PRAVAFENIX 40 mg/160 mg HARD CAPSULES

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Pravafenix 40mg/160mg hard capsules

pravastatin sodium/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 only. 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.

Contents of the pack

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

1. What is Pravafenix and what is it used for

Pravafenix contains two active substances: pravastatin and fenofibrate. Both are cholesterol/lipid-modifying medicines.

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

• To reduce the levels of "bad" cholesterol (LDL cholesterol). It does this by reducing the levels of total cholesterol and certain fatty substances (triglycerides) in the blood.
• To increase the levels of "good" cholesterol (HDL cholesterol).

What should you know about cholesterol and triglycerides?

Cholesterol is one of the different types of fat present in the blood. Total cholesterol is mainly made up of LDL cholesterol and HDL cholesterol.

LDL cholesterol is known as "bad" cholesterol because it can build up in the walls of the arteries and form plaques. Over time, the buildup of plaques can block the arteries, slowing or stopping the flow of blood to vital organs such as the heart and brain. When the flow is blocked, it can cause a heart attack or stroke.

HDL cholesterol is known as "good" cholesterol because it helps prevent "bad" cholesterol from building up in the arteries and protects against heart disease.

Triglycerides are another type of fat present in the blood that can increase the risk of heart problems.

In most people, cholesterol problems go unnoticed at first. Your doctor can find out your cholesterol levels with a simple blood test. Visit your doctor regularly to have your cholesterol checked.

Pravafenix is used in adult patients with a high risk of coronary heart disease to reduce blood cholesterol and triglyceride levels when "bad" cholesterol levels are adequately controlled with pravastatin or another moderate-intensity statin (cholesterol-reducing medicine) as monotherapy.

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 have liver disease.
• if you are under 18 years of age.
• if you have kidney disease.
• if you have had a photoallergic reaction (an allergic reaction caused by sunlight or exposure to ultraviolet radiation) or phototoxic reactions (skin damage caused by exposure to sunlight or ultraviolet radiation) during treatment with fibrates (lipid-modifying medicines) or ketoprofen (an anti-inflammatory that can be taken orally or applied to the skin for the treatment of musculoskeletal disorders, and orally for pain caused by gout or menstruation).

• if you have gallbladder disease.
• if you have pancreatitis (inflammation of the pancreas that causes abdominal pain).

• if you are pregnant or breastfeeding.
• if you have a history of muscle problems (such as myopathy or rhabdomyolysis) during treatment with cholesterol-reducing 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 points apply to you. If you are unsure, consult your doctor or pharmacist before taking Pravafenix.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Pravafenix.

Before taking Pravafenix, you must inform your doctor if you have or have had any medical problems.

• Tell your doctor about all your medical problems, including allergies.
• Tell your doctor if you consume large amounts of alcohol (if you consume more than the recommended daily amount; consult your doctor or pharmacist if you are unsure) or have ever had liver disease. See the section "Using Pravafenix with food and drinks" below.
• Your doctor will perform a blood test before you start treatment with Pravafenix to check if your liver and kidneys are working properly.
• Your doctor may also want to perform blood tests to check the proper functioning of your liver after you start taking Pravafenix.
• If you have or have had myasthenia (a disease characterized by generalized muscle weakness that can affect the muscles used for breathing) or ocular myasthenia (a disease that causes weakness of the eye muscles), as statins can sometimes worsen the disease or cause myasthenia (see section 4).

Contact your doctor immediately if you experience muscle pain, tenderness to the touch, or muscle weakness without apparent reason: in exceptional cases, muscle problems can be serious, including muscle destruction, which can cause kidney damage and, in very rare cases, death.

Also, inform your doctor or pharmacist if you experience constant muscle weakness. Additional tests and medications may be necessary to diagnose and treat this problem.

The risk of muscle destruction is higher in some patients. Inform your doctor if any of the following points apply to you:

• Liver or kidney problems.
• Thyroid problems.
• Age over 70 years.
• History of muscle problems during treatment with cholesterol-reducing medicines called "statins" (such as simvastatin, atorvastatin, pravastatin, or rosuvastatin) or fibrates (such as fenofibrate and bezafibrate).
• You are taking or have taken in the last 7 days a medicine called "fusidic acid" (an antibiotic used to treat bacterial infections) orally or by injection. The combination of fusidic acid and Pravafenix can lead to serious muscle problems (rhabdomyolysis) in rare cases. You can find more information about rhabdomyolysis in section 4.
• Personal or family history of hereditary muscle disease.
• Problems related to alcohol consumption (regular consumption of large amounts of alcohol).

Consult your doctor or pharmacist before taking Pravafenix if you have acute respiratory failure; for example, if you have respiratory problems, such as persistent non-productive cough, general health deterioration, such as fatigue (tiredness), weight loss, shortness of breath, or fever.

If you notice any of these symptoms, stop taking Pravafenix and inform your doctor.

During treatment with this medicine, your doctor will closely monitor you if you are diabetic or have a high risk of developing diabetes. You are more likely to develop diabetes if your blood sugar and fat levels are high, you are overweight, or you have high blood pressure.

Children and adolescents

Pravafenix should not be taken by children under 18 years of age.

Other medicines and Pravafenix

Using Pravafenix with other medicines

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines.It is important that you inform your doctor if you are already receiving treatment with any of the following medicines:

• Bile acid resins, such as cholestyramine/colestipol (a cholesterol-reducing medicine), as they alter the effect of Pravafenix.
• Cyclosporin (a medicine used in patients who receive organ transplants).
• Medicines to prevent blood clots, such as warfarin, fluindione, phenprocoumon, or acenocoumarol (anticoagulants).
• An antibiotic such as erythromycin or clarithromycin for the treatment of bacterial infections.
• Fusidic acid: If you need to take fusidic acid orally to treat a bacterial infection, you will have to temporarily stop using this medicine. Your doctor will tell you when it is safe to resume using Pravafenix. Taking Pravafenix with fusidic acid can lead to serious muscle problems (rhabdomyolysis) in rare cases. You can find more information about rhabdomyolysis in section 4.
• Glecaprevir/pibrentasvir (used to treat hepatitis C virus infections), as it may increase some side effects, including muscle problems.
• A particular category of medicines for the treatment of diabetes (such as rosiglitazone, pioglitazone)

Taking Pravafenix with food, drinks, and alcohol

• Always take Pravafenix with food, as it is absorbed less well on an empty stomach.
• You should always minimize your alcohol consumption. If you want to know how much alcohol you can drink while taking this medication, talk to your doctor.

If you are unsure, follow your doctor's instructions.

Pregnancy and breastfeeding

Do not take Pravafenix if you are pregnant or think you may be pregnant or are planning to become pregnant. If you intend to become pregnant, consult your doctor immediately. The use of this medicine should be discontinued due to the possible risk to the fetus.

Do not take Pravafenix if you are breastfeeding.

Driving and using machines

Pravafenix does not normally affect your ability to drive or use machines. If you experience dizziness, blurred vision, or double vision during treatment, check that you are fit to drive vehicles and use machinery before attempting to do so.

Pravafenix contains lactose and sodium

This medicine contains lactose. If your doctor has told you that you have an intolerance to some sugars, consult them before taking this medicine.

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

3. How to take Pravafenix

Follow the instructions for administration of this medicine exactly as indicated by your doctor. If you are unsure, consult your doctor or pharmacist again.

• Before starting to take Pravafenix, you must follow a diet to reduce cholesterol.
• You must maintain this diet throughout the treatment with Pravafenix.

The recommended dose is one capsule per day, taken with dinner. The capsule should be swallowed with water, and it is essential to take it with food, as it does not work as effectively on an empty stomach.

If your doctor has prescribed Pravafenix with cholestyramine or other bile acid sequestrants (cholesterol-reducing medicines), take Pravafenix 1 hour before, or 4 to 6 hours after the resin. This is because cholestyramine or other bile acid sequestrants often reduce the absorption of medicines when not taken at a sufficient distance, which can prevent the absorption of Pravafenix. If you need antacids (used to neutralize stomach acid), wait one hour to take Pravafenix.

If you take more Pravafenix than you should

Consult your doctor or pharmacist.

If you forget to take Pravafenix

Do not take a double dose to make up for forgotten doses. Simply take your normal dose of Pravafenix at the usual time the next day.

If you stop taking Pravafenix

Do not stop taking Pravafenix without talking to your doctor first.

If you have any other questions about 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 require immediate action.

Tell your doctor immediately if you experience pain or cramps, tenderness to the touch, or muscle weakness without apparent reason; in exceptional cases (can affect up to 1 in 10,000 people), muscle problems can be serious, including muscle destruction, which can cause kidney damage and, in very rare cases, death.

Severe allergic reactions with swelling of the face, lips, tongue, or trachea can greatly impair breathing. This is a very rare reaction, but it can be serious if it occurs. If it occurs, you must inform your doctor immediately.

Other side effects

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

• Gastrointestinal disorders: gastrointestinal or intestinal disorders (abdominal pain, nausea, vomiting, diarrhea, and flatulence, constipation, dry mouth, upper abdominal pain with flatulence [dyspepsia], belching [eructation]).
• Liver effects: elevated serum transaminases.

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

• Abnormal heartbeat (palpitations), formation of blood clots in the veins (deep vein thrombosis), and blockage of the pulmonary arteries by blood clots (pulmonary embolism).
• Rash, skin rash, itching, hives, or reactions to sunlight or exposure to ultraviolet radiation (photosensitivity reactions), scalp/hair anomalies (such as alopecia).
• Effects on the nervous system: dizziness (feeling of instability), headache, sleep disturbances (such as difficulty sleeping and nightmares), sensation of tingling (paresthesia).
• Muscle and joint pain (myalgia, arthralgia), back pain, alterations in the results of some clinical tests of muscle function.
• Vision problems, such as blurred or double vision.
• Kidney problems (elevated or decreased levels of certain body enzymes obtained in a clinical test), bladder problems (painful or frequent urination, need to urinate at night), sexual dysfunction.
• Fatigue, weakness, pseudo-flu-like illness.
• Hypersensitivity.
• Elevated blood cholesterol, elevated triglycerides in blood, increased LDL, elevated gamma-glutamyltransferase (various liver enzymes), liver pain (upper right abdominal pain, with or without back pain), weight gain.
• Obesity.
• Muscle inflammation (myositis), muscle cramps, and weakness.

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

• Decreased hemoglobin (the pigment that carries oxygen in the blood) and white blood cells (leukocytes).

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

• Liver inflammation (hepatitis), whose symptoms can range from mild yellowing of the skin and the whites of the eyes (jaundice) to abdominal pain and itching.
• Muscle breakdown (rhabdomyolysis), some cases of tendon problems, sometimes complicated by rupture.
• A disorder characterized by inflammation of the muscles and skin (dermatomyositis).
• Skin rash, possibly with joint pain (lupus-like syndrome).
• Tingling or numbness (peripheral neuropathy).

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

• Constant muscle weakness.
• Muscle rupture.
• Skin rash (lichenoid eruption).
• Severe myasthenia (a disease that causes generalized muscle weakness that can affect the muscles used for breathing).
• Ocular myasthenia (a disease that causes weakness of the eye muscles).
• Consult your doctor if you experience weakness in your arms or legs that worsens after periods of activity, double vision, or drooping eyelids, difficulty swallowing, or difficulty breathing.

Possible side effects reported with some statins (a type of cholesterol-reducing medicine, such as pravastatin)

• Memory loss.
• Depression.
• Respiratory problems, including persistent cough, difficulty breathing, or fever.
• Diabetes. Its presence is more likely if your blood sugar and fat levels are high, you are overweight, or you have high blood pressure. Your doctor will monitor you while you are taking this medicine.

Reporting side effects

If you experience any side effects, talk to your doctor or pharmacist, even if it is possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use Medicines: www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of 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 on the blister or bottle after 'CAD'. The expiry date is the last day of the month stated.

This medicine does not require any special storage conditions.

Do not throw any medicine away via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Pravafenix

• The active substances are fenofibrate and pravastatin sodium. Each hard capsule contains 40 mg of pravastatin sodium and 160 mg of fenofibrate.
• The other ingredients are:

• capsule content:lactose monohydrate, microcrystalline cellulose, ascorbyl palmitate, povidone, sodium carboxymethyl starch, magnesium stearate, talc, triacetin, sodium bicarbonate, lauryl macrogol glycerides, hydroxypropylmethylcellulose, macrogol 20,000.
• capsule shell:gelatin, indigo carmine (E-132), black iron oxide (E-172), titanium dioxide (E-171), yellow iron oxide (E-172).

Appearance of the Product and Package Contents

The capsules are hard and gelatinous, with an olive green cap and a light green body containing a beige-white waxy mass and a tablet. The capsules are presented 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.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization 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 more information about this medicine, please contact the local representative of the marketing authorization holder:

Date of the last revision of this leaflet: 21-10-2024

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