PRAVASTATIN SANDOZ 20 mg TABLETS

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

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 you have had abnormal liver function tests (increased liver enzymes in the blood),
• if you are pregnant or breast-feeding,
• if you have liver problems (see section 2: "Warnings and precautions"),

Consult your doctor if you are unsure whether you can take Pravastatina Sandoz.

Warnings and precautions

Consult your doctor or pharmacist before taking Pravastatina Sandoz if you have:

• kidney disease or an underactive thyroid gland,
• excessive alcohol consumption,
• a hereditary muscle disorder,
• muscle problems while taking other cholesterol-lowering medicines (such as statins or fibrates),
• myasthenia gravis (a disease characterized by muscle weakness) or ocular myasthenia (a disease that causes weakness of the eye muscles), as statins can sometimes worsen the condition or trigger the onset of myasthenia (see section 4),
• a history of liver problems,
• severe respiratory failure,
• taken or are taking a medicine containing fusidic acid (used to treat bacterial infections) by mouth or by injection in the last 7 days. 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.

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

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

While taking this medicine, 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 blood test that detects increased liver enzymes 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 persistent muscle weakness. Additional tests and medication may be necessary to diagnose and treat this problem.

Children and adolescents (8-18 years of age) with heterozygous familial hypercholesterolemia:

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

Taking Pravastatina Sandoz with other medicines

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

It is particularly important that you 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 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 lead to an increased risk of muscle problems,
• a lipid-lowering agent of the resin type, such as colestyramine or colestipol. Pravastatin should normally be taken at least 1 hour before or 4 hours after taking the resin. This is because the resin can affect the absorption of pravastatin if the two medicines are taken close together,
• rifampicin(an antibiotic). The combination may result in increased levels of pravastatin. Pravastatin should normally be taken at least 2 hours before taking rifampicin,
• colchicine(used to treat gout attacks). The combination may result in an increased risk of muscle problems,
• lenalidomide(a medicine that affects the functioning of your immune system). The combination may result in an increased risk of muscle problems.

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

If you need to take fusidic acid by mouth to treat a bacterial infection, you will need to stop taking this medicine temporarily. Your doctor will tell you when you can restart the 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 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.

Do not take pravastatin during pregnancy. Your doctor will be extremely cautious when prescribing this medicine to young women who may become pregnant and will explain the possible risks associated with treatment with pravastatin during pregnancy. If you are pregnant or planning to become pregnant, stop taking pravastatin and inform your doctor immediately (see section 2: "Do not take Pravastatina Sandoz").

Do not take pravastatin during breast-feeding because pravastatin passes into breast milk (see section 2: "Do not take Pravastatina Sandoz").

Driving and using machines

Pravastatina Sandoz normally does not affect the ability to drive or use machines, but if you experience dizziness, blurred vision, or double vision before driving or operating machinery, make sure you are well before doing so.

Pravastatina Sandoz contains lactose

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

Pravastatina Sandoz contains sodium

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

3. How to take Pravastatina Sandoz

Always take this medicine exactly as your doctor or pharmacist has told you. If you are unsure, check with your doctor or pharmacist.

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 of age) with heterozygous familial hypercholesterolemia

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

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

Renal and hepatic impairment

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

After organ transplantation

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

Other medicines

Pravastatina Sandoz should normally be taken at least 1 hour before or 4 hours after taking colestyramineor colestipol.

The usual starting dose for people taking medicines to adjust or adapt the immune response (e.g., ciclosporin) 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 tell you how long to take this medicine. This medicine should be used regularly and for as long as your doctor tells you, even if it is for a long time. Do not stop treatment on your own initiative.

If you think that the effect of pravastatin is too strong or too weak, talk to 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 by accident, contact your doctor, pharmacist, or the Toxicology Information Service (telephone: 91 562 04 20), stating the medicine and the amount taken. It is recommended to take the packaging and leaflet to the healthcare professional.

If you forget to take Pravastatina Sandoz

If you have missed 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 forgotten doses.

If you stop taking Pravastatina Sandoz

Always consult your doctor if you want to stop treatment.

If you have any further questions on the use of this product, 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 Pravastatina Sandoz and contact your doctor immediatelyif you experience symptoms such as:

• swelling of the face, tongue, mouth, eyes, or throat, difficulty swallowing, hives, and difficulty breathing, dizziness. These are symptoms of a severe allergic reaction (angioedema, anaphylaxis) that need to 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 the whites of the eyes and/or loss of appetite and generally feeling unwell, stomach pain. These are symptoms of severe liver inflammation and/or pancreatitis and rapid loss of liver function.

Other side effects

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

• dizziness, headache, sleep disturbances, 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 that may indicate nerve damage,
• allergic reactions that cause joint pain, skin rash, 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 with frequency not known(frequency cannot be estimated from the available data)

• Persistent muscle weakness,
• rash, including lichenoid rash,
• severe myasthenia gravis (a disease that causes generalized muscle weakness that can affect 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 reported with some statins (medicines 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 medicine.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Pravastatina Sandoz

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 or blister after EXP. The expiry date refers to the last day of the month shown.

Store in the original package to protect from moisture.

Medicines should not be disposed of via wastewater or household waste. Return any unused medicine to a pharmacy for disposal. Ask your pharmacist how to dispose of medicines no longer required. 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.

Product Appearance and Packaging 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/