Luvinsta XL 80mg Prolonged-Release Tablets
Fluvastatin
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.
Luvinsta XL has been prescribed for you. Do not pass Luvinsta XL 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 Luvinsta XL is and what it is used for
2. Before you take Luvinsta XL
3. How to take Luvinsta XL
4. Possible side effects
5. How to store Luvinsta XL
6. Further information
What Luvinsta Xl Is And What It Is Used For
Effect
Luvinsta XL is one of a group of drugs called statins, which are cholesterol regulating drugs.
Use
Your doctor has prescribed Luvinsta XL to reduce your cholesterol, and recommended changes in your life style and diet. High levels of cholesterol in the blood are linked to an increased risk of heart disease and stroke.
Luvinsta XL has also been shown to prevent heart attacks in patients who had recently had catheter treatment for narrowed coronary arteries.
Before You Take Luvinsta Xl
Before taking this medicine, you should have started a standard cholesterol-lowering diet. Continue with this diet while taking Luvinsta XL.
Follow carefully all instructions given to you by your doctor. They may be different from the information contained in this leaflet.
Read the following explanations before you take Luvinsta XL:
Do not take Luvinsta XL:
- if you are hypersensitive (allergic) to fluvastatin or any of the other ingredients(see section 6).
- if you have an active liver disease, or yellowing of the skin or whites of the eyes caused by liver problems
or unexplained, continually high liver function values (transaminases) - if you are pregnant
- if you are breast feeding
If you think you may be allergic, ask your doctor for advice.
Take special care with Luvinsta XL
- If you have a history of liver disease. Liver function tests will normally be done before starting Luvinsta XL, when the dose is increased and at various intervals during treatment to check for undesirable effects.
- If you have severe respiratory failure.
- If you suffer from kidney disease.
- If you suffer from thyroid disease.
- If you or your family have a medical history of muscle diseases.
- If you are older than 70 years your doctor may want to clarify whether you are at risk from muscular diseases.
- If you have experienced muscular problems with a lipid lowering medicine before.
- If you regularly consume large amounts of alcohol.
If any of the above applies to you, tell your doctor before taking Luvinsta XL.
Under any of these circumstances your doctor will take a blood sample from you for an analysis before prescribing Luvinsta XL.
Luvinsta XL has been used for adolescents and children over 9 years of age with a certain type of inherent elevation of blood cholesterol but the experience is limited.
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 and pharmacist if you are taking any of the following:
- 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. cholestyramine), the combination may reduce the effects of Luvinsta XL (see also section 3).
- Rifampicin (an antibiotic), the combination may reduce the effects of Luvinsta XL.
- 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 Luvinsta XL with food and drink
You should avoid drinking alcohol when you are treated with Luvinsta XL
Pregnancy and breast feeding
Please ask your doctor or pharmacist for advice before taking any medicine.
Do not take Luvinsta XL 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 Luvinsta XL if you are breast-feeding.
Driving and using machines
Luvinsta XL may cause dizziness and tiredness that can affect the ability to drive and use machines.
How To Take Luvinsta Xl
Always take Luvinsta XL exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
Before treatment with Luvinsta XL you should start a cholesterol lowering diet, which should be continued during treatment with this medicine.
You can take Luvinsta XL with or without food and drink.
Swallow the tablets whole with a glass of water.
Adults
Dose to lower elevated cholesterol and triglyceride levels:
Luvinsta XL 80mg Prolonged-Release Tablets are not suitable for starting a treatment! Do not break the tablets. If a suitable dose cannot be achieved with Luvinsta XL 80mg Prolonged-Release Tablets, other tablet strengths/ pharmaceutical forms containing fluvastatin are available.
The dose will be decided by your doctor. Take Luvinsta XL exactly as your doctor has told you.
Dose after widening the vessels of the heart by surgical intervention with a cardiac catheter:
Recommended dose is 80 mg fluvastatin once a day (corresponding to 1 Luvinsta XL 80mg Prolonged-Release Tablet).
Duration of treatment
Maximum effect will show within 4 weeks after starting treatment and is maintained by taking Luvinsta XL continuously. Seek advice from your doctor if you need to change your dose.
Elderly
No changes to the recommended dose of 80 mg Fluvastatin daily are needed for elderly patients.
Children and young people
Dose to lower elevated cholesterol and triglyceride levels in heterozygous familial hypercholesterolemia
The recommended starting dose is 40 mg fluvastatin (1 capsule 40 mg once daily) or 80 mg fluvastatin (1 Luvinsta XL 80 mg once daily or 1 capsule 40 mg twice daily). In mild cases a dose of 20mg of fluvastatin may be prescribed. The dose will be decided by your doctor. Take Luvinsta XL exactly as your doctor has told you.
Reduced kidney function
No changes to the recommended dose of 80 mg Fluvastatin daily are needed for patients with kidney problems.
Reduced liver function
Seek advice from your doctor if you have severe liver problems. Fluvastatin should not be used in this condition.
If you take more Luvinsta XL than you should
If you accidentally have taken too much of your medicine, tell your doctor immediately or go to your nearest casualty
department.
No information available concerning symptoms of an overdose.
If you forget to take Luvinsta XL
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 Luvinsta XL
To maintain the benefits of your treatment, you should not stop taking Luvinsta XL 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, Luvinsta XL 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 Luvinsta Xl
Keep out of the reach and sight of children.
Keep the blisters in the outer carton in order to protect from light.
Do not store above 30°C.
Do not use Luvinsta XL after the expiry date, which is stated on the blister and carton, respectively, after EXP. The
expiry date refers to the last day of a month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose medicines no longer required. These measures will help to protect the environment.
Further Information
What Luvinsta XL contains:
- The active substance is: Fluvastatin. Each prolonged release tablet contains 80 mg fluvastatin (as fluvastatin
sodium). - The other ingredients are:
Tablet core:
Povidone, microcrystalline cellulose, hydroxyethyl cellulose, mannitol, magnesium stearate
Film-coating:
Hypromellose 50, macrogol 6000, iron oxide yellow (E172), titanium dioxide (E171).
What Luvinsta XL looks like and contents of the pack
Luvinsta XL 80mg Prolonged-Release Tablets are yellow, round, biconvex prolonged release tablets.
Pack sizes:
10, 20, 28, 30, 50, 60, 98 and 100 prolonged release tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Manufacturers:
This leaflet was last approved in July 2010
If you would like a leaflet with larger text, please contact 01271 311257.
L19299ACT-30
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