Pravastatin TecniGen 10 mg tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Pravastatina TecniGen 10 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, pharmacist, or nurse.
• This medicine has been prescribed for you and should not be given to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if these effects are not listed in this leaflet. See section 4.

Leaflet contents:

1. What Pravastatina TecniGen is and what it is used for.
2. What you need to know before taking Pravastatina TecniGen.
3. How to take Pravastatina TecniGen.
4. Possible side effects.
5. How to store Pravastatina TecniGen.
6. Contents of the pack and other information.

1. What Pravastatina TecniGen is and what it is used for

Pravastatina TecniGen are tablets containing 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.

Therapeutic Indications

Hypercholesterolemia

Treatment of primary hypercholesterolemia or mixed dyslipidemia, in combination with 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 at 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, along with correction of other risk factors.

Post-transplant

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

2. What you need to know before taking Pravastatina TecniGen

Do not take Pravastatina TecniGen if:

• You are allergic (hypersensitive) to pravastatin or any of the excipients of Pravastatina TecniGen.
• You have active liver disease, including unexplained elevations of serum transaminases above 3 times the upper limit of normal (see section Before taking Pravastatina TecniGen).
• You are pregnant or breastfeeding.

Warnings and Precautions

Consult your doctor or pharmacist before taking this medicine.

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

• In case of liver disorders, as with other similar lipid-lowering drugs, mild 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.

• 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), as statins may sometimes worsen the condition or trigger the onset of myasthenia (see section 4).

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

Consult your doctor or pharmacist before taking Pravastatina TecniGen if:

• You have severe respiratory insufficiency.
• You 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 Pravastatina TecniGen may cause serious muscle problems (rhabdomyolysis).

While 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 fats in the blood, are overweight, or have high blood pressure.

Inform your doctor or pharmacist if you experience persistent muscle weakness. Additional tests and treatments may be needed to diagnose and manage this condition.

Children and adolescents

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

Elderly

Dose adjustment may be necessary in elderly patients with risk factors.

Patients with renal or hepatic impairment

Dosage should be adjusted according to blood lipid levels and under medical supervision.

Before starting treatment:

• Measurement of creatine kinase levels is recommended 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. 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, resuming statin therapy is not recommended.

Use of Pravastatina TecniGen with other medicines

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

Fusidic acid:

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 Pravastatina TecniGen. Using pravastatin with fusidic acid may cause muscle weakness, tenderness, or pain (rhabdomyolysis). For more information on rhabdomyolysis, see section 4.

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 such 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 is 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 has been observed (see section How to take Pravastatina TecniGen).

Cyclosporine: Concomitant administration of pravastatin and cyclosporine increases systemic exposure to pravastatin. Clinical and biochemical monitoring is recommended for patients receiving this combination (see section How to take Pravastatina 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: The absence of significant pharmacokinetic interactions has specifically been demonstrated 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).

Special caution is required 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 TecniGen with food, drinks, and alcohol

Pravastatin is administered once daily, preferably at night. Tablets may 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, breastfeeding, and fertility

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

Pregnancy

Pravastatin is contraindicated during pregnancy.

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

Breastfeeding

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

Consult your doctor or pharmacist before using any medicine.

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 noted that dizziness may occur during treatment.

Pravastatina TecniGen contains lactose

If your doctor has diagnosed you with an intolerance to certain sugars, consult him before taking this medicine.

3. How to take Pravastatina TecniGen

Follow exactly the instructions for administering Pravastatina TecniGen as given 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 should be placed on a standard hypolipidemic diet (a diet aimed at lowering blood lipid levels), which should be maintained throughout the treatment period.

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

Hypercholesterolemia

The recommended dosage range is 10 to 40 mg once daily. A response to treatment is observed after one week, with maximum effect reached by 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 initiation and maintenance was 40 mg per day.

Dosage after organ transplantation

After organ transplantation, an initial dose of 20 mg per day 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 TecniGen).

Use in children and adolescents

Available data on safety and efficacy in patients under 18 years of age are limited; therefore, the use of Pravastatina TecniGen 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 TecniGen).

Renal or hepatic impairment

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

Concomitant treatment

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

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

If you feel that the effect 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 pravastatin overdose and its treatment. Therefore, if you have taken more Pravastatina TecniGen 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 TecniGen

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 treatment with Pravastatina TecniGen

Contact your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, Pravastatina TecniGen may cause 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, insomnia.

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, blistering accompanied by itching, abnormalities of hair and scalp (including hair loss).

Renal and urinary disorders:

Uncommon: urinary elimination disturbances (such as difficulty urinating, increased frequency of urination, and increased nighttime urination).

Reproductive system and breast disorders:

Uncommon: sexual disturbances.

General disorders and administration site conditions:

Uncommon: fatigue.

Adverse effects of particular clinical relevance

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

Hepatobiliary disorders: increased 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 sensation (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 the 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 the 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 erythematosus-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), marked muscle weakness (polymyositis) (see section 2).

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

Frequency not known: Persistent muscle weakness, muscle rupture.

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

• Sleep disturbances, 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 your 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 effect not listed 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 through the Spanish Pharmacovigilance System for Human Medicines: www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Pravastatin TecniGen

Keep this medicine out of sight and reach of children.

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

Do not use this medicine after the expiry date stated on the container. 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 containers and medicines at the SIGRE collection point at your pharmacy. If you are in doubt, ask your pharmacist how to dispose of containers and unused medicines. This will help protect the environment.

6. Contents of the pack and other information

Composition of Pravastatina TecniGen 10 mg tablets

The active substance is pravastatin. Each tablet contains 10 mg of pravastatin.

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

Appearance of the medicinal product and contents of the pack

Pravastatina TecniGen 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

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 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