Pravastatin Viatris 20 mg tablets EFG

Patient Information Leaflet

Introduction

Package Leaflet: Information for the patient

Pravastatin Viatris 20 mg tablets EFG

sodium pravastatin

Read the entire leaflet carefully before you start taking this 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 you should not give it to other people, 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 it is a side effect not listed in this leaflet. See section 4.

Leaflet Contents:

1. What Pravastatin Viatris is and what it is used for
2. What you need to know before taking Pravastatin Viatris
3. How to take Pravastatin Viatris
4. Possible side effects
5. How to store Pravastatin Viatris
6. Contents of the pack and other information

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

The active substance, pravastatin sodium, belongs to a group of medicines known as statins (or HMG-CoA reductase inhibitors). It prevents the liver from producing cholesterol and consequently 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, causing them to become narrowed or blocked.

This condition is known as hardening of the arteries or atherosclerosis and can lead to:

• Chest pain (angina), when a blood vessel of the heart is partially blocked.
• Heart attack (myocardial infarction), when a blood vessel of the heart is completely blocked.
• Stroke, when a blood vessel in the brain is completely blocked.

Pravastatin sodium is used in three situations:

Treatment of high levels of cholesterol and fats in the blood

Pravastatin sodium is indicated to lower high levels of "bad" cholesterol and to 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 cholesterol levels in the blood and risk factors that contribute to these diseases (such as smoking, being overweight, having high blood sugar or high blood pressure, or not exercising regularly), pravastatin sodium is indicated to reduce the risk of developing heart and blood vessel problems, and reduces the risk of dying from these diseases.

• If you have already had a stroke or suffer from chest pain (unstable angina), pravastatin sodium is indicated to reduce the risk of having another heart attack or stroke in the future, even if your cholesterol levels are normal, and reduces the risk of dying from these diseases.

After an organ transplant

If you have undergone an organ transplant and are receiving medication to prevent your body from rejecting the transplanted organ, pravastatin sodium is indicated to reduce elevated levels of fat in the blood.

2. What you need to know before taking Pravastatin Viatris

Do not take Pravastatin Viatris

• If you are allergic to pravastatin or to any of the other ingredients of this medicine (listed in section 6).
• If you have liver disease or if liver function tests show elevated values without any identifiable cause (your doctor will advise you on this).
• If you are pregnant, planning to become pregnant, or breastfeeding (see Pregnancy and breastfeeding).

Warnings and precautions

Talk to your doctor or pharmacist before starting to take Pravastatin Viatris:

• If you have or have had myasthenia (a disease characterized by generalized muscle weakness, which in some cases affects the muscles used for breathing) or ocular myasthenia (a condition causing weakness of the eye muscles), as statins may sometimes worsen the condition or trigger the onset of 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 reduced thyroid gland function.
• If you are taking other medicines (for example, fibrates) to lower blood lipid levels.
• If you have experienced muscle problems during previous lipid-lowering treatment, or if you or a family member has a hereditary muscle disorder, especially if you are over 65 years of age.

Your doctor will perform a blood test before you start taking pravastatin and if you develop any symptoms or liver problems during treatment. This is to check whether your liver is functioning properly.

Your doctor may also need to carry out blood tests after starting pravastatin treatment to monitor your liver function.

The risk of muscle problems is higher in some patients. Consult your doctor in the following cases:

• If you are taking, or have taken within the last 7 days, oral or injectable fusidic acid (used to treat bacterial infections). The combination of fusidic acid and pravastatin may cause serious 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 treatment with pravastatin to assess your risk of muscle-related adverse effects. This blood test may also be needed if you are 70 years of age or older.

Contact your doctor immediately if, while taking pravastatin, you develop unexplained muscle pain, muscle weakness, cramps, or muscle tenderness, especially if accompanied by fatigue, fever, or dark brown-red urine (rhabdomyolysis), which may indicate kidney problems. These symptoms may be caused by the use of pravastatin.

If you have diabetes or are at risk of developing diabetes, your doctor will monitor you during treatment with pravastatin. Your risk of developing diabetes is higher if you have high blood sugar or lipid levels, are overweight, or have high blood pressure.

Also inform your doctor or pharmacist if you experience persistent muscle weakness. Additional tests and treatments may be needed to diagnose and manage this condition.

Children

This medicine is not recommended for children under 8 years of age.

Other medicines and Pravastatin Viatris

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

If you take pravastatin together with other medicines, the effect of pravastatin, the effect of the other medicine, or the effect of both may be altered, and the risk of muscle problems may increase.

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

• Medicines known as fibrates (for example, gemfibrozil and fenofibrate), which reduce blood fat levels, or nicotinic acid (Vitamin B). Taking these medicines with pravastatin may cause serious muscle disorders.
• Medicines such as cholestyramine and colestipol used to reduce high cholesterol levels, which may reduce the effectiveness of pravastatin. Pravastatin should be taken at least one hour before or four hours after taking these medicines.
• Cyclosporine (a medicine used to suppress the immune system), because the effect of pravastatin may be increased and your doctor may need to adjust your dose.
• Antibiotics such as erythromycin, clarithromycin, roxithromycin, and rifampicin because they increase the effect of pravastatin.
• If you need to take oral fusidic acid to treat a bacterial infection, you must stop using this medicine. Your doctor will advise you when you can restart treatment with pravastatin. Using pravastatin with fusidic acid may rarely cause muscle weakness, tenderness, or pain (rhabdomyolysis). For more information about rhabdomyolysis, see section 4.
• If you are taking a medicine used to treat and prevent blood clots called a vitamin K antagonist, inform your doctor before taking pravastatin, as the concomitant use of vitamin K antagonists with pravastatin may increase the results of blood tests used to monitor treatment with vitamin K antagonists.
• Colchicine (used for the treatment of gout).
• Lenalidomide (used for the treatment of a blood cancer called multiple myeloma).

Pravastatin Viatris with food, drinks and alcohol

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

You should always keep your alcohol consumption to a minimum. If you are concerned about how much alcohol you can drink while taking this medicine, you should consult your doctor.

Pregnancy and breastfeeding

You should not take pravastatin during pregnancy or breastfeeding, as pravastatin may be harmful to your baby.

Before starting pravastatin, inform your doctor if you are pregnant or intend to become pregnant. If you become pregnant while taking this medicine, you must stop taking pravastatin and consult your doctor immediately.

Women of childbearing potential must use a reliable contraceptive method while taking this medicine.

Consult your doctor or pharmacist before using any medication.

Driving and operating machinery

Pravastatin usually does not affect the ability to drive or operate machinery. However, you may feel slightly dizzy or your vision may be affected. Avoid driving or operating machinery if you feel unwell after taking pravastatin.

Pravastatina Viatris contains lactose and sodium

If you have an intolerance to certain sugars, consult your doctor before taking this medicine. This medicine also contains less than 1 mmol of sodium (23 mg) per dose unit, therefore it is considered essentially "sodium-free".

3. How to take Pravastatin Viatris

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

Always follow exactly the instructions given by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist.

To lower high blood cholesterol levels

The recommended dose is 10–40 mg of pravastatin once daily, preferably in the evening. The maximum daily dose is 40 mg of pravastatin.

To prevent heart and vascular diseases

The recommended dose is 40 mg of pravastatin once daily, preferably in the evening.

After transplantation

The recommended dose is 20 mg of pravastatin once daily. The dose may be adjusted up to 40 mg of pravastatin. Your doctor will tell you which dose to take.

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

The recommended dose is 10–20 mg of pravastatin once daily in children aged 8–13 years and 10–40 mg of pravastatin once daily in adolescents aged 14–18 years.

Elderly patients

No dose adjustment is required for this group. The same dose as in adult patients may be used. Your doctor will tell you which dose to take.

Dose adjustment in renal or hepatic impairment

The usual dose is 10 mg of pravastatin once daily, but it may be higher. Your doctor will tell you which dose to take.

Use with other medicines

If you are taking pravastatin together with other medicines containing cholestyramine or colestipol (medicines also used to treat high cholesterol levels), pravastatin should be taken at least one hour before or four hours after taking these medicines.

If you are also taking a medicine that suppresses the immune system (cyclosporine), your doctor may prescribe an initial dose of 20 mg of pravastatin once daily. The dose may be adjusted by your doctor up to 40 mg. Your doctor will tell you which dose to take.

Take pravastatin once daily, preferably in the evening, with or without food. Swallow the tablets with sufficient liquid (e.g., a glass of water).

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

Your doctor will determine how long you should be treated with pravastatin. This depends on the type of disease for which you are taking this medicine.

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

If you take more Pravastatin Viatris than you should

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately, or call the Toxicology Information Service at 91 562 04 20 (indicating the medicine and the amount taken).

If you forget to take Pravastatina Viatris

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

If you stop taking Pravastatina Viatris

Take pravastatin for as long as your doctor has prescribed. If you stop taking pravastatin, your cholesterol levels may rise again.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects.

Contact your doctor immediately if you develop any of the following adverse effects while taking pravastatin:

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

• Hypersensitivity reactions:
  • Severe allergic reaction causing swelling of the face, lips, throat, or tongue, and excessive fluid accumulation in the body, which may cause difficulty swallowing or breathing (angioedema, anaphylaxis).
  • Skin rash, possibly with joint pain (pseudolupus erythematosus).
• Breakdown of muscle fibers (rhabdomyolysis), which may be associated with acute kidney failure (see also section 2, “What you need to know before taking Pravastatin Viatris”), inflammation of a muscle or multiple muscles (myositis/polymyositis). This may cause muscle pain, muscle weakness not due to exercise, reduced urine output, darkening of the urine, and increased creatine kinase levels observed in blood tests. Presence of myoglobin in the urine observed in urine tests (myoglobinuria).
• Serious liver problems, including yellowing of the skin or eyes (jaundice), body tissues and fluids, inflammation of the liver (hepatitis), rapid and sudden destruction of liver tissue (fulminant hepatic necrosis). This may cause nausea or vomiting, loss of appetite, general malaise, fever, skin itching, dark urine, or pale stools.
• Inflammation of the pancreas. This causes moderate to severe stomach pain spreading to the back (pancreatitis).
• Sensory disturbances, including burning sensation/tingling, numbness, or tingling (paraesthesia); this may be a sign of nerve ending damage (peripheral neuropathy).
• Disease 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 levels of sugar or fat in your blood, 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).
• Persistent muscle weakness (immune-mediated necrotizing myopathy).
• Myasthenia gravis (a disease causing generalized muscle weakness which, in some cases, affects the muscles used for breathing).
• Ocular myasthenia (a disease causing weakness of the eye muscles).
• Muscle strains, tears, and ruptures.

Consult your doctor if you experience worsening weakness in the arms or legs after periods of activity, double vision or drooping eyelids, difficulty swallowing, or difficulty breathing.

Other possible adverse effects could include:

Common (may affect up to 1 in 10 people)

• Joint pain (arthralgia).
• Increased production of liver enzymes (observed in blood tests).

Uncommon (may affect up to 1 in 100 people)

• Dizziness, headache, sleep disorders, difficulty sleeping.
• Vision problems, blurred vision, or double vision.
• Digestive problems or slow digestion, indigestion/heartburn, abdominal pain, feeling unwell/nausea or vomiting, difficulty or delay in intestinal emptying, diarrhea, flatulence.
• Itching, rash, urticaria, scalp and hair problems (including hair loss).
• Abnormal urination, for example, pain, frequency, or frequent urination during the night.
• Problems with sexual function.
• Fatigue.
• Inflamed tendons, sometimes associated with tearing.

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

• Increased sensitivity to light (photosensitivity).

The following adverse effects have been observed with other medicines similar to pravastatin and may also occur with this medicine.

Frequency not known (cannot be estimated from available data)

• Nightmares.
• Memory loss.
• Depression.

Reporting of adverse effects:

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

5. Storage of Pravastatin Viatris

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

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.

Store in the original packaging to protect from moisture.

Medicines must not be disposed of via wastewater or household waste. Any unused medicines and waste materials, including packaging, should be returned to the SIGRE point at your pharmacy. If you are unsure how to dispose of unused medicines or their packaging, please consult your pharmacist. This will help protect the environment.

6. Contents of the pack and other information

Composition of Pravastatin Viatris

• The active substance is pravastatin sodium. Each tablet contains 20 mg of pravastatin sodium.
• The other components are: monohydrate lactose (see section 2 “Pravastatin Viatris contains lactose”), sodium dihydroxyaluminium carbonate, sodium stearyl fumarate, yellow iron oxide (E172).

Appearance of the product and contents of the pack

Yellow, mottled, round tablets, marked with the inscription "20" on one side and a score line on the other. The tablet may be divided into two equal parts.

Pravastatin Viatris is available in packs of 10, 14, 20, 28, 30, 50, 60, 84, 90, 98 or 100 tablets.

Only certain pack sizes may be commercially available.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Viatris Limited

Damastown Industrial Park

Mulhuddart, Dublin 15

Dublin

Ireland

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

Further information on this medicinal product is available from the local representative of the Marketing Authorization Holder:

Viatris Pharmaceuticals, S.L.U.

C/ General Aranaz, 86

28027 - Madrid

Spain

This medicinal product is authorized in the European Economic Area member states under the following names:

Belgium Pravastatine Viatris 20 mg tabletten

Spain Pravastatina Viatris 20 mg comprimidos EFG

France Pravastatine Mylan Pharma 20 mg comprime sécable

Netherlands Pravastatinenatrium Mylan 20 mg tabletten

Ireland Pravastatin Mylan 20 mg Tablets

Italy Pravastatina Mylan 20 mg compresse

Portugal Pravastatina Mylan

United Kingdom Pravastatin Sodium 20 mg Tablets

Date of the most recent review of this leaflet: July 2024

Detailed information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) https://www.aemps.gob.es/