Vastin (Fluvastatin) Capsules 40MG (Pack Of 28)

VASTIN(R)

Fluvastatin

Consumer Medicine Information

What is in this leaflet

This leaflet answers some of the common questions people ask about Vastin. It does not contain all the information that is known about Vastin.

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

All medicines have risks and benefits. Your doctor will have weighed the risks of you taking Vastin 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 Vastin is for

Vastin lowers the amount of cholesterol made by the body.

Everyone has cholesterol in their blood. It is a type of fat needed by the body for many things, such as building cells, making bile acids (which help to digest foods) and making some hormones. However, having too much cholesterol in the blood can contribute to the development of heart disease.

Cholesterol is present in many foods and is also made by your body. If your body does not balance the amount of cholesterol it makes with the amount of cholesterol you eat, then your cholesterol level becomes too high.

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

Vastin does not reduce the cholesterol that comes from fat in food. Because of this, when you are taking Vastin, you will also have to follow a low fat diet, control your weight and exercise regularly.

Vastin belongs to a group of medicines known as HMG-CoA reductase inhibitors.

Your doctor will have explained why you are being treated with Vastin and told you what dose to take.

Follow all directions given to you by your doctor carefully.

They may differ from the information contained in this leaflet.

Your doctor may prescribe this medicine for another use. Ask your doctor if you want more information.

Vastin is not addictive

Before you use Vastin

When you must not use it

Do not use Vastin if you are pregnant or breast feeding. Ask your doctor about the risks and benefits involved.

You must not fall pregnant while you are taking Vastin. Ask your doctor about effective methods of contraception.

If you become pregnant, stop taking Vastin as soon as you find out and see your doctor immediately.

We do not know if your baby can take in Vastin from breast milk if you are breast feeding.

Do not give Vastin to children.

We do not know how it affects children.

Do not use after the use by (expiry) date printed on the pack.

It may have no effect at all, or worse, an entirely unexpected effect if you take it after the expiry date.

Do not use Vastin if the packaging is torn or shows signs of tampering.

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

Do not give this medicine to anyone else.

Before you start to use it

You must tell your doctor if:

  • 1. you have any allergies to
  • any other HMG-CoA reductase inhibitors e.g. simvastatin, other “statin” cholesterol lowering drugs
  • any other substances
  • any ingredients listed at the end of this leaflet
  • If you have an allergic reaction, you may get a skin rash, hay fever, difficulty breathing or feel faint.

  • 2.you have any of these medical conditions
  • liver problems
  • kidney problems
  • thyroid problems
  • personal or family history of muscle disorders
  • muscle pain, tenderness or weakness with a cholesterol lowering medicine including gemfibrozil and nicotinic acid
  • It may not be safe for you to take Vastin if you have any of these conditions.

  • 3.if you regularly drink alcohol
  • It may not be safe for you to take Vastin if you drink alcohol regularly.

    Taking other medicines

    Tell your doctor if you are taking any other medicines including

  • other cholesterol lowering medicines, including gemfibrozil and nicotinic acid
  • erythromycin
  • cyclosporin
  • medicines to thin the blood (anticoagulants)
  • medicines that you buy at the chemist, supermarket or health food shop.
  • These medicines may affect the way Vastin works.

    Your doctor or pharmacist can tell you what to do if you are taking any of these medicines.

    If you have not told your doctor about any of these things, tell them before you take any Vastin.

    Using Vastin

    How to take it

    You should have tried to lower your cholesterol by dieting for at least three months before you start taking Vastin.

    The usual dose of Vastin is 20mg or 40mg taken once a day in the evening. At very high cholesterol levels your dose may be increased to 40mg twice daily.

    Take Vastin with a full glass of water or other liquid.

    Vastin can be taken with or after your evening meal. If you are taking Vastin twice a day, take one capsule in the evening and one in the morning, with or after breakfast.

    How long to take it

    Vastin helps lower your cholesterol. It does not cure your condition.

    You must continue to take it as directed to keep your cholesterol levels down.

    You may have to take cholesterol-lowering medicines for the rest of your life. If you stop taking Vastin, your cholesterol levels may rise again.

    If you forget to take it

    If you forget to take a dose of Vastin, take it as soon as you remember, as long as it is more than 6 hours before your next dose is due.

    Otherwise, wait until your next dose is due and take it as normal.

    Do not double the dose to make up for the one you missed.

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

    Overdose

    Telephone your doctor or the Poisons Information Centre (13 11 26), or go to casualty at your nearest hospital immediately if you think that you or anyone else may have taken too much Vastin even if there are no signs of discomfort or poisoning.

    While you are using it

    Things you must do

    Have your blood fats checked when your doctor says so to make sure Vastin is working.

    Stop taking Vastin and contact your doctor immediately if you become pregnant while you are taking Vastin.

    Things you must not do

    Do not stop taking Vastin unless you have discussed it with your doctor.

    Please talk to your doctor or pharmacist about these possibilities if you think they may bother you.

    Side effects

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

    Vastin helps most people with too much 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:

  • upset stomach or heartburn
  • diarrhoea
  • stomach pain
  • nausea (feeling sick)
  • headache
  • difficulty sleeping
  • flu-like symptoms
  • rash or itchiness
  • These are all mild side effects of Vastin.

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

  • unexplained bruising, muscle or joint pain
  • unusual tenderness or weakness
  • unusual tiredness
  • fever
  • swelling of the face, eyelids and lips
  • These are all serious side effects. You may need urgent medical attention

    Serious side effects are rare.

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

    Some people may get other side effects while taking Vastin.

    After using it

    Storage

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

    If you take Vastin out of the blister pack it will not keep well.

    Keep it in a cool dry place where the temperature stays below 25 degrees C.

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

    Heat and dampness can destroy some medicines.

    Keep it where young children cannot reach it.

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

    Do not leave it in the car on hot days.

    Disposal

    Ask your pharmacist what to do with any Vastin capsules you have left over if your doctor tells you to stop taking them, or you find that the expiry date has passed.

    Product description

    What Vastin looks like

    Vastin 20mg are opaque pale yellow capsules, with the body marked 20mg/ASTRA, and the cap marked A/CA in red.

    Vastin 40mg are opaque orange yellow capsules, with the body marked 40mg/ASTRA, and the cap marked A/CB in red.

    Both are available in packs of 28.

    Ingredients

    Vastin contains fluvastatin sodium as the active ingredient, equivalent to fluvastatin 20mg or 40mg,

    plus,

    Magnesium stearate (E572)

    Sodium bicarbonate (E500)

    Talc (E 553(b))

    Cellulose microcrystalline (E460)

    Maize starch

    Calcium carbonate (E170).

    The gelatine (E441) capsules are coloured with titanium dioxide (E171), iron oxide red (E172) and iron oxide yellow (E172). They are coated with shellac.

    Manufacturer

  • Novartis Medicines
  • ABN 188 004 244 160
  • 54 Waterloo Road
  • North Ryde NSW 2113
  • (R) = Registered Trademark
  • This leaflet was prepared in July 2003.
  • Australian Registration Number
  • 20mg 51328
  • 40mg 51329
  • ENQUIRE

    1800 200 736