Pravastatin Kern Pharma 10 mg tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Pravastatin Kern Pharma 10 mg tablets EFG

Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this leaflet; 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, and you should not give it to others, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents:

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

Pack contents and additional information

1. What Pravastatin Kern Pharma is and what it is used for

Pravastatin Kern Pharma belongs to a group of medicines known as statins, which work by reducing lipid, cholesterol, and triglyceride levels in the blood.

Pravastatin Kern Pharma is indicated, together with an appropriate diet, for:

• The treatment of primary hypercholesterolemia and mixed dyslipidemia, conditions characterized by elevated cholesterol and/or triglycerides in the blood, when diet or other measures (such as exercise or weight reduction) have not been effective.
• The prevention of cardiovascular events (myocardial infarction) and cardiovascular death in patients with high cholesterol levels and a high risk of experiencing a first cardiovascular event (primary prevention).
• The prevention of cardiovascular events and cardiovascular death in patients with normal or high cholesterol levels who have already experienced a cardiovascular event, such as myocardial infarction or angina pectoris (secondary prevention).
• The reduction of blood lipid levels in patients who have undergone organ transplantation and are receiving immunosuppressive therapy.

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 to any of the other ingredients of this medicine.

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

• If you are pregnant or think you might be pregnant.

• If you are breastfeeding.

Warnings and precautions

Talk to your doctor or pharmacist before starting this medicine:

• If you have or have had myasthenia (a disease characterized by generalized muscle weakness, which in some cases affects the muscles used for breathing) or ocular myasthenia (a disease causing weakness of the eye muscles), as statins may sometimes worsen the condition or trigger the onset of myasthenia (see section 4).
• If you have had liver disease or have a history of alcoholism.

Mild increases in liver transaminase levels may occur, which in most cases return to normal without the need to stop treatment.

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

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

Also inform your doctor or pharmacist if you have persistent muscle weakness. Additional tests and treatments may be required to diagnose and manage this condition.

Talk to 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 medicine containing fusidic acid (used to treat bacterial infection) taken orally or by injection. The combination of fusidic acid and Pravastatina Kern Pharma can cause serious muscle problems (rhabdomyolysis).

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

Your doctor may recommend blood tests to assess your muscle status before starting and during treatment, to determine whether to initiate, continue, or discontinue treatment.

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

• Fibrates (reduce cholesterol levels).
• Nicotinic acid (reduces cholesterol levels).

Talk to your doctor, even if any of the above conditions have occurred in the past.

Taking other medicines

Tell your doctor or pharmacist if you are using or have recently used any other medicines, including those obtained without a prescription.

Certain medicines may interact with pravastatin; in such cases, it may be necessary to adjust the dose or stop treatment with one of the medicines.

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

• Other drugs used to lower cholesterol such as cholestyramine or colestipol (which may reduce pravastatin levels in the blood) and fibrates (which may increase the risk of muscle-related adverse reactions).
• Cyclosporine, a medicine used to prevent transplant rejection (when taken together, cyclosporine increases pravastatin blood levels).
• Antibiotics such as erythromycin or clarithromycin (which may increase pravastatin blood levels).

If you need to take oral fusidic acid to treat a bacterial infection, you must stop using this medicine. Your doctor will advise you when you can restart treatment with Pravastatina Kern Pharma. Taking Pravastatina Kern Pharma with fusidic acid may cause muscle weakness, tenderness, or pain (rhabdomyolysis). For more information on rhabdomyolysis, see section 4.

Taking Pravastatina Kern Pharma with food and drink

Pravastatin may be taken with or without food.

This medicine should be used with caution in patients who consume alcohol. If you regularly drink alcohol, consult your doctor.

Pregnancy and breastfeeding

Pregnancy

Consult your doctor or pharmacist before taking any medicine. Pravastatin must not be administered during pregnancy. If you become pregnant or suspect you may be pregnant, stop treatment immediately and inform your doctor.

Breastfeeding

Consult your doctor or pharmacist before taking any medicine.

Pravastatin must not be administered during breastfeeding, as it passes into breast milk.

Driving and using machines

At normal doses, pravastatin 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 react to the medicine.

3. How to take Pravastatina Kern Pharma

Follow exactly the administration instructions for this medicine as indicated by your doctor. If in doubt, consult your doctor or pharmacist again.

Your doctor will determine the duration of your treatment with pravastatin. Do not stop treatment prematurely.

The tablets should be swallowed with water and may be taken with or without food, preferably at night. The usual dose ranges from 10–40 mg once daily. Your doctor will determine the appropriate dose for you and will make any necessary adjustments based on your response to the medication.

Concomitant treatment: Patients receiving pravastatin and cyclosporine should start treatment with 20 mg of pravastatin once daily; your doctor will adjust the dose up to 40 mg if necessary. For patients taking pravastatin and a bile acid sequestrant resin (e.g., cholestyramine, colestipol), pravastatin should be administered one hour before or four hours after the resin.

Children and adolescents: Pravastatin is not recommended for patients under 18 years of age, as efficacy and safety have not been established in this age group.

Elderly patients: Dose adjustment is not necessary in elderly patients unless other risk factors are present.

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

If you feel that the effect of this medicine 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 pravastatin than you should, contact your doctor, pharmacist, or the nearest hospital.

In case of overdose or accidental ingestion, contact the Toxicology Information Service at telephone: 91 562 04 20.

If you forget to take Pravastatina Kern Pharma

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

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

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 polyneuropathy, particularly when used for prolonged periods, and tingling sensation.

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

Eye disorders:

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

Frequency not known: ocular myasthenia* (a disease causing 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, flatulence.

Very rare: pancreatitis (inflammation of the pancreas).

Hepatobiliary disorders:

Very 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 itchy blisters, hair and scalp abnormalities (including hair loss).

Musculoskeletal and connective tissue disorders:

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

Frequency not known: persistent muscle weakness, muscle rupture.

Renal and urinary disorders:

Uncommon: disturbances in urination (such as difficulty urinating, increased frequency of urination, and increased frequency of urination at night).

Reproductive system and breast disorders:

Uncommon: sexual disturbances.

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 levels of creatine kinase (an enzyme indicating muscle damage).

Hepatic disorders:

Elevations in serum transaminases (enzymes indicating 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. This is more likely if you have high levels of sugar and fats in your blood, are overweight, and have high blood pressure. Your doctor will monitor you while you are taking this medicine.

If you consider any of the adverse effects you experience to be severe or if you notice any adverse effects not mentioned in this leaflet, inform your doctor or pharmacist.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Pravastatin Kern Pharma

Keep out of sight and reach of children.

Do not store above 30°C.

Store in the original container, protected from light and moisture.

Do not use this medicine after the expiry date stated on the packaging after "EXP". The expiry date refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE Point at your pharmacy. If you are in doubt, ask your pharmacist how to dispose of unused medicines and containers. This will help protect the environment.

6. Package contents and other information

Composition of Pravastatin Kern Pharma

• The active substance is sodium pravastatin.

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

Appearance of the medicine and contents of the pack

Each tablet contains 10 mg of pravastatin.

It is presented as yellow tablets. Each pack contains 28 tablets.

Other presentations:

Pravastatin Kern Pharma 20 mg tablets EFG

Pravastatin 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 most recent revision of this leaflet: February 2024

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