Irbesartan Almus 300 mg film-coated tablets EFG

Patient Information Leaflet

Introduction

Patient Information Leaflet

Irbesartán Almus 300 mg film-coated tablets EFG

Read the entire 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 personally; do not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you think any of the side effects you experience is severe 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 Irbesartán Almus 300 mg is and what it is used for.
2. What you need to know before taking Irbesartán Almus 300 mg.
3. How to take Irbesartán Almus 300 mg.
4. Possible side effects.
5. How to store Irbesartán Almus 300 mg.
6. Contents of the pack and other 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 binds to receptors, causing blood vessels to constrict. This results in an increase in 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.

Irbesartan Almus 300 mg is used to treat high blood pressure (hypertension) and for 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 300 mg

Do not take Irbesartán Almus 300 mg

• If you are allergic (hypersensitive) to irbesartan or to 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 failure and are being treated with a blood pressure-lowering medicine containing aliskiren.

Irbesartan must not be given 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 have severe vomiting or diarrhoea.

• If you have kidney problems.

• If you have heart problems.

• If you are taking Irbesartán Almus 300 mg for diabetic kidney disease. In this case, your doctor may carry out regular blood tests, especially to measure potassium levels if kidney function is impaired.

• If you are going to undergo surgery or if you are to be given 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 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 300 mg”.

If you are pregnant, suspect you may be pregnant, or plan to become pregnant, you must inform your doctor. Use of Irbesartán Almus 300 mg is not recommended during early pregnancy (first 3 months), and it must not be used during the last 6 months of pregnancy because it may cause serious harm to your baby; see section on pregnancy or breastfeeding.

Use of other medicines

Inform your doctor or pharmacist if you are using, have recently used, or might use 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 300 mg” and “Take special care with Irbesartán Almus 300 mg”).

Generally, Irbesartán Almus 300 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 taking a type of painkiller known as non-steroidal anti-inflammatory drugs (NSAIDs), the effect of irbesartan may be altered.

Taking Irbesartán Almus 300 mg with food and drink:

Irbesartán Almus 300 mg can be taken with or without food. 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 300 mg during early pregnancy (first 3 months), and in no case should it be used during the last 6 months of pregnancy because it may cause serious harm to your baby.

Normally, before you become pregnant, your doctor will replace Irbesartán Almus 300 mg with another appropriate antihypertensive medicine. In any case, Irbesartán Almus 300 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 300 mg as soon as you know you are pregnant. If you become pregnant while being treated with Irbesartán Almus 300 mg, inform and see your doctor immediately.

Driving and use of machines

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

It is unlikely that Irbesartán Almus 300 mg will affect the ability to drive vehicles or use machines. However, during treatment for hypertension, dizziness or fatigue may occasionally occur. If you experience these symptoms, consult your doctor before engaging in such activities.

Irbesartán Almus 300 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 Irbesartán Almus 300 mg

Follow your doctor's instructions for taking Irbesartán Almus 300 mg exactly. Consult your doctor or pharmacist if you have any doubts.

Method of administration:

Irbesartán Almus 300 mg is administered orally. The tablets should be swallowed with a sufficient amount of liquid (for example, a glass of water). Irbesartán Almus 300 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. Subsequently, depending on the blood pressure response, this dose may 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 kidney impairment is 300 mg once daily.

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

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

If you take more Irbesartán Almus 300 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 at telephone number 915 620 420, indicating the medicine and the amount ingested.

Children must not take Irbesartán Almus 300 mg

Irbesartán Almus 300 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 Irbesartán Almus 300 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 a missed dose. If you have any other questions about the use of this product, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, Irbesartán Almus 300 mg may produce adverse effects, although not everyone experiences them.

However, some effects may be serious and may require immediate 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 such a reaction or develop shortness of breath, stop taking Irbesartán Almus 300 mg 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 people.
Common: affects at least 1 in 100 people.
Uncommon: affects at least 1 in 1,000 people.
Rare: affects at least 1 in 10,000 people.

Adverse effects reported in clinical trials conducted in patients treated with Irbesartán Almus 300 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 (impaired 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 disturbances, 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 300 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 properly dispose of any unused medicine and its packaging. This will help protect the environment.

6. Contents of the pack and other information

If you would like further information about your condition or your 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 components are: Core: lactose monohydrate, microcrystalline cellulose E 460i, croscarmellose sodium, hypromellose E 464, anhydrous colloidal silica E 551, magnesium stearate E 470B. Coating: lactose monohydrate, titanium dioxide E 171, hypromellose E464 and macrogol 3350.

Appearance of the product and contents of the pack

White, oblong film-coated tablets.

Presented in a blister pack containing 28 tablets.

Marketing Authorization Holder and Manufacturer

Marketing Authorization 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 review of this leaflet: 02/2025

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/