Pravafenix 40 mg/160 mg hard capsules

 

What is it and how is it used?

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 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).

What do you have to consider before using it?

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.

How is it used?

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.

What are possible side effects?

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 rare side 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.

How should it be stored?

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 is it?

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 it 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 it 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 it 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 it 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 benefits has it 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?

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 it 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 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.

Further information

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. 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.