Irbesartan Alter 150 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Irbesartan Alter 150 mg film-coated tablets EFG

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

• Keep this leaflet. 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 other people, even if they have the same symptoms as you, because it may harm them.
• If you get any side effects, talk to your doctor or pharmacist. This includes any side effects not listed in this leaflet. See section 4.

Contents of this leaflet

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

1. What is Irbesartan Alter and what is it used for?

Irbesartan Alter 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 Alter prevents angiotensin-II from binding to these receptors, relaxing blood vessels and thereby lowering blood pressure. Irbesartan Alter slows the decline in kidney 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 impaired kidney function.

2. What you need to know before taking Irbesartan Alter

Do not take Irbesartan Alter

• if you are allergic to irbesartan or to any of the other ingredients of this medicine (listed in section 6)
• if you are more than 3 months pregnant. (In any case, it is better to avoid taking this medicine also during early pregnancy – see Pregnancy section)
• if you have diabetes or kidney failure and are being treated with a blood pressure-lowering medicine containing aliskiren.

Warnings and precautions

Talk to your doctor or pharmacist before taking Irbesartan Alter and if any of the following apply to you.

• if you have excessive vomiting or diarrhoea
• if you have kidney problems
• if you have heart problems
• if you are taking Irbesartan Alter 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 due to undergo surgery (operation) 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 Irbesartan Alter. Your doctor will decide whether to continue treatment. Do not stop taking Irbesartan Alter when used as monotherapy.

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 Irbesartan Alter”.

If you are pregnant, think you might be pregnant or plan to become pregnant, you must inform your doctor. The use of Irbesartan Alter is not recommended during the first trimester of pregnancy (first 3 months), and must not be administered from the third month of pregnancy onwards, as it may cause severe harm to your baby (see section Pregnancy).

Children and adolescents

This medicine should not be used in children and adolescents, as safety and efficacy have not yet been established.

Taking Irbesartan Alter with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken or might need to take any other medicines.

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 Irbesartan Alter” and “Warnings and precautions”).

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

• potassium supplements
• salt substitutes containing potassium
• potassium-sparing medicines (such as certain diuretics)
• 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 reduced.

Taking Irbesartan Alter with food and drink

Irbesartan Alter can be taken with or without food.

Pregnancy and breastfeeding

Pregnancy

You must inform your doctor if you are pregnant, think you might be pregnant or 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 will recommend an alternative antihypertensive medicine. Irbesartan Alter is not recommended during early pregnancy and must not be used from the third month of pregnancy onwards, as it may cause severe harm to your baby when administered from that time.

Breastfeeding

Inform your doctor if you are planning to breastfeed or are currently breastfeeding, as Irbesartan Alter is not recommended for women during this period. Your doctor may decide to prescribe a treatment more suitable if you wish to breastfeed, especially if the baby is a newborn or premature.

Driving and using machines

No studies on the effects on the ability to drive and use machines have been performed. It is unlikely that Irbesartan Alter 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 driving or using machines.

Irbesartan Alter contains lactose

If your doctor has informed you that you have an intolerance to certain sugars, consult him before taking this medicine.

3. How to take Irbesartan Alter

Follow exactly the instructions for use of this medicine as given by your doctor. If in doubt, consult your doctor or pharmacist again.

Method of administration

Irbesartan Alter is administered orally. 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 each day. It is important that you continue taking this medicine unless 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 (two tablets per 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 daily (two tablets per day).

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

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

Use in children and adolescents

Irbesartan Alter must not be given to children under 18 years of age. 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 Centre or contact the Toxicology Information Service, telephone 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Irbesartan Alter

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 missed doses.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

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

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

The adverse effects listed below are grouped according to their frequency.

Adverse 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 increased 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 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 (haemoglobin).
• Uncommon (may affect up to 1 in 100 people): tachycardia, skin redness, cough, diarrhoea, indigestion/heartburn, sexual dysfunction (disturbances in sexual function), and chest pain.

Since the marketing of Irbesartan, some adverse effects have been reported. Adverse effects observed with frequency not known (frequency cannot be estimated from available data) include: sensation of spinning, headache, taste disturbance, tinnitus, muscle cramps, muscle and joint pain, reduction in platelet count, 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). Rare cases (may affect up to 1 in 1,000 people) of jaundice (yellowing of the skin and/or whites of the eyes) have also been observed.

Adverse effects observed with rare frequency (may affect up to 1 in 1,000 people) are: Intestinal angioedema: swelling in the intestine presenting symptoms such as abdominal pain, nausea, vomiting, and diarrhoea.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Irbesartan Alter

Keep this medicine out of sight and reach of children.

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

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

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE point at your pharmacy. If you are unsure, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Irbesartan Alter

• The active substance is Irbesartan. Each tablet contains 150 mg of irbesartan.
• The other components are: monohydrate lactose, microcrystalline cellulose, hypromellose, sodium croscarmellose, polysorbate 80, anhydrous colloidal silica, magnesium stearate, titanium dioxide (E171) and glyceryl triacetate.

Appearance of the product and contents of the pack

Film-coated tablets, white in colour, round and biconvex.

The tablets are presented in blister packs containing 28 tablets.

Marketing Authorization Holder and Manufacturer

Laboratorios Alter S.A.
C/ Mateo Inurria 30
28036 Madrid
Spain

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 of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/.