Pravastatin Davur 20 mg tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Pravastatin Davur 20 mg tablets EFG

Package leaflet contents

1. What Pravastatina Davur 20 mg tablets are and what they are used for
2. What you need to know before starting to take Pravastatina Davur 20 mg tablets
3. How to take Pravastatina Davur 20 mg tablets
4. Possible side effects
5. Storage of Pravastatina Davur 20 mg tablets
6. Contents of the pack and other information

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

Pravastatin belongs to a group of medicines known as statins (or HMG-CoA reductase inhibitors). It prevents the liver from producing cholesterol and consequently reduces the levels of cholesterol and other fats (triglycerides) in your body. When there are excessive levels of cholesterol in the blood, cholesterol accumulates in the walls of blood vessels, causing them to become narrowed.

This condition is known as hardening of the arteries or atherosclerosis and may lead to:

• Chest pain (angina), when a blood vessel of the heart is partially blocked.
• Heart attack (myocardial infarction), when a blood vessel of the heart is completely blocked.
• Stroke (cerebrovascular accident), when a blood vessel in the brain is completely blocked.

This medicine is indicated in three situations:

In the treatment of high levels of cholesterol and fats in the blood

Pravastatin is indicated to lower high levels of "bad" cholesterol and to increase levels of "good" cholesterol in the blood when diet and exercise have not been effective.

Prevention of heart and blood vessel diseases

• If you have high cholesterol levels in the blood and risk factors that contribute to these diseases (such as smoking, being overweight, having high blood sugar or hypertension, or lack of physical activity), Pravastatin is indicated to reduce the risk of developing heart and blood vessel problems, and to reduce the risk of death from these conditions.
• If you have already had a stroke or suffer from chest pain (unstable angina), Pravastatin is indicated to reduce the risk of future heart attack or stroke, even if your cholesterol levels are normal, and to reduce the risk of death from these conditions.

After organ transplantation

If you have undergone an organ transplant and are receiving medication to prevent your body from rejecting the transplanted organ, Pravastatin is indicated to reduce elevated blood fat levels.

2. What you need to know before taking Pravastatin Davur

Do not take Pravastatin Davur

• if you are allergic (hypersensitive) to sodium pravastatin or to any of the other ingredients of this medicine (listed in section 6)
• if you have active liver disease or elevated transaminase levels (enzymes indicating liver disease)
• if you are pregnant or think you might be pregnant
• if you are breastfeeding

Warnings and precautions

Before taking this medicine, consult your doctor if you have or have had any of the following medical conditions:

• If you have had liver disease or a history of alcoholism.

Mild increases in liver transaminase levels may occur, which in most cases return to normal without the need to discontinue treatment.

• You should also inform your doctor if you have kidney impairment, hypothyroidism, a personal or family history of muscle disorders, or if you regularly consume alcohol.

• Consult your doctor or pharmacist before taking Pravastatin Davur if you have severe respiratory insufficiency.

• 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 blood sugar and fat levels, are overweight, or have high blood pressure.

• During treatment, some patients may experience muscle pain, tenderness, weakness, or muscle cramps. If you experience any of these symptoms, inform your doctor immediately.

• If you are taking or have taken within the last 7 days a medicine containing fusidic acid (used to treat bacterial infection) by oral or injectable route. The combination of fusidic acid and pravastatin may cause serious muscle problems (rhabdomyolysis).

• If you have or have had myasthenia gravis (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).

Your doctor will perform a blood test before you start taking Pravastatin Davur and if you develop any symptoms or liver problems during treatment. This is to check that your liver is functioning properly.

Your doctor may also need to perform blood tests after starting treatment with Pravastatin Davur to monitor liver function.

Your doctor may recommend blood tests to assess your muscle status before and during treatment to consider starting, continuing, or stopping treatment.

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

Inform your doctor if you are taking other medicines that may also cause muscle disorders such as:

• Fibrates (reduce cholesterol levels)
• Nicotinic acid (a medicine used to treat high blood cholesterol)
• Colchicine (a medicine used to treat gout)
• Rifampicin (a medicine used to treat the infection called tuberculosis)
• Lenalidomide (a medicine used to treat a type of blood cancer called multiple myeloma)

Consult your doctor, even if any of the above conditions occurred in the past.

Other medicines and Pravastatin Davur

Inform your doctor or pharmacist if you are using, have recently used, or might need to use any other medicines.

Certain medicines may interact with Pravastatin; in such cases, it may be necessary to adjust the dose or discontinue one of the treatments.

It is important that you inform your doctor if you are using or have recently used any of the following medicines:

• A medicine that lowers blood cholesterol levels (fibrates, e.g. gemfibrozil, fenofibrate)
• A medicine that suppresses the body's immune defenses (cyclosporine)
• A medicine used to treat bacterial infections (an antibiotic such as erythromycin or clarithromycin)
• If you need to take oral fusidic acid to treat a bacterial infection, you will need to temporarily stop taking this medicine. Your doctor will advise you when it is safe to restart Pravastatin treatment. Taking Pravastatin with fusidic acid may rarely cause muscle weakness, tenderness, or pain (rhabdomyolysis). See more information on rhabdomyolysis in section 4.
• Colchicine (a medicine used to treat gout)
• Nicotinic acid (a medicine used to lower high blood cholesterol)
• Rifampicin (a medicine used to treat the infection called tuberculosis)
• Lenalidomide (a medicine used to treat a type of blood cancer called multiple myeloma)
• If you are taking a medicine used to treat and prevent blood clots known as a “vitamin K antagonist”, inform your doctor before taking pravastatin, as concomitant use of vitamin K antagonists with pravastatin may increase the results of blood tests used to monitor vitamin K antagonist therapy.
• If you are also taking a medicine to lower blood fat levels of the resin type (such as cholestyramine or colestipol), this treatment should be taken at least one hour before or four hours after taking the resin. This is because the resin may affect the absorption of Pravastatin if both medicines are taken simultaneously.

Taking Pravastatin Davur with food and drinks

Pravastatin can be taken with or without food.

Pravastatin should be used with caution in patients who consume alcohol. If you regularly drink alcohol, consult your doctor.

Pregnancy and breastfeeding

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. Pravastatin must not be administered during pregnancy. If you become pregnant or suspect pregnancy, you must stop treatment and inform your doctor immediately.

Pravastatin must not be administered during breastfeeding, as it passes into breast milk.

Driving and using machines

At normal doses, Pravastatin does not affect the ability to drive or operate machinery. However, if you experience dizziness, do not drive or operate machinery until you know how you react to the medicine.

Pravastatin Davur contains lactose and sodium

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

This medicine contains less than 1 mmol of sodium (23 mg) per tablet; therefore, it is essentially “sodium-free”.

3. How to take Pravastatin Davur

Follow exactly the instructions for use of this medicine as given by your doctor. If in doubt, consult your doctor or pharmacist.

The tablets should be swallowed with water and may be taken with or without food, preferably at night.

The recommended dose ranges from 10–40 mg once daily. Your doctor will determine the appropriate dose for you and will make any necessary adjustments based on your response to the medication.

Concomitant therapy: patients receiving pravastatin and cyclosporine should start treatment with 20 mg of pravastatin once daily; your doctor will adjust the dose up to 40 mg if needed. For patients taking pravastatin and a bile acid sequestrant resin (e.g. cholestyramine, colestipol), Pravastatin Davur 20 mg should be administered either one hour before or four hours after the resin.

Use in children and adolescents (8–18 years) with heterozygous familial hypercholesterolemia: the recommended dose for patients aged 8–13 years is 10–20 mg once daily; the recommended dose for patients aged 14–18 years is 10–40 mg once daily.

Elderly patients: dose adjustment is not necessary in these patients unless other risk factors are present.

Patients with renal or hepatic impairment: in patients with moderate or severe renal dysfunction or significant hepatic impairment, treatment should be initiated at a dose of 10 mg.

If you think the effect of Pravastatin Davur 20 mg is too strong or too weak, inform your doctor or pharmacist.

Duration of treatment

Your doctor will advise you on how long to take pravastatin. This medicine should be taken regularly for the duration recommended by your doctor, even if this is for a long period. Do not stop treatment prematurely on your own.

If you take more Pravastatin Davur than you should

If you have taken more pravastatin than you should, or if someone accidentally swallowed some tablets, contact your doctor, pharmacist, or the nearest hospital.

Contact your doctor, pharmacist, or call the Toxicology Information Service at telephone: 915 620 420, indicating the medicine and the amount taken.

If you forget to take Pravastatin Davur

If you forget to take a dose, simply take your next dose at the usual time.

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

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

4. Possible adverse effects

Like all medicines, pravastatin may cause adverse effects, although not everyone experiences them.

Adverse effects are classified as follows:

Very common (affects more than 1 in 10 people), common (affects between 1 and 10 in 100 people),

Uncommon (affects between 1 and 10 in 1,000 people),

Rare (affects between 1 and 10 in 10,000 people),

Very rare (affects fewer than 1 in 10,000 people), and

Frequency not known (cannot be estimated from available data)

Immune system disorders

Very rare: allergic reactions, angioedema (swelling of arms, legs, face, lips, tongue and/or throat), lupus-like syndrome (skin inflammation).

Nervous system disorders

Uncommon: dizziness, headache, sleep disorders, insomnia.

Very rare: peripheral polyneuropathy, particularly when used for prolonged periods, and tingling sensation.

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

Eye disorders

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

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

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

Gastrointestinal disorders

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

Very rare: pancreatitis (inflammation of the pancreas).

Hepatobiliary disorders

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

Frequency not known: liver failure.

Skin and subcutaneous tissue disorders

Uncommon: itching, rash, blistering accompanied by itching, hair and scalp abnormalities (including hair loss).

Rare: photosensitivity reaction.

Very rare: dermatomyositis.

Frequency not known: rash, including lichenoid rash.

Musculoskeletal and connective tissue disorders

Very rare: rhabdomyolysis (destruction of muscle fibres), which may be associated with kidney disorders, myopathy (muscle abnormalities), miositis (inflammation of muscle tissue), polymyositis (simultaneous miositis in several muscles).

Uncommon: tendon abnormalities, sometimes complicated by rupture.

Frequency not known: persistent muscle weakness, sprains, muscle strains, and muscle ruptures.

Renal and urinary disorders

Uncommon: abnormalities in urine elimination (such as difficulty urinating, increased frequency of urination, and increased frequency of night-time urination).

Reproductive system and breast disorders

Uncommon: sexual dysfunction.

General disorders

Uncommon: fatigue.

The following adverse effects of special clinical interest have also been reported during clinical studies:

Musculoskeletal and connective tissue disorders

Musculoskeletal pain, including joint pain, muscle cramps, muscle pain (very common), and elevated levels of creatine kinase (an enzyme indicating muscle damage).

Hepatobiliary disorders

Elevations in serum transaminases (enzymes indicating liver disease).

The following adverse reactions have been reported with some statins:

• Sleep disorders, including insomnia and nightmares
• Memory loss
• Sexual dysfunction
• Depression
• Respiratory problems including persistent cough and/or difficulty breathing or fever
• Diabetes Mellitus: The frequency will depend on the presence or absence of risk factors (fasting glucose ≥5.6 mmol/L, BMI>30 kg/m², elevated triglycerides, history of hypertension). Your doctor will monitor you while you are taking this medicine.
• Dermatomyositis (a disease characterized by inflammation of muscles and skin).

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may 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 Davur

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

Do not store above 30°C.

Do not use this medicine after the expiry date stated on the packaging after the abbreviation EXP. 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 medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Pravastatina Davur 20 mg tablets

• The active substance is pravastatin sodium. Each tablet contains 20 mg of pravastatin sodium.
• The other components (excipients) are: anhydrous lactose, povidone, crospovidone, anhydrous calcium hydrogen phosphate, sodium stearyl fumarate, microcrystalline cellulose, sodium croscarmellose, and yellow iron oxide (E – 172).

Appearance of the product and contents of the pack

Pravastatina Davur 20 mg is presented as tablets. The tablets are round, pale yellow, slightly convex, and scored on both sides. The tablet can be divided into equal doses.

Each pack contains 28 tablets.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Teva Pharma, S.L.U.

C/Anabel Segura 11, Edificio Albatros B, 1st floor,

Alcobendas, 28108 Madrid (Spain)

Manufacturer

Teva Pharma S.L.U.

Polígono Industrial Malpica, calle C.4

50016-Zaragoza.

Spain

or

Teva Pharmaceutical Works Private Limited Company

Pallagi ut, 13 Debrecen

Hungary

Date of the most recent revision of this leaflet: October 2025

Other sources of information

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.es/