PATIENT INFORMATION LEAFLET

Pravastatina NORMON 20 mg film-coated tablets

Pravastatina sodium

Read this leaflet carefully before you start taking this medicine.

• 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. Do not pass it on to others even if their symptoms are the same. It may harm them.
• If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, tell your doctor or pharmacist.

Pravastatina belongs to a group of medicines known as 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 situation is known as hardening of the arteries or atherosclerosis and 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.
• Stroke (cerebral infarction), when a cerebral artery is completely obstructed.

This medicine is indicated in three situations:

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

Pravastatina NORMON 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 levels of cholesterol in 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 NORMON 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 stroke or have unstable angina and even with normal cholesterol levels, Pravastatina NORMON is indicated to reduce the risk of suffering another heart attack or stroke in the future, and decreases the risk of dying from these diseases.

After an organ transplant:

If you have undergone an organ transplant and receive medication to prevent your body from rejecting the transplant, Pravastatina NORMON is indicated toreduce elevated levels of fat in the blood.

Do not take Pravastatina NORMON

• If you are allergic (hypersensitive) to pravastatina sodium or to any of the other components of Pravastatina NORMON (see Additional Information).
• If you are pregnant, intend to become pregnant or if you are breastfeeding (see Pregnancy and Breastfeeding).
• If you have any liver disease (active liver disease).
• If several blood tests show an abnormal liver function (elevated levels of liver enzymes in the blood).

Be especially careful with Pravastatina NORMON

Before taking this treatment, you must consult your doctor if you suffer or have suffered from any of the following medical conditions:

• Liver disease.
• Hypothyroidism.
• Liver disease or problems with alcohol (drinking large amounts of alcohol).
• Muscular alterations caused by a hereditary disease.
• Muscle problems caused by another medication belonging to the group of statins (medicines inhibitors of HMG-Coa reductase) or belonging to the group known as fibrates (see Taking other medicines).
• If you are taking or have taken in the last 7 days a medication that contains fusidic acid, (used for the treatment of bacterial infection) by oral or injection route. The combination of fusidic acid and Pravastatina NORMON may produce severe muscle problems (rhabdomyolysis).

If you have suffered from any of these problems, or if you are over 70 years old, your doctor will perform a blood test before and probably during treatment. These blood tests will be used to evaluate the risk of you suffering from adverse muscle effects.

If you feel inexplicable cramps or muscle pain during treatment, inform your doctor immediately.

Also inform your doctor or pharmacist if you experience persistent muscle weakness. Further tests and additional medications may be necessary to diagnose and treat this problem.

Consult your doctor or pharmacist before takingPravastatina NORMONif you:

• Have severe respiratory failure.
• 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 (see section 4).

While you are taking this medication, your doctor will monitor if you have diabetes or a risk of developing diabetes. This risk of diabetes increases if you have high levels of sugars and fats in your blood, overweight and high blood pressure.

Use of other medicines

When combined with this treatment, the following medicines may increase the risk of suffering from muscle problems (see Possible side effects). It is essential to inform your doctor if you are being treated with:

• A medicine that lowers cholesterol levels in the blood (fibrates, for example, gemfibrozil, fenofibrate);
• A medicine that lowers the body's defenses (ciclosporin);
• A medicine that treats bacterial infections (an antibiotic such as erythromycin or clarithromycin);
• Any other medicine that lowers cholesterol levels in your blood (nicotinic acid).

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

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 the treatment with Pravastatina NORMON. The use of Pravastatina NORMON with fusidic acid can produce muscle weakness, sensitivity or pain (rhabdomyolysis). For more information on rhabdomyolysis, see section 4.

Inform your doctor or pharmacist if you are using or have used recently other medicines, even those acquired without a prescription.

Take Pravastatina NORMON 20 mg with food and drinks

This medication can be administered with or without food, with half a glass of water.

You should reduce 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 using any medication.

Pregnancy

Do not take Pravastatina NORMON during pregnancy. If you discover that you are pregnant, inform your doctor immediately.

Breastfeeding

Pravastatina NORMON should not be administered during the breastfeeding period as this treatment passes into breast milk.

Driving and operating machines

Pravastatina NORMON does not affect the ability to drive or operate machines. However, if you experience symptoms of dizziness, blurred vision or double vision during treatment, do not drive or operate machines until you are sure you are in a condition to do so.

Pravastatina NORMON contains lactose

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

Pravastatina NORMON contains sodium

This medication contains less than 23 mg of sodium (1mmol) per tablet; this is, essentially "sodium-free".

Your doctor will advise you to follow a low-fat diet, which you should continue until the end of treatment.

Follow exactly the administration instructions for this Pravastatina NORMON as indicated by your doctor. Consult your doctor or pharmacist if you have any doubts.

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

Dosage:

Adults:

• For the treatment of high cholesterol and blood fat levels: the usual dose is 10-40 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.

Do not exceed the maximum daily dose of 40 mg of pravastatina sodium. Your doctor will establish the appropriate dose for you.

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

The recommended dose between 8 and 13 years is 10-20 mg once a day, and the recommended dose between 14 and 18 years is 10-40 mg once a day.

After an organ transplant:

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

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

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

If you estimate that the action of Pravastatina NORMON is too strong or too weak, inform your doctor or pharmacist.

Treatment duration

Your doctor will indicate the duration of treatment with Pravastatina NORMON. This medication should be taken regularly for the time recommended by your doctor, even if it is for a long period of time. Do not stop treatment on your own.

If you take morePravastatina NORMONthan you should

If you have taken more Pravastatina NORMON than you should, or if someone accidentally ingested some tablets, contact your doctor or pharmacist or the nearest hospital.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone: 915 620 420, indicating the medication and the amount taken.

If you forget to takePravastatina NORMON

If you forget to take a dose, simply take your regular dose when it is due next.

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

If you interrupt treatment with Pravastatina NORMON

Always consult your doctor if you want to interrupt treatment.

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

Like all medicines, Pravastatina NORMON may cause side effects, although not everyone will experience them.

Stop taking Pravastatina NORMON and inform your doctor immediatelyif you notice unexplained or persistent muscle pain, pain on movement, weakness, or cramps, especially if you also feel unwell or have a fever.

In rare cases, muscle problems can be severe (rhabdomyolysis) and may cause a life-threatening kidney disease.

Severe and sudden allergic reactions such as facial swelling, lip, tongue, or throat swelling can cause serious breathing difficulties. This is a rare reaction that can be serious if it occurs. Inform your doctor immediately if this happens.

The following side effects are infrequent and may affect more than 1 in 1000 people:

• Nervous system disorders:dizziness, fatigue, headache, sleep disorders
• Eye disorders:blurred vision or double vision;
• Gastrointestinal disorders:indigestion, nausea, vomiting, stomach pain or discomfort, diarrhea, constipation, and gas.

• Hepatobiliary disorders:Very rare: jaundice (yellowing of the skin), hepatitis (inflammation of the liver), fulminant hepatic necrosis (destruction of liver cells).
• Skin and hair disorders:itching, skin rash, appearance of blisters accompanied by itching, hair and scalp abnormalities (including hair loss).
• Urinary and genital disorders:urination changes (such as difficulty urinating, urinating more frequently, and urinating more frequently at night) and sexual problems.
• Musculoskeletal and connective tissue disorders:muscle and joint pain.

The following side effects are very rare and may affect fewer than 1 in 10,000 people:

• Nervous system disorders: alterations in the sense of touch, including burning or tingling sensations, or numbness indicating nerve damage;
• Skin disorders: severe skin alteration (lupus erythematosus-like syndrome);
• Liver disorders: inflammation of the liver or pancreas; jaundice (recognized by yellowing of the skin and white of the eyes); rapid destruction of liver cells (fulminant hepatic necrosis);
• Musculoskeletal and bone disorders: inflammation of one or more muscles causing muscle pain or weakness (myositis or polymyositis); muscle or joint pain, inflammation in tendons, sometimes complicated by rupture.

Altered blood tests: increased transaminases (a group of blood enzymes) that may indicate liver problems. Your doctor may want to perform periodic tests to monitor this.

Unknown frequency: Muscle weakness, muscle rupture.

Myasthenia gravis (a disease that causes generalized muscle weakness that, in some cases, affects the muscles used for breathing).

Myasthenic eye (a disease that causes weakness of the eye muscles).

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

If you consider any of the side effects you are experiencing to be severe or if you notice any side effects not mentioned in this prospectus, inform your doctor or pharmacist.

Other possible side effects:

• Sleep disorders, including insomnia and nightmares
• Memory loss
• Sexual dysfunction
• Depression
• Respiratory problems, including persistent cough and/or difficulty breathing or fever.

Diabetes. 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.

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a side effect not mentioned in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for human use:www.notificaRAM.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

Keepout of the reach and sight of children.

Do not store at a temperature above30 °C.

Do not use Pravastatina NORMON after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through drains or in the trash. Dispose of packaging and medicines you no longer need at the SIGRE collection pointofthe pharmacy. Incase of doubt, ask your pharmacist how to dispose of packaging and medicines you no longer need. By doing so, you will help protect the environment.

Composition of Pravastatina NORMON

The active ingredient is pravastatina sodium. Each tablet contains 20 mg of pravastatina sodium.

The other components are: lactose monohydrate (see section 2: ‘Pravastatina NORMON contains lactose’), microcrystalline cellulose, yellow iron oxide (E-172), sodium croscarmellose (see section 2: ‘Pravastatina NORMON contains sodium), magnesium stearate, colloidal silica, and heavy magnesium carbonate.

Appearance of the product and contents of the package

Pravastatina NORMON 20 mg is presented in the form of tablets. The tablets are yellow, round, biconvex, and scored. Each package contains 28 tablets.

Holder of the marketing authorization and responsible for manufacturing

LABORATORIOS NORMON, S.A.

Ronda de Valdecarrizo, 6 – 28760 Tres Cantos – Madrid (SPAIN)

OTHER PRESENTATIONS

Pravastatina NORMON 10 mg tablets.

Pravastatina NORMON 40 mg tablets.

Last review date of this leaflet: March 2024

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