PATIENT INFORMATION LEAFLET

Irbesartan NORMON 75 mg tablets EFG

Irbesartan

Read this leaflet carefully before you start to take 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 and you should not give it to others, even if they have the same symptoms, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

6. Contents of the pack and additional information

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 blood vessels and reducing blood pressure. Irbesartán Normon delays the deterioration of renal 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 kidneys in patients with high blood pressure, type 2 diabetes, and clinical evidence of altered renal function.

Do not take Irbesartán NORMON:

Irbesartán Normon should not be administered to children and adolescents (under 18 years).

Warnings and precautions:

Consult your doctor before starting to take Irbesartán NORMON

Consult 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 in monotherapy.

Your doctor may monitor your renal function, blood pressure, and electrolyte levels in the blood (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, inform your doctor. Irbesartán NORMON is not recommended for use at the beginning of pregnancy (first 3 months) and should not be used in any case in the last 6 months of pregnancy because it may cause serious harm to your baby, see Pregnancy and breastfeeding section.

Use of Irbesartán NORMON with other medications:

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication.

Your doctor may need to modify your dose and/or take other precautions: If you are taking a converting enzyme inhibitor (ACEI) or aliskirén (see also the information under the headings “Do not take Irbesartán NORMON” and “Warnings and precautions”).

You may need to have blood tests if you are taking:

If you are using a type of analgesic, known as non-steroidal anti-inflammatory drugs (NSAIDs), the effect of irbesartán may be reduced.

Use of Irbesartán NORMON with food and beverages:

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 usually advise you to take another medication instead of Irbesartán NORMON, as Irbesartán NORMON is not recommended for use at the beginning of pregnancy (first 3 months) and should not be used in any case in the last 6 months of pregnancy because it may cause serious harm to your baby. Normally, before you become pregnant, your doctor will replace Irbesartán NORMON with another suitable anti-hypertensive medication. In any case, Irbesartán Normon should not be taken during the second or third trimester of pregnancy or during breastfeeding.

Normally, your doctor will advise you to stop treatment with Irbesartán NORMON as soon as you know you are pregnant. If you become pregnant while taking Irbesartán NORMON, inform and visit your doctor immediately.

Consult your doctor or pharmacist before using any medication.

Driving and operating machinery:

No studies have been conducted on the effects on the ability to drive and operate machinery. It is unlikely that Irbesartán NORMON will affect your ability to drive vehicles or operate machinery. However, during hypertension treatment, occasional dizziness or fatigue may occur. If you experience these symptoms, discuss them with your doctor before driving or operating machinery.

Irbesartán NORMON 75 mg tablets contain lactose, ricin oil, and sodium.

This medication contains lactose. If your doctor has indicated that you have a certain sugar intolerance, consult with them before taking this medication.

This medication may cause stomach discomfort or diarrhea because it contains hydrogenated ricin oil.

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

Follow exactly the administration instructions for this medication as indicated by your doctor. Consult your doctor or pharmacist if you have any doubts.

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 every day. It is essential that you continue taking this medication until your doctor advises you otherwise.

In patients with high blood pressure, the usual dose is 150 mg once a day (2 tablets a day). Subsequently, and depending on the blood pressure response, this dose may be increased to 300 mg once a day (4 tablets a day).

In patients with high blood pressure and type 2 diabetes with kidney impairment, the recommended maintenance dose for the treatment of associated renal impairment is 300 mg once a day (4 tablets a day).

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 beginning of treatment, in certain patients, such as those undergoing hemodialysis or those over 75 years old.

?If you take moreIrbesartán NORMONthan you should:

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

?Children should not take Irbesartán NORMON:

Irbesartán Normon should not be administered to children under 18 years old. If a child swallows several tablets, contact your doctor immediately.

?If you forgot to takeIrbesartán NORMON:

If you accidentally forget to take a dose, simply take your regular dose when it is due next.

Do not take a double dose to compensate for the missed doses.

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

Like all medicines, Irbesartán Normon may cause side effects, although not everyone will experience them.

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

The following side effects are grouped by frequency:

Very common: Occurs in at least 1 in 10 patients

Common: Occurs in at least 1 in 100 patients

Uncommon: Occurs in at least 1 in 1,000 patients

The side 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 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 impairment, 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: Tachycardia, skin redness, cough, diarrhea, indigestion/heartburn, sexual dysfunction (sexual function alterations), and chest pain.

Rare: Intestinal angioedema: intestinal swelling presenting symptoms such as abdominal pain, nausea, vomiting, and diarrhea.

Since the marketing of Irbesartán Normon, some side effects have been reported, but their frequency is unknown. These observed side effects are: headache, taste alteration, tinnitus, muscle cramps, muscle and joint pain, abnormal liver function, increased potassium levels in blood, renal insufficiency, and inflammation of small blood vessels, mainly in the skin area (condition known as leukocytoclastic vasculitis), and a decrease in the number of platelets.

Like with similar medicines, in rare cases, skin allergic reactions (skin rash, urticaria) and localized inflammation in the face, lips, and/or tongue have been reported in patients treated with irbesartán. If you think you may have this type of reaction or experience shortness of breath, stop taking Irbesartán Normon and seek immediate medical attention.

If you consider any of the side effects you experience to be serious or if you notice any side effect not mentioned in this leaflet, inform your doctor or pharmacist.

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a side effect not listed in this leaflet. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use, Website:www.notificaRAM.es.By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep out of reach and sight of children.

Store in the original packaging to protect it from light.

Expiration Date:

Do not use Irbesartan Normonafter the expiration date indicated on the packaging after “Cad”. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through drains or in the trash. Dispose of packaging and medicines you no longer need at the SIGRE collection point of the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and medicines you no longer need. In this way, you will help protect the environment.

Composition of Irbesartán NORMON 75 mg Tablets

The active ingredient is irbesartan. Each tablet contains 75 mg of irbesartan.

The other components (excipients) are: Povidone (E-1201), magnesium stearate, microcrystalline cellulose (E-460), lactose monohydrate, sodium croscarmellose, anhydrous colloidal silica, hydrogenated ricin oil, and cornstarch.

Appearance of the Product and Contents of the Package

Irbesartán Normon 75 mg is presented in the form oftablets. They are white, cylindrical, and biconvex tablets.Each package contains 28 tablets.

Holder of the Marketing Authorization and Responsible for Manufacturing:

Laboratorios Normon, S.A.

Ronda de Valdecarrizo, 6 – 28760 Tres Cantos – Madrid (SPAIN)

OTHER PRESENTATIONS

IRBESARTÁN NORMON 150 mg TABLETS EFG

IRBESARTÁN NORMON 300 mg TABLETS EFG

This leaflet has been approved inFebruary 2025

The detailed and updated information of this medication is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/