The text only version may be available in large print, Braille or audio CD. For further information call emc accessibility on 0800 198 5000. The product code(s) for this leaflet is: PL35533/0151 .
Fluvastatin 80mg prolonged release tablets
Fluvastatin 80mg prolonged release tablets
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
Fluvastatin contains the active substance fluvastatin sodium which belongs to a group of medicines known as statins, which are lipid-lowering medicines: they lower the fat (lipids) in your blood. They are used in patients whose conditions cannot be controlled by diet and exercise alone.
If any of these apply to you, do not take Fluvastatin and tell your doctor.
Talk to your doctor or pharmacist before taking Fluvastatin
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 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.
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:
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’.
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. Do not exceed the recommended dose.
Your doctor will recommend you to follow a low-cholesterol diet. Stay on this diet while taking Fluvastatin.
Recommended doses in adults
Use in children and adolescents
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.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Some rare (may affect up to 1 in 1,000 people) or very rare (may affect up to 1 in 10,000 people) side effects could be serious: get medical help immediately.
If you experience any of these, tell your doctor straight away.
Other side effects: tell your doctor if they worry you.
Common (may affect up to 1 in 10 people):
Difficulty in sleeping, headache, stomach discomfort, abdominal pain, nausea. Abnormal blood test values for muscle and liver.
Very rare (may affect up to 1 in 10,000 people):
Tingling or numbness of the hands or feet, disturbed or decreased sensitivity.
Not known (frequency cannot be estimated from the available data):
Impotence, muscle weakness that is constant, breathing problems including persistent cough and/or shortness of breath or fever, diarrhoea, myasthenia gravis (a disease causing general muscle weakness including in some cases muscles used when breathing), ocular myasthenia (a disease causing eye muscle weakness).
Talk to your doctor if you experience weakness in your arms or legs that worsens after periods of activity, double vision or drooping of your eyelids, difficulty swallowing, or shortness of breath.
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.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton and blister after “EXP”. The expiry date refers to the last day of that month.
Do not store above 30°C.
Store in the original package in order to protect from moisture.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.
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.
Marketing Authorisation Holder
Date of last revision: 03/2023