IRBESARTAN LICONSA 300 mg TABLETS

Introduction

Leaflet: information for theuser

Irbesartan Liconsa 300 mg tabletsEFG

Read the entire leaflet carefully before starting to take themedicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed to you only, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience side effects, consult your doctor, pharmacist, even if they are side effects not listed in this leaflet. See section 4.

Contents of theleaflet:

1. What is Irbesartan Liconsa and what is it used for
2. What you need to know before taking Irbesartan Liconsa
3. How to take Irbesartan Liconsa
4. Possible side effects
5. Storage of Irbesartan Liconsa
6. Contents of the pack and additional information

1. What is Irbesartan Liconsa and what is it used for

Irbesartan 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, contracting blood vessels.

This causes an increase in blood pressure. Irbesartan prevents angiotensin-II from binding to these receptors, relaxing blood vessels and reducing blood pressure. Irbesartan slows down the deterioration of kidney function in patients with high blood pressure and type 2 diabetes.

Irbesartan is used in adults:

• to treat high blood pressure (essential hypertension)
• to protect the kidneys in patients with high blood pressure, with type 2 diabetes and with clinical evidence of impaired kidney function.

2. What you need to know before taking Irbesartan Liconsa

Do not take Irbesartan Liconsa

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

Warnings and precautions

Consult your doctor or pharmacist before starting to take irbesartan and if any of the following aspects affect 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, tremors, headache, flushing or paleness, 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 plan to become pregnant, you must inform your doctor. It is not recommended to take irbesartan at the beginning of pregnancy (first 3 months) and it should not be taken if you have been pregnant for more than three months, as it may cause serious harm to your baby (see the section "Pregnancy").

Children and adolescents

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

Taking Irbesartan Liconsa and othermedicines

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

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 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 that contain 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 andbreastfeeding

Pregnancy

You should inform your doctor if you are pregnant, think you may be pregnant, or plan to become pregnant. Your doctor will usually advise you to stop taking irbesartan before becoming pregnant or as soon as you become pregnant and recommend taking another anti-hypertensive medicine instead.

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

Breastfeeding

Tell your doctor if you are breastfeeding or about to start breastfeeding. It is not recommended to use irbesartan in breastfeeding women. Your doctor will advise you on another treatment if you want to breastfeed your baby, especially if it is a newborn or premature baby.

Driving and usingmachines

It is unlikely that irbesartan will affect your ability to drive or use machines. However, during hypertension treatment, 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 certain sugars, consult with them 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 your doctor's instructions for taking irbesartan exactly. Consult your doctor or pharmacist if you have any doubts.

Method of administration

Irbesartan is taken 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 every day at the same time. It is important that you continue taking this medicine until your doctor advises you otherwise.

• Patients with high blood pressure

The normal dose is 150 mg (half a tablet) once a day. Later, and depending on the response of the blood pressure, this dose can be increased to 300 mg once a day (1 tablet a day).

• 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 a day (1 tablet a day).

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

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 given 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 next. Do not take a double dose to make up for missed doses.

If you have any other questions about the use of this product, consult 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 can be serious and may require medical attention.

As with similar medicines, in rare cases, the following side effects have been reported in patients treated with irbesartan: allergic skin reactions (skin rash, urticaria), as well as localized inflammation in the face, lips, and/or tongue. If you think you may have a reaction of this type or experience shortness of breath, stop taking irbesartan and go immediately to a medical center.

The following side effects are grouped by frequency:

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 an increase in potassium levels.
• Common (may affect up to 1 in 10 people): 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 (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 of the skin, 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, some side effects have been reported. The side effects with unknown frequency are: feeling of spinning, headache, altered taste, ringing in the ears, muscle cramps, muscle and joint pain, decreased number of red blood cells (anemia - symptoms may include fatigue, headaches, difficulty breathing when exercising, dizziness, and paleness), reduced number of platelets, abnormal liver function, increased potassium levels in the blood, kidney failure, 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. Jaundice (yellowing of the skin and/or whites of the eyes) has also been observed in rare cases.

Reporting side effects

If you experience any side effects, consult your doctor or pharmacist, even if they are possible side effects not listed in this leaflet. You can also report them directly through the Spanish Medicines and Healthcare Products Agency's (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 sight and reach of children.

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

The expiry date is the last day of the month indicated.

Store in the original package to protect from light.

Medicines should not be disposed of via wastewater or household waste. Place the packaging and any unused medicines in the pharmacy's SIGRE collection point. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medicines. This will help protect the environment.

6. Contents of the pack and additional information

Composition of Irbesartan Liconsa

• The active ingredient is irbesartan. Each tablet contains 300 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 castor oil.

Appearance of Irbesartan Liconsa and contents of thepack

Irbesartan Liconsa 300 mg tablets are white, oblong, and biconvex tablets. 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 authorization holder andmanufacturer

Marketing authorization 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/.