Irbesartan Stada 75 mg tablets EFG
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the user
Irbesartán Stada 75 mg tablets EFG
Read the entire 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, consult your doctor or pharmacist.
- This medicine has been prescribed for you only, and you should not give it to other people, 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
- Storage of 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 the blood vessels and thereby reducing blood pressure. Irbesartan slows 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 diarrhoea
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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 in case of impaired kidney function
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if you have low blood sugar levels (symptoms may include sweating, weakness, hunger, dizziness, tremors, headache, flushing or paleness, numbness, rapid and strong heartbeat), especially if you are being treated for diabetes
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if you are going to have surgery (surgical procedure) or if you are to be given anaesthetics
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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.
Consult your doctor if you experience abdominal pain, nausea, vomiting or diarrhoea 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 Pregnancy section).
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
Inform 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 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 or 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 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 vehicles 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; hence, 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 you are unsure, 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). Irbesartan may be taken with or without food. You should try to take your daily dose at the same time every day. It is important that you continue taking this medicine unless your doctor advises otherwise.
- Patients with high blood pressure
The usual dose is 150 mg once daily (two tablets per day). Subsequently, depending on the blood pressure response, this dose may be increased to 300 mg once daily (four 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 treatment of associated kidney impairment is 300 mg once daily (four tablets per day).
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-lowering effect should be achieved within 4–6 weeks after starting treatment.
Use in children and adolescents
Irbesartan 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’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 the missed dose.
If you have any further questions about the use of this medicine, ask 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), 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 experiencing such a reaction or have 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 enzyme). 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 found 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 (disturbances in sexual function), and chest pain.
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Rare (may affect up to 1 in 1,000 people): intestinal angioedema: swelling in the intestine presenting symptoms such as abdominal pain, nausea, vomiting, and diarrhoea.
Since the marketing of irbesartan, some adverse effects have been reported. Adverse effects observed with unknown frequency include: sensation of spinning, headache, taste disturbances, tinnitus (ringing in the ears), muscle cramps, muscle and joint pain, reduction in the number of red blood cells (anaemia – symptoms may include tiredness, headaches, shortness of breath on exertion, dizziness, and paleness), reduction in the number of platelets, abnormal liver function, increased blood potassium levels, impaired kidney function, inflammation of small blood vessels, mainly in the skin area (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, 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 Irbesartán Stada
Keep out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after "CAD". The expiry date refers to the last day of the month indicated.
Store in the original packaging to protect from light.
Medicines must not be disposed of via wastewater or household waste. Dispose of containers and unused medicines at the SIGRE collection point at your pharmacy. Ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.
6. Contents of the pack and other information
Composition of Irbesartán Stada
- The active substance is irbesartan. Each tablet contains 75 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 75 mg tablets are white, round, and biconvex.
Irbesartán Stada 75 mg tablets are available 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 latest 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 for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/