Package Leaflet: Information for the User

Irbesartán Stada 300 mg Tablets EFG

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

• 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 only. Do not pass it on to others even if they have similar symptoms, as it may harm them.
• If you experience any side effects, talk to your doctor or pharmacist. See section 4.

Contents of thePackage Leaflet

1.What Irbesartán Stada is and what it is used for

2.What you need to know before you start taking Irbesartán Stada

3.How to take Irbesartán Stada

4.Possible side effects

5.Storage of Irbesartán Stada

6.Contents of the pack 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 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 clinical evidence of altered renal function.

Do not take IrbesartánStada

• if you areallergicto irbesartán or to any of the other components of this medication (listed in section 6)
• if you aremore than 3 months pregnant.(In any case, it is better to avoid taking this medication also at the beginning of your pregnancy – see Pregnancy section)
• if you havediabetes or kidney insufficiencyand are being treated with a medication to lower blood pressure that contains aliskirén

Warnings and precautions

Consult your doctor before starting to take Irbesartán Stada andif any of the followingaspects affect you:

• if you haveexcessive vomiting or diarrhea
• if you havekidney problems
• if you haveheart problems
• if you are taking irbesartán fordiabetic nephropathy. In this case, your doctor may perform regular blood tests, especially to measure potassium levels in case of renal dysfunction
• if you presentlow blood sugar levels(symptoms may include sweating, weakness, hunger, dizziness, tremors, headache, flushing or pallor, numbness, rapid and strong heartbeats), especially if you are being treated for diabetes
• ifyou are to be operated(surgical intervention) orif you are to receive anesthetics
• if you are taking any of the following medications used to treat high blood pressure (hypertension):

-a converting enzyme inhibitor (ACEI) (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 Stada. Your doctor will decide whether to continue treatment. Do not stop taking Irbesartán Stada 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 Stada”.

If you are pregnant, if you suspect you may beor if you plan to becomepregnant, inform your doctor. Irbesartán is not recommended for use at the beginning of pregnancy (first 3 months), and in no case should it be administered from the third month of pregnancy, as it may cause serious harm to your baby (see Pregnancy section).

Children and adolescents

This medication should not be used in children and adolescents as its safety and efficacy have not been fully established.

Othermedicinesand Irbesartán Stada

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication.

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

if you are taking a converting enzyme inhibitor (ACEI) or aliskirén (see also the information under the headings “Do not take Irbesartán Stada” and “Warnings and precautions”).

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

• potassium supplements
• potassium-containing salt substitutes
• potassium-sparing medications (such as certain diuretics)
• medications containing lithium
• repaglinide (a medication used to reduce blood sugar levels)

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

Irbesartán Stadawith food and drinks

Irbesartán can be taken with or without food.

Pregnancyandbreastfeeding

If you are pregnant, breastfeeding, or suspect you may beor plan to becomepregnant, consult your doctor or pharmacist before using this medication.

Pregnancy

You should inform your doctor if you are pregnant, if you suspect you may beor if you plan to becomepregnant. Your doctor will usually advise you to stop taking irbesartán before becoming pregnant or as soon as you become pregnant and recommend taking another antihypertensive medication instead. Irbesartán is not recommended for use at the beginning of pregnancy and should not be administered from the third month of pregnancy as it may cause serious harm to your baby when administered from that point onwards.

Breastfeeding

Inform your doctor if you plan to start or are breastfeeding, as irbesartán is not recommended for use during this period. Your doctor may decide to administer a more suitable treatment if you want to breastfeed, especially for newborns or premature babies.

Driving and operating machines

It is unlikely that irbesartán will affect your ability to drive vehicles or use machines. However, during hypertension treatment, dizziness or fatigue may occasionally occur. If you experience these symptoms, inform your doctor before driving or using machines.

Irbesartán Stadacontains lactose and sodium

This medication contains lactose. If your doctor has indicated that you have a certain sugar intolerance, consult with them before taking this medication.

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

Follow exactly the administration instructions for this medication as indicated by your doctor. If in doubt, consult your doctor or pharmacist again.

Administration Method:

Irbesartán Stada is administered orally. The tablets should be swallowed with a sufficient amount of liquid (e.g., a glass of water). Irbesartán 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 as those undergoing hemodialysis or those over 75 years old.

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

Use in Children and Adolescents

Irbesartán should not be administered to children under 18 years old. If a child swallows several tablets, contact your doctor immediately.

If You Take More Irbesartán Stada Than You Should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately, or call the Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested. It is recommended to bring the packaging and the medication leaflet to the healthcare professional.

If You Forget to Take Irbesartán Stada

If you accidentally forget to take a dose, simply take your regular dose when it is due next. Do not take a double dose to compensate for the missed doses.

If you have any other questions about the use of this medication, consult your doctor or pharmacist.

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

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

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

The side effects mentioned below are grouped by frequency:

Very frequent: may affect more than 1 in 10 people.

Frequent: may affect up to 1 in 10 people.

Infrequent: may affect up to 1 in 100 people.

The side effects reported in clinical trials conducted in patients treated with Irbesartan Stada were:

• Very frequent(may affect more than 1 in 10 people): if you have high blood pressure and type 2 diabetes with kidney impairment, blood tests may show an increase in potassium levels.

• Frequent(may affect up to 1 in 10 people): dizziness, nausea/vomiting, fatigue, and 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).

• Infrequent(may affect up to 1 in 100 people): tachycardia, skin redness, cough, diarrhea, indigestion/heartburn, sexual dysfunction (sexual function alterations), and chest pain.

• Rare(may affect up to 1 in 1000 people): intestinal angioedema: intestinal swelling that presents symptoms such as abdominal pain, nausea, vomiting, and diarrhea.

Since the marketing of irbesartan, some side effects have been reported. The side effects observed with unknown frequency are: feeling of spinning, headache, taste alteration, ringing in the ears, muscle cramps, muscle and joint pain,decreased red blood cell count (anemia – symptoms may include fatigue, headaches, difficulty breathing during exercise, dizziness, and paleness),reduced platelet count, abnormal liver function, increased potassium levels in blood, kidney function impairment, inflammation of small blood vessels, mainly in the skin area (condition known as leukocytoclastic vasculitis), severe allergic reactions (anaphylactic shock), and low blood sugar levels. Cases of rare ictericia (yellowing of the skin and/or white of the eyes) have also been observed.

Reporting of side effects:

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep out of the sight and 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.

Store in the original packaging to protect it from light.

Medicines should not be disposed of through drains or in the trash. Dispose of the packaging and medicines you no longer need at the SIGRE collection point of the pharmacy. Ask your pharmacist how to dispose of the packaging and medicines you no longer need. This will help protect the environment.

Composition ofIrbesartánStada

-The active ingredient is irbesartan. Each tablet contains 300 mg of irbesartan.

-The other components are: povidone (E-1201), magnesium stearate, microcrystalline cellulose (E-460), lactose monohydrate, croscarmellose sodium, anhydrous colloidal silica, hydrogenated ricin oil, cornstarch.

Appearance of the product and content of the packaging

The Irbesartán Stada 300 mg tablets are white, oblong, biconvex, and scored.

The score is only for breaking the tablet if it is difficult to swallow whole.

The Irbesartán Stada 300 mg tablets are presented in blister packaging of 28 tablets.

Holder of the marketing authorization and responsible for the manufacture

Holder of the marketing authorization

STADA, S.L. Laboratory

Frederic Mompou, 5

08960, Sant Just Desvern (Barcelona)

Spain

[email protected]

Responsible for the manufacture

Liconsa, S.A. Laboratories

Avd. Miralcampo, nº 7

Polígono Industrial Miralcampo

19200 Azuqueca de Henares (Guadalajara)

Spain

Date of the last review of this leaflet:February 2025

The detailed and updated information of this medicine is available on the webpage of the Spanish Agency of Medicaments and Sanitary Products (AEMPS)http://www.aemps.gob.es/