Product Information for the Patient

Irbesartan Alter 300 mg Film-Coated Tablets

Read this entire product information carefully before starting to take this medicine, as it contains important information for you.

• Keep this product information, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed only for you, and you should not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this product information. See section 4.

Irbesartan Alter belongs to a group of medications 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 Alter prevents the binding of angiotensin-II to these receptors, relaxing blood vessels and reducing blood pressure. Irbesartan Alter slows the deterioration of renal function in patients with high blood pressure and type 2 diabetes.

Irbesartan Alter 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 Irbesartan Alter

• if you areallergicto irbesartan or 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 have diabetes or kidney failure and are being treated with a medication to lower blood pressure that contains aliskirén.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Irbesartan Alter andif any of the following aspects affect you.

• if you haveexcessive vomiting or diarrhea
• if you havekidney problems
• if you haveheart problems
• if you are taking Irbesartan Alter fordiabetic nephropathy. In this case, your doctor may perform regular blood tests, especially to measure potassium levels in case of impaired renal function
• if you are to be operated(surgical intervention) orif you are to be administered anesthetics
• if you are taking any of the following medications used to treat high blood pressure (hypertension):
• • a converting enzyme inhibitor (ACEI) (such as 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 Irbesartan Alter. Your doctor will decide whether to continue treatment. Do not stop taking Irbesartan Alter in monotherapy.

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 Irbesartan Alter”.

If you are pregnant, if you suspect you may beor if you plan to become pregnant, you must inform your doctor. It is generally recommended that you stop taking Irbesartan Alter before becoming pregnant or as soon as you become pregnant and your doctor will recommend taking another antihypertensive medication instead. Irbesartan Alter is not recommended for use at the beginning of pregnancy and should not be administered at all after 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.

Taking Irbesartan Alter with other medications

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication.

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

if you are taking an ACEI or aliskirén (see also the information under the headings “Do not take Irbesartan Alter” and “Warnings and precautions”).

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

• potassium supplements
• potassium-sparing salt substitutes
• potassium-saving medications (such as certain diuretics)
• medications containing lithium.

If you are using a type of analgesic, known as non-steroidal anti-inflammatory drugs, the effect of Irbesartan may be reduced.

Taking Irbesartan Alter with food and drinks

Irbesartan Alter can be taken with or without food.

Pregnancy and breastfeeding

Pregnancy

You must inform your doctor if you are pregnant, if you suspect you may beor if you plan to become pregnant. Generally, your doctor will advise you to stop taking Irbesartan Alter before becoming pregnant or as soon as you become pregnant and recommend taking another antihypertensive medication instead. Irbesartan Alter is not recommended for use at the beginning of pregnancy and should not be administered at all after 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 Irbesartan Alter 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 machinery

No studies have been conducted on the effects on the ability to drive and operate machinery. It is unlikely that Irbesartan Alter will modify the ability to drive vehicles or operate machinery. However, during hypertension treatment, occasional dizziness or fatigue may occur. If you experience these symptoms, consult your doctor before driving or operating machinery.

Irbesartan Alter contains lactose

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

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

Administration Method

Irbesartan Alter is administered byoral route. The tablets should be swallowed with a sufficient amount of liquid (e.g. a glass of water). Irbesartan Alter can be taken with or without food. You should try to take your daily dose at the same time every day. It is essential that you 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 Renal Alteration

In patients with high blood pressure and type 2 diabetes, the recommended maintenance dose for the treatment of associated renal alteration is 300 mg once a day.

Your doctor may advise a lower dose, especially at the beginning of treatment, in certain patients, such ashemodialysispatients or thoseover 75 years old.

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

Use in Children and Adolescents

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

If You Take More Irbesartan Alter Than You Should

If you accidentally take too many tablets, contact your doctor immediately.

In case of overdose or accidental ingestion, go to a Medical Center or consult the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

If You Forget to Take Irbesartan Alter

If you accidentally forget to take a dose, simply take your regular dose when it is due again. 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, patients treated with Irbesartan have reported cases of skin allergic reactions (skin rash, urticaria), as well as localized inflammation in the face, lips, and/or tongue. If you think you may be having this type of reaction or experience shortness of breath,stop taking Irbesartan Alter and seek immediate medical attention.

The side effects mentioned below are grouped by their frequency.

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

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

Since the marketing of Irbesartan, some side effects have been reported. The side effects observed with unknown frequency (the frequency cannot be estimated from the available data) are: feeling of spinning, headache, altered taste, ringing in the ears, muscle cramps, muscle and joint pain, reduced platelet count, abnormal liver function, increased potassium levels in the blood, kidney function impairment, and inflammation of small blood vessels, mainly in the skin area (condition known as leukocytoclastic vasculitis. Also, cases of jaundice (yellowing of the skin and/or the white part of the eyes) have been observed in rare cases (may affect up to 1 in 100 people).

The side effects observed with rare frequency (may affect up to 1 in 1,000 people) are: Angioedema intestinal: swelling in the intestine that presents symptoms such as abdominal pain, nausea, vomiting, and diarrhea.

Reporting of side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is possible side effects that do not appear in this prospectus. You can also report them directly through the Spanish System of 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 this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the box and on the blister after CAD. The expiration date is the last day of the month indicated.

No special storage conditions are required. Store in the original packaging.

Medications should not be disposed of through drains or in the trash. Dispose of the containers and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medications you no longer need. By doing so, you will help protect the environment.

Composition of Irbesartan Alter

• The active ingredient is Irbesartan. Each tablet contains 300 mg of irbesartan.
• The other components are: lactose monohydrate, microcrystalline cellulose, hypromellose, sodium croscarmellose, polisorbate 80, anhydrous colloidal silica, magnesium stearate, titanium dioxide (E171), and triacetin.

Appearance of the product and contents of the packaging

Coated tablets, white in color, and oblong in shape.

The tablets are presented in blister packs of 28 tablets.

Holder of the marketing authorization and responsible manufacturer

Laboratorios Alter, S.A.

C/ Mateo Inurria 30

28036 Madrid

Spain

Last review date of this leaflet: February 2025

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