Irbesartan Normon 75 mg tablets EFG
Spain
Table of Contents
Package Leaflet: Information for the User
Introduction
PACKAGE LEAFLET: INFORMATION FOR THE USER
Irbesartan NORMON 75 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, consult your doctor or pharmacist.
- This medicine has been prescribed for you and should not be given to other people, even if they have the same symptoms, as it may 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 Irbesartan Normon is and what it is used for
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What you need to know before taking Irbesartan Normon
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How to take Irbesartan Normon
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Possible adverse effects
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Storage of Irbesartan 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 increased blood pressure. Irbesartán Normon prevents angiotensin-II from binding to these receptors, relaxing blood vessels and thereby lowering blood pressure. Irbesartán Normon delays the decline in 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. What you need to know before taking Irbesartán Normon
Do not take Irbesartán NORMON:
- if you are allergic to irbesartan or to any of the other ingredients of this medicine (listed in section 6)
- during the last 6 months of pregnancy; see section Pregnancy and breastfeeding.
- if you are breastfeeding.
- if you have diabetes or renal insufficiency and are being treated with a blood pressure-lowering medicine containing aliskiren.
Irbesartán Normon should not be administered to children and adolescents (under 18 years of age).
Warnings and precautions:
Consult your doctor before starting to take Irbesartán NORMON
- if you have excessive vomiting or diarrhoea.
- if you have kidney problems.
- if you have heart problems.
- 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 renal function.
- if you are scheduled for surgery or will receive anaesthetics.
- if you are taking any of the following medicines used to treat high blood pressure (hypertension):
- an angiotensin-converting enzyme inhibitor (ACE inhibitor) (e.g. enalapril, lisinopril, ramipril), particularly if you have kidney problems related to diabetes.
- aliskiren.
Consult your doctor if you experience abdominal pain, nausea, vomiting or diarrhoea 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 the 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 it 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 additional precautions: If you are taking an angiotensin-converting enzyme inhibitor (ACE inhibitor) or aliskiren (see also information under the headings “Do not take Irbesartán NORMON” and “Warnings and precautions”).
You may need 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 taking 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:
You must inform your doctor if you are pregnant, suspect you may be pregnant, or plan to become pregnant. Generally, your doctor will advise you to take 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 appropriate antihypertensive medicine. In any case, Irbesartán Normon must not be taken during the second or third trimester of pregnancy or during breastfeeding.
Generally, your doctor will advise you to stop treatment with Irbesartán NORMON as soon as pregnancy is confirmed. If you become pregnant while taking Irbesartán NORMON, inform and see your doctor immediately.
Consult your doctor or pharmacist before taking any medicine.
Driving and use of 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 hypertension, dizziness or fatigue may occasionally occur. If you experience these symptoms, discuss with your doctor before driving or operating machinery.
Irbesartán NORMON 75 mg tablets contain lactose, hydrogenated castor oil, and sodium.
This medicine contains lactose. If your doctor has diagnosed you with an intolerance to certain sugars, consult him or her before taking this medicine.
This medicine may cause stomach discomfort or diarrhoea because it contains hydrogenated castor oil.
This medicine contains less than 23 mg of sodium (1 mmol) per tablet; hence, it is essentially “sodium-free”.
3. How to take Irbesartán Normón
Follow exactly the instructions given by your doctor for taking this medicine. If you have any doubts, consult your doctor or pharmacist.
Irbesartán Normón is administered orally. The tablets should be swallowed with a sufficient amount of liquid (e.g. a glass of water). Irbesartán Normón 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 (2 tablets per day). Subsequently, depending on the blood pressure response, this dose may be increased to 300 mg once daily (4 tablets per day).
In patients with high blood pressure and type 2 diabetes with kidney impairment, the recommended maintenance dose for the treatment of associated kidney damage is 300 mg once daily (4 tablets per day).
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 haemodialysis or patients over 75 years of age.
? If you take more Irbesartán NORMON than you should:
If you have taken more Irbesartán Normón than you should, contact your doctor, pharmacist, or call the Toxicology Information Service immediately at telephone number 91-562 04 20, indicating the medicine and the amount taken.
?Children must not take Irbesartán NORMON:
Irbesartán Normón 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 missed doses.
If you have any further questions about the use of this product, ask your doctor or pharmacist.
4. Possible adverse effects
Like all medicines, Irbesartán Normon may produce 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 Irbesartán 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, diarrhoea, indigestion/acid reflux, sexual dysfunction (alterations in sexual function), and chest pain.
Rare: intestinal angioedema: swelling in the intestine causing symptoms such as abdominal pain, nausea, vomiting, and diarrhoea.
Since the marketing of Irbesartán Normon, some adverse effects have been reported, but their frequency is unknown. These observed adverse effects include: headache, taste disturbance, tinnitus (ringing in the ears), muscle cramps, muscle and joint pain, abnormal liver function, increased blood potassium levels, renal failure, and inflammation of small blood vessels, mainly 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), as well as 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 Irbesartán 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 Medicines 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.
Expiry:
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 should not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. If you are unsure, please ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.
6. Additional information
Composition of Irbesartán NORMON 75 mg tablets:
The active substance is irbesartan. Each tablet contains 75 mg of irbesartan.
The other components (excipients) are: Povidone (E-1201), magnesium stearate, microcrystalline cellulose (E-460), monohydrate lactose, sodium croscarmellose, anhydrous colloidal silica, hydrogenated castor oil, and maize starch.
Appearance of the product and contents of the pack
Irbesartán Normon 75 mg is presented as tablets. The tablets are white, cylindrical, and biconvex. Each pack contains 28 tablets.
Marketing Authorization Holder and Manufacturer:
LABORATORIOS NORMON, S.A.
Ronda de Valdecarrizo, 6 – 28760 Tres Cantos – Madrid (SPAIN)
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This patient information leaflet 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/