Informations for option: Luvinsta Xl 80 Mg Prolonged-Release Tablets, show other option

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1. Luvinsta Xl 80 Mg Prolonged-Release Tablets
2. Luvinsta Xl 80 Mg Prolonged-Release Tablets

What is in this leaflet:

1.    What Luvinsta XL is and what it is used for

2.    What you need to know before you take Luvinsta XL

3.    How to take Luvinsta XL

4.    Possible side effects

5.    How to store Luvinsta XL

6.    Contents of the pack and other information

1.    What Luvinsta is and what it is used for

Luvinsta contains the active fluvastatin (as 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.

•    Luvinsta 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 Luvinsta 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 Luvinsta XL

Follow all instructions given to you by your doctor carefully. They may be differ from the information contained in this leaflet.

Read the following explanations before you take Luvinsta XL:

Do not take Luvinsta XL:

•    if you are allergic to fluvastatin or any of the other ingredients of this medicine (listed in section 6 of this leaflet).

•    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 Luvinsta and tell your doctor.

Warnings and precautions

Talk to your doctor or pharmacist before taking Luvinsta XL

•    If you previously had a liver disease. Liver function tests will normally be done before you start Luvinsta XL, 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 any of these apply to you, tell your doctor before you take Luvinsta XL.Your doctor will take a blood test before prescribing Luvinsta XL.

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.

Luvinsta and people over 70 years

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.

Children and adolescents

Luvinsta 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 Luvinsta in combination with nicotinic acid, cholestyramine or fibrates in children and adolescents.

Other medicines and Luvinsta

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. Luvinsta 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 Luvinsta.

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).

Luvinsta XL with food and drink

You can take Luvinsta with or without food.

Pregnancy and breast feeding

Do not take Luvinsta 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 Luvinsta. Use reliable contraception for the whole time that you are taking Luvinsta.

If you become pregnant while taking this medicine, stop taking Luvinsta and see your doctor.

Driving and using machines

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

3.    How to take Luvinsta XL

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 Luvinsta.

How much Luvinsta 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 much of Luvinsta to take.

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

Luvinsta is only available as 80mg prolonged-release tablets. For lower doses (20mg and 40mg), your doctor will prescribe other fluvastatin medicines.

When to take Luvinsta

You can take Luvinsta 80mg prolonged-release tablets at any time of the day.

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

If you take more Luvinsta XL than you should

If you have accidentally taken too much Luvinsta, talk to your doctor straight away. You may need medical attention.

If you forget to take Luvinsta XL

Take one 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 Luvinsta XL

To maintain the benefits of your treatment, do not stop taking Luvinsta unless your doctor tells you to.

You must continue to take Luvinsta as directed to keep the levels of your 'bad' cholesterol down. Luvinsta 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

4.    Possible side effects

Like all medicines, Luvinsta can cause side effects, although not everybody gets them.

Very common: affects more than 1 user in 10

Common: affects 1 to 10 users in 100

Uncommon: affects 1 to 10 users in 1,000

Rare: affects 1 to 10 users in 10,000

Very rare: affects less than 1 user in 10,000

Not known: frequency cannot be estimated from the

available data.

Some rare or very rare effects could be serious: get medical help immediately.

•    if you have unexplained muscle pain, tenderness or weakness. These might be early signs of a potentially severe muscle degradation. 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).

•    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 have skin swelling, difficulty in breathing, dizziness (signs of severe allergic reaction).

•    if you bleed or bruise more easily than normal (signs of decreased number of blood 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, nausea, loss of appetite (signs of lupus erythematous-like reaction).

•    if you have severe upper stomach pain (signs of inflamed pancreas).

If you experience any of these, tell your doctor straight away.

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Other side effects: tell your doctor if they worry you. Common: Difficulty in sleeping, headache, stomach discomfort, abdominal pain, nausea.

Very rare: Tingling or numbness of the hands or feet, disturbed or decreased sensibility.

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.

If you get any side effects, talk to your doctor or pharmacist. This includes any side effects not listed in this leaflet.

5.    How to store Luvinsta XL

Keep this medicine out of the reach and sight of children.

Do not store above 30 °C.

Blisters: Keep the blisters in the outer carton in order to protect from light.

Do not use this medicine after the expiry date, which is stated on the blister and carton, after EXP. The expiry date refers to the last day of that month.

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 protect the environment.

6.    Contents of the pack and other information

What Luvinsta XL contains:

•    The active substance is: Fluvastatin sodium.

Each prolonged-release tablet contains 84.48mg fluvastatin sodium equivalent to 80mg fluvastatin free acid.

•    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 are yellow, round, biconvex prolonged release tablets.

Pack sizes:

Blister (OPA/Alu/PVC-Alu): 10, 20, 28, 30, 50, 60, 98 and 100 prolonged release tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Actavis Group PTC ehf.

Reykjavikurvegur 76-78,

220 Hafnarfjordur,

Iceland

Manufacturers:

Actavis hf.

Reykjavikurvegi 78,

P.O. Box 420,

220 Hafnarfjordur,

Iceland

Actavis Ltd.

BLB016, Bulebel Industrial Estate,

Zejtun ZTN 3000,

Malta

This leaflet was last revised in April 2012

If you would like a leaflet with larger text, please contact 01271 311257.

Actavis, Barnstaple, EX32 8NS, UK