Fluvastatin 40 Mg Capsules
PACKAGE LEAFLET INFORMATION FOR THE USER
FLUVASTATIN 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, ask your doctor or pharmacist.
• This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms 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.
• Fluvastatin 40mg Capsules hereinafter referred to as Fluvastatin.
IN THIS LEAFLET
1. What Fluvastatin is and what it is used for
2. What you need to know 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
1 WHAT FLUVASTATIN IS AND WHAT IT IS USED FOR
Fluvastatin contains the active 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.
Fluvastatin is a medicine used
• to treat raised levels of fats in the blood in adults, in particular total cholesterol and so called "bad" or LDL cholesterol, which is associated with an increased risk of heart disease and stroke
• in adult patients with high blood levels of cholesterol
• in adult patients with high blood levels of both cholesterol and triglycerides (another sort of blood lipid).
Your doctor can also prescribe Fluvastatin to prevent further serious cardiac events (e.g. heart attack) in patients after they already went through a heart catheterisation, with an intervention in the heart vessel.
2 WHAT YOU NEED TO KNOW BEFORE YOU TAKE FLUVASTATIN
Follow all instructions given to you by your doctor carefully. They may differ from the information contained in this leaflet. Read the following explanations before you take Fluvastatin.
Do NOT take Fluvastatin:
• if you are allergic (hypersensitive) to fluvastatin or to any of the other ingredients of Fluvastatin listed in section 6 of this leaflet
• if you currently have liver problems, or if you have unexplained, persistently high levels 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.
Warnings and precautions
Talk to your doctor or pharmacist before taking fluvastatin:
• 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 lipidlowering medicine
• if you regularly drink large amounts of alcohol
• if you have severe respiratory failure
• 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.
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.
Children/adolescents
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.
Other medicines and fluvastatin
Tell your doctor or pharmacist if you are taking, have
recently taken or might take any other medicines.
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).
Taking Fluvastatin with food and drink You can take Fluvastatin with or without food. Pregnancy and breast-feeding
Please ask your doctor or pharmacist for advice before taking any medicine.
Do not take Fluvastatin if you are pregnant or breastfeeding 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. If you are pregnant, consult your doctor or pharmacist before taking Fluvastatin. Use reliable contraception for the whole time that you are taking Fluvastatin. If you become pregnant whilst taking this medicine, stop taking Fluvastatin and see your doctor.
Driving and using machines
There is no information on the effects of Fluvastatin on
your ability to drive and use machines.
Fluvastatin contains lactose
This medicinal product contains a small amount of lactose which is a sugar: if you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
3 HOW TO TAKE FLUVASTATIN
Always take Fluvastatin exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
Adults
Follow your doctor's instructions carefully. Do not exceed the recommended dose.Your doctor will recommend you to follow a low-cholesterol diet. Stay on this diet while taking Fluvastatin.
(continued overleaf)
|
WIP URN |
y |
130415-PIL-GF10-08 |
|
APPROVED URN |
N/A | |
|
Job |
Fluvastatin 40mg PIL - Side 1 | |
|
Size |
340 x 160mm | |
|
Date |
13 April 2015 | |
|
BOH Approval Date | ||
|
Saved as |
14057/08 40mg PIL S1.ai M1 | |
|
Prints |
1 Colour - Black |
How much Fluvastatin to take
The dose range 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.
For children (aged 9 years and older)
The usual starting dose is 20mg 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 many capsules or tablets of Fluvastatin to take. Depending on how you respond to the treatment, your doctor may suggest a higher or lower dose.
When to take Fluvastatin If you are taking Fluvastatin once per day, take your dose in the evening or at bedtime. If you are taking Fluvastatin twice per day, take one capsule in the morning and one in the evening or at bedtime. Fluvastatin can be taken with or without meals.
Swallow whole with a glass of water.
If you take more Fluvastatin than you should If you have accidentally taken too many Fluvastatin, talk to your doctor straight away. You may need medical attention.
If you forget to take Fluvastatin 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 the one that you missed.
If you stop taking Fluvastatin
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 regulatory to monitor your progress.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4 POSSIBLE SIDE EFFECTS
Like all medicines, Fluvastatin can cause side effects, although not everybody gets them.
If you get any of the following, stop taking fluvastatin and go to your doctor or to the nearest hospital straight away:
• if you have unexplained muscle pain, tenderness or weakness. These might be early signs of a potentially severe muscle degradation called rhabdomyolysis. This can be avoided if your doctor stops your treatment with fluvastatin as quickly as possible. These side effects have also been found with similar medicines of this class (statins). This side effect is very rare (may affect up to 1 in 10,000 people)
• if you have unusual tiredness or fever, yellowing of the skin and eyes, dark-coloured urine (signs
of hepatitis). This side effect is very rare (may effect up to 1 in 10,000 people)
• if you have signs of skin reactions such as skin rash, hives, redness, itching, swelling of the face, eyelids, and lips. This side effect is rare (may affect up to 1 in 1,000 people)
• if you have skin swelling, difficulty in breathing, dizziness (signs of severe allergic reaction called anaphylactic reaction). This side effect is very rare (may affect up to 1 in 10,000 people)
• if you bleed or bruise more easily than normal (signs of decreased number of blood platelets thrombocytopenia). This side effect is very rare (may affect up to 1 in 10,000 people)
• if you have red or purple skin lesions (signs of blood vessel inflammation - vasculitis). This side effect is very rare (may affect up to 1 in 10,000 people)
• if you have a red blotchy rash mainly on the face which may be accompanied by fatigue, fever, nausea, loss of appetite (signs of lupus erythematous-like reaction). This side effect is very rare (may affect up to 1 in 10,000 people)
• If you have severe upper stomach pain (signs of an inflamed pancreas - pancreatitis). This side effect is very rare (may affect up to 1 in 10,000 people).
Other side effects:
Common (may affect up to 1 in 10 people):
Difficulty in sleeping, headache, stomach discomfort, abdominal pain, nausea.
Very rare (may affect up to 1 in 10,000 people):
Tingling or numbness of the hands or feet, disturbed or decreased sensitivity.
Other possible side effects:
• Sleep disturbances, including insomnia and nightmares
• Memory loss
• Sexual difficulties
• Depression
• Breathing problems including persistent cough and/or shortness of breath or fever
• 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.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at www.mhra.gov.uk/yellowcard. By reporting side effects, you can help provide more information on the safety of this medicine.
5 HOW TO STORE FLUVASTATIN
Keep out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the blister and carton. The expiry date refers to the last day of the month.
Do not store above 30 C.
If you notice any signs of deterioration of this product, please tell your pharmacist.
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.
6 CONTENTS OF THE PACK AND OTHER INFORMATION
What Fluvastatin contains
The active ingredient is fluvastatin sodium.
One 40mg capsule contains 40mg fluvastatin (as fluvastatin sodium).
The other ingredients are lactose monohydrate, colloidal anhydrous silica, crospovidone, magnesium stearate, red iron oxide (E172), yellow iron oxide (E172), black iron oxide (E172), titanium dioxide (E171), gelatin, shellac and propylene glycol.
What Fluvastatin looks like and contents of the pack
Fluvastatin 40mg Capsules have a yellow opaque body and pink opaque cap marked 93 7443.
Blister pack of 30 capsules.
The capsule should be pushed out carefully from the blister as shown by the picture, in order to avoid damaging the capsule.
Procured from within the EU,
PL holder: Manx Pharma Ltd, Taylor Group House, Wedgnock Lane, Warwick, CV34 5YA, UK.
PL 15833/0034
Fluvastatin is manufactured by Pharmachemie BV, Swensweg 5, Postbus 552, 2003 RN, Harlem,
The Netherlands.
To request a copy of this leaflet in large print, audio or Braille please call 01926 482511.
This leaflet was revised in April 2015 lPOM
WIP URN: 130415-PIL-GF10-PIL-08
|
WIP URN |
>/ |
130415-PIL-GF10-08 |
|
APPROVED URN |
N/A | |
|
Job |
Fluvastatin 40mg PIL - Side 2 | |
|
Size |
340 x 160mm | |
|
Date |
13 April 2015 | |
|
BOH Approval Date | ||
|
Saved as |
14057/08 40mg PIL S2.ai M1 | |
|
Prints |
1 Colour - Black |