Pravafenix

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  • Heiti vöru:
  • Pravafenix
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  • Mannfólk
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  • Allópatísk lyf

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Staðsetning

  • Fáanlegt í:
  • Pravafenix
    Evrópusambandið
  • Tungumál:
  • enska

Meðferðarupplýsingar

  • Meðferðarhópur:
  • LIPID MODIFYING AGENTS
  • Lækningarsvæði:
  • Dyslipidemias
  • Ábendingar:
  • Pravafenix is indicated for the treatment of high-coronary-heart-disease (CHD)-risk adult patients with mixed dyslipidaemia characterised by high triglycerides and low HDL-cholesterol (C) levels whose LDL-C levels are adequately controlled while on a treatment with pravastatin-40-mg monotherapy.,
  • Vörulýsing:
  • Revision: 4

Staða

  • Heimild:
  • EMA - European Medicines Agency
  • Leyfisstaða:
  • Authorised
  • Leyfisnúmer:
  • EMEA/H/C/001243
  • Leyfisdagur:
  • 13-04-2011
  • EMEA númer:
  • EMEA/H/C/001243
  • Síðasta uppfærsla:
  • 31-03-2019

Opinber matsskýrsla

7 Westferry Circus

Canary Wharf

London E14 4HB

United Kingdom

Telephone

+44 (0)20 7418 8400

Facsimile

+44 (0)20 7418 8416

E-mail

info@ema.europa.eu

Website

www.ema.europa.eu

An agency of the European Union

© European Medicines Agency, 2011. Reproduction is authorised provided the source is acknowledged.

EMA/79515/2011

EMEA/H/C/001243

EPAR summary for the public

Pravafenix

pravastatin/fenofibrate

This is a summary of the European public assessment report (EPAR) for Pravafenix. It explains how the

Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in

favour of granting a marketing authorisation and its recommendations on the conditions of use for

Pravafenix.

What is Pravafenix?

Pravafenix is a medicine that contains the active substances pravastatin and fenofibrate. It is available

as green and olive capsules containing 40 mg pravastatin and 160 mg fenofibrate.

What is Pravafenix used for?

Pravafenix is used in adults at high risk of heart disease whose ‘low-density-lipoprotein’ (LDL or ‘bad’)

cholesterol is already being controlled with pravastatin alone but who still need to improve their

cholesterol levels and to reduce their levels of triglycerides (a type of fat).

The medicine can only be obtained with a prescription.

How is Pravafenix used?

Before starting treatment with Pravafenix, the doctor should first investigate all possible causes of the

patient’s abnormal cholesterol and triglycerides levels and place the patient on a suitable diet.

The recommended dose is one capsule a day taken during the evening meal. The medicine should

always be taken with food as it is less well absorbed from an empty stomach. The patient’s blood

should be monitored regularly to see how the medicine is working. The doctor should stop treatment if

an adequate response is not seen within three months.

How does Pravafenix work?

The active substances in Pravafenix, pravastatin and fenofibrate, work in different ways and their

actions have a complementary effect.

Pravastatin belongs to the group called ‘statins’. It reduces total blood cholesterol by blocking the

action of HMG-CoA reductase, an enzyme in the liver involved in the production of cholesterol. As the

liver needs cholesterol to produce bile, the reduced blood cholesterol level causes the liver cells to

produce receptors that draw cholesterol from the blood, reducing its level even further. The cholesterol

drawn out of the blood in this way is the LDL, or ‘bad’ cholesterol.

Fenofibrate is a ‘PPAR agonist’. It activates a type of receptor called the ‘peroxisome

proliferator-activated receptor alpha’, which is involved in breaking down fat from the diet, especially

triglycerides. When the receptors are activated, the breakdown of fats is accelerated, and this helps

clear the blood of cholesterol and triglycerides.

How has Pravafenix been studied?

Because pravastatin and fenofibrate have been used in medicines for a number of years, the company

presented information from the scientific literature in addition to results from its own studies.

The company carried out one main study, in which Pravafenix was compared with pravastatin alone in

248 patients at high risk of heart disease who had abnormal levels of cholesterol and triglyceride fats.

The main measure of effectiveness was the reduction in the level of cholesterol after 12 weeks

(excluding HDL or ‘good’ cholesterol).

What benefit has Pravafenix shown during the studies?

In the main study Pravafenix was shown to be more effective than pravastatin alone in reducing non-

HDL-cholesterol levels. Non-HDL-cholesterol levels were reduced on average by around 14% in

patients taking Pravafenix compared with 6% in patients taking pravastatin alone.

What is the risk associated with Pravafenix?

The most common side effects with Pravafenix (seen in between 1 and 10 patients in 100) are

abdominal distension (bloating), abdominal pain (stomach ache), constipation, diarrhoea, dry mouth,

dyspepsia (heartburn), eructation (belching), flatulence (gas), nausea (feeling sick), abdominal

discomfort, vomiting and raised blood levels of liver enzymes. For the full list of all side effects

reported with Pravafenix, see the package leaflet.

Pravafenix should not be used in people who may be hypersensitive (allergic) to the active substances

or any of the other ingredients. Pravafenix must not be used in patients aged below 18 years or in

patients with severe liver problems, moderate to severe kidney problems, photo allergy or phototoxic

reactions (allergic reaction or skin damage due to light exposure) during treatment with fibrates or

ketoprofen. It must also not be used in patients with gall bladder disease, chronic or acute pancreatitis

(inflammation of the pancreas) or a history of myopathy (muscle disorders) or rhabdomyolysis

(breakdown of muscle fibres) following treatment with a statin or a fibrate. It must not be given to

women who are pregnant or breastfeeding.

Why has Pravafenix been approved?

The CHMP looked at newly published data on the benefits of the combination of statins and fenofibrate.

The Committee also noted that the benefits of Pravafenix were mainly in patients who had high levels

Pravafenix

EMA/79515/2011

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Pravafenix

EMA/79515/2011

Page 3/3

of triglyceride fats and low levels of HDL cholesterol. The Committee therefore decided that

Pravafenix’s benefits are greater than its risks in this group of patients and recommended that it be

given marketing authorisation.

Other information about Pravafenix

The European Commission granted a marketing authorisation valid throughout the European Union for

Pravafenix to Laboratoires SMB s.a. on 14 April 2011. The marketing authorisation is valid for five

years, after which it can be renewed.

The full EPAR for Pravafenix can be found on the Agency’s website: ema.europa.eu/Find

medicine/Human medicines/European Public Assessment Reports. For more information about

treatment with Pravafenix, read the package leaflet (also part of the EPAR) or contact your doctor or

pharmacist.

This summary was last updated in 02-2011.

Upplýsingar um fylgiseðil sjúklinga: samsetning, vísbendingar, aukaverkanir, skammtar, milliverkanir, aukaverkanir, meðgöngu, brjóstagjöf

B. PACKAGE LEAFLET

Package leaflet: Information for the user

Pravafenix 40 mg/160 mg hard capsules

Pravastatin/Fenofibrate

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. 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

What Pravafenix is and what it is used for

What you need to know before you take Pravafenix

How to take Pravafenix

Possible side effects

How to store Pravafenix

Contents of the pack and other information

1.

What pravafenix is and what it is used for

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 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).

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 (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, in the last 7 days, have taken or been given a medicine called fusidic acid (a

medicine for bacterial infection

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: do not take fusidic acid (a medicine for bacterial infections) while using this

medicine. Also see section 4 of this leaflet.

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

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.

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 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

(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.

Tingling and numbness (peripheral polyneuropathy).

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

Muscle weakness that is constant

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 in Appendix 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 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.

6.

Contents of the pack and other information

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 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.

България

Synapsis Bulgaria Ltd

Teл.: + 359.2.444.24.94

Luxembourg/Luxemburg

Laboratoires SMB S.A.

Tél/Tel: + 32.2.411.48.28.

Česká rep

ublika

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 Pharmaceuticals Ltd

Τηλ: +30 210 67 26 260

Österreich

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

România

Laboratoires SMB S.A.

Tel: + 32.2.411.48.28.

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.

Κύπρος

Synapsis Trading Limited

Τηλ: +30 210 67 26 260

Sverige

Laboratoires SMB S.A.

Tel: + 32.2.411.48.28.

Latvija

Laboratoires SMB S.A.

Tel: + 32.2.411.48.28.

United Kingdom

Laboratoires SMB S.A.

Tel: + 32.2.411.48.28.

This leaflet was last approved in

Detailed information on this medicine is available on the European Medicines Agency website:

http://www.ema.europa.eu/.