Package Leaflet: Information for the User

Pravastatina Aurovitas 40 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.

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

2.What you need to know before you start taking Pravastatina Aurovitas

3.How to take Pravastatina Aurovitas

4.Possible side effects

5.Storage of Pravastatina Aurovitas

6.Contents of the pack and additional information

Pravastatina belongs to a group of medications known as statins (or HMG-CoA reductase inhibitors). It prevents the production of cholesterol by the liver and as a consequence reduces the levels of cholesterol and other fats (triglycerides) in your body. When there are excessive levels of cholesterol in the blood, cholesterol accumulates in the walls of blood vessels, obstructing them.

This situation is known as hardening of the arteries or atherosclerosis and may lead to:

•Chest pain (angina pectoris), when a coronary artery is partially obstructed.

•Heart attack (myocardial infarction), when a coronary artery is completely obstructed.

•Cerebral infarction (stroke), when a cerebral artery is completely obstructed.

This medication is indicated in three situations:

For the treatment of high levels of cholesterol and fats in the blood

Pravastatina is used to decrease high levels of "bad" cholesterol and increase levels of "good" cholesterol in the blood when diet and exercise have not been effective.

Prevention of heart and blood vessel diseases

•If you have high levels of cholesterol in the blood and risk factors that favor these diseases (if you smoke, are overweight, have high blood sugar levels or hypertension or do little exercise), pravastatina is used to reduce the risk of suffering a heart and blood vessel problem and decrease the risk of dying from these diseases.

•If you have already suffered a cerebral infarction or have chest pains (unstable angina), even with normal cholesterol levels, pravastatina is used to reduce the risk of suffering another heart attack or cerebral infarction in the future and decrease the risk of dying from these diseases.

After an organ transplant

If you have undergone an organ transplant and are receiving medication to prevent your body from rejecting the transplant, pravastatina is used to reduce elevated levels of fat in the blood.

Do not takePravastatina Aurovitas

•if you are allergic to pravastatina or any of the other ingredients of this medication (listed in section 6).

•if you are pregnant, trying to become pregnant, or breastfeeding (see Pregnancy and Breastfeeding).

•if you have any liver disease (active liver disease).

•if several blood tests show abnormal liver function (elevated liver enzymes in the blood).

Warnings and precautions

Consult your doctor or pharmacist before starting treatment if:

Before starting this treatment, you must consult your doctor if you have or have had any of the following medical conditions:

•kidney disease.

•hypothyroidism.

•liver disease or problems with alcohol (drinking large amounts of alcohol).

•muscle disorders caused by a hereditary disease.

•muscle problems caused by another medication belonging to the group of statins (HMG-CoA reductase inhibitors) or belonging to the group known as fibrates (see Taking Pravastatina Aurovitas with other medications).

Your doctor will perform a blood test before starting pravastatina and if you have any symptoms or liver problems during treatment. This is to check if your liver is functioning correctly.

Your doctor may also need to perform a blood test after starting pravastatina treatment to check your liver function. The risk of muscle failure is higher in some patients. Consult your doctor in the following cases.

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

If you have had any of these problems, or if you are over 70 years old, your doctor will perform a blood test before and probably during treatment. These blood tests will be used to evaluate the risk of you experiencing adverse muscle effects.

If you feel unexplained cramps or muscle pain during treatment, inform your doctor immediately.

If you have diabetes or are at risk of developing it, your doctor will perform a careful control during treatment with this medication. You are likely to be at risk of developing diabetes if you have high blood sugar and fat levels, obesity, and hypertension.

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

Consult your doctor before takingpravastatina.

If you have or have had myasthenia (a disease that involves 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 can sometimes worsen the disease or cause myasthenia (see section 4).

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

•have severe respiratory failure.

TakingPravastatina Aurovitaswith other medications

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

The administration ofpravastatinawith any of the following medications may increase the risk of muscle problems:

•a medication that lowers cholesterol levels in the blood (fibrates, e.g. gemfibrozil, fenofibrate).

•a medication that lowers the body's defenses (ciclosporin).

•a medication that treats infections caused by bacteria (an antibiotic such as erythromycin or clarithromycin).

•if you need to take fusidic acid orally to treat a bacterial infection, you will need to stop taking this medication temporarily. Your doctor will indicate when it is safe to restart pravastatina treatment. The use of pravastatina with fusidic acid may cause, in rare cases, weakness, sensitivity, or muscle pain (rhabdomyolysis). For more information on rhabdomyolysis in section 4.

•colchicine (used for the treatment of gout).

•nicotinic acid (used for the treatment of high cholesterol levels in the blood).

•rifampicin (used for the treatment of the infection called tuberculosis).

•lenalidomide (used for the treatment of a type of blood cancer called multiple myeloma).

If you are also taking a medication to lower fat levels in your blood (of the type resin such as cholestyramine or colestipol), this treatment should be taken at least one hour before or four hours after taking the resin. This is becausethe resin may affect the absorption of pravastatina if these two medications are taken simultaneously.

Taking Pravastatina Aurovitas with food, drinks, and alcohol

This treatment can be taken with or without food, with half a glass of water.

You should reduce your alcohol consumption to a minimum. If you have any doubts about how much alcohol you can drink while on treatment with this medication, consult your doctor.

Pregnancy, breastfeeding, and fertility

Pregnancy

Do not take pravastatina during pregnancy. If you discover you are pregnant, inform your doctor immediately. Consult your doctor or pharmacist before using any medication.

Breastfeeding

Pravastatina should not be administered during the breastfeeding period as this treatment passes into breast milk.

Driving and operating machinery

Generally, pravastatina does not affect the ability to drive or operate machinery. However, if you experience dizziness, blurred vision, or double vision during treatment, do not drive or operate machinery until you are sure you are in a condition to do so.

Pravastatina Aurovitas contains lactose

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

Pravastatina Aurovitas contains sodium

This medication contains less than 1 mmol of sodium (23 mg) per tablet; it is essentially “sodium-free”.

Your doctor will advise you to follow a low-fat diet, which you should follow throughout the treatment.

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

Pravastatinacan be taken with or without food, with half a glass of water.

Dose

Adults:

•In the treatment of high cholesterol and blood fat levels: the usual dose is 10-40 mg once a day, preferably at night.

•In the prevention of heart and blood vessel diseases: the usual dose is 40 mg once a day, preferably at night.

Do not exceed the maximum daily dose of 40 mg of pravastatina. Your doctor will establish the appropriate dose for you.

Children (8-13 years) and adolescents (14-18 years) with a hereditary disease that increases blood cholesterol levels:

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.

After an organ transplant:

Your doctor may prescribe an initial dose of 20 mg once a day. Your doctor may adjust the dose up to 40 mg.

If you are also taking a medication that reduces the body's immune system (ciclosporina), your doctor may prescribe an initial dose of 20 mg once a day. This dose may be adjusted up to 40 mg by your doctor.

If you have kidney or severe liver disease, your doctor may prescribe a lower dose of pravastatina.

If you estimate that the effect of this treatment is too strong or too weak, inform your doctor or pharmacist.

Treatment duration

Your doctor will indicate the duration of treatment with pravastatina. This medication should be taken regularly for the time your doctor recommends, even if it is for a long period. Do not stop treatment on your own.

If you take morePravastatinaAurovitasthan you should

If you have taken more pravastatina than you should, or if someone accidentally swallowed some tablets, contact your doctor or pharmacist or the nearest hospital.

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 takePravastatinaAurovitas

If you forgot to take a dose, simply take your regular dose when it is due next.

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 may cause side effects, although not everyone will experience them.

Stop taking pravastatinaand tell your doctor immediatelyif you notice unexplained or persistent muscle pain, pain on movement, weakness or cramps, especially if you also feel unwell or have a fever.

In rare cases, muscle problems can be severe (rhabdomyolysis) and may cause a kidney disease that can be life-threatening.

Severe and sudden allergic reactions such as swelling of the face, lips, tongue, or throat can cause serious breathing difficulties. This is a very rare reaction that can be serious if it occurs. Inform your doctor immediately if this happens.

The following side effects are infrequent and may affect up to 1 in 100 people:

•Nervous system effects: dizziness, fatigue, headache, sleep disturbances, including insomnia.

•Visual effects: blurred vision or double vision.

•Digestive effects: indigestion, nausea, vomiting, stomach pain or discomfort, diarrhea, constipation, and gas.

•Skin and hair effects: itching, acne, skin rash, hair and scalp problems (including hair loss).

•Urinary and genital effects: urinary problems (such as pain while urinating, urinating more frequently, or having to urinate at night) and sexual problems.

•Muscle and joint effects: muscle pain and joint pain.

The following side effects are rare and may affect up to 1 in 1,000 people:

• Sensitivity to sunlight

The following side effects are very rare and may affect up to 1 in 10,000 people:

•Nervous system effects:alterations in the sense of touch, including burning or tingling sensations, which could indicate nerve damage.

•Skin effects:a severe skin disease (lupus erythematosus-like syndrome).

•Liver effects:inflammation of the liver or pancreas, jaundice (recognized by yellowing of the skin and white of the eyes), very rapid destruction of liver cells (fulminant hepatic necrosis).

•Muscle and bone effects:inflammation of one or more muscles that causes muscle pain or weakness (myositis, polymyositis, or dermatomyositis), muscle pain or weakness, tendon inflammation, which may be complicated by rupture.

•Blood test abnormalities:increased transaminases (a group of enzymes that naturally appear in the blood), which may indicate liver problems. Your doctor may want to perform periodic tests to monitor this.

If you consider that any of the side effects you experience are severe or if you notice any side effects not mentioned in this leaflet, inform your doctor or pharmacist.

Possible side effects

•Nightmares.

•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 you are taking this medicine.

Side effects of unknown frequency (cannot be estimated from available data):

•Constant muscle weakness, liver failure.

• Muscle rupture.
• Myasthenia gravis (a disease that causes generalized muscle weakness, which in some cases affects the muscles used for breathing).

Myasthenia ocular (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.

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect not mentioned in this leaflet. You can also report them directly through the Spanish System for 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 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 carton and on the blister pack after CAD. The expiration date is the last day of the month indicated.

Store in the original packaging to protect it from moisture.

Medications should not be disposed of through drains or in the trash. Dispose of containers and medications you no longer need at the SIGRE collection point at the pharmacy.Ask your pharmacist how to dispose of containers and medications you no longer need. This will help protect the environment.

Composition of Pravastatina Aurovitas

- The active ingredient is pravastatina sodium. Each tablet contains 40 mg of pravastatina sodium.

- The other components are: microcrystalline cellulose, lactose monohydrate, heavy magnesium oxide, sodium croscarmellose, yellow iron oxide (E172), povidone K30, magnesium stearate.

Appearance of the product and contents of the packaging

Uncoated yellow tablets, in capsule shape, biconvex, speckled, scored on both sides, with the mark “Z” on one side and “18” on the other. The tablet can be divided into equal doses.

Pravastatina Aurovitas is available in blister packs of 20, 28, 30, 60, and 98 tablets.

Only some sizes of packaging may be commercially available.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization:

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16-D

28036 Madrid

Spain

Responsible for manufacturing:

APL Swift Services (Malta) Limited

HF26, Hal Far Industrial Estate, Hal Far

Birzebbugia, BBG 3000

Malta

This medicine is authorized in the member states of the Economic European Space with the following names:

Last review date of this leaflet: March 2024

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