Irbesartan CINFA 300 mg tablets EFG
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the user
irbesartán cinfa 300 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, ask 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 could 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 cinfa is and what it is used for
- What you need to know before taking irbesartán cinfa
- How to take irbesartán cinfa
- Possible side effects
- How to store irbesartán cinfa
- Contents of the pack and other information
1. What irbesartán cinfa is and what it is used for
irbesartán cinfa 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 lowering blood pressure. Irbesartan slows the decline in renal function in patients with high blood pressure and type 2 diabetes.
irbesartán cinfa is used in adult patients:
- to treat high blood pressure (essential hypertension)
- 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 cinfa
Do not take irbesartán cinfa
- 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 section “Pregnancy”).
- If you have diabetes or renal insufficiency and are being treated with a blood pressure-lowering medicine containing aliskiren.
Warnings and precautions
Talk to your doctor or pharmacist before taking irbesartán cinfa 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 for diabetic kidney disease. In this case, your doctor may perform regular blood tests, especially to monitor potassium levels if kidney function is impaired.
- 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 (surgical intervention) 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.
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 cinfa”.
Contact your doctor if you experience abdominal pain, nausea, vomiting, or diarrhoea after taking irbesartán. Your doctor will decide whether to continue treatment. Do not stop taking irbesartán on your own.
If you are pregnant, think you might be pregnant, or are planning to become pregnant, you must inform your doctor. The use of irbesartan is not recommended during the first trimester of pregnancy, and it must not be used from the third month of pregnancy onwards, as it may cause serious 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.
Other medicines and irbesartán cinfa
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 cinfa” and “Warnings and precautions”).
You may need 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 taking a type of painkiller known as non-steroidal anti-inflammatory drugs (NSAIDs), the effect of irbesartan may be reduced.
Taking irbesartán cinfa with food and drink
The tablets 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 are planning to become pregnant. Generally, your doctor will advise you to stop taking irbesartan before becoming pregnant or as soon as pregnancy occurs, 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 onwards, as it may cause serious harm to your baby when used from that time.
Breastfeeding
Inform your doctor if you are planning to start or are currently breastfeeding, as irbesartan 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
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, talk to your doctor before driving or operating machinery.
irbesartán cinfa contains lactose.
This medicine contains lactose. If your doctor has told you that you have an intolerance to certain sugars, consult him before taking this medicine.
irbesartán cinfa contains hydrogenated castor oil.
This medicine may cause stomach discomfort and diarrhoea because it contains hydrogenated castor oil.
irbesartán cinfa contains sodium.
This medicine contains less than 1 mmol of sodium (23 mg) per tablet; this is essentially “sodium-free”.
3. How to take irbesartan cinfa
Follow exactly the instructions for administering this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.
Method of administration
Irbesartan 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 each day. It is important that you continue taking this medicine until your doctor advises you otherwise.
The tablet may be divided into equal doses.
- Patients with high blood pressure
The usual dose is 150 mg once daily. Subsequently, and 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 haemodialysed 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 irbesartan cinfa than you should
If you accidentally take too many tablets, contact your doctor immediately.
In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medicine and the amount ingested.
If you forget to take irbesartan cinfa
If you accidentally miss a dose, simply take your next scheduled 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, ask your doctor or pharmacist.
4. Possible adverse effects
Like all medicines, this medicine may cause adverse effects, although not everyone experiences them.
However, some of these adverse effects can be serious and may require immediate 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 experiencing a reaction of this type or have difficulty breathing, 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:
- Very common (may affect more than 1 in 10 patients): 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 patients): 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 patients): tachycardia, skin redness, cough, diarrhoea, indigestion/acid reflux, sexual dysfunction (sexual function disorders), and chest pain.
Since the marketing of irbesartan, some adverse effects have been reported. Adverse effects observed with unknown frequency (cannot be estimated from the available data) include: sensation of spinning, headache, taste disturbances, tinnitus, 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 pallor), 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 (a condition known as leukocytoclastic vasculitis), severe allergic reactions (anaphylactic shock), and low blood sugar levels. Rare cases of jaundice (yellowing of the skin and/or whites of the eyes) have also been observed. Rare frequency: intestinal angioedema: swelling in the intestine causing symptoms such as abdominal pain, nausea, vomiting and diarrhoea.
Reporting of adverse effects
If you experience any type of adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can 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 cinfa
Keep this medicine out of the sight and reach of children.
Store in the original packaging to protect it from light.
Do not use this medicine after the expiry date stated on the pack after EXP. The expiry date is the last day of the month indicated.
Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of containers and unused medicines. This will help protect the environment.
6. Contents of the pack and other information
Composition of irbesartan cinfa
- The active substance is irbesartan. Each tablet contains 300 mg of irbesartan.
- The other components are: povidone (E-1201), magnesium stearate (E-470b), microcrystalline cellulose (E-460), lactose monohydrate, sodium croscarmellose, colloidal anhydrous silica, hydrogenated castor oil, and maize starch.
Appearance of the product and contents of the pack
White, oblong, biconvex tablets, scored on one side and marked with the code “Ir3” on the other side.
Presented in PVC-PVDC/Aluminum blisters. Each pack contains 28 tablets.
Marketing Authorization Holder and Manufacturer
Laboratorios Cinfa, S.A.
Carretera Olaz-Chipi, 10. Polígono Industrial Areta
31620 Huarte (Navarra) – Spain
Date of the most recent review 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/
You can access detailed and up-to-date information about this medicine by scanning with your mobile phone (smartphone) the QR code included in the package leaflet and packaging. You can also access this information at the following web address: https://cima.aemps.es/cima/dochtml/p/70120/P_70120.html
QR code to: https://cima.aemps.es/cima/dochtml/p/70120/P_70120.html