PRAVASTATIN SANDOZ 10 mg TABLETS

Introduction

Patient Information: Leaflet

Pravastatina Sandoz 10 mg tablets EFG

Pravastatina Sandoz 20 mg tablets EFG

Pravastatina Sandoz 40 mg tablets EFG

Read the entire leaflet carefully before starting to take this medication, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.

• This medication has been prescribed to you only, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Contents of the leaflet:

1. What is Pravastatina Sandoz and what is it used for
2. What you need to know before taking Pravastatina Sandoz
3. How to take Pravastatina Sandoz
4. Possible side effects
5. Storage of Pravastatina Sandoz
6. Package contents and additional information

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

Pravastatina Sandoz belongs to a group of medications called HMG-CoA reductase inhibitors (or statins) that work by reducing the production of "bad" cholesterol and increasing the levels of "good" cholesterol in your body. Cholesterol is a lipid that can cause coronary heart disease by narrowing the blood vessels that supply blood to the heart. This disease, known as arteriosclerosis or hardening of the arteries, can cause chest pain (angina pectoris), a heart attack (myocardial infarction), or stroke.

If you have already had a heart attack or have unstable angina pectoris (chest pain at rest), pravastatin reduces the risk of having another heart attack or stroke in the future, regardless of your cholesterol levels.

If you have high cholesterol levels but do not have coronary heart disease, pravastatin will reduce the risk of having a heart attack in the future.

When taking pravastatin, your doctor will recommend other complementary actions, such as following a low-fat diet, exercising, and losing weight, as part of your treatment.

Pravastatin reduces the increase in lipid levels in cases where you have undergone an organ transplant and are taking medications to prevent your body from rejecting the transplant.

2. What you need to know before taking Pravastatina Sandoz

Do not takePravastatina Sandoz:

• if you are allergic to pravastatin sodium or any of the other components of this medication (listed in section 6),
• if you have shown abnormal liver function in several blood tests (elevated liver enzyme levels in blood),
• if you are pregnant or may become pregnant,
• if you are breastfeeding (see section "Pregnancy and breastfeeding"),
• if you have liver problems (see section 2: "Warnings and precautions").

Consult your doctor if you have doubts about whether you can take Pravastatina Sandoz.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Pravastatina Sandoz if you have had any of the following conditions:

• kidney disease or non-functional thyroid,
• alcohol problems (habitual consumption of large amounts of alcohol),
• a hereditary muscle disorder, which you or a blood relative have,
• side effects that affect your muscles when taking other cholesterol-lowering medications, such as statins or fibrates,
• if you have or have had myasthenia (a disease that causes generalized muscle weakness, which 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),
• if you have a history of liver problems,
• if you have severe respiratory failure,
• if you are taking or have taken in the last 7 days a medication that contains fusidic acid (used to treat bacterial infections) orally or by injection. The combination of fusidic acid and pravastatin can lead to a serious muscle problem (rhabdomyolysis).

If you have had any of these problems, your doctor will need to perform a blood test before and possibly during treatment with pravastatin to assess the risk of muscle-related side effects. You may also need this blood test if you are over 70 years old.

Go to your doctor as soon as possible to discuss your concerns and follow the recommended precautions.

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.

While taking this medication, your doctor will carefully monitor you if you have diabetes or are at risk of developing diabetes. You may develop diabetes if you have high blood sugar and fat levels, are overweight, and have high blood pressure.

In a small number of people, statins can affect the liver. This is identified by a simple test that detects elevated liver enzyme levels in the blood. For this reason, your doctor will normally perform this blood test (liver function test) before and during treatment with pravastatin.

If you experience unexplained muscle pain, weakness, or cramps and are taking statins, contact your doctor immediately without delay.

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.

Children and adolescents (8-18 years old) with inherited high cholesterol (heterozygous familial hypercholesterolemia):

In children before puberty, before starting treatment, the doctor must carefully evaluate the benefit-risk balance of treatment.

Taking Pravastatina Sandoz with other medications

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

It is essential that you inform your doctor if you are already being treated with any of the following medications:

• other cholesterol-lowering medications called fibrates (e.g., gemfibrozil, fenofibrate) and nicotinic acid. The combination can increase the risk of developing muscle problems,
• medications used to adjust or adapt the immune response, e.g., cyclosporine. The combination can increase the risk of side effects,
• antibiotics such as erythromycin, clarithromycin, and roxithromycin. The combination can lead to an increased risk of developing muscle problems,
• a lipid-lowering agent of the resin type, such as cholestyramine or colestipol. Pravastatin should normally 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 the two medications are taken in a short period),
• rifampicin(antibiotic). The combination can result in increased pravastatin levels. Pravastatin should normally be taken at least two hours before taking rifampicin,
• colchicine(used to treat gout attacks). The combination can result in an increased risk of developing muscle problems,
• lenalidomide(a medication that affects the functioning of your immune system). The combination can result in an increased risk of developing muscle problems.

If you are taking a medication used to treat and prevent blood clot formation called a "vitamin K antagonist," consult your doctor before taking pravastatin, as the use of vitamin K antagonists concomitantly with pravastatin may increase the results of blood tests used to monitor treatment with vitamin K antagonists.

If you need to take oral fusidic acid to treat a bacterial infection, you will need to temporarily stop taking this medication. Your doctor will indicate when you can restart treatment with pravastatin. The use of pravastatin with fusidic acid can cause muscle weakness, sensitivity, or pain (rhabdomyolysis). For more information on rhabdomyolysis, see section 4.

Taking Pravastatina Sandoz with food, drink, and alcohol

Pravastatina Sandoz can be taken with or without food. Inform your doctor if you regularly consume large amounts of alcohol.

If you are unsure, follow your doctor's recommendations.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medication.

You should not take pravastatin during pregnancy. Your doctor will exercise special caution when prescribing this medication to young women who may become pregnant and will explain the possible risk associated with treatment with pravastatin during pregnancy. If you are pregnant or plan to become pregnant, you should stop taking pravastatin and inform your doctor immediately (see section 2: "Do not take Pravastatina Sandoz").

You should not take pravastatin during breastfeeding, as pravastatin passes into breast milk (see section 2: "Do not take Pravastatina Sandoz").

Driving and using machines

Pravastatina Sandoz normally does not affect your ability to drive, but if you notice symptoms such as dizziness, blurred vision, or double vision before driving and operating machinery, make sure you are well enough to do so.

Pravastatina Sandoz contains lactose

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

Pravastatina Sandoz contains sodium

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

3. How to take Pravastatina Sandoz

Follow the administration instructions for this medication exactly as indicated by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist again.

Adults

The recommended dose is 10 to 40 mg once a day, preferably in the evening. Pravastatina Sandoz can be taken with or without food, with a half glass of water. The tablet can be divided into equal doses.

Use in children and adolescents (8-18 years old) with heterozygous familial hypercholesterolemia

Use in children and adolescents (8-13 years old): The recommended dose range is 10 to 20 mg once a day.

Use in children and adolescents (14-18 years old): The recommended dose range is 10 to 40 mg once a day.

Renal and hepatic impairment

The normal dose is 10 mg once a day in patients with renal or hepatic impairment.

After organ transplantation

The normal starting dose is 20 mg once a day. The dose can be increased up to 40 mg per day under medical supervision.

Other medications

Pravastatina Sandoz should be taken normally at least one hour before or four hours after taking cholestyramineor colestipol.

The normal starting dose for people taking medications to adjust or adapt an immune response (e.g., cyclosporine) is 20 mg once a day. This dose can be increased up to 40 mg per day under medical supervision.

Duration of treatment

Your doctor will indicate the duration of your treatment with this medication. This medication should be used regularly and for as long as your doctor indicates, even if it is for a very long period. Do not interrupt treatment on your own initiative.

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

If you take more Pravastatina Sandoz than you should

If you have taken more Pravastatina Sandoz than you should or if someone has taken it accidentally, consult your doctor, pharmacist, or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medication and the amount used. It is recommended to bring the packaging and leaflet to the healthcare professional.

If you forget to take Pravastatina Sandoz

If you have forgotten a dose, do not worry. Simply take your usual dose at the next scheduled time. Do not take a double dose to make up for missed doses.

If you interrupt treatment with Pravastatina Sandoz

Always consult your doctor if you want to interrupt treatment.

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

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone will experience them.

Stop taking Pravastatina Sandoz and go to your doctor immediatelyif you experience symptoms such as:

• swelling in the face, tongue, mouth, eyes, or throat, difficulty swallowing, hives, and difficulty breathing, dizziness. These are symptoms of a severe allergic reaction (angioedema, anaphylaxis), which should be treated immediately, usually in a hospital,
• unexplained muscle pain or persistent muscle weakness, sensitivity, or cramps, especially if you feel unwell or have a high temperature. In very rare cases, muscle problems can be serious (rhabdomyolysis) and can lead to potentially life-threatening kidney disease,
• yellowing of the skin or whites of the eyes and/or loss of appetite and general malaise, stomach pain. These are symptoms of severe liver inflammation and/or pancreatitis, and rapid loss of liver function can occur.

Other side effects

Uncommon side effects(may affect up to 1 in 100 people)

• dizziness, headache, sleep disorders, insomnia,
• vision problems such as double vision or blurred vision,

• stomach and intestine problems such as indigestion, heartburn, stomach pain, discomfort, nausea, vomiting, diarrhea, or constipation and flatulence,
• skin reactions such as itching and rash, hives (urticaria), or hair and scalp problems, including hair loss,

• bladder problems (frequent or painful urination, with nighttime losses),
• sexual difficulties,
• fatigue,
• muscle and joint pain,
• tendon inflammation, which can lead to tendon rupture.

Rare side effects(may affect up to 1 in 1,000 people)

• increased sensitivity of the skin to sunlight.

Very rare side effects(may affect up to 1 in 10,000 patients)

• problems with touch, including burning or tingling sensations or numbness, which can indicate nerve damage,
• allergic reactions that cause joint pain, skin rashes, and fever (lupus erythematosus),
• muscle pain or weakness (myopathy), muscle inflammation (myositis, polymyositis),
• abnormal blood tests: increased transaminases (a group of enzymes that occur naturally in the blood), which can be a sign of liver problems. Your doctor may want to perform periodic blood tests to review them,
• skin and muscle inflammation (dermatomyositis).

Side effects with unknown frequency(the frequency cannot be estimated from the available data)

• constant muscle weakness,
• rash, including lichenoid rash,
• severe myasthenia (a disease that causes generalized muscle weakness, which in some cases affects the muscles used for breathing),
• ocular myasthenia (a disease that causes weakness of the eye muscles)
• muscle rupture.

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.

The following side effects have been detected with some statins (medications of the same type):

• nightmares,
• memory loss,
• depression,
• respiratory problems, including persistent cough and/or shortness of breath,
• diabetes. This may occur more frequently 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 medication.

Reporting side effects

If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medications: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Pravastatina Sandoz

Keep this medication out of sight and reach of children.

Do not use this medication after the expiration date shown on the packaging or 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 wastewater or household waste. Deposit the packaging and medications you no longer need at the SIGRE collection point in your pharmacy. If you have any doubts, ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Pravastatina Sandoz

• The active ingredient is: pravastatin sodium.

Pravastatina Sandoz 10 mg:

Each tablet contains 10 mg of pravastatin sodium.

Pravastatina Sandoz 20 mg.

Each tablet contains 20 mg of pravastatin sodium.

Pravastatina Sandoz 40 mg:

Each tablet contains 40 mg of pravastatin sodium.

• The other components are: microcrystalline cellulose, lactose monohydrate, anhydrous disodium phosphate, sodium croscarmellose, sodium lauryl sulfate, povidone K25, iron oxide (brown E172), anhydrous colloidal silica, and magnesium stearate.

Appearance of the Product and Package Contents

Pravastatina Sandoz 10 mg:

Light brown, speckled, oval tablets with a score line on both sides and engraved with "P 10" on one side.

Pravastatina Sandoz 20 mg:

Light brown, speckled, oval tablets with a score line on both sides and engraved with "P 20" on one side.

Pravastatina Sandoz 40 mg:

Light brown, speckled, oval tablets with a score line on both sides and engraved with "P 40" on one side.

Alu/Alu Blister:

1, 7, 10, 14, 20, 21, 28, 30, 50, 60, 98, 100, 100x1 tablets.

Only some pack sizes may be marketed.

Marketing Authorization Holder

Sandoz Farmacéutica, S.A.

Centro Empresarial Parque Norte

Edificio Roble

C/ Serrano Galvache, 56

28033 Madrid

Spain

Manufacturer

Lek Pharmaceuticals d.d

Verovskova 57

SI-1526 Ljubljana

Slovenia

or

Lek S.A Ul.Domaniewska 50C

02-672 Warszawa

Poland

or

Salutas Pharma GmbH Otto-von Guericke Alle 1

39179 Barleben

Germany

or

Lek Pharmaceuticals d.d.

Trimlini 2 D

9220 Lendava,

Slovenia

This medicinal product is approved in the Member States of the European Economic Area under the following names:

Belgium: Pravastatine Sandoz 20 mg tablets

Pravastatine Sandoz 40 mg tablets

Denmark: Pravastatin Sandoz

Finland: Pravastatina Sandoz 20 mg tablets

Pravastatina Sandoz 40 mg tablets

France: Pravastatine Sandoz 10 mg, scored tablet

Pravastatine Sandoz 20 mg, scored tablet

Pravastatine Sandoz 40 mg, scored tablet

Italy: PRAVASTATINA SANDOZ GMBH

Netherlands: PRAVASTATINENATRIUM SANDOZ 10, tablets 10

PRAVASTATINENATRIUM SANDOZ 20, tablets 20

PRAVASTATINENATRIUM SANDOZ 40, tablets 40

Norway: Pravastatin Sandoz 20 mg tablets

Pravastatin Sandoz 40 mg tablets

Portugal: PRAVASTATINA SANDOZ

United Kingdom: Pravastatin Sodium 10 mg Tablets

Pravastatin Sodium 20 mg Tablets

Pravastatin Sodium 40 mg Tablets

Sweden: Pravastatin Sandoz 20 mg tablets

Pravastatin Sandoz 40 mg tablets

Date of the Last Revision of this Leaflet:April 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/