Pravastatin Kern Pharma 40 mg tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Pravastatin Kern Pharma 40 mg tablets EFG

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

Contents of the leaflet

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
6. Contents of the pack and other information

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

Pravastatin belongs to a group of medicines known as statins, which reduce blood levels of LDL cholesterol (a type of cholesterol harmful to health) and of fat substances called triglycerides.

Pravastatina Kern Pharma is indicated for:

Hyperlipidemia:

If you have high levels of cholesterol and/or triglycerides in the blood, pravastatin is indicated to reduce, together with diet, elevated levels of cholesterol (total and LDL) and triglycerides in patients with primary hypercholesterolemia (increased amount of cholesterol in the blood) and mixed dyslipidemia (increased levels of both cholesterol and triglycerides in the blood), when diet or other non-medicinal measures have not been effective.

Primary prevention of coronary heart disease (blockage or hardening of blood vessels carrying oxygen and nutrients to the heart):

If you are a male patient over 45 years of age, with no history of coronary disease, and you have moderate to severe hypercholesterolemia and at least one other cardiovascular risk factor such as smoking, diabetes mellitus, family history of premature coronary heart disease, minor electrocardiographic abnormalities, hypertension, or low HDL levels (a type of cholesterol beneficial to health), pravastatin is indicated, together with an appropriate diet, to prevent myocardial infarction.

Coronary heart disease:

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

• prevent the risk of having a myocardial infarction,
• slow the progression of atherosclerotic disease (blockage and hardening of the arteries).

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

• reduce the risk of death,
• reduce the risk of death due to coronary causes,
• reduce the risk of death due to cardiovascular causes,
• prevent the risk of having 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.

2. What you need to know before starting to take Pravastatin Kern Pharma

Do not take Pravastatin Kern Pharma

• if you are allergic to sodium pravastatin 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,
• if you are breastfeeding.

Warnings and precautions

Talk to your doctor or pharmacist before starting to take this medicine.

If you have or have had myasthenia (a disease characterized by generalized muscle weakness that, in some cases, affects the muscles used for breathing) or ocular myasthenia (a disease causing weakness of the eye muscles), since 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. Your doctor may perform a blood test to monitor liver function before and during treatment. If any abnormalities occur, your doctor may recommend stopping the treatment.

As with other cholesterol-lowering medicines, some patients may experience muscle pain, tenderness, muscle 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 have persistent muscle weakness. Additional tests and treatments may be needed to diagnose and manage this condition.

You should also inform your doctor if you have any kidney problems, hypothyroidism, a family history of muscle disorders, a previous history of muscle problems, or if you regularly consume alcohol.

Talk to your doctor or pharmacist before taking Pravastatin Kern Pharma if you:

• Have severe respiratory insufficiency
• Are taking or have taken within the last 7 days an oral or injectable medication containing fusidic acid (used to treat bacterial infection). The combination of fusidic acid and Pravastatin Kern Pharma may 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 sugars 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 evaluate whether to initiate, continue, or discontinue treatment.

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

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

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

Use of other medicines

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

It is important that you inform your doctor if you are taking the following medicines:

• other drugs used to lower cholesterol levels such as cholestyramine, colestipol, or fibrates
• cyclosporine (a medicine used to prevent transplant rejection)
• warfarin (an oral anticoagulant).

Although no clinically significant interactions have been observed with pravastatin, it is advisable to inform your doctor if you are taking gemfibrozil; nicotinic acid; acetylsalicylic acid; antacids; cimetidine; probucol; phenytoin; quinidine; diuretics; medicines used to treat high blood pressure and other cardiovascular conditions such as ACE inhibitors, digitalis, calcium channel blockers, or nitroglycerin.

Likewise, although no clinically significant interactions have been observed when pravastatin was administered with drugs metabolized via the cytochrome P450 system (liver metabolic pathway), it is also advisable to inform your doctor if you are taking: certain heart medications (diltiazem, verapamil), antifungal drugs (itraconazole, ketoconazole, fluconazole), HIV medications (protease inhibitors), grapefruit juice, or certain antibiotics (erythromycin and clarithromycin).

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 Pravastatin Kern Pharma. Using Pravastatin Kern Pharma with fusidic acid may cause muscle weakness, tenderness, or pain (rhabdomyolysis). For more information on rhabdomyolysis, see section 4.

Taking Pravastatin Kern Pharma with food and drinks

Pravastatin can be taken with or without food.

Pregnancy and breastfeeding

Pregnancy

Consult your doctor or pharmacist before taking any medicine.

This medicine must not be used 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.

This medicine must not be used during breastfeeding.

Driving and using machines

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

3. How to take Pravastatin Kern Pharma

Follow exactly the instructions given by your doctor for taking this medicine. If in doubt, consult your doctor or pharmacist again.

Your doctor will determine how long you should take the treatment. Do not stop treatment without discussing it with your doctor.

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

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 therapy: Patients receiving pravastatin and cyclosporine should start treatment with 10 mg of pravastatin once daily. For patients taking pravastatin and a resin (e.g. cholestyramine), pravastatin should be administered either one hour before or four hours after the resin.

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

Elderly patients; patients with renal impairment; patients with hepatic impairment: In patients with significantly impaired renal or hepatic function, as well as in elderly patients, treatment should be initiated at a dose of 10 mg.

If you think that the effect of this medicine is too strong or too weak, tell your doctor or pharmacist.

If you take more Pravastatin Kern Pharma than you should

If you have taken more pravastatin than you should, contact your doctor or pharmacist immediately.

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

If you forget to take Pravastatin 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 may cause adverse effects, although not everyone will experience them.

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

The most frequently reported adverse effects are:

Nervous system disorders

Common: headache.

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

Eye disorders:

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

• Consult your doctor if you experience arm or leg weakness that worsens after periods of activity, double vision or drooping eyelids, difficulty swallowing, or difficulty breathing.

Gastrointestinal disorders

Uncommon: nausea, vomiting, diarrhoea.

Skin and subcutaneous tissue disorders

Common: skin rashes.

Musculoskeletal, connective tissue and bone disorders

Common: muscle pain.

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

Frequency not known: persistent muscle weakness, muscle rupture.

General disorders

Common: chest pain.

Uncommon: fatigue.

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

Immune system disorders

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

Musculoskeletal, connective tissue and bone disorders

Very rare: myopathy (muscle disorders), rhabdomyolysis (destruction of muscle fibres) with kidney disorders.

Nervous system disorders

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

Pravastatin has been administered concomitantly with cholestyramine, colestipol, nicotinic acid and probucol. No adverse reactions due to combination therapy have been reported, nor any additional to those described for each drug individually.

The administration of pravastatin has not been associated with the development of cataracts.

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 the 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 listed 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 Medicinal Products: 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 have any doubts, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Pravastatin Kern Pharma

• The active substance is pravastatin sodium.

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

Appearance of the product and contents of the pack

Each tablet contains 40 mg of pravastatin.

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

Other presentations:

Pravastatin Kern Pharma 10 mg tablets EFG

Pravastatin Kern Pharma 20 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

Date of the most recent review of this leaflet: February 2024

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