Pravafenix - patient leaflet, side effects, dosage

1. What Pravafenix is and what it is used for

Pravafenix 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 an adult with an elevated risk for heart disease and need 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).

2. What you need to know before you take Pravafenix

Do not take Pravafenix

• – if you are allergic to fenofibrate, pravastatin, or any of the other ingredients of this medicine

(listed in section 6).

• – if you suffer from liver disease.

• – if you are under 18 years old.

• – if you suffer from kidney disease.

• – if 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)

• – if you suffer from gallbladder disease.

• – if you suffer from pancreatitis (inflammation of the pancreas leading to abdominal pain)

• – if you are pregnant or breast-feeding.

• – if you have a history of muscle problems (e.g. myopathy or rhabdomyolysis) 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.

Warnings and precautions

Talk to your doctor or pharmacist before taking 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 (if you drink more than the recommended daily amount; ask your doctor or pharmacist if you are unsure) or have ever had liver disease. See also below section “Taking Pravafenix with food and drink”.

• – 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.

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.

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 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 Pravafenix can lead to serious muscle problems (rhabdomyolysis).

• – 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.

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.

Children and adolescents

Do not take Pravafenix if you are under 18 years old

Other medicines and Pravafenix

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. 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, clarithromycin to treat infections caused by bacteria.

• – Fusidic acid: 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 Pravafenix. Taking Pravafenix with fusidic acid may rarely lead to muscle weakness, tenderness or pain (rhabdomyolysis). See more information regarding rhabdomyolysis in section 4.

• – Glecaprevir/pi­brentasvir (used to treat hepatitis C virus infection) because it can increase some adverse events including muscle problems.

• – a particular class of medicines to treat diabetes (such as rosiglitazone, pioglitazone)

Pravafenix with food, drink and alcohol

• – 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

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 must 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.

Pravafenix contains lactose and sodium

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

This medicine contains 33.3 mg sodium (main component of cooking/table salt) in each capsule (excipients and active substance). This is equivalent to 1.7% of the recommended maximum daily dietary intake of sodium for an adult.

3. How to take Pravafenix

Always take Pravafenix exactly as your doctor has told you. 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 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.

4. Possible side effects

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

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

Tell your doctor straight away if you have any unexplained muscular pain or cramps, tenderness, or weakness. This is because on very rare occasions (may affect up to 1 in 10,000 people), 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.

Other Side effects

Common side effects (may affect up to 1 in 10 people)

• 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 (may affect up to 1 in 100 people)

• Abnormal heartbeat (palpitations), formation of blood clots in veins (deep vein thrombosis) and blockage of the lung arteries by blood clots (pulmonary embolism)
• Rashes, skin rash, 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 gammaglutamyl 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 (may affect up to 1 in 1,000 people)

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

Very rare side effects (may affect up to 1 in 10,000 people)

• 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.
• A condition characterised by an inflammation of the muscles and the skin (dermatomyositis).
• Skin rash, possibly with pain in the joints (Erythematous lupus like syndrome).
• Tingling and numbness (peripheral polyneuropathy).

Side effects of unknown frequency (frequency cannot be estimated from the available data)

• Muscle weakness that is constant
• Skin rash (lichenoid eruption)

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.
• 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 national reporting system listed inBy reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Pravafenix

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 carton and the blister/bottle after EXP. The expiry date refers to the last day of that month.

This medicine does not require any special storage conditions.

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 to protect the environment.

6. Contents of the pack and other information

What Pravafenix contains

• The active substances are fenofibrate and pravastatin sodium. 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 14, 30, 60 or 90 capsules.

Not all pack sizes may be marketed.

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

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

België/Belgiqu­e/Belgien Laboratoires SMB S.A. Tél/Tel: + 32.2.411.48.28.	Lietuva Laboratoires SMB S.A. Tel: + 32.2.411.48.28.
Efcnrapua Thea Pharma Ltd Ten.: +359.2.444.24.66	Luxembourg/Lu­xemburg Laboratoires SMB S.A. Tél/Tel: + 32.2.411.48.28.
Česká republika Laboratoires SMB S.A. Tel: + 32.2.411.48.28.	Magyarorszag Laboratoires SMB S.A. Tel.: + 32.2.411.48.28.
Danmark Galephar Nordic ApSTlf: +45 5666 0490	Malta Laboratoires SMB S.A. Tel: + 32.2.411.48.28.
Deutschland Galephar Pharma GmbH Tel: +49 7164 66 26	Nederland Galephar B.V. Tel: +31 71 562 15 02
Eesti Laboratoires SMB S.A. Tel: + 32.2.411.48.28.	Norge Laboratoires SMB S.A. Tlf: + 32.2.411.48.28.
EXXáóa	Österreich

Angelini Pharma Hellas SA Tql: +30 210 62 69 200	Laboratoires SMB S.A. Tel: + 32.2.411.48.28.
España Lacer S.A. Tel: +34 934 46 53 00	Polska Laboratoires SMB S.A. Tel.: + 32.2.411.48.28.
France Laboratoires SMB S.A. Tél: + 32.2.411.48.28.	Portugal Technimede Sociedade Técnico-Medicinal S.A. Tel: +351 21 041 41 00
Hrvatska Laboratoires SMB S.A. Tel: + 32.2.411.48.28.	România Solartium Group S.r.l. Tel: +40 21 211 71 83
Ireland Laboratoires SMB S.A. Tel: + 32.2.411.48.28.	Slovenija Laboratoires SMB S.A. Tel: + 32.2.411.48.28.
Ísland Laboratoires SMB S.A. Sími: + 32.2.411.48.28.	Slovenská republika Laboratoires SMB S.A. Tel: + 32.2.411.48.28.
Italia Abiogen Pharma S.p.A. Tel: +39 050 3154 101	Suomi/Finland Laboratoires SMB S.A. Puh/Tel: + 32.2.411.48.28.
Kùnpoç Synapsis Trading Limited Tql: +30 210 67 26 260	Sverige Galephar Nordic ApS Tlf: +45 5666 0490
Latvija Laboratoires SMB S.A. Tel: + 32.2.411.48.28.	United Kingdom (Northern Ireland) Laboratoires SMB S.A. Tel: + 32.2.411.48.28.

This leaflet was last revised in

Detailed information on this medicine is available on the European Medicines Agency website: http://www. ema.europa.eu/.

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