Pravastatin Normon 20 mg tablets EFG
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
PACKAGE LEAFLET: INFORMATION FOR THE USER
Pravastatin NORMON 20 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 only and should not be given to other people, even if they have the same symptoms as you, since it could harm them.
- If you experience any serious adverse effects or any adverse effects not mentioned in this leaflet, inform your doctor or pharmacist.
Leaflet contents:
- WHAT Pravastatin NORMON IS AND WHAT IT IS USED FOR
- BEFORE TAKING Pravastatin NORMON
- HOW TO TAKE Pravastatin NORMON
- POSSIBLE SIDE EFFECTS
- HOW TO STORE Pravastatin NORMON
- FURTHER 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 consequently reduces 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.
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 (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 developing heart and blood vessel problems and reduces the risk of dying from these diseases.
- If you have already had a stroke or suffer from 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 fat levels in the blood.
2. Before taking Pravastatin NORMON
Do not take Pravastatin NORMON
- If you are allergic (hypersensitive) to sodium pravastatin or to any of the other components of Pravastatin NORMON (see Additional Information).
- If you are pregnant, planning to become pregnant, or breastfeeding (see Pregnancy and Breastfeeding).
- If you have any 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 Pravastatin NORMON
Before starting this treatment, consult your doctor if you have or have previously 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 group of statins (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 Pravastatin NORMON may cause serious muscle problems (rhabdomyolysis).
If you have had any of these conditions, 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 assess your risk of developing muscle-related adverse effects.
If you experience unexplained cramps or muscle pain during treatment, inform your doctor immediately.
Also inform your doctor or pharmacist if you experience persistent muscle weakness. Additional tests and treatments may be needed to diagnose and manage this condition.
Consult your doctor or pharmacist before taking Pravastatin NORMON if you:
- Have severe respiratory insufficiency.
- 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), as 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 Pravastatin 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 Pravastatin NORMON. Using Pravastatin NORMON with fusidic acid may cause muscle weakness, tenderness, or pain (rhabdomyolysis). For further information on 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 Pravastatin NORMON 20 mg with food and drink
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 Pravastatin NORMON during pregnancy. If you find out you are pregnant, inform your doctor immediately.
Breastfeeding
Pravastatin NORMON must not be administered during breastfeeding, as this medicine passes into breast milk.
Driving and using machines
Pravastatin 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 able to do so safely.
Pravastatin 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.
Pravastatin NORMON contains sodium
This medicine contains less than 23 mg of sodium (1 mmol) per tablet; hence, 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 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 an inherited condition causing high blood cholesterol levels:
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 organ transplantation:
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 advise you on how long to take Pravastatin NORMON. This medicine should be taken regularly for as long as your doctor recommends, even if this is for a prolonged 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 accidentally swallowed any tablets, contact your doctor, pharmacist, or the nearest hospital immediately.
In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately, or call the Toxicology Information Service at: 915 620 420, stating the name of 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, Pravastatin NORMON can cause adverse effects, although not everyone experiences them.
Stop taking Pravastatin NORMON and contact your doctor immediately if you experience unexplained or persistent muscle pain, pain upon palpation, weakness, or cramps, especially if you also feel unwell or have a fever.
In very rare cases, muscle problems may 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 but potentially serious reaction 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:
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Nervous system disorders: dizziness, fatigue, headache, sleep disturbances
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Eye disorders: blurred vision or double vision
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Gastrointestinal disorders: indigestion, nausea, vomiting, stomach pain or discomfort, diarrhea, constipation, and flatulence
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Hepatobiliary disorders: Very rare: jaundice (yellowing of the skin), hepatitis (inflammation of the liver), fulminant hepatic necrosis (destruction of liver cells)
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Skin and hair disorders: itching, skin rash, appearance of itchy blisters, abnormalities of hair and scalp (including hair loss)
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Urinary and genital disorders: changes in urination (such as difficulty urinating, increased frequency of urination, and increased nighttime urination) and sexual problems
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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 that, 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 arm or leg weakness that worsens 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 sugar and fats in the blood, are overweight, and 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 it is an effect 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 must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE Point at your pharmacy. If in doubt, ask your pharmacist how to properly dispose of medicines and containers you no longer need. This will help protect the environment.
6. Information for the user
Composition of Pravastatin NORMON
The active substance is pravastatin sodium. Each tablet contains 20 mg of pravastatin sodium.
The other components are: lactose monohydrate (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 20 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 10 mg tablets.
Pravastatin NORMON 40 mg tablets.
Date of the most recent revision 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/.