PRAVASTATIN CINFAMED 40 mg TABLETS

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

pravastatin cinfamed 40 mg belongs to a group of medicines called statins (or HMG-CoA reductase inhibitors). It prevents the production of cholesterol by the liver and as a consequence 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 the blood vessels, blocking them.

This disease is known as hardening of the arteries or arteriosclerosis, and can 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 of the brain is completely blocked

This medicine is indicated in three situations:

In the treatment of high levels of cholesterol and fats in the blood.

Pravastatin is indicated to decrease high levels of "bad" cholesterol and increase levels of "good" cholesterol in the blood when diet and exercise have not been effective.

The 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 levels of sugar in the blood or high blood pressure, or do little exercise), pravastatin cinfamed is indicated to reduce the risk of you suffering from a heart or blood vessel problem and decreases the risk of dying from these diseases.

• If you have already suffered a heart attack or unstable angina (chest pain), and have normal levels of cholesterol, pravastatin sodium reduces the risk of these problems recurring in the future.

After an organ transplant:

If you have a transplanted organ and are taking medication to prevent transplant rejection, pravastatin cinfamed 40 mg reduces increased fat levels after the transplant.

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

Do not take pravastatin cinfamed 40 mg:

• If you are allergic to pravastatin sodium or any of the other ingredients of pravastatin cinfamed 40 mg (see the section on "Further information").
• If you have liver problems (active liver disease).
• If you are pregnant, may be pregnant or are breastfeeding (see the section on "Pregnancy and breastfeeding").
• If several blood tests have shown abnormal liver function (elevated liver enzymes in the blood).

Warnings and precautions

Consult your doctor or pharmacist before starting to take pravastatin 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.
• If you have had muscle side effects when taking other cholesterol-lowering medications, such as a statin or a fibrate.
• Also, inform your doctor or pharmacist if you experience constant muscle weakness. Additional tests and medications may be necessary to diagnose and treat this problem.
• If you are taking or have taken in the last 7 days a medication that contains fusidic acid (used to treat bacterial infections) orally or by injection. The combination of fusidic acid and pravastatin can cause serious muscle problems (rhabdomyolysis).

If you have or have had myasthenia (a disease that causes generalized muscle weakness that, in some cases, affects the muscles used for breathing) or ocular myasthenia (a disease that causes weakness of the eye muscles), as statins can sometimes worsen the disease or cause myasthenia to appear (see section 4).

If you are in any of the above situations or are over 70 years old, your doctor will recommend that you have a blood test to determine the condition of your muscles before starting treatment and during treatment.

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

While taking this medication, your doctor will closely monitor you for the development of diabetes. It is likely that there is a risk of developing diabetes if you have high levels of sugar and fat in the blood, are overweight, and have high blood pressure.

Consult 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 old.

Use of other medicines and Pravastatin cinfamed tablets:

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

If you are already taking any of the following medications, consult your doctor before starting to take 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).
• Cyclosporin (used to inhibit 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 1 hour before or 4 hours after taking the resin. This is because the resin can affect the absorption of pravastatin if these two medications are taken simultaneously.
• Warfarin and other oral anticoagulants (oral anticoagulants that prevent blood clot formation).
• Certain medications 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 medication used to treat and prevent blood clot formation called a vitamin K antagonist, consult your doctor before taking pravastatin because the use of vitamin K antagonists concomitantly with pravastatin may increase the results of blood tests used to monitor treatment with vitamin K antagonists.
• If you need to take oral fusidic acid to treat a bacterial infection, you will need to stop using this medication. Your doctor will tell you when you can restart treatment with pravastatin. The use of pravastatin with fusidic acid can cause muscle weakness, sensitivity, or pain (rhabdomyolysis). For more information on rhabdomyolysis, see section 4.
• Colchicine (used to treat gout).
• Rifampicin (used to treat 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 keep your alcohol consumption to a minimum. If you have doubts about how much alcohol you can drink while taking this medication, consult your doctor.

Pregnancy and breastfeeding:

Consult your doctor or pharmacist before taking any medication.

Do not take pravastatin cinfamed 40 mg if you are pregnant, trying to become pregnant, or think you may be pregnant, as safety in pregnant women has not been established. In case of pregnancy or suspected pregnancy, you should stop treatment and inform your doctor as soon as possible.

pravastatin cinfamed 40 mg should not be taken 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 use machines. However, if you notice symptoms of dizziness, do not drive or use machines until you know how you tolerate the medication.

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

This medication contains lactose. If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication.

3. How to take pravastatin cinfamed 40 mg

Follow the instructions for administration of pravastatin cinfamed 40 mg indicated by your doctor. Consult your doctor or pharmacist if you have doubts.

Your doctor will indicate the duration of your treatment with pravastatin cinfamed 40 mg. Do not stop treatment before.

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

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

Adults and adolescents (14-18 years):

For the treatment of high levels of cholesterol and other fats: the normal dose is 10 to 40 mg once a day, preferably at night.

For the prevention of heart and blood vessel diseases: the normal dose is 40 mg once a day, preferably at night.

Do not exceed the maximum dose of 40 mg of pravastatin per day. Your doctor will recommend the dose that best suits your treatment.

Children (8-13 years) and adolescents (14-18 years) with a hereditary disorder that increases cholesterol levels in the blood:

Between 8 and 13 years, the normal dose is 10 to 20 mg once a day, and between 14 and 18 years, the usual dose is 10-40 mg once a day.

Transplanted patients:

Your doctor may recommend an initial dose of 20 mg per day. It may be necessary to adjust the dose, increasing up to 40 mg, according to your doctor's judgment.

If you are also taking immunosuppressive treatment (cyclosporin), your doctor may prescribe an initial dose of 20 mg per day. It may be necessary to adjust the dose, increasing up to 40 mg, according to your doctor's judgment.

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

If you think the action of this medication is too strong or too weak, consult your doctor or pharmacist.

Duration of treatment:

Your doctor will indicate the duration of treatment with pravastatin cinfamed. You should take this medication regularly and for the time indicated by your doctor, even if you think it is a long time. 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 your doctor has indicated, or if someone takes your medication accidentally, consult the emergency service of the nearest hospital. Remember to take the remaining tablets or the empty package to facilitate identification.

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

If you forget to take pravastatin cinfamed 40 mg

Do not take a double dose to make up for forgotten doses. Take the next dose at the usual time and continue with your treatment.

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

4. Possible side effects

Like all medicines, pravastatin cinfamed 40 mg can cause side effects, although not everybody gets them.

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

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

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

• Pancreatitis (inflammation of the pancreas).
• Alterations in touch (burning sensation, tingling, or numbness), which may indicate damage to nerve endings (peripheral neuropathy).
• Yellowing of the skin, tissues, or body fluids (jaundice).
• Hepatitis (inflammation of the liver) or acute liver failure.
• Inflammation of one or more muscles that causes pain or muscle weakness (myositis or polymyositis or dermatomyositis); pain or muscle weakness, inflammation of the tendons that can lead to rupture.
• Chronic autoimmune inflammatory disorder (a disease that occurs when tissues are attacked by the immune system), characterized by chronic alterations in the skin (signs of systemic lupus erythematosus).
• Elevations of liver transaminases (enzymes indicative of liver disease). Your doctor may consider it necessary to perform periodic blood tests to monitor this.

Uncommon side 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 acid, abdominal pain, nausea, vomiting, constipation, diarrhea, flatulence, skin reactions (itching, hives, urticaria, and rash), hair and scalp abnormalities (including hair loss), urination disorders (such as difficulty or pain when urinating, frequent urination at night), sexual difficulties, fatigue (tiredness).

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

• Sensitivity of the skin to the sun

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

• Constant muscle weakness
• Liver failure
• Severe myasthenia (a disease that causes generalized muscle weakness that, in some cases, affects the muscles used for breathing).
• Ocular myasthenia (a disease that causes weakness of the eye muscles).
• Muscle rupture.

Consult your doctor if you experience weakness in the arms or legs that worsens 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 (pauses during breathing), or fever
• Dermatomyositis (a condition characterized by inflammation of the muscles and skin)
• Diabetes mellitus: the frequency will depend on the presence or absence of risk factors (fasting blood glucose at 5.6mmol/L, BMI>30kg/m2, increased triglycerides, history of hypertension). It is more likely if you have high levels of sugar and fat in the blood, are overweight, and have high blood pressure. Your doctor will monitor you while you are taking this medication.

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 Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of pravastatin cinfamed 40 mg

• Keep out of the reach and sight of children.
• Store below 25°C. Store in the original package to protect it from light and moisture.
• Do not use pravastatin cinfamed 40 mg after the expiration date that appears on the package and on the blister strip after "EXP". The expiration date is the last day of the month indicated.

Medicines should not be disposed of through wastewater or household waste. Deposit the packages and medications you no longer need at the SIGRE point in the pharmacy. If in doubt, ask your pharmacist how to dispose of packages and medications you no longer need. This will help protect the environment.

6. Additional Information

Composition of Pravastatin Cinfamed 40 mg:

The active ingredient is pravastatin sodium. The 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 packaging content:

The pravastatin sodium 40 mg tablets are yellow, rectangular in shape with rounded edges, biconvex, uncoated, with the letters "PDT" engraved on one face and the number "40" engraved on the other face.

The pravastatin sodium tablets are packaged in blister strips and in packs of 28 tablets.

Marketing authorization holder and 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

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

Date of the last revision of this prospectus:April 2024

Detailed and updated 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/

You can access detailed and updated information about this medicinal product by scanning the QR code included in the prospectus and packaging with your mobile phone (smartphone). You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/70156/P_70156.html

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