PRAVASTATIN STADA 40 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the Patient

Pravastatina STADA 10 mg film-coated tablets EFG

Pravastatina STADA 20 mg film-coated tablets EFG

Pravastatina STADA 40 mg film-coated tablets EFG

pravastatin sodium

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

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

1. What is Pravastatina Stada and what is it used for
2. What you need to know before you take Pravastatina Stada
3. How to take Pravastatina Stada
4. Possible side effects
5. Storing Pravastatina Stada
6. Pack contents and further information

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

Pravastatin, the active substance of Pravastatina Stada, belongs to a group of medicines known as statins (or HMG-CoA reductase inhibitors). It prevents the production of cholesterol by the liver and, as a result, reduces cholesterol and other fat levels (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:

• chest pain (angina pectoris), when a blood vessel of the heart is partially obstructed.
• heart attack (myocardial infarction), when a blood vessel of the heart is completely obstructed.
• stroke (cerebrovascular accident), when a blood vessel of the brain is completely obstructed.

This medicine is indicated in three situations:

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

This medicine is indicated to lower high levels of "bad" cholesterol and raise levels of "good" cholesterol in the blood when diet and exercise have not been effective.

The prevention of heart and blood vessel diseases

• If you have high cholesterol levels 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 medicine is indicated to reduce the risk of you suffering from a heart or blood vessel problem, and reduces the risk of dying from these diseases.

• If you have already suffered a stroke or have unstable angina, and even with normal cholesterol levels, this medicine is indicated to reduce the risk of you suffering another heart attack or stroke in the future, and reduces the risk of dying from these diseases.

After an organ transplant

If you have undergone an organ transplant and are taking medication to prevent your body from rejecting the transplant, this medicine is indicated to reduce high fat levels in the blood.

2. What you need to know before you take Pravastatina Stada

DO NOT takePravastatina Stada:

• if you are allergicto pravastatin or any of the other components of this medicine (listed in section 6).
• if you are pregnant, plan to become pregnant, or are breast-feeding (see Pregnancy and Breast-feeding).
• 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, you should consult your doctor if you have or have had any of the following medical problems:

• Kidney disease
• Decreased thyroid gland activity (hypothyroidism)
• Liver disease or alcohol problems (drinking large amounts of alcohol)
• Muscle disorders caused by a hereditary disease
• Muscle problems caused by another medicine belonging to the group of statins (HMG-CoA reductase inhibitors) or belonging to the group known as fibrates (see Other medicines 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 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).

Your doctor will perform a blood test before you start taking this medicine and if you have any symptoms or liver problems during treatment. This is to check if your liver is working properly.

Your doctor may also need to perform a blood test after starting treatment with this medicine to check 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 medicine called fusidic acid (an antibiotic used to treat bacterial infections) orally or by injection. The combination of fusidic acid and pravastatin can produce serious 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 assess the risk of you suffering from muscle side effects.

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

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

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

Consult your doctor before taking this medicine.

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

• have severe respiratory failure.

Other medicines and Pravastatina Stada

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

Taking pravastatin with any of the following medicines may increase the risk of muscle problems:

• a medicine that lowers blood cholesterol levels (fibrates, e.g., gemfibrozil, fenofibrate).
• a medicine that lowers the body's defenses (ciclosporin).
• a medicine that treats bacterial infections (an antibiotic such as erythromycin or clarithromycin).
• Colchicine (a medicine used to treat gout)
• Nicotinic acid (a medicine used to treat high cholesterol levels in the blood)
• Rifampicin (a medicine used to treat tuberculosis infection)
• Lenalidomide (a medicine used to treat a type of blood cancer called multiple myeloma).

If you are also using a medicine to lower fat levels in your blood (such as a resin like cholestyramine or colestipol), this treatment should be taken at least one hour before or four hours after taking the resin. This is because the resin can affect the absorption of pravastatin if these two medicines are taken simultaneously.

Taking Pravastatina Stada with alcohol

You should minimize your alcohol consumption. If you have doubts about how much alcohol you can drink while taking this medicine, consult your doctor.

Pregnancy and Breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy

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

Breast-feeding

Do not take pravastatin during breast-feeding, as this treatment passes into breast milk.

Driving and using machines

Pravastatin does not affect your ability to drive or use machines. If you experience symptoms such as dizziness, blurred vision, or double vision during treatment, do not drive or use machines until you are sure you can do so safely.

Pravastatina Stada contains lactose and sodium

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

Sodium: This medicine contains less than 1 mmol of sodium (23 mg) per tablet; this is essentially "sodium-free".

3. How to take Pravastatina Stada

Your doctor will advise you on a low-fat diet, which you should continue throughout treatment.

Follow the instructions for taking this medicine exactly as indicated by your doctor. If you are unsure, consult your doctor or pharmacist again.

Dose

Adults

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

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

Do not exceed the maximum daily dose of 40 mg of pravastatin sodium. Your doctor will determine the suitable dose for you.

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

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 medicine that lowers the body's immune system (ciclosporin), 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 severe kidney or liver disease, your doctor may prescribe a lower dose of pravastatin.

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

Method of administration

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

Duration of treatment

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

If you take more Pravastatina Stada than you should

If you have taken more pravastatin than you should, or if someone has 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 Toxicology Information Service, phone: 915 620 420, indicating the medicine and the amount ingested.

If you forget to take Pravastatina Stada

If you forget to take a dose, simply take your normal dose when the next one is due. Do not take a double dose to make up for forgotten doses.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Stop taking pravastatin and inform your doctor immediately if you notice unexplained muscle pain or persistent pain, pain on palpation, weakness, or cramps, especially if you do not feel well or have a fever.

In very rare cases, muscle problems can be serious (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 trachea can cause serious breathing difficulties. This is a very rare reaction that can be serious if it occurs. You should inform your doctor immediately if this happens.

The following side effects are uncommon and may 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, rash, blistering accompanied by itching, hair and scalp abnormalities (including hair loss).
• Urinary and genital disorders:changes in urination (such as pain when urinating, frequent urination, and increased urination at night) and sexual problems.
• Muscle and joint disorders:muscle 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 disorders:alterations in touch sensation, including burning or tingling, or numbness, which indicates nerve damage.
• Skin disorders:severe skin disorder (lupus-like syndrome),
• Liver disorders:liver inflammation or pancreatitis, jaundice (recognized by yellowing of the skin and whites of the eyes), rapid destruction of liver cells (fulminant hepatic necrosis).
• Muscle and bone disorders:inflammation of one or more muscles causing pain or muscle weakness (myositis or polymyositis or dermatomyositis), pain or weakness in muscles, tendon inflammation, sometimes complicated by rupture.
• Blood test alterations:increased transaminases (a group of blood enzymes) that may be a sign of liver problems. Your doctor may want to perform periodic tests to monitor this.

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

• constant muscle weakness
• liver failure
• severe myasthenia (a disease that causes generalized muscle weakness that, in some cases, affects the muscles used for breathing)1
• ocular myasthenia (a disease that causes weakness of the eye muscles)1
• muscle rupture

1 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.

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 sugar and fat levels in the blood, are overweight, and have high blood pressure. Your doctor will monitor you during treatment with 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 side effects directly to the Spanish Pharmacovigilance System for Human Use: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storing Pravastatina Stada

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

Do not use this medicine after the expiry date which is stated on the carton and blister after EXP. The expiry date is the last day of the month stated.

Do not store above 25°C.

Store in the original package.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Container Content and Additional Information

Composition of Pravastatina Stada

• The active ingredientis pravastatin sodium.

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

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

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

• The other 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 container content

10 mg: Film-coated tablet of pink-peach color, marked with “10” on one side.

20 mg: Film-coated tablet of yellow color, marked with “20” on one side.

40 mg: Film-coated tablet of yellow color, marked with “40” on one side.

The tablet can be divided into equal doses.

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

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

Only some pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Laboratorio STADA, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona)

info@stada.es

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 BREDA Netherlands

Date of the last revision of this leaflet: February 2024

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

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