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.
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.