Irbesartan Normon 300 mg tablets EFG
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
PACKAGE LEAFLET: INFORMATION FOR THE USER
Irbesartán NORMON 300 mg tablets EFG
Irbesartan
Read the entire 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 and must not be given to other people, even if they have the same symptoms, as it could harm them.
- If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.
Leaflet contents:
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What Irbesartán Normon is and what it is used for
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What you need to know before taking Irbesartán Normon
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How to take Irbesartán Normon
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Possible side effects
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How to store Irbesartán Normon
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Contents of the pack and other information
1. What Irbesartán Normon is and what it is used for
Irbesartán Normon belongs to a group of medicines known as angiotensin-II receptor antagonists. Angiotensin-II is a substance produced in the body that binds to receptors, causing blood vessels to constrict. This results in an increase in blood pressure. Irbesartán Normon prevents angiotensin-II from binding to these receptors, relaxing the blood vessels and thereby lowering blood pressure. Irbesartán Normon delays the worsening of kidney function in patients with high blood pressure and type 2 diabetes.
Irbesartán Normon is used to treat high blood pressure (essential hypertension) and to protect the kidney in patients with high blood pressure, type 2 diabetes, and clinical evidence of impaired kidney function.
2. Before taking Irbesartán Normon
Do not take Irbesartán NORMON:
- if you are allergic (hypersensitive) to irbesartan or to any of the other components of Irbesartán Normon
- during the last 6 months of pregnancy; see section Pregnancy and breastfeeding
- if you are breastfeeding
- if you have diabetes or kidney failure and are being treated with a blood pressure-lowering medicine containing aliskiren.
Irbesartán Normon should not be given to children and adolescents (under 18 years of age).
Warnings and precautions
Talk to your doctor before starting to take Irbesartán NORMON:
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if you have severe vomiting or diarrhea
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if you have kidney problems
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if you have heart problems
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if you are taking Irbesartán Normon for diabetic kidney disease. In this case, your doctor may perform regular blood tests, especially to monitor potassium levels in case of impaired kidney function
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if you are due to undergo surgery or will be receiving anesthetics
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if you are taking any of the following medicines used to treat high blood pressure (hypertension):
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an angiotensin-converting enzyme inhibitor (ACE inhibitor) (e.g. enalapril, lisinopril, ramipril), particularly if you have kidney problems related to diabetes
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aliskiren.
Talk to your doctor if you experience abdominal pain, nausea, vomiting, or diarrhea after taking Irbesartán NORMON. Your doctor will decide whether to continue treatment. Do not stop taking Irbesartán NORMON when used as monotherapy.
Your doctor may monitor your kidney function, blood pressure, and blood electrolyte levels (e.g. potassium) at regular intervals.
See also information under the heading “Do not take Irbesartán NORMON”.
If you are pregnant, suspect you may be pregnant, or plan to become pregnant, you must inform your doctor. Use of Irbesartán Normon is not recommended during early pregnancy (first 3 months) and must not be used during the last 6 months of pregnancy as it may cause serious harm to your baby; see section Pregnancy and breastfeeding.
Use of Irbesartán NORMON with other medicines
Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.
Your doctor may need to adjust your dose and/or take other precautions:
- if you are taking an angiotensin-converting enzyme inhibitor (ACE inhibitor) or aliskiren (see also information under the headings “Do not take IRBESARTAN NORMON” and “Warnings and precautions”).
You may need to have blood tests if you are taking:
- potassium supplements
- salt substitutes containing potassium
- potassium-sparing medicines (such as certain diuretics)
- medicines containing lithium.
If you are using a type of painkiller known as non-steroidal anti-inflammatory drugs (NSAIDs), the effect of irbesartan may be reduced.
Use of IRBESARTÁN NORMON with food and drink
The tablets can be taken with or without food.
Pregnancy and breastfeeding:
Inform your doctor if you are pregnant, suspect you may be pregnant, or plan to become pregnant. Your doctor will generally advise switching to another medicine instead of Irbesartán Normon, as use of Irbesartán Normon is not recommended during early pregnancy (first 3 months) and must not be used during the last 6 months of pregnancy because it may cause serious harm to your baby. Usually, before you become pregnant, your doctor will switch Irbesartán Normon to another suitable antihypertensive medicine. In any case, Irbesartán Normon must not be taken during the second or third trimester of pregnancy or during breastfeeding.
Your doctor will generally advise stopping treatment with Irbesartán Normon as soon as pregnancy is confirmed. If you become pregnant while taking Irbesartán Normon, inform your doctor and seek medical advice immediately.
Consult your doctor or pharmacist before taking any medicine.
Driving and using machines:
No studies on the effects on the ability to drive and use machines have been performed. It is unlikely that Irbesartán Normon will affect your ability to drive or operate machinery. However, during treatment for high blood pressure, dizziness or fatigue may occasionally occur. If you experience these symptoms, talk to your doctor before driving or operating machinery.
Irbesartán NORMON 300 mg tablets contain lactose, hydrogenated castor oil, and sodium.
This medicine contains lactose. If your doctor has informed you that you have an intolerance to certain sugars, consult him/her before taking this medicine.
This medicine may cause stomach discomfort or diarrhea because it contains hydrogenated castor oil.
This medicine contains less than 23 mg of sodium (1 mmol) per tablet; this is essentially “sodium-free”.
3. How to take Irbesartán Normon
Follow exactly the instructions for using this medicine as given by your doctor. If you have any doubts, consult your doctor or pharmacist.
Irbesartán Normon is administered orally. The tablets should be swallowed with a sufficient amount of liquid (e.g. a glass of water). Irbesartán Normon can be taken with or without food. You should try to take your daily dose at the same time each day. It is important that you continue taking this medicine unless your doctor advises you otherwise.
In patients with high blood pressure, the usual dose is 150 mg once daily. Subsequently, and depending on the blood pressure response, this dose may be increased to 300 mg once daily.
In patients with high blood pressure and type 2 diabetes with kidney impairment, the recommended maintenance dose for the treatment of associated kidney impairment is 300 mg once daily.
The maximum blood pressure-lowering effect should be achieved within 4–6 weeks after starting treatment. Your doctor may recommend a lower dose, especially at the beginning of treatment, in certain patients, such as those undergoing hemodialysis or patients over 75 years of age.
If you take more IRBESARTÁN NORMON than you should:
If you have taken more Irbesartán Normon than you should, contact your doctor, pharmacist, or call the Toxicology Information Service at telephone number 91-562 04 20, indicating the medicine and the amount taken.
Children must not take IRBESARTÁN NORMON:
Irbesartán Normon must not be given to children under 18 years of age. If a child swallows several tablets, contact your doctor immediately.
If you forget to take IRBESARTÁN NORMON:
If you accidentally miss 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 have any further questions about the use of this product, ask your doctor or pharmacist.
4. Possible adverse effects
Like all medicines, Irbesartan Normon may cause adverse effects, although not everyone experiences them.
Adverse effects are generally mild and transient. However, some effects may be serious and require medical attention.
The adverse effects listed below are grouped according to their frequency as follows:
Very common: at least 1 in 10 patients
Common: at least 1 in 100 patients
Uncommon: at least 1 in 1,000 patients
Adverse effects reported in clinical trials conducted in patients treated with Irbesartan Normon were:
Very common: If you have high blood pressure and type 2 diabetes with kidney impairment, blood tests may show increased potassium levels.
Common: dizziness, nausea/vomiting, fatigue, and blood tests may show elevated levels of an enzyme that measures muscle and heart function (creatine kinase enzyme). In patients with high blood pressure and type 2 diabetes with kidney impairment, dizziness (especially upon standing), low blood pressure (especially upon standing), muscle or joint pain, and decreased levels of a protein present in red blood cells (hemoglobin).
Uncommon: tachycardia, skin redness, cough, diarrhea, indigestion/acid reflux, sexual dysfunction (sexual function disturbances), and chest pain.
Rare: intestinal angioedema: swelling in the intestine presenting symptoms such as abdominal pain, nausea, vomiting, and diarrhea.
Since the marketing of Irbesartan Normon, some adverse effects have been reported, but their frequency is unknown. These observed adverse effects include: headache, taste disturbance, tinnitus, muscle cramps, muscle and joint pain, abnormal liver function, increased blood potassium levels, renal failure, inflammation of small blood vessels, primarily in the skin area (a condition known as leukocytoclastic vasculitis), and reduced platelet count.
As with other similar medicines, rare cases of skin allergic reactions (rash, urticaria) and localized swelling of the face, lips and/or tongue have been reported in patients treated with irbesartan. If you think you may be experiencing such a reaction or develop shortness of breath, stop taking Irbesartan Normon and seek immediate medical attention.
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.
Reporting of adverse effects
If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is an adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products at the website: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of Irbesartán Normon
Keep out of the reach and sight of children.
Store in the original packaging to protect from light.
Expiration:
Do not use Irbesartán Normon after the expiry date stated on the container after "Exp". The expiry date refers to the last day of the month indicated.
Medicines must not be disposed of via wastewater drains or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.
6. Package contents and other information
Composition of Irbesartan Normon 300 mg tablets:
The active substance is irbesartan. Each tablet contains 300 mg of irbesartan.
The other components (excipients) are: Povidone (E-1201), magnesium stearate, microcrystalline cellulose (E-460), monohydrate lactose, sodium croscarmellose, colloidal anhydrous silica, hydrogenated castor oil, and corn starch.
Appearance of the medicinal product and contents of the pack
Irbesartan Normon 300 mg is presented as tablets. They are white, oblong, biconvex, and scored tablets. Each pack contains 28 tablets.
Marketing Authorization Holder and Manufacturer:
LABORATORIOS NORMON, S.A.
Ronda de Valdecarrizo, 6 – 28760 Tres Cantos – Madrid (SPAIN)
OTHER PRESENTATIONS
IRBESARTAN NORMON 75 mg TABLETS EFG
IRBESARTAN NORMON 150 mg TABLETS EFG
This summary of product characteristics was approved in February 2025
Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/