IRBESARTAN PENSA 300 mg TABLETS

Introduction

Package Leaflet: Information for the User

Irbesartan Pensa 300 mg film-coated tablets EFG

Read all of this leaflet carefully before you start taking this medicine.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

1. What is Irbesartan Pensa and what is it used for
2. Before you take Irbesartan Pensa
3. How to take Irbesartan Pensa
4. Possible side effects
5. Storing Irbesartan Pensa
6. Further information

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

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

Irbesartan Pensa is used

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

2. Before you take Irbesartan Pensa

Do not takeIrbesartan Pensa

• if you are allergic (hypersensitive) to Irbesartan or any of the other ingredients of Irbesartan Pensa.
• if you are pregnant for more than 3 months. (In any case, it is better to avoid taking this medicine also at the beginning of your pregnancy – see section Pregnancy).
• if you have diabetes or kidney insufficiency and are being treated with a blood pressure-lowering medicine that contains aliskiren.

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

Be particularly cautious withIrbesartan Pensa

You must inform your doctorin any of the following cases:

• if you have excessive vomiting or diarrhea
• if you have kidney problems
• if you have heart problems
• if you are taking Irbesartan Pensa 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), particularly if you have kidney problems related to diabetes.
  • Aliskiren

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

Your doctor may check 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 Pensa”

If you are pregnant, think you may be pregnant, or are planning to become pregnant, inform your doctor. Irbesartan Pensa is not recommended during the first trimester of pregnancy and should not be taken after the third month of pregnancy, as it may cause serious harm to your baby (see section Pregnancy).

Using other medicines

Tell your doctor or pharmacist if you are using or have recently used any other medicines, including those obtained without a prescription.

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 Pensa” and “Be particularly cautious with Irbesartan Pensa”)

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.

TakingIrbesartan Pensawith food and drink

Irbesartan Pensa can be taken with or without food.

Pregnancy and breastfeeding

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 Pensa before you become pregnant or as soon as you find out you are pregnant and will recommend that you take another medicine to treat your high blood pressure. Irbesartan Pensa is not recommended during the first trimester of pregnancy and should not be taken after the third month of pregnancy, as it may cause serious harm to your baby.

Breastfeeding

Tell your doctor if you are breastfeeding or about to start breastfeeding, as Irbesartan Pensa is not recommended for women who are breastfeeding. Your doctor may decide to give you a different treatment that is more suitable if you want to breastfeed, especially for newborn or premature babies.

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 Pensa 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.

Important information about some of the ingredients ofIrbesartan Pensa

Irbesartan Pensa contains lactose. If your doctor has told you that you have an intolerance to some sugars (e.g., lactose), consult him before taking this medicine.

This medicine may cause stomach upset and diarrhea because it contains hydrogenated castor oil.

3. How to take Irbesartan Pensa

Follow exactly the instructions of administration of Irbesartan Pensa given by your doctor. Consult your doctor or pharmacist if you have any doubts.

Method of administration

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

Patient with high blood pressure

The normal dose is 150 mg once daily. Depending on the response to blood pressure, this dose may be increased to 300 mg once daily.

Patient 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.

Your doctor may advise a lower dose, especially at the beginning of treatment, in certain patients, such as those on hemodialysis or over 75 years of age.

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

If you take moreIrbesartan Pensathan you should

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

If you have taken more Irbesartan Pensa than you should, consult your doctor or pharmacist immediately or contact the Toxicology Information Service, telephone: 91 562 04 20, indicating the medicine and the amount used. Do not forget to take the packaging with you, even if it is empty.

Children should not take Irbesartan Pensa

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

If you forget to takeIrbesartan Pensa

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 the missed doses.

If you have any further questions about the use of this product, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Irbesartan Pensa can cause side effects, although not everybody gets them. However, some of these side effects can be serious and may require medical attention.

As with similar medicines, in rare cases, allergic skin reactions (rash, urticaria) 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 Pensa and go immediately to a medical center.

The following side effects are grouped by frequency:

Very common:at least 1 in 10 patients.

Common:at least 1 in 100 patients and less than 1 in 10 patients.

Uncommon:at least 1 in 1,000 patients and less than 1 in 100 patients.

Rare:at least 1 in 10,000 patients.

The side effects reported in clinical trials performed in patients treated with Irbesartan Pensa 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, 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, reduced platelet count, kidney function insufficiency, and inflammation of small blood vessels, mainly in the skin area (a condition known as leucocytoclastic vasculitis).

Reporting of side effects:

If you experience any side effects, talk to your doctor or pharmacist, even if it is possible that they are not listed in this leaflet. You can also report side effects directly through the Spanish Medicines and Health Products Agency (AEMPS) website: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storing Irbesartan Pensa

Keep out of the reach and sight of children.

No special storage conditions are required.

Store in the original package.

Do not use Irbesartan Pensa after the expiration date stated on the packaging after EXP. The expiration date is the last day of the month indicated.

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. Further information

Composition of Irbesartan Pensa

• The active substance is Irbesartan. Each Irbesartan Pensa tablet contains 300 mg of Irbesartan.

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

Appearance of the product and packaging contents

White, scored tablets.

Each pack contains 28 tablets.

Marketing authorization holder:

Towa Pharmaceutical, S.A.

C/ de Sant Martí, 75-97

08107 Martorelles (Barcelona)

Spain

Manufacturer:

Laboratorios Liconsa, S.A.

Avd. Miralcampo, nº 7

Polígono Industrial Miralcampo

19200 Azuqueca de Henares (Guadalajara)

Spain

Date of last revision of this leaflet:December 2024

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