PRAVASTATIN KERN PHARMA 10 mg TABLETS

2. What you need to know before taking Pravastatina Kern Pharma

Do not take Pravastatina Kern Pharma

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

• If you have active liver disease or 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 starting to take this medication:

• If you have or have had myasthenia (a disease characterized by generalized muscle weakness that can affect 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).
• 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, a family history of or have previously had muscle disorders, or if you normally consume alcohol.

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

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.

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

• Have severe respiratory failure
• Are taking or have taken in 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 can cause serious muscle problems (rhabdomyolysis).

While you are taking this medication, your doctor will monitor you for diabetes or the risk of developing diabetes. This risk of diabetes increases if you have high levels of sugars and fats in the blood, are overweight, and have high blood pressure.

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 medications 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.

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 can interact with pravastatin; 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 medications:

• Other medications used to lower cholesterol levels, such as colestyramine or colestipol (can decrease pravastatin levels in the blood), and fibrates (can increase the risk of adverse muscle reactions).
• Cyclosporine, a medication used to prevent transplant rejection (when administered together, 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 medication. Your doctor will indicate when you can restart treatment with Pravastatina Kern Pharma. The use of Pravastatina Kern Pharma with fusidic acid can cause muscle weakness, sensitivity, or pain (rhabdomyolysis). For more information on rhabdomyolysis, see section 4.

Taking Pravastatina Kern Pharma with food and drinks

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 breastfeeding

Pregnancy

Consult your doctor or pharmacist before taking a medication. Pravastatina should not be administered during pregnancy. In case of pregnancy or suspected pregnancy, you should suspend treatment and inform your doctor as soon as possible.

Breastfeeding

Consult your doctor or pharmacist before taking a medication.

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

Driving and using machines

At normal doses, pravastatina 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 medication.

3. How to take Pravastatina Kern Pharma

Follow the administration instructions for this medication exactly as indicated by your doctor. If you have any doubts, consult your doctor or pharmacist again.

Your doctor will indicate the duration of your treatment with pravastatina. 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 any necessary adjustments based on your response to the medication.

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

Children and adolescents:the administration of pravastatina is not recommended for minors 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, it is recommended to start treatment with a dose of 10 mg.

If you think 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, contact your doctor or pharmacist or the nearest hospital.

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

If you forget to take Pravastatina Kern Pharma

Do not take a double dose to make up for forgotten doses.

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

4. Possible adverse effects

Like all medications, this medication can cause adverse effects, although not all people experience them.

Immune system disorders:

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

Nervous system disorders:

Uncommon: dizziness, headache, sleep disorders, insomnia.

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

Frequency not known: severe myasthenia* (a disease that causes generalized muscle weakness that can affect the muscles used for breathing).

Eye disorders:

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

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

• 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.

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, blistering 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, frequent urination, and increased urination at night).

Reproductive system and breast disorders:

Uncommon: sexual disorders.

General disorders:

Uncommon: fatigue.

The following adverse 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 (enzyme indicative of muscle disorder).

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 levels of sugars and fats in the blood, are overweight, and have high blood pressure. Your doctor will monitor you while you are taking this medication.

If you think any of the adverse effects you are experiencing is serious or if you notice any adverse effect not mentioned in this prospectus, inform your doctor or pharmacist.

Reporting adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is an adverse effect not listed in this prospectus. You can also report them directly through the Spanish Medication Surveillance System for human use: www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Pravastatina Kern Pharma

Keep out of sight and reach of children.

Do not store above 30°C.

Keep in the original package, protected from light and moisture.

Do not use this medication after the expiration date shown on the package after "CAD". The expiration date is the last day of the month indicated.

Medications should not be disposed of through wastewater or household waste. Deposit the packages and medications you no longer need in the SIGRE collection point at the pharmacy. If you have any doubts, ask your pharmacist how to dispose of the packages and medications you no longer need. This way, you will help protect the environment.

6. Package Contents and Additional Information

Composition of Pravastatina Kern Pharma

• The active ingredient is pravastatin sodium.

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

Appearance of the product and package contents

Each tablet contains 10 mg of pravastatin.

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

Other presentations:

Pravastatina Kern Pharma 20 mg tablets EFG

Pravastatina Kern Pharma 40 mg tablets EFG

Marketing authorization holder and manufacturer

Marketing authorization holder

Kern Pharma, S.L.

Venus, 72 - Pol. Ind. Colón II

08228 Terrassa - Barcelona

Spain

Manufacturer

Kern Pharma, S.L.

Venus, 72 - Pol. Ind. Colón II

08228 Terrassa - Barcelona

Spain

or

Salutas Pharma GmbH

Otto Von Guericke Alle, 1 (Barleben)

D-39179

Germany

Date of the last revision of this prospectus: February 2024

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