PRAVASTATIN TECNIGEN 10 mg TABLETS

2. What you need to know before you take Pravastatin TecniGen

Do not take Pravastatin TecniGen if:

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

Warnings and Precautions

Consult your doctor or pharmacist before taking this medicine.

• 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, 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 who presents with unexplained muscle symptoms such as muscle pain or sensitivity, muscle weakness, or muscle cramps.

• If you have or have had myasthenia (a disease that causes 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).

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 taking Pravastatin TecniGen if you:

• Have severe respiratory failure.
• If you are taking or have taken in the last 7 days a medicine that contains fusidic acid (used to treat bacterial infections) orally or by injection. The combination of fusidic acid and Pravastatin TecniGen can cause serious muscle problems (rhabdomyolysis).

While you are taking this medicine, your doctor will check if you have diabetes or are at 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.

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

Children and adolescents

The use of Pravastatin TecniGen is not recommended due to limited data on safety and efficacy in these patients.

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 insufficiency, 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 people 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 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 Pravastatin TecniGen with other medicines

Tell your doctor or pharmacist if you are using, have recently used, or might use other medicines.

Fusidic acid:

If you need to take fusidic acid orally to treat a bacterial infection, you will need to stop using this medicine. Your doctor will tell you when you can restart treatment with Pravastatin TecniGen. The use of Pravastatin with fusidic acid can cause serious muscle problems (rhabdomyolysis).

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 concomitant 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 TecniGen).

Ciclosporin: concomitant administration of pravastatin and ciclosporin results in an increased systemic exposure to pravastatin. Clinical and biochemical monitoring of patients receiving this combination is recommended (see section How to take Pravastatin TecniGen).

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 with 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 medicines: 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 TecniGen with food, drinks, and alcohol

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, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy

Pravastatin is contraindicated in pregnancy.

In case of pregnancy or suspected pregnancy, you should inform your doctor immediately and discontinue treatment with pravastatin due to the potential risk to the fetus.

Breastfeeding

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

Ask your doctor or pharmacist for advice before taking any medicine.

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.

Pravastatin TecniGen contains lactose

If your doctor has told you that you have an intolerance to some sugars, consult them before taking this medicine.

3. How to take Pravastatin TecniGen

Follow the instructions for administration of Pravastatin TecniGen exactly as indicated by your doctor. Ask your doctor or pharmacist if you have any doubts.

Before starting treatment with Pravastatin TecniGen, 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 TecniGen 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 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 starting and maintenance dose studied 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 close medical supervision (see section Before taking Pravastatin TecniGen).

Use in children and adolescents

The use of Pravastatin TecniGen is not recommended in these patients due to limited data on safety and efficacy.

Elderly patients

No dose adjustment is necessary in these patients unless there are other risk factors (see section Before taking Pravastatin TecniGen).

Patients with 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 TecniGen increases when associated with a bile acid sequestrant (e.g., colestyramine, colestipol). Pravastatin TecniGen should be administered one hour before or at least four hours after the sequestrant (see section Before taking Pravastatin TecniGen).

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

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

If you take more Pravastatin TecniGen than you should

There is limited information available on overdose with pravastatin or its treatment. If you have taken more Pravastatin 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 Toxicology Information Service. Phone: 91 562 0420.

If you forget to take Pravastatin TecniGen

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

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

If you stop taking Pravastatin TecniGen

Contact your doctor or pharmacist.

4. Possible Adverse Effects

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

Effects are classified as: 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 (frequency cannot be estimated from available data), and isolated cases.

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

Nervous System Disorders:

Infrequent:dizziness, headache, sleep disorders, insomnia.

Eye Disorders:

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

Gastrointestinal Disorders:

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

Skin and Subcutaneous Tissue Disorders:

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

Renal and Urinary Disorders:

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

Reproductive System and Breast Disorders:

Infrequent:sexual changes

General Disorders and Administration Site Conditions:

Infrequent:fatigue

Adverse Effects of Special Clinical Relevance

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

Hepatobiliary Disorders: elevated 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 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.

Eye 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), liver inflammation (hepatitis), destruction of liver cells (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 changes (myopathy), muscle inflammation (myositis), significant muscle weakness (polymyositis) (see section 2).

Isolated cases of tendon disorders, sometimes complicated by rupture.

Unknown frequency: constant muscle weakness, muscle rupture.

Possible adverse 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

This is more likely if you have high levels of sugars and fats in your blood, are overweight, and have high blood pressure. Your doctor will monitor you while you are taking this medication.

If you consider that any of the adverse effects you are experiencing 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 does not appear in this prospectus. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Pravastatina TecniGen

Keep this medicine out of sight and reach of children.

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

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

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

6. Package Contents and Additional Information

Composition of Pravastatina TecniGen 10 mg tablets

The active ingredient is pravastatina. Each tablet contains 10 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 Package Contents

Pravastatina TecniGen 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

Marketing Authorization Holder

Tecnimede España Industria Farmacéutica, S.A.

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

28108 Alcobendas (Madrid) SPAIN

Manufacturer

Atlantic Pharma – Produções Farmacêuticas, S.A.

Rua da Tapada Grande, n.º 2; Abrunheira, 2710-089 Sintra, Portugal

Date of the Last Revision of this Prospectus: February 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