IRBESARTAN NORMON 150 mg TABLETS

2. What you need to know before you take Irbesartan Normon

Do not take Irbesartan 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 insufficiency 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 severe 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 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 Irbesartan NORMON”.

If you are pregnant, think you may be pregnant, or plan 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 Irbesartan 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 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
• potassium-containing salt substitutes
• 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 Irbesartan NORMON with food and drink

The tablets can be taken with or without food.

Pregnancy and breastfeeding:

Inform your doctor if you are pregnant, think you may be pregnant, or plan 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 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.

Normally, your doctor will 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.

Consult your doctor or pharmacist before taking 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.

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 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 Irbesartan Normon

Follow exactly the instructions of your doctor or pharmacist. Consult your doctor or pharmacist if you have any doubts.

Irbesartan Normon is taken 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 tells you to stop.

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

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 (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 start of treatment, in certain patients, such as those on hemodialysis or the elderly.

If you take more Irbesartan NORMON than you should:

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

Children should not take Irbesartan NORMON:

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

If you forget to take Irbesartan 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 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, taste disturbance, 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 swelling 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 Irbesartan Normon and go immediately to a medical center.

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

Reporting of side effects

If you get 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 via the Spanish Medicines and Health Products Agency (AEMPS) website: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Irbesartan Normon

Keep out of the reach and sight of children.

Store in the original package to protect from light.

Expiry date:

Do not use Irbesartan 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 further information

Composition of IRBESARTAN NORMON 150 mg film-coated tablets:

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

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

Appearance and packaging of the product

Irbesartan Normon 150 mg is presented in the form of film-coated tablets. They are white, cylindrical, biconvex, and scored. 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 film-coated tablets

IRBESARTAN NORMON 300 mg film-coated tablets

This leaflet was approved in February 2025

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/