Package Insert: Information for the User

Irbesartan pensa 150 mg Tablets EFG

Read this package insert carefully before starting to take the medication, as it contains important information for you.

• Keep this package insert, as you may need to refer to it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed only for you and should not be given to others, even if they have the same symptoms, as it may harm them.
• If you consider any of the adverse effects you are experiencing to be severe or if you notice any adverse effect not mentioned in this package insert, inform your doctor or pharmacist. See section 4.

1. What Irbesartan Pensa is and for what it is used

2. Before taking Irbesartan Pensa

3. How to take Irbesartan Pensa

4. Possible adverse effects

5. Storage of Irbesartan Pensa

6. Additional information

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 the binding of angiotensin-II to these receptors, relaxing blood vessels and reducing blood pressure. Irbesartan Pensa slows the deterioration of renal function in patients with high blood pressure and type 2 diabetes.

Irbesartan Pensa is used

• totreat high blood pressure(essential hypertension)
• toprotect thekidney in patientswith high blood pressure,type 2 diabetes and with clinical evidence of alteredkidney function.

Do not takeIrbesartan 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 medication also at the beginning of your pregnancy – see Pregnancy section).
• if you have diabetes or kidney failure and are being treated with a medication to lower blood pressure that contains aliskirén.

Irbesartan should not be administered to children and adolescents (under 18 years).

Be especially careful withIrbesartan Pensa

You must inform your doctorin any of the following cases:

• if you have excessive vomiting or diarrhea
• if you have kidney problems
• if you have heart problems
• if you are taking Irbesartan Pensa for diabetic nephropathy. In this case, your doctor may perform regular blood tests, especially to measure potassium levels in case of impaired renal function
• if you are to be operated (surgical intervention) or if you are to be administered anesthetics.
• If you are taking any of the following medications used to treat high blood pressure (hypertension):
• • a converting enzyme inhibitor (ACE inhibitor) (for example enalapril, lisinopril, ramipril), particularly if you have kidney problems related to diabetes.
  • Aliskirén

Consult your doctor if you experience abdominal pain, nausea, vomiting, or diarrhea 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 renal function, blood pressure, and electrolyte levels in the blood (for example, potassium), at regular intervals.

See also the information under the heading “Do not take Irbesartan Pensa”

If you are pregnant, if you suspect that you may be, or if you plan to become pregnant, you must inform your doctor. It is generally recommended that you stop taking Irbesartan Pensa before becoming pregnant or as soon as you become pregnant and your doctor will recommend taking another antihypertensive medication instead. Irbesartan Pensa should not be administered during the first three months of pregnancy, and in no case should it be administered from the third month of pregnancy, as it may cause serious damage to your baby (see Pregnancy section).

Use of other medications

Inform your doctor or pharmacist if you are using or have recently used other medications, including those purchased without a prescription.

Your doctor may need to modify your dose and/or take other precautions.

If you are taking an ACE inhibitor or aliskirén (see also the information under the headings “Do not take Irbesartan Pensa” and “Be especially careful with Irbesartan Pensa”)

You may need to have blood tests if you are taking:

• potassium supplements
• potassium-sparing salt substitutes
• potassium-saving medications (such as certain diuretics)
• medications containing lithium

If you are using a type of analgesic, known as nonsteroidal anti-inflammatory drugs (NSAIDs), the effect of Irbesartan may be reduced.

TakeIrbesartan Pensawith food and drinks

Irbesartan Pensa can be taken with or without food.

Pregnancy and breastfeeding

Pregnancy

You must inform your doctor if you are pregnant, if you suspect that you may be, or if you plan to become pregnant. It is generally recommended that you stop taking Irbesartan Pensa before becoming pregnant or as soon as you become pregnant and your doctor will recommend taking another antihypertensive medication instead. Irbesartan Pensa should not be administered during the first three months of pregnancy, and in no case should it be administered from the third month of pregnancy, as it may cause serious damage to your baby when administered from that time.

Breastfeeding

Inform your doctor if you are to start or are in the breastfeeding period, as it is not recommended to administer Irbesartan Pensa to women during this period. Your doctor may decide to administer a more suitable treatment if you want to breastfeed, especially to newborns or premature babies.

Driving and operating machines

No studies have been conducted on the effects on the ability to drive and operate machines.

It is unlikely that Irbesartan Pensa will modify the ability to drive vehicles or operate machines. However, during hypertension treatment, occasional dizziness or fatigue may occur.

If you experience these symptoms, discuss them with your doctor before driving or operating machines.

Important information about some of the components ofIrbesartan Pensa

Irbesartan Pensa contains lactose. If your doctor has indicated that you have a certain sugar intolerance (for example, lactose), consult with them before taking this medication.

This medication may cause stomach discomfort and diarrhea because it contains hydrogenated ricin oil.

Follow exactly the administration instructions for Irbesartan Pensa provided by your doctor. Consult your doctor or pharmacist if you have any doubts.

Administration Method

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 every day. It is essential to continue taking this medication until your doctor advises you otherwise.

Patients with High Blood Pressure

The usual dose is 150 mg once a day. Subsequently, and depending on the blood pressure response, this dose may be increased to 300 mg once a day (two tablets a 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 a day (two tablets a day).

Your doctor may advise a lower dose, especially at the beginning of treatment, in certain patients, such as those undergoing hemodialysis or those over 75 years old.

The maximum blood pressure-lowering effect should be achieved within 4-6 weeks after starting treatment.

If You Take MoreIrbesartan PensaThan 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 the Toxicology Information Service, phone: 91 562 04 20, indicating the medication and the amount used. Do not forget to bring the packaging with you, even if it is empty.

Children Should Not Take Irbesartan Pensa

Irbesartan Pensa should not be administered to children under 18 years old. If a child swallows several tablets, contact your doctor immediately.

If You Forget to TakeIrbesartan Pensa

If you accidentally forget to take a dose, simply take your regular dose when it is due. Do not take a double dose to make up for the missed doses.

If you have any other questions about the use of this product, consult your doctor or pharmacist.

Like all medicines, Irbesartan Pensa can cause side effects, although not everyone will experience them.However, some of these side effects can be serious and may require medical attention.

Like with similar medicines, in rare cases, skin allergic reactions (skin rash, urticaria) and localized inflammation in the face, lips, and/or tongue have been reported in patients treated with Irbesartan. If you think you may be having this type of reaction or experience shortness of breath,stop taking Irbesartan Pensa and seek immediate medical attention.

The side effects listed below are grouped by frequency:

Very common:At least 1 in 10 patients

Common:At least 1 in 100 patients and fewer than 1 in 10 patients

Uncommon:At least 1 in 1,000 patients and fewer than 1 in 100 patients

Rare:At least 1 in 1,000 patients

The side effects reported in clinical trials conducted in patients treated with Irbesartan Pensa were:

• Very common:If you have high blood pressure and type 2 diabetes with kidney damage, blood tests may show an increase in potassium levels.

• Common: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 damage, 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:Tachycardia, skin redness, cough, diarrhea, indigestion/heartburn, sexual dysfunction (sexual function alterations), and chest pain.

• Rare:Intestinal angioedema: intestinal swelling that presents symptoms such as abdominal pain, nausea, vomiting, and diarrhea.

Since the marketing of Irbesartan, some side effects have been reported, but their frequency is unknown. These observed side effects are: headache, altered taste, tinnitus, muscle cramps, muscle and joint pain, abnormal liver function, increased potassium levels in blood, reduced platelet count, kidney function insufficiency, and inflammation of small blood vessels, mainly in the skin area (a condition known as leukocytoclastic vasculitis).

Reporting side effects:

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through the Spanish System of Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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 expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through drains or in the trash. Dispose of the packaging and medicines you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. By doing so, you will help protect the environment.

Composition of Irbesartan Pensa

• The active ingredient is Irbesartan. Each Irbesartan Pensa tablet contains 150 mg of Irbesartan.

• The other components are: Povidone(E-1201), magnesium stearate, microcrystalline cellulose (E-460), lactose monohydrate, sodium croscarmellose, anhydrous colloidal silica, hydrogenated ricin oil, and cornstarch.

Appearance of the product and contents of the package

Scored white tablets.

Each package contains 28 tablets.

Marketing Authorization Holder:

Towa Pharmaceutical, S.A.

C/ de Sant Martí, 75-97

08107 Martorelles (Barcelona)

Spain

Responsible for manufacturing:

Laboratorios Liconsa, S.A.

Avd. Miralcampo, nº 7

Polígono Industrial Miralcampo

19200 Azuqueca de Henares (Guadalajara)

Spain

Last review date of this leaflet:December 2024

The detailed information of this medication is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/