Package Insert: Information for the User

Irbesartán Kern Pharma 75 mg Film-Coated Tablets

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 for you only, and you should not give it to others who have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.

6. Contents of the pack and additional information

Irbesartán Kern Pharma 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.

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

Irbesartán Kern Pharma is used:

• to treat high blood pressure (essential hypertension)

to protect the kidneys in patients with high blood pressure, type 2 diabetes, and clinical evidence of altered renal function.

Do not take Irbesartán Kern Pharma

• if you areallergic(hypersensitive) to irbesartán or to any of the other components of Irbesartán Kern Pharma
• during thelast 6 months of pregnancy, see Pregnancy and Breastfeeding section
• if you arebreastfeeding
• if you have diabetes or kidney insufficiency and are being treated with a medication to lower blood pressure that contains aliskirén

Irbesartán Kern Pharma should not be administered to children and adolescents (under 18 years old).

Be especially careful with Irbesartán Kern Pharma

You must inform your doctor in 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 Irbesartán Kern Pharma for diabetic nephropathy. In this case, your doctor may perform regular blood tests, especially to measure potassium levels in case of renal dysfunction
• if you are going to be operated (surgical intervention) or if you are going to be administered anesthetics.
• if you are taking any of the following medications used to treat high blood pressure (hypertension):
• a converting enzyme inhibitor (IECA) (for example, enalapril, lisinopril, ramipril), particularly if you have kidney problems related to diabetes.
• aliskirén

Your doctor may control 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 Irbesartán Kern Pharma”

Consult your doctor if you experience abdominal pain, nausea, vomiting, or diarrhea after taking Irbesartán Kern Pharma. Your doctor will decide whether to continue treatment. Do not stop taking Irbesartán Kern Pharma in monotherapy.

If you are pregnant, if you suspect you may be, or if you plan to become pregnant, you must inform your doctor. Irbesartán Kern Pharma is not recommended for use in the first 3 months of pregnancy and should not be used in the last 6 months of pregnancy because it may cause serious harm to your baby, see Pregnancy and Breastfeeding section.

Use of other medications

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication.

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

If you are taking a converting enzyme inhibitor (IECA) or aliskirén (see also the information under the headings “Do not take Irbesartán Kern Pharma” and “Be especially careful with Irbesartán Kern Pharma”).

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

• potassium supplements
• substitutes for salt that contain potassium
• potassium-sparing medications (such as certain diuretics)
• medications that contain lithium.

If you are using a type of analgesic, known as non-steroidal anti-inflammatory drugs, the effect of irbesartán may be reduced.

Taking Irbesartán Kern Pharma with food and drinks

Irbesartán Kern Pharma can be taken with or without food.

Pregnancy and breastfeeding

You must inform your doctor if you are pregnant, if you suspect you may be, or if you plan to become pregnant. In general, your doctor will advise you to take another medication instead of Irbesartán Kern Pharma, as Irbesartán Kern Pharma is not recommended for use in the first 3 months of pregnancy and should not be used in the last 6 months of pregnancy because it may cause serious harm to your baby. Normally, before you become pregnant, your doctor will replace Irbesartán Kern Pharma with another suitable anti-hypertensive medication. In any case, Irbesartán Kern Pharma should not be taken during the second or third trimester of pregnancy or during breastfeeding.

In general, your doctor will advise you to stop treatment with Irbesartán Kern Pharma as soon as you know you are pregnant. If you become pregnant while taking Irbesartán Kern Pharma, inform and see your doctor immediately.

Driving and operating machines

No studies have been conducted on the effects on the ability to drive and operate machines. It is unlikely that Irbesartán Kern Pharma 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, consult your doctor before driving or operating machines.

Important information about one of the components of Irbesartán Kern Pharma

Irbesartán Kern Pharma contains lactose. If your doctor has told you that you have an intolerance to certain sugars (for example, lactose), consult with him before taking this medication.

Follow exactly the administration instructions for Irbesartán Kern Pharma as indicated by your doctor. Consult your doctor or pharmacist if you have any doubts.

Administration mode

Irbesartán Kern Pharma is administered orally. The tablets should be swallowed with a sufficient amount of liquid (e.g., a glass of water). Irbesartán Kern Pharma 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 (four 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 (four 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-reducing effect should be achieved within 4-6 weeks after starting treatment.

If you take more Irbesartán Kern Pharma than you should

If you accidentally take too many tablets, contact your doctor immediately.

In case of overdose or accidental ingestion, go to a Medical Center or consult the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

Children should not take Irbesartán Kern Pharma

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

If you forgot to take Irbesartán Kern Pharma

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

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

Like all medicines, Irbesartán Kern Pharma may 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 irbesartán. If you think you may be having this type of reaction or experience shortness of breath, stop taking Irbesartán Kern Pharma and seek immediate medical attention.

The side effects listed below are grouped by frequency:

Very common: Occurs in at least 1 in 10 patients

Common: Occurs in at least 1 in 100 patients

Uncommon: Occurs in at least 1 in 1,000 patients

Rare: Affects 1 to 10 patients in 10,000 patients

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

• Very common: If you have high blood pressure and type 2 diabetes with kidney impairment, 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 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 (hemoglobin).

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

- Rare:

Intestinal angioedema: Swelling in the intestine that presents symptoms such as abdominal pain, nausea, vomiting, and diarrhea.

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

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 for Pharmacovigilance of Medicines for human use:www.notificaRAM.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep this medication out of the sight and reach of children.

Do not use Irbesartán Kern Pharma after the expiration date that appears on the box and on the blister pack after CAD. The expiration date is the last day of the month indicated.

No special storage conditions are required. Store in the original packaging.

Medicines should not be disposed of through drains or in the trash. Deposit 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 Irbesartán Kern Pharma

• The active ingredient is irbesartan. Each Irbesartán Kern Pharma 75 mg tablet contains 75 mg of irbesartan.
• The other components are lactose monohydrate, povidone, microcrystalline cellulose, sodium croscarmellose, anhydrous colloidal silica, sodium stearate fumarate, titanium dioxide (E-171)/cellulose derivative/propylene glycol and cellulose derivative/poloxyl-40 stearate.

Appearance of the product and content of the packaging

The film-coated tablets of Irbesartán Kern Pharma 75 mg are white or almost white and cylindrical.

The tablets of Irbesartán Kern Pharma 75 mg are presented in blister-type packaging of 28 film-coated tablets.

Holder of the marketing authorization and responsible for manufacturing

Kern Pharma, S.L.

Venus, 72 – Pol. Ind.Colón II

08228 Terrassa -Barcelona

Spain

Last review date of this leaflet: February 2025.

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