PROSPECTO : INFORMATION FOR THE USER

PravastatinaMABO10 mg Tablets EFG

(Pravastatina sodium)

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

2. What you need to know before starting to take Pravastatina MABO

3. How to take Pravastatina MABO

4. Possible adverse effects

5. Storage ofPravastatinaMABO

6. Contents of the package and additional information

Pravastatina belongs to a group of medications known as statins that act by reducing levels of lipids, cholesterol, and triglycerides in the blood.

Pravastatina MABO is indicated, along with an appropriate diet, for:

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

• The prevention of cardiovascular problems (myocardial infarction) and cardiovascular death in patients with elevated cholesterol levels and a high risk of experiencing a first cardiovascular event (Primary Prevention).

• The prevention of cardiovascular problems 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).

• Thereduction of lipid levels in the bloodin patients undergoing organ transplantation and receiving immunosuppressive treatment.

Do not take Pravastatina MABO

• if you are allergic to pravastatina sodium or any of the other ingredients of this medication (listed in section 6),
• if you have any active liver disease or have elevated transaminases (enzymes indicative of liver disease),
• if you are pregnant or there is a possibility that you may be pregnant,
• if you are breastfeeding.

Warnings and precautions

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

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

It is possible that moderate increases in liver transaminases 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 insufficiency, hypothyroidism, if you have a family history or have previously had muscle alterations or if you normally consume alcohol.

• During treatment, some patients may experience muscle pain, sensitivity, weakness, or muscle cramps. If you experience any of these symptoms, inform your doctor immediately.
• If you have severe respiratory insufficiency
• If you have or have had myasthenia (a disease that causes generalized muscle weakness, which in some cases affects the muscles used for breathing) or ocular myasthenia (a disease that causes weakness of the eye muscles), as statins may exacerbate the disease or cause myasthenia (see section 4).

While you are taking this medication, your doctor will monitor whether you have diabetes or are at risk of developing diabetes. This risk of diabetes increases if you have high blood sugar and fat levels, obesity, and high blood pressure.

It may be necessary for your doctor to perform blood tests to determine the state of your muscles before starting treatment and during treatment, to consider starting, continuing, or discontinuing treatment.

Inform your doctor if you are taking other medications that can cause muscle alterations, such as:

• Fibrates (lower cholesterol levels).
• Nicotinic acid (lowers cholesterol levels).
• If you are taking or have taken within the last 7 days a medication containing fusidic acid (used to treat bacterial infections), orally or by injection. The combination of fusidic acid and Pravastatina MABO may cause severe muscle problems (rhabdomyolysis).

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

Consult your doctor, even if any of the previously mentioned circumstances have occurred at any time.

Interaction of Pravastatina MABO with other medications

Inform your doctor or pharmacist if you are using, have used recently, or may use any other medication.

Certain medications may interact with Pravastatina MABO; in these cases, it may be necessary to change the dose or discontinue treatment with one of them.

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

• Other medications used to lower cholesterol levels, such as cholestyramine or cholestipol (may decrease pravastatina levels in the blood) and fibrates (may increase the risk of muscle adverse reactions).
• Ciclosporin, a medication used to prevent transplant rejection (administered with pravastatina, ciclosporin increases pravastatina levels in the blood).
• Antibiotics such as erythromycin or clarithromycin (may increase pravastatina levels in the blood).
• If you need to take oral fusidic acid to treat a bacterial infection, you will need to stop taking this medication. Your doctor will indicate when you can resume treatment with Pravastatina MABO. The use of Pravastatina MABO with fusidic acid may cause muscle weakness, sensitivity, or pain (rhabdomyolysis). For more information on rhabdomyolysis, see section 4.

Pravastatina MABO with food and beverages

Pravastatina MABO can be taken with or without food.

Pravastatina MABO should be administered with caution to patients who consume alcohol. If you normally drink alcohol, consult your doctor.

Pregnancy, breastfeeding, and fertility

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

Pregnancy

Pravastatina MABO should not be administered during pregnancy. If you become pregnant or suspect you may be pregnant, discontinue treatment and inform your doctor as soon as possible.

Breastfeeding

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

Driving and operating machinery

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 medication.

Pravastatina MABO contains lactose

If your doctor has indicated that you have a lactose intolerance, consult with them before taking this medication.

Follow exactly the administration instructions for this medication as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

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

Remember to take your medication.

Your doctor will indicate the duration of your treatment with Pravastatina MABO. Do not discontinue treatment before.

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

The normal dose is between 10-40 mg once a day. Your doctor will establish the appropriate dose for you and make any necessary adjustments based on your response to the medication.

The tablet can be divided into equal doses.

Associated treatment:patients taking pravastatina and ciclosporina should start treatment with 20 mg of pravastatina once a day, your doctor will adjust the dose up to 40 mg. Patients taking pravastatina and a bile acid sequestrant (e.g. colestiramine, colestipol) should be given Pravastatina MABO one hour before or four hours after the sequestrant.

Use in children and adolescents (8-18 years) with familial hypercholesterolemia:The recommended dose between 8 and 13 years is 10-20 mg once a day and the recommended dose between 14 and 18 years is 10-40 mg once a day.

Older patients:No dose adjustment is necessary in these patients unless there are other risk factors.

Patients with renal or hepatic insufficiency:In patients with moderate or severe renal impairment or significant liver dysfunction, it is recommended to start treatment with a dose of 10 mg.

If you estimate that the action 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, consult your doctor or pharmacist immediately, or call the Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

If you forgot to take Pravastatina MABO

Do not take a double dose to compensate for the missed dose, wait for the next scheduled dose.

Like all medicines, Pravastatina MABO can cause side effects, although not everyone will experience them.

These side effects may occur at certain frequencies, which are defined as follows:

Very common: affect more than 1 in 10 patients,

Common: affect between 1 and 10 in 100 patients,

Uncommon: affect between 1 and 10 in 1000 patients,

Rare: affect between 1 and 10 in 10000 patients,

Very rare: affect less than 1 in 10000 patients,

Frequency not known: the frequency cannot be estimated from the available data

Immune system disorders:

Very rare: allergic reactions, angioedema (swelling of the 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 neuropathy, particularly when used for a prolonged period and a sensation of tingling.

Frequency not known: Myasthenia gravis (a disease that causes generalized muscle weakness, which 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:

Uncommon: vision disturbances (including blurred vision and double vision of objects).

Frequency not known: Myasthenic eye disease (a disease that causes weakness of the eye muscles).

Gastrointestinal disorders:

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

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

Musculoskeletal and connective tissue disorders:

Very rare: rhabdomyolysis (destruction of muscle fibers), which may be associated with renal disorders, myopathy (muscle alterations).

Alterations in tendons, sometimes complicated with rupture.

Frequency not known: persistent muscle weakness, muscle rupture.

Renal and urinary disorders:

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

Reproductive and breast disorders:

Uncommon: sexual dysfunction.

General disorders and administration site conditions:

Uncommon: fatigue.

Also, the following clinically significant side effects have 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 creatine kinase levels (enzyme indicative of muscle alteration).

Hepatobiliary disorders:

Elevations of serum transaminases (enzymes indicative of liver disease).

Other possible side effects:

• Memory loss
• Depression
• Respiratory problems, including persistent cough and/or difficulty breathing or fever.

Diabetes. It is more likely if you have high blood sugar and fat levels, obesity, and high blood pressure. Your doctor will monitor you while taking this medication.

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use:www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication

Keep out of sight and reach of children.

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

Do not use Pravastatina MABO after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through drains or in the trash. Dispose of the packaging and medicines you no longer need at the SIGRE collection point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. In this way, you will help protect the environment.

Composition of Pravastatina MABO 10 mg tablets EFG:

• The active ingredient is pravastatina sodium.Each tablet contains 10 mg of pravastatina sodium.
• The other components are:anhydrous lactose, povidone, crospovidone, anhydrous calcium phosphate, sodium stearate fumarate, microcrystalline cellulose, sodium croscarmellose, and red iron oxide (E-172).

Appearance of the product and content of the container

Pravastatina MABO 10 mg is presented in the form of tablets. The tablets are round, slightly convex, pink speckled, and have a notch on both faces. Each container contains 28 tablets.

Other presentations:

Pravastatina MABO 20 mg Tablets EFG: container of 28 tablets

Pravastatina MABO 40 mg Tablets EFG: container of 28 tablets

Marketing Authorization Holder

MABO-FARMA S.A.

Vía de los Poblados, 3, Building 6

28033 Madrid,

Spain.

Responsible for manufacturing

Teva Pharmaceutical Works private limited company

Pallagi ut 13.

Debrecen H-4042 Hungary

or

Teva Pharma, S.L.U.

Malpica Industrial Estate, street C.4

50016-ZaragozaSpain

Last review date of this leaflet: March 2024

The detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/