PRAVASTATIN VIR 10 mg TABLETS

2. Before taking PRAVASTATINA VIR

Do not take PRAVASTATINA VIR:

• If you are allergic to pravastatin sodium or any of the other components of PRAVASTATINA VIR.

PRAVASTATINA VIR.

• If you have active liver disease (liver) or have elevated transaminases (enzymes indicative of liver disease).

• If you are pregnant or may be pregnant.
• If you are breastfeeding.

Warnings and precautions

Consult your doctor or pharmacist before taking PRAVASTATINA VIR if you:

• Have severe respiratory failure
• Are taking or have taken in the last 7 days a medicine containing fusidic acid (used to treat bacterial infections) orally or by injection. The combination of fusidic acid and pravastatin can cause serious muscle problems (rhabdomyolysis).
• 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 to appear (see section 4).

While you are taking this medicine, your doctor will check if you have diabetes or are at risk of developing diabetes. This risk of diabetes increases if you have high levels of sugar and fat in the blood, are overweight, and have high blood pressure.

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.

Be careful with PRAVASTATINA VIR:

• If you have had liver disease or have a history of alcoholism.

It is possible that moderate increases in liver transaminase levels may occur, which, in most cases, return to their initial level without the need to suspend treatment.

• You should also inform your doctor if you have kidney failure, hypothyroidism, if you have a family history or have previously had muscle disorders, or if you normally consume alcohol.
• During treatment, some patients may experience pain, sensitivity, muscle weakness, or muscle cramps. If you experience any of these symptoms, you should immediately inform your doctor.

It is possible that your doctor may recommend blood tests to determine the condition of your muscles before starting treatment and during treatment, to consider starting, continuing, or suspending treatment.

Inform your doctor if you are taking other medicines that can also cause muscle disorders, such as:

• Fibrates (lower cholesterol levels).
• Nicotinic acid (lowers cholesterol levels).

Consult your doctor, even if any of the above circumstances have occurred to you at any time.

Taking PRAVASTATINA VIR with food and drinks:

PRAVASTATINA VIR can be taken with or without food.

PRAVASTATINA VIR should be administered with caution to patients who consume alcohol. If you drink alcohol regularly, consult your doctor.

Pregnancy:

Consult your doctor or pharmacist before taking a medicine.

PRAVASTATINA VIR should not be taken during pregnancy. In case of pregnancy or suspected pregnancy, treatment should be suspended and your doctor informed as soon as possible.

Breastfeeding:

Consult your doctor or pharmacist before taking a medicine.

PRAVASTATINA VIR should not be taken during breastfeeding, as it passes into breast milk.

Driving and using machines:

At normal doses, PRAVASTATINA VIR does not affect the ability to drive or use machines. However, if you notice symptoms of dizziness, do not drive or use machines until you know how you tolerate the medicine.

Using other medicines:

Inform your doctor or pharmacist if you are taking or have recently taken any other medicine, including those obtained without a prescription.

Certain medicines can interact with PRAVASTATINA VIR; in these cases, it may be necessary to change the dose or interrupt treatment with one of them.

It is essential that you inform your doctor if you are taking or have recently taken any of the following medicines:

• Other drugs used to lower cholesterol levels, such as colestyramine or colestipol (can decrease pravastatin levels in the blood), and fibrates (can increase the risk of muscle side effects).
• Cyclosporine, a medicine used to prevent transplant rejection (when administered with pravastatin, cyclosporine increases pravastatin levels in the blood).
• Antibiotics such as erythromycin or clarithromycin (can increase pravastatin levels in the blood).

If you need to take oral fusidic acid to treat a bacterial infection, you will need to stop using this medicine. Your doctor will indicate when you can restart treatment with pravastatin. The use of pravastatin with fusidic acid can cause muscle weakness, sensitivity, or pain (rhabdomyolysis). For more information on rhabdomyolysis, see section 4.

3. How to take PRAVASTATINA VIR

Follow these instructions unless your doctor has given you different instructions.

Remember to take your medicine.

Your doctor will indicate the duration of your treatment with PRAVASTATINA VIR. Do not suspend treatment before.

The tablets should be swallowed with water and can be administered with or without food, preferably at night.

The normal dose is between 10-40 mg once a day. Your doctor will establish the suitable dose for you and make the necessary adjustments based on your response to the medicine.

Combined treatment:patients treated with pravastatin and cyclosporine should start treatment with 20 mg of pravastatin once a day; your doctor will adjust the dose up to 40 mg. For patients treated with pravastatin and a bile acid sequestrant (e.g., colestyramine, colestipol), PRAVASTATINA VIR should be administered one hour before or four hours after the sequestrant.

Children and adolescents:the administration of pravastatin is not recommended for children under 18 years of age, as its efficacy and safety have not been established in this age group.

Elderly patients:it is not necessary to adjust the dose in these patients unless there are other risk factors.

Patients with renal or hepatic insufficiency:in patients with moderate or severe renal function impairment or significant hepatic function impairment, treatment should be initiated with a dose of 10 mg.

If you think the effect of PRAVASTATINA VIR is too strong or too weak, talk to your doctor or pharmacist.

If you take more PRAVASTATINA VIR than you should:

If you have taken more PRAVASTATINA VIR than you should, contact your doctor, pharmacist, or the nearest hospital.

In case of overdose or accidental ingestion, consult the Toxicological Information Service. Phone: 915 620 420.

If you forget to take PRAVASTATINA VIR:

Do not take a double dose to make up for forgotten doses; wait for the next dose.

4. Possible side effects

Like all medicines, PRAVASTATINA VIR can have side effects.

Immune system disorders:

Very rare: allergic reactions, angioedema (swelling of the arms, legs, face, lips, tongue, and/or throat), lupus-like syndrome (skin inflammation).

Nervous system disorders:

Uncommon: dizziness, headache, sleep disorders, insomnia.

Very rare: peripheral neuropathy, particularly when used for a prolonged period, and a sensation of tingling.

Frequency not known: severe myasthenia (a disease that causes generalized muscle weakness that, in some cases, affects the muscles used for breathing).

Eye disorders:

Uncommon: vision disturbances (including blurred vision and double vision of objects).

Frequency not known: ocular myasthenia (a disease that causes weakness of the eye muscles).

Gastrointestinal disorders:

Uncommon: indigestion/heartburn, abdominal pain, nausea, vomiting, constipation, diarrhea, gas. Very rare: pancreatitis (inflammation of the pancreas).

Hepatobiliary disorders:

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

Skin and subcutaneous tissue disorders:

Uncommon: itching, skin rash, appearance of blisters accompanied by itching, hair and scalp abnormalities (including hair loss).

Musculoskeletal and connective tissue disorders:

Very rare: rhabdomyolysis (destruction of muscle fibers), which can be associated with kidney disorders, myopathy (muscle disorders). Tendon disorders, sometimes complicated by rupture.

Frequency not known: constant muscle weakness, muscle rupture.

Renal and urinary disorders:

Uncommon: changes in urine elimination (such as difficulty urinating, urinating more frequently, and urinating more frequently at night).

Reproductive system and breast disorders:

Uncommon: sexual disorders.

General disorders:

Uncommon: fatigue.

The following side effects of special clinical interest have also been reported during clinical studies:

Musculoskeletal and connective tissue disorders:

musculoskeletal pain, including joint pain, muscle cramps, muscle pain (very common), muscle weakness (common), and elevated creatine kinase levels (an enzyme indicative of muscle disorder).

Hepatic disorders:

elevations of serum transaminases (enzymes indicative of liver disease).

Other possible side effects

• Sleep disorders, including insomnia and nightmares
• Memory loss
• Sexual dysfunction
• Depression
• Respiratory problems, including persistent cough and/or difficulty breathing or fever

Diabetes. This is more likely if you have high levels of sugar and fat in the blood, are overweight, and have high blood pressure. Your doctor will monitor you while you are taking this medicine.

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

If you notice any other side effect not described in this leaflet, consult your doctor or pharmacist.

Reporting side effects

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

5. Storage of PRAVASTATINA VIR

Keep out of the reach and sight of children.

Storage conditions

Do not store above 30°C

Keep in the original package, protected from light and moisture

Expiration date

Do not use after the expiration date stated on the package. The expiration date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Place the packages and medicines you no longer need in the SIGRE collection point at the pharmacy. Ask your pharmacist how to dispose of packages and medicines you no longer need. This will help protect the environment.

6. FURTHER INFORMATION

Composition of PRAVASTATINA VIR:

The active ingredient is pravastatin sodium. Each tablet contains 10 mg of pravastatin sodium.

The other components (excipients) are: calcium phosphate monobasic anhydrous, sodium starch glycolate, microcrystalline cellulose, tromethamine, sodium phosphate dibasic dihydrate, polyvinylpyrrolidone K30, magnesium stearate, yellow iron oxide (E-172)

PRAVASTATINA VIR 10 mg is presented in the form of yellow tablets. Each package contains 28 tablets.

Other presentations:

PRAVASTATINA VIR 20 mg TABLETS EFG

PRAVASTATINA VIR 40 mg TABLETS EFG

Marketing authorization holder and manufacturer:

INDUSTRIA QUÍMICA Y FARMACÉUTICA VIR, S.A.

C/ Laguna 66-68-70, Polígono Industrial Urtinsa II - 28923 ALCORCÓN (Madrid)

Manufacturer:

Industria Química y Farmacéutica VIR, S.A.

C/ Laguna 66-70, Polígono Industrial Urtinsa II - 28923 Alcorcón (Madrid)

or

SALUTAS PHARMA GmbH. Otto Von Guericke Alle 1. 39179 Barleben. GERMANY

Date of the last revision of this leaflet: March 2024

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es