IRBESARTAN KERN PHARMA 300 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Irbesartan Kern Pharma 300 mg film-coated tablets EFG

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack and other information:

1. What is Irbesartan Kern Pharma 300 mg film-coated tablets and what is it used for
2. What you need to know before you take Irbesartan Kern Pharma 300 mg film-coated tablets
3. How to take Irbesartan Kern Pharma 300 mg film-coated tablets
4. Possible side effects
5. Storing Irbesartan Kern Pharma 300 mg film-coated tablets

1. Contents of the pack and further information

1. What is Irbesartan Kern Pharma 300 mg film-coated tablets and what is it used for

Irbesartan Kern Pharma belongs to a group of medicines called 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 Kern Pharma prevents angiotensin-II from binding to these receptors, relaxing blood vessels and reducing blood pressure. Irbesartan Kern Pharma slows the deterioration of kidney function in patients with high blood pressure and type 2 diabetes.

Irbesartan 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 evidence of altered kidney function.

2. What you need to know before you take Irbesartan Kern Pharma 300 mg film-coated tablets

Do not take Irbesartan Kern Pharma

• if you are allergic(hypersensitive) to irbesartan or any of the other ingredients of Irbesartan Kern Pharma
• during the last 6 months of pregnancy, see section Pregnancy and Breast-feeding
• if you are breast-feeding
• if you have diabetes or kidney insufficiency and are being treated with a blood pressure-lowering medicine that contains aliskiren

Irbesartan Kern Pharma should not be given to children and adolescents (under 18 years).

Be cautious with Irbesartan Kern Pharma

You should inform your doctor in 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 Kern Pharma for diabetic kidney disease. In this case, your doctor may regularly perform blood tests, especially to measure potassium levels in case of impaired kidney function
• if you are going to have surgery (surgical intervention) or if you are going to be given anesthetics.
• if you are taking any of the following medicines used to treat high blood pressure:
• an angiotensin-converting enzyme inhibitor (ACE inhibitor) (e.g., enalapril, lisinopril, ramipril), especially 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 Irbesartan Kern Pharma”

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

If you are pregnant, think you may be pregnant, or are planning to become pregnant, inform your doctor. Irbesartan Kern Pharma is not recommended during the first trimester of pregnancy and should not be used during the last 6 months of pregnancy as it may cause serious harm to your baby, see section Pregnancy and Breast-feeding.

If you become pregnant while taking Irbesartan Kern Pharma, inform your doctor immediately.

Using other medicines

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines.

Your doctor may need to modify 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 Irbesartan Kern Pharma” and “Be cautious with Irbesartan Kern Pharma”).

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

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

If you are using a type of pain reliever known as non-steroidal anti-inflammatory medicines, the effect of irbesartan may be reduced.

Taking Irbesartan Kern Pharma with food and drinks

Irbesartan Kern Pharma can be taken with or without food.

Pregnancy and Breast-feeding

Inform your doctor if you are pregnant, think you may be pregnant, or are planning to become pregnant. Your doctor will normally advise you to take a different medicine instead of Irbesartan Kern Pharma, as it is not recommended during the first trimester of pregnancy and should not be used during the last 6 months of pregnancy as it may cause serious harm to your baby. Normally, before you become pregnant, your doctor will switch you to a different blood pressure medicine. In any case, Irbesartan Kern Pharma should not be taken during the second or third trimester of pregnancy or during breast-feeding.

Normally, your doctor will advise you to stop treatment with Irbesartan Kern Pharma as soon as you know you are pregnant. If you become pregnant while taking Irbesartan Kern Pharma, inform your doctor immediately.

Driving and using machines

No studies have been performed on the effects of Irbesartan Kern Pharma on the ability to drive and use machines. It is unlikely that Irbesartan Kern Pharma will affect your ability to drive or use machines.

However, during treatment for high blood pressure, dizziness or fatigue may occasionally occur. If you experience these symptoms, consult your doctor before driving or using machines.

Important information about some of the ingredients of Irbesartan Kern Pharma

Irbesartan Kern Pharma contains lactose. If your doctor has told you that you have an intolerance to some sugars, contact your doctor before taking this medicine.

3. How to take Irbesartan Kern Pharma 300 mg film-coated tablets

Follow exactly the instructions of administration of Irbesartan Kern Pharma given by your doctor. Consult your doctor or pharmacist if you have any doubts.

Method of administration

Irbesartan Kern Pharma is administered orally. The tablets should be swallowed with a sufficient amount of liquid (e.g., a glass of water). Irbesartan 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 important that you continue to take this medicine until your doctor tells you to stop.

• Patient with high blood pressure

The normal dose is 150 mg once daily. Depending on the response to blood pressure, this dose may be increased to 300 mg once daily (1 tablet daily).

• Patient with high blood pressure and type 2 diabetes with kidney damage

In patients with high blood pressure and type 2 diabetes, the recommended maintenance dose for the treatment of kidney damage is 300 mg once daily (1 tablet daily)

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

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

If you take more Irbesartan 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 Toxicology Information Service, phone 91 562 04 20, indicating the medicine and the amount taken.

Children should not take Irbesartan Kern Pharma

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

If you forget to take Irbesartan Kern Pharma

If you accidentally miss a dose, simply take your normal dose when it is due. Do not take a double dose to make up for forgotten doses.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Irbesartan Kern Pharma can cause side effects, although not everybody gets them.

However, some of these side effects can be serious and may require medical attention.

As with similar medicines, in rare cases, the following allergic reactions have been reported in patients treated with irbesartan: skin rash (including urticaria), and localized swelling in the face, lips, and/or tongue. If you think you may have such a reaction or experience difficulty breathing, stop taking Irbesartan Kern Pharma and go immediately to a medical center.

The following side effects are grouped by frequency:

Very common: at least 1 in 10 patients

Common: at least 1 in 100 patients

Uncommon: at least 1 in 1,000 patients

Rare: affects 1 to 10 users in 10,000

The following side effects were reported in clinical trials in patients treated with irbesartan:

• 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: rapid heartbeat, skin flushing, cough, diarrhea, indigestion/heartburn, sexual dysfunction (sexual function disorders), 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 irbesartan, some side effects have been reported, but their frequency is not known. These observed side effects include: headache, taste disturbance, ringing in the ears, muscle cramps, muscle and joint pain, abnormal liver function, increased potassium levels in the blood, kidney function insufficiency, and inflammation of small blood vessels, mainly in the skin area (a condition known as leucocytoclastic vasculitis), reduction in the number of platelets.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the Spanish Medicines and Health Products Agency (AEMPS) at www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storing Irbesartan Kern Pharma 300 mg film-coated tablets

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

Do not use Irbesartan Kern Pharma after the expiry date which is stated on the carton and blister after EXP. The expiry date is the last day of the month stated.

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

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and further information

Composition of Irbesartan Kern Pharma

• The active substance is irbesartan. Each Irbesartan Kern Pharma 300 mg tablet contains 300 mg of irbesartan.
• The other ingredients are lactose monohydrate, povidone, microcrystalline cellulose, sodium croscarmellose, anhydrous colloidal silica, sodium stearyl fumarate, titanium dioxide (E-171)/cellulose derivative/propylene glycol, and cellulose derivative/polyoxyl 40 stearate.

Appearance of the product and pack contents

Irbesartan Kern Pharma 300 mg film-coated tablets are white or almost white and cylindrical.

Irbesartan Kern Pharma 300 mg tablets are available in blister packs of 28 film-coated tablets.

Marketing authorization holder and manufacturer

Kern Pharma, S.L.

Venus, 72 – Pol. Ind. Colón II

08228 Terrassa - Barcelona

Spain

Date of last revision of this leaflet: February 2025.

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/