Pravastatin Normon 10 mg tablets EFG

Package leaflet: Information for the user

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Pravastatina NORMON 10 mg tablets EFG

Sodium pravastatin

Read the entire 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 give it to others, even if they have the same symptoms as you, since it could harm them.
• If you experience any serious adverse reactions or any adverse reactions not listed in this leaflet, inform your doctor or pharmacist.

Leaflet contents:

1. WHAT Pravastatina NORMON IS AND WHAT IT IS USED FOR
2. BEFORE TAKING Pravastatina NORMON
3. HOW TO TAKE Pravastatina NORMON
4. POSSIBLE ADVERSE EFFECTS
5. STORAGE OF Pravastatina NORMON
6. ADDITIONAL INFORMATION

1. What Pravastatina NORMON is and what it is used for

Pravastatin belongs to a group of medicines known as statins (or HMG-CoA reductase inhibitors). It prevents the liver from producing cholesterol and, as a result, reduces 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.

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:

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

Pravastatina NORMON 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 promote these diseases (such as smoking, being overweight, having high blood sugar levels or hypertension, or lack of physical activity), Pravastatina NORMON is indicated to reduce the risk of developing heart and blood vessel problems and reduces the risk of dying from these diseases.
• If you have already suffered a stroke or have chest pain (unstable angina), even with normal cholesterol levels, Pravastatina NORMON is indicated to reduce the risk of future heart attack or stroke, and reduces the risk of dying from these conditions.

After organ transplantation:

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

2. Before taking Pravastatina NORMON

Do not take Pravastatina NORMON

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

Take special care with Pravastatina NORMON

Before starting this treatment, consult your doctor if you have or have had any of the following medical conditions:

• Kidney disease.
• Hypothyroidism.
• Liver disease or problems related to alcohol (drinking large amounts of alcohol).
• Muscle disorders caused by an inherited disease.
• Muscle problems caused by another medicine belonging to the statin group (HMG-CoA reductase inhibitor medicines) or to the group known as fibrates (see Taking other medicines).
• If you are taking or have taken within the last 7 days a medicine containing fusidic acid (used to treat bacterial infection) by oral route or by injection. The combination of fusidic acid and Pravastatina NORMON may cause serious muscle problems (rhabdomyolysis).

If you have experienced any of these conditions, or if you are over 70 years of age, your doctor will perform a blood test before and probably during treatment. These blood tests will be used to assess your risk of developing adverse muscle effects.

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

Also inform your doctor or pharmacist if you develop persistent muscle weakness. Additional tests and treatments may be required to diagnose and manage this condition.

Consult your doctor or pharmacist before taking Pravastatina NORMON if you:

• Have severe respiratory insufficiency.
• Have or have had myasthenia (a disease characterized by generalized muscle weakness that, 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).

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

Use of other medicines

When combined with this treatment, the following medicines may increase the risk of muscle problems (see Possible side effects). It is important that you 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 suppresses the body's immune defenses (cyclosporine);
• A medicine used to treat bacterial infections (an antibiotic such as erythromycin or clarithromycin);
• Any other medicine that lowers cholesterol levels in the blood (nicotinic acid).

If you are also taking a medicine to lower fat levels in your blood (a resin-type 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 may interfere with the absorption of Pravastatina NORMON if both medicines are taken simultaneously.

If you need to take oral fusidic acid to treat a bacterial infection, you will need to stop using this medicine. Your doctor will advise you when you can restart treatment with Pravastatina NORMON. The use of Pravastatina NORMON with fusidic acid may cause muscle weakness, tenderness, or pain (rhabdomyolysis). For more information about rhabdomyolysis, see section 4.

Inform your doctor or pharmacist if you are currently using or have recently used any other medicines, including those obtained without a prescription.

Taking Pravastatina NORMON with food and drinks

This medicine can be taken with or without food, with half a glass of water.

You should 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 using any medicine.

Pregnancy

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

Breastfeeding

Pravastatina NORMON must not be administered during breastfeeding, as this medicine passes into breast milk.

Driving and using machines

Pravastatina NORMON does not affect the ability to drive or use machines. However, if you experience symptoms such as dizziness, blurred vision, or double vision during treatment, do not drive or operate machinery until you are certain you are fit to do so.

Pravastatina NORMON contains lactose

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

Pravastatina NORMON contains sodium

This medicine contains less than 23 mg of sodium (1 mmol) per tablet; therefore, it is essentially “sodium-free”.

3. How to take Pravastatin NORMON

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

Always follow exactly the instructions provided by your doctor for taking this Pravastatin NORMON. If you are unsure, consult your doctor or pharmacist.

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

Dosage:

Adults:

• For the treatment of high cholesterol and fat levels in the blood: the usual dose is 10–40 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 sodium pravastatin must not be exceeded. Your doctor will determine the appropriate dose for you.

Children (8–13 years) and adolescents (14–18 years) with a hereditary condition causing high cholesterol levels in the blood:

The recommended dose for children aged 8 to 13 is 10–20 mg once daily. The recommended dose for adolescents aged 14 to 18 is 10–40 mg once daily.

After an organ transplant:

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

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

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

If you feel that the effect of Pravastatin NORMON is too strong or too weak, inform your doctor or pharmacist.

Duration of treatment

Your doctor will determine how long you should take Pravastatin NORMON. This medicine should be taken regularly for the length of time recommended by your doctor, even if this is for a long period. Do not stop treatment prematurely on your own.

If you take more Pravastatin NORMON than you should

If you have taken more Pravastatin NORMON than you should, or if someone has accidentally swallowed any tablets, contact your doctor, pharmacist, or the nearest hospital.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately, or call the Toxicology Information Service at telephone number: 915 620 420, indicating the medicine and the amount taken.

If you forget to take Pravastatin NORMON

If you forget to take a dose, simply take your next dose at the usual time.

Do not take a double dose to make up for a missed dose.

If you stop taking Pravastatin NORMON

Always consult your doctor if you wish to stop treatment.

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

4. Possible adverse effects

Like all medicines, Pravastatina NORMON may produce adverse effects, although not everyone experiences them.

Stop taking Pravastatina NORMON and contact your doctor immediately if you experience unexplained or persistent muscle pain, pain on palpation, weakness or cramps, especially if you also feel unwell or have a fever.

In very rare cases, muscle problems can be serious (rhabdomyolysis) and may lead to kidney disease that can be life-threatening.

Severe and sudden allergic reactions such as swelling of the face, lips, tongue or trachea may cause serious breathing difficulties. This is a very rare reaction, but it can be serious if it occurs. You must inform your doctor immediately if this happens.

The following adverse effects are uncommon and may affect more than 1 in 1,000 people:

• Nervous system disorders: dizziness, fatigue, headache, sleep disturbances

• Eye disorders: blurred vision or double vision;

• Gastrointestinal disorders: indigestion, nausea, vomiting, stomach pain or discomfort, diarrhea, constipation and flatulence.

• 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 itchy blisters, hair and scalp abnormalities (including hair loss).

• Urinary and genital disorders: changes in urination (such as difficulty urinating, increased frequency of urination, and increased nighttime urination) and sexual problems.

• Musculoskeletal disorders: muscle and joint pain.

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

• Nervous system disorders: disturbances in the sense of touch including burning sensations, tingling, or numbness indicating nerve damage;
• Skin disorders: severe skin reactions (lupus-like syndrome);
• Liver disorders: inflammation of the liver or pancreas; jaundice (recognized by yellowing of the skin and whites of the eyes); rapid destruction of liver cells (fulminant hepatic necrosis);
• Muscle and bone disorders: inflammation of one or more muscles causing muscle pain or weakness (myositis or polymyositis); muscle pain or weakness, tendon inflammation, sometimes complicated by rupture.
• Abnormal blood test results: increased transaminases (a group of blood enzymes) which may indicate liver problems. Your doctor may wish to perform periodic tests to monitor this.

Frequency not known: Muscle weakness, muscle rupture.

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

Ocular myasthenia (a disease causing weakness of the eye muscles).

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

If you consider any of the adverse effects you experience to be severe or if you notice any adverse effects not listed in this leaflet, inform your doctor or pharmacist.

Other possible adverse effects:

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

Diabetes. This is more likely if you have high levels of sugars and fats in the blood, are overweight, or have high blood pressure. Your doctor will monitor you while you are taking this medicine.

If you experience any type of adverse effect, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Pravastatin NORMON

Keep out of the reach and sight of children.

Do not store above 30 °C.

Do not use Pravastatin NORMON after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.

Medicines should not be disposed of via wastewater drains or household waste. Dispose of unused medicines and their packaging at the SIGRE collection point at your pharmacy. If you are in doubt, ask your pharmacist how to dispose of unused medicines and packaging. This will help protect the environment.

6. Additional information

Composition of Pravastatin NORMON

The active substance is sodium pravastatin. Each tablet contains 10 mg of sodium pravastatin.

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

Appearance of the medicinal product and contents of the pack

Pravastatin NORMON 10 mg is presented as tablets. The tablets are yellow, round, biconvex, and scored. Each pack contains 28 tablets.

Marketing Authorization Holder and Manufacturer

LABORATORIOS NORMON, S.A.
Ronda de Valdecarrizo, 6 – 28760 Tres Cantos – Madrid (SPAIN)

OTHER PACK SIZES

Pravastatin NORMON 20 mg tablets.
Pravastatin NORMON 40 mg tablets.

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

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