Patient Information Leaflet

Pravastatina STADA 10 mg Film-Coated Tablets

Pravastatina STADA 20 mg Film-Coated Tablets

Pravastatina STADA 40 mg Film-Coated Tablets

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 Stada and what it is used for

2.What you need to know before taking Pravastatina Stada

3.How to take Pravastatina Stada

4.Possible side effects

5.Storage of Pravastatina Stada

6.Contents of the pack and additional information

Pravastatina, the active ingredient of Pravastatina Stada, 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 result 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 can lead to:

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

• chest pain (angina pectoris), when a coronary artery is partially obstructed.
• heart attack (myocardial infarction), when a coronary artery is completely obstructed.
• stroke (cerebral infarction), when a cerebral artery is completely obstructed.

This medication is indicated in three situations:

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

This medication is indicated to reduce 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), this medication is indicated to reduce the risk of suffering a heart and blood vessel problem, and decreases the risk of dying from these diseases.

• If you have already suffered a stroke or have unstable angina, even with normal cholesterol levels, this medication is indicated to reduce the risk of suffering another heart attack or stroke in the future, and decreases 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, this medication is indicated to reduce elevated levels of fat in the blood.

Do not takePravastatina Stada:

• if you areallergicto pravastatina or to any of the other components of this medication (listed in section 6).
• if you are pregnant, intend to become pregnant, or are 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

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

• Liver disease
• Decreased activity of the thyroid gland (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 (medications inhibiting HMG-CoA reductase) or belonging to the group known as fibrates (see Other Medications and Pravastatina Stada).
• If you have or 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 will perform a blood test before starting this medication and if you have any liver symptoms or 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 treatment with this medication 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, in the last 7 days, have taken a medication called fusidic acid (a medication used to treat bacterial infections) orally or by 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 adverse muscle effects.

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

While 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.

Consult your doctor before taking this medication.

Consult your doctor or pharmacist before starting Pravastatina Stada if you:

• have severe respiratory failure.

Other Medications and Pravastatina Stada

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

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

• a medication that lowers blood cholesterol levels (fibrates, e.g. gemfibrozil, fenofibrate).
• a medication that reduces the body's defenses (ciclosporin).
• a medication that treats bacterial infections (an antibiotic such as erythromycin or clarithromycin).
• if you need to take fusidic acid orally to treat a bacterial infection, you will need to temporarily stop taking this medication. Your doctor will indicate when it is safe to resume treatment with this medication. Taking pravastatina with fusidic acid may rarely cause muscle weakness, sensitivity, or pain (rhabdomyolysis). See more information on rhabdomyolysis in section 4.
• Colchicine (a medication used to treat gout)
• Nicotinic acid (a medication used to treat high blood cholesterol)
• Rifampicin (a medication used to treat the infection called tuberculosis)
• Lenalidomide (a medication used to treat a type of blood cancer called multiple myeloma).

If you are also taking a medication to lower your blood fat levels (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.

Pravastatina Stada and Alcohol

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

Pregnancy and Breastfeeding

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

Pregnancy

Do not take pravastatina during pregnancy. If you discover you are pregnant, inform your doctor immediately.

Breastfeeding

Do not take pravastatina during the breastfeeding period as this treatment passes into breast milk.

Driving and Operating Machines

Pravastatinadoes not affect your ability to drive or operate machines. If you experience symptoms of dizziness, blurred vision, or double vision during treatment, do not drive or operate machines until you are sure you are in a condition to do so.

Pravastatina Stada contains lactose and sodium

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

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 continue until the end of treatment.

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

Dosage

Adults

??In the treatment of high levels of cholesterol and blood fat: 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 40mg once a day, preferably at night.

Do not exceed the maximum daily dose of 40 mg of pravastatina sodium. Your doctor will establish the suitable 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 disease or severe liver disease, your doctor may prescribe a lower dose of pravastatina.

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

Administration form

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

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 of time. Do not stop treatment on your own.

If you take more Pravastatina Stada than 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: 915 620 420, indicating the medication and the amount ingested.

If you forgot to take Pravastatina Stada

If you forgot to take a dose, simply take your regular dose when it is due. Do not take a double dose to compensate for the missed doses.

If you have any other doubts 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.

Stop taking pravastatina and inform your doctor immediatelyif you notice unexplained or persistent muscle pain, pain on examination, weakness or cramps, especially if you do not feel well or have a fever at the same time.

In very rare cases, muscle problems can be severe (rhabdomyolysis) and can 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 can affect up to 1 in 100 people:

• Nervous system disorders:dizziness, fatigue, headache, sleep disorders, including insomnia.
• Eye disorders:blurred vision or double vision.
• Gastrointestinal disorders:indigestion, nausea, vomiting, stomach pain or discomfort, diarrhea, constipation, and gas.
• Skin and hair disorders:itching, acne, skin rash, appearance of blisters accompanied by itching, hair and scalp abnormalities (including hair loss).
• Urinary and genital disorders:urination changes (such as pain while urinating, urinating more frequently, and urinating more frequently at night) and sexual problems.
• Muscle and joint disorders:muscle and joint pain

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

• Sensitivity to sunlight

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

• Nervous system disorders:changes in sensation including burning or tingling, or numbness indicating nerve damage.
• Skin disorders:severe skin alteration (lupus erythematosus-like syndrome),
• Liver disorders:inflammation of the liver or pancreas, jaundice (recognized by yellow coloration of the skin and white of the eyes), rapid destruction of liver cells (fulminant hepatic necrosis).
• Muscle and bone disorders:inflammation of one or more muscles causing muscle pain or weakness (myositis, polymyositis, or dermatomyositis), muscle pain or weakness, tendon inflammation, sometimes complicated by rupture.
• Altered blood tests:increase in transaminases (a group of blood enzymes) that may indicate liver problems. Your doctor may want to perform periodic tests to monitor it.

Adverse reactions with unknown frequency(frequency cannot be estimated from available data):

• Constant muscle weakness
• Liver failure
• Myasthenia gravis (a disease that causes generalized muscle weakness, which in some cases affects the muscles used for breathing)1
• Myasthenia ocular (a disease that causes weakness of the eye muscles)1
• Muscle rupture

1Consult 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.

Possible side effects that have been reported with some statins:

• 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, overweight, and hypertension. Your doctor will monitor you during treatment with 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 prospectus. You can also report them through the Spanish System for the Pharmacovigilance of Medicines for Human Use: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication

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 and in the blister pack after CAD. The expiration date is the last day of the month indicated.

Do not store at a temperature above 25°C.

Store in the original packaging.

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 at the pharmacy. 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 Stada

• Theactive ingredientis pravastatina sodium.

10 mg:Each tablet contains 10 mg of pravastatina sodium.

20 mg:Each tablet contains 20 mg of pravastatina sodium.

40 mg:Each tablet contains 40 mg of pravastatina sodium.

• Theother componentsare:

Tablet core:

10 mg:microcrystalline cellulose (E460), sodium croscarmellose (E468), macrogol 8000, copovidone, heavy magnesium carbonate (E504), lactose monohydrate, magnesium stearate (E470b), red iron oxide (E172), anhydrous colloidal silica (E551).

20 mg:microcrystalline cellulose (E460), sodium croscarmellose (E468), macrogol 8000, copovidone, heavy magnesium carbonate (E504), lactose monohydrate, magnesium stearate (E470b), yellow iron oxide (E172), anhydrous colloidal silica (E551).

40 mg:microcrystalline cellulose (E460), sodium croscarmellose (E468), macrogol 8000, copovidone, heavy magnesium carbonate (E504), lactose monohydrate, magnesium stearate (E470b), yellow iron oxide (E172), anhydrous colloidal silica (E551).

Tablet coating: hypromellose (E463), macrogol 400, macrogol 3350, hypromellose (E464).

Appearance of the product and contents of the package

10 mg:film-coated tablet with a peach-colored film, marked with “10” on one side.

20 mg:film-coated tablet with a yellow film, marked with “20” on one side.

40 mg:film-coated tablet with a yellow film, marked with “40” on one side.

The tablet can be divided into equal doses.

Pravastatina Stada (10 mg and 20 mg) is available in blisters of 7, 10, 20, 28, 30, 48, 50, 56, 98, 100, and 200 tablets.

Pravastatina Stada (40 mg) is available in blisters of 7, 10, 14, 20, 28, 30, 48, 50, 56, 98, 100, and 200 tablets.

Only some package sizes may be marketed.

Marketing authorization holder and responsible manufacturer:

Marketing authorization holder

STADA, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona)

[email protected]

Responsible manufacturer:

Dragenopharm Apotheker Püschl GmbH

Göllstrasse 1

84529 Tittmoning

Germany

or

Swiss Caps GmbH

Grassingerstraße 9

83043 Bad Aibling

Germany

or

STADA Arzneimittel AG

Stadastrasse 2-18

61118 Bad Vilbel

Germany

or

Centrafarm Services B.V.

Van de Reijtstraat 31 E,

4814 NE BREDANetherlands

Last review date of this leaflet:February 2024

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/

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