PATIENT INFORMATION LEAFLET

Irbesartan NORMON 150 mg tablets EFG

Irbesartan

Read this 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 and should not be given 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:

• if you are allergic (hypersensitive) to irbesartán or to any of the other components of Irbesartán Normon
• during the last 6 months of pregnancy, see Pregnancy and breastfeeding section
• if you are breastfeeding
• if you have diabetes or kidney failure and are being treated with a medication to lower blood pressure that contains aliskirén.

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

• if you have excessive vomiting or diarrhea
• if you have kidney problems
• if you have heart problems
• if you are taking Irbesartán Normon for diabetic nephropathy. In this case, your doctor may perform regular blood tests, especially to measure potassium levels in case of renal dysfunction
• if you are to be operated (surgical intervention) or if you are to be administered anesthetics.
• if you are taking any of the following medications used to treat high blood pressure (hypertension):
• a converting enzyme inhibitor (IECA) (for example enalapril, lisinopril, ramipril), particularly if you have kidney problems related to diabetes
• aliskirén.

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 (for example, potassium), at regular intervals.

See also information under the heading “Do not take Irbesartan NORMON”.

If you are pregnant, if you suspect you may be, or if you plan to become pregnant, you must 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 during the last 6 months of pregnancy as 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 (IECA) or aliskirén (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
• potassium-sparing salt substitutes
• potassium-sparing medications (such as certain diuretics)
• medications containing lithium.

If you are using a type of analgesic, known as non-steroidal anti-inflammatory drugs, 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:

You must inform your doctor if you are pregnant, if you suspect you may be, or if you 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 during the last 6 months of pregnancy as it may cause serious harm to your baby. Normally, before you become pregnant, your doctor will substitute Irbesartán Normon with another suitable antihypertensive medication. In any case, Irbesartán Normon should not be taken during the second or third trimester of pregnancy or during breastfeeding.

Your doctor will usually 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 with your doctor before driving or operating machinery.

Irbesartán NORMON contains 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; this 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. Subsequently, and depending on the blood pressure response, this dose may be increased to 300 mg once a day (2 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 (2 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 more Irbesartán NORMON than you should:

If you have taken more Irbesartán Normon than you should, consult your doctor, pharmacist, or call the Toxicological Information Service, phone 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 take Irbesartán 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 side effects listed below 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, altered taste, tinnitus, muscle cramps, muscle and joint pain, abnormal liver function, increased potassium levels in the blood, renal insufficiency, and inflammation of small blood vessels, mainly in the skin area (a condition known as leukocytoclastic vasculitis), and a reduction in the number of platelets.

Like with similar medications, in rare cases, cases of allergic skin reactions (skin rash, urticaria) have been reported in patients treated with irbesartán, as well as localized inflammation in the face, lips, and/or tongue. 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 are experiencing 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 medication.

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 the packaging and medicines you no longer need at the SIGRE collection pointat the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This will help protect the environment.

Composition of IRBESARTÁN NORMON 150 mg TABLETS

The active ingredient is irbesartán. Each tablet contains 150 mg of irbesartán.

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 packaging

Irbesartán Normon 150 mg is presented in the form oftablets. They are white, cylindrical, biconvex, and scored 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 75 mg TABLETS EFG

IRBESARTÁN NORMON 300 mg TABLETS EFG

This prospectus was approved inFebruary 2025

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