatives or dyes.

Tell your doctor if you are pregnant or intend to become pregnant.

Like most medicines of this kind, Simvastatin Winthrop is not recommended to be used during pregnancy. Your doctor or pharmacist will discuss the risks and benefits of taking it if you are pregnant.

Tell your doctor if you are breastfeeding or planning to breastfeed.

It is not known whether Simvastatin Winthrop passes into breast milk.Your doctor will discuss the risks and benefits of taking it if you are breastfeeding or planning to breastfeed.

Tell your doctor if you have or have had any medical conditions, especially the following:

Kidney problems

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

Tell your doctor if you drink alcohol regularly

If you have not told your doctor about any of the above, tell him/her before you start taking Simvastatin Winthrop.

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

Some medicines may interfere with the absorption of Simvastatin Winthrop. These include:

Nefazodone, used to treat depression

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

Erythromycin and clarithromycin and fusidic acid, antibiotics used to treat infections

Ketoconazole and itraconazole, used to treat certain fungal infections

If you are taking any of the medicines listed above, your doctor may suggest stopping Simvastatin Winthrop temporarily or permanently.

Taking Simvastatin Winthrop with any of the medicines listed below can increase the risk of muscle problems. Tell your doctor if you take any of the following:

Other medicines used to lower cholesterol levels, e.g. fibric acid derivatives (such as gemfibrozil) or large doses (=1g/day) of nicotinic acid (also known as niacin)

Warfarin, used to prevent blood clots

Fenofibrate, another fibric acid derivative

Cyclosporin, used to suppress the immune system

Verapamil, used to treat high blood pressure and angina

Diltiazem, used to treat high blood pressure and angina

Danazol, used to treat certain uterine disorders

Amiodarone, used to treat irregular heartbeat

These medicines may be affected by Simvastatin Winthrop, or may affect how well it works. You may need to use different amounts of your medicine, or take different medicines. Your doctor will advise you.

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

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

They may differ from the information contained in this leaflet.

The amount of Simvastatin Winthrop to be taken depends on your cholesterol and triglyceride levels and other factors, such as kidney disease.

The recommended starting dose is 10 mg or 20 mg per day, taken in the evening. To have the best effect, this may need to be increased to up to 80 mg daily.

The 80mg dose is only for patients who have not reached their cholesterol goal on the 40mg dose.

For people with CHD or risk factors for CHD, the usual starting dose is 40 mg per day, taken in the evening.

Your doctor may have prescribed a different dose.

Ask your doctor or pharmacist if you are unsure of the correct dose for you.

They will tell you exactly how much to take.

Follow the instructions they give you.

If you take the wrong dose, Simvastatin Winthrop may not work as well and your, Simvastatin Winthrop may not work as well and your problem may not improve.

Swallow the tablets with a full glass of water or other liquid. If you need to break Simvastatin Winthrop, hold the tablet with both hands and snap along break-line.

Take Simvastatin Winthrop once a day in the evening. Try to take it at about the same time each evening. This will also help you to remember when to take your tablet.

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 they are asleep. Therefore, Simvastatin Winthrop is more effective when taken in the evening. It does not matter whether you take it with or without food, but a good time would be after your evening meal.

Your doctor will determine how long you have to take Simvastatin Winthrop.

As Simvastatin Winthrop helps to lower your cholesterol levels, but does not cure your condition, you may have to take cholesterol-lowering medicines for the rest of your life. You must continue to take it as directed by your doctor if you expect to lower your cholesterol and keep it down.

This medicine helps to lower your cholesterol levels but does not cure your condition. If you stop taking Simvastatin Winthrop, your cholesterol levels may rise again.

If it is almost time for your next dose, skip the dose you missed and take the next dose when you are meant to.

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

This may increase the chance of getting an unwanted side effect.

If you are not sure what to do, ask your doctor or pharmacist.

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

Immediately telephone your doctor, or the Poisons Information Centre (telephone Australia 13 11 26 or New Zealand 0800 POISON or 0800 764766), or go to Accident and Emergency at your nearest hospital, if you think you or anyone else may have taken too much Simvastatin Winthrop.

Do this even if there are no signs of discomfort or poisoning.

You may need urgent medical attention.

Have your blood fats checked when your doctor says so, to make sure Simvastatin Winthrop is working.

If you become pregnant while you are taking Simvastatin Winthrop stop taking it and contact your doctor immediately.

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

If you plan to have surgery that needs a general anaesthetic, tell your doctor or dentist that you are taking this medicine.

Your doctor may advise you to stop taking this medicine a few days before surgery.

Do not stop taking Simvastatin Winthrop, or lower the dosage, without checking with your doctor.

Your doctor may want you to gradually reduce the amount you are using before stopping completely.

Do not stop taking your tablets because you are feeling better, unless advised by your doctor or pharmacist.

Do not take more than the recommended dose unless your doctor or pharmacist tells you to.

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

Do not use this medicine to treat any other complaints unless your doctor tells you to.

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

This medicine generally does not cause any problems with your ability to drive a car or operate machinery, however, as with many other medicines, Simvastatin Winthrop may cause dizziness in some people.

Avoid drinking large quantities of alcohol.

It may increase your chance of Simvastatin Winthrop causing liver problems.

Avoid drinking large quantities of grapefruit juice each day (over 1 litre), as it contains some components that influence the metabolism of Simvastatin Winthrop.

This increases the risk of Simvastatin Winthrop causing side effects, such as aching muscles, muscle tenderness or weakness, not caused by exercise. However, one glass (250mL) of grapefruit juice each day has not been shown to have any significant effect.

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, a 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.

Exercise

Make moderate exercise a part of your routine, e.g. walking, cycling or swimming.

Ask your doctor for advice before starting exercise.

Weight

Your doctor may advise you to lose weight if you are overweight.

Smoking

Your doctor may advise you to stop smoking or at least cut down.

All medicines can have some unwanted side effects. Sometimes they are serious, but most of the time they are not.

Your doctor has weighed the risks of using this medicine against the benefits they expect it will have for you.

Do not be alarmed by this list of possible side effects.

You may not experience any of them.

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

It helps most people with high cholesterol, but it may have unwanted side effects in a few people.

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

Nightmares

Memory loss

Sexual dysfunction

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

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

Brown/black coloured urine

On rare occasions, muscle problems can be serious, including muscle breakdown resulting in kidney damage.

The risk of muscle problems is greater for:

patients taking higher doses of Simvastation Winthrop

older patients (65 years of age and older)

patients with abnormal kidney function

patients with thyroid problems

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

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

Larger breasts than normal in men

Bruising more easily than normal

Skin rash, itchiness

Fever, generally feeling unwell

Pinkish, itchy swellings on the skin, also called hives or nettle rash

Painful, swollen joints.

These may be serious side effects of Simvastatin Winthrop. You may need urgent medical attention. Serious side effects are uncommon.

Tell your doctor immediately, or go to Accident and Emergency at your nearest hospital if you notice any of the following:

Swelling of the limbs, face, lips, mouth or throat which may cause difficulty in swallowing or breathing, shortness of breath, itchy rash or hives. These are the symptoms of an allergic reaction.

These are serious side effects. You may need urgent medical attention or hospitalisation. Serious side effects are very rare.

Also, tell your doctor if you notice:

Hair loss

Muscle cramps

Trouble sleeping

Poor memory

These are other side effects that have been reported with Simvastatin Winthrop.

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

Tell you doctor or pharmacist if you notice anything else that is making you feel unwell.

Other side effects not listed above may occur in some consumers.

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

If you have any queries about any aspect of your medicine, or any questions regarding the information in this leaflet, discuss them with your doctor or pharmacist.

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

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

Keep the medicine in a cool, dry place where the temperature stays below 25°C. Protect from light.

Do not store it or any other medicine in the bathroom, near a sink, or on a windowsill.

Do not leave it in the car.

Heat and damp 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.

If your doctor tells you to stop taking Simvastatin Winthrop or the medicine has passed its expiry date, ask your pharmacist what to do with any that are left over.

Return any unused medicine to your pharmacist.

Simvastatin Winthrop comes in four types of tablets:

Simvastatin Winthrop 10 mg – pale pink, oval, scored, convex, film-coated tablets, coded ‘SIM 10’ on one side.

Simvastatin Winthrop 20 mg – orange, oval, scored, convex film-coated tablets, coded ‘SIM 20’ on one side.

Simvastatin Winthrop 40 mg – pink, oval, scored, convex film-coated tablets, coded ‘SIM 40’ on one side.

Simvastatin Winthrop 80 mg – light green, oval, scored, convex film-coated tablets, coded ‘SIM 80’ on one side.

They are all available in blisters of 30 tablets.

Active Ingredient:

Simvastatin Winthrop 10 mg – 10 mg simvastatin per tablet

Simvastatin Winthrop 20 mg – 20 mg simvastatin per tablet

Simvastatin Winthrop 40 mg – 40 mg simvastatin per tablet

Simvastatin Winthrop 80 mg – 80 mg simvastatin per tablet

Inactive Ingredients:

pregelatinised maize starch

lactose

microcrystalline cellulose

butylated hydroxyanisole

ascorbic acid

citric acid monohydrate

magnesium stearate

hypromellose

purified talc

titanium dioxide

yellow iron oxide (10 mg & 20 mg only)

red iron oxide (10 mg, 20 mg & 40 mg only)

indigo carmine aluminium lake (80 mg only)

quinoline yellow aluminium lake (80 mg only)

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

Simvastatin Winthrop is supplied in Australia by:

sanofi-aventis australia pty ltd

12-24 Talavera Road

Macquarie Park NSW 2113.

 

Simvastatin Winthrop is supplied in New Zealand by:

sanofi -aventis new zealand limited

Level 8, James and Wells Tower

56 Cawley Street

Ellerslie

Auckland

 

This leaflet was prepared in July 2010.

 

Australian Register Numbers

10 mg tablets: AUST R 129967

20 mg tablets: AUST R 129979

40 mg tablets: AUST R 129985

80 mg tablets: AUST R 129986

 

® Registered Trademark