Patient Information Leaflet

Pravastatina Viatris 20 mg Tablets EFG

Pravastatina Sodium

Read this leaflet carefully before you start taking the medicine, as 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 and should not be given to others, even if they have the same symptoms, as it may harm them.
• If you experience any of the side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

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

2.What you need to know before you start taking Pravastatina Viatris

3.How to take Pravastatina Viatris

4.Possible side effects

5.Storage of Pravastatina Viatris

6.Contents of the pack and additional information

The active ingredient, pravastatina sodium,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 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 cause:

• 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.

Pravastatina sodium is used in three situations:

Treatment of high levels of cholesterol and fats in the blood

Pravastatina sodium 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 not exercise regularly), pravastatina sodium is indicated to reduce the risk of experiencing a heart and blood vessel problem, and decreases the risk of dying from these diseases.

• If you have already experienced a stroke or have chest pain (unstable angina), even with normal cholesterol levels,pravastatina sodium is indicated to reduce the risk of experiencing 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 receive medication to prevent your body from rejecting the transplant, pravastatina sodium is indicated to reduce elevated levels of fat in the blood.

Do not takePravastatina Viatris

• If you are allergic to pravastatina or any of the other ingredients in this medication (listed in section6).
• If you have any liver disease or if liver function tests show high values without any identifiable reason (your doctor will advise you on this).
• If you are pregnant, planning to become pregnant or breastfeeding (see Pregnancy and breastfeeding).

Warnings and precautions

Consult your doctor or pharmacist before starting to take Pravastatina Viatris:

• 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 myasthenia gravis (a disease that causes weakness of the eye muscles), as statins may sometimes worsen the disease or cause myasthenia (see section 4).
• If you have kidney disease or a history of liver disease.
• If you regularly drink large amounts of alcohol.
• If you have a decreased function of the thyroid gland.
• If you are taking other medications (e.g., fibrates) to lower blood fats.
• If you have had muscle problems during previous treatment to lower blood fats or if you or a family member suffers from a hereditary muscle disease, especially if you are over 65 years old.

Your doctor will perform a blood test before starting pravastatina and if you have any symptoms or liver 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 pravastatina treatment 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 have taken within the last 7 days a medication containing fusidic acid (used to treat bacterial infections) by mouth or injection. The combination of fusidic acid and pravastatina may cause severe muscle problems (rhabdomyolysis).
• If you have severe respiratory failure.

If you have experienced any of these problems, your doctor will need to perform a blood test before and possibly during pravastatina treatment to evaluate your risk of developing muscle-related adverse effects. You may also need this blood test if you are 70 years old or older.

Consult your doctor immediately if, during pravastatina treatment, you experience unexplained muscle pain, muscle weakness, cramps or muscle sensitivity, especially in combination with fatigue, fever, and a change in urine color to brown-red (rhabdomyolysis), which may be a sign of kidney problems. These symptoms may be caused by pravastatina use.

If you have diabetes or are at risk of developing it, your doctor will monitor you during pravastatina treatment. You are at higher risk of developing diabetes if you have high blood sugar or fat levels, if you are overweight, or if you have high blood pressure.

Inform your doctor or pharmacist if you experience persistent muscle weakness. Additional tests and medications may be necessary to diagnose and treat this problem.

Children

This medication is not recommended for children under 8 years old.

Other medications and Pravastatina Viatris

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication, including those purchased without a prescription.

If you take pravastatina with other medications, either the effect of pravastatina, the effect of the other medication, or the effect of both may be modified and may increase the risk of muscle problems.

Inform your doctor or pharmacist especially if you are taking or have taken recently any of the following medications:

• Medications known as fibrates (e.g., gemfibrozil and fenofibrate), which lower blood fat levels or nicotinic acid (Vitamin B). Taking these medications with pravastatina may cause severe muscle problems.
• Medications such as cholestyramine and colestipol used to reduce elevated cholesterol levels may reduce the effectiveness of pravastatina.Pravastatinashould be taken at least one hour before or four hours after taking these medications.
• Ciclosporin (a medication used to suppress the immune system), as the effect of pravastatina may be increased and your doctor may need to change your dose.
• Antibiotics such as erythromycin, clarithromycin, roxithromycin, and rifampicin, as they increase the effect of pravastatina.
• If you need to take oral fusidic acid to treat a bacterial infection, you will need to stop using this medication. Your doctor will indicate when you can restart pravastatina treatment. The use of pravastatina with fusidic acid may causein rare casesmuscle weakness, sensitivity, or pain (rhabdomyolysis). For more information on rhabdomyolysis, see section 4.
• If you are taking a medication used to treat and prevent blood clotting called a vitamin K antagonist, inform your doctor before taking pravastatina, as the simultaneous use of vitamin K antagonists with pravastatina may increase the results of blood tests used to monitor vitamin K antagonist treatment.
• Colchicine (used to treat gout).
• Lenalidomide (used to treat a blood cancer called multiple myeloma).

Pravastatina Viatris with food, drinks, and alcohol

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

Always keep your alcohol consumption to a minimum. If you are concerned about how much alcohol you can drink while taking this medication, consult your doctor.

Pregnancy and breastfeeding

Do not take pravastatina during pregnancy or breastfeeding, as pravastatina may be harmful to your baby.

Before starting pravastatina treatment, inform your doctor if you are pregnant or planning to become pregnant. If you become pregnant during treatment, stop taking pravastatina and consult your doctor.

Women of childbearing age should use a reliable contraceptive while taking this medication.

Consult your doctor or pharmacist before using any medication.

Driving and operating machinery

Pravastatinausually does not affect your ability to drive and use machines. However, you may feel a little dizzy or your vision may be affected. Avoid driving or using machines if you feel unwell after taking pravastatina.

Pravastatina Viatris contains lactose and sodium

If you have intolerance to certain sugars, contact your doctor before taking this medication. This medication also contains less than 1 mmol of sodium (23 mg) per dose, making it essentially "sodium-free."

Your doctor will advise you to follow a low-fat diet, which should be continued until the end of treatment.

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist. Consult your doctor or pharmacist if you have any doubts.

To reduce elevated blood cholesterol levels

The recommended dose is 10-40 mg of pravastatina once a day, preferably at night. The maximum daily dose is 40 mg of pravastatina.

To prevent cardiovascular diseases

The recommended dose is 40 mg of pravastatina once a day, preferably at night.

After a transplant

The recommended dose is 20 mg of pravastatina once a day. The dose may be adjusted to 40 mg of pravastatina. Your doctor will tell you what dose to take.

Use in children and adolescents with high blood cholesterol levels (familial hypercholesterolemia)

The recommended dose is 10-20 mg of pravastatina once a day in children aged 8-13 years and 10-40 mg of pravastatina once a day in adolescents aged 14-18 years.

Older patients

No dose adjustment is required for this group. The same dose as adult patients can be taken. Your doctor will tell you what dose to take.

Dose adjustment in renal or hepatic disorders

The usual dose is 10 mg of pravastatina once a day, but it may be higher. Your doctor will tell you what dose to take.

Use with other medications

If you are taking pravastatina and other medications that contain cholestyramine or cholestipol (medications also used to treat high cholesterol levels), you should take pravastatina at least one hour before or four hours after taking these medications.

If you are also taking an immunosuppressive medication (ciclosporin), your doctor may prescribe an initial dose of 20 mg once a day. The dose may be adjusted by your doctor to 40 mg. Your doctor will tell you what dose to take.

Take pravastatina once a day, preferably at night, with or without food. Swallow the tablets with a sufficient amount of liquid (e.g., a glass of water).

The 20 mg and 40 mg tablets can be divided into equal doses.

Your doctor will indicate the duration of treatment with pravastatina. This depends on the type of disease for which you are taking this medication.

If you consider that the effect of pravastatina is too strong or too weak, consult your doctor or pharmacist.

If you take more Pravastatina Viatris than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone 91 562 04 20 (indicating the medication and the amount ingested).

If you forgot to take Pravastatina Viatris

If you forget a dose, do not worry. Simply take your normal dose when it is time for the next dose. Do not take a double dose to compensate for the missed doses.

If you interrupt treatment with Pravastatina Viatris

Take pravastatina for the time your doctor has indicated. If you stop taking pravastatina, cholesterol levels may increase again.

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

Like all medicines,this medicinecan cause side effects.

Contact your doctor immediately if you develop any of the following side effects while taking pravastatina:

Very rare (may affect up to 1 in 10,000 people)

• Allergic reactions:
• • Severe allergic reaction, which causes swelling of the face, lips, throat, tongue, and excessive fluid in the body, which can cause difficulty swallowing or breathing (angioedema, anaphylaxis).
  • Skin rash, possibly with joint pain (pseudolupuseritematous).
• Muscle fibre degeneration (rhabdomyolysis) that may be associated with acute kidney failure (see also section 2. “What you need to know before starting to take Pravastatina Viatris”), inflammation of one or more muscles (myositis/polymyositis). This can cause muscle pain, muscle weakness not caused by exercise, decreased urine production, dark urine, and increased creatine kinase, observed through blood tests. Presence of myoglobin in the urine observed through urine tests (myoglobinuria).
• Severe liver problems, including yellowing of the skin or eyes (jaundice), tissues, and body fluids, liver inflammation (hepatitis), rapid and sudden destruction of liver tissue (fulminant hepatic necrosis). This can cause nausea, vomiting, loss of appetite, general feeling of discomfort, fever, itching skin, dark urine, or pale stools.
• Pancreatitis. This causes moderate to severe stomach pain that radiates to the back.
• You may experience numbness, tingling, or burning sensations in your skin, which can be a sign of nerve damage (peripheral neuropathy).
• A condition characterized by inflammation of the muscles and skin (dermatomyositis).

Frequency not known (cannot be estimated from available data)

• Diabetes. This is more likely if you have high blood sugar or fat levels, are overweight, or have high blood pressure. Your doctor will monitor you while you are taking this medicine.
• Respiratory problems, such as persistent cough with shortness of breath or fever (interstitial lung disease).
• Constant muscle weakness (immunemediated necrotizing myopathy).
• 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 strains, tears, or ruptures.

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.

Other possible side effects may be:

Frequent (may affect up to 1 in 10 people)

• Joint pain (arthralgia).
• Increased liver enzyme production (observed through blood tests).

Rare (may affect up to 1 in 100 people)

• Dizziness, headache, sleep disturbances, difficulty sleeping.
• Eye problems, blurred vision, or double vision.
• Digestive problems or slow digestion, indigestion/heartburn, abdominal pain, feeling unwell/vomiting, difficulty or delayed emptying of the intestine, diarrhea, gas.
• Itching, hives, urticaria, scalp and hair problems (including hair loss).
• Abnormal urination, for example, pain, frequency, urinating frequently at night.
• Sexual function problems.
• Fatigue.
• Tendon inflammation, sometimes associated with tears.

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

• Increased sensitivity to light (photophobia).

The following side effects have been observed with other similar medicines to pravastatina and may be observed with this medicine.

Frequency not known (cannot be estimated from available data)

• Nightmares.
• Memory loss.
• Depression.

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 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 medicine.

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

Do not usethis medicationafter the expiration date that appears on the packaging 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 trash. Dispose of the packaging and medications you no longer need at the SIGRE collection pointat the pharmacy. If in doubt, 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 Viatris

• The active ingredient is pravastatina sodium.Each tablet contains 20 mg of pravastatina sodium.
• The other components are: lactose monohydrate (see section 2 “Pravastatina Viatris contains lactose”), dihydroxyaluminum sodium carbonate, sodium stearate fumarate, yellow iron oxide (E172).

Appearance of the product and contents of the package

Yellow, speckled, round tablets, marked with the inscription "20" on one face and a line of breakage on the other. The tablet can be divided into two equal halves.

Pravastatina Viatrisis available in packages of 10, 14, 20, 28, 30, 50, 60, 84, 90, 98 or 100 tablets.

Only some package sizes may be commercially available.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder:

Viatris Limited

Damastown Industrial Park

Mulhuddart, Dublin 15

Dublin

Ireland

Responsible manufacturer:

McDermott Laboratories Ltd. trading as Gerard Laboratories

35/36 Baldoyle Industrial Estate

Grange Road, Dublin 13

Ireland

or

Mylan Hungary Kft.

H-2900 Komárom

Mylan utca 1

Hungary

You can request more information about this medication by contacting the local representative of the marketing authorization holder:

Viatris Pharmaceuticals, S.L.U.

C/ General Aranaz, 86

28027 - Madrid

Spain

This medication is authorized in the member states of the European Economic Area with the following names:

BelgiumPravastatine Viatris 20 mg tabletten

SpainPravastatina Viatris 20 mg comprimidos EFG

FrancePravastatine Mylan Pharma 20 mg comprime secable

NetherlandsPravastatinenatrium Mylan 20 mg tabletten

IrelandPravastatin Mylan 20 mg Tablets

ItalyPravastatina Mylan 20 mg compresse

PortugalPravastatina Mylan

United KingdomPravastatin Sodium 20 mg Tablets

Last review date of this leaflet:July 2024

More detailed information about this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) https://www.aemps.gob.es/