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Nandovar Xl 80mg Prolonged Release Tablets

Informations for option: Nandovar Xl 80mg Prolonged Release Tablets, show other option
Document: leaflet MAH BRAND 2_PL 00101-0587 change

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Package leaflet:

Information for the user

NANDOVAR XL 80 mg Prolonged Release Tablets

Fluvastatin

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

•    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 only. Do not pass it on to others. It may harm them, even if their signs of illness 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.

What is in this leaflet:

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

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

3.    How to take Nandovar XL

4.    Possible side effects

5.    How to store Nandovar XL

6.    Contents of the pack and other information

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

Nandovar XL 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.

•    Nandovar XL 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 Nandovar XL 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 Nandovar XL

Follow all the doctor’s instructions carefully. They may differ

from the general information contained in this leaflet.

Read the following explanations before you take Nandovar XL.

Do not take Nandovar XL

•    if you are allergic (hypersensitive) to fluvastatin or any of the other ingredients of Nandovar XL 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 Nandovar XL and tell

your doctor.

Warnings and precautions

Talk to your doctor or pharmacist before taking Nandovar XL.

•    if you previously had a liver disease. Liver function tests will normally be done before you start Nandovar 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 lipid-lowering medicine.

•    if you regularly drink large amounts of alcohol.

•    if you have a serious infection.

•    if you have very low blood pressure (signs may include dizziness, light-headedness).

•    if you have controlled or uncontrolled excessive muscle exercise.

•    if you are about to have an operation.

•    if you have severe metabolic, endocrine or electrolyte disorders such as decompensated diabetes and low blood potassium.

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 Nandovar XL:

•    if you have severe respiratory failure.

If any of these apply to you, tell your doctor before taking

Nandovar XL. Your doctor will take a blood test before prescribing Nandovar XL.

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 Nandovar XL, 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.

Nandovar XL 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.

Nandovar XL and children/adolescents

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

Other medicines and Nandovar XL

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines including medicines

obtained without a prescription.

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Nandovar XL 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 Nandovar XL. 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).

Nandovar XL with food and drink

You can take Nandovar XL with or without food.

Pregnancy and breast-feeding

Do not take Nandovar XL 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. If you are pregnant, consult your doctor or pharmacist before taking Nandovar XL. Take adequate precaution against pregnancy while taking Nandovar XL.

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

Your doctor will discuss with you the potential risk of taking Nandovar XL during pregnancy.

Driving and using machines

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

3. How to take Nandovar XL

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 Nandovar XL.

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How much Nandovar XL to take

•    The dose for adults is 80 mg per day. Dose adjustments may be made by your doctor at 4-week or longer intervals.

•    For children (aged 9 years and older) the maximum daily dose is 80 mg. Dose adjustments may be made by your doctor at 6-week intervals.

Your doctor will tell you exactly how many tablets of Nandovar XL to take. Depending on how you respond to the treatment, your doctor may suggest a higher or lower dose.

When to take Nandovar XL

You can take your Nandovar XL dose at any time of the day. Nandovar XL can be taken with or without meals. Swallow whole with a glass of water.

If you take more Nandovar XL than you should

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

If you forget to take Nandovar XL

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 Nandovar XL

To maintain the benefits of your treatment, do not stop taking Nandovar XL unless your doctor tells you to. You must continue to take Nandovar XL as directed to keep the levels of your ‘bad’ cholesterol down. Nandovar XL 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 product, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Nandovar XL 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 side 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.

Other side effects: tell your doctor if they worry you.

Common:

Difficulty in sleeping, headache, stomach discomfort, abdominal pain, nausea, abnormal blood test values for muscle and liver.

Very rare:

Tingling or numbness of the hands or feet, disturbed or decreased sensitivity.

Not known:

Impotence, muscle weakness that is constant.

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 may monitor you while you are taking this medicine.

•    Inflammation, swelling, and irritation of a tendon

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor.

Reporting of side effects

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 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 Nandovar XL

•    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 pack. The expiry date refers to the last day of that month.

•    Do not store Nandovar XL tablets above 30°C. Store in the original package in order to protect from moisture.

•    Do not use this medicine if you notice that the pack is damaged or shows signs of tampering.

•    Leave your Nandovar XL tablet in the blister pack until required for use, in order to protect from moisture.

•    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 Nandovar XL contains

•    The active substance is fluvastatin sodium

Each Nandovar XL 80 mg tablet contains 84.24 mg

fluvastatin sodium equivalent to 80 mg fluvastatin free acid. The other ingredients of Nandovar XL 80 mg tablets are: cellulose microcrystalline, hypromellose, hydroxypropyl cellulose, potassium hydrogen carbonate, povidone, magnesium stearate, macrogol 8000, iron oxide yellow (E172), titanium dioxide (E171).

What Nandovar XL looks like and contents of the pack

•    Nandovar 80 mg prolonged-release tablets are yellow, round, slightly biconvex with bevelled edges. They have the letters “LE” on one side and “NVR” on the other.

•    Bottles: The prolonged-release tablets are supplied in packs of 20 (samples not for sale or parts of hospital packs), 28, 30, 50, 98 or 100 (2 x 50 or 1 x 100) tablets and in hospital packs of 300 (15 x 20) or 600 (30 x 20) tablets.

•    Blisters: The prolonged-release tablets are supplied in packs of 7, 14, 28 (4 x 7 or 2 x 14), 28 (in a perforated unit dose blister), 30, 42, 49 (7 x 7), 56 (8 x 7), 70, 84, 90 or 98 (14 x 7 or 7 x 14) tablets and in hospital packs of 28, 56, 98 or 490 tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

The Marketing Authorisation Holder is:

Novartis Pharmaceuticals UK Limited

Trading as:

Sandoz Pharmaceuticals, Frimley Business Park, Frimley, Camberley, Surrey, GU16 7SR,United Kingdom.

Nandovar XL tablets are distributed by:

Sandoz Ltd, Frimley Business Park, Frimley, Camberley, Surrey, GU16 7SR, United Kingdom.

Nandovar XL tablets are released onto the market by:

Novartis Pharmaceuticals UK Limited, Frimley Business Park, Frimley, Camberley, Surrey, GU16 7SR, United Kingdom If you would like any more information, or would like this leaflet in a different format, please contact Medical Information at Novartis Pharmaceuticals UK Ltd, telephone number 01276 698370.

This leaflet was last revised in 04/2015.

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