Irbesartan Kern Pharma 75 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the user

Irbesartan Kern Pharma 75 mg film-coated 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 others, 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:

1. What Irbesartan Kern Pharma 75 mg film-coated tablets are and what they are used for

2. What you need to know before taking Irbesartan Kern Pharma 75 mg film-coated tablets

3. How to take Irbesartan Kern Pharma 75 mg film-coated tablets

4. Possible side effects

5. How to store Irbesartan Kern Pharma 75 mg film-coated tablets

6. Contents of the pack and other information

1. What Irbesartán Kern Pharma 75 mg film-coated tablets is and what it is used for

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 angiotensin-II from binding to these receptors, thereby relaxing blood vessels and reducing blood pressure. Irbesartán Kern Pharma slows the decline in kidney 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 impaired kidney function.

2. What you need to know before taking Irbesartán Kern Pharma 75 mg film-coated tablets

Do not take Irbesartán Kern Pharma

• if you are allergic (hypersensitive) to irbesartan or to any of the other components of Irbesartán Kern Pharma
• during the last 6 months of pregnancy, see section Pregnancy and Breastfeeding
• if you are breastfeeding
• if you have diabetes or renal insufficiency and are being treated with a blood pressure-lowering medicine containing aliskiren

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

Take special care with Irbesartán Kern Pharma

You should 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 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 due to undergo surgery or will be receiving anesthetics
• 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 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 as monotherapy.

If you are pregnant, suspect you may be pregnant, or plan to become pregnant, you must inform your doctor. Use of Irbesartán Kern Pharma is not recommended during the first months of pregnancy (first 3 months), and it must not be used during the last 6 months of pregnancy as it may cause serious harm to your baby; see section Pregnancy and Breastfeeding.

Use of other medicines

Inform your doctor or pharmacist if you are using, have recently used, or might need to use 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 information under the headings “Do not take Irbesartán Kern Pharma” and “Take special care with Irbesartán Kern Pharma”).

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 Irbesartán Kern Pharma with food and drink

Irbesartán Kern Pharma may be taken with or without food.

Pregnancy and breastfeeding

Inform your doctor if you are pregnant, suspect you may be pregnant, or plan to become pregnant. Your doctor will generally advise you to take another medicine instead of Irbesartán Kern Pharma, as its use is not recommended during early pregnancy (first 3 months) and must not be used during the last 6 months of pregnancy because it may cause serious harm to your baby. Usually, before you become pregnant, your doctor will switch Irbesartán Kern Pharma to another suitable antihypertensive medicine. In any case, Irbesartán Kern Pharma must not be taken during the second or third trimester of pregnancy or during breastfeeding.

Your doctor will generally advise you to stop treatment with Irbesartán Kern Pharma as soon as pregnancy is confirmed. If you become pregnant while taking Irbesartán Kern Pharma, inform and see your doctor immediately.

Driving and using machines

No studies on the effects on the ability to drive and use machines have been performed. It is unlikely that Irbesartán Kern Pharma will affect the ability to drive vehicles 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 Irbesartán Kern Pharma

Irbesartán Kern Pharma contains lactose. If your doctor has diagnosed you with an intolerance to certain sugars (e.g., lactose), consult your doctor before taking this medicine.

3. How to take Irbesartán Kern Pharma 75 mg film-coated tablets

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

Method of administration

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 may 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 taking this medicine until your doctor advises otherwise.

• Patients with high blood pressure

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

Your doctor may recommend a lower dose, especially at the beginning of treatment, in certain patients, such as those undergoing haemodialysis 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 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 Centre or contact the Toxicology Information Service, telephone 91 562 04 20, indicating the medication and the amount ingested.

Children must not take Irbesartán Kern Pharma

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

If you forget to take Irbesartán Kern Pharma

If you accidentally miss a dose, simply take your next dose at the usual time. Do not take a double dose to make up for forgotten doses.

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

4. Possible adverse effects

Like all medicines, Irbesartan Kern Pharma may cause adverse effects, although not everyone experiences them.

However, some of these adverse effects may be serious and may require immediate 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 having such a reaction or experience difficulty breathing, stop taking Irbesartan Kern Pharma and seek immediate medical help.

The adverse effects listed below are categorized according to their frequency as follows:

Very common: affects at least 1 in 10 patients
Common: affects at least 1 in 100 patients
Uncommon: affects at least 1 in 1,000 patients
Rare: affects 1 to 10 in 10,000 patients

Adverse effects reported in clinical trials conducted in patients treated with irbesartan were:

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

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

• Rare:

Intestinal angioedema: swelling in the intestine causing symptoms such as abdominal pain, nausea, vomiting, and diarrhea.

Since the marketing of irbesartan, some additional adverse effects have been reported, although their frequency is unknown. These observed adverse effects include: headache, taste disturbance, tinnitus (ringing in the ears), muscle cramps, muscle and joint pain, abnormal liver function, increased blood potassium levels, kidney function impairment, inflammation of small blood vessels, mainly in the skin (a condition known as leukocytoclastic vasculitis), and reduced platelet count.

Reporting of adverse effects

If you experience any adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Irbesartán Kern Pharma 75 mg film-coated tablets

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

Do not use Irbesartán Kern Pharma after the expiry date stated on the pack and blister after EXP. The expiry date refers to the last day of the month indicated.

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

Medicines should not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE Point in your pharmacy. If you are unsure, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the container and additional information

Composition of Irbesartán Kern Pharma

• The active substance is irbesartan. Each 75 mg tablet of Irbesartán Kern Pharma contains 75 mg of irbesartan.
• The other components are monohydrate lactose, 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 contents of the container

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

The 75 mg film-coated tablets of Irbesartán Kern Pharma are supplied in blister packs containing 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 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 of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/