Consumer medicine information

SYNTHON SIMVASTATIN®

Simvastatin

Consumer Medicine Information

What is in this leaflet

This leaflet answers some common questions about SYNTHON SIMVASTATIN. 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 risks of you taking SYNTHON SIMVASTATIN against the benefits they expect it will 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.

What SYNTHON SIMVASTATIN is used for

SYNTHON SIMVASTATIN helps to lower cholesterol and triglyceride levels.

SYNTHON SIMVASTATIN 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).

SYNTHON SIMVASTATIN may be used in these people, regardless of their cholesterol level to:

  • help prolong life by reducing the risk of a heart attack
  • reduce the risk of stroke
  • reduce the need for surgery to
  • increase blood flow to the heart
  • reduce the need for hospitalisation due to angina.

Cholesterol

Everyone has cholesterol and triglycerides in their blood. They are types of blood fat needed by the body for many things, including 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 people with CHD, SYNTHON SIMVASTATIN may slow down the hardening of blood vessels and reduce the risk of developing new plaques.

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 SYNTHON SIMVASTATIN works

SYNTHON SIMVASTATIN 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, SYNTHON SIMVASTATIN reduces the bad cholesterol and raises the good cholesterol.

SYNTHON SIMVASTATIN does not reduce the cholesterol and triglycerides that come from fat in food.

Therefore, when you are taking SYNTHON SIMVASTATIN, 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 or triglycerides. Your doctor can measure your cholesterol and triglycerides with a simple blood test.

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

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

SYNTHON SIMVASTATIN is not addictive.

Before you take SYNTHON SIMVASTATIN

When you must not take it

Do not take SYNTHON SIMVASTATIN if:

  • you have an allergy to SYNTHON SIMVASTATIN or other brands of simvastatin, 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 breastfeeding
    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 SYNTHON SIMVASTATIN, talk to your doctor.

Before you start to take it

Tell your doctor if:

  1. you intend to become pregnant or plan to breast feed
    SYNTHON SIMVASTATIN should not be used during pregnancy or while breastfeeding.
  2. you have unexplained muscle pain, tenderness or weakness not caused by exercise. This is because on rare occasions, muscle problems can be serious, including muscle breakdown resulting in kidney damage that can lead to death.
    Your doctor may do a blood test to check for certain muscle problems.
  3. you are taking niacin or a niacin-containing product, particularly if you are Chinese you have ever had liver disease
    Your doctor will do a blood test to make sure you have no problems with your liver.
  4. you have kidney disease or any other medical problems
  5. you drink alcohol regularly
  6. 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 SYNTHON SIMVASTATIN.

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 should not be taken with SYNTHON SIMVASTATIN as they may increase the risk of muscle side effects with SYNTHON SIMVASTATIN. It is particularly important to tell your doctor if you are taking:

  • nefazodone, used to treat depression
  • protease inhibitors, used to treat HIV infection, including indinavir, nelfinavir, ritonavir, saquinavir
  • certain hepatitis C virus protease inhibitors (such as boceprevir or telaprevir)
  • gemfibrozil, used to treat high cholesterol levels
  • cyclosporin, used to suppress the immune system
  • danazol
  • erythromycin, clarithromycin, telithromycin and fusidic acid antibiotics used to treat infections
  • ketoconazole, itraconazole and posaconazole, used to treat certain fungal infections

If you are taking any of the above, your doctor may suggest stopping SYNTHON SIMVASTATIN temporarily or permanently.

Some medicines and SYNTHON SIMVASTATIN may interfere with each other. Because taking SYNTHON SIMVASTATIN with any of the following drugs can increase the risk of muscle problems (see Side Effects), it is particularly important to tell your doctor if you are taking:

  • other medicines to lower cholesterol levels, for example, other fibrates, nicotinic acid (also known as niacin)
  • warfarin, or other drugs used to prevent blood clots
  • colchicine, used for gout
  • verapamil, diltiazem or amlodipine, used to treat high blood pressure, angina or other heart conditions
  • amiodarone, used to treat irregular heart beat
  • digoxin, used to treat heart failure

These medicines may be affected by SYNTHON SIMVASTATIN, may affect how well it works, or may increase the risk of side effects with SYNTHON SIMVASTATIN. 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 SYNTHON SIMVASTATIN.

You should also tell any doctor who is prescribing a new medication for you that you are taking SYNTHON SIMVASTATIN.

How to take SYNTHON SIMVASTATIN

How much to take

Take SYNTHON SIMVASTATIN 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 and triglyceride levels and other factors, such as kidney disease.

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

Because of the increased risk of muscle problems, the 80 mg dose is only for patients at high risk of heart disease problems who have not reached their cholesterol goal on lower doses.

People with CHD or risk factors for CHD are usually started on 40 mg per day, taken in the evening.

For children (10-17 years old), the recommended usual starting dose is 10 mg a day in the evening. The maximum recommended dose is 40 mg a day.

Swallow SYNTHON SIMVASTATIN 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, ask your doctor or pharmacist for help.

When to take it

Take SYNTHON SIMVASTATIN 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, SYNTHON SIMVASTATIN 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 SYNTHON SIMVASTATIN 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

SYNTHON SIMVASTATIN 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 cholesterollowering medicine for the rest of your life. If you stop taking SYNTHON SIMVASTATIN, 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 Poisons Information Centre (telephone 13 11 26), or go to accident and emergency at your nearest hospital, if you think that you or anyone else may have taken too much SYNTHON SIMVASTATIN. Do this even if there are no signs of discomfort or poisoning.

While you are using SYNTHON SIMVASTATIN

Things you must do

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

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

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

If you are about to have elective surgery, tell your doctor that you are taking SYNTHON SIMVASTATIN. Your doctor may suggest stopping the tablets a few days before surgery.

Things you must not do

Do not give SYNTHON SIMVASTATIN 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 SYNTHON SIMVASTATIN causing liver problems.

Avoid drinking large quantities of grapefruit juice. Grapefruit juice contains one or more components that alter the metabolism of some medicines, including SYNTHON SIMVASTATIN. Therefore, drinking very large quantities (over 1 litre) of grapefruit juice each day increases your chance of SYNTHON SIMVASTATIN causing side effects. These include 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.

Be careful driving or operating machinery until you know how SYNTHON SIMVASTATIN affects you. SYNTHON SIMVASTATIN generally does not cause any problems with your ability to drive a car or operate machinery. However, as with many other medicines, SYNTHON SIMVASTATIN may cause dizziness in some people. Make sure you know how you react to SYNTHON SIMVASTATIN 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.

Side Effects

Tell your doctor or pharmacist as soon as possible if you do not feel well while you are taking SYNTHON SIMVASTATIN. SYNTHON SIMVASTATIN helps most people with high cholesterol, but it may have unwanted side effects in a few people. All medicines can have side effects. Sometimes they are serious, most of the time they are not. You may need medical treatment if you get some of the side 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 side effects of SYNTHON SIMVASTATIN. 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
  • brown/black coloured urine

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

The risk of muscle problems is greater for:

  • patients taking higher doses of SYNTHON SIMVASTATIN, particularly the 80 mg dose
  • older patients (65 years of age and older)
  • female patients
  • 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
  • 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 side effects of SYNTHON SIMVASTATIN. Some of these may be symptoms of an allergic reaction to SYNTHON SIMVASTATIN. You may need urgent medical attention. Serious side 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 side effects. If you have them, you may have had a serious allergic reaction to SYNTHON SIMVASTATIN. You may need urgent medical attention or hospitalisation. Serious side effects are rare.

Also, tell your doctor if you notice:

  • hair loss
  • muscle cramps
  • trouble sleeping
  • poor memory, memory loss, confusion
  • feelings of depression
  • erectile dysfunction
  • breathing problems including persistent cough and/or shortness of breath or fever

These are other side effects that have been reported with SYNTHON SIMVASTATIN.

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

Tell your doctor immediately if you have the following symptoms of liver problems:

  • feel tired or weak
  • loss of appetite
  • upper belly pain
  • dark urine
  • yellowing of your skin or the whites of your eyes

Other side 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 side effects. You may not experience any of them.

After using SYNTHON SIMVASTATIN

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 SYNTHON SIMVASTATIN in a cool dry place where the temperature stays below 25°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-anda-half metres above the ground is a good place to store medicines.

Disposal

If your doctor tells you to stop taking SYNTHON SIMVASTATIN 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

SYNTHON SIMVASTATIN comes in five types of tablets:

  • SYNTHON SIMVASTATIN 5 mg – yellow coloured oblong, biconvex breakable tablets with ‘SVT’ and ‘5’ marked on them
  • SYNTHON SIMVASTATIN 10 mg – white coloured oblong, biconvex breakable tablets with ‘SVT’ and ‘10’ marked on them
  • SYNTHON SIMVASTATIN 20 mg white coloured oblong, biconvex breakable tablets with ‘SVT’ and ‘20’ marked on them
  • SYNTHON SIMVASTATIN 40 mg – white coloured oblong, biconvex breakable tablets with ‘SVT’ and ‘40’ marked on them
  • SYNTHON SIMVASTATIN 80 mg – white coloured oblong, biconvex breakable tablets with ‘SVT’ and ‘80’ marked on them

A starter pack of SYNTHON SIMVASTATIN contains 5 tablets. A trade pack of SYNTHON SIMVASTATIN contains 30 tablets.

Ingredients

Active ingredient:

  • SYNTHON SIMVASTATIN 5 mg – 5 mg simvastatin per tablet
  • SYNTHON SIMVASTATIN 10 mg – 10 mg simvastatin per tablet
  • SYNTHON SIMVASTATIN 20 mg – 20 mg simvastatin per tablet
  • SYNTHON SIMVASTATIN 40 mg – 40 mg simvastatin per tablet
  • SYNTHON SIMVASTATIN 80 mg – 80 mg simvastatin per tablet

Inactive ingredients:

  • butylated hydroxyanisole
  • cellulose- microcrystalline
  • starch – pregelatinised maize
  • magnesium stearate
  • lactose anhydrous
  • talc-purified
  • Opadry White colour system 20A28793 (10mg, 20mg, 40mg and 80mg)
  • Opadry Yellow colour system 20A22578 (5mg tablets)

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

Manufacturer/Supplier

SYNTHON SIMVASTATIN is supplied in Australia by:
Synthon AU Pty Ltd
Suite 201, 6-12 Atchison St
St Leonards NSW 2065

This leaflet was prepared in July 2012.

Australian Register Numbers:
SYNTHON SIMVASTATIN 5 mg – AUST R 100845
SYNTHON SIMVASTATIN 10 mg – AUST R 100863
SYNTHON SIMVASTATIN 20 mg – AUST R 100865
SYNTHON SIMVASTATIN 40 mg – AUST R 100866
SYNTHON SIMVASTATIN 80 mg – AUST R 100868

Published by MIMS October 2012