Irbesartan Stada 150 mg tablets EFG
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the user
Irbesartán Stada 150 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 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, and you should not give it to others, even if they have the same symptoms as you, because it may harm them.
- If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.
Contents of the leaflet
- What Irbesartán Stada is and what it is used for
- What you need to know before taking Irbesartán Stada
- How to take Irbesartán Stada
- Possible adverse effects
- How to store Irbesartán Stada
- Contents of the pack and other information
1. What Irbesartán Stada is and what it is 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 prevents angiotensin-II from binding to these receptors, relaxing blood vessels and thereby lowering blood pressure. Irbesartan slows down the decline in kidney function in patients with high blood pressure and type 2 diabetes.
Irbesartan is used in adult patients
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to treat high blood pressure (essential hypertension)
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to protect the kidney 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:
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if you have excessive vomiting or diarrhea
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if you have kidney problems
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if you have heart problems
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if you are taking irbesartan for diabetic kidney disease. In this case, your doctor may perform regular blood tests, especially to measure potassium levels if kidney function is impaired
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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
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if you are scheduled for surgery (surgical procedure) or if you are to receive anesthetics
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if you are taking any of the following medicines used to treat high blood pressure (hypertension):
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an angiotensin-converting enzyme inhibitor (ACE inhibitor) (e.g., enalapril, lisinopril, ramipril), particularly if you have kidney problems related to diabetes.
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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 in no case should it be administered from the third month of pregnancy onward, 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 fully established.
Other medicines and Irbesartán Stada
Tell your doctor or pharmacist if you are using, have recently used, or might need to use 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 may 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
You must inform your doctor if you are pregnant, suspect you may be pregnant, or plan to become pregnant. Generally, your doctor will 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 administered from that time.
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 you if you wish to breastfeed, especially if your baby 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 diagnosed you with an intolerance to certain sugars, consult him before taking this medicine.
This medicine contains less than 23 mg of sodium (1 mmol) per tablet; therefore, it is essentially “sodium-free”.
3. How to take Irbesartán Stada
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
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 (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 those undergoing hemodialysis 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
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, consult your doctor or pharmacist immediately, or call the Toxicology Information Service at telephone: 91 562 04 20, indicating the medicine and the amount ingested. It is recommended to bring the medicine’s packaging 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 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 with similar medicines, rare cases of skin allergic reactions (rash, urticaria) and localized swelling of the face, lips, and/or tongue have been reported in patients treated with irbesartan. If you think you may be having such a reaction or experience shortness of breath, stop taking irbesartan 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.
Adverse effects reported in clinical trials conducted in patients treated with irbesartan were:
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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.
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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 upon standing), low blood pressure (especially upon standing), muscle or joint pain, and decreased levels of a protein present in red blood cells (haemoglobin).
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Uncommon (may affect up to 1 in 100 people): tachycardia, skin redness, cough, diarrhoea, indigestion/acid reflux, sexual dysfunction (sexual function disorders), and chest pain.
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Rare (may affect up to 1 in 1,000 people): intestinal angioedema: swelling in the intestine causing symptoms such as abdominal pain, nausea, vomiting, and diarrhoea.
Since the marketing of irbesartan, additional adverse effects have been reported. Adverse effects observed with unknown frequency include: sensation of spinning (vertigo), headache, taste disturbances, tinnitus, muscle cramps, muscle and joint pain, reduction in the number of red blood cells (anaemia – symptoms may include tiredness, headaches, difficulty breathing during exercise, dizziness, and pallor), 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 type of adverse effect, consult 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 Medicinal Products: 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 sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after "EXP". The expiry date refers to 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 medicines and their containers at the SIGRE collection point at your pharmacy. Ask your pharmacist how to properly dispose of containers and medicines you no longer need. This helps protect the environment.
6. Contents of the pack and other information
Composition of Irbesartán Stada
- The active substance is irbesartan. Each tablet contains 150 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 medicine and contents of the pack
Irbesartán Stada 150 mg tablets are white, round, biconvex and scored.
The score line is intended only to facilitate tablet splitting if you have difficulty swallowing the tablet whole.
Irbesartán Stada 150 mg tablets are supplied in 28-tablet blister packs.
Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder:
Laboratorio STADA, S.L.
Frederic Mompou, 5
08960, Sant Just Desvern (Barcelona)
Spain
Manufacturer
Laboratorios Liconsa, S.A.
Avd. Miralcampo, nº 7
Polígono Industrial Miralcampo
19200 Azuqueca de Henares (Guadalajara)
Spain
Date of the most recent revision of this leaflet: February 2025
Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS): http://www.aemps.gob.es/