Pravastatin Mabo 40 mg tablets EFG

Package leaflet: Information for the user

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Pravastatin MABO 40 mg Tablets EFG

(Sodium pravastatin)

Package leaflet contents:

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. Storage of 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, along with an appropriate diet, for:

• The treatment of primary hypercholesterolemia and mixed dyslipidemia, conditions characterized by elevated cholesterol and/or triglycerides 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 undergoing organ transplantation who 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 transaminase levels (enzymes indicating liver disease),
• if you are pregnant or think you might be pregnant,
• if you are breastfeeding.

Warnings and precautions

Talk to your doctor or pharmacist before starting Pravastatina MABO:

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

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

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

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

• If you have severe respiratory insufficiency.

• If you have or have had myasthenia gravis (a disease characterized by generalized muscle weakness that in some cases affects the muscles used for breathing) or ocular myasthenia (a condition causing weakness of the eye muscles), as 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 you for diabetes or risk factors for developing diabetes. This risk increases 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 and during treatment, to evaluate whether to initiate, continue, or discontinue treatment.

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

• Fibrates (reduce cholesterol levels).
• Nicotinic acid (reduces cholesterol levels).
• If 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 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 taking, have recently taken, or might need to take 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 organ 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 using this medicine. Your doctor will advise you when you can restart treatment with 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 drink

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, you must 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 tolerate the medicine.

Pravastatina MABO contains lactose

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

3. HOW TO TAKE PRAVASTATIN MABO

Follow exactly the administration instructions for 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 ones.

Remember to take your medicine.

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

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

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.

Combination 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 as needed. For patients receiving pravastatin and a bile acid sequestrant resin (e.g. cholestyramine, colestipol), Pravastatin 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 8–13 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 kidney function impairment or significant liver function impairment, treatment should be initiated at a dose of 10 mg.

If you think that the effect of Pravastatin MABO is too strong or too weak, tell your doctor or pharmacist.

If you take more Pravastatin MABO than you should

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

If you forget to take Pravastatin 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, pravastatin 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 the 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 the eye muscles).

Gastrointestinal disorders:

Uncommon: indigestion/heartburn, abdominal pain, nausea, vomiting, constipation, diarrhea, 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, hair and scalp abnormalities (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 abnormalities, sometimes complicated by tendon rupture.
Frequency not known: persistent muscle weakness, muscle rupture.

Renal and urinary disorders:

Uncommon: urinary abnormalities (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 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), 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, or have high blood pressure. Your doctor will monitor you while you are taking this medicine.

Reporting of adverse effects

If you experience any 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 pack 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 refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater drains or household waste. Dispose of unused containers and medicines at the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to properly dispose of unused containers and medicines. This will help protect the environment.

6. CONTENTS OF THE PACKAGE AND OTHER INFORMATION

Composition of Pravastatina MABO 40 mg tablets EFG:

• The active substance is sodium pravastatin. Each tablet contains 40 mg of sodium pravastatin.
• The other components are: anhydrous lactose, povidone, crospovidone, anhydrous calcium hydrogen phosphate, sodium stearyl fumarate, microcrystalline cellulose, sodium croscarmellose, quinoline yellow WS (E-104) and brilliant blue (E-133).

Appearance of the product and contents of the pack

Pravastatina MABO 40 mg is presented as tablets. The tablets are round, slightly convex, pale green in colour, and have a score line on both sides. Each pack contains 28 tablets.

Other pack sizes:

Pravastatina MABO 10 mg EFG Tablets: pack of 28 tablets
Pravastatina MABO 20 mg EFG Tablets: pack of 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 medicine is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/