PRODUCT INFORMATION FOR THE USER

PRAVASTATINA PHARMA COMBIX 20 mg FILM-COATED TABLETS

Pravastatin Sodium

1. What Pravastatina Pharma Combix is and what it is used for

2. Before taking Pravastatina Pharma Combix

3. How to take Pravastatina Pharma Combix

4. Possible side effects

5. Storage of Pravastatina Pharma Combix

6. Additional information

Pravastatina Pharma Combix 20 mg belongs to a group of medications known as statins (or HMG-CoA reductase inhibitors). It prevents the production of cholesterol by the liver and as a result reduces levels of cholesterol and other fats (triglycerides) in the body. When there are excessive levels of cholesterol in the blood, cholesterol accumulates in the walls of blood vessels, obstructing them.

This situation is known as hardening of the arteries or atherosclerosis, and can lead to:

· chest pain (angina pectoris), when a coronary artery is partially obstructed

· heart attack (myocardial infarction), when a coronary artery is completely obstructed,

· stroke (cerebral infarction) when a cerebral artery is completely obstructed.

This medication is indicated in three situations:

For the treatment of high levels of cholesterol and fats in the blood.

Pravastatina Pharma Combix is indicated to reduce high levels of "bad" cholesterol and increase levels of "good" cholesterol in the blood when diet and exercise have not been effective.

Prevention of heart and blood vessel diseases.

- If you have high levels of cholesterol in the blood and risk factors that favor these diseases (if you smoke, are overweight, have high blood sugar levels or hypertension, or do little exercise), Pravastatina Pharma Combix is indicated to reduce the risk of suffering a heart and blood vessel problem and decreases the risk of dying from these diseases.

- If you have already suffered a stroke or have unstable angina, even with normal cholesterol levels. Pravastatina Pharma Combix is indicated to reduce the risk of suffering another heart attack or stroke in the future, and decreases the risk of dying from these diseases.

After an organ transplant

If you have undergone an organ transplant and are receiving medication to prevent your body from rejecting the transplant, Pravastatina Pharma Combix 20 mg is indicated to reduce elevated levels of fat in the blood.

Do not take Pravastatina Pharma Combix 20 mg:

• If you are allergic (hypersensitive) to pravastatina sodium or to any of the other components of this medication (see Additional Information).
• If you are pregnant, intend to become pregnant, or if you are breastfeeding (see "Pregnancy and Breastfeeding").
• If you have any liver disease (active liver disease);
• If several blood tests show abnormal liver function (elevated levels of liver enzymes in the blood).

Be especially careful with Pravastatina Pharma Combix 20 mg:

Before taking this treatment, you must consult your doctor if you have or have had any of the following medical problems:

• Liver disease;
• Hypothyroidism;
• Liver disease or problems with alcohol (drinking large amounts of alcohol);
• Muscle alterations caused by a hereditary disease;
• Muscle problems caused by another medication belonging to the group of statins (medications inhibiting HMG-Coa reductase) or belonging to the group known as fibrates (see Taking Other Medications).
• If you are taking or have taken in the last 7 days any medication that contains fusidic acid, you should not take Pravastatina Pharma Combix. Your doctor will tell you when you can restart the treatment with Pravastatina Pharma Combix. The use of Pravastatina Pharma Combix with fusidic acid may produce muscle weakness, sensitivity, or pain (rhabdomyolysis). For more information on rhabdomyolysis, see section 4.

If you have had any of these problems or if you are over 70 years old, your doctor will perform a blood test before and probably during treatment. These blood tests will be used to evaluate the risk of you experiencing muscle side effects.

If you feel inexplicable cramps or muscle pain during treatment, inform your doctor immediately.

Consult your doctor or pharmacist before taking Pravastatina Pharma Combix if you:

Have severe respiratory insufficiency.

If you have or have had myasthenia (a disease that causes generalized muscle weakness, which in some cases affects the muscles used for breathing) or myasthenia gravis (a disease that causes weakness of the eye muscles), as statins may sometimes worsen the disease or cause myasthenia (see section 4).

Also inform your doctor or pharmacist if you experience persistent muscle weakness. You may need additional tests and medications to diagnose and treat this problem.

Use of other medications:

When combined with this treatment, the following medications may increase the risk of experiencing muscle problems (see Possible Side Effects). It is essential to inform your doctor if you are being treated with:

• A medication that lowers cholesterol levels in the blood (fibrates, e.g. gemfibrozil, fenofibrate);
• A medication that lowers the body's defenses (ciclosporin);
• A medication that treats infections caused by bacteria (an antibiotic such as erythromycin or clarithromycin);
• Any other medication that lowers cholesterol levels in your blood (nicotinic acid)

Inform your doctor or pharmacist if you are using or have used recently other medications, even those acquired without a prescription.

Taking Pravastatina Pharma Combix 20 mg with food and drinks:

This treatment can be taken with or without food, with half a glass of water.

You should reduce your alcohol consumption to a minimum. If you have doubts about how much alcohol you can drink while taking this medication, consult your doctor.

Pregnancy:

Do not take Pravastatina Pharma Combix 20 mg during pregnancy. If you discover you are pregnant, inform your doctor immediately.

Consult your doctor or pharmacist before using any medication.

Breastfeeding:

Pravastatina Pharma Combix 20 mg should not be administered during the lactation period since this treatment passes into breast milk.

Driving and operating machines:

Pravastatina Pharma Combix 20 mg usually does not affect your ability to drive or operate machines. However, if you experience symptoms of dizziness, blurred vision, or double vision during treatment, do not drive or operate machines until you are sure you are in a condition to do so.

Important information about some of the components of Pravastatina Pharma Combix 20 mg:

This medication contains lactose.

If your doctor has indicated that you have an intolerance to certain sugars, consult with him before taking this medication.

Your doctor will advise you to follow a low-fat diet, which you should continue until the end of your treatment.

Follow exactly the administration instructions for this treatment as indicated by your doctor. Consult with your doctor or pharmacist if you have any doubts.

Pravastatina Pharma Combix 20 mg can be taken with or without food, with half a glass of water.

Dose:

Adults

• For the treatment of high cholesterol and blood fat levels: the usual dose is 10-40 mg once a day, preferably at night.
• For the prevention of heart and blood vessel diseases: the usual dose is 40 mg once a day, preferably at night.

Do not exceed the maximum daily dose of 40 mg of pravastatina sodium. Your doctor will establish the appropriate dose for you.

Children (8-13 years) and adolescents (14-18 years) with a hereditary disease that increases blood cholesterol levels:

The recommended dose between 8 and 13 years is 10-20 mg once a dayand the recommended dose between 14 and 18 years is 10-40 mg once a day.

After an organ transplant:

:

Your doctor may prescribe an initial dose of 20 mg once a day. Your doctor may adjust the dose up to 40 mg.

If you are also taking a medication that reduces the body's immune system (ciclosporina), your doctor may prescribe an initial dose of 20 mg once a day. Thisdosemay be adjustedup to 40 mgbyyour doctor.

If you have severe kidney or liver disease, your doctor may prescribe a lower dose of Pravastatina Pharma Combix.

Ifyou estimatethatthe actionof thistreatmentis too strong or weak,inform your doctor or pharmacist.

Treatment duration:

Your doctor will indicate the duration of your treatment with Pravastatina Pharma Combix. This medication should be taken regularly for the time your doctor recommends,even if it is for a long period oftime. Do not stop the treatment on your own.

If you take more Pravastatina Pharma Combix 20 mg than you should:

If you have taken more Pravastatina Pharma Combix 20 mg than you should, or if someone accidentally swallowed some tablets, contact your doctor or pharmacist or the nearest hospital.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

If you forgot to take Pravastatina Pharma Combix 20 mg:

If you forgot to take a dose, simply take your regular dose when it is due next.

Do not take a double dose to compensate for the missed doses.

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

Like all medicines, Pravastatina Pharma Combix 20 mg may cause side effects, although not everyone will experience them.

Stop taking Pravastatina Pharma Combix 20 mg and inform your doctor immediatelyif you notice unexplained or persistent muscle pain, pain on movement, weakness, or cramps, especially if you also feel unwell or have a fever.

In rare cases, muscle problems can be severe (rhabdomyolysis) and may cause a life-threatening kidney disease.

Severe and sudden allergic reactions such as swelling of the face, lips, tongue, or throat may cause serious breathing difficulties. This is a rare reaction that can be serious if it occurs. Inform your doctor immediately if this happens.

The following side effects are infrequent and may affect more than 1 in 1,000 people:

• Nervous system disorders:dizziness, fatigue, headache, sleep disorders, including insomnia
• Eye disorders:blurred vision or double vision
• Gastrointestinal disorders:indigestion, nausea, vomiting, stomach pain or discomfort, diarrhea, constipation, and gas
• Hepatobiliary disorders:

Rare: jaundice (yellowing of the skin), hepatitis (inflammation of the liver), fulminant hepatic necrosis (destruction of liver cells).

• Skin and hair disorders:itching, acne, skin rash, appearance of blisters accompanied by itching, hair and scalp abnormalities (including hair loss)
• Urinary and genital disorders:urination alterations (such as pain while urinating, urinating more frequently, and urinating more frequently at night), and sexual problems
• Musculoskeletal disorders:muscle and joint pain

The following side effects are very rare and may affect fewer than 1 in 10,000 people:

• Nervous system disorders:alterations in the sense of touch, including burning or tingling sensations, or numbness indicating nerve damage.
• Skin disorders:severe skin alteration (lupus erythematosus-like syndrome);
• Liver disorders: liver or pancreas inflammation; jaundice (recognized by yellowing of the skin and white of the eyes); rapid destruction of liver cells (fulminant hepatic necrosis);
• Musculoskeletal disorders: inflammation of one or more muscles causing muscle pain or weakness (myositis or polymyositis); muscle or joint pain or weakness; tendon inflammation, sometimes complicated by rupture.
• Altered blood tests:increased transaminases (a group of blood enzymes) that may indicate liver problems. Your doctor may want to perform periodic tests to monitor this.

Possible side effects:

• Nightmares
• Memory loss
• Depression
• Respiratory problems, including persistent cough and/or difficulty breathing or fever

Side effects of unknown frequency:

• Constant muscle weakness.
• 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).
• Muscle rupture.

Consult your doctor if you experience weakness in your arms or legs that worsens after periods of activity, double vision, eyelid drooping, difficulty swallowing, or difficulty breathing.

Reporting side effects

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

Keep out of reach and sight of children.

Do not use this treatment after the expiration date that appears on the carton and on the blister after “CAD”. The expiration date is the last day of the month indicated.

Do not store above 25°C.

Store in the original packaging to protect it from moisture and light.

Medicines should not be disposed of through drains or in the trash. Deposit the containers and medicines you no longer need at the Sigre Point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medicines you no longer need.This will help protect the environment.

Composition of Pravastatina Pharma Combix 20 mg:

• The active ingredient is pravastatina sodium.Each Pravastatina Pharma Combix tablet contains 20 mg of pravastatina sodium.
• The other components are lactose monohydrate, sodium croscarmellose, magnesium stearate, light magnesium oxide, microcelac 100, povidone K-30, and yellow iron oxide (E172).

Appearance of the product and contents of the package:

Pravastatina Pharma Combix 20 mg tablets are presented in the form of a yellow-colored, rectangular, rounded-edged, biconvex, uncoated tablet, with the letters “PDT” engraved on one face and the number “20” engraved on the other face.

Pravastatina Pharma Combix 20 mg tablets are packaged in blister strips and in containers of 28 tablets.

Holder of the marketing authorization:

Combix, S.L.U. Laboratories

C/ Badajoz 2. Edificio 2

28223 Pozuelo de Alarcón (Madrid)

Spain

Responsible for manufacturing:

Fundació DAU Laboratories

C/ C, 12-14 Pol. Ind. Zona Franca

08040 Barcelona

Spain

Last review date of this prospectus: March 2024

The detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.es/