Fluvastatin 20mg and 40mg capsules
Read all of this leaflet carefully before you start taking this medicine
- Keep this leaflet. You may need to read it again.
- If you have any further questions, please ask your doctor or pharmacist.
- Fluvastatin capsules has been prescribed for you. Do not pass Fluvastatin on to others. It may harm them, even if
their symptoms are the same as yours. - If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please inform your doctor or pharmacist.
In this leaflet:
- 1. What Fluvastatin is and what it is used for
- 2. Before you take
- 3. How to take
- 4. Possible side effects
- 5. How to store
- 6. Further information
What Fluvastatin Is And What It Is Used For
Fluvastatin belongs to a group of medicines that lowers the levels of cholesterol and triglycerides in the blood. Cholesterol and triglycerides are fats (lipids) in the blood, which in high concentrations can damage the blood vessels.
The fats are deposited on the walls of the blood vessels narrowing the vessels and making them less elastic (coronary arteriosclerosis). This increases the risk of heart-attacks and strokes.
Fluvastatin is used when a dietetic treatment only is insufficient for lowering the level of cholesterol in the blood.
Fluvastatin is used in patients with coronary arteriosclerosis and too high level of cholesterol in the blood to prevent
further serious cardiac events (e.g. heart attack), after heart catheterization (intervention to widen the vessels of the
heart).
Before You Take
Do not take Fluvastatin if you
- are hypersensitive (allergic) to fluvastatin or any of the other ingredients.
- have current liver problems or persistent and unexpected changes in liver test
- are pregnant
- are breast feeding
Take special care with Fluvastatin if you
- have a history of liver disease. Liver function tests will normally be done before starting Fluvastain, when the dose is increased and at various intervals during treatment to check for undesirable effects.
- have severe respiratory failure.
- suffer from kidney disease.
- suffer from thyroid disease.
- or your family have a medical history of muscle diseases.
- are older than 70 years your doctor may want to clarify whether you are at risk from muscular diseases.
- have experienced muscular problems with a lipid lowering medicine before.
- regularly consume large amounts of alcohol.
If any of the above applies to you, tell your doctor before taking Fluvastatin.
Under any of these circumstances your doctor will take a blood sample from you for an analysis before prescribing Fluvastatin.
If you experience muscular soreness, muscular weakness, muscular cramps or muscle tenderness especially if followed
by fever and discomfort (these symptoms may occur without any reason and may occur after heavy exercise), you must contact your doctor immediately.
The effect of fluvastatin is expected to be low when you suffer from a rare condition known as homozygous familial
hypercholesterolaemia. Therefore, use of fluvastatin is not recommended.
Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines
obtained without a prescription.
Tell your doctor if you are also taking:
- Ciclosporin (a medicine used to suppress the immune system), fluconazole (medicine used to treat fungal infections), or colchicine (a medicine used to treat gout), the combination may result in an increased risk of developing
muscle problems. - Fibrates (e.g. gemfibrozil, bezafibrate, ciprofibrate), or nicotinic acid (niacin) (medicines used to lower cholesterol levels), the combination may result in an increased risk of developing muscle problems.
- Resins used to lower your cholesterol (e.g. colestyramine), the combination may reduce the effects of Fluvastatin (see also section 3).
- Rifampicin (an antibiotic), the combination may reduce the effects of Fluvastatin.
- Phenytoin (a medicine used to treat epilepsy), the combination may result in an increased amount of phenytoin in the blood which may cause side effects.
- Medicines used to reduce blood clotting, such as warfarin; the combination may increase the effects of warfarin and cause bleeding.
- Glibenclamide and tolbutamide (medicines used to treat diabetes); if your doctor thinks the combination is necessary you should be aware that it may increase the amount of glibenclamide and tolbutamide, respectively, in the bloodstream, which in turn may lead to an increased risk of low blood sugar (hypoglycaemia).
Taking Fluvastatin with food and drink
You can take Fluvastatin with or without food but with a large glass of water. Before treatment with Fluvastatin you should start a cholesterol lowering diet, which should be continued during treatment with this medicine.
Pregnancy and breast feeding
Ask your doctor or pharmacist for advice before taking any medicine.
Do not take Fluvastatin if you are pregnant, if you think you may be pregnant, or if you are trying to become pregnant.
Women of child-bearing age must use effective birth control.
Do not take Fluvastatin if you are breast-feeding.
Driving and using machines
Use of Fluvastatin has no influence on your ability to drive or cycle or your ability to use machinery.
How To Take
Always take Fluvastatin exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
Before treatment with Fluvastatin you should start a cholesterol lowering diet, which should be continued during
treatment with this medicine.
Dose to lower elevated cholesterol and triglyceride levels
Adults:
The recommended starting dose is 40mg or in mild cases 20mg taken once a day in the evening.
If necessary your doctor will prescribe a dose of 80mg daily corresponding to Fluvastatin 40mg capsule twice a day, which
is also the maximum dose.
Dose after widening the vessels of the heart by surgical intervention with a cardiac catheter
In this case the recommended dose is 80 mg daily corresponding to 1 capsule Fluvastatin 40mg twice a day.
How to take Fluvastatin
Swallow the capsules whole with a large glass of water.
Duration of treatment
Maximum effect will show within 4 weeks after starting treatment and is maintained by taking Fluvastatin continuously.
Adjust the dose only after advice from your doctor.
Elderly
Same dose as for adults.
Children and young people
As there is no experience with the use of fluvastatin in individuals less than 18 years of age, do not use Fluvastatin in
this group.
Reduced kidney function
Dose adjustment is not necessary in patients with mild to moderate reduction in kidney function.
Reduced liver function
Do not use Fluvastatin if you have liver problems. Ask your doctor.
If you take more Fluvastatin than you should
If you accidentally have taken too much of your medicine, tell your doctor immediately or go to the nearest casualty
department.
There is no information available concerning symptoms of an overdose.
If you forget to take Fluvastatin
If you forget to take a dose, take one as soon as you remember, unless it is almost time for you to take your next dose. Then go on as before. Do not ever double the dose.
If you stop taking Fluvastatin
To maintain the benefits of your treatment, you should not stop taking Fluvastatin without asking your doctor first.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
Possible Side Effects
Like all medicines, Fluvastatin may cause side effects, although not everybody gets them.
Serious side effects:
The following are all serious side effects. You may need urgent medical attention if you have any of them.
Frequency unknown
- If you suffer from depression
- If you have breathing problems including persistent cough and/or shortness of breath or fever.
Rare (affecting less than 1 in 1000 patients) or very rare (affecting less than 1 in 10,000 patients).
- If you have unexplained muscle pain, tenderness or weakness, and particularly, if at the same time, you feel unwell or have fever. These might be early signs of a potentially severe muscle degradation which can be avoided if your doctor stops your treatment with fluvastatin as quickly as possible. These side effects have also been found with similar drugs of this class (statins).
- If you have unusual tiredness or fever, yellowing of the skin and eyes, dark coloured urine (signs of hepatitis).
- If you have signs of skin reactions such as skin rash, hives, redness, itching, swelling of the face, eyelids, and lips.
- If you bleed or bruise more easily than normal (signs of decreased number of platelets).
- If you have red or purple skin lesions (signs of blood vessel inflammation).
- If you have red blotchy rash mainly on the face which may be accompanied by fatigue, fever, joint pain, muscle pain (signs of lupus erythematosus-like reaction).
- If you have severe upper stomach pain (signs of inflamed pancreas).
If you experience any of these, tell your doctor straight away.
Other side effects:
Common (affecting less than 1 in 10 patients): Difficulty in sleeping including sleeplessness and nightmares, headache, fatigue, dizziness, stomach discomfort, abdominal pain, constipation, flatulence, diarrhoea, nausea, joint pain, blood tests which show changes in the way the liver is working.
Very rare (affecting less than 1 in 10000 patients): Tingling or numbness of the hands or feet, disturbed or decreased sensations.
Frequency unknown: Memory loss, sexual difficulties.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
How To Store
Keep out of the reach and sight of children.
Do not store above 25oC. Store in original container in order to protect from moisture and light.
Do not use Fluvastatin after the expiry date, which is stated on the blister, bottle and carton (after EXP). The expiry date refers to the last day of that month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
Further Information
Fluvastatin capsules contain:
The active substance is fluvastatin. Each capsule contains 20mg or 40mg fluvastatin (as fluvastatin sodium).
The other ingredients are mannitol, talc, magnesium stearate.
20mg:
Capsule body: Gelatin, titanium dioxide (E171), yellow iron oxide (E 172), red iron oxide (E 172).
Capsule cap: Gelatin, titanium dioxide (E 171), red iron oxide (E 172).
Ink:
White ink on capsule cap: Titanium dioxide (E171), Shellac, Soya lecithin, Antifoam DC 1510
Brown ink on capsule body: Shellac, Iron oxide, red (E172), Iron oxide, black (E172), Titanium dioxide (E171), Propylene glycol
40mg:
Capsule body: Gelatin, titanium dioxide (E171), yellow iron oxide (E 172).
Capsule cap: Gelatin, titanium dioxide (E 171), red iron oxide (E 172).
Ink
White ink on capsule cap: Titanium dioxide (E171), Shellac, Soya lecithin, Antifoam DC 1510
Brown ink on capsule body: Shellac, Iron oxide, red (E172), Iron oxide, black (E172), Titanium dioxide, (E171), Propylene glycol
What Fluvastatin looks like and contents of the pack
20mg:
Capsule cap: orange, opaque marked with white imprint ”20”
Capsule body: ivory, opaque marked with brown imprint ”FST”
40mg:
Capsule cap: orange, opaque marked with white imprint ”40”
Capsule body: yellow, opaque marked with brown imprint ”FST”
Blister packs.
HDPE container with desiccant (silica gel), closed with a sealed plastic cap.
Pack sizes:
Blister packs: 10, 14, 20, 28, 30, 50, 56, 60, 98 and 100 capsules
HDPE bottle with desiccant and plastic cap: 28, 30, 56 and 60 capsules
Not all pack sizes may be marketed
Marketing Authorisation Holder
Manufacturer
This leaflet was last revised in March 2009
If you would like a leaflet with larger text, please contact 01271 311257.
ACTPL075
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