IRBESARTAN ALTER 300 mg FILM-COATED TABLETS

Introduction

Patient Information: Summary of Product Characteristics

Irbesartan Alter 300 mg film-coated tablets EFG

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• 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 signs of illness 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 Alter and what is it used for
2. What you need to know before you take Irbesartan Alter
3. How to take Irbesartan Alter
4. Possible side effects
5. Storage of Irbesartan Alter
6. Contents of the pack and other information

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

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

Irbesartan Alter is used in adult patients:

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

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

Do not take Irbesartan Alter

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

Warnings and precautions

Consult your doctor or pharmacist before starting to take Irbesartan Alter 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 Alter 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 (hypertension):
• • 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 Alter. Your doctor will decide whether to continue treatment. Do not stop taking Irbesartan Alter on your own.

Your doctor may regularly check your kidney function, blood pressure, and blood electrolyte levels (e.g., potassium).

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

If you are pregnant, think you may be pregnant, or are planning to become pregnant, inform your doctor. Irbesartan Alter is not recommended during the first three months 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).

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 Alter with other medicines

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 Alter” 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.

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 Alter with food and drink

Irbesartan Alter can be taken with or without food.

Pregnancy and breastfeeding

Pregnancy

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 Alter 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.

Irbesartan Alter is not recommended during the first three months of pregnancy and should not be taken after the third month of pregnancy as it may cause serious harm to your baby.

Breastfeeding

Inform your doctor if you are about to start or are already breastfeeding. It is not recommended to take Irbesartan Alter while breastfeeding. Your doctor may decide to give you a different treatment that is more suitable if you want to breastfeed, especially if you are breastfeeding a newborn or premature baby.

Driving and using machines

No studies have been performed on the effects of Irbesartan Alter on the ability to drive and use machines. It is unlikely that Irbesartan Alter 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.

Irbesartan Alter contains lactose

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

3. How to take Irbesartan Alter

Always take this medicine exactly as your doctor has told you. If you are not sure, check with your doctor or pharmacist.

Method of administration

Irbesartan Alter is taken by mouth. The tablets should be swallowed with a sufficient amount of liquid (e.g., a glass of water). Irbesartan Alter can be taken with or without food. Try to take your daily dose at the same time each day. It is important that you continue to take this medicine until your doctor tells you to stop.

• Patients with high blood pressure

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

Your doctor may advise a lower dose, especially when starting treatment, in certain patients, such as those on hemodialysisor over 75 years of age.

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

Use in children and adolescents

Irbesartan Alter 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 Alter than you should

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

In case of overdose or accidental ingestion, go to a Medical Center or consult the Toxicology Information Service, phone 91 562 04 20, indicating the medicine and the amount taken.

If you forget to take Irbesartan Alter

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 forgotten doses.

If you have any further questions on the use of this medicine, 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 can be serious and may need medical attention.

As with similar medicines, rare cases of 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 an allergic reaction or experience difficulty breathing, stop taking Irbesartan Alter and go to a medical center immediately.

The following side effects have been reported in clinical trials in patients treated with Irbesartan:

• 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 (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 (may affect up to 1 in 100 people): rapid heartbeat, flushing, cough, diarrhea, indigestion/heartburn, sexual dysfunction, and chest pain.

Since the marketing of Irbesartan, the following side effects have been reported: feeling of spinning, headache, altered taste, ringing in the ears, muscle cramps, muscle and joint pain, reduced platelet count, abnormal liver function, high potassium levels in the blood, kidney function impairment, and inflammation of small blood vessels, mainly in the skin area (a condition known as leucocytoclastic vasculitis). Rare cases (may affect up to 1 in 1,000 people) of jaundice (yellowing of the skin and/or the whites of the eyes) have also been observed.

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: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Irbesartan Alter

Keep this medicine 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 shown.

No special storage conditions are required. Store in the original package.

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 other information

Composition of Irbesartan Alter

• The active substance is Irbesartan. Each tablet contains 300 mg of irbesartan.
• The other ingredients are: lactose monohydrate, microcrystalline cellulose, hypromellose, sodium croscarmellose, polysorbate 80, anhydrous colloidal silica, magnesium stearate, titanium dioxide (E171), and glycerol triacetate.

Appearance and packaging

White, oblong, film-coated tablets.

The tablets are available in blister packs of 28 tablets.

Marketing authorization holder and manufacturer

Laboratorios Alter, S.A.

C/ Mateo Inurria 30

28036 Madrid

Spain

Date of last revision of this leaflet: February 2025

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