Simvasyn Simvastatin 80mg Tablets (Pack Of 30)

SIMVASTATIN-RL

simvastatin
Consumer Medicine Information

What is in this leaflet?

Please read this leaflet carefully before you take SIMVASTATIN-RL.

This leaflet answers some common questions about SIMVASTATIN-RL. It does not contain all of the available information.

It does not take the place of talking to your doctor or pharmacist.

All medicines have risks and benefits. Sometimes new risks are found even when a medicine has been used for many years. Your doctor has weighed the expected benefits of you taking SIMVASTATIN-RL against the risks this medicine could 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 is SIMVASTATIN-RL used for?

  • SIMVASTATIN-RL 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-RL 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.

    • Cholesterol

  • 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-RL to help prolong your life and to lessen the risk of a heart attack or further attacks, or stroke. SIMVASTATIN-RL 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

  • 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 realise 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-RL 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-RL reduces the `bad` cholesterol and raises the `good` cholesterol. In patients with CHD accompanied by high cholesterol levels, SIMVASTATIN-RL may slow down the hardening of blood vessels and reduces the risk of new plaque development.
  • SIMVASTATIN-RL 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-RL 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-RL is addictive.

    Your doctor may have prescribed SIMVASTATIN-RL for another reason. Ask your doctor if you have any questions about why SIMVASTATIN-RL was prescribed for you.

    Before you take SIMVASTATIN-RL

    Do not take if:

    You must not take SIMVASTATIN-RL if:

  • you have ever had an allergic reaction to simvastatin or any of the ingredients listed toward the end of this leaflet. (See “Ingredients”)
  • you are pregnant or breastfeeding.

    • SIMVASTATIN-RL may affect your baby if you take it while you are pregnant. It is not known if the active ingredient of SIMVASTATIN-RL passes into breast milk. For safety reasons, it is not recommended to breastfeed your baby if you are taking SIMVASTATIN-RL.

  • you have liver disease.
  • you have had muscle pain, tenderness or weakness from other medicines used to treat high cholesterol or triglycerides before.
  • the expiry date (EXP) printed on the pack has passed.
  • the packaging is torn or shows signs of tampering

    • Tell your doctor if:

    You must tell your doctor if:

  • you are allergic to foods, dyes, preservatives or any other medicines.
  • you are breastfeeding, pregnant or trying to become pregnant.
  • you have any other medical problems, such as kidney or liver problems.

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

  • you are taking any other medicines, including medicines you buy without a prescription.

    • Some medicines should not be taken with SIMVASTATIN-RL as this may increase the risk of muscle side effects, for example:

  • Nefazodone, used to treat depression.
  • Protease inhibitors, used to treat HIV infection, including indinavir, nelfinavir, ritonavir and saquinavir.
  • Erythromycin and clarithromycin, 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-RL temporarily or permanently.

    Also tell your doctor if you take any of the following:

  • Other medicines used to lower cholesterol levels, e.g. gemfibrozil or nicotinic acid (also known as niacin).
  • Warfarin, used to prevent blood clots.
  • Cyclosporin, used to suppress the immune system.
  • Verapamil, used to treat high blood pressure and angina.
  • Amiodarone, used to treat irregular heartbeat.
  • Digoxin, used to treat heart failure or irregular heartbeat.

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

    How do I take SIMVASTATIN-RL?

    How much to take

    Take SIMVASTATIN-RL as directed by your doctor or pharmacist.

    How to take it

    Take SIMVASTATIN-RL once a day in the evening, with a full glass of water. 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-RL 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.

    If you need to break SIMVASTATIN-RL, hold tablet with both hands and snap along break line.

    How long to take it for

    Your doctor will determine how long you have to take SIMVASTATIN-RL.

    As SIMVASTATIN-RL 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.

    If you stop taking SIMVASTATIN-RL, your cholesterol levels may rise again.

    Do not stop taking SIMVASTATIN-RL, or change the dose without first checking with your doctor.

    Use in children

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

    What do I do if I take too much? (Overdose)

    Immediately telephone your doctor or Poisons Information Centre (telephone 131126) for advice, if you think you or anyone else may have taken too much SIMVASTATIN-RL, even if there are no signs of discomfort or poisoning.

    If you are not sure what to do, contact your doctor, pharmacist or nearest hospital.

    While you are taking SIMVASTATIN-RL

    Things you must do

  • Tell your doctor if, for any reason, you have not taken your medicine exactly as directed.
  • Always follow your doctor`s instructions carefully.
  • Tell your doctor immediately if you become pregnant while taking SIMVASTATIN-RL and stop taking it.
  • If you are about to start taking a new medicine, tell your doctor and pharmacist that you are taking SIMVASTATIN-RL.
  • Have your blood fats checked when your doctor says so, to make sure SIMVASTATIN-RL is working.
  • If you are about to have surgery, tell your doctor that you are taking SIMVASTATIN-RL. Your doctor may advise you to stop taking SIMVASTATIN-RL a few days before surgery.

    • If you forget to take it

    Take your dose as soon as you remember, and continue to take it as you would normally.

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

    Do not take a double dose to make up for the dose you missed. Otherwise, your doctor may think that it was not working as it should and change your treatment unnecessarily.

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

    Things you must not do

    Do not give this medicine to anyone else, even if their symptoms seem similar to yours.

    Do not stop taking SIMVASTATIN-RL without your doctors permission.

    Do not use SIMVASTATIN-RL to treat any other complaints unless your doctor says to.

    Things to be careful of

    Avoid drinking large quantities of alcohol. It may increase your chance of SIMVASTATIN-RL 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-RL. This increases the risk of SIMVASTATIN-RL 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.

    Be careful driving or operating machinery until you know how SIMVASTATIN-RL affects you. SIMVASTATIN-RL may cause dizziness or light-headedness in some people, especially after the first dose.

    What are the side-effects?

    Check with your doctor as soon as possible if you think you are experiencing any side effects or allergic reactions due to taking SIMVASTATIN-RL, even if the problem is not listed below.

  • Like other medicines, SIMVASTATIN-RL can cause some side-effects. If they occur, they are most likely to be minor and temporary. However, some may be serious and need medical attention.
  • The most commonly reported side-effects are:
  • Constipation, diarrhoea, wind.
  • Stomach upset or pain, feeling sick (nausea).
  • Headache.
  • Sleeplessness.
  • Dizziness.
  • Other side-effects reported are:
  • Hair loss.
  • Muscle cramps.

    • 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.
  • 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 nettlerash.
  • Painful, swollen joints.
  • Wheezing, swelling of the lips/mouth, difficulty in breathing, hayfever, lumpy rash (hives) or fainting. These could be symptoms of an allergic reaction.

    • This is not a complete list of all possible side-effects. Others may occur in some people and there may be some side-effects not yet known.

    Tell your doctor or pharmacist if you notice any side effects from your medicine which are not mentioned here.

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

    How do I store SIMVASTATIN-RL?

    Keep this medicine where children cannot reach it, such as in a locked cupboard.

    Do not leave in a car, on a window sill or in the bathroom.

    Keep SIMVASTATIN-RL in its bottle/blister pack until time to take.

    Return any unused or expired medicine to your pharmacist.

    Product description

    What it looks like

    SIMVASTATIN-RL 5mg: yellow coated, oval, scored, convex tablets, coded `SIM 5` on one side. They are available in blisters of 30 tablets.

    SIMVASTATIN-RL 10mg: light red coated, oval, scored, convex tablets, coded `SIM 10` on one side. They are available in blisters of 30 tablets.

    SIMVASTATIN-RL 20mg: orange coated, oval, scored, convex tablets, coded `SIM 20` on one side. They are available in blisters of 30 tablets.

    SIMVASTATIN-RL 40mg: red-brown coated, oval, scored, convex tablets, coded `SIM 40` on one side. They are available in blisters of 30 tablets.

  • SIMVASTATIN-RL 80mg: light green coated, oval, scored, convex tablets, coded `SIM 80` on one side. They are available in blisters of 30 tablets.

    Ingredients

    SIMVASTATIN-RL contains the active ingredient simvastatin.

    SIMVASTATIN-RL also contains maize starch – pregelatinised, lactose, cellulose – microcrystalline, butylated hydroxyanisole, ascorbic acid, citric acid monohydrate, magnesium stearate, hypromellose, talc – purified, titanium dioxide, yellow iron oxide CI77492 (SIMVASTATIN-RL 5mg, 10mg and 20mg only), red iron oxide CI77491 (SIMVASTATIN-RL 10mg, 20mg and 40mg only), indigo carmine CI73015 (SIMVASTATIN-RL 80mg only) and quinoline yellow CI47005 (SIMVASTATIN-RL 80mg only).

  • Your SIMVASTATIN-RL is supplied by:
  • REAL-RL
  • A Division of
  • GlaxoSmithKline Australia Pty Ltd
  • 1061 Mountain Highway
  • Boronia, Victoria, 3155
  • Australia.

    • Where to go for further information

  • Pharmaceutical companies are not in a position to give people an individual diagnosis or medical advice. Your doctor or pharmacist is the best person to give you advice on the treatment of your condition.
  • This leaflet was prepared on 10 January 2006.
  • The information provided applies only to: SIMVASTATIN-RL(TM)
  • (TM) SIMVASTATIN-RL is a trademark of the GlaxoSmithKline Group of Companies.

    • Blister pack

  • SIMVASTATIN-RL 5mg: AUST R 116796
  • SIMVASTATIN-RL 10mg: AUST R 116799
  • SIMVASTATIN-RL 20mg: AUST R 116802
  • SIMVASTATIN-RL 40mg: AUST R 116806
  • SIMVASTATIN-RL 80mg: AUST R 116826
  • (C) 2005 GlaxoSmithKline
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