Irbesartan Stada 300 mg tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Irbesartan Stada 300 mg 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 further 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 experience any adverse reactions, talk to your doctor or pharmacist, even if the adverse reactions are not listed in this leaflet. See section 4.

Contents of the leaflet

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

1. What is Irbesartan Stada 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 leads to an increase in blood pressure. Irbesartan blocks 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 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 Irbesartán Stada

Do not take Irbesartán Stada

• 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 before starting to take Irbesartán Stada and if any of the following apply to you:

• if you have excessive vomiting or diarrhea

• if you have kidney problems

• if you have heart problems

• if you are taking irbesartan for diabetic kidney disease. In this case, your doctor may perform regular blood tests, especially to measure potassium levels in case of impaired kidney function

• if you have low blood sugar levels (symptoms may include sweating, weakness, hunger, dizziness, trembling, headache, flushing or paleness, numbness, rapid and strong heartbeat), especially if you are being treated for diabetes

• if you are going to have surgery (operation) or if you are to receive anesthetics

• 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.

Talk to 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 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 Stada”.

If you are pregnant, suspect you may be pregnant, or plan to become pregnant, you must inform your doctor. Use of irbesartan is not recommended during early pregnancy (first 3 months), and it must not be administered from the third month of pregnancy onward, as it may cause severe harm to your baby (see Pregnancy section).

Children and adolescents

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

Other medicines and Irbesartán Stada

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 Irbesartán Stada” 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
• repaglinide (a medicine used to lower blood sugar levels)

If you are using a type of painkiller known as non-steroidal anti-inflammatory drugs (NSAIDs), the effect of irbesartan may be reduced.

Taking Irbesartán Stada with food and drink

Irbesartan can be taken with or without food.

Pregnancy and breastfeeding

If you are pregnant, breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

Pregnancy

Inform your doctor if you are pregnant, suspect you may be pregnant, or plan to become pregnant. Your doctor will usually advise you to stop taking irbesartan before becoming pregnant or as soon as pregnancy is confirmed, and will recommend an alternative antihypertensive medicine. Irbesartan is not recommended during early pregnancy and must not be used from the third month of pregnancy onward, as it may cause severe harm to your baby when used from that stage.

Breastfeeding

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

Driving and using machines

It is unlikely that irbesartan will affect your ability to drive or operate machinery. However, during treatment for hypertension, dizziness or fatigue may occasionally occur. If you experience these symptoms, discuss them with your doctor before driving or operating machinery.

Irbesartán Stada contains lactose and sodium

This medicine contains lactose. If your doctor has informed you that you have an intolerance to certain sugars, consult with 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 Stada

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

Method of administration:

Irbesartán Stada is administered orally. The tablets should be swallowed with a sufficient amount of liquid (e.g., a glass of water). Irbesartán 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 patients over 75 years of age.

Maximum blood pressure reduction is expected to be achieved within 4–6 weeks after starting treatment.

Use in children and adolescents

Irbesartán 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 Irbesartán Stada than you should

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately, or call the Toxicology Information Service at: 91 562 04 20, stating the medicine and the amount ingested. It is recommended to bring the medicine package and leaflet to the healthcare professional.

If you forget to take Irbesartán Stada

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 the missed dose.

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 irbesartán and seek immediate medical attention.

The adverse effects listed below are grouped according to their frequency as follows:

Very common: may affect more than 1 in 10 people.
Common: may affect up to 1 in 10 people.
Uncommon: may affect up to 1 in 100 people.

The adverse effects reported in clinical trials conducted in patients treated with Irbesartán Stada 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 (hemoglobin).

• Uncommon (may affect up to 1 in 100 people): tachycardia, skin redness, cough, diarrhea, indigestion/acid reflux, sexual dysfunction (sexual function disturbances), and chest pain.

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

Since the marketing of irbesartan, some adverse effects have been reported. The adverse effects observed with unknown frequency are: sensation of spinning, headache, taste disturbances, tinnitus, muscle cramps, muscle and joint pain, decreased number of red blood cells (anemia – symptoms may include tiredness, headaches, difficulty breathing during exercise, dizziness, and paleness), reduction in platelet count, abnormal liver function, increased blood potassium levels, impaired kidney function, inflammation of small blood vessels, mainly in the skin (a condition known as leukocytoclastic vasculitis), severe allergic reactions (anaphylactic shock), and low blood sugar levels. Uncommon cases of jaundice (yellowing of the skin and/or whites of the eyes) have also been observed.

Reporting of adverse effects:

If you experience any adverse effect, talk to 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. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Irbesartan Stada

Keep out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the packaging after "EXP". The expiry date is the last day of the month indicated.

Store in the original packaging to protect from light.

Medicines should not be disposed of via wastewater or household waste. Dispose of unused containers and medicines at the SIGRE collection point at your pharmacy. Ask your pharmacist how to properly dispose of containers and medicines you no longer need. This will help protect the environment.

6. Package contents and additional information

Composition of Irbesartán Stada

• The active substance is irbesartan. Each tablet contains 300 mg of irbesartan.
• The other components are: povidone (E-1201), magnesium stearate, microcrystalline cellulose (E-460), lactose monohydrate, sodium croscarmellose, colloidal anhydrous silica, hydrogenated castor oil, corn starch.

Appearance of the product and contents of the pack

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

The score line is intended solely to facilitate breaking the tablet if you have difficulty swallowing it whole.

Irbesartán Stada 300 mg tablets are available in blister packs of 28 tablets.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Laboratorio STADA, S.L.
Frederic Mompou, 5
08960, Sant Just Desvern (Barcelona)
Spain
[email protected]

Manufacturer

Laboratorios Liconsa, S.A.
Avd. Miralcampo, nº 7
Polígono Industrial Miralcampo
19200 Azuqueca de Henares (Guadalajara)
Spain

Date of latest revision of this package leaflet: February 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/