Package Insert: Information for the User

PRAVASTATINA VIR 20 mg TABLETS EFG

Read this package insert carefully before starting to take the medication.

• Keep this package insert. You may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medication has been prescribed to you personally and should not be given to other people. It may harm them, even if their symptoms are the same as yours.
• If you consider that any of the adverse effects you are experiencing is severe or if you notice any adverse effect not mentioned in this package insert, inform your doctor or pharmacist.

1. What PRAVASTATINA VIR is and for what it is used

2. Before taking PRAVASTATINA VIR

3. How to take PRAVASTATINA VIR

4. Possible adverse effects

5. Storage of PRAVASTATINA VIR

6. Additional information

PRAVASTATINA VIR belongs to a group of medications known as statins that act by reducing the levels of lipids, cholesterol, and triglycerides in the blood. PRAVASTATINA VIR is indicated, along with an appropriate diet, for:

- The treatment ofprimary hypercholesterolemia and mixed dyslipidemia,a disease characterized by an increase in cholesterol and/or triglycerides in the blood, when diet or other measures (exercise or weight reduction) have not been effective.

- The prevention of cardiovascular problems (myocardial infarction) and cardiovascular death in patients with elevated cholesterol levels and a high risk of suffering a first cardiovascular event (Primary Prevention)

- The prevention of cardiovascular problems and cardiovascular death in patients with normal or high cholesterol levels who have already had some cardiovascular event, such as myocardial infarction or angina pectoris (Secondary Prevention)

-The reduction of lipid levels in the bloodin patients undergoing organ transplantation and receiving immunosuppressive treatment

Do not take PRAVASTATINA VIR:

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

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

• If you are pregnant or there is a possibility that you may be pregnant.

• If you are breastfeeding.

Warnings and precautions

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

• Have severe respiratory insufficiency
• Are taking or have taken within the last 7 days a medication that contains fusidic acid (used to treat bacterial infections) by mouth or injection. The combination of fusidic acid and pravastatina may cause severe 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 may sometimes worsen the disease or cause myasthenia (see section 4).

While you are taking this medication, your doctor will monitor if you have diabetes or are at risk of developing diabetes. This risk of diabetes increases if you have high blood sugar and fat levels, obesity, and high blood pressure.

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.

Be especially careful with PRAVASTATINA VIR:

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

It is possible that moderate increases in liver enzymes will occur, which in most cases will return to normal without the need to discontinue treatment.

- You should also inform your doctor if you have kidney insufficiency, hypothyroidism, have a family history or have previously had muscle disorders, or consume alcohol regularly.

- During treatment, some patients may experience muscle pain, sensitivity, weakness, or muscle cramps. If you experience any of these symptoms, inform your doctor immediately.

Your doctor may recommend blood tests to determine the state of your muscles before starting treatment and during treatment, to consider starting, continuing, or discontinuing treatment.

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

• Fibrates (lower cholesterol levels).

• Nicotinic acid (lowers cholesterol levels).

Consult with your doctor, even if any of the previously mentioned circumstances have occurred 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 regularly drink alcohol, consult with your doctor.

Pregnancy:

Consult with your doctor or pharmacist before taking a medication.

PRAVASTATINA VIR should not be administered during pregnancy. If you become pregnant or suspect that you may be pregnant, discontinue treatment and inform your doctor as soon as possible.

Lactation:

Consult with your doctor or pharmacist before taking a medication.

PRAVASTATINA VIR should not be administered during lactation as it passes into breast milk.

Driving and operating machinery:

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

Use of other medications:

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

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

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

- Other medications used to lower cholesterol levels, such as cholestyramine or cholestipol (may decrease pravastatina levels in the blood) and fibrates (may increase the risk of muscle adverse reactions).

- Cyclosporine, a medication used to prevent transplant rejection (administered with pravastatina, cyclosporine increases pravastatina levels in the blood).

- Antibiotics such as erythromycin or clarithromycin (may increase pravastatina levels in the blood).

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

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

Remember to take your medicine.

Your doctor will tell you how long you should take PRAVASTATINA VIR. Do not stop treatment before.

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

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

Associated treatment:patients taking pravastatina and ciclosporina should start treatment with 20 mg of pravastatina once a day, your doctor will adjust the dose up to 40 mg. Patients taking pravastatina and a bile acid sequestrant (e.g. colestiramina, colestipol) should take PRAVASTATINA VIR one hour before or four hours after the sequestrant.

Children and adolescents:pravastatina should not be administered to individuals under

18 years of age since its efficacy and safety have not been established in this age group.

Elderly patients:no dose adjustment is necessary in these patients unless other risk factors are present.

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

If you estimate that the action of PRAVASTATINA VIR is too strong or too weak, inform 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 or pharmacist or the nearest hospital.

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

If you forgot to take PRAVASTATINA VIR:

Do not take a double dose to make up for the missed dose, wait for the next scheduled dose.

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 erythematosus 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.

Unknown frequency: myasthenia gravis (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).

Unknown frequency: myasthenic eye disease (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 (yellow discoloration 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 renal disorders, myopathy (muscle alterations). Alterations in tendons, sometimes complicated with rupture.

Unknown frequency: Constant muscle weakness, muscle rupture.

Renal and urinary disorders:

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

Reproductive and mammary disorders:

Uncommon: sexual alterations.

General disorders:

Uncommon: fatigue.

Also, the following adverse effects of special clinical interest have been reported during clinical studies:

Musculoskeletal and connective tissue disorders:

Musculoskeletal pain, including joint pain, muscle cramps, muscle pain (very common), muscle weakness (frequent), and elevated creatine kinase levels (enzyme indicative of muscle alteration).

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. It is more likely if you have high blood sugar and fat levels, obesity, and high blood pressure. Your doctor will monitor you while taking this medication.

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

If any other side effect not described in this prospectus is observed, consult your doctor or pharmacist.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse,

even if it is a possible side effectadversosthat noappeareninthisprospecto.También maycomunicarlosdirectamentea travésdel SistemaEspañoldeFarmacovigilancia de Medicamentos deUsoHumano:www.notificaram.es.Mediantelacomunicación deefectos adversosusted maycontribuiraproporcionar másinformaciónenlaseguridad de estemedicamento

Keep out of reach and sight of children.

Storage Conditions

Do not store above 86°F (30°C)

Store in the original packaging, protected from light and moisture

Expiration Date

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

Do not dispose of medications through drains or in the trash. Dispose of empty packaging and unused medications at the SIGRE collection point at your pharmacy. Ask your pharmacist how to properly dispose of unused packaging and medications. This will help protect the environment.

Composition of PRAVASTATINA VIR:

The active ingredient is pravastatina sodium. Each tablet contains 20 mg of pravastatina sodium.

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

PRAVASTATINA VIR 20 mg is presented in the form of yellow tablets. Each package contains 28 tablets.

Other presentations:

PRAVASTATINA VIR 10 mg TABLETS EFG

PRAVASTATINA VIR 40 mg TABLETS EFG

Marketing Authorization Holder:

Industria Química y Farmacéutica VIR, S.A.

C/ Laguna 66-70, 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

Last review date of this leaflet: March 2024

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