Pravastatin Korhispana 20 mg tablets EFG

Package leaflet: Information for the user

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

PRAVASTATIN KORHISPANA 20 mg tablets EFG

Sodium pravastatin

Read the entire leaflet carefully before you start taking this medicine.

• 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 and should not be given to other people, even if they have the same symptoms, as it may harm them.
• If you consider any of the side effects you experience to be serious, or if you notice any side effects not listed in this leaflet, please inform your doctor or pharmacist.

Leaflet contents:

1. What Pravastatin Korhispana 20 mg tablets are and what they are used for.
2. Before you take Pravastatin Korhispana 20 mg tablets.
3. How to take Pravastatin Korhispana 20 mg tablets.
4. Possible side effects.
5. How to store Pravastatin Korhispana 20 mg tablets.
6. Further information.

1. What Pravastatina Korhispana 20 mg tablets are and what they are used for

Pravastatina Korhispana are tablets containing sodium pravastatin as the active substance, available on the market in the following strengths: 10 mg, 20 mg, and 40 mg. It belongs to the class of lipid-lowering agents (anti-dyslipidemics).

Therapeutic indications

Hypercholesterolemia

Treatment of primary hypercholesterolemia or mixed dyslipidemia, in addition to diet, when response to diet and other non-pharmacological treatments (e.g., exercise, weight reduction) has been inadequate.

Primary prevention

Reduction of cardiovascular mortality and morbidity in patients with moderate to severe hypercholesterolemia and a high risk of a first cardiovascular event, as an adjunct 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, in addition to management of other risk factors.

Post-transplant

Reduction of post-transplant hyperlipidemia (blood lipid levels) in patients receiving immunosuppressive therapy after solid organ transplantation (see sections Before taking Pravastatina Korhispana and How to take Pravastatina Korhispana).

2. Before taking Pravastatina Korhispana 20 mg tablets

Do not take Pravastatina Korhispana:

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

Take special care with Pravastatina Korhispana:

In patients with familial hypercholesterolemia, as pravastatin has not been evaluated in patients with this condition.

In patients with liver disorders, as with other similar lipid-lowering drugs, moderate increases in serum transaminase levels may occur, which in most cases return to baseline levels 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 who experiences unexplained muscle symptoms such as muscle pain or tenderness, muscle weakness, or muscle cramps.

The risk and severity of muscle disorders during statin therapy increase when co-administered with drugs that interact with statins. Muscle symptoms associated with statins usually resolve after discontinuation of treatment.

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

? Have severe respiratory insufficiency.

? Also inform your doctor or pharmacist if you experience persistent muscle weakness. Additional tests and medications may be needed to diagnose and treat this condition.

• 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).

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 fat in the blood, are overweight, or have high blood pressure.

Children under 18 years of age: the use of Pravastatina Korhispana is not recommended due to limited data on safety and efficacy in this patient group.

Elderly patients: dose adjustment may be necessary in elderly patients with risk factors.

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 measure creatine kinase levels before starting treatment in patients with specific predisposing factors and in patients who develop muscle symptoms during statin therapy.

• Caution should be exercised in patients with predisposing factors such as renal insufficiency, hypothyroidism, previous history of muscle toxicity with a statin or fibrate, personal or family history of hereditary muscle disorders, or alcohol abuse. In these cases, creatine kinase levels should be measured before starting treatment. The measurement of creatine kinase levels should also be considered before starting treatment in individuals over 70 years of age, especially those with other predisposing factors.

During treatment:

• Patients should be advised to promptly report any unexplained muscle pain, tenderness, weakness, or cramps. In such cases, creatine kinase levels should be measured. If a hereditary muscle disorder is suspected in the patient, resumption of statin therapy is not recommended.

Use of other medicines:

Inform your doctor or pharmacist if you are taking, or have recently taken, any other medicines, including those obtained without a prescription.

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

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

Cyclosporine: concomitant administration of pravastatin and cyclosporine increases systemic exposure to pravastatin. Clinical and biochemical monitoring is recommended in patients receiving this combination (see section How to take Pravastatina 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: the absence of significant pharmacokinetic interactions has been specifically demonstrated between pravastatin and other drugs, particularly those that are substrates/inhibitors of CYP3A4, such as diltiazem, verapamil, itraconazole, ketoconazole, protease inhibitors, grapefruit juice, and CYP2C9 inhibitors (e.g., fluconazole).

Special caution should be taken when pravastatin is administered with erythromycin or clarithromycin.

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

Taking Pravastatina Korhispana with food and drink:

Pravastatin is administered once daily, 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 who have a history of liver disease.

Pregnancy and breastfeeding:

Consult your doctor or pharmacist before taking any medicine.

Pravastatin is contraindicated during pregnancy.

If a patient plans to become pregnant, she should immediately inform her doctor and discontinue pravastatin treatment 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 operating machinery, it should be borne in mind that dizziness may occur during treatment.

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

This medicine contains lactose. If your doctor has informed you that you have an intolerance to certain sugars, consult with him before taking this medicine.

3. How to take Pravastatina Korhispana 20 mg tablets

Follow exactly the instructions for use of Pravastatina Korhispana provided by your doctor. If you have any doubts, consult your doctor or pharmacist.

Before starting treatment with Pravastatina Korhispana, secondary causes of hypercholesterolemia should be ruled out, and patients must follow a standard lipid-lowering diet (a diet aimed at reducing blood lipid levels), which should be maintained throughout the treatment period.

Pravastatina Korhispana is administered orally once daily, preferably at night, with or without food.

Hypercholesterolemia: the recommended dose range is 10 to 40 mg once daily. Response to treatment is observed after one week, with maximum effect reached within four weeks; therefore, periodic blood lipid measurements should be performed and the dose 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 dose studied for both initiation and maintenance was 40 mg per day.

Dosage after organ transplantation: after an organ transplant, an initial dose of 20 mg daily is recommended for patients receiving immunosuppressive therapy. Depending on blood lipid levels, the dose may be increased up to 40 mg under close medical supervision (see section Before Taking Pravastatina Korhispana).

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

Elderly patients: dose adjustment is not necessary in these patients unless other risk factors are present (see section Before Taking Pravastatina Korhispana).

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

Concomitant treatment: the cholesterol-lowering effect of Pravastatina Korhispana on total cholesterol and LDL-cholesterol is enhanced when combined with a bile acid sequestrant resin (e.g., cholestyramine, colestipol). Pravastatina Korhispana should be taken either one hour before or at least four hours after the resin (see section Before Taking Pravastatina Korhispana).

Patients receiving cyclosporine, with or without other immunosuppressive agents, should start therapy with 20 mg of pravastatin once daily, and dose adjustment to 40 mg should be done cautiously (see section Before Taking Pravastatina Korhispana).

If you think that the effect of Pravastatina Korhispana is too strong or too weak, consult your doctor or pharmacist.

If you take more Pravastatina Korhispana than you should:

There is limited information available on pravastatin overdose and its treatment. Therefore, if you have taken more Pravastatina Korhispana than recommended, contact your doctor, pharmacist, or nearest hospital so that appropriate symptomatic treatment can be administered.

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

If you forget to take Pravastatina Korhispana:

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

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

If you stop taking Pravastatina Korhispana:

Contact your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, Pravastatina Korhispana may produce adverse effects, although not everyone experiences them.

Adverse effects are classified as: very common (affecting at least 1 in 10 people), common (affecting at least 1 in 100 people), uncommon (affecting at least 1 in 1,000 people), rare (affecting at least 1 in 10,000 people), very rare (affecting fewer than 1 in 10,000 people), frequency not known (cannot be estimated from available data), and isolated cases.

The effects observed during clinical studies with pravastatin 40 mg were:

Nervous system disorders:

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

Eye disorders:

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

Gastrointestinal disorders:

Uncommon: indigestion/heartburn, abdominal pain, nausea/vomiting, constipation, diarrhoea, flatulence.

Skin and subcutaneous tissue disorders:

Uncommon: itching, skin rash, development of itchy blisters, hair and scalp abnormalities (including hair loss).

Renal and urinary disorders:

Uncommon: urinary elimination disturbances (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.

Possible side effects reported with some statins (medicines of the same type):

• Memory loss
• Sexual dysfunction
• Depression
• Respiratory problems including persistent cough and/or shortness of breath 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.

Adverse effects of particular clinical relevance:

Musculoskeletal disorders: musculoskeletal pain including joint pain, muscle cramps, muscle pain (very common), and elevations in creatine kinase levels (an enzyme indicating muscle damage).

Frequency not known: persistent muscle weakness.

Hepatic disorders: elevations in serum transaminases (enzymes indicating liver disease).

During post-marketing experience with pravastatin, the following adverse reactions have been reported:

Nervous system disorders:

Very rare: peripheral polyneuropathy, particularly when used for prolonged periods, and tingling sensations (paraesthesia).

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

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

Eye disorders:

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

Consult your doctor if you experience worsening weakness in your arms or legs 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: inflammation of the pancreas (pancreatitis).

Hepatobiliary disorders:

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

Musculoskeletal and connective tissue disorders:

Very rare: destruction of muscle fibres (rhabdomyolysis), which may be associated with acute kidney failure secondary to myoglobinuria (red-coloured urine) and muscle disorders (myopathy), inflammation of muscles (myositis), significant muscle weakness (polymyositis) (see section 2).

Isolated cases of tendon disorders, sometimes complicated by tendon rupture.

Frequency not known: muscle rupture.

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, talk to your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Pravastatin Korhispana 20 mg Tablets

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

Do not store above 25°C. Store in the original container tightly closed.

Expiry:

Do not use this medicinal product after the expiry date stated on the packaging. 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 medicines and containers you no longer need. This will help protect the environment.

6. Additional Information

Composition of Pravastatina Korhispana 20 mg tablets:

The active substance is pravastatin sodium. Each tablet contains 20 mg of pravastatin sodium.

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

Appearance of the product and contents of the pack:

Pravastatina Korhispana is presented as white, oblong, biconvex tablets, scored on both sides. Each pack 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 summary of product characteristics was approved in March 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/