Patient Information Leaflet

Pravastatina Kern Pharma 40 mg Tablets

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 only. Do not give it to others even if they have similar symptoms to you, 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.

Pravastatina belongs to a group of medications known as statins that reduce the levels of LDL cholesterol (a type of harmful cholesterol) and triglycerides in the blood.

Pravastatina Kern Pharma is indicated for:

Hiperlipidemia:

If you have high levels of cholesterol and/or triglycerides in the blood, pravastatina is indicated to reduce, along with a diet, high levels of total and LDL cholesterol and triglycerides in patients with primary hypercholesterolemia (increased amount of cholesterol in the blood) and mixed dyslipidemia (increased amount of cholesterol and triglycerides in the blood) when diet or other measures other than medications have not worked.

Primary prevention of coronary heart disease(obstruction or hardening of blood vessels that transport oxygen and nutrients to the heart):

If you are a male, over 45 years old, without a history of coronary disease, have moderate to severe hypercholesterolemia and another cardiovascular risk factor such as smoking, diabetes mellitus, family history of premature coronary disease, minimal electrocardiographic alterations, hypertension or low levels of HDL (a type of beneficial cholesterol); pravastatina is indicated, along with an adequate diet, to prevent myocardial infarction.

Coronary heart disease:

If you have coronary disease and have moderate or high levels of cholesterol, Pravastatina Kern Pharma 40 mg is indicated, along with an adequate diet, to:

- prevent the risk of suffering a myocardial infarction,

- slow the progression of atherosclerotic disease (obstruction and hardening of the arteries).

If you have had a myocardial infarction or unstable angina and have normal or high levels of cholesterol, Pravastatina Kern Pharma 40 mg is indicated to:

- reduce the risk of death,

- reduce the risk of death from coronary causes,

- reduce the risk of death from cardiovascular causes,

- prevent the risk of suffering a myocardial infarction,

- reduce the risk of stroke or transient ischemic attack,

- reduce the need for surgical intervention to increase blood flow to the heart,

- reduce the need for hospitalization.

Do not take Pravastatina Kern Pharma

• if you are allergic to pravastatina sodium or any of the other components of this medication,
• if you have any active liver disease or have elevated transaminases (enzymes indicative of liver disease),

• if you are pregnant,

• if you are breastfeeding.

Warnings and precautions

Consult your doctor or pharmacist before starting to take this medication.

If you have or have had myasthenia (a disease that involves 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).

If you have had any liver disease or have a history of alcoholism. Your doctor may perform a blood test to check liver function before and during treatment. If you notice any abnormalities, your doctor may recommend suspending treatment.

Like other cholesterol-lowering medications, some patients may experience muscle pain, sensitivity, weakness, or muscle cramps during treatment. If you experience any of these symptoms, inform your doctor immediately.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.

You should also inform your doctor if you experience any kidney problems, hypothyroidism, if you have a family history or have previously experienced muscle problems, or if you regularly consume alcohol.

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

• have severe respiratory failure
• are taking or have taken within the last 7 days a medication containing fusidic acid (used to treat bacterial infections) orally or by injection. The combination of fusidic acid and Pravastatina Kern Pharma may cause severe muscle problems (rhabdomyolysis).

While you are taking this medication, your doctor will monitor whether 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.

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

Inform your doctor if you are taking other medications that may cause muscle problems, such as:

• fibrates (lower cholesterol levels)
• nicotinic acid (lowers cholesterol levels)
• ciclosporin (prevents transplant rejection)

Consult your doctor as soon as any of the above circumstances occur.

Use of other medications

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

It is essential to inform your doctor if you are taking the following medications:

- other cholesterol-lowering medications such as cholestyramine, colestipol, or fibrates

- ciclosporin (medication used to prevent transplant rejection)

- warfarin (oral anticoagulant).

Although no clinically significant interactions have been observed with pravastatina, it is recommended that you inform your doctor if you are taking gemfibrozil; nicotinic acid; acetylsalicylic acid; antacids; cimetidine; probucol; phenytoin; quinidine; diuretics; medications used to treat high blood pressure, as well as other cardiovascular problems such as IECAs, digitals, calcium antagonists, or nitroglycerin.

Similarly, although no clinically significant interactions have been observed when pravastatina was administered with medications that are metabolized through the cytochrome P450 system (liver metabolic pathway), it is also recommended that you inform your doctor if you are taking: some medications for heart problems (diltiazem, verapamil), medications for fungal infections (itraconazole, ketoconazole, fluconazole), medications for HIV infection (protease inhibitors), grapefruit juice, and some antibiotics (erythromycin and clarithromycin).

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

Pravastatina Kern Pharma with food and beverages

Pravastatina can be taken with or without food.

Pregnancy and breastfeeding

Pregnancy

Consult your doctor or pharmacist before taking a medication.

Do not administer during pregnancy. If you become pregnant or suspect you are pregnant, you should discontinue treatment and inform your doctor as soon as possible.

Breastfeeding

Consult your doctor or pharmacist before taking a medication.

Do not administer during the breastfeeding period.

Driving and operating machinery

At the recommended doses, this medication does not affect the ability to drive or operate machinery.

Follow exactly the administration instructions for this medication as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

Your doctor will inform you of the treatment duration. Do not discontinue treatment without consulting your doctor.

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

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

Associated treatment:Patients taking pravastatina and ciclosporin should start treatment with 10 mg of pravastatina once a day; patients taking pravastatina and a resin (e.g. colestiramine) should take pravastatina one hour before or four hours after the resin.

Children:Pravastatina is not recommended for individuals under 18 years of age as its efficacy and safety have not been established in this age group.

Older patients; patients with renal insufficiency; patients with hepatic insufficiency:In patients with significant renal or hepatic dysfunction, as well as in the elderly, it is recommended to start treatment with a dose of 10 mg.

If you estimate that the effect of this medication is too strong or too weak, inform your doctor or pharmacist.

If you take more Pravastatina Kern Pharma than you should

If you have taken more pravastatina than you should, consult your doctor or pharmacist immediately.

In case of overdose or accidental ingestion, contact the Toxicological Information Service, phone: 91 562 04 20.

If you forgot to take Pravastatina Kern Pharma

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

These side effects have been shown to be mild and of short duration.

The side effects described most frequently are:

Nervous system disorders

Frequent: headache.

Unknown frequency: severe myasthenia* (a disease that causes generalized muscle weakness that, in some cases, affects the muscles used for breathing).

Eye disorders:

Unknown frequency: 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, eyelid drooping, difficulty swallowing, or difficulty breathing.

Gastrointestinal disorders

Rare: nausea, vomiting, diarrhea.

Skin and subcutaneous tissue disorders

Frequent: skin rash.

Musculoskeletal, connective tissue, and bone disorders

Frequent: muscle pain.

Rare: musculoskeletal pain, including joint pain, muscle cramps.

Unknown frequency: constant muscle weakness, muscle rupture.

General disorders

Frequent: chest pain.

Rare: fatigue.

During the marketing of the medicine, very rarely have been reported:

Immune system disorders

Very rare: hypersensitivity reactions accompanied by one or more of the following disorders: anaphylaxis, angioedema (swelling of the arms, legs, face, lips, tongue, and/or throat), lupus-like syndrome (skin inflammation), photosensitivity, alterations in blood cell count, and modification of some blood test parameters, vasculitis, dermatomyositis.

Musculoskeletal, connective tissue, and bone disorders

Very rare: myopathy (muscle alterations), rhabdomyolysis (muscle fiber destruction) with kidney disorders.

Nervous system disorders

Very rare: tingling, cramps, or numbness in the arms or legs.

Pravastatina has been administered concurrently with cholestyramine, cholestipol, nicotinic acid, and probucol. No adverse reactions have been described due to concomitant therapy, or additional to those described for each drug separately.

The administration of pravastatina has not been associated with the appearance of cataracts.

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 medicine.

If you consider that any of the side effects you experience are severe or if you appreciate any side effect not mentioned in this prospectus, inform your doctor or pharmacist.

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a side effect that does 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 out of sight and reach of children.

Do not store at a temperature above30°C.

Store in the original packaging protected from light and moisture.

Do not usethis medicationafter the expiration date that appears on the packaging after “CAD”. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through drains or in the trash. Dispose of packaging and medicines you no longer need at the SIGRE collection pointat the pharmacy.If in doubt, ask your pharmacist how to dispose of packaging and medicines you no longer need. By doing so, you will help protect the environment.

Composition of Pravastatina Kern Pharma

• The active ingredient is pravastatina sodium.

• The other components are:povidone, microcrystalline cellulose, yellow iron oxide E-172, dihydrophosphate disodium, magnesium stearate, trometamol, anhydrous calcium hydrogen phosphate, and sodium glycolate starch.

Appearance of the product and contents of the packaging

Each tablet contains 40 mg of pravastatina.

It is presented in the form of yellow tablets. Each package contains 28 tablets.

Other presentations:

Pravastatina Kern Pharma10 mg tablets EFG

Pravastatina Kern Pharma20 mg tablets EFG

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Kern Pharma, S.L.

Venus, 72 - Pol. Ind.Colón II

08228 Terrassa - Barcelona

Spain

Responsible for manufacturing

Kern Pharma, S.L.

Venus, 72 - Pol. Ind.Colón II

08228 Terrassa - Barcelona

Spain

Last review date of this prospectus: February 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.gob.es