Patient Information Leaflet

Pravastatina Alter 20 mg Tablets EFG

(Pravastatina sodium)

Read this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

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

Pravastatina Alter, along with an adequate diet, is indicated for:

• The treatment ofprimary hypercholesterolemia and mixed dyslipidemia, diseases characterized by increased 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 suffering 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 had some 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 Alter

• If you are allergic to pravastatina sodium or any of the other components 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 Alter:

• If you are taking or have taken within the last 7 days a medication that contains fusidic acid (used for the treatment of bacterial infection) by mouth or injection. The combination of fusidic acid and Pravastatina Alter may cause severe muscle problems (rhabdomyolysis).

• If you have had any 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 normal without the need to suspend treatment.

• You must 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, you must inform your doctor immediately.

• If you haveor have had myasthenia (a disease that causes generalized muscle weakness that, in some cases, affects the muscles used for breathing) or myasthenia gravis (a disease that causes weakness of the eye muscles), as statins may sometimes worsen the disease or cause myasthenia (see section 4).

Your doctor may recommend that you undergo blood tests to determine the state of your muscles before starting treatment and during treatment, to consider the initiation, continuation, or suspension of treatment.

Inform your doctor if you are taking other medications that may also cause muscle alterations:

• Fibrates (lower cholesterol levels).
• Nicotinic acid (lowers cholesterol levels).

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

Consult your doctor or pharmacist before taking Pravastatina Alter if you:

• Have severe respiratory insufficiency.

While you are taking this medication, your doctor will monitor 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, obesity, and high blood pressure.

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.

Pravastatina Alter with other medications

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication.

• 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 restart treatment with Pravastatina Alter. The use of Pravastatina Alter with fusidic acid may cause muscle weakness, sensitivity, or pain (rhabdomyolysis). For more information on rhabdomyolysis, see section 4.

Certain medications may interact withPravastatina Alter;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:

• Colestiramine or colestipol (may decrease pravastatina levels in the blood) and fibrates (may increase the risk of muscle side effects), which are other medications used to lower cholesterol levels.
• 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 are taking a medication used in the treatment and prevention of blood clot formation called“antagonists of vitamin K”, inform your doctor before taking pravastatina because the concomitant use of antagonists of vitamin K with pravastatina may increase the results of blood tests used to monitor treatment with antagonists of vitamin K.

Pravastatina Alter with food and drinks

Pravastatina Alter can be taken with or without food.

If you normally consume alcohol, consult your doctor before taking this medication.

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 Alter is contraindicated during pregnancy. If you become pregnant or suspect you may be pregnant, you must suspend treatment and inform your doctor as soon as possible.

Breastfeeding:

Pravastatina Alter is contraindicated during the breastfeeding period as it passes into breast milk.

Driving and operating machines

At the recommended doses,Pravastatina Alterdoes not affect the ability to drive or operate machines. However, if you experience symptoms of dizziness, do not drive or operate machines until you know how the medication affects you.

Pravastatina Alter contains lactose

This medication contains lactose. If your doctor has indicated that you have an intolerance to certain sugars, consult with them before taking this medication.

Follow exactly the administration instructions for this medication as indicated by your doctor. If in 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 Alter. 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.

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

Children and Adolescents (8-18 years) with Familial Heterozygous 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 Insufficiency:In patients with moderate or severe renal impairment or significant hepatic impairment, treatment should be initiated with a dose of 10 mg.

If you estimate that the action of Pravastatina Alter is too strong or too weak, inform your doctor or pharmacist.

If You Take More Pravastatina Alter Than You Should

If you have taken more Pravastatina Alter than you should, consult your doctor, pharmacist, or call the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount taken.

If You Forget to Take Pravastatina Alter

In case of a missed dose, wait for the next one. Do not take a double dose to compensate for the missed doses.

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

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

Immune system disorders:

Rare (may affect up to 1 in 10,000 people): allergic reactions, angioedema (swelling of the arms, legs, face, lips, tongue, and/or throat), lupus-like syndrome (skin inflammation).

Nervous system disorders:

Uncommon (may affect up to 1 in 100 people): dizziness, headache, sleep disorders, insomnia.

Rare (may affect up to 1 in 10,000 people): peripheral neuropathy, particularly when used for a prolonged period and a sensation of tingling.

Frequency not known(the frequency cannot be estimated from the available data):myasthenia gravis (a disease that causes generalized muscle weakness, which in some cases affects the muscles used for breathing).

Eye disorders:

Uncommon (may affect up to 1 in 100 people): vision disturbances (including blurred vision and double vision of objects).

Frequency not known(the frequency cannot be estimated from the available data): myasthenia oculis (a disease that causes weakness of the eye muscles).

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

Gastrointestinal disorders:

Uncommon (may affect up to 1 in 100 people): indigestion/heartburn, abdominal pain, nausea, vomiting, constipation, diarrhea, gas.

Rare (may affect up to 1 in 10,000 people): pancreatitis (inflammation of the pancreas).

Hepatobiliary disorders:

Rare (may affect up to 1 in 10,000 people): jaundice (yellowing of the skin), hepatitis (inflammation of the liver), fulminant hepatic necrosis (destruction of liver cells).

Skin and subcutaneous tissue disorders:

Uncommon (may affect up to 1 in 100 people): itching, skin rash, appearance of blisters accompanied by itching, hair and scalp abnormalities (including hair loss).

Musculoskeletal and connective tissue disorders:

Rare (may affect up to 1 in 10,000 people): rhabdomyolysis (destruction of muscle fibers), which may be associated with renal disorders, myopathy (muscle alterations).

Alterations in tendons, sometimes complicated by rupture.

Frequency not known (the frequency cannot be estimated from the available data): muscle rupture.

Renal and urinary disorders:

Uncommon (may affect up to 1 in 100 people): alterations in urine elimination (such as difficulty urinating, urinating more frequently, and urinating more frequently at night).

Reproductive and breast disorders:

Uncommon (may affect up to 1 in 100 people): sexual alterations.

General disorders:

Uncommon (may affect up to 1 in 100 people): fatigue.

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 blood glucose levels of 5.6 mmol/L, BMI > 30 kg/m2, elevated triglycerides, hypertension antecedents). Your doctor will monitor you while you are taking this medicine.

Also, the following adverse reactions of special clinical interest have been reported during clinical trials:

Musculoskeletal and connective tissue disorders:

Musculoskeletal pain, including joint pain, muscle cramps, muscle pain (very common), muscle weakness (frequent), and elevated creatine kinase levels (enzyme indicative of muscle alteration).

Frequency not known (the frequency cannot be estimated from the available data): Constant muscle weakness.

Hepatic disorders:

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

Reporting of adverse reactions:

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

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

Do not use this medication after the expiration date that appears on the packaging. The expiration date is the last day of the month indicated.

Do not store at a temperature above 30 °C.

Medications should not be disposed of through drains or in the trash. Dispose of the packaging and medications you no longer need at the SIGRE collection point (or any other medication waste collection system) at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Pravastatina Alter

• The active ingredient is pravastatina sodium. Each tablet contains 20 mg of pravastatina.
• The other components are: Lactose monohydrate, Povidone 30, Magnesium oxide, Microcrystalline cellulose, Sodium croscarmellose, Magnesium stearate

Appearance of the product and contents of the packaging

Pravastatina Alter are white, round, and scored tablets.

The tablet can be divided into equal doses.

They are presented in Al/Al blisters that are packaged in boxes of 28 tablets.

Holder of the marketing authorization and responsible for manufacturing:

Laboratorios Alter, S.A.

C/ Mateo Inurria 30

28036 Madrid

Spain

Last review date of this leaflet: April 2024

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