Pravastatin Cinfamed 40 mg tablets EFG

Package leaflet: Information for the user

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

PRAVASTATIN CINFAMED 40 mg FILM-COATED TABLETS EFG

sodium pravastatin

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet. 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. Do not pass it on to other people, even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, talk to your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Leaflet contents

1. What pravastatin cinfamed 40 mg is and what it is used for
2. What you need to know before taking pravastatin cinfamed 40 mg
3. How to take pravastatin cinfamed 40 mg
4. Possible side effects
5. How to store pravastatin cinfamed 40 mg
6. Contents of the pack and other information

1. What pravastatina cinfamed 40 mg is and what it is used for

pravastatina cinfamed 40 mg belongs to a group of medicines called statins (or HMG-CoA reductase inhibitors). It prevents the liver from producing cholesterol and thereby reduces the 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 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 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 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 activity), pravastatina cinfamed is indicated to reduce the risk of developing heart and vascular problems and reduces 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 a transplanted organ and are taking medication to prevent transplant rejection, pravastatina cinfamed 40 mg reduces the elevated fat levels that may occur after transplantation.

2. What you need to know before taking pravastatin cinfamed 40 mg

Do not take pravastatin cinfamed 40 mg:

• If you are allergic to pravastatin sodium or to any of the other ingredients of pravastatin cinfamed 40 mg (see section “Additional information”).
• If you have liver problems (active liver disease).
• If you are pregnant, think you might be pregnant, or are breastfeeding (see section “Pregnancy and breastfeeding”).
• If repeated blood tests have shown abnormal liver function (elevated liver enzymes in the blood).

Warnings and precautions

Talk to your doctor or pharmacist before starting pravastatin cinfamed:

• If you have kidney failure.
• If you have underactive thyroid (hypothyroidism).
• If you have a history of liver disease.
• If you have problems related to excessive alcohol consumption.
• If you have muscle disorders or a family history of such conditions.
• If you have experienced adverse muscle 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 or treatments may be needed to diagnose and manage this condition.
• If you are taking or have taken within the last 7 days a medicine containing fusidic acid (used to treat bacterial infection) by mouth or by injection. The combination of fusidic acid and pravastatin may cause serious muscle problems (rhabdomyolysis).

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 disease causing weakness of the eye muscles), since 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 of age, your doctor may recommend a blood test to assess your muscle status before 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, or have high blood pressure.

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

Children

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

Taking other medicines and Pravastatin 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 pravastatin cinfamed 40 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): pravastatin cinfamed 40 mg tablets should be taken at least one hour before or four hours after taking the resin. This is because the resin may interfere with the absorption of pravastatin if both medicines are taken at the same time.
• Warfarin and other oral anticoagulants (oral anticoagulants that prevent blood clots).
• Certain medicines metabolized by cytochrome P450 in the liver (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 using vitamin K antagonists together 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 will need to stop taking this medicine. Your doctor will advise you when you can restart pravastatin treatment. Taking pravastatin with fusidic acid may cause muscle weakness, tenderness, or pain (rhabdomyolysis). For more 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 pravastatin cinfamed 40 mg with food and drinks:

• pravastatin cinfamed 40 mg can be taken with or without food and with or without drinks.
• You should always minimize your alcohol consumption. If you have any doubts about how much alcohol you can drink while taking this medicine, consult your doctor.

Pregnancy and breastfeeding:

Consult your doctor or pharmacist before taking any medicine.

Do not take pravastatin cinfamed 40 mg if you are pregnant, trying to become pregnant, or think you might be pregnant, as safety in pregnant women has not been established. If you become pregnant or suspect pregnancy, stop treatment immediately and inform your doctor.

pravastatin cinfamed 40 mg must not be used during breastfeeding, as it passes into breast milk.

Driving and using machines:

At normal doses, pravastatin cinfamed 40 mg does not affect the ability to drive or operate machinery. However, if you experience dizziness, do not drive or use machines until you know how the medicine affects you.

Important information about some of the ingredients of pravastatin cinfamed 40 mg:

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

3. How to take pravastatin cinfamed 40 mg

Follow exactly the instructions for use of pravastatin cinfamed 40 mg provided by your doctor. If you have any doubts, consult your doctor or pharmacist.

Your doctor will inform you of how long you should take pravastatin cinfamed 40 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 blood 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 best suited to 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 to 40 mg once daily.

Transplant patients:

Your doctor may recommend an initial dose of 20 mg daily. 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 daily. 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 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 inform you of the duration of treatment with pravastatin cinfamed. You must take this medicine regularly and for the length of time prescribed by your doctor, even if this seems long. Do not stop treatment on your own.

If you take more pravastatin cinfamed 40 mg than you should:

If you take more pravastatin cinfamed 40 mg than prescribed by your doctor, or if someone accidentally takes your medicine, contact the emergency department of the nearest hospital. Remember to bring the remaining tablets or empty packaging with you to assist identification.

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 ingested.

If you forget to take pravastatin cinfamed 40 mg:

Do not take a double dose to make up for missed doses. 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 40 mg can cause adverse effects, although not everyone will experience 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 difficulty breathing.
• 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), myositis (muscle inflammation), myopathy (muscle disease), or 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 nerve damage (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 (myositis, polymyositis, or dermatomyositis); muscle pain or weakness, tendon inflammation that may progress and lead to tendon ruptures.
• Chronic autoimmune inflammatory disorder (a disease occurring when the body's own immune system attacks tissues), characterized by chronic skin changes (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, acid reflux, 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, which in some cases affects muscles used for breathing).
• Ocular myasthenia (a disease causing weakness of the 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 (interruptions in breathing), 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 levels of blood sugar and fats, 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 type of adverse effect, consult your doctor or pharmacist, even if they are possible adverse effects not listed in this leaflet. You may 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 40 mg

• Keep out of the reach and sight of children.
• Store below 25°C. Keep in the original container to protect it from light and moisture.
• Do not use pravastatin cinfamed 40 mg after the expiry date stated on the packaging and on the blister strip after “EXP”. The expiry date refers to the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Dispose of unused medicines and their packaging at the SIGRE point located 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 pravastatin cinfamed 40 mg:

The active substance is pravastatin sodium. Pravastatin cinfamed 40 mg tablets contain 40 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 40 mg tablets are yellow, rectangular-shaped with rounded edges, biconvex, uncoated, with the initials “PDT” engraved on one side and the number “40” engraved on the other side.

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 European Union Member States under the following names:

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

Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency for 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 package leaflet and outer packaging. You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/70156/P_70156.html

QR code to: https://cima.aemps.es/cima/dochtml/p/70156/P_70156.html