IRBESARTAN PENSA 75 mg TABLETS

Introduction

Package Leaflet: Information for the User

Irbesartan Pensa 75 mg 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, do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any of the side effects, inform your doctor or pharmacist. See section 4.

Contents of the Package Leaflet

1. What is Irbesartan Pensa and what is it used for
2. Before taking Irbesartan Pensa
3. How to take Irbesartan Pensa
4. Possible side effects
5. Storage of 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 leads to 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 down 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 taking 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 best to avoid taking this medicine during the first trimester of pregnancy – see section Pregnancy).
• if you have diabetes or kidney failure 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), 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 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 (first 3 months) and should not be taken after the third month of pregnancy, as it may cause serious harm to your baby (see section Pregnancy).

Use of 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 testsif you are taking:

• potassium supplements
• potassium-containing salt substitutes
• potassium-sparing diuretics (such as certain water pills)
• lithium-containing medicines

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

TakingIrbesartan Pensawith food and drinks

Irbesartan Pensa can be taken with or without food.

Pregnancy and breastfeeding

Pregnancy

Tell your doctor if you are pregnant, think you may be pregnant, or are planning to become pregnant. Your doctor will advise you to stop taking Irbesartan Pensa before you become pregnant or as soon as you find out you are pregnant, and will recommend an alternative blood pressure-lowering medicine. 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 plan to start breastfeeding. Irbesartan Pensa is not recommended for women during breastfeeding. Your doctor may decide to give you a different treatment that is more suitable if you want to breastfeed, especially for newborns or premature babies.

Driving and using machines

No studies have been conducted 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, consult 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 your doctor 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 your doctor's instructions for taking Irbesartan Pensa exactly. Consult your doctor or pharmacist if you have any doubts.

Method of administration

Irbesartan Pensa is taken 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 taking this medicine until your doctor tells you to stop.

Patient with high blood pressure

The usual dose is 150 mg once daily (two tablets daily). Depending on the response to blood pressure, this dose may be increased to 300 mg once daily (four tablets 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 (four tablets daily).

Your doctor may advise a lower dose, especially at the start 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, phone: 91 562 04 20, stating 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 of age. 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 forgotten 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, the following allergic reactions have been reported in patients treated with Irbesartan: skin rash, urticaria, and localized swelling in the face, lips, and/or tongue. If you think you may have an allergic reaction or experience difficulty breathing, stop taking Irbesartan Pensa and seek immediate medical attention.

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 following side effects have been reported in clinical trials with Irbesartan Pensa:

• 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, skin flushing, cough, diarrhea, indigestion/heartburn, sexual dysfunction (sexual function disorders), and chest pain.

• Rare:intestinal angioedema: swelling in the intestine that presents with 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 include: headache, altered taste, ringing in the ears, muscle cramps, muscle and joint pain, abnormal liver function, increased potassium levels in the blood, decreased platelet count, kidney function impairment, and inflammation of small blood vessels, mainly in the skin area (a condition known as leucocytoclastic vasculitis).

Reporting side effects:

If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. You can also report them directly through the Spanish Medicines and Healthcare 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. Storage of 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. Return the packaging and any unused medicine to a pharmacy. If you have any doubts, ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Further information

Composition of Irbesartan Pensa

• The active ingredient is Irbesartan. Each Irbesartan Pensa tablet contains 75 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 corn starch.

Appearance of the product and packaging contents

White tablets.

Each package 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 the last revision of this leaflet:December 2024

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