Irbesartan Normon 150 mg tablets EFG

Package leaflet: Information for the user

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Irbesartán NORMON 150 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 and must not be given to other people, even if they have the same symptoms as you, as it could harm them.
• If you experience any side effects, talk to your doctor or pharmacist, even if they are side effects not listed in this leaflet. See section 4.

Leaflet contents:

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

2. What you need to know before taking Irbesartán Normon

3. How to take Irbesartán Normon

4. Possible side effects

5. How to store Irbesartán Normon

6. 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 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 kidneys in patients with high blood pressure, type 2 diabetes, and clinical evidence of impaired kidney function.

2. What you need to know before you start taking Irbesartan Normon

Do not take Irbesartan Normon:

• if you are allergic (hypersensitive) to irbesartan or to 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 an antihypertensive medicine containing aliskiren.

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

Warnings and precautions:

Talk to your doctor before taking Irbesartan Normon

• if you have severe vomiting or diarrhoea
• 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 carry out regular blood tests, especially to measure potassium levels if kidney function is impaired
• if you are due to have surgery or will be receiving 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.

Talk to your doctor if you experience abdominal pain, nausea, vomiting or diarrhoea after taking Irbesartan Normon. Your doctor will decide whether to continue treatment. Do not stop taking Irbesartan 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 Irbesartan Normon”.

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

Use of Irbesartan Normon with other medicines

Tell 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 taking a type of painkiller known as non-steroidal anti-inflammatory drugs (NSAIDs), the effect of irbesartan may be reduced.

Use of Irbesartan 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, think you might be pregnant or are planning to become pregnant. Your doctor will usually advise you to take another medicine instead of Irbesartan Normon, as use of Irbesartan Normon is not recommended during the first three months of pregnancy and must not be used during the last six months of pregnancy because it may cause serious harm to your baby. Usually, before you become pregnant, your doctor will switch you from Irbesartan Normon to another suitable antihypertensive medicine. In any case, Irbesartan Normon must not be taken during the second and third trimesters of pregnancy or during breastfeeding.

Your doctor will usually advise you to stop treatment with Irbesartan Normon as soon as you know you are pregnant. If you become pregnant while taking Irbesartan Normon, inform your doctor immediately and seek medical advice.

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 Irbesartan Normon affects the ability to drive vehicles or operate machinery. However, during treatment for hypertension, dizziness or fatigue may occasionally occur. If you experience these symptoms, talk to your doctor before driving or using machines.

Irbesartan Normon contains lactose, hydrogenated castor oil and sodium.

This medicine contains lactose. If your doctor has told you that you have an intolerance to certain sugars, consult him/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; this is essentially “sodium-free”.

3. How to take Irbesartán Normon

Follow exactly the instructions for use of this medicine as prescribed 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 each day. It is important that you continue taking this medicine until 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 (2 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 (2 tablets per day).

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 Normon 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 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 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 cause adverse effects, although not everyone experiences them.

Adverse effects are generally mild and transient. However, some may be serious and require medical attention.

The adverse effects listed below are grouped according to their frequency as follows:

Very common: Affects at least 1 in 10 patients

Common: Affects at least 1 in 100 patients

Uncommon: Affects at least 1 in 1,000 patients

The 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 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/acid reflux, sexual dysfunction (sexual function disorders), and chest pain.

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

Since the marketing of Irbesartán Normon, some adverse effects have been reported, but their frequency is unknown. These observed adverse effects include: headache, taste disturbances, tinnitus, muscle cramps, muscle and joint pain, abnormal liver function, increased blood potassium levels, renal failure, inflammation of small blood vessels, mainly in the skin area (a condition known as leukocytoclastic vasculitis), and reduced platelet count.

As with 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 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 effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products, 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 date:

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 or household waste. Dispose of unused medicines and their packaging 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. Contents of the pack and other information

Composition of IRBESARTAN NORMON 150 mg TABLETS:

The active substance is irbesartan. Each tablet contains 150 mg of irbesartan.

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

Appearance of the product and contents of the pack

Irbesartan Normon 150 mg is presented as tablets. They are white, cylindrical, 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 300 mg TABLETS EFG

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 Medical Devices (AEMPS) http://www.aemps.gob.es/