Irbesartan Almus 150 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Irbesartán Almus 150 mg film-coated 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 further 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, tell your doctor or pharmacist. See section 4.

Leaflet contents:

1. What Irbesartán Almus 150 mg is and what it is used for.
2. What you need to know before taking Irbesartán Almus 150 mg.
3. How to take Irbesartán Almus 150 mg.
4. Possible side effects.
5. How to store Irbesartán Almus 150 mg.
6. Contents of the pack and other information.

1. What Irbesartán Almus 150 mg is and what it is 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 binds to receptors, causing blood vessels to constrict. This results in increased blood pressure. Irbesartan prevents angiotensin II from binding to these receptors, relaxing blood vessels and thereby lowering blood pressure. Irbesartan slows the decline in renal function in patients with high blood pressure and type 2 diabetes.

Irbesartán Almus 150 mg is used to treat high blood pressure (hypertension) and to provide kidney protection in hypertensive patients with type 2 diabetes and clinical evidence of impaired kidney function.

2. What you need to know before taking Irbesartán Almus 150 mg

Do not take Irbesartán Almus 150 mg

• If you are allergic (hypersensitive) to irbesartan or to any of the other components 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 renal insufficiency and are being treated with a blood pressure-lowering medicine containing aliskiren.

Irbesartan must not be administered to children and adolescents (under 18 years of age).

Warnings and precautions

You must inform your doctor in any of the following cases:

• If you experience severe vomiting or diarrhea.

• If you have kidney problems.

• If you have heart problems.

• If you are taking Irbesartán Almus 150 mg for diabetic kidney disease. In this case, your doctor may perform regular blood tests, especially to monitor potassium levels if kidney function is impaired.

• If you are due to undergo surgery or if you will be receiving 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), particularly if you have kidney problems related to diabetes.

• aliskiren

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

Your doctor may monitor 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 Irbesartán Almus 150 mg”.

If you are pregnant, suspect you may be pregnant, or plan to become pregnant, you must inform your doctor. Irbesartán Almus 150 mg is not recommended during early pregnancy (first 3 months), and must not be used during the last 6 months of pregnancy, as it may cause serious harm to your baby. See the section on pregnancy or breastfeeding.

Use of other medicines

Inform 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 Irbesartán Almus 150 mg” and “Take special care with Irbesartán Almus 150 mg”).

Generally, Irbesartán Almus 150 mg does not present interactions with other medicines.

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

• Potassium supplements.
• Salt substitutes containing potassium.
• Potassium-sparing medicines.
• 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 altered.

Taking Irbesartán Almus 150 mg with food and drinks:

Irbesartán Almus 150 mg can be taken with or without food. The tablets should be swallowed with water.

Pregnancy and breastfeeding:

You must inform your doctor if you are pregnant, suspect you may be pregnant, or plan to become pregnant. Generally, your doctor will advise you to take another medicine instead of Irbesartán Almus 150 mg during early pregnancy (first 3 months), and it must not be used during the last 6 months of pregnancy, as it may cause serious harm to your baby.

Usually, before you become pregnant, your doctor will switch Irbesartán Almus 150 mg to another appropriate antihypertensive medicine. In any case, Irbesartán Almus 150 mg must not be taken during the second or third trimester of pregnancy or during breastfeeding.

Generally, your doctor will advise you to stop treatment with Irbesartán Almus 150 mg as soon as pregnancy is confirmed. If you become pregnant while taking Irbesartán Almus 150 mg, inform and consult your doctor immediately.

Driving and using machines

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

It is unlikely that Irbesartán Almus 150 mg 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, consult your doctor before performing such activities.

Irbesartán Almus 150 mg contains lactose and sodium

If your doctor has informed you that you have an intolerance to certain sugars, consult him 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 150 mg

Follow exactly your doctor's instructions for taking Irbesartan Almus 150 mg. If you have any doubts, consult your doctor or pharmacist.

Method of administration:

Irbesartan Almus 150 mg is administered orally. The tablets should be swallowed with a sufficient amount of liquid (for example, a glass of water). Irbesartan Almus 150 mg may 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 you otherwise.

Patients with high blood pressure

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

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 renal impairment is 300 mg once daily.

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

Maximum blood pressure reduction should be achieved within 4–6 weeks after starting treatment.

If you take more Irbesartan Almus 150 mg than you should

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

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

Children must not take Irbesartan Almus 150 mg

Irbesartan Almus 150 mg tablets 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 Almus 150 mg

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 Almus 150 mg can cause adverse effects, although not everyone experiences them.

However, some effects may be serious and may require medical attention.

As 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 a reaction of this type or have shortness of breath, stop taking Irbesartan Almus 150 mg and go immediately to a medical center.

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.
Uncommon: affects at least 1 in 1,000 patients.
Rare: affects at least 1 in 10,000 patients.

Adverse effects reported in clinical trials conducted in patients treated with Irbesartan Almus 150 mg were:

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

Common: dizziness, nausea/vomiting, fatigue. 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 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: tachycardia, skin redness, cough, diarrhea, indigestion/acid reflux, sexual dysfunction (impairment of sexual function), and chest pain.

Since the update 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, kidney function impairment, and inflammation of small blood vessels, mainly in the skin area (a condition known as leukocytoclastic vasculitis), reduction in the number of platelets.

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

If you consider any of the adverse effects you experience to be severe, or if you notice any adverse effects not listed in this leaflet, inform your doctor or pharmacist.

Reporting suspected adverse reactions:

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 via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es.

5. Storage of Irbesartan Almus 150 mg

Keep out of the reach of children.

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

No special storage conditions are required.

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

6. Contents of the pack and other information

If you would like more information about your condition or your treatment, you should consult your doctor or pharmacist.

Composition of Irbesartan Almus 150 mg film-coated tablets EFG:

The active substance is irbesartan. Each tablet contains 150 mg of irbesartan.

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

Appearance of the product and contents of the pack

Film-coated, oblong tablets, scored on one side and white in colour.

Presented in blister packs containing 28 tablets.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:

Almus Farmacéutica, S.A.U.

Marie Curie, 54

08840 Viladecans (Barcelona), Spain

Telephone: 93 739 71 80

Email: [email protected]

Manufacturer:

Atlantic Pharma – Produções Farmacêuticas, S.A.

Rua De Tapada Grande 2,

Abrunheira, Sintra, 2710-228

Portugal

Date of the most recent revision of this leaflet: February 2025

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