IRBESARTAN LICONSA 150 mg TABLETS

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

Do not take Irbesartan Liconsa

• if you are allergicto irbesartan or any of the other ingredients of this medicine (listed in section 6).
• if you are pregnant for more than 3 months(in any case, it is better to avoid taking irbesartan also at the start of your pregnancy – see section Pregnancy).
• if you have diabetes or kidney problemsand are being treated with a blood pressure-lowering medicine containing aliskiren.

Warnings and precautions

Consult your doctor or pharmacist before starting to take irbesartan and if any of the following applies to you:

• if you have excessive vomiting or diarrhea
• if you have kidney problems
• if you have heart problems
• if you are taking irbesartan 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 have low blood sugar levels(symptoms may include sweating, weakness, hunger, dizziness, trembling, headache, flushing or pallor, numbness, rapid and strong heartbeat), especially if you are being treated for diabetes.
• if you are going to have surgery(surgical intervention) or if you are going to be givenanesthetics.

• 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 the kidney
• aliskiren.

Your doctor may monitor your kidney function, blood pressure, and blood electrolyte levels (e.g., potassium) at regular intervals.

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

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

If you are pregnant, think you may be pregnant, or are planning to become pregnant, inform your doctor. It is not recommended to take irbesartan at the start of pregnancy (first 3 months) and it should not be taken if you have been pregnant for more than 3 months, as it may cause serious harm to your baby (see section Pregnancy).

Children and adolescents

This medicine should not be used in children and adolescents as the safety and efficacy have not been fully established.

Taking Irbesartan Liconsa with othermedicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

Your doctor may need to modify 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 Liconsa” 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 containing lithium.
• repaglinide (a medicine used to lower blood sugar levels)

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

Taking Irbesartan Liconsa with food anddrinks

Irbesartan Liconsa can be taken with or without food.

Pregnancy andbreast-feeding

Pregnancy

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 stop taking irbesartan before you become pregnant or as soon as you know you are pregnant and will advise you to take another medicine to treat your high blood pressure.

It is not recommended to take irbesartan during the first few months of pregnancy and it should not be taken after the third month, as it may cause serious harm to your baby.

Breast-feeding

Inform your doctor if you are breast-feeding or about to start breast-feeding. It is not recommended to use irbesartan in women who are breast-feeding. Your doctor will advise you to use another treatment if you want to breast-feed, especially if your baby is a newborn or premature.

Driving and usingmachines

Irbesartan is unlikely to 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, consult your doctor before driving or using machines.

Irbesartan Liconsa contains lactose

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

Irbesartan Liconsa contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per tablet, which is essentially “sodium-free”.

3. How to take Irbesartan Liconsa

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

Method of administration

Irbesartan is administered orally. The tablets should be swallowed with a sufficient amount of liquid (e.g., a glass of water). Irbesartan 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.

• Patients with high blood pressure

The normal dose is 150 mg (1 tablet) once daily. Later, and depending on the response of the blood pressure, this dose may be increased to 300 mg once daily (2 tablets daily).

• Patients with high blood pressure and type 2 diabetes with kidney damage

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

Your doctor may advise a lower dose, especially at the start of treatment, in certain patients, such as hemodialysis patientsor patients over 75 yearsof age.

The maximum blood pressure-lowering effect should be achieved within 4-6 weeks after starting treatment.

Use in children and adolescents

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

If you take more Irbesartan Liconsa than you should

If you accidentally take too many tablets, contact your doctor immediately.

If you forget to take Irbesartan Liconsa

If you accidentally miss a dose, simply take your normal dose when it is due. 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, this medicine can cause side effects, although not everybody gets them.

Some of these side effects may be serious and may require medical attention.

As with similar medicines, in rare cases, the following allergic reactions have been reported in patients treated with irbesartan: skin reactions (rash, urticaria), as well as localized swelling in the face, lips, and/or tongue. If you think you may have such a reaction or experience difficulty breathing, stop taking irbesartan and seek immediate medical attention.

The following side effects have been reported:

Very common: may affect more than 1 in 10 people

Common: may affect up to 1 in 10 people

Uncommon: may affect up to 1 in 100 people

Rare: may affect up to 1 in 1,000 people

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

• Very common (may affect more than 1 in 10 people): if you have high blood pressure and type 2 diabetes with kidney damage, blood tests may show high potassium levels.
• Common (may affect up to 1 in 10 people): dizziness, nausea/vomiting, fatigue, and blood tests may show high 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 (when standing up from a lying or sitting position), low blood pressure (when standing up from a lying or sitting position), muscle or joint pain, and decreased levels of a protein present in red blood cells (hemoglobin).
• Uncommon (may affect up to 1 in 100 people): rapid heartbeat, flushing, cough, diarrhea, indigestion/heartburn, sexual dysfunction (sexual function disorders), chest pain.
• Rare (may affect up to 1 in 1,000 people): Intestinal angioedema: swelling in the intestine that occurs with symptoms such as abdominal pain, nausea, vomiting, and diarrhea.

Since the marketing of irbesartan, the following side effects have been reported: dizziness, headache, altered taste, ringing in the ears, muscle cramps, muscle and joint pain, decreased red blood cell count (anemia - symptoms may include fatigue, headaches, difficulty breathing when exercising, dizziness, and pallor), reduced platelet count, abnormal liver function, high potassium levels in the blood, kidney function impairment, inflammation of small blood vessels, mainly in the skin area (a condition known as leucocytoclastic vasculitis), severe allergic reactions (anaphylactic shock), and low blood sugar levels. Rare cases of jaundice (yellowing of the skin and/or whites of the eyes) have also been reported.

Reporting of side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Spanish Medicines and Healthcare 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 Liconsa

Keep out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton and blister after EXP.

The expiry date refers to the last day of the month stated.

Store in the original package to protect from light.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and further information

Composition of Irbesartan Liconsa

• The active substance is irbesartan. Each tablet contains 150 mg of irbesartan.
• The other ingredients are microcrystalline cellulose (E460), sodium croscarmellose (E468), lactose monohydrate, magnesium stearate (E572), anhydrous colloidal silica (E551), corn starch, povidone K29/32 (E1201), and hydrogenated ricin oil.

Appearance of Irbesartan Liconsa and contents of thepack

Irbesartan Liconsa 150 mg tablets are white, cylindrical, and biconvex. The tablet can be divided into equal doses.

This medicine is available in blister packs of 14, 28, 56, or 98 tablets.

Not all pack sizes may be marketed.

Marketing authorisation holder andmanufacturer

Marketing authorisation holder:

Laboratorios Liconsa, S.A.

C/Dulcinea S/N

Alcalá de Henares, 28805 Madrid, Spain

Manufacturer

Laboratorios Liconsa, S.A.

Avda. Miralcampo, Nº7, Polígono Industrial Miralcampo

19200 Azuqueca de Henares, Guadalajara, Spain

Date of last revision of this leaflet:January 2025

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