PRAVASTATIN KORHISPANA 40 mg TABLETS

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

PRAVASTATIN KORHISPANA 40 mg tablets EFG

Pravastatin sodium

Read all of this leaflet carefully before you start taking this medicine.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

Contents of the pack:

1. What Pravastatin Korhispana 40 mg tablets are and what they are used for.
2. Before you take Pravastatin Korhispana 40 mg tablets.
3. How to take Pravastatin Korhispana 40 mg tablets.
4. Possible side effects.
5. Storing Pravastatin Korhispana 40 mg tablets.
6. Further information.

1. What Pravastatin Korhispana 40 mg tablets are and what they are used for

Pravastatin Korhispana are tablets that contain pravastatin sodium as the active ingredient, available on the market in the following dosages: 10 mg, 20 mg, and 40 mg. It is included in the category of anti-dyslipidemics.

Therapeutic indications

Hypercholesterolemia

Treatment of primary or mixed hypercholesterolemia, along with diet, when the response to diet and other non-pharmacological treatments (e.g., exercise, weight reduction) has failed.

Primary prevention

Reduction of cardiovascular mortality and morbidity in patients with moderate or severe hypercholesterolemia and high risk of a first cardiovascular event, as additional treatment to diet.

Secondary prevention

Reduction of cardiovascular mortality and morbidity in patients with a history of myocardial infarction or unstable angina and with normal or elevated cholesterol levels, along with the correction of other risk factors.

Post-transplant

Reduction of post-transplant hyperlipidemia (blood lipid levels) in patients receiving immunosuppressive treatment after solid organ transplantation (see sections Before taking Pravastatin Korhispanaand How to take Pravastatin Korhispana)

2. Before taking Pravastatin Korhispana 40 mg tablets

Do not take Pravastatin Korhispana:

• If you are allergic (hypersensitive) to pravastatin or any of the other components of Pravastatin Korhispana.
• If you have any active liver disease (including unexplained elevations of serum transaminases above 3 times the upper limit of normal) (see section Before taking Pravastatin Korhispana).
• In case of pregnancy or breastfeeding.

Be especially careful with Pravastatin Korhispana:

In the case of familial hypercholesterolemia, since pravastatin has not been evaluated in patients with this pathology.

In case of liver conditions, since, as with other lipid-lowering drugs, it is possible that moderate increases in serum transaminase levels may occur, which, in most cases, return to their initial level without the need to discontinue treatment.

As with other statins, treatment with pravastatin has been associated with the occurrence of muscle problems: myalgia, myopathy, and, rarely, rhabdomyolysis. The possibility of myopathy should be considered in any patient treated with statins and presenting unexplained muscle symptoms such as muscle pain or sensitivity, muscle weakness, or muscle cramps.

The risk and severity of muscle conditions during statin treatment increase with the concomitant administration of interacting medications. Muscle symptoms, when associated with statins, usually disappear after discontinuing treatment.

Consult your doctor or pharmacist before starting to take Pravastatin Korhispana if you:

? Have severe respiratory failure.

? Also inform your doctor or pharmacist if you have constant muscle weakness. Additional tests and medications may be necessary to diagnose and treat this problem.

• 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 that causes weakness of the eye muscles), since statins can sometimes exacerbate the disease or cause the onset of myasthenia (see section 4).

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.

Children under 18 years:the use of Pravastatin Korhispana is not recommended in these patients due to limited data on safety and efficacy.

Elderly:in elderly patients with risk factors, it may be necessary to adjust the dose.

Patients with renal or hepatic impairment:the dose should be adjusted according to blood lipid levels and under medical supervision.

Before starting treatment:

• It is recommended to determine creatine kinase levels before starting treatment in patients with special predisposing factors and in patients who develop muscle symptoms during statin treatment.

• Caution should be exercised in patients with predisposing factors such as renal impairment, hypothyroidism, history of muscle toxicity with a statin or fibrate, personal or family history of hereditary muscle diseases, or alcohol abuse. In these cases, creatine kinase levels should be determined before starting treatment. It is also recommended to determine creatine kinase levels before starting treatment in individuals over 70 years old, especially those with other predisposing factors.

During treatment:

• Patients should be advised to promptly report any unexplained muscle pain, sensitivity, weakness, or muscle cramps. In these cases, creatine kinase levels should be determined. If a hereditary muscle disease is suspected in the patient, it is not recommended to resume treatment with statins.

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.

Fibrates: the use of fibrates alone is occasionally associated with the onset of myopathy. An increased risk of muscle adverse reactions, including rhabdomyolysis, has been reported with the concomitant administration of fibrates and other statins. Since the occurrence of these adverse reactions cannot be ruled out with pravastatin, the simultaneous use of pravastatin and fibrates (e.g., gemfibrozil, fenofibrate) should be avoided.

Colestyramine/colestipol: concomitant administration resulted in a decrease in the bioavailability of pravastatin. When pravastatin was administered one hour before or four hours after colestyramine or one hour before colestipol and a standard meal, no clinically significant decrease in bioavailability or therapeutic effect was observed (see section How to take Pravastatin Korhispana).

Cyclosporine: concomitant administration of pravastatin and cyclosporine results in an increase in systemic exposure to pravastatin. Clinical and biochemical monitoring of patients receiving this combination is recommended (see section How to take Pravastatin Korhispana).

Warfarin and other anticoagulants: chronic administration of pravastatin and warfarin does not produce any change in the anticoagulant effect of warfarin.

Drugs metabolized by cytochrome P450: significant pharmacokinetic interactions between pravastatin and other drugs, especially those that are substrates/inhibitors of CYP3A4, such as diltiazem, verapamil, itraconazole, ketoconazole, protease inhibitors, grapefruit juice, and CYP2C9 inhibitors (e.g., fluconazole), have been specifically demonstrated to be absent.

Special caution should be exercised when administering pravastatin with erythromycin or clarithromycin.

Other medications: no statistically significant differences in bioavailability were observed when pravastatin was administered in interaction studies with acetylsalicylic acid, antacids (one hour before pravastatin), nicotinic acid, or probucol.

Taking Pravastatin Korhispana with food and drinks:

Pravastatin is administered once a day, preferably at night. The tablets can be taken with or without food.

Pravastatin should be administered under strict supervision in patients who consume large amounts of alcohol or have pre-existing liver disease.

Pregnancy and breastfeeding:

Consult your doctor or pharmacist before taking any medication.

Pravastatin is contraindicated during pregnancy.

If a patient plans to become pregnant, she should immediately inform her doctor and discontinue treatment with pravastatin due to the potential risk to the fetus.

Pravastatin passes into breast milk in small amounts; therefore, it is contraindicated during breastfeeding.

Driving and using machines:

Pravastatin has no or negligible influence on the ability to drive and use machines. However, when driving or using machines, it should be taken into account that dizziness may be felt during treatment.

Important information about some of the components of Pravastatin Korhispana tablets:

This medication contains lactose. If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication.

3. How to take Pravastatin Korhispana 40 mg tablets

Follow the instructions for administration of Pravastatin Korhispana indicated by your doctor. Consult your doctor or pharmacist if you have any doubts.

Before starting treatment with Pravastatin Korhispana, secondary causes of hypercholesterolemia should be ruled out, and patients should undergo a standard hypolipidemic diet (diet to reduce blood lipid levels), which should be maintained during treatment.

Pravastatin Korhispana is administered orally once a day, preferably at night, with or without food.

Hypercholesterolemia:the recommended dosage range is 10 to 40 mg once a day. The response to treatment is observed after one week, reaching its maximum effect at four weeks; therefore, periodic determinations of blood lipids should be performed, and the dose should be adjusted accordingly. The maximum dose is 40 mg per day.

Cardiovascular prevention:in all morbidity and mortality studies (studies analyzing complications and mortality), the only studied initial and maintenance dose was 40 mg per day.

Dosage after transplants:after organ transplantation, an initial dose of 20 mg per day is recommended in patients receiving immunosuppressive treatment. Depending on blood lipid levels, the dose may be increased up to 40 mg under strict medical supervision (see section Before taking Pravastatin Korhispana).

Children:the available information on safety and efficacy in patients under 18 years old is limited; therefore, the use of Pravastatin Korhispana is not recommended in these patients.

Elderly patients:no dose adjustment is necessary in these patients unless there are other risk factors (see section Before taking Pravastatin Korhispana).

Renal or hepatic impairment:in patients with moderate or severe renal impairment or significant hepatic impairment, an initial dose of 10 mg per day is recommended. The dose should be adjusted according to blood lipid levels and under medical supervision.

Concomitant treatment:the cholesterol-lowering effect of Pravastatin Korhispana increases when associated with a bile acid sequestrant (e.g., colestyramine, colestipol). Pravastatin Korhispana should be administered one hour before or at least four hours after the resin (see section Before taking Pravastatin Korhispana).

Patients treated with cyclosporine, with or without other immunosuppressive medications, should initiate therapy with 20 mg of pravastatin once a day, and dose adjustment to 40 mg should be done with caution (see section Before taking Pravastatin Korhispana).

If you think the action of Pravastatin Korhispana is too strong or too weak, consult your doctor or pharmacist.

If you take more Pravastatin Korhispana than you should:

There is not much information about overdose with pravastatin or its treatment. If you have taken more Pravastatin Korhispana than you should, contact your doctor or pharmacist or the nearest hospital for appropriate symptomatic treatment.

In case of overdose or accidental ingestion, consult the Toxicology Information Service. Telephone: 91 562 0420.

If you forget to take Pravastatin Korhispana:

Do not take a double dose to make up for the forgotten dose; wait for the next scheduled dose.

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

If you interrupt treatment with Pravastatin Korhispana:

Contact your doctor or pharmacist.

4. Possible Adverse Effects

Like all medicines, Pravastatina Korhispana can cause adverse effects, although not all people suffer from them.

The effects are classified into: very frequent (at least 1 in 10 patients), frequent (at least 1 in 100 patients), infrequent (at least 1 in 1,000 patients), rare (at least 1 in 10,000 patients), very rare (less than 1 in 10,000 patients), unknown frequency (the frequency cannot be estimated from the available data), and isolated cases.

The effects found during the studies conducted with pravastatina 40 mg have been:

Nervous System Disorders:

Infrequent: dizziness, headache, sleep disorders, including insomnia and nightmares.

Ocular Disorders:

Infrequent: vision disturbances (including blurred vision and double vision of objects)

Gastrointestinal Disorders:

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

Disorders of the Skin and Subcutaneous Tissue:

Infrequent: itching, skin rash, appearance of blisters accompanied by itching, hair and scalp abnormalities (including hair loss).

Renal and Urinary Disorders:

Infrequent: alterations in urine elimination (such as difficulty urinating, urinating more frequently, and urinating more frequently at night).

Disorders of the Reproductive System and Breast:

Infrequent: sexual disorders

General Disorders:

Infrequent: fatigue

Possible secondary effects of some statins (medicines of the same type):

• 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.

Adverse Effects of Special Clinical Relevance:

Musculoskeletal Disorders: musculoskeletal pain including joint pain, muscle cramps, muscle pain (very frequent) and elevations of creatine kinase levels (enzyme indicative of muscle alteration).

Unknown frequency: constant muscle weakness.

Hepatic Disorders: elevations of serum transaminases (enzymes indicative of liver disease).

During the post-marketing experienceof pravastatina, the following adverse reactions have been reported:

Nervous System Disorders:

Very rare: peripheral polyneuropathy, particularly when used for a prolonged period, and tingling sensation (paresthesia).

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

Consult your doctor if you experience weakness in your arms or legs that worsens after periods of activity, double vision, or drooping eyelids, difficulty swallowing, or difficulty breathing.

Ocular 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, or drooping eyelids, difficulty swallowing, or difficulty breathing.

Immune System Disorders:

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

Gastrointestinal Disorders:

Very rare: pancreatitis (inflammation of the pancreas)

Hepatobiliary Disorders:

Very rare: yellowing of the skin (jaundice), hepatitis (inflammation of the liver), fulminant hepatic necrosis (destruction of liver cells).

Musculoskeletal and Connective Tissue Disorders:

Very rare: rhabdomyolysis (destruction of muscle fibers) that may be associated with acute renal failure secondary to myoglobinuria (red-colored urine) and muscle disorders (myopathy), muscle inflammation (myositis), significant muscle weakness (polymyositis) (see section 2).

Isolated cases of tendon disorders, sometimes complicated by rupture.

Unknown frequency: muscle rupture.

If you consider that any of the adverse effects you suffer from is serious or if you notice any adverse effect not mentioned in this prospectus, inform your doctor or pharmacist.

Reporting of Adverse Effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect that is not listed in this prospectus. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Conservation of Pravastatina Korhispana 40 mg Tablets

Keep Pravastatina Korhispana out of the reach and sight of children.

Do not store at a temperature above 25°C. Store in the original container, tightly closed.

Expiry Date:

Do not use this medicine after the expiry date stated on the packaging. The expiry date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Deposit the packaging and medicines you no longer need at the SIGRE point in the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This way, you will help protect the environment.

6. Additional Information

Composition of Pravastatina Korhispana 40 mg Tablets:

The active ingredient is pravastatina sodium. Each tablet contains 40 mg of pravastatina sodium.

The other components (excipients) are: anhydrous lactose, microcrystalline cellulose, sodium croscarmellose, magnesium stearate, talc, and anhydrous disodium phosphate.

Appearance of the Product and Packaging Contents:

Pravastatina Korhispana is presented in the form of white, oblong, convex, and scored tablets on both sides. Each package contains 28 tablets in high-density polyethylene bottles.

Marketing Authorization Holder and Manufacturer:

Holder:

KORHISPANA, S.L.

Ctra. Castellvell, 24

43206 REUS (Tarragona)

Manufacturer:

West Pharma - Producções de Especialidades Farmacêuticas, S.A.

Rua João de Deus, nº 11, Venda Nova. 2700 Amadora (Portugal).

This prospectus was approved in March 2024

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