Irbesartan Pensa 75 mg tablets EFG

Package leaflet: Information for the user

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, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.
• If you think any of the side effects you experience is serious, or if you notice any side effects not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Contents of the leaflet

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

1. What Irbesartan Pensa is and what it is 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 blocks angiotensin-II from binding to these receptors, relaxing blood vessels and thereby reducing blood pressure. Irbesartan Pensa slows down the decline in 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 kidney in patients with high blood pressure, type 2 diabetes, and clinical evidence of impaired kidney function.

2. Before taking Irbesartan Pensa

Do not take Irbesartan Pensa:

• if you are allergic (hypersensitive) to irbesartan or to any of the other components of Irbesartan Pensa.
• if you are more than 3 months pregnant. (In any case, it is better to avoid taking this medicine also during the first trimester of pregnancy – see Pregnancy section).
• if you have diabetes or impaired kidney function and are being treated with a blood pressure-lowering medicine containing aliskiren.

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

Take special care with Irbesartan Pensa:

You must inform your doctor if any of the following apply to you:

• if you have vomiting or excessive diarrhoea
• 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 monitor potassium levels in case of impaired kidney function
• if you are going to undergo surgery or if you will receive anaesthetics
• if you are taking any of the following medicines used to treat high blood pressure (hypertension):
  • 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 diarrhoea after taking Irbesartan Pensa. Your doctor will decide whether to continue treatment. Do not stop taking Irbesartan Pensa on your own.

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

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

If you are pregnant, suspect you may be pregnant, or plan to become pregnant, you must inform your doctor. Use of Irbesartan Pensa is not recommended during early pregnancy (first 3 months) and must not be used from the third month of pregnancy onwards, as it may cause serious harm to your baby (see Pregnancy section).

Use of other medicines

Inform your doctor or pharmacist if you are taking, have recently taken or might take 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 information under the headings “Do not take Irbesartan Pensa” and “Take special care with Irbesartan Pensa”).

You may need to have blood tests if you are taking:

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

If you are using a type of painkiller known as non-steroidal anti-inflammatory drugs (NSAIDs), the effect of irbesartan may be reduced.

Taking Irbesartan Pensa with food and drink

Irbesartan Pensa can be taken with or without food.

Pregnancy and breast-feeding

Pregnancy

Inform your doctor if you are pregnant, suspect you may be pregnant, or plan to become pregnant. Your doctor will usually advise you to stop taking Irbesartan Pensa before becoming pregnant or as soon as pregnancy is confirmed, and will recommend an alternative antihypertensive treatment. Use of Irbesartan Pensa is not recommended during early pregnancy and must not be used from the third month of pregnancy onwards, as it may cause serious harm to your baby when used from that stage.

Breast-feeding

Inform your doctor if you are breast-feeding or plan to breast-feed, as Irbesartan Pensa is not recommended for use in women during this period. Your doctor may choose a treatment more suitable for you if you intend to breast-feed, especially if your baby is a newborn or premature.

Driving and using machines

No studies on the effects on the ability to drive and use machines have been conducted.

It is unlikely that Irbesartan Pensa will affect your ability to drive or operate machinery. However, during treatment for hypertension, dizziness or fatigue may occasionally occur.

If you experience these symptoms, discuss with your doctor before driving or operating machinery.

Important information about some of the ingredients of Irbesartan Pensa

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

This medicine may cause stomach discomfort and diarrhoea because it contains hydrogenated castor oil.

3. How to take Irbesartan Pensa

Follow exactly the instructions for using 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 each day. It is important that you continue taking this medicine until your doctor advises otherwise.

Patients with high blood pressure

The normal dose is 150 mg once daily (two tablets per day). Subsequently, depending on the blood pressure response, this dose may be increased to 300 mg once daily (four tablets per day).

Patients with high blood pressure and type 2 diabetes with kidney impairment

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

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

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

If you take more Irbesartan Pensa than 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 or the Poison Information Service immediately, telephone: 91 562 04 20, stating the medication and the amount taken. Do not forget to bring the container with you, even if it is empty.

Children must not take Irbesartan Pensa

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

If you forget to take Irbesartan Pensa

If you accidentally miss a dose, simply take your next dose at the usual time. Do not take a double dose to make up for forgotten doses.

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

4. Possible adverse effects

Like all medicines, Irbesartan Pensa may cause adverse effects, although not everyone experiences them. However, some of these adverse effects may be serious and require immediate medical attention.

As occurs with similar medicines, rare cases of skin allergic reactions (rash, urticaria) and localized swelling of the face, lips and/or tongue have been reported in patients treated with Irbesartan. If you think you may be experiencing such a reaction or develop shortness of breath, stop taking Irbesartan Pensa and seek immediate medical attention.

The adverse effects listed below are grouped according to their frequency as follows:

Very common: Affects at least 1 in 10 patients.

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

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

Rare: Affects at least 1 in 1,000 patients.

Adverse effects reported in clinical trials conducted in patients treated with Irbesartan Pensa were:

• Very common: If you have high blood pressure and type 2 diabetes with kidney impairment, blood tests may show increased levels of potassium.

• Common: Dizziness, nausea/vomiting, fatigue, and blood tests may show elevated levels of an enzyme that measures muscle and heart function (creatine kinase enzyme). In patients with high blood pressure and type 2 diabetes with kidney impairment, dizziness (especially upon standing), low blood pressure (especially upon standing), muscle or joint pain, and decreased levels of a protein present in red blood cells (haemoglobin).

• Uncommon: Tachycardia, skin redness, cough, diarrhoea, indigestion/acid reflux, sexual dysfunction (alterations in sexual function), and chest pain.

• Rare: Intestinal angioedema: swelling in the intestine presenting symptoms such as abdominal pain, nausea, vomiting and diarrhoea.

Since the marketing of Irbesartan, some adverse effects have been reported, but their frequency is unknown. These observed adverse effects include: headache, taste disturbance, tinnitus, muscle cramps, muscle and joint pain, abnormal liver function, increased blood potassium levels, reduced platelet count, kidney function impairment, and inflammation of small blood vessels, primarily in the skin area (a condition known as leukocytoclastic vasculitis).

Reporting of adverse effects:

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es. By reporting adverse 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 container.

Do not use Irbesartan Pensa after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE Point at your pharmacy. If you have any doubts, ask your pharmacist how to properly dispose of unused medicines and their containers. This will help protect the environment.

6. Additional Information

Composition of Irbesartan Pensa

• The active substance is Irbesartan. Each tablet of Irbesartan Pensa contains 75 mg of Irbesartan.
• The other components are: Povidone (E-1201), magnesium stearate, microcrystalline cellulose (E-460), monohydrate lactose, sodium croscarmellose, colloidal anhydrous silica, hydrogenated castor oil, and corn starch.

Appearance of the medicinal product and contents of the pack

White 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 the most recent review 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/