PRAVAFENIX 40 mg/160 mg Hard Capsule

Содержание инструкции

1. Pravafenix 40 mg/160 mg hard capsules
   1. WHAT IS PRAVAFENIX AND WHAT IT IS USED FOR
   2. WHAT YOU NEED TO KNOW BEFORE TAKING PRAVAFENIX
   3. HOW TO TAKE PRAVAFENIX
   4. POSSIBLE SIDE EFFECTS
   5. HOW TO STORE PRAVAFENIX
   6. PACKAGE CONTENTS AND OTHER INFORMATION

Pravafenix 40 mg/160 mg hard capsules

pravastatin sodium salt/fenofibrate

Read this leaflet carefully before you start to use this medicine as it contains important
information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist. This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

• 1. What Pravafenix is and what it is used for
• 2. What you need to know before you take Pravafenix
• 3. How to take Pravafenix
• 4. Possible side effects
• 5. How to store Pravafenix 6. Contents of the pack and other information

1. WHAT IS PRAVAFENIX AND WHAT IT IS USED FOR

Pravafenix contains two active ingredients: pravastatin and fenofibrate. Both are medicines that
modify lipids and cholesterol.

Pravafenix is used in adults together with a low-fat diet

• to reduce the level of “bad” cholesterol (LDL cholesterol).
• This is achieved by reducing the levels of total cholesterol and fats called triglycerides in the blood.
• to increase the level of “good” cholesterol (HDL cholesterol). What should I know about cholesterol and triglycerides?Cholesterol is one of many fats found in the blood. Total cholesterol is mainly made up of LDL and HDL cholesterol. LDL cholesterol is commonly called “bad” cholesterol because it can build up in the walls of the arteries and form plaques. Over time, these plaques grow in size and end up blocking the arteries. This blockage can slow down or stop the flow of blood to vital organs such as the heart and brain. When blood flow is blocked, you can have a heart attack or stroke. HDL cholesterol is often called “good” cholesterol because it prevents “bad” cholesterol from building up in the arteries and because it protects against heart disease.

Triglycerides are another type of fat in the blood. They can increase the risk of having
heart problems.
In most people, there are initially no signs indicating the cholesterol problem.
Your doctor can measure cholesterol with a simple blood test. See your doctor regularly to
keep your cholesterol levels under control.
Pravafenix is used in adults with a high risk of heart disease and if it is necessary to
improve cholesterol and triglyceride levels in the blood when “bad” cholesterol levels
are adequately controlled with pravastatin alone or with another statin of moderate intensity (a
medicine for reducing cholesterol).

2. WHAT YOU NEED TO KNOW BEFORE TAKING 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 a liver disease
• if you are under 18 years of age and suffer from a kidney disease or if you have suffered from photoallergy (allergic reactions caused by sunlight or exposure to UV light) or phototoxic reactions (skin damage caused by exposure to sunlight or UV light) during therapy with fibrates (medicines that modify lipidemia) or ketoprofen (a medicine for inflammation that can be taken orally or applied to the skin for muscle or bone problems, and orally for gout or menstrual pains) if you suffer from a disease of the cystic bile duct if you suffer from pancreatitis (inflammation of the pancreas that causes abdominal pain)
• if you are pregnant or breastfeeding
• if you have had muscle problems (for example myopathy or rhabdomyolysis) during therapy with medicines for cholesterol control called “statins” (such as simvastatin, atorvastatin, pravastatin, rosuvastatin) or fibrates (such as fenofibrate or bezafibrato).

Do not take Pravafenix if any of the conditions listed above apply to you. If you are unsure
talk to your doctor or pharmacist before taking Pravafenix.

Warnings and precautions
Talk to your doctor or pharmacist before taking Pravafenix.
Before taking Pravafenix, tell your doctor if you have or have had any health problems.

• Inform your doctor about your health conditions, including allergies. Inform your doctor if you drink large amounts of alcohol (if you consume more than the recommended daily amount; if in doubt, consult your doctor or pharmacist) - or if you have had a liver disease. See further in the paragraph “Taking Pravafenix with food, drinks and alcohol”. The doctor must request a blood test before you begin taking Pravafenix. This is to check the function of your liver and kidneys.
• The doctor may also request a blood test to check the function of your liver and kidneys after you have started taking Pravafenix. If you have or have had myasthenia (a disease characterized by generalized muscle weakness including, in some cases, the muscles used for breathing) or ocular myasthenia (a disease that causes weakness of the eye muscles), as statins can sometimes worsen myasthenia or cause it to appear (see section 4).

Contact your doctor immediately if you experience unexplained muscle pain, tenderness
or muscle weakness. This is because, rarely, muscle problems can be serious and lead to
muscle destruction with kidney damage and very rarely deaths have occurred.
Also, inform your doctor or pharmacist if you have persistent muscle weakness. Further
tests and medicines may be necessary for diagnosis and treatment of this condition.
The risk of muscle destruction is higher in certain patients. Tell your doctor if any of the following
conditions apply to you:

• liver or kidney diseases thyroid diseases age over 70 years muscle problems during treatment with medicines to lower cholesterol such as statins or fibrates you are taking or have taken in the last 7 days a medicine called fusidic acid (a medicine for bacterial infections) orally or by injection. The combination of fusidic acid and Pravafenix can lead to serious muscle problems (rhabdomyolysis). hereditary muscle diseases (you or a close relative) alcohol problems (drinking large amounts of alcohol regularly) Before taking Pravafenix consult your doctor or pharmacist if: you have severe respiratory failure, i.e. breathing problems with persistent dry cough, general deterioration such as asthenia (fatigue), weight loss and/or shortness of breath or fever. If you have any of these symptoms, you should stop Pravafenix and inform your doctor.

During treatment with 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
your blood sugar and fat levels are high, if you are overweight and have high blood pressure.

Children and adolescents
Do not take Pravafenix if you are under 18 years of age.

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 to inform your doctor if you are already taking any of the following
medicines:

• bile acid binding resins such as cholestyramine/colestipol (a medicine to lower cholesterol), because it alters the effect of Pravafenix cyclosporine (a medicine often used in patients who have received a transplant) medicines to prevent blood clots such as warfarin, fluindione, fenprocoumone or acenocoumarol (anticoagulants) an antibiotic such as erythromycin or clarithromycin to treat infections caused by bacteria fusidic acid: if you need to take fusidic acid orally to treat a bacterial infection, you must temporarily stop using this medicine. Your doctor will tell you when you can start taking Pravafenix again. Taking Pravafenix with fusidic acid can rarely lead to muscle weakness, tenderness or pain (rhabdomyolysis). See more information regarding rhabdomyolysis in section 4.
• Glecaprevir/pibrentasvir (used for the treatment of hepatitis C virus infection) because it may increase certain adverse events including muscle problems.
• a particular class of medicine for the treatment of diabetes (such as rosiglitazone and pioglitazone).

Pravafenix with food, drinks and alcohol

• Always take Pravafenix with food, as Pravafenix is less well absorbed on an empty stomach. You should always keep alcohol consumption to a minimum. If you have doubts about how much alcohol you can drink while taking these medicines, you should discuss this with your doctor. If you are unsure, follow your doctor’s advice.

Pregnancy and breastfeeding
Do not take Pravafenix if you are pregnant, suspect you may be pregnant, or are planning
a pregnancy. If you are planning a pregnancy or become pregnant, inform your doctor immediately.
The medicine must be stopped due to the potential risk to the fetus.
Do not take Pravafenix during breastfeeding.

Driving and using machines
Pravafenix usually does not affect the ability to drive vehicles or operate machinery. If you experience
dizziness, double vision or blurred vision during
therapy, make sure you are able to drive and
operate machinery before doing so.

Pravafenix contains lactose and sodium
Pravafenix contains a sugar called lactose. If your
doctor has told you that you are intolerant to some sugars, contact your doctor before taking
this medicine.
This medicine contains 33.3 mg of sodium (the main component of table salt) per capsule
(excipients and active ingredient). This is equivalent to 1.7% of the maximum daily intake of sodium
for an adult.

3. HOW TO TAKE PRAVAFENIX

Always take Pravafenix exactly as your doctor has instructed. If you have any doubts, consult your
doctor or pharmacist.

• Before starting to take Pravafenix, you must follow a diet to lower your cholesterol. Continue the diet while taking Pravafenix.

The recommended dose is one capsule taken every day during the evening meal. Swallow the capsules
whole with water. It is important to take the capsules with food as they do not work as well on an empty
stomach. If your doctor has prescribed Pravafenix together with colestyramine, another bile acid sequestrant
(medicines to lower cholesterol), take Pravafenix 1 hour before to 4-6 hours after the resin.
This is because colestyramine or other bile acid sequestrants often reduce the absorption of
medicines if taken too close together and may therefore prevent the absorption
of Pravafenix. If you take medicines for dyspepsia (used to neutralize stomach acid)
take Pravafenix one hour after.

If you take more Pravafenix than you should
Contact your doctor or pharmacist.

If you forget to take Pravafenix
Do not take a double dose to make up for the missed dose, just take the normal dose of
Pravafenix at the usual time the next day.

If you stop taking Pravafenix
Do not stop taking Pravafenix without discussing it first with your doctor.
If you have any doubts about the use of Pravafenix, 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 side effects are important and require immediate medical attention.
Tell your doctor immediately if you experience any muscle pain or cramp, tenderness or weakness
of unknown origin. This is because very rarely (may affect up to 1 in 10,000 people) muscle
problems can be severe and lead to muscle breakdown with kidney damage and very
rarely deaths have occurred.
Severe and sudden allergic reactions causing swelling of the face, lips, tongue or throat which can
lead to significant difficulty in breathing. This is a very rare reaction which can be
serious. Tell your doctor immediately if it happens.

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

• Effects on digestion: gastrointestinal disorders (abdominal pain, nausea, vomiting, diarrhoea and flatulence, constipation, dry mouth, abdominal pain and bloating (dyspepsia), eructation).
• Effects on the liver: increased transaminases.

Uncommon side effects (may affect up to 1 in 100 people)

• Heartbeat alterations (palpitations), formation of blood clots in the veins (deep vein thrombosis) and blockage of the pulmonary arteries by blood clots (pulmonary embolism)Skin rashes, itching, urticaria or reactions to sunlight or UV exposure (photosensitivity reactions), hair/scalp abnormalities (including hair loss).Effects on the nervous system: dizziness (feeling unstable), headache, sleep disorders (including difficulty sleeping and nightmares), tingling sensation (paresthesia).
• Muscle and joint pain (myalgia, arthralgia), back pain, alteration of some laboratory tests related to muscle function.Vision problems such as double or blurred visionKidney problems (increase or decrease in levels of certain enzymes in the body measurable with some analyses), bladder problems (frequent or painful urination, need to urinate at night), sexual dysfunction.Asthenia, fatigue, flu-like symptoms.Hypersensitivity.Increased cholesterol, increased triglycerides, increased LDL, increased gamma-glutamyl transferase (some liver enzymes), liver pain

(abdominal pain in the upper right quadrant with or without back pain), weight gain.Obesity.Muscle inflammation (myositis), muscle cramps and weakness.

Rare side effects (may affect up to 1 in 1,000 people)

• Reduction of haemoglobin (pigment that carries oxygen in the blood) and leukocytes (red blood cells). Very rare side effects (may affect up to 1 in 10,000 people)
• Inflammation of the liver (hepatitis), with symptoms such as a slight yellowing of the skin and the whites of the eyes (jaundice), abdominal pain and itching.
• Muscle breakdown (rhabdomyolysis), some cases with tendon problems, sometimes complicated by rupture.
• A condition characterized by inflammation of the muscles and skin (dermatomyositis).
• Skin rash, with possible joint pain (lupus-like syndrome).
• Tingling and numbness (peripheral neuropathy).

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

• Persistent muscle weakness.
• Muscle tearing.
• Skin rash (lichenoid eruption)
• Myasthenia gravis (a disease that causes generalized muscle weakness including, in some cases, the muscles used for breathing).
• Ocular myasthenia (a disease that causes weakness of the eye muscles). See a doctor if you experience weakness in your arms or legs that worsens after periods of activity, double vision or drooping eyelids, difficulty swallowing or shortness of breath. Possible side effects observed with some statins (same type of medicines for cholesterol reductionas pravastatin)
• Memory loss
• Depression
• Breathing problems including persistent cough/reduced breathing capacity or fever.
• Diabetes. This is more likely if you have high levels of sugars and fats in your blood, if you are overweight and have high blood pressure. Your doctor will check you while you are taking this medicine.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor or pharmacist. You can also report side effects directly through the
national reporting system listed in Annex V.
By 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 package and on the blister/bottle after “Exp.”. The expiry date refers to the last day of that month.
This medicine does not require special storage conditions.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. PACKAGE CONTENTS AND OTHER INFORMATION

What Pravafenix contains

• The active ingredients are fenofibrate and pravastatin sodium salt. Each hard capsule contains 40 mg of pravastatin sodium and 160 mg of fenofibrate.
• The excipients are:
• capsule content:lactose monohydrate, microcrystalline cellulose, ascorbyl palmitate, povidone, sodium starch glycolate, magnesium stearate, talc, triacetin, sodium bicarbonate, lauroyl macrogol glycerides, hydroxypropylcellulose, macrogol 20,000.
• capsule coating:gelatin, indigotin (E132), black iron oxide (E172), titanium dioxide (E171), yellow iron oxide (E172).

Description of Pravafenix and package contents
Pravafenix consists of a hard gelatin capsule with an olive-colored cap and a light green body containing a white-beige waxy mass and a tablet. The capsules are contained in
polyamide-aluminum-PVC/aluminum blisters containing 30, 60, or 90 capsules, and in opaque white plastic bottles containing 14, 30, 60 or 90 capsules.
Not all pack sizes may be marketed.

Marketing Authorisation HolderManufacturer
Laboratoires SMB s.a. SMB Technology s.a.
Rue de la Pastorale, 26-28 Rue du Parc Industriel 39
B-1080 Bruxelles B-6900 Marche en Famenne
Belgium Belgium
For further information on this medicinal product, 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.

България
Laboratoires SMB S.A.
Тел.: + 32.2.411.48.28.

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.

Magyarország
Laboratoires SMB S.A.
Tel.: + 32.2.411.48.28.

Danmark
Laboratoires SMB S.A.
Tlf: + 32.2.411.48.28.

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.

Ελλάδα
Meditrina LTD
Τηλ: +30 2106726260

Österreich
Laboratoires SMB S.A.
Tel: + 32.2.411.48.28.

España
Lacer S.A.

Polska
Laboratoires SMB S.A.
Tel: +34 934 46 53 00 Tel.: + 32.2.411.48.28.

France
Laboratoires SMB S.A.
Tél: + 32.2.411.48.28.

Portugal
Tecnimede Sociedade
Técnico-Medicinal S.A.
Tel: +351 21 041 41 00

Hrvatska
Laboratoires SMB S.A.
Tel: + 32.2.411.48.28.

România
Meditrina Pharmaceuticals S.r.lTel: +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
Laboratoires SMB S.A.
Tel: + 32.2.411.48.28.

Suomi/Finland
Laboratoires SMB S.A.
Puh/Tel: + 32.2.411.48.28.

Κύπρος
Multi-Pharm Co. Ltd.
Τηλ: +357 22438443

Sverige
Laboratoires SMB S.A.
Tlf: + 32.2.411.48.28.

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.
More detailed information on this medicinal product is available on the website of the European
Medicines Agency: http://www.ema.europa.eu/.