Package leaflet: Information for the user Mithestan 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. See section 4.

What is in this leaflet

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

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

3.    How to take Mithestan XL

4.    Possible side effects

5.    How to store Mithestan XL

6.    Contents of the pack and other information

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

Mithestan XL contains the active substance 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.

Mithestan 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 Mithestan 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 Mithestan XL

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 Mithestan XL.

Do not take Mithestan XL

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

-    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 “pregnany and breast-feeding”).

If any of these apply to you, do not take Mithestan XL and tell your doctor.

Warnings and precautions

Talk to your doctor or pharmacist before taking Mithestan XL if you are taking fusidic acid (medicine to treat bacterial infections). Taking Fluvastatin with fusidic acid can increase the risk of muscle problems (see section 4).

Talk to your doctor or pharmacist before taking Mithestan XL name

-    if you previously had a liver disease. Liver function tests will normally be done before you start Mithestan XL, when your dose is increased and at various intervals during treatment to check for side effects.

-    if you are taking or have taken in the last 7 days a medicine called fusidic acid (a medicine for bacterial infection) orally or by injection. The combination of fusidic acid and Mithestan XL can lead to serious muscle problems (rhabdomyolysis).

-    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.

Check with your doctor or pharmacist before taking Mithestan XL

-    if you have severe respiratory failure

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.

If any of these apply to you, tell your doctor before you take Mithestan XL. Your doctor will take a blood test before prescribing Mithestan 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.

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

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

Other medicines and Mithestan XL

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

If you need to take oral fusidic acid to treat a bacterial infection you will need to temporarily stop using this medicine. Your doctor will tell you when it is safe to restart Mithestan XL. Taking Mithestan XL with fusidic acid may rarely lead to muscle weakness, tenderness or pain (rhabdomyolysis). See more information regarding rhabdomyolysis in section 4.

Mithestan 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 Mithestan XL.

Tell your doctor and pharmacist if you are taking any of the following:

-    Fusidic acid (a medicine used to treat bacterial infections). Do not take Mithestan XL while taking fusidic acid or within 7 days after you have taken fusidic acid.

-    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).

-    Phenprocoumon or Warfarin (medicines used to reduce blood clotting).

-    Glibenclamide (a medicine used to treat diabetes).

-    Colchicine (used to treat gout).

Mithestan XL with food and drink

You can take Mithestan XL with or without food.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

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

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

Driving and using machines

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

3. How to take Mithestan XL

Always take this medicine exactly as your doctor 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 Mithestan XL.

How much fluvastatin to take

-    The dose range for adults is 20 to 80 mg 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 20 mg per day. 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 much fluvastatin to take.

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

dose.

For lower dosages other dosage forms are available.

When to take Mithestan XL

You can take Mithestan XL at any time of the day.

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

If you take more Mithestan XL than you should

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

If you forget to take Mithestan 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 a forgotten dose.

If you stop taking Mithestan XL

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

4. Possible side effects

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

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.

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.

Not known:

Muscle weakness that is constant.

Other possible side effects:

-    Sleep disturbances,    including    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 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 Mithestan XL:

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

Do not store above 30°C.

Store in the original package in order to protect from moisture.

Do not use this medicine after the expiry date which is stated on the carton and blister after EXP.

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 Mithestan XL contains:

-    The active substance is: fluvastatin. Each tablet contains 80 mg of fluvastatin as fluvastatin sodium.

-    The other ingredients are:

Tablet core: Carageenan, Magnesium stearate

Film-coating: Hydroxypropyl cellulose, Hypromellose 6cP, Iron oxide yellow, Titanium dioxide, Macrogol 8000, Iron oxide red

What Mithestan XL looks like and contents of the pack

Mithestan XL are dark yellow, round, biconvex tablets and are packed in Aluminium/Aluminium blisters strips.

Each pack of Mithestan XL contains 10, 20, 30, 50 or 100 tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

ratiopharm GmbH, Graf-Arco-Str.3, 89079 Ulm, Germany

Manufacturer: Pharmathen S.A., 6 Dervenakion str, 153 51 Pallini, Attiki, Greece

Or

Merckle GmbH, Ludwig-Merckle-Strasse 3, 89143 Blaubeuren, Germany This leaflet was last revised in September 2015 PL 15773/0896