Package Insert: Information for the Patient

Pravastatina Sandoz 10 mg Tablets EFG

Pravastatina Sandoz 20 mg Tablets EFG

Pravastatina Sandoz 40 mg Tablets EFG

Read this package insert carefully before you start taking this medicine, because it contains important information for you.

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

-This medicine has been prescribed only for you, 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 any side effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.

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

2. What you need to know before starting to take Pravastatina Sandoz

3. How to use Pravastatina Sandoz

4. Possible side effects

5. Storage of Pravastatina Sandoz

6. Contents of the pack and additional information

Pravastatina Sandoz belongs to a group of medications called HMG-CoA reductase inhibitors (or statins) that act by reducing the production in your body of "bad cholesterol" and increasing levels of "good cholesterol". 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 atherosclerosis 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 chest pain (angina pectoris) at rest, pravastatina 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, pravastatina will reduce the risk of having a heart attack in the future.

When you take pravastatina, your doctor will recommend as part of the treatment that you perform other complementary actions such as following a low-fat diet, exercising, and weight reduction.

Pravastatina reduces the increase in lipid levels in the case that you have undergone an organ transplant and are taking medications to prevent your body from rejecting the transplant.

Do not takePravastatina Sandoz:

• if you are allergic to pravastatin sodium or any of the other ingredients of this medicine (listed in section 6),
• if several blood tests have shown abnormal liver function (elevated levels of liver enzymes in the blood),
• if you are pregnant or there is a possibility that you 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 any 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:

• kidney disease or a non-functioning thyroid gland,
• problems with alcohol (habitual consumption of large amounts of alcohol),
• a hereditary muscular disorder, which you or a close relative have,
• side effects that affect your muscles when taking other cholesterol-lowering medicines 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 (see section 4),
• if you have a history of liver problems,
• if you have severe respiratory failure,
• if you are taking or have taken within the last 7 days a medicine that contains fusidic acid (used to treat bacterial infections) by mouth or injection. The combination of fusidic acid and pravastatin can lead to a severe 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 developing any 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 persistent muscle weakness. Further tests and additional medicines may be needed to diagnose and treat this problem.

While taking this medicine, your doctor will carefully monitor whether you have diabetes or are at risk of developing diabetes. You may develop diabetes if you have high blood sugar and cholesterol 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 increased levels of liver enzymes in the blood. For this reason, your doctor will usually perform this blood test (liver function test) before and during treatment with pravastatin.

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

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

Children and adolescents (8-18 years old) with a hereditary disease that increases cholesterol levels in the blood (familial hypercholesterolemia):

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

Taking Pravastatina Sandoz with other medicines

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

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

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

If you are taking a medicine used to treat and prevent blood clotting called an antagonist of vitamin K, consult your doctor before taking pravastatin because the use of antagonists of vitamin K concomitantly with pravastatin may increase the results of blood tests used to monitor treatment with antagonists of vitamin K.

If you need to take fusidic acid orally to treat a bacterial infection, you will need to temporarily stop taking this medicine. Your doctor will tell you 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, or think you may be pregnant, consult your doctor or pharmacist before using this medicine.

You should not take pravastatin during pregnancy.Your doctor will take special precautions when prescribing this medicine to young women who may become pregnant, and will explain the possible risk associated with pravastatin treatment during pregnancy.If you are pregnant or intend 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 because pravastatin passes into breast milk (see section 2: “Do not take Pravastatina Sandoz”).

Driving and operating machines

Pravastatin normally does not affect your ability to drive, but if you experience symptoms of dizziness, blurred vision, or double vision before driving and operating machinery, you should ensure that you are well enough to do so.

Pravastatina Sandoz contains lactose

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

Pravastatina Sandoz contains sodium

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

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

Adults

The recommended dose is 10 to 40 mg once a day, preferably at night.Pravastatinacan be taken with or without food, with half a glass of water. The tablet can be divided into equal doses.

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

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

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

Renal and hepatic insufficiency

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

After organ transplantation

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

Other medications

Pravastatina should be taken normally at least one hour before, or four hours after, takingcolestiramineorcolestipol.

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

Treatment duration

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

If you consider that pravastatina's action 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 Pravastatina Sandoz accidentally, consult your doctor, pharmacist, or call the Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount used.It is recommended to bring the packaging and the 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 compensate for the missed doses.

If you interrupt treatment with Pravastatina Sandoz

Always consult your doctor if you want to interrupt treatment.

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 Sandoz and seek immediate medical attention if 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 or persistent muscle pain, sensitivity, weakness, or cramps, especially if you also feel unwell or have a high temperature. In rare cases, muscle problems can be serious (rhabdomyolysis) and may lead to potentially fatal kidney disease.
• Yellowing of the skin or the white part of the eyes and/or loss of appetite and general feeling of illness, stomach pain. These are symptoms of severe inflammation of the liver and/or pancreas and rapid loss of liver function.

Other side effects

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

• Dizziness, headache, sleep disturbances, insomnia,
• Visual problems such as double vision or blurred vision,

• Problems in the stomach and intestines such as indigestion, heartburn, stomach pain, discomfort, nausea, vomiting, diarrhea, or constipation, and flatulence,
• Skin reactions such as itching and exanthema, rashes (urticaria), or problems with hair and scalp, including hair loss,

• Urinary problems (frequent or painful urination, with nighttime losses),
• Sexual difficulties,
• Fatigue,
• Muscle and joint pain,
• Tendon inflammation, which may be complicated by tendon rupture.

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

• Increased skin sensitivity to sunlight.

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

• Problems with touch that include burning/tingling or numbness sensations that may indicate nerve damage,
• Allergic reactions that cause joint pain, skin eruptions, 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 may be a sign of liver problems. Your doctor may want to perform periodic blood tests to check them,
• Skin and muscle inflammation (dermatomyositis).

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

• Constant muscle weakness,
• Rash, including lichenoid rash,
• 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)
• Muscle rupture.

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.

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

• Nightmares,
• Memory loss,
• Depression,
• Respiratory problems including persistent cough and/or shortness of breath or fever,
• Diabetes.This may occurmore frequentlyif you have high blood sugar and fat levels,if you are overweight and if you have high blood pressure. Your doctor will monitor you while taking this medicine.

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 leaflet. You can also report them directly through the Spanish System for 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 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 or in 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 the packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medications.This will help protect the environment.

Composition of Pravastatina Sandoz

-The active ingredient is: pravastatina sodium.

Pravastatina Sandoz 10 mg:

Each tablet contains 10 mg of pravastatina sodium.

Pravastatina Sandoz 20 mg.

Each tablet contains 20 mg of pravastatina sodium.

Pravastatina Sandoz 40 mg:

Each tablet contains 40 mg of pravastatina sodium.

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

Appearance of the product and contents of the package

Pravastatina Sandoz 10 mg:

Light brown, speckled, oval-shaped tablets with a groove on both sides and embossed with “P 10” on one of them.

Pravastatina Sandoz 20 mg:

Light brown, speckled, oval-shaped tablets with a groove on both sides and embossed with “P 20” on one of them.

Pravastatina Sandoz 40 mg:

Light brown, speckled, oval-shaped tablets with a groove on both sides and embossed with “P 40” on one of them.

Alu/Alu blister:

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

Only some package sizes may be marketed.

Marketing Authorization Holder

Sandoz Farmacéutica, S.A.

Centro Empresarial Parque Norte

Edificio Roble

C/ Serrano Galvache, 56

28033 Madrid

Spain

Responsible for manufacturing

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 medicine is approved in the Member States of the European Economic Area with the following names:

Bélgica:Pravastatine Sandoz 20 mg tabletten

Pravastatine Sandoz 40 mg tabletten

Dinamarca:Pravastatin Sandoz

Finlandia:Pravastatina Sandoz 20 mg Tabletti

Pravastatina Sandoz 40 mg Tabletti

Francia:Pravastatine Sandoz 10 mg, comprimé sécable

Pravastatine Sandoz 20 mg, comprimé sécable

Pravastatine Sandoz 40 mg, comprimé sécable

Italia:PRAVASTATINA SANDOZ GMBH

Holanda:PRAVASTATINENATRIUM SANDOZ 10, tabletten 10

PRAVASTATINENATRIUM SANDOZ 20, tabletten 20

PRAVASTATINENATRIUM SANDOZ 40, tabletten 40

Noruega:Pravastatin Sandoz 20 mg tabletter

Pravastatin Sandoz 40 mg tabletter

Portugal: PRAVASTATINA SANDOZ

Reino Unido: Pravastatin Sodium 10 mg Tablets

Pravastatin Sodium 20 mg Tablets

Pravastatin Sodium 40 mg Tablets

Suecia:Pravastatin Sandoz 20 mg tabletter

Pravastatin Sandoz 40 mg tabletter

Last review date of this leaflet:April 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/