Pravafenix 40 mg/160 mg hard capsules

The name of your medicine is Pravafenix. It contains two active substances: pravastatin and fenofibrate. Both are cholesterol/lipid modifying medicines.

Pravafenix is used in addition to low fat diet in adults

• To lower the level of your ?bad? cholesterol (LDL cholesterol). It does this by lowering the level of total cholesterol, and fatty substances called triglycerides in the blood.
• To raise the level of your ?good? cholesterol (HDL cholesterol).

What should I know about cholesterol and triglycerides?
Cholesterol is one of several fats found in your blood. Your total cholesterol is made up mainly of LDL and HDL cholesterol.

LDL cholesterol is often called ?bad? cholesterol because it can build up in the walls of your arteries and form plaque. Over time, this plaque build-up can lead to a clogging of your arteries. This clogging can slow or block blood flow to vital organs such as the heart and brain. When the blood flow is blocked, the result can be a heart attack or stroke.

HDL cholesterol is often called ?good? cholesterol because it helps keep the ?bad? cholesterol from building up in the arteries and because it protects against heart disease.

Triglycerides are another fat in your blood. They may raise your risk of having heart problems.

In most people, there are no signs of cholesterol problems at first. Your doctor can measure your cholesterol with a simple blood test. Visit your doctor regularly to keep track of your cholesterol level.

Pravafenix is used if you are a patient with an elevated risk for heart disease andneed to improve cholesterol and triglycerides fat levels in your blood when your ?bad? cholesterol levels are being adequately controlled with pravastatin alone (a statin, a cholesterol-lowering medicine).

Do not take Pravafenix if

• You are allergic (hypersensitive) to fenofibrate, pravastatin, or any of the other ingredients of Pravafenix (see section 6: Further information).
• You suffer from liver disease.
• You are under 18 years old.
• You suffer from kidney disease.
• You have had photoallergy (allergic reaction caused by sunlight or exposure to UV light) or phototoxic reactions (damage to skin caused by exposure to sunlight or UV light) during treatment with fibrates (lipid-modifying medicines) or ketoprofen (an anti-inflammatory medicine that can be used orally or on the skin for muscle and bone disorders, and orally for gout or period pain)
• You suffer from gallbladder disease.
• You suffer from pancreatitis (inflammation of the pancreas leading to abdominal pain)
• You are pregnant or breast-feeding.
• You have a history of muscle problems during treatment with cholesterol-controlling medicines called ?statins? (such as simvastatin, atorvastatin, pravastatin or rosuvastatin) or fibrates (such as fenofibrate and bezafibrate).

Do not take Pravafenix if any of the above applies to you. If you are not sure, talk to your doctor or pharmacist before taking Pravafenix.

Children
Do not take Pravafenix if you are under 18 years old

Take special care with Pravafenix

Before you take Pravafenix you should tell your doctor if you have or have had any medical problems.

• Tell your doctor about all your medical conditions including allergies.
• Tell your doctor if you drink large amounts of alcohol (see below section Taking Pravafenix with food and drink) or have ever had liver disease.
• Your doctor should do a blood test before you start taking Pravafenix. This is to check how well your liver and your kidneys are working.
• Your doctor may also want you to have blood tests to check how well your liver is working after you start taking Pravafenix.

Contact your doctor immediately if you experience unexplained muscle pain, tenderness, or weakness. This is because, on rare occasions, muscle problems can be serious, including muscle breakdown resulting in kidney damage, and very rarely deaths have occurred.

The risk of muscle breakdown is greater in certain patients. Tell your doctor if any of the following applies to you:

• Liver or kidney problems
• Thyroid problems
• You are more than 70 years old
• You have ever had muscle problems during a treatment with cholesterol-lowering medicines such as a statin or fibrate
• You or your close family members have a hereditary muscle disorder
• You have alcohol problems (regularly drinking large amounts of alcohol)

Check with your doctor or pharmacist before taking Pravafenix if you have severe respiratory failure, e.g. you have breathing problems including, persistent non-productive cough, deterioration in general health like fatigue (tiredness), weight loss and/or shortness of breath or fever.
If you feel any of these symptoms you should stop taking Pravafenix and inform your doctor.

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. It is important that you inform your doctor if you are already being treated with any of the following:

• Bile acid resins such as colestyramine/colestipol (a medicine for lowering cholesterol), because it affects the way Pravafenix works.
• Ciclosporin (a medicine often used in organ transplant patients).
• Medicines to prevent blood clots, such as warfarin, fluindione, phenprocoumon or acenocoumarol (anticoagulants)
• An antibiotic such as erythromycin or clarithromycin to treat infections caused by bacteria.

Taking Pravafenix with food and drink

• Always take Pravafenix with food as Pravafenix is less well absorbed from an empty stomach.
• You should always keep your alcohol intake to a minimum. If you are concerned about how much alcohol you can drink while you are taking this medicine, you should discuss this with your doctor. If you are not sure about this, please follow your doctor?s advice.

Pregnancy and breast-feeding

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

Do not take Pravafenix if you are pregnant or trying to get pregnant or think you may be pregnant. If you plan to become pregnant or become pregnant, inform your doctor immediately. The medicine should be discontinued because of the potential risk to the foetus.

Do not take Pravafenix if you are breast-feeding.

Driving and using machines
Pravafenix does not usually affect your ability to drive or use machines. If you experience any dizziness, blurred or double vision during treatment, make sure you are fit to drive and use machines before attempting to do so.

Important information about some of the ingredients of Pravafenix

Pravafenix contains a sugar called lactose. If you have been told by your doctor that you have intolerance to some sugars, contact your doctor before taking this medicine.

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

• Before starting taking Pravafenix, you should be on a diet to lower your cholesterol.
• You should keep to this diet while taking Pravafenix

The usual dose for adults is one capsule taken daily during the evening meal. Swallow the capsule with water. It is important to take the capsule with food, as it won?t work as well if your stomach is empty.

When your doctor has prescribed Pravafenix along with colestyramine or any other bile acid binding resins (medicines for lowering cholesterol), take Pravafenix 1 hour before, or 4 to 6 hours after the resin. This is because colestyramine or other bile acid binding resins frequently reduce the absorption of medicines when taken too closely together and so may impede the absorption of Pravafenix. If you take indigestion remedies (used to neutralise acid in your stomach), take Pravafenix 1 hour after.

If you take more Pravafenix than you should
Please contact your doctor or pharmacist

If you forget to take Pravafenix

Do not take a double dose to make up for a forgotten dose, just take your normal amount of Pravafenix at the usual time the next day.

If you stop taking Pravafenix

Do not stop taking Pravafenix without first discussing it with your doctor.

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

Like all medicines, Pravafenix can cause side effects, although not everybody gets them. If the side-effects don?t go away after a few days, or you feel unwell in any other way, talk to your doctor before you take your next dose.
Tell your doctor straight away if you have any unexplained muscular pain or cramps, tenderness, or weakness. This is because on very rare occasions, muscle problems can be serious, including muscle breakdown resulting in kidney damage, and very rarely deaths have occurred.
Sudden severe allergic reactions including swelling of the face, lip, tongue or wind pipe which can cause great difficulty in breathing. This is a very rare reaction which can be serious if it occurs. You should tell your doctor immediately if it happens.

The following side effects are important and will require immediate action.

Common side effects(affects 1 to 10 users in 100)

• Digestive effects: gastric or intestinal disorders (abdominal pain, nausea, vomiting, diarrhoea and flatulence, constipation, dry mouth, upper abdominal pain with bloating (dyspepsia), burping (eructation)).
• Effects on liver: raised serum transaminases.

Uncommon side effects(affects 1 to 10 users in 1000)

• Abnormal heartbeat (palpitations), formation of blood clots in veins (deep vein thrombosis) and blockage of the lung arteries by blood clots (pulmonary embolism)
• Rashes, itching, hives or reactions to sunlight or exposure to UV light (photosensitivity reactions), scalp/hair abnormality (including hair loss)
• Effects on nervous system: dizziness (sensation of unsteadiness), headache, sleep disturbances (including difficulty sleeping and nightmares), pins and needles sensation (paresthesia).
• Muscle and joint pain (myalgia, arthralgia), back pain, alterations in some laboratory blood tests for muscle function.
• Problems with sight such as blurred or double vision.
• Kidney problems (increased or decreased levels of certain enzymes within the body seen in a test) bladder problems (painful or frequent urination, having to pass water at night), sexual dysfunction.
• Tiredness, weakness, influenza-like illness.
• Hypersensitivity.
• Increased blood cholesterol, increased blood triglycerides, increased LDL, increased gamma-glutamyl transferase (various liver enzymes), liver pain (upper right abdominal pain with or without pain in the back), increased weight.
• Obesity.
• Muscle inflammation (myositis), muscular cramps and weakness.

Rare side effects(affects 1 to 10 users in 10 000)

• Decrease in haemoglobin (oxygen-carrying pigment in blood) and leukocytes (white blood cells).

Very rareside effects(affects less than 1 user in 10 000)

• Inflammation of the liver (hepatitis), symptoms of which may be mild yellowing of the skin and whites of the eyes (jaundice), abdominal pain and itching.
• Muscle breakdown (rhabdomyolysis), some cases of tendon problems, sometimes complicated by rupture.

Possible side effects reported with some statins (same type of cholesterol-lowering medicines as pravastatin)

• Memory loss
• Depression
• Breathing problems including persistent cough/or shortness of breath or fever.

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.

Keep out of the reach and sight of children.

Do not use Pravafenix after the expiry date which is stated on the carton and the blister/bottle after EXP.

This medicine does not require any special storage conditions.

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 Pravafenix contains

• The active substances are fenofibrate and pravastatin. Each hard capsule contains 40 mg pravastatin sodium and 160 mg fenofibrate.
• The other ingredients are:
• capsule content: lactose monohydrate, cellulose microcrystalline, ascorbyl palmitate, povidone, sodium starch glycolate, magnesium stearate, talc, triacetin, sodium hydrogen carbonate, lauroyl macrogolglycerides, hydroxypropylcellulose, macrogol 20 000.
• capsule shell: gelatine, indigo carmine (E132), black iron oxide (E172), titanium dioxide (E171), yellow iron oxide (E172).

What Pravafenix looks like and contents of the pack

The capsules are hard gelatine capsule with olive cap and light green body containing a waxy white beige mass and a tablet. The capsules are supplied in Polyamide-Aluminium-PVC/aluminium blister packs containing 30, 60, or 90 capsules, and in opaque white plastic bottles containing either 30, 60 or 90 capsules.

Not all pack sizes may be marketed.

Marketing Authorisation Holder Manufacturer

Laboratoires SMB s.a. Rue de la Pastorale, 26-28 B-1080 Brussels Belgium SMB Technology s.a. Rue du Parc Industriel 39 B-6900 Marche en Famenne Belgium

This leaflet was last approved in