Pravastatin Mabo 20 mg tablets EFG

Package leaflet: Information for the user

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

PravastatinaMABO 20 mg Tablets EFG

(Sodium pravastatin)

Package leaflet:

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

1. What PRAVASTATIN MABO is and what it is used for

Pravastatin belongs to a group of medicines known as statins, which work by reducing lipid, cholesterol, and triglyceride levels in the blood.

Pravastatin MABO is indicated, together with an appropriate diet, for:

• The treatment of primary hypercholesterolemia and mixed dyslipidemia, conditions characterized by elevated cholesterol and/or triglyceride levels in the blood, when diet or other measures (such as exercise or weight reduction) have not been effective.

• The prevention of cardiovascular events (myocardial infarction) and cardiovascular death in patients with high cholesterol levels and a high risk of experiencing a first cardiovascular event (primary prevention).

• The prevention of cardiovascular events and cardiovascular death in patients with normal or high cholesterol levels who have already experienced a cardiovascular event, such as myocardial infarction or angina pectoris (secondary prevention).

• The reduction of blood lipid levels in patients who have undergone organ transplantation and are receiving immunosuppressive therapy.

2. WHAT YOU NEED TO KNOW BEFORE TAKING Pravastatina MABO

Do not take Pravastatina MABO

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

Warnings and precautions

Talk to your doctor or pharmacist before starting to take Pravastatina MABO:

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

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

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

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

• If you have severe respiratory failure.

• If you 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), since 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 is higher if you have high blood sugar and fat levels, are overweight, or have high blood pressure.

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

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

• Fibrates (lower cholesterol levels).
• Nicotinic acid (lowers cholesterol levels).
• If you are taking or have taken within the last 7 days fusidic acid (used to treat bacterial infection) orally or by injection. Combining fusidic acid with Pravastatina MABO may cause serious muscle problems (rhabdomyolysis).

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.

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

Interaction of Pravastatina MABO with other medicines

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

Certain medicines may interact with Pravastatina MABO; in such cases, it may be necessary to adjust the dose or stop treatment with one of the medicines.

It is important to inform your doctor if you are taking or have recently taken any of the following medicines:

• Other cholesterol-lowering drugs such as cholestyramine or colestipol (which may reduce pravastatin blood levels) and fibrates (which may increase the risk of muscle-related adverse reactions).
• Cyclosporine, a medicine used to prevent transplant rejection (when taken with pravastatin, cyclosporine increases pravastatin blood levels).
• Antibiotics such as erythromycin or clarithromycin (which may increase pravastatin blood levels).
• If you need to take oral fusidic acid to treat a bacterial infection, you must stop taking this medicine. Your doctor will advise you when you can restart Pravastatina MABO. Using Pravastatina MABO with fusidic acid may cause muscle weakness, tenderness, or pain (rhabdomyolysis). For further information on rhabdomyolysis, see section 4.

Taking Pravastatina MABO with food and drinks

Pravastatina MABO can be taken with or without food.

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

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, or think you might be pregnant, consult your doctor or pharmacist before using this medicine.

Pregnancy

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

Breastfeeding

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

Driving and using machines

At normal doses, Pravastatina MABO 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.

Pravastatina MABO contains lactose

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

3. How to TAKE Pravastatina MABO

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

Follow these instructions unless your doctor has given you different advice.

Remember to take your medicine.

Your doctor will tell you how long to continue treatment with Pravastatina MABO. Do not stop treatment prematurely.

The tablets should be swallowed with water and may be taken with or without food, preferably in the evening.

The usual 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.

The tablet may be divided into equal doses.

Concomitant treatment: 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), Pravastatina MABO 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 to 13 years is 10–20 mg once daily; the recommended dose for patients aged 14 to 18 years is 10–40 mg once daily.

Elderly patients: Dose adjustment is not usually necessary in this population 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 that the effect of Pravastatina MABO is too strong or too weak, inform your doctor or pharmacist.

If you take more Pravastatina MABO than you should

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately, or call the Toxicology Information Service at 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take Pravastatina MABO

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

4. Possible adverse effects

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

These adverse effects may occur with certain frequencies, defined as follows:

very common: affects more than 1 in 10 patients,
common: affects between 1 and 10 in 100 patients,
uncommon: affects between 1 and 10 in 1,000 patients,
rare: affects between 1 and 10 in 10,000 patients,
very rare: affects fewer than 1 in 10,000 patients,
frequency not known: frequency cannot be estimated from the 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, including insomnia and nightmares.
Very rare: peripheral polyneuropathy, particularly when used for prolonged periods, and tingling sensations.
Frequency not known: Myasthenia gravis (a disease causing generalized muscle weakness which, in some cases, affects muscles used for breathing).

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.

Eye disorders:

Uncommon: visual disturbances (including blurred vision and double vision).
Frequency not known: Ocular myasthenia (a disease causing weakness of eye muscles).

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).

Skin and subcutaneous tissue disorders:

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

Musculoskeletal and connective tissue disorders:

Very rare: rhabdomyolysis (destruction of muscle fibres), which may be associated with kidney disorders, myopathy (muscle disorders).
Tendon disorders, sometimes complicated by tendon rupture.
Frequency not known: persistent muscle weakness, muscle rupture.

Renal and urinary disorders:

Uncommon: disturbances in urination (such as difficulty urinating, increased frequency of urination, and increased frequency of urination at night).

Reproductive system and breast disorders:

Uncommon: sexual dysfunction.

General disorders and administration site conditions:

Uncommon: fatigue.

The following clinically significant adverse effects have also been reported during clinical studies:

Musculoskeletal and connective tissue disorders:

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

Hepatobiliary disorders:

Elevations in serum transaminases (enzymes indicating liver disease).

Other possible adverse effects:

• Memory loss
• 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 fat in your blood, are overweight, and have high blood pressure. Your doctor will monitor you while you are taking this medicine.

Reporting of adverse effects

If you experience any type of adverse effect, consult 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: www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Pravastatin MABO

Keep out of the sight and reach of children.

Store below 30°C. Keep the blister in the outer packaging to protect it from light and moisture.

Do not use Pravastatin MABO after the expiry date stated on the packaging after EXP. The expiry date is the last day of the month indicated.

Medicines must not be disposed of via wastewater drains or household waste. Dispose of unused medicines and their containers at the SIGRE Point at your pharmacy. If in doubt, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. CONTENTS OF THE PACKAGE AND ADDITIONAL INFORMATION

Composition of Pravastatina MABO 20 mg tablets EFG:

• The active substance is pravastatin sodium. Each tablet contains 20 mg of pravastatin sodium.
• The other components 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 package

Pravastatina MABO 20 mg is presented as tablets. The tablets are round, slightly convex, pale yellow in colour, and have a score line on both sides. Each pack contains 28 tablets.

Other presentations:

Pravastatina MABO 10 mg Tablets EFG: pack containing 28 tablets

Pravastatina MABO 40 mg Tablets EFG: pack containing 28 tablets

Marketing Authorization Holder

MABO-FARMA S.A.

Calle Vía de los Poblados, 3, Edificio 6

28033 Madrid,

Spain.

Manufacturer

Teva Pharmaceutical Works private limited company

Pallagi ut 13. Debrecen H-4042 Hungary

or

Teva Pharma, S.L.U.

Polígono Industrial Malpica, calle C.4

50016-Zaragoza

Spain

Date of the most recent revision of this leaflet: March 2024

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.gob.es/