Pravastatin Cinfamed 20 mg tablets EFG

Package Leaflet: Information for the User

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

PRAVASTATIN CINFAMED 20 mg TABLETS EFG

Pravastatin Sodium

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 only, and you should not give it to others, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Leaflet Contents

1. What pravastatin cinfamed 20 mg is and what it is used for
2. What you need to know before taking pravastatin cinfamed 20 mg
3. How to take pravastatin cinfamed 20 mg
4. Possible adverse effects
5. How to store pravastatin cinfamed 20 mg
6. Contents of the pack and other information

1. What pravastatina cinfamed 20 mg is and what it is used for

pravastatina cinfamed 20 mg belongs to a group of medicines called statins (or HMG-CoA reductase inhibitors). It prevents the liver from producing cholesterol and consequently reduces the levels of cholesterol and other fats (triglycerides) in your body. When excessive levels of cholesterol are present 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 pectoris) 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 (cerebrovascular accident) when a blood vessel in 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 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 hypertension, or lack of physical exercise), pravastatina cinfamed is indicated 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 heart attack or unstable angina (chest pain), and have normal cholesterol levels, sodium pravastatin reduces the risk of these problems recurring in the future.

After organ transplantation:

If you have received a transplanted organ and are taking medication to prevent transplant rejection, pravastatina cinfamed 20 mg reduces elevated fat levels that may occur after transplantation.

2. What you need to know before taking pravastatina cinfamed 20 mg

Do not take pravastatina cinfamed 20 mg:

• If you are allergic to pravastatin sodium or to any of the other components of pravastatina cinfamed 20 mg (see section “Additional information”).
• If you have liver problems (active liver disease).
• If you are pregnant, think you may be pregnant, or are breastfeeding (see section “Pregnancy and breastfeeding”).
• If repeated blood tests have shown abnormal liver function (elevated liver enzyme levels in the blood).

Warnings and precautions

Talk to your doctor or pharmacist before starting pravastatina cinfamed

• If you have kidney failure.

• If you have poor thyroid function (hypothyroidism).

• If you have a history of liver disease.

• If you have problems with excessive alcohol consumption.

• If you have muscle disorders or a family history of muscle disorders.

• If you have experienced muscle-related side effects when taking other cholesterol-lowering medicines, such as a statin or a fibrate.

• 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.

• 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 or have had myasthenia gravis (a disease characterized by generalized muscle weakness, which 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).

If you are in any of the above situations or are over 70 years old, your doctor may recommend a blood test to assess your muscle status before starting and during treatment.

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

While taking this medicine, your doctor will closely monitor whether you have developed or are at risk of developing diabetes. The risk of developing diabetes is higher if you have high levels of sugar and fats in the blood, are overweight, and have high blood pressure.

Talk to your doctor or pharmacist before starting treatment with pravastatin if you have severe respiratory failure.

Children

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

Taking other medicines and Pravastatina cinfamed tablets:

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

If you are already taking any of the following medicines, consult your doctor before starting pravastatina cinfamed 20 mg, as the combination may increase the risk of muscle problems:

• Gemfibrozil, fenofibrate, or nicotinic acid (used to lower cholesterol levels in the blood).
• Cyclosporine (used to suppress the immune system and prevent transplant rejection).
• Erythromycin or clarithromycin (antibiotics).
• Cholestyramine or colestipol (resins used to reduce cholesterol levels in the blood): pravastatina cinfamed 20 mg tablets 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 at the same time.
• Warfarin and other oral anticoagulants (oral anticoagulants that prevent blood clot formation).
• Certain medicines metabolized by liver cytochrome P450 (diltiazem, verapamil, itraconazole, ketoconazole, protease inhibitors, and CYP2C9 enzyme inhibitors such as fluconazole).
• If you are taking a medicine used to treat and prevent blood clots called a vitamin K antagonist, consult your doctor before taking pravastatin, as concomitant use of vitamin K antagonists with pravastatin may increase the results of blood tests used to monitor vitamin K antagonist therapy.
• If you need to take oral fusidic acid to treat a bacterial infection, you must stop taking this medicine. Your doctor will tell you when you can restart treatment with pravastatin. Taking pravastatin with fusidic acid may cause muscle weakness, tenderness, or pain (rhabdomyolysis). For further information on rhabdomyolysis, see section 4.
• Colchicine (used to treat gout).
• Rifampicin (used to treat an infection called tuberculosis).
• Lenalidomide (used to treat a type of blood cancer called multiple myeloma).

Taking pravastatina cinfamed 20 mg with food and drink:

• pravastatina cinfamed 20 mg can be taken with or without food and with or without drinks.
• You should always minimize alcohol consumption. If you have any doubts about how much alcohol you can drink while taking this medicine, consult your doctor.

Pregnancy and breastfeeding:

Talk to your doctor or pharmacist before taking any medicine.

Do not take pravastatina cinfamed 20 mg if you are pregnant, trying to become pregnant, or think you may be pregnant, as safety in pregnant women has not been established. If you become pregnant or suspect pregnancy, you must stop treatment and inform your doctor immediately.

pravastatina cinfamed 20 mg must not be administered during breastfeeding, as it passes into breast milk.

Driving and using machines:

At normal doses, pravastatina cinfamed 20 mg does not affect the ability to drive or use machines. However, if you experience symptoms of dizziness, do not drive or use machines until you know how you react to the medicine.

Important information about some of the components of pravastatina cinfamed 20 mg:

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

3. How to take pravastatin cinfamed 20 mg

Follow exactly the administration instructions for pravastatin cinfamed 20 mg given by your doctor. Consult your doctor or pharmacist if you have any doubts.

Your doctor will indicate how long you should take pravastatin cinfamed 20 mg. Do not stop treatment prematurely.

The tablets should be swallowed with a glass of water and may be taken with or without food, preferably at night.

Your doctor will recommend that you follow a low-fat diet throughout your treatment.

Adults and adolescents (14–18 years):

For the treatment of elevated cholesterol and other fats: The usual dose is 10 to 40 mg once daily, preferably at night.

For the prevention of heart and blood vessel diseases: The usual dose is 40 mg once daily, preferably at night.

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

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

For children aged 8 to 13 years, the usual dose is 10 to 20 mg once daily; for adolescents aged 14 to 18 years, the usual dose is 10–40 mg once daily.

Transplant patients:

Your doctor may recommend an initial dose of 20 mg per day. The dose may need to be adjusted upward to 40 mg, according to your doctor's judgment.

If you are also taking a treatment used to suppress the immune system (cyclosporine), your doctor may prescribe an initial dose of 20 mg per day. The dose may need to be adjusted upward to 40 mg, according to your doctor's judgment.

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

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

Duration of treatment:

Your doctor will indicate how long you should take pravastatin cinfamed. You must take this medicine regularly and for the duration prescribed by your doctor, even if you consider it to be a long time. Do not stop treatment on your own.

If you take more pravastatin cinfamed 20 mg than you should:

If you take more pravastatin cinfamed 20 mg than your doctor has prescribed, or if someone accidentally takes your medicine, contact the emergency department of the nearest hospital. Remember to bring any remaining tablets or the empty packaging to assist with identification.

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

If you forget to take pravastatin cinfamed 20 mg:

Do not take a double dose to make up for a missed dose. Take the next dose at the usual time and continue your treatment as prescribed.

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

4. Possible adverse effects

Like all medicines, pravastatin cinfamed 20 mg can cause adverse effects, although not everyone experiences them.

You must stop taking pravastatin and contact your doctor immediately if you experience symptoms such as:

• Hypersensitivity reactions (angioedema, anaphylaxis): signs of an allergic reaction such as swelling of the face, lips, tongue, and trachea, which may cause breathing difficulties.
• Rarely, some patients have developed muscle breakdown or inflammation, and very rarely this progresses to a very serious condition (called rhabdomyolysis). Acute renal failure secondary to myoglobinuria (presence of myoglobin in urine), miositis (muscle inflammation), myopathy (muscle disease), and polymyositis (chronic muscle inflammation) may be associated with rhabdomyolysis. If you experience unexplained muscle pain, tenderness, or weakness, and especially if you also feel unwell or have a fever, stop taking pravastatin cinfamed and contact your doctor immediately.

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

• Pancreatitis (inflammation of the pancreas).
• Sensory disturbances (burning sensation, tingling, or numbness [paresthesia]), which may indicate damage to nerve endings (peripheral neuropathy).
• Yellowing of the skin, tissues, or body fluids (jaundice).
• Hepatitis (liver inflammation) or acute liver failure.
• Inflammation of one or more muscles causing muscle pain or weakness (miositis, polymiositis, or dermatomyositis); muscle pain or weakness, tendon inflammation which may become complicated and lead to tendon ruptures.
• Chronic autoimmune inflammatory disorder (a disease occurring when tissues are attacked by the body's own immune system), characterized by chronic skin disorders (signs of systemic lupus erythematosus-type reaction).
• Elevations in liver transaminases (enzymes indicative of liver disease). Your doctor may consider periodic blood tests necessary to monitor this.

Uncommon adverse effects (may affect up to 1 in 100 patients):

• Dizziness, headache, sleep disorders (including insomnia), eye disorders (including blurred vision or double vision), indigestion, stomach acidity, abdominal pain, nausea, vomiting, constipation, diarrhea, flatulence, skin reactions (itching, acne, urticaria, and skin rash), hair and scalp abnormalities (including hair loss), urinary disturbances (such as difficulty or pain during urination, increased frequency of urination at night), sexual difficulties, fatigue (tiredness).

Rare adverse effects (may affect up to 1 in 1,000 patients):

• Skin sensitivity to sunlight

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

• Persistent muscle weakness
• Liver failure
• Myasthenia gravis (a disease causing generalized muscle weakness that, in some cases, affects muscles used for breathing).
• Ocular myasthenia (a disease causing weakness of eye muscles).
• Muscle rupture.

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

Possible side effects:

• Nightmares
• Memory loss
• Depression
• Respiratory problems, including persistent cough, apnea (breathing pauses), or fever
• Dermatomyositis (a condition characterized by inflammation of muscles and skin)
• Diabetes mellitus: Frequency depends on the presence or absence of risk factors (fasting blood glucose ≥5.6 mmol/L, BMI >30 kg/m², elevated triglycerides, history of hypertension). It is more likely 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 adverse effects

If you experience any 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 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 cinfamed 20 mg

• Keep out of the reach and sight of children.
• Store below 25°C. Keep in the original packaging to protect from light and moisture.
• Do not use pravastatin cinfamed 20 mg after the expiry date stated on the packaging and on the blister strip following "EXP". The expiry date refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Additional Information

Composition of pravastatina cinfamed 20 mg:

The active substance is pravastatin sodium. Pravastatina cinfamed 20 mg tablets contain 20 mg of pravastatin sodium.

The other components are: microcelac 100, lactose monohydrate, light magnesium oxide, sodium croscarmellose, yellow iron oxide (E172), povidone K-30 and magnesium stearate.

Appearance of the product and contents of the pack:

Pravastatin sodium 20 mg tablets are yellow, rectangular-shaped with rounded edges, biconvex, film-coated-free tablets, engraved with the initials “PDT” on one side and the number “20” on the other.

Pravastatin sodium tablets are packed in blister strips and available in packs of 28 tablets.

Marketing Authorization Holder and Manufacturer:

Marketing Authorization Holder

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10 Polígono Industrial Areta

31620 Huarte (Navarra) – Spain

Manufacturer:

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10 Polígono Industrial Areta

31620 Huarte (Navarra) – Spain

or

Accord Healthcare Polska Sp.z o.o.,

ul. Lutomierska 50,95-200 Pabianice, Poland

or

Accord Healthcare Single Member S.A.

64th Km National Road Athens,

Lamia, Schimatari, 32009, Greece

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

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

Detailed and up-to-date information about this medicine is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/

You can access detailed and up-to-date information about this medicine by scanning with your mobile phone (smartphone) the QR code included in the leaflet and packaging. You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/70154/P_70154.html

QR code to: https://cima.aemps.es/cima/dochtml/p/70154/P_70154.html