PATIENT INFORMATION LEAFLET

Pravastatina TecniGen20 mg film-coated tablets

Read this 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, pharmacist or nurse.
• This medicine has been prescribed for you. Do not pass it on to others even if they have similar symptoms, as it may harm them.
• If you experience any side effects, talk to your doctor, pharmacist or nurse, even if they are not listed in this leaflet. See section 4.

Pravastatina TecniGen are tablets that contain pravastatina as the active ingredient, available in the market in the following dosages: 10 mg, 20 mg, and 40 mg. It is included in the category of anti-dislipidemics.

Therapeutic indications

Hypcholesterolemia

Treatment of primary hypercholesterolemia or mixed dyslipidemia, in conjunction 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 an 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, in conjunction with 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 the sectionsBefore taking Pravastatina TecniGenandHow to take Pravastatina TecniGen).

Do not take Pravastatina TecniGen if:

• You are allergic (hypersensitive) to pravastatina or any of the excipients of Pravastatina TecniGen.
• You have any active liver disease (liver disease), including unexplained elevations of serum transaminases above three times the upper limit of normal (see the sectionBefore taking Pravastatina TecniGen).
• You are pregnant or breastfeeding.

Warnings and Precautions

Consult your doctor or pharmacist before taking this medication.

• In the case of familial hypercholesterolemia, since pravastatina has not been evaluated in patients with this condition.

• In case of liver disease, since, like other lipid-lowering drugs, it is possible that moderate increases in serum transaminases may occur, which in most cases return to their initial level without the need to suspend treatment.

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

• If you have or have had myasthenia (a disease that presents with 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 may sometimes worsen the disease or cause myasthenia (see section 4).

The risk and severity of muscle problems during treatment with statins increase with the concomitant administration of medications that interact with them. Muscle symptoms, when associated with statins, usually disappear after suspending treatment.

Consult your doctor or pharmacist before taking Pravastatina TecniGen if you:

• Have severe respiratory failure
• Have taken or are taking within the last 7 days a medication that contains fusidic acid (used for the treatment of bacterial infections) by the oral or intravenous route.

The combination of fusidic acid and Pravastatina TecniGen may produce severe muscle problems (rhabdomyolysis).

While taking this medication, your doctor will monitor if you have diabetes or are at risk of developing diabetes. This risk of diabetes increases if you have high blood sugar and lipid levels, obesity, and high blood pressure.

Inform your doctor or pharmacist if you experience persistent muscle weakness. Additional tests and medications may be necessary to diagnose and treat this problem.

Children and adolescents

Pravastatina TecniGen is not recommended for use due to the limited available data on safety and efficacy in these patients.

Older adults

In elderly patients with risk factors, it may be necessary to adjust the dose.

Patients with renal or hepatic insufficiency

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 treatment with statins.

• Care should be taken in patients with predisposing factors such as renal insufficiency, hypothyroidism, history of statin or fibrate toxicity, personal or family history of hereditary muscle diseases, or alcohol abuse. In these cases, creatine kinase levels should be determined before starting treatment. Additionally, creatine kinase levels should be evaluated before starting treatment in patients over 70 years old, especially those with other predisposing factors.

During treatment:

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

Use of Pravastatina TecniGen with other medications

Inform your doctor or pharmacist if you are using, have used recently, or may need to use other medications.

Fusidic acid:

If you need to take oral fusidic acid to treat a bacterial infection, you will need to stop taking this medication. Your doctor will indicate when you can restart treatment with Pravastatina TecniGen.

The use of Pravastatina with fusidic acid may produce muscle weakness, sensitivity, or pain (rhabdomyolysis). For more information on rhabdomyolysis, see section 4.

Fibrates::The use of fibrates alone is sometimes associated with the appearance of myopathy. There has been a reported increase in the risk of adverse muscle reactions, including rhabdomyolysis, associated with the concomitant administration of fibrates with other statins. Since the appearance of these adverse reactions cannot be ruled out with pravastatina, it is recommended to avoid the simultaneous use of pravastatina and fibrates (e.g., gemfibrozil, fenofibrate).

Colestiramine/colestipol::The simultaneous administration resulted in a decrease in pravastatina bioavailability. When pravastatina was administered one hour before or four hours after colestiramine or one hour before colestipol and a standard meal, no clinically significant decrease in bioavailability or therapeutic effect was observed (see the section How to takePravastatina TecniGen)

Ciclosporina::The simultaneous administration of pravastatina and ciclosporina produces an increase in systemic exposure to pravastatina. It is recommended to perform clinical and biochemical monitoring of patients receiving this combination (see the section How to takePravastatina TecniGen).

Warfarina and other anticoagulants::The chronic administration of pravastatina and warfarin does not produce any change in the anticoagulant effect of warfarin.

Drugs metabolized by the cytochrome P450::Specifically, there has been no demonstration of significant pharmacokinetic interactions with pravastatina 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).

Special caution should be exercised when pravastatina is administered with erythromycin or clarithromycin.

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

Taking Pravastatina TecniGen with food, drinks, and alcohol

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

Pravastatina should be administered under strict supervision in patients who take large amounts of alcohol or have previous liver disease.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, or if you think you may be pregnant or plan to become pregnant, consult your doctor or pharmacist before using this medication.

Pregnancy

Pravastatina is contraindicated in pregnancy.

If you become pregnant or suspect pregnancy, you should immediately inform your doctor and discontinue treatment with pravastatina due to the potential risk to the fetus.

Breastfeeding

Pravastatina passes in small amounts into breast milk, so it is contraindicated during breastfeeding.

Consult your doctor or pharmacist before using any medication.

Driving and operating machinery

Pravastatina has no or has a negligible effect on the ability to drive and operate machinery. However, when driving or operating machinery, you should be aware that you may feel dizziness during treatment.

Pravastatina TecniGen contains lactose

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

Follow exactly the administration instructions for Pravastatina TecniGen indicated by your doctor. Consult your doctor or pharmacist if you have any doubts.

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

Pravastatina TecniGen is administered orally once a day, preferably at night, with or without food.

Hypercholesterolemia

The recommended dosage interval is 10to 40mg once a day. The response to treatment is observed after one week, with maximum effect achieved in four weeks; therefore, periodic determinations of blood lipids and adjustment of the dose should be made accordingly. The maximum dose is 40mg per day.

Cardiovascular Prevention

In all morbidity and mortality studies, the only starting and maintenance dose studied was 40mg per day.

Posology after Transplants

After an organ transplant, an initial dose of 20mg per day is recommended in patients receiving immunosuppressive treatment. Depending on blood lipid levels, the dose may be increased to 40mg under close medical supervision (see sectionBefore Taking Pravastatina TecniGen).

Use in Children and Adolescents

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

Older Patients

No dose adjustment is necessary in these patients unless other risk factors are present (see sectionBefore Taking Pravastatina TecniGen).

Renal or Hepatic Insufficiency

In patients with moderate or severe renal impairment or significant hepatic impairment, an initial dose of 10mg 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 Pravastatina TecniGen increases when combined with a bile acid sequestrant (e.g. cholestyramine, colestipol). Pravastatina TecniGen should be taken one hour before or at least four hours after the sequestrant (see sectionBefore Taking Pravastatina TecniGen).

Patients treated with ciclosporin with or without other immunosuppressants should start therapy with 20mg of pravastatina once a day, and the dose adjustment to 40mg should be made with caution (see sectionBefore Taking Pravastatina TecniGen).

If you estimate that the action of Pravastatina TecniGen is too strong or too weak, consult your doctor or pharmacist.

If You Take More Pravastatina TecniGen Than You Should

There is limited information on pravastatina overdose and its treatment. If you have taken more Pravastatina TecniGen 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 Toxicological Information Service. Phone: 91 562 0420.

If You Forget to Take Pravastatina TecniGen

Do not take a double dose to compensate for the missed dose, wait for the next scheduled dose.

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

If You Discontinue Treatment with Pravastatina TecniGen

Contact your doctor or pharmacist.

Like all medicines, Pravastatina TecniGen can cause side effects, although not everyone will experience them.

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

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

Nervous system disorders:

Uncommon:dizziness, headache, sleep disorders, insomnia.

Eye disorders:

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

Gastrointestinal disorders:

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

Skin and subcutaneous tissue disorders:

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

Renal and urinary disorders:

Uncommon:urination disturbances (such as difficulty urinating, urinating more frequently, and urinating more frequently at night).

Reproductive and breast disorders:

Uncommon:sexual alterations

General disorders and administration site conditions:

Uncommon:fatigue

Important clinical side effects

Musculoskeletal disorders: muscle and skeletal pain including joint pain, muscle cramps, muscle pain (very common), muscle weakness (common), and elevations of creatine kinase levels (enzyme indicative of muscle damage).

Hepatobiliary disorders: elevations of serum transaminases (enzymes indicative of liver disease).

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

Nervous system disorders:

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

Frequency unknown: Myasthenia gravis (a disease that causes generalized muscle weakness, which 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 eyelid drooping, difficulty swallowing or difficulty breathing.

Eye disorders:

Frequency unknown: Myasthenic eye disease (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 eyelid drooping, 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), liver inflammation (hepatitis), fulminant hepatic necrosis.

Musculoskeletal and connective tissue disorders:

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

Isolated cases of tendon disorders, sometimes complicated with rupture.

Frequency unknown:constant muscle weakness, muscle rupture.

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

• 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 blood sugar and fat levels, obesity, and high blood pressure. Your doctor will monitor you while taking this medication.

If you consider that any of the side effects you experience are severe or if you notice any side effect not mentioned in this prospectus, inform your doctor or pharmacist.

Reporting of adverse reactions

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

Keep this medication out of the sight and reach of children.

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

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

Medications should not be disposed of through drains or in the trash.Deposit empty containers and unused medications at the SIGRE collection point at your pharmacy.If in doubt, ask your pharmacist how to dispose of empty containers and unused medications. By doing so, you will help protect the environment.

Composition of Pravastatina TecniGen 20 mg tablets

The active ingredient is pravastatina. Each tablet contains 20 mg of pravastatina.

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 packaging

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

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Tecnimede España Industria Farmacéutica, S.A.

Avda. de Bruselas, 13, 3º D. Edificio América. Polígono Arroyo de la Vega,

28108 Alcobendas (Madrid) SPAIN

Responsible for manufacturing

Atlantic Pharma - Produções Farmacêuticas, S.A.

Rua da Tapada Grande, nº 2, Abrunheira, 24710-189 Sintra

Portugal

Last review date of this leaflet: February 2024

The detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es