PRAVASTATIN MABO 40 mg TABLETS

2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE PRAVASTATIN MABO

Do not take Pravastatin MABO

• if you are allergic to pravastatin sodium or any of the other ingredients of this medicine (listed in section 6),
• if you have active liver disease or elevated transaminases (enzymes indicative of liver disease),
• if you are pregnant or think you may be pregnant,
• if you are breast-feeding.

Warnings and precautions

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

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

It is possible that moderate increases in liver transaminase levels may occur, which in most cases return to their initial level without the need to discontinue treatment.

• You should also inform your doctor if you have kidney failure, hypothyroidism, if you have a family history or have previously suffered from muscle disorders, 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, you should immediately inform your doctor.
• If you have severe respiratory failure.
• 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 that causes weakness of the eye muscles), as statins can sometimes worsen the disease or cause myasthenia to appear (see section 4).

While you are taking this medicine, your doctor will check if you have diabetes or are at risk of developing diabetes. This risk of diabetes increases if you have high blood sugar and fat levels, are overweight, and have high blood pressure.

It is possible that your doctor may recommend blood tests to determine the condition of your muscles before starting treatment and during treatment, to consider starting, continuing, or discontinuing treatment.

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

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

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

Consult your doctor, even if any of the above circumstances have occurred to you at any time.

Interaction of Pravastatin MABO with other medicines

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

Certain medicines can interact with Pravastatin MABO; in these cases, it may be necessary to change the dose or interrupt treatment with one of them.

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

• Other drugs used to lower cholesterol levels, such as colestyramine or colestipol (can decrease pravastatin levels in the blood), and fibrates (can increase the risk of adverse muscle reactions).
• Cyclosporin, a medicine used to prevent transplant rejection (when administered with pravastatin, cyclosporin increases pravastatin blood levels).
• Antibiotics such as erythromycin or clarithromycin (can increase pravastatin levels in the blood).
• If you need to take oral fusidic acid to treat a bacterial infection, you will need to stop using this medicine. Your doctor will tell you when you can restart treatment with Pravastatin MABO. The use of Pravastatin MABO with fusidic acid can cause muscle weakness, sensitivity, or pain (rhabdomyolysis). For more information on rhabdomyolysis, see section 4.

Taking Pravastatin MABO with food and drinks

Pravastatin MABO can be taken with or without food.

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

Pregnancy, breast-feeding, and fertility

If you are pregnant or breast-feeding, or think you may be pregnant, consult your doctor or pharmacist before using this medicine.

Pregnancy

Pravastatin MABO should not be administered during pregnancy. In case of pregnancy or suspected pregnancy, treatment should be discontinued and your doctor informed as soon as possible.

Breast-feeding

Pravastatin MABO should not be administered during breast-feeding, as it passes into breast milk.

Driving and using machines

At normal doses, Pravastatin MABO does not affect the ability to drive or use machines. However, if you notice symptoms of dizziness, do not drive or use machines until you know how the medicine affects you.

Pravastatin MABO contains lactose

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

3. HOW TO TAKE PRAVASTATIN MABO

Follow the administration instructions of this medicine 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 medicine.

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

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

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

The tablet can be divided into equal doses.

Combined treatment:patients treated with pravastatin and cyclosporin should start treatment with 20 mg of pravastatin once a day; your doctor will adjust the dose up to 40 mg. For patients treated with pravastatin and a bile acid sequestrant (e.g., colestyramine, colestipol), Pravastatin MABO should be administered 1 hour before or 4 hours after the sequestrant.

Use in children and adolescents (8-18 years) with heterozygous 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.

Elderly patients:no dose adjustment is necessary in these patients unless there are other risk factors.

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

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

If you take more Pravastatin MABO than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately, or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Pravastatin MABO

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

4. Possible side effects

Like all medicines, Pravastatin MABO can cause side effects, although not everybody gets them.

These side effects may occur with certain frequencies, which are defined below:

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 1,000 patients,

rare: affect between 1 and 10 in 10,000 patients,

very rare: affect less than 1 in 10,000 patients,

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

Disorders of the immune system:

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

Disorders of the nervous system:

Uncommon: dizziness, headache, sleep disorders, including insomnia and nightmares.

Very rare: peripheral neuropathy, particularly when used for a long time, and tingling sensation.

Frequency not known: severe myasthenia (a disease that causes generalized muscle weakness that, in some cases, affects the muscles used for breathing).

Consult your doctor if you experience weakness in the 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: ocular myasthenia (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).

Disorders of the skin and subcutaneous tissue:

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 fibers), which can be associated with kidney disorders, myopathy (muscle disorders).

Tendon disorders, sometimes complicated by rupture.

Frequency not known: constant muscle weakness, muscle rupture.

Renal and urinary disorders:

Uncommon: changes in urine elimination (such as difficulty urinating, urinating more frequently, and urinating more frequently 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 creatine kinase levels (enzyme indicative of muscle disorder).

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. This is more likely if you have high blood sugar and fat levels, are overweight, and have high blood pressure. Your doctor will monitor you while you are taking this medicine.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist, even if it is possible side effects not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: www.notificaram.es. By reporting side 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 should not be disposed of via wastewater or household waste. Place the packaging and any unused medicines in the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This will help protect the environment.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

Composition of Pravastatin MABO 40 mg tablets EFG:

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

Appearance of the product and packaging contents

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

Other presentations:

Pravastatin MABO 10 mg Tablets EFG: pack of 28 tablets

Pravastatin MABO 20 mg Tablets EFG: pack of 28 tablets

Marketing authorization holder

MABO-FARMA S.A.

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 last revision of this leaflet: March 2024

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/