Irbesartan Pensa 300 mg tablets EFG
Spain
Table of Contents
Patient Information Leaflet
Introduction
Patient Information Leaflet
Irbesartan Pensa 300 mg tablets EFG
Read the entire leaflet carefully before you start taking this medicine.
- 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 and you should not give it to others, even if they have the same symptoms, as it may harm them.
- If you consider any of the side effects you experience to be severe, or if you notice any side effects not listed in this leaflet, inform your doctor or pharmacist. See section 4.
Leaflet Contents
- What Irbesartan Pensa is and what it is used for
- Before you take Irbesartan Pensa
- How to take Irbesartan Pensa
- Possible side effects
- How to store Irbesartan Pensa
- Further information
1. What Irbesartan Pensa is and what it is used for
Irbesartan Pensa 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 an increase in blood pressure. Irbesartan Pensa prevents angiotensin-II from binding to these receptors, relaxing blood vessels and thereby lowering blood pressure. Irbesartan Pensa slows down the decline in kidney function in patients with high blood pressure and type 2 diabetes.
Irbesartan Pensa is used
- 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. Before taking Irbesartan Pensa
Do not take Irbesartan Pensa
- if you are allergic (hypersensitive) to Irbesartan or to any of the other components of Irbesartan Pensa.
- if you are more than 3 months pregnant. (In any case, it is better to avoid taking this medicine also during the early months of pregnancy – see Pregnancy section).
- if you have diabetes or kidney failure and are being treated with a blood pressure-lowering medicine containing aliskiren.
Irbesartan should not be given to children and adolescents (under 18 years of age).
Take special care with Irbesartan Pensa
You must inform your doctor in any of the following cases:
- if you have severe vomiting or diarrhoea
- if you have kidney problems
- if you have heart problems
- if you are taking Irbesartan Pensa for diabetic kidney disease. In this case, your doctor may regularly perform blood tests, especially to monitor potassium levels in case of impaired kidney function
- if you are going to have surgery or will receive 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 Pensa. Your doctor will decide whether to continue treatment. Do not stop taking Irbesartan Pensa on your own.
Your doctor may monitor your kidney function, blood pressure and blood electrolyte levels (e.g. potassium) at regular intervals.
See also information under the heading “Do not take Irbesartan Pensa”
If you are pregnant, suspect you may be pregnant, or plan to become pregnant, you must inform your doctor. Use of Irbesartan Pensa is not recommended during the first trimester of pregnancy (first 3 months), and must not be used from the third month of pregnancy onwards, as it may cause severe harm to your baby (see Pregnancy section).
Use of other medicines
Inform your doctor or pharmacist if you are using or have recently used any other medicines, including those obtained without a prescription.
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 Irbesartan Pensa” and “Take special care with Irbesartan Pensa”)
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 Pensa with food and drink
Irbesartan Pensa can be taken with or without food.
Pregnancy and breastfeeding
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 Pensa before becoming pregnant or as soon as pregnancy is confirmed, and will recommend an alternative antihypertensive treatment. Use of Irbesartan Pensa 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 used from that time.
Breastfeeding
Inform your doctor if you are planning to start or are currently breastfeeding, as Irbesartan Pensa is not recommended for women during this period. Your doctor may decide to prescribe a more suitable treatment if you intend to breastfeed, especially if your baby is a newborn or premature.
Driving and using machines
No studies have been conducted on the effects on the ability to drive and use machines.
It is unlikely that Irbesartan Pensa 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, consult your doctor before driving or operating machinery.
Important information about some of the components of Irbesartan Pensa
Irbesartan Pensa contains lactose. If your doctor has informed you that you have an intolerance to certain sugars (e.g. lactose), consult him before taking this medicine.
This medicine may cause stomach discomfort and diarrhoea because it contains hydrogenated castor oil.
3. How to take Irbesartan Pensa
Follow exactly your doctor's instructions for taking Irbesartan Pensa. If you have any doubts, consult your doctor or pharmacist.
Method of administration
Irbesartan Pensa is administered orally. The tablets should be swallowed with a sufficient amount of liquid (e.g., a glass of water). Irbesartan Pensa 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 until your doctor advises otherwise.
Patients with high blood pressure
The usual dose is 150 mg once daily. Depending on the blood pressure response, this dose may later 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 treating associated kidney impairment is 300 mg once daily.
Your doctor may recommend a lower dose, particularly at the beginning of treatment, in certain patients such as those undergoing hemodialysis or patients over 75 years of age.
Maximum blood pressure-lowering effect should be achieved within 4–6 weeks after starting treatment.
If you take more Irbesartan Pensa than you should
If you accidentally take too many tablets, contact your doctor immediately.
If you have taken more Irbesartan Pensa than you should, consult your doctor or pharmacist immediately or contact the Toxicology Information Service at telephone number: 91 562 04 20, stating the name of the medicine and the amount taken. Do not forget to bring the container with you, even if it is empty.
Children must not take Irbesartan Pensa
Irbesartan Pensa must not be given to children under 18 years of age. If a child swallows several tablets, contact your doctor immediately.
If you forget to take Irbesartan Pensa
If you accidentally miss a dose, simply take your usual dose at the next scheduled time. Do not take a double dose to make up for forgotten doses.
If you have any other questions about the use of this product, consult your doctor or pharmacist.
4. Possible adverse effects
Like all medicines, Irbesartan Pensa may cause adverse effects, although not everyone gets 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 a reaction of this type or develop shortness of breath, stop taking Irbesartan Pensa and seek immediate medical attention.
The adverse effects listed below are grouped according to their frequency as follows:
Very common: Affects at least 1 in 10 patients.
Common: Affects at least 1 in 100 patients and less than 1 in 10 patients.
Uncommon: Affects at least 1 in 1,000 patients and less than 1 in 100 patients.
Rare: Affects at least 1 in 1,000 patients.
Adverse effects reported in clinical trials conducted in patients treated with Irbesartan Pensa were:
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Very common: If you have high blood pressure and type 2 diabetes with kidney impairment, blood tests may show an increase in potassium levels.
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Common: 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 upon standing), muscle or joint pain, and decreased levels of a protein present in red blood cells (haemoglobin).
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Uncommon: Tachycardia, skin redness, cough, diarrhoea, indigestion/acid reflux, sexual dysfunction (disturbances in sexual function), and chest pain.
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Rare: 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, but their frequency is unknown. These observed adverse effects include: headache, taste disturbance, tinnitus, muscle cramps, muscle and joint pain, abnormal liver function, increased blood potassium levels, reduced platelet count, kidney function impairment, and inflammation of small blood vessels, primarily in the skin area (a condition known as leukocytoclastic vasculitis).
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 can 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 Pensa
Keep out of the reach and sight of children.
No special storage conditions are required.
Store in the original packaging.
Do not use Irbesartan Pensa after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.
Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their packaging at the SIGRE point at your pharmacy. If you have any doubts, ask your pharmacist how to properly dispose of unused medicines and their packaging. This way, you will help protect the environment.
6. Information for the user
Composition of Irbesartan Pensa
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The active substance is Irbesartan. Each Irbesartan Pensa tablet contains 300 mg of Irbesartan.
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The other components are: Povidone (E-1201), magnesium stearate, microcrystalline cellulose (E-460), lactose monohydrate, sodium croscarmellose, colloidal anhydrous silica, hydrogenated castor oil, and maize starch.
Appearance of the medicinal product and contents of the pack
White, scored tablets.
Each pack contains 28 tablets.
Marketing Authorisation Holder:
Towa Pharmaceutical, S.A.
C/ de Sant Martí, 75-97
08107 Martorelles (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: December 2024
Detailed information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS): http://www.aemps.gob.es/