PRODUCT INFORMATION FOR THE USER

PRAVASTATINA CINFAMED 10 mg TABLETS EFG

pravastatina sodium

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

1. What is pravastatina cinfamed 10 mg and what is it used for

2. What you need to know before you start taking pravastatina cinfamed 10 mg

3. How to take pravastatina cinfamed 10 mg

4. Possible side effects

5. Storage of pravastatina cinfamed 10 mg

6. Contents of the pack and additional information

Pravastatina cinfamed 10 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 result 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, obstructing them.

This disease is known as hardening of the arteries or arteriosclerosis, and it can lead to:

· chest pain (angina pectoris) when a coronary artery is partially obstructed

· heart attack (myocardial infarction) when a coronary artery is completely obstructed,

· cerebral infarction (cerebrovascular accident) when a cerebral artery is completely obstructed.

This medicine is indicated in three situations:

For the treatment of high levelsof cholesterol and fats in the blood.

Pravastatina 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.

The prevention of heart and blood vessel diseases.

- If you have high levels of cholesterolin the blood and risk factors that favor these diseases (if you smoke, are overweight, have high blood sugar levels or hypertension, or do little exercise), pravastatina cinfamed is indicated to reduce the risk of suffering a heart and 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 cholesterol levels, pravastatina Sodium reduces the risk of these problems recurring in the future.

After an organ transplant

If you have a transplanted organ and are taking a medicine to prevent transplant rejection, pravastatina cinfamed 10 mg reduces increased fat levels after the transplant.

Do not take pravastatina cinfamed 10 mg:

• If you are allergic to pravastatina sodium or to any of the other components of pravastatina cinfamed 10 mg (see Additional Information).
• If you have liver problems (active liver disease).
• If you are pregnant, think you may be pregnant or are breastfeeding (see Pregnancy and Breastfeeding).
• If several blood tests have shown abnormal liver function (elevated levels of liver enzymes in the blood).

Warnings and Precautions

Consult your doctor or pharmacist before starting to take pravastatina cinfamed.

• If you have kidney failure.
• If you have hypothyroidism (poor thyroid function).
• If you have a history of liver disease.

• If you have a history of excessive alcohol consumption.
• If you have muscle problems or a family history.
• If you have 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 persistent 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) by mouth or injection. The combination of fusidic acid and pravastatina may cause severe 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 myasthenia gravis (a disease that causes weakness of the eye muscles), as statins may sometimes worsen the disease or cause myasthenia (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 state 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 if you have developed or are at risk of developing diabetes. There may be a risk of developing diabetes if you have high blood sugar and fat levels, obesity, and high blood pressure.

Consult your doctor or pharmacist before starting treatment with pravastatina if you have severe respiratory failure.

Children

This medication is not recommended for children under 8 years old.

Use of other medications and Pravastatina cinfamed tablets:

Inform your doctor or pharmacist if you are taking, have taken recently 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 pravastatina cinfamed 10 mg, as the combination may increase the risk of muscle problems:

• Gemfibrozil, fenofibrate or nicotinic acid (used to lower blood cholesterol levels).
• Ciclosporin (used to inhibit the immune system and prevent transplant rejection).
• Erythromycin or clarithromycin (antibiotics).
• Colestiramine or colestipol (resins used to reduce blood cholesterol levels): pravastatina cinfamed 10 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 pravastatina if the two medications are taken simultaneously.
• Warfarin and other oral anticoagulants (oral anticoagulants that prevent blood clotting).
• Certain medications metabolized by the cytochrome P450 enzyme 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 clotting called a vitamin K antagonist, consult your doctor before taking pravastatina because the use of vitamin K antagonists concomitantly with pravastatina 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 taking this medication. Your doctor will indicate when you can restart treatment with pravastatina. The use of pravastatina with fusidic acid may cause muscle weakness, sensitivity or pain (rhabdomyolysis). For more information on rhabdomyolysis, see Section 4.
• Colchicine (used to treat gout).
• Rifampicin (used to treat a bacterial infection called tuberculosis).
• Lenalidomide (used to treat a type of blood cancer called multiple myeloma).

Taking pravastatina cinfamed 10 mg with food and drinks:

• Pravastatina cinfamed 10 mg can be taken with or without food and with or without drinks.
• Always reduce your alcohol consumption to a minimum. If you are unsure 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 pravastatina cinfamed 10 mg if you are pregnant, think you may be pregnant or are breastfeeding, as the safety in pregnant women has not been established. If you become pregnant or suspect you may be pregnant, you should stop treatment and inform your doctor as soon as possible.

Pravastatina cinfamed 10 mg should not be administered during lactation, as it passes into breast milk.

Driving and operating machinery:

At normal doses, pravastatina cinfamed 10 mg does not affect the ability to drive or operate machinery. However, if you experience dizziness, do not drive or operate machinery until you know how you tolerate the medication.

Important information about one of the components of pravastatina cinfamed 10 mg:

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

Follow exactly the administration instructions for pravastatina cinfamed 10 mg as indicated by your doctor. Consult your doctor or pharmacist if you have any doubts.

Your doctor will indicate the duration of your treatment with pravastatina cinfamed 10 mg. Do not discontinue treatment beforehand.

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 the treatment.

Adults and adolescents (14-18 years):

For the treatment of high cholesterol and other fats: The usual dose is10 to40 mg once a day, preferably at night.

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

You should not exceed the maximum dose of 40 mg of pravastatina 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 blood cholesterol levels:

Between 8 and 13 years, the usual dose is10 to20 mg once a day, and between 14 and 18 years, the usual dose is 10-40 mg once a day.

Transplant 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, as determined by your doctor.

If you are also taking a treatment used to inhibit the immune system (ciclosporina), 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, as determined by your doctor.

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

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

Treatment duration:

Your doctor will indicate the duration of treatment with pravastatina cinfamed. You should take this medication regularly and for the time your doctor indicates, even if you consider it to be a long time. Do not discontinue treatment on your own.

If you take more pravastatina cinfamed 10 mg than you should:

If you take more pravastatina cinfamed 10 mg than your doctor has indicated, or if someone takes your medication accidentally, consult the nearest hospital emergency service. Remember to bring the remaining tablets or the empty packaging to facilitate identification.

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

If you forgot to take pravastatina cinfamed 10 mg

Do not take a double dose to compensate for the missed 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.

Like all medicines, pravastatina cinfamed 10 mg can cause side effects, although not everyone will experience them.

You should stop taking pravastatina and see your doctor immediately if you experience symptoms such as:

• Allergic reactions (angioedema, anaphylaxis): signs of allergic reaction such as swelling of the face, lips, tongue, and throat, which can cause breathing difficulties.
• Rarely, some patients have developed muscle damage or inflammation, and very rarely this progresses to a severe alteration (called rhabdomyolysis). The appearance of acute renal failure secondary to myoglobinuria (presence of myoglobin in the urine), myositis (muscle inflammation), myopathy (muscle disease), polymyositis (chronic muscle inflammation) may be associated with rhabdomyolysis.If you experience unexplained muscle pain, painful sensitivity or weakness, and especially if you feel unwell or have a feverstop taking pravastatina 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 sensation (burning, tingling or numbness (paresthesia)), which may indicate damage to nerve endings (peripheral neuropathy).
• Yellowing of the skin, tissues or bodily fluids (jaundice).
• Hepatitis (inflammation of the liver) or acute liver failure.
• Inflammation of one or more muscles causing muscle pain or weakness (myositis or polymyositis or dermatomyositis); muscle pain or weakness, inflammation of the tendons that may complicate and lead to tendon ruptures.
• Chronic autoimmune inflammatory alteration (a disease that occurs when tissues are attacked by the body's own immune system), characterized by chronic changes in the skin (signs of reaction of the type 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 disturbances (including insomnia), eye disorders (including blurred vision or double vision), indigestion, stomach acid, abdominal pain, nausea, vomiting, constipation, diarrhea, flatulence, skin reactions (itching, acne, urticaria and skin rash), hair and scalp abnormalities (including hair loss), urinary abnormalities (such as difficulty or pain urinating, urinating more frequently at night), sexual difficulties, fatigue (tiredness).

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

• Sensitivity to the sun

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

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

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

Possible side effects:

• Nightmares
• Memory loss
• Depression
• Respiratory problems, including persistent cough, apnea (breathing pauses) or fever.
• Dermatomyositis (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 of 5.6mmol/L, BMI>30kg/m 2, increased triglycerides, history of hypertension). It is more likely if you have high blood sugar and fat levels, obesity and high blood pressure. Your doctor will monitor you while 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 prospectus. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

• Keep out of reach and sight of children.
• Store below25°C. Store in the original packaging to protect it from light and humidity.
• Do not use pravastatina cinfamed 10 mg after the expiration date that appears on the packaging and on the blister strip after “EXP”. The expiration date is the last day of the month indicated.

Medicinesshould not be disposed of through drains or in the trash.Deposit the packaging and unusedmedicines at theSIGREpoint ofthepharmacy.In case of doubt, please ask your pharmacist how to dispose of unused packaging and medicines. By doing so, you will help protect the environment..

Composition of pravastatina cinfamed 10 mg:

The active ingredient is pravastatina sodium. Pravastatina cinfamed 10 mg tablets contain 10 mg of pravastatina 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 package:

Pravastatina sodium 10 mg tablets are yellow, rectangular in shape with rounded edges, biconvex, uncoated, with the letters “PDT” engraved on one face and the number “10” engraved on the other face.

Pravastatina sodium tablets are packaged in blister strips and in containers of 28 tablets.

Holder of the marketing authorization and responsible manufacturer:

Cinfa Laboratories, S.A.

Carretera Olaz-Chipi, 10 Industrial Estate Areta

31620 Huarte (Navarra) – Spain

or

Accord Healthcare Polska Sp.z o.o.,

ul. Lutomierska 50, 95-200 Pabianice, Poland

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

Last review date of this leaflet:April 2024

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/

You can access detailed and updated information on this medicine by scanning the QR code included in the leaflet and packaging with your smartphone. You can also access this information at the following internet address:https://cima.aemps.es/cima/dochtml/p/70155/P_70155.html

QR code to:https://cima.aemps.es/cima/dochtml/p/70155/P_70155.html