Package Leaflet: Information for the User

Pravastatina Kern Pharma 20 mg Film-coated 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 pass it on to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, talk to your doctor or pharmacist. See section 4.

Table of Contents

1. What Pravastatina Kern Pharma is and what it is used for
2. What you need to know before you start taking Pravastatina Kern Pharma
3. How to take Pravastatina Kern Pharma
4. Possible side effects
5. Storage of Pravastatina Kern Pharma

Contents of the pack and additional information

Pravastatina Kern Pharma belongs to a group of medications known as statins that act by reducing levels of lipids, cholesterol, and triglycerides in the blood.

Pravastatina Kern Pharma is indicated, along with an adequate 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 Kern Pharma

• If you are allergic to pravastatina sodium or any of the other components of this medication.

• If you have an active liver disease or have elevated transaminases (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 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 liver disease or have a history of alcoholism.

Moderate increases in liver transaminases levels may occur, which in most cases return to normal without the need to discontinue treatment.

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

• During treatment, some patients may experience muscle pain, sensitivity, weakness, or muscle cramps. 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.

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

• Have severe respiratory insufficiency
• 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 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 blood tests to determine the state of your muscles before starting treatment and during treatment, to consider the initiation, continuation, or discontinuation of treatment.

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

• Fibrates (lower cholesterol levels).

• Nicotinic acid (lowers cholesterol levels).

Consult your doctor, even if any of the previously mentioned circumstances have occurred at any time.

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.

Certain medications may interact with pravastatina; in these cases, the dose may need to be changed or treatment with one of them may need to be discontinued.

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 together, 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 oral fusidic acid to treat a bacterial infection, you will need to stop taking this medication. Your doctor will indicate when you can resume 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.

Taking Pravastatina Kern Pharma with food and beverages

Pravastatina can be taken with or without food.

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

Pregnancy and lactation

Pregnancy

Consult your doctor or pharmacist before taking a medication. Pravastatina should not be administered during pregnancy. If you become pregnant or suspect you may be pregnant, discontinue treatment and inform your doctor as soon as possible.

Lactation

Consult your doctor or pharmacist before taking a medication.

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

Driving and operating machinery

At normal doses, pravastatina does not affect the ability to drive or operate machinery. However, if you experience dizziness, do not drive or operate machinery until you know how you tolerate the medication.

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

Your doctor will inform you of the duration of your treatment with pravastatina. Do not discontinue 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 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 20 mg of pravastatina once a day, and your doctor will adjust the dose up to 40 mg. Patients taking pravastatina and a bile acid sequestrant resin (e.g. colestiramine, colestipol) should take pravastatina one hour before or four hours after the resin.

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

Older patients:No dose adjustment is necessary in these patients unless other risk factors are present.

Patients with renal or hepatic insufficiency: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 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, contact your doctor or pharmacist or the nearest hospital.

In case of overdose or accidental ingestion, consult 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 dose.

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.

Immune system disorders:

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

Nervous system disorders:

Uncommon: dizziness, headache, sleep disorders, insomnia.

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

Frequency not known: 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).

Frequency not known: myasthenic eye disease* (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:

Uncommon: indigestion/heartburn, abdominal pain, nausea, vomiting, constipation, diarrhea, gas.

Rare: pancreatitis (pancreas inflammation).

Hepatobiliary disorders:

Rare: jaundice (yellowing of the skin), hepatitis (liver inflammation), 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:

Rare: rhabdomyolysis (muscle fiber destruction), which may be associated with kidney disorders, myopathy (muscle alterations). Tendon alterations, sometimes complicated by rupture.

Frequency not known: constant muscle weakness, muscle rupture.

Renal and urinary disorders:

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

Reproductive and breast disorders:

Uncommon: sexual alterations.

General disorders:

Uncommon: fatigue.

Also, the following clinically significant adverse reactions have 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 (enzyme indicative of muscle alteration).

Hepatic disorders:

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

Other possible adverse 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.

Adverse effect reporting:

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is an adverse 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 adverse 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 use this medication after 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 unused medicines at the SIGRE collection pointof the pharmacy.If in doubt, ask your pharmacist how to dispose of packaging and unused medicines. By doing so, you will help protect the environment.

Composition of Pravastatina Kern Pharma

• The active ingredient is pravastatina sodium.

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

Appearance of the product and contents of the packaging

Each tablet contains 20 mg of pravastatina.

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

Other presentations:

Pravastatina Kern Pharma 10 mg tablets EFG

Pravastatina Kern Pharma 40 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 leaflet: 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