IRBESARTAN ALMUS 300 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Irbesartan Almus 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 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 and other information

1. What is Irbesartan Almus 300 mg and what is it used for.
2. What you need to know before you take Irbesartan Almus 300 mg.
3. How to take Irbesartan Almus 300 mg.
4. Possible side effects.
5. Storing Irbesartan Almus 300 mg.
6. Contents of the pack and further information.

1. What is Irbesartan Almus 300 mg 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 attaches to receptors, causing blood vessels to constrict. This results in an increase in blood pressure. Irbesartan prevents angiotensin II from attaching to these receptors, relaxing blood vessels and reducing blood pressure. Irbesartan slows the deterioration of kidney function in patients with high blood pressure and type 2 diabetes.

Irbesartan Almus 300 mg is used to treat high blood pressure (hypertension) and to protect the kidneys in hypertensive patients with type 2 diabetes and evidence of kidney damage.

2. What you need to know before you take Irbesartan Almus 300 mg

Do not take Irbesartan Almus 300 mg

• If you are allergic (hypersensitive) to irbesartan or any of the other ingredients of this medicine.
• If you are in the second or third trimester of pregnancy (last 6 months of pregnancy).
• If you are breastfeeding.
• If you have diabetes or kidney problems and are being treated with a blood pressure medicine that contains aliskiren.

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

Warnings and precautions

You should tell your doctorin any of the following cases:

• If you have severe vomiting or diarrhea.
• If you have kidney problems.
• If you have heart problems.
• If you are taking Irbesartan Almus 300 mg 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 Almus. Your doctor will decide whether to continue treatment. Do not stop taking Irbesartan Almus 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 Almus 300 mg”.

If you are pregnant, think you may be pregnant, or plan to become pregnant, inform your doctor. Irbesartan Almus 300 mg is not recommended during the first trimester of pregnancy and should not be used during the last 6 months of pregnancy, as it may cause serious harm to your baby, see section pregnancy and breastfeeding.

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 change your dose and/or take other precautions:

If you are taking an ACE inhibitor or aliskiren (see also the information under the headings “Do not take Irbesartan Almus 300 mg” and “Be especially careful with Irbesartan Almus 300 mg”).

In general, Irbesartan Almus 300 mg does not interact with other medicines.

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

• Potassium supplements.
• Salt substitutes that contain potassium.
• Potassium-sparing medicines.
• Medicines that contain lithium.

If you are taking a type of pain reliever known as non-steroidal anti-inflammatory drugs, the effect of irbesartan may be altered.

Taking Irbesartan Almus 300 mg with food and drinks:

Irbesartan Almus 300 mg can be taken with or without food. The tablets should be swallowed with a sufficient amount of liquid (e.g., a glass of water). Irbesartan Almus 300 mg can be taken with or without food.

Pregnancy and breastfeeding:

Inform your doctor if you are pregnant, think you may be pregnant, or plan to become pregnant. Your doctor will usually advise you to take a different medicine instead of Irbesartan Almus 300 mg during the first trimester of pregnancy and will not recommend its use during the last 6 months of pregnancy, as it may cause serious harm to your baby.

Normally, before you become pregnant, your doctor will switch you to a different blood pressure medicine. In any case, Irbesartan Almus 300 mg should not be taken during the second or third trimester of pregnancy or during breastfeeding.

Usually, your doctor will advise you to stop treatment with Irbesartan Almus 300 mg as soon as you know you are pregnant. If you become pregnant while taking Irbesartan Almus 300 mg, inform your doctor immediately.

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 Almus 300 mg 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 performing these activities.

Irbesartan Almus 300 mg contains lactose and sodium

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

This medicine contains less than 23 mg of sodium (1 mmol) per tablet; this is essentially “sodium-free”.

3. How to take Irbesartan Almus 300 mg

Follow exactly the instructions of administration of Irbesartan Almus 300 mg given by your doctor. Consult your doctor or pharmacist if you have any doubts.

Method of administration:

Irbesartan Almus 300 mg is administered orally. The tablets should be swallowed with a sufficient amount of liquid (e.g., a glass of water). Irbesartan Almus 300 mg 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 advises you to stop.

Patient 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.

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 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.

If you take more Irbesartan Almus 300 mg than you should

If you accidentally take too many tablets, or if a child swallows some, contact your doctor immediately.

In case of overdose or accidental ingestion, go to the nearest hospital or contact the Toxicology Information Service, phone 915 620 420, indicating the medicine and the amount taken.

Children should not take Irbesartan Almus 300 mg

Irbesartan Almus 300 mg tablets should not be given to children under 18 years. If a child swallows several tablets, contact your doctor immediately.

If you forget to take Irbesartan Almus 300 mg

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 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, Irbesartan Almus 300 mg can cause side effects, although not everybody gets them.

However, some effects may 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, hives), 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 Almus 300 mg 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.

Uncommon: at least 1 in 1,000 patients.

Rare: at least 1 in 10,000 patients.

The following side effects were reported in clinical trials in patients treated with Irbesartan Almus 300 mg:

Very common:if you have high blood pressure and type 2 diabetes with kidney damage, blood tests may show high potassium levels.

Common:dizziness, nausea/vomiting, fatigue. 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 disorder), and chest pain.

Since the update 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, 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), reduction in platelet count.

Rare:intestinal angioedema (swelling in the intestine that presents symptoms such as abdominal pain, nausea, vomiting, and diarrhea).

If you think any of the side effects you are experiencing is serious or if you notice any side effects not listed in this leaflet, inform your doctor or pharmacist.

Reporting suspected adverse reactions:

If you experience any side effects, consult your doctor or pharmacist, even if it is a possible side effect not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es.

5. Storing Irbesartan Almus 300 mg

Keep out of the reach and sight of children

Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiry date refers to the last day of the month.

No special storage precautions are required.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and further information

If you want more information about your illness or treatment, you should consult your doctor or pharmacist.

Composition of Irbesartan Almus 300 mg film-coated tablets EFG:

The active substance is irbesartan. Each tablet contains 300 mg of irbesartan.

The other ingredients are: Core: lactose monohydrate, microcrystalline cellulose E 460i, croscarmellose sodium, hypromellose E 464, colloidal anhydrous silica E 551, magnesium stearate E 470B. Coating: lactose monohydrate, titanium dioxide E 171, hypromellose E464, and macrogol 3350.

Appearance and packaging

White, oblong, film-coated tablets.

It is presented in a blister pack with 28 tablets.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Almus Pharmaceutical, S.A.U.

Marie Curie, 54

08840 Viladecans (Barcelona), Spain

Phone: 93 739 71 80

Email: farmacovigilancia@almusfarmaceutica.es

Manufacturer:

Atlantic Pharma – Produções Farmacêuticas, S.A.

Rua De Tapada Grande 2,

Abrunheira, Sintra, 2710-228

Portugal

Date of last revision of this leaflet: 02/2025

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