IRBESARTAN NORMON 300 mg TABLETS

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Irbesartan NORMON 300 mg film-coated tablets

Irbesartan

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack and other information

1. What is Irbesartan Normon and what is it used for
2. What you need to know before you take Irbesartan Normon
3. How to take Irbesartan Normon
4. Possible side effects
5. Storing Irbesartan Normon

1. Contents of the pack and other information

1. What is Irbesartan Normon and what is it used for

Irbesartan 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 leads to an increase in blood pressure. Irbesartan Normon prevents angiotensin-II from binding to these receptors, relaxing blood vessels and reducing blood pressure. Irbesartan Normon delays the deterioration of kidney function in patients with high blood pressure and type 2 diabetes.

Irbesartan Normon is used to treat high blood pressure (essential hypertension) and to protect the kidneys in patients with high blood pressure, type 2 diabetes, and evidence of altered kidney function.

2. Before taking Irbesartan Normon

Do not takeIrbesartan NORMON:

• if you are allergic (hypersensitive) to irbesartan or any of the other ingredients of Irbesartan 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 that contains aliskiren.

Irbesartan Normon should not be given to children and adolescents (under 18 years).

Warnings and precautions

Consult your doctor before starting to take Irbesartan NORMON:

• if you have excessive vomiting or diarrhea
• if you have kidney problems
• if you have heart problems
• if you are taking Irbesartan Normon for diabetic kidney disease. In this case, your doctor may regularly perform blood tests, especially to measure potassium levels in case of impaired kidney function
• if you are going to have surgery (surgical intervention) or if you are going to be given anesthetics
• if you are taking any of the following medicines used to treat high blood pressure:

• an angiotensin-converting enzyme inhibitor (ACE inhibitor) (e.g., enalapril, lisinopril, ramipril), especially if you have kidney problems related to diabetes
• aliskiren.

Consult your doctor if you experience abdominal pain, nausea, vomiting, or diarrhea after taking Irbesartan NORMON. Your doctor will decide whether to continue treatment. Do not stop taking Irbesartan NORMON on your own.

Your doctor may check 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 Irbesartan NORMON”

If you are pregnant, think you may be pregnant, or are planning to become pregnant, inform your doctor. Irbesartan Normon is not recommended during the first trimester of pregnancy and should not be used during the last 6 months of pregnancy, as it may cause serious harm to your baby, see section Pregnancy and breastfeeding.

Using Irbesartán NORMON with other medicines

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines.

Your doctor may need to change your dose and/or take other precautions:

• if you are taking an angiotensin-converting enzyme inhibitor (ACE inhibitor) or aliskiren (see also the 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 that contain potassium
• potassium-sparing medicines (such as certain diuretics)
• medicines that contain lithium.

If you are using a type of pain reliever known as non-steroidal anti-inflammatory medicines, the effect of irbesartan may be reduced.

Using IRBESARTÁN NORMON with food and drinks

The tablets can be taken with or without food.

Pregnancy and breastfeeding:

You should inform your doctor if you are pregnant, think you may be pregnant, or are planning to become pregnant. Your doctor will normally advise you to take a different medicine instead of Irbesartan Normon, as it is not recommended during the first trimester of pregnancy (the first 3 months) and should not be used during the last 6 months of pregnancy, as it may cause serious harm to your baby. Normally, before you become pregnant, your doctor will switch you to a different blood pressure-lowering medicine. In any case, Irbesartan Normon should not be taken during the second or third trimester of pregnancy or during breastfeeding.

Your doctor will normally advise you to stop taking Irbesartan Normon as soon as you know you are pregnant. If you become pregnant while taking Irbesartan Normon, inform your doctor immediately.

Consult your doctor or pharmacist before using any medicine.

Driving and using machines:

No studies have been performed on the effects on the ability to drive and use machines. It is unlikely that Irbesartan Normon will affect your ability to drive or use machines. However, during treatment for high blood pressure, dizziness or fatigue may occasionally occur. If you experience these symptoms, discuss them with your doctor before driving or using machines.

Irbesartán NORMON 300mg film-coated tablets contain lactose, hydrogenated castor oil, and sodium.

This medicine contains lactose. If your doctor has told you that you have an intolerance to some sugars, consult them before taking this medicine.

This medicine may cause stomach upset 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 of administration of this medicine indicated by your doctor. Consult your doctor or pharmacist if you have any doubts.

Irbesartan Normon is administered orally. The tablets should be swallowed with a sufficient amount of liquid (e.g., a glass of water). Irbesartan Normon can be taken with or without food. You should try to take your daily dose at the same time every day. It is important that you continue to take this medicine until your doctor advises you to stop.

In patients with high blood pressure, the normal dose is 150 mg once daily. Depending on the response to blood pressure, this dose may be increased to 300 mg once daily.

In patients with high blood pressure and type 2 diabetes with kidney damage, the recommended maintenance dose for the treatment of kidney damage is 300 mg once daily.

The maximum blood pressure-lowering effect should be achieved within 4-6 weeks after starting treatment. Your doctor may advise a lower dose, especially at the start of treatment, in certain patients, such as those on hemodialysis or those over 75 years of age.

If you take moreIRBESARTÁN NORMONthan you should:

If you have taken more Irbesartan Normon than you should, consult your doctor, pharmacist, or call the Toxicology Information Service, telephone 91-562 04 20, indicating the medicine and the amount taken.

Children should not take IRBESARTÁN NORMON:

Irbesartan Normon should not be given to children under 18 years of age. If a child swallows several tablets, contact your doctor immediately.

If you forget to takeIRBESARTÁN NORMON:

If you accidentally miss a dose, simply take your normal dose when it is due next.

Do not take a double dose to make up for forgotten doses.

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

4. Possible side effects

Like all medicines, Irbesartan Normon can cause side effects, although not everybody gets them.

Side effects are generally mild and temporary. However, some effects may be serious and may require medical attention.

The side effects listed below are grouped by frequency:

Very common: at least 1 in 10 patients

Common: at least 1 in 100 patients

Uncommon: at least 1 in 1,000 patients

The side effects reported in clinical trials in patients treated with Irbesartan Normon were:

Very common: if you have high blood pressure and type 2 diabetes with kidney damage, blood tests may show an increase in 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). In patients with high blood pressure and type 2 diabetes with kidney damage, dizziness (especially when standing up), low blood pressure (especially when standing up), muscle or joint pain, and decreased levels of a protein present in red blood cells (hemoglobin).

Uncommon: rapid heartbeat, flushing, cough, diarrhea, indigestion/heartburn, sexual dysfunction (sexual function disorders), and chest pain.

Rare: intestinal angioedema: swelling in the intestine that presents with symptoms such as abdominal pain, nausea, vomiting, and diarrhea.

Since the marketing of Irbesartan Normon, some side effects have been reported, but their frequency is not known. These observed side effects are: headache, altered taste, ringing in the ears, muscle cramps, muscle and joint pain, abnormal liver function, increased potassium levels in the blood, kidney failure, and inflammation of small blood vessels, mainly in the skin area (a condition known as leucocytoclastic vasculitis), and a decrease in the number of platelets.

As with similar medicines, in rare cases, allergic skin reactions (skin rash, hives) and localized inflammation in the face, lips, and/or tongue have been reported in patients treated with irbesartan. If you think you may have a reaction of this type or experience shortness of breath, stop taking Irbesartán Normon and go immediately to a medical center.

If you think any of the side effects you are experiencing are serious, or if you notice any side effects not listed in this leaflet, inform your doctor or pharmacist.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the Spanish Medicines and Healthcare Products Agency (AEMPS) via their website: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storing Irbesartán Normon

Keep out of the reach and sight of children.

Store in the original package to protect from light.

Expiry date:

Do not use Irbesartán Normon after the expiry date stated on the packaging after “EXP”. The expiry date is the last day of the month stated.

Medicines should not be disposed of via wastewater or household waste. Return any unused medicine to your pharmacist. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

Composition of Irbesartán NORMON 300 mg film-coated tablets:

The active substance is irbesartan. Each tablet contains 300 mg of irbesartan.

The other ingredients (excipients) are: povidone (E-1201), magnesium stearate, microcrystalline cellulose (E-460), lactose monohydrate, sodium croscarmellose, anhydrous colloidal silica, hydrogenated castor oil, and maize starch.

Appearance of the product and packaging

Irbesartán Normon 300 mg is presented in the form of film-coated 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

IRBESARTÁN NORMON 75 mg film-coated tablets

IRBESARTÁN NORMON 150 mg film-coated tablets

This leaflet was approved inFebruary 2025

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