Label: information for the user

Irbesartán Almus 300 mg film-coated tablets EFG

Read this label carefully before starting to take the medicine:

• Keep this label, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed for you and should not be given to others, even if they have the same symptoms, as it may harm them.
• If you consider that any of the adverse effects you are experiencing are serious or if you notice any adverse effect not mentioned in this label, inform your doctor or pharmacist. See section 4.

1. What is Irbesartán Almus 300 mg and for what it is used.

2.What you need to know before taking Irbesartán Almus 300 mg.

3. How to take Irbesartán Almus 300 mg.

4. Possible adverse effects.

5. Storage of Irbesartán Almus 300 mg.

6. Contents of the package and additional information.

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

Irbesartán Almus 300 mg is used for the treatment of high blood pressure (hypertension) and for the protection of the kidneys in hypertensive patients with type 2 diabetes and clinical evidence of altered renal function.

Do not take Irbesartán Almus 300 mg

• If you are allergic (hypersensitive) to irbesartán or to any of the other components of this medication.
• 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 insufficiency and are being treated with a medication to lower blood pressure that contains aliskirén.

Irbesartán should not be administered to children and adolescents (under 18 years).

Warnings and precautions

You must inform your doctorin any of the following cases:

• If you have vomiting or diarrhea.
• If you have kidney problems.
• If you have heart problems.
• If you are taking Irbesartán Almus 300 mg for diabetic nephropathy. In this case, your doctor may perform regular blood tests, especially to measure potassium levels in case of renal function deterioration.
• If you are going to be operated (surgical intervention) or if you are going to be administered anesthetics.
• If you are taking any of the following medications used to treat high blood pressure (hypertension):

- an angiotensin-converting enzyme inhibitor (ACE inhibitor) (for example enalapril, lisinopril, ramipril), particularly if you have kidney problems related to diabetes.

- aliskirén

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 renal function, blood pressure, and electrolyte levels in the blood (such as potassium), at regular intervals.

See also the information under the heading “Do not take Irbesartán Almus 300 mg”.

If you are pregnant, if you suspect you may be, or if you plan to become pregnant, you must inform your doctor. Irbesartán Almus 300 mg is not recommended to be used at the beginning of pregnancy (first 3 months) and should not be used in any case during the last 6 months of pregnancy because it may cause severe damage to your baby, see pregnancy or breastfeeding section.

Use of other medications

Inform your doctor or pharmacist if you are using or have recently used other medications, including those purchased without a prescription.

Your doctor may need to modify your dose and/or take other precautions:

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

Irbesartán Almus 300 mg generally does not present interactions with other medications.

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

• Potassium supplements.
• Substitutes for salt that contain potassium.
• Potassium-sparing medications.
• Medications that contain lithium.

If you are using a type of analgesic, known as nonsteroidal anti-inflammatory drugs (NSAIDs), the effect of irbesartán may be modified.

Taking Irbesartán Almus 300 mg with food and drinks:

Irbesartán Almus 300 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, if you suspect you may be, or if you plan to become pregnant. In general, your doctor will advise you to take another medication instead of Irbesartán Almus 300 mg at the beginning of pregnancy (first 3 months) and in no case should it be used during the last 6 months of pregnancy because it may cause severe damage to your baby.

Normally, before becoming pregnant, your doctor will substitute Irbesartán Almus 300 mg with another suitable antihypertensive medication. In any case, Irbesartán Almus 300 mg should not be taken during the second or third trimester of pregnancy or during breastfeeding.

In general, your doctor will advise you to interrupt treatment with Irbesartán Almus 300 mg as soon as you know you are pregnant. If you become pregnant while taking Irbesartán Almus 300 mg, inform and visit your doctor immediately.

Driving and operating machines

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

It is unlikely that Irbesartán Almus 300 mg will modify the ability to drive vehicles or use machines. However, during hypertension treatment, occasional dizziness or fatigue may appear. If you experience these symptoms, you should consult your doctor before performing these activities.

Irbesartán Almus 300 mg contains lactose and sodium

If your doctor has indicated that you have an intolerance to certain sugars, consult with them before taking this medication.

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

Follow exactly the administration instructions for Irbesartán Almus 300 mg provided by your doctor. Consult your doctor or pharmacist if you have any doubts.

Administration Method:

Irbesartán Almus 300 mg is administered orally. The tablets should be swallowed with a sufficient amount of liquid (e.g., a glass of water). Irbesartán 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 essential to continue taking this medication until your doctor advises you otherwise.

Patients with High Blood Pressure

The usual dose is 150 mg once a day. Subsequently, and depending on the blood pressure response, this dose may be increased to 300 mg once a 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 a day.

Your doctor may advise a lower dose, especially at the beginning of treatment, in certain patients, such asthose undergoing hemodialysisorthose 75 years of age or older.

The 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 consult the Toxicology Information Service, phone 915 620 420, indicating the medication and the amount ingested.

Children should not take Irbesartán Almus 300 mg

Irbesartán Almus 300 mg tablets should not be administered 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 forget to take a dose, simply take your regular 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 product, consult your doctor or pharmacist.

Like all medicines, Irbesartán Almus 300 mg can cause side effects, although not everyone will experience them.

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

Like with similar medicines, in rare cases, skin allergic reactions (skin rash, urticaria) have been reported in patients treated with irbesartán, as well as localized inflammation in the face, lips, and/or tongue. If you think you may have this type of reaction or experience shortness of breath,stop taking Irbesartán Almus 300 mg and seek immediate medical attention.

The side effects mentioned below 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 side 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 an increase in 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 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:rapid heartbeat, skin redness, cough, diarrhea, indigestion/heartburn, sexual dysfunction (alteration of sexual function), and chest pain.

Since the irbesartán update, some side effects have been reported, but their frequency is unknown. These observed side effects are: headache, altered taste, tinnitus, muscle cramps, muscle and joint pain, abnormal liver function, increased potassium levels in the blood, kidney function impairment, and inflammation of small blood vessels, mainly in the skin area (a condition known as leukocytoclastic vasculitis),reduction in platelet count.

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

If you consider that any of the side effects you are experiencing are severe or if you notice any side effect not mentioned in this leaflet, inform your doctor or pharmacist.

Reporting of suspected adverse reactions:

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

Keep out of the reach of children

Do not use this medicine after the expiration date that appears on the packaging, after CAD. The expiration date is the last day of the month indicated.

No special storage conditions are required.

Medicines should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the packaging and medicines you no longer need. In this way, you will help protect the environment.

If you want more information about your disease or treatment, you must consult with your doctor or pharmacist.

Composition of Irbesartán Almus 300 mg film-coated tablets:

The active ingredient 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 packaging

Film-coated oblong tablets of white color.

It is presented in a blister pack with 28 tablets.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization:

Almus Farmacéutica, S.A.U.

Marie Curie, 54

08840 Viladecans (Barcelona), Spain

Phone: 93 739 71 80

Email: [email protected]

Responsible for manufacturing:

Atlantic Pharma – Produções Farmacêuticas, S.A.

Rua da Tapada Grande, n.º 2, Abrunheira, 2710-089 Sintra

Portugal

Date of the last review of this leaflet: 02/2025

The detailed and updated information about this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/