Pravastatin Aurovitas 10 mg tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the user

Pravastatina Aurovitas 10 mg tablets EFG

Sodium pravastatin

Read the entire leaflet carefully before you start taking this medicine, because 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 only, and you should not give it to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Contents of the leaflet

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

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

Pravastatin belongs to a group of medicines known as statins (or HMG-CoA reductase inhibitors). It prevents the liver from producing cholesterol and thereby reduces cholesterol and other fat (triglyceride) levels 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 may lead to:

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

This medicine is indicated in three situations:

Treatment of high levels of cholesterol and fats in the blood

Pravastatin is used 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 levels or hypertension, or lack of physical activity), pravastatin is used to reduce the risk of developing heart and blood vessel problems and to reduce the risk of dying from these conditions.
• If you have already had a stroke or suffer from chest pain (unstable angina), pravastatin is used, even if your cholesterol levels are normal, to reduce the risk of future heart attacks or strokes and to reduce the risk of death from these conditions.

After organ transplantation

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

2. What you need to know before starting to take Pravastatin Aurovitas

Do not take Pravastatin Aurovitas

• if you are allergic to pravastatin or to any of the other ingredients of this medicine (listed in section 6).
• if you are pregnant, trying to become pregnant, or breastfeeding (see Pregnancy and Breastfeeding).
• if you have any liver disease (active liver disease).
• if repeated blood tests show abnormal liver function (elevated levels of liver enzymes in the blood).

Warnings and precautions

Consult your doctor or pharmacist before starting this medicine if:

Before taking this medicine, you should consult your doctor if you have or have had any of the following medical conditions:

• kidney disease.
• hypothyroidism.
• liver disease or problems related to alcohol (drinking large amounts of alcohol).
• muscle disorders caused by an inherited disease.
• muscle problems caused by another medicine belonging to the group of statins (HMG-CoA reductase inhibitor medicines) or to the group known as fibrates (see Taking Pravastatin Aurovitas with other medicines).

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 perform blood tests after starting treatment with pravastatin to monitor 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 an oral or injectable medicine containing fusidic acid (used to treat bacterial infection), the combination of fusidic acid and pravastatin may cause serious muscle problems (rhabdomyolysis).

If you have experienced any of these problems, or if you are over 70 years old, your doctor will perform blood tests before and probably during treatment. These blood tests will be used to assess your risk of developing adverse muscle effects.

If you experience unexplained cramps or muscle pain during treatment, inform your doctor immediately.

If you have diabetes or are at risk of developing it, your doctor will carefully monitor you during treatment with this medicine. You may be at risk of developing diabetes if you have high levels of sugar and fats in the blood, are overweight, or have hypertension.

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.

Consult your doctor before taking pravastatin:

• if you have or have had myasthenia (a disease characterized by generalized muscle weakness that, in some cases, affects the muscles used for breathing) or ocular myasthenia (a disease causing weakness of the eye muscles), as statins may sometimes worsen the condition or trigger the onset of myasthenia (see section 4).

Consult your doctor or pharmacist before taking Pravastatin Aurovitas if you:

• have severe respiratory insufficiency.

Taking Pravastatin Aurovitas with other medicines

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

Taking pravastatin together with any of the following medicines may increase the risk of muscle problems:

• a medicine that lowers blood cholesterol levels (fibrates, e.g. gemfibrozil, fenofibrate).
• a medicine that suppresses the body's immune defenses (cyclosporine).
• a medicine used to treat bacterial infections (an antibiotic such as erythromycin or clarithromycin).
• if you need to take oral fusidic acid to treat a bacterial infection, you must temporarily stop taking this medicine. Your doctor will advise you when it is safe to restart pravastatin treatment. Using pravastatin with fusidic acid may rarely cause muscle weakness, tenderness, or pain (rhabdomyolysis). For more information on rhabdomyolysis, see section 4.
• colchicine (used to treat gout).
• nicotinic acid (used to treat high blood cholesterol).
• rifampicin (used to treat the infection called tuberculosis).
• lenalidomide (used to treat a type of blood cancer called multiple myeloma).

If you are also taking a medicine to lower fat levels in your blood (a resin-type such as cholestyramine or colestipol), this medicine should be taken at least one hour before or four hours after taking the resin. This is because the resin may affect the absorption of pravastatin if both medicines are taken simultaneously.

Taking Pravastatin Aurovitas with food, drinks, and alcohol

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

You should minimize your alcohol consumption. If you have any doubts about how much alcohol you can drink while taking this medicine, consult your doctor.

Pregnancy, breastfeeding, and fertility

Pregnancy

Do not take pravastatin during pregnancy. If you discover you are pregnant, inform your doctor immediately. Consult your doctor or pharmacist before using any medicine.

Breastfeeding

Pravastatin must not be administered during breastfeeding, as this medicine passes into breast milk.

Driving and using machines

Generally, pravastatin does not affect the ability to drive or operate machinery. However, if you experience dizziness, blurred vision, or double vision during treatment, do not drive or operate machinery until you are certain you are fit to do so.

Pravastatin Aurovitas contains lactose

This medicine contains lactose. If your doctor has informed you of an intolerance to certain sugars, consult him before taking this medicine.

Pravastatin Aurovitas contains sodium

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

3. How to take Pravastatin Aurovitas

Your doctor will advise you to follow a low-fat diet, which you should maintain throughout your treatment.

Always follow exactly the instructions provided by your doctor or pharmacist for taking this medicine. If in doubt, consult your doctor or pharmacist again.

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

Dosage

Adults:

• For the treatment of high levels of cholesterol and fat in the blood: the usual dose is 10–40 mg once daily, preferably taken at night.
• For the prevention of heart and blood vessel diseases: the usual dose is 40 mg once daily, preferably taken at night.

The maximum daily dose of 40 mg of pravastatin must not be exceeded. Your doctor will determine the appropriate dose for you.

Children (8–13 years) and adolescents (14–18 years) with an inherited condition causing high blood cholesterol levels:

The recommended dose for children aged 8 to 13 years is 10–20 mg once daily. The recommended dose for adolescents aged 14 to 18 years is 10–40 mg once daily.

After organ transplantation:

Your doctor may prescribe an initial dose of 20 mg once daily. Your doctor may adjust the dose up to 40 mg.

If you are also taking a medicine that suppresses the body's immune system (cyclosporine), your doctor may prescribe an initial dose of 20 mg once daily. This dose may be adjusted by your doctor up to 40 mg.

If you have kidney disease or severe liver disease, your doctor may prescribe a lower dose of pravastatin.

If you feel the effect of this treatment is too strong or too weak, inform your doctor or pharmacist.

Duration of treatment

Your doctor will determine how long you should take pravastatin. This medicine should be taken regularly for as long as your doctor recommends, even if this is for a prolonged period. Do not stop treatment prematurely on your own.

If you take more Pravastatin Aurovitas than you should

If you have taken more pravastatin than prescribed, or if someone accidentally swallowed some tablets, contact your doctor, pharmacist, or nearest hospital.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately, or call the Toxicology Information Service at 91 562 04 20, stating the name of the medicine and the amount ingested.

If you forget to take Pravastatin Aurovitas

If you forget to take a dose, simply take your next dose at the usual scheduled time.

Do not take a double dose to make up for a missed dose.

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, although not everyone will experience them.

Stop taking pravastatin and contact your doctor immediately if you experience unexplained or persistent muscle pain, tenderness, weakness, or cramps, especially if you also feel unwell or have a fever.

In very rare cases, muscle problems can be serious (rhabdomyolysis) and may lead to kidney disease that can be life-threatening.

Severe and sudden allergic reactions, such as swelling of the face, lips, tongue, or trachea, may cause serious breathing difficulties. This is a very rare but potentially serious reaction. You must inform your doctor immediately if this occurs.

The following adverse effects are uncommon and may affect up to 1 in 100 people:

• Effects on the nervous system: dizziness, fatigue, headache, sleep disorders including insomnia.
• Effects on vision: blurred vision or double vision.
• Gastrointestinal effects: indigestion, nausea, vomiting, stomach pain or discomfort, diarrhea, constipation, and flatulence.
• Effects on the skin and hair: itching, acne, skin rash, hair and scalp problems (including hair loss).
• Urinary and genital effects: bladder problems (such as pain when urinating, increased frequency of urination, or nocturia) and sexual problems.
• Effects on muscles and joints: muscle and joint pain.

The following adverse effects are rare and may affect up to 1 in 1,000 people:

• Increased skin sensitivity to sunlight.

The following adverse effects are very rare and may affect up to 1 in 10,000 people:

• Effects on the nervous system: disturbances in the sense of touch, including sensations of burning, tingling, or numbness, which could indicate nerve damage.
• Effects on the skin: a serious skin disorder (lupus-like syndrome).
• Effects on the liver: inflammation of the liver or pancreas, jaundice (recognized by yellowing of the skin and whites of the eyes), very rapid destruction of liver cells (fulminant hepatic necrosis).
• Effects on muscles and bones: inflammation of one or more muscles causing muscle pain or weakness (myositis, polymyositis, or dermatomyositis), muscle pain or weakness, inflammation of tendons, which may lead to rupture.
• Abnormal blood test results: increased transaminases (a group of enzymes naturally present in the blood), which may indicate liver problems. Your doctor may wish to perform periodic blood tests to monitor this.

If you consider any of the adverse effects you experience to be severe, or if you notice any adverse effects not listed in this leaflet, inform your doctor or pharmacist.

Possible adverse effects

• Nightmares.
• Memory loss.
• Depression.
• Respiratory problems including persistent cough and/or difficulty breathing or fever.
• Diabetes. This is more likely if you have high levels of sugars and fats in the blood, are overweight, and have high blood pressure. Your doctor will monitor you while you are taking this medicine.

Adverse effects with unknown frequency (cannot be estimated from available data):

• Ongoing muscle weakness, liver failure.
• Muscle rupture.
  • Myasthenia gravis (a disease causing generalized muscle weakness that, in some cases, affects the muscles used for breathing).

Ocular myasthenia (a disease causing weakness of the eye muscles).

Consult your doctor if you experience arm or leg weakness that worsens after periods of activity, double vision or drooping eyelids, difficulty swallowing, or difficulty breathing.

Reporting of adverse effects

If you experience any type of adverse effect, consult 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 Medicinal Products: www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Pravastatin Aurovitas

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 outer packaging and on the blister 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. Dispose of packaging and unused or expired medicines at the SIGRE collection point at your pharmacy. Ask your pharmacist how to properly dispose of packaging and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Pravastatin Aurovitas

• The active substance is pravastatin sodium. Each tablet contains 10 mg of pravastatin sodium.
• The other components are: microcrystalline cellulose, lactose monohydrate, heavy magnesium oxide, sodium croscarmellose, yellow iron oxide (E172), povidone K30, magnesium stearate.

Appearance of the product and contents of the pack

Uncoated yellow capsule-shaped biconvex tablets, mottled, scored on both sides, marked with "Y" on one side and "60" on the other. The tablet can be divided into equal doses.

Pravastatin Aurovitas is available in blister packs containing 20, 28, 30, 60 and 98 tablets.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16-D

28036 Madrid

Spain

Manufacturer:

APL Swift Services (Malta) Limited

HF26, Hal Far Industrial Estate, Hal Far

Birzebbugia, BBG 3000

Malta

or

Generis Farmacêutica, S.A.

Rua João de Deus, nº 19, Venda Nova

2700-487 Amadora

Portugal

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

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

Detailed 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/).