PATIENT INFORMATION LEAFLET

Pravafenix 40mg/160mg hard capsules

pravastatina sódica/fenofibrato

Read this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you onlyaloneand not for others even if they have similar symptomsto yours, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist,even if they are not listed in this leaflet. See section 4

Pravafenix contains two active principles: pravastatina and fenofibrate. Both are lipid-lowering medications.

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

• For reducing levels of "bad" cholesterol (LDL cholesterol). It achieves this by reducing blood concentrations of total cholesterol and certain types of fatty substances calledtriglycerides.
• To increase levels of "good" cholesterol (HDL cholesterol).

What should I know about cholesterol and triglycerides?

Cholesterol is one of the different types of fats present in the blood. Total cholesterol is mainly composed of LDL cholesterol and HDL cholesterol.

LDL cholesterol is known as "bad" cholesterol because it can accumulate in the walls of arteries and form plaques. Over time, the accumulation of plaques can lead to the obstruction of arteries, slowing or interrupting blood flow to vital organs, such as the heart and brain. When blood flow is obstructed, it can cause a myocardial infarction or a stroke.

HDL cholesterol is known as "good" cholesterol because it helps prevent the accumulation of "bad" cholesterol in arteries and protects against cardiovascular diseases.

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

Most people are unaware of cholesterol problems at first. Your doctor may know your cholesterol levels with a simple blood test. Visit your doctor regularly for them to monitor your cholesterol.

Pravafenix is used in adult patients with a high risk of coronary disease to reduce blood concentrations of cholesterol and triglycerides when LDL cholesterol levels are adequately controlled with pravastatina or with another moderate-intensity statin (cholesterol-lowering medication) as monotherapy.

Do not take Pravafenix

• if you are allergic to fenofibrate, pravastatin, or any of the other components of this medication (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 ultraviolet radiation) or phototoxic reactions (skin damage caused by sunlight or ultraviolet radiation) during treatment with fibrates (lipid-modifying drugs) or ketoprofen (an anti-inflammatory that can be taken orally or applied topically for musculoskeletal disorders, and orally for gout or menstrual pain).

• 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-lowering medications 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, inform your doctor if you have or have had any medical problems.

• Inform your doctor of all your medical problems, including allergies.
• Inform 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 had liver disease at any time. See the section "Use of Pravafenix with food and drinks" for more information.
• Your doctor should perform a blood test before you start treatment with Pravafenix. This test will check if your liver and kidneys are functioning correctly.
• Your doctor may also want to perform blood tests to check the proper functioning of your liver after you have started taking Pravafenix.
• If you have or have had myasthenia (a disease that causes generalized muscle weakness that, in some cases, affects 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, or weakness without apparent reason: in rare cases, severe muscle problems can occur, sometimes with kidney damage and, in very rare cases, patient death.

Also inform your doctor or pharmacist if you experience persistent 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 70 years or older.
• History of muscle problems during treatment with cholesterol-lowering medications, such as statins or fibrates.
• You are taking or have taken within the last 7 days a medication called "fusidic acid" (an antibiotic used to treat bacterial infections) orally or by injection. The combination of fusidic acid and Pravafenix can cause severe muscle problems (rhabdomyolysis).
• Personal or family history of inherited muscle disease.
• Problems related to alcohol consumption (habitual consumption of large amounts of alcohol).

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

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

Your doctor will closely monitor you during treatment with this medication if you are diabetic or have a high risk of developing diabetes. You are at higher risk of developing diabetes if your blood sugar and lipid levels are elevated, you are overweight, or you have high blood pressure.

Children and adolescents

Children under 18 years of age should not take Pravafenix

Other medications and Pravafenix

Use of Pravafenix with other medications

Inform your doctor or pharmacist if you are using, have used recently, or may need to use another medication.It is essential to inform your doctor if you are already receiving treatment with any of the following medications:

• Cholestyramine/colestipol (a medication to reduce cholesterol), as it alters the effect of Pravafenix.
• Ciclosporin (a medication used in patients who have received organ transplants).
• Medications to prevent blood clotting, 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 need to temporarily stop taking this medication. Your doctor will tell you when it is safe to resume taking Pravafenix. Taking Pravafenix with fusidic acid can cause rare cases of muscle weakness, sensitivity, or pain (rhabdomyolysis). See section 4 for more information on rhabdomyolysis.
• Glecaprevir/pibrentasvir (used to treat hepatitis C infections), as it can increase some side effects, including muscle problems.
• A particular category of medications for the treatment of diabetes (such as rosiglitazone, pioglitazone).

Use of Pravafenix with food, drinks, and alcohol

• Always take Pravafenix with food, as it is absorbed poorly on an empty stomach.
• Always minimize alcohol consumption. If you want to know how much alcohol you can drink while taking this medication, consult 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 trying to become pregnant. If you plan to become pregnant, consult your doctor immediately. Taking this medication should be discontinued due to the possible risk to the fetus.

Do not take Pravafenix if you are breastfeeding.

Driving and operating machinery

Pravafenix generally does not affect the ability to drive or operate machinery. If you experience dizziness, blurred vision, or double vision during treatment, check that you are capable of driving vehicles and operating machinery before attempting to do so.

Pravafenix contains lactose and sodium

This medication contains lactose. If your doctor has told you that you have a intolerance to certain sugars, consult with them before taking this medication.

This medication contains 33.3 mg of sodium (the main component of table salt / for cooking) in each capsule (excipients and active ingredient included). This is equivalent to 1.7% of the maximum daily sodium intake recommended for an adult.

Follow exactly the administration instructions for this medication as indicated by your doctor. In case of doubt, 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 must be swallowed with water, and it is essential to take it with food, as it does not act with the same efficacy on an empty stomach.

If your doctor has prescribed Pravafenix along with cholestyramine or other bile acid sequestrants (medications to reduce cholesterol), take Pravafenix 1 hour before, or between 4 and 6 hours after the resin. This is because cholestyramine or other bile acid sequestrants often reduce the absorption of medications when not taken far enough apart, which can prevent the absorption of Pravafenix. If you need medications for indigestion (used to neutralize stomach acids), wait an hour to take Pravafenix.

If you take more Pravafenix than you should

Consult your doctor or pharmacist.

If you forgot to take Pravafenix

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

If you interrupt the treatment with Pravafenix

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

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

The following two side effects are important and will require immediate action.

Inform your doctor immediately if you experience pain or muscle cramps, sensitivity to palpation, or muscle weakness without apparent cause; in exceptional cases (which can affect up to 1 in 10,000 people), muscle problems can be severe, including muscle destruction, causing kidney damage and, in very rare cases, patient death.

Severe allergic reactions, with swelling of the face, lips, tongue, or trachea, can significantly hinder 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

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

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

Less frequent side effects (which can affect up to 1 in 100 people)

• Abnormal heart rhythm (palpitations), formation of blood clots in veins (deep vein thrombosis) and obstruction of pulmonary arteries by blood clots (pulmonary embolism).
• Rash, skin rash, itching, hives, or reactions to sunlight or exposure to ultraviolet radiation (phototoxicity), hair and scalp abnormalities (such as alopecia).
• Effects on the nervous system: dizziness (sensation 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 analysis of muscle function.
• Visual problems, such as blurred vision or double vision.
• Renal problems (elevation or decrease of certain enzymes in the body obtained in an analysis), urinary problems (painful or frequent urination, nocturia), sexual dysfunction.
• Fatigue, weakness, pseudogripal disease.
• Hypersensitivity.
• Elevation of blood cholesterol, elevation of blood triglycerides, increase of LDL, elevation of 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 muscle weakness.

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

• Decrease in hemoglobin (the pigment that transports oxygen in the blood) and leukocytes (white blood cells).

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

• Liver inflammation (hepatitis), whose symptoms can vary from a mild yellowing of the skin and the white of the eyes (jaundice) to abdominal pain and pruritus.
• Muscle degradation (rhabdomyolysis), some cases of tendon problems, sometimes complicated with 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 (the frequency cannot be estimated from the available data)

• Constant muscle weakness.
• Muscle rupture.
• Maculopapular rash.
• Myasthenia gravis (a disease that causes generalized muscle weakness, which in some cases affects the muscles used for breathing).
• Myasthenia ocular (a disease that causes weakness of the eye muscles).
• Consult your doctor if you experience weakness in the arms or legs that worsens after periods of activity, double vision, or eyelid drooping, difficulty swallowing, or difficulty breathing.

Possible side effects reported with some statins (medicines of the same type as pravastatin, cholesterol-lowering)

• 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 elevated, you are overweight, or you have high blood pressure. Your doctor will monitor you while you are on treatment with this medicine.

Reporting side effects

If you experienceany type of side effect, consult your doctor or pharmacist, even if it ispossibleside effects that do not appear in this prospectus.You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use: www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep this medication out of the sight and reach of children.

Do not usethis medicationafter the expiration date that appears on the box and on the blister pack or bottle after «CAD».The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

Do not dispose of any medication through the drains or in the trash. Ask your pharmacist how to dispose of the containers and unused medications. By doing so, you will help protect the environment.

Composition of Pravafenix

• The active principles are fenofibrate and pravastatina sodium. Each hard capsule contains 40mg of pravastatina sodium and 160mg of fenofibrate.
• The other components are:

• capsule content:lactose monohydrate, microcrystalline cellulose, ascorbyl palmitate, povidone, sodium carboxymethylcellulose, magnesium stearate, talc, triacetin, sodium bicarbonate, lauril macrogol glycerides, hydroxypropylmethylcellulose, macrogol 20000.
• capsule coating:gelatin, indigo carmine (E-132), iron oxide black (E-172), titanium dioxide (E-171), iron oxide yellow (E-172).

Appearance of the product and contents of the package

The capsules are hard and gelatinous, with a green olive-colored cap and a light green-colored body containing a beige-white paste and a tablet. The capsules are presented in blisters of polyamide-aluminum-PVC/aluminum containing 30, 60 or 90capsules, and in opaque white plastic bottles containing 14, 30, 60or 90capsules.

Only some package sizes may be marketed.

Marketing authorization holder and responsible manufacturer

Marketing authorization holderResponsible manufacturer

Laboratoires SMB s.a.SMB Technology s.a.

Rue de la Pastorale, 26-28Rue du Parc Industriel 39

B-1080BrusselsB-6900Marche-en-Famenne

BelgiumBelgium

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

Last revision date of thissummary of product characteristics 21-10-2024

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