Vastatifix 10 mg, filmomhulde tabletten

Pravastatin, the active substance of Vastatifix, belongs to a group of medicines called statins which work by reducing high cholesterol levels in the blood. Cholesterol is a fatty substance (lipid) that can cause the narrowing of the heart muscle blood vessels (coronary heart disease).

Vastatifix is used

1. to lower a high cholesterol level in the blood when there is no sufficient response to diet, more exercise, weight reduction etcetera.
2. if you are at risk of narrowing of the blood vessels in your heart caused by too much cholesterol in your blood, as a supplement to your diet.
3. to reduce the chance of having another heart attack if you have had a heart attack or if you have chest pain attacks (unstable angina pectoris).
4. to lower the fatty substances (lipids) in the blood following an organ transplant.

Do not take Vastatifix

1. if you are hypersensitive (allergic) to pravastatin, the active ingredient of Vastatifix, or any of the other ingredients of Vastatifix.
2. if you suffer from a liver disease in an active stage or if liver function tests keep showing excessive values without any identifiable reason.
3. if you are pregnant or breastfeeding.

Take special care with Vastatifix

1. if you suffer from a kidney disease of have a history of liver disease.
2. if you regularly drink large amounts of alcohol.
3. if you suffer from a low function of your thyroid gland.
4. if you use other medication (fibrates) to lower the fatty substances at the same time.
5. if you experienced muscle problems during previous treatment medication to lower the fatty substances or if anyone in your family suffers from a hereditary muscle disease.

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 Vastatifix

• if you have severe respiratory failure.

Consult your doctor if this applies to you or has applied to you in the past.

16 if you suffer from muscle weakness or cramps during treatment or if certain parts of your body become unusually sensitive to touching.

Consult your doctor immediately if, while using Vastatifix, you get unexplained muscle ache, muscle weakness or muscle cramps, particularly in combination with tiredness and fever. These complaints may be caused by the use of Vastatifix.

If necessary, your doctor may decide to stop treatment. Vastatifix should not be used if you suffer from a muscle disease or if you develop kidney problems which are probably a result of destruction of muscle tissue associated with muscle cramps, fever and red-brown discoloration of the urine (rhabdomyolysis).

Use in children

Children younger than 8 years should not use this medicine, because safety and efficacy is not proven in this patient group.

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.

If you take Vastatifix together with certain other medicines, the effect either of Vastatifix or of the other medicine or of both may be influenced.

Inform your doctor or pharmacist especially if you use or have recently used any of the following medicines:

1. gemfibrozil and fenofibrate (medicines known as fibrates, which decrease fat levels in the blood).The concomitant use with pravastatin, the active ingredient of Vastatifix, may result in, sometimes severe, muscle disorders.
2. colestyramine and colestipol (medicines used for the treatment of a high cholesterol level). The effect of pravastatin is weakened when taken simultaneously with one of those medicines.
3. ciclosporin (a medicine used to suppress the immune system). The effect of pravastatin is highly intensified when being used together.
4. erythromycin and clarithromycin. Those antibiotics intensify the effect of pravastatin.

Taking Vastatifix with food and drink

It is best not to drink any alcohol until your treatment with Vastatifix has finished.

Pregnancy and breast-feeding

You should not use Vastatifix during pregnancy or breast-feeding.

During pregnancy the active substance pravastatin is very likely to harm the foetus. During breast-feeding small amounts pass into the mother's milk which is bad for the baby's health. Before you start using Vastatifix, you should inform your doctor if you are pregnant or intend to become pregnant. Girls and women of childbearing age should use reliable contraceptives. If, however, you become pregnant during treatment, you should stop using Vastatifix and consult your doctor.

Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines

Vastatifix does not usually affect the ability to drive and use machines. You may, however, feel a bit dizzy. In this case make sure that you are fit to drive and operate machinery.

Important information about some of the ingredients of Vastatifix

This medicine contains lactose. If you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

Always take Vastatifix exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

Take Vastatifix once daily, preferably in the evening, whether or not during meals. Swallow the tablets with a sufficient quantity of liquid (e.g. one glass of water).

Unless otherwise prescribed by the doctor, the usual dose is:

For lowering an increased cholesterol level in the blood

1-4 tablets (respectively 10-40 mg pravastatin) once daily. The maximum daily dosage is 4 tablets (respectively 40 mg pravastatin).

To prevent heart and vessel diseases

4 tablets (respectively 40 mg pravastatin) once daily.

Following a transplant

2 tablets (respectively 20 mg pravastatin) once daily. The dosage can be adjusted up to 4 tablets (respectively 40 mg pravastatin).

Children and adolescents with hereditarily increased cholesterol in the blood (heterozygous familial

hypercholesterolaemia)

The recommended dose is 1-2 tablets (respectively 10-20 mg pravastatin) once daily for children 8-13 years of age and 1-4 tablets (respectively 10-40 mg pravastatin) once daily in adolescents 14-18 years of age.

Elderly

No dosage adjustment is required for this group. The same dosage as for adult patients can be used.

Dosage adjustment in kidney or liver disorder

Initial dosage 1 tablet (respectively 10 mg pravastatin) once daily; the dosage can be adjusted, if necessary.

Concomitant use with other medicines

In case of concomitant use of other medicines with the active ingredients colestyramine or colestipol (medicines used for the treatment of high cholesterol levels), you should take Vastatifix at least one hour before or four hours after these medicines.

If at the same time you use other medicines with the active ingredient ciclosporin (a medicine used to suppress the immune system), the initial dosage of Vastatifix is 2 tablets (respectively 20 mg pravastatin) once daily. This can be adjusted to up to 4 tablets (respectively 40 mg pravastatin).

Follow these instructions unless your doctor gave you different advice. Remember to take your medicine.

Your doctor will tell you how long you have to continue using Vastatifix. This depends on the disease you have.

If you have the impression that the effect of Vastatifix is too strong or too weak, talk to your doctor or pharmacist.

If you take more Vastatifix than you should

If you have taken too many tablets, or if someone has accidentally swallowed some tablets, contact your doctor or pharmacist immediately.

If you forget to take Vastatifix

If you miss a dose do not worry. Simply take your normal dose when it is next due. Do not take a double dose to make up for the one you have missed.

If you stop taking Vastatifix

Take Vastatifix as long as your doctor has told you. If you stop taking Vastatifix, your cholesterol levels may increase again.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

Like all medicines, Vastatifix can cause side effects, although not everybody gets them. Generally, these are mild and transient. However, the following side effects may occur in some patients during treatment.

The frequencies of side effects are ranked according to the following:

Very common: in more than 1 in 10 patients

Common: between 1 in 10 and 1 in 100

Uncommon: between 1 in 100 and 1 in 1000

Rare: between 1 in 1000 and 1 in 10,000

Very rare: less than 1 in 10,000

1 Nervous system disorders:

Uncommon: dizziness, headache, sleep disturbances, lack of sufficient sleep.

Very rare: problems with touch including burning/tingling sensation, numbness or pins and needles [paresthesia] may occur which may be a sign of damage to the nerve endings (peripheral polyneuropathy).

Unknown frequency: nightmares, memory loss, depression.

2 Respiratory, thoracic and mediastinal disorders:

Unknown frequency: breathing problems including persistent cough and/or shortness of breath or fever.

1 Eye problems:

Uncommon: vision disturbance (blurred vision or double vision).

1 Gastrointestinal disorders:

Uncommon: digestive problems or slow digestion (dyspepsia)/heartburn, abdominal pain, nausea/vomiting, constipation, diarrhoea, wind.

Very rare: inflammation of the pancreas (pancreatitis).

1 Skin disorders:

Uncommon: itching, rash, hives, scalp and hair problems (inclusive of hair loss).

1 Kidney and urinary tract problems:

Uncommon: abnormal urination, e.g. pain, frequency, frequent urination at night (dysuria).

1 Reproductive system disorders: Uncommon: disturbed sexual functions.

1 General disorders: Uncommon: tiredness.

1 Skeleton, muscle and connective tissue disorders:

Common: tender muscles and bones, painful joints (athralgia), muscle cramps, muscle pain and muscle weakness. Very rare: inflammation of a muscle, destruction of fibres in skeletal muscle (rhabdomyolysis) that may be associated with acute kidney failure.

In some cases tendon disorders, sometimes associated with tearing.

Contact your doctor immediately if you develop one of these symptoms during the use of Vastatifix, because muscle disorders may be serious in rare cases (see also 2. Before you take Vastatifix).

1 Liver disorders:

Common: increased production of liver enzymes.

Very rare: yellowish discoloration of the skin (jaundice), tissues and body fluids, liver inflammation (hepatitis), sudden rapid destruction of all liver tissue (hepatitis necrosis).

1 Immune system disorders:

Very rare: Hypersensitivity reactions (angiooedema, anaphylaxis) such as serious allergic reactions with swelling of the face, tongue and wind pipe [oedema] which can cause great difficulty in breathing. This is a very rare reaction which can be serious if it occurs.

You should see a doctor immediately if this occurs.

A certain type of chronic skin disorder (lupus like syndrome).

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

Keep out of the reach and sight of children.

Do not store above 25°C. Store in the original pack age.

Do not use Vastatifix after the expiry date which is stated after "Exp:" on the carton and blister. The expiry date refers to the last day of that month.

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.

What Vastatifix contains

The active substance is: pravastatin sodium.

Each tablet contains 10 mg pravastatin sodium.

The other ingredients are:

Tablet core: microcrystalline cellulose (E460), croscarmellose sodium (E468), macrogol 8000, copovidone, magnesium carbonate, heavy (E504), lactose monohydrate, magnesium stearate (E470b), iron oxide red (E172), silica, colloidal anhydrous (E551).

Tablet coating: hyprolose (E463), macrogol 400, macrogol 3350, hypromellose (E464).

What Vastatifix looks like and contents of the pack

Pink-peach film-coated tablet with "10" on one side. The tablet can be divided into equal halves.

Vastatifix is available in blister packs with 7, 10, 20, 28, 30, 50, 56, 98, 100 and 200 tablets. Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Autorisation Holder:

<To be completed nationally>

Manufacturer:

Dragenopharm Apotheker Püschl GmbH

Göllstrasse 1

84529 Tittmoning

Germany

Swiss Caps GmbH

Grassingerstraße 9

83043 Bad Aibling

Germany

Genericon Pharma Gesellschaft m.b.H. Hafnerstrasse 211

8054 Graz Austria

STADA Arzneimittel AG

Stadastr. 2-18

61118 Bad Vilbel

Germany

This leaflet was last approved in September 2011.