Fluvastatin 80mg prolonged release tablets

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

1. What Fluvastatin is and what it is used for
2. Before you take Fluvastatin
3. How to take Fluvastatin
4. Possible side effects
5. How to store Fluvastatin
6. Contents of the pack and other information

• If you are allergic to fluvastatin or any of the other ingredients of this medicine (listed in section 6).
• If you currently have liver problems or if you have unexplained, persistently high level of certain liver enzymes (transaminases).
• If you are pregnant or breast-feeding (see “pregnancy and breast-feeding”).

If any of these apply to you, do not take Fluvastatin and tell your doctor.

Talk to your doctor or pharmacist before taking Fluvastatin

• if you are taking or have taken in the last 7 days a medicine called fusidic acid, (a medicine for bacterial infection) orally or by injection. The combination of fusidic acid and Fluvastatin can lead to serious muscle problems (rhabdomyolysis).
• if you previously had a liver disease. Liver function tests will normally be done before you start Fluvastatin, when your dose is increased and at various intervals during treatment to check for side effects.
• if you have a kidney disease.
• if you have a thyroid disease (hypothyroidism).
• if you have a medical history of muscle diseases yourself or in your family.
• if you had muscle problems with another lipid-lowering medicine.
• if you regularly drink large amounts of alcohol.
• if you have a serious infection.
• if you have very low blood pressure (signs may include dizziness, light-headedness).
• if you have controlled or uncontrolled excessive muscle exercise.
• if you are about to have an operation.
• if you have severe metabolic, endocrine or electrolyte disorders such as decompensated diabetes and low blood potassium.
• if you have or have had myasthenia (a disease with general muscle weakness including in some cases muscles used when breathing), or ocular myasthenia (a disease causing eye muscle weakness) as statins may sometimes aggravate the condition or lead to the occurrence of myasthenia (see section 4).

While you are on this medicine your doctor will monitor you closely if you have diabetes or are at risk of developing diabetes. You are likely to be at risk of developing diabetes if you have high levels of sugars and fats in your blood, are overweight and have high blood pressure.

Check with your doctor or pharmacist before taking Fluvastatin:

• if you have severe respiratory failure

If any of these apply to you, tell your doctor before taking Fluvastatin. Your doctor will take a blood test before prescribing Fluvastatin.

Also tell your doctor or pharmacist if you have a muscle weakness that is constant. Additional tests and medicines may be needed to diagnose and treat this.

If during treatment with Fluvastatin, you develop symptoms or signs such as nausea, vomiting, loss of appetite, yellow eye or skin, confusion, euphoria or depression, mental slowing, slurred speech, sleep disturbance, tremors or easy bruising or bleeding, these may be signs of liver failure. In such case contact a doctor immediately.

If you are over 70 years your doctor may want to check if you have risk factors for muscular diseases. You may need specific blood tests.

Fluvastatin has not been investigated and is not intended for the use in children below 9 years.

For dose information in children and adolescents over 9 years, see section 3.

There is no experience with the use of Fluvastatin in combination with nicotinic acid, cholestyramine or fibrates in children and adolescents.

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines including medicines obtained without a prescription.

• If you need to take oral fusidic acid to treat a bacterial infection you will need to temporarily stop using this medicine. Your doctor will tell you when it is safe to restart Fluvastatin.
  Taking Fluvastatin with fusidic acid may rarely lead to muscle weakness, tenderness or pain (rhabdomyolysis). See more information regarding rhabdomyolysis in section 4.

Fluvastatin can be taken on its own or with other cholesterol-lowering medicines prescribed by your doctor.

After intake of a resin, e.g. cholestyramine (primarily used to treat high cholesterol) wait at least 4 hours before taking Fluvastatin.

Tell your doctor and pharmacist if you are taking any of the following:

• Ciclosporin (a medicine used to suppress the immune system).
• Fibrates (e.g. gemfibrozil), nicotinic acid or bile acid sequestrants (medicines used to lower bad cholesterol levels).
• Fluconazole (a medicine used to treat fungal infections).
• Rifampicin (an antibiotic).
• Phenytoin (a medicine used to treat epilepsy).
• Oral anticoagulants like warfarin (medicines used to reduce blood clotting).
• Glibenclamide (a medicine used to treat diabetes).
• Colchicines (used to treat gout).

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Do not take Fluvastatin if you are pregnant or breast-feeding as the active ingredient may lead to harm to your unborn child, and it is not known whether the active ingredient is excreted in human breast milk.

Take adequate precautions against pregnancy while taking Fluvastatin. If you become pregnant while taking this medicine, stop taking Fluvastatin and see your doctor.

Your doctor will discuss with you the potential risk of taking Fluvastatin during pregnancy.

There is no information on the effects of Fluvastatin on your ability to drive and use machines.

This medicine contains less than 1mmol sodium (23mg) per tablet, that is to say essentially ‘sodium-free’.

Recommended doses in adults

• The dose range of Fluvastatin for adults is 20 to 80mg per day and depends on the extent of cholesterol lowering which needs to be achieved. Dose adjustments may be made by your doctor at 4-week or longer intervals.

Use in children and adolescents

• For children (aged 9 years and older) the usual starting dose is 20mg of Fluvastatin per day. The maximum daily dose is 80mg. Dose adjustments may be made by your doctor at 6-week intervals.

Your doctor will tell you exactly how much Fluvastatin to take.

Depending on how you respond to the treatment, your doctor may suggest a higher or lower dose.

If you are taking Fluvastatin tablets you can take your dose at any time of the day.

Fluvastatin can be taken with or without meals. Swallow whole with a glass of water.

If you have accidentally taken many tablets of Fluvastatin, talk to your doctor straight away. You may need medical attention.

Take one dose as soon as you remember. However, do not take it if there is less than 4 hours before your next dose. In this case take your next dose at the usual time.

Do not take a double dose to make up for a forgotten dose.

To maintain the benefits of your treatment, do not stop taking Fluvastatin unless your doctor tells you to. You must continue to take Fluvastatin as directed to keep the levels of your ‘bad’ cholesterol down. Fluvastatin will not cure your condition but it does help control it. Your cholesterol levels need to be checked regularly to monitor your progress.

• Sleep disturbances, including insomnia and nightmares.
• Memory loss.
• Sexual difficulties.
• Depression.
• Diabetes. This is more likely if you have high levels of sugars and fats in your blood, are overweight and have high blood pressure. Your doctor will monitor you while you are taking this medicine.
• Inflammation, swelling, and irritation of a tendon.

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme (Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store).

By reporting side effects you can help provide more information on the safety of this medicine.

The active substance is: fluvastatin sodium.

Each Fluvastatin tablet contains 84.2mg fluvastatin sodium equivalent to 80mg fluvastatin free acid.

The other ingredients of Fluvastatin are:

Tablet core: Carrageenan, Magnesium stearate.

Film-coating: Hydroxypropyl cellulose, Hypromellose 6cP, Iron oxide yellow (E172), Titanium dioxide (E171), Macrogol 8000, Iron oxide red (E172).

Fluvastatin tablets are dark yellow, round, biconvex tablets and are packed in Aluminium/Aluminium blisters strips.

Each pack of Fluvastatin contains 7 or 28 or 56 tablets.

Not all pack sizes may be marketed.

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