Irbesartan Kern Pharma 300 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the user

Irbesartán 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 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 may harm them.
• If you experience any adverse effects, talk to your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Contents of this leaflet:

1. What Irbesartán Kern Pharma 300 mg film-coated tablets are and what they are used for
2. What you need to know before taking Irbesartán Kern Pharma 300 mg film-coated tablets
3. How to take Irbesartán Kern Pharma 300 mg film-coated tablets
4. Possible side effects
5. How to store Irbesartán Kern Pharma 300 mg film-coated tablets
6. Contents of the pack and other information

1. What Irbesartán Kern Pharma 300 mg film-coated tablets are and what they are 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, relaxing blood vessels and thereby reducing blood pressure. Irbesartán Kern Pharma slows the progression of kidney function deterioration 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 kidney 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 300 mg film-coated tablets

Do not take Irbesartán Kern Pharma

• if you are allergic (hypersensitive) to irbesartan or to any of the other ingredients of Irbesartán 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 failure 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 diarrhoea
• 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 perform regular blood tests, especially to measure potassium levels if kidney function is impaired
• if you are due to undergo surgery or if you are to be given 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

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 diarrhoea 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 trimester of pregnancy (first 3 months) and must 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.

Use of other medicines

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take 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 the 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 taking 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 can be taken with or without food.

Pregnancy and breast-feeding

You should inform your doctor if you are pregnant, suspect you may be pregnant, or plan to become pregnant. Generally, your doctor will advise you to take another medicine instead of Irbesartán Kern Pharma, as use of Irbesartán Kern Pharma is not recommended during the first trimester of pregnancy (first 3 months) and must in no case 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 you from Irbesartán Kern Pharma to another appropriate antihypertensive medicine. In any case, Irbesartán Kern Pharma must not be taken during the second and third trimesters of pregnancy or during breast-feeding.

Generally, your doctor will 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 consult 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 use machines.

However, during treatment for hypertension, 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 Irbesartán Kern Pharma

Irbesartán Kern Pharma 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.

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

Follow exactly the administration instructions for Irbesartan Kern Pharma as indicated 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 each day. It is important that you continue taking this medicine until your doctor advises you 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 (1 tablet 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 (1 tablet per day).

Your doctor may recommend a lower dose, particularly at the beginning of treatment, for 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 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 contact the Toxicology Information Service, telephone 91 562 04 20, indicating the medicine and the amount ingested.

Children must not take Irbesartan Kern Pharma

Irbesartan 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 Irbesartan 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 missed 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 produce adverse effects, although not everyone experiences 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 having such a reaction or experience shortness of breath, stop taking Irbesartan Kern Pharma 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
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/acid reflux, sexual dysfunction (disturbances in sexual function), and chest pain.

• Rare:

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

Since the marketing of irbesartan, some adverse effects have been reported, but their frequency is unknown. These observed adverse effects include: headache, taste disturbances, tinnitus, 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 area (a condition known as leukocytoclastic vasculitis), and reduced platelet count.

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 may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: 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 300 mg film-coated tablets

Keep this medicine out of sight and reach of children.

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

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

Medicines must not be disposed of via wastewater or household waste. Return unused medicines and their containers to the SIGRE point at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Irbesartan Kern Pharma

• The active substance is irbesartan. Each tablet of Irbesartan Kern Pharma 300 mg contains 300 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 pack

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

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

Marketing Authorization Holder and Manufacturer

Kern Pharma, S.L.

Venus, 72 – Pol. Ind. Colón II

08228 Terrassa -Barcelona

Spain

Date of the most recent revision 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/