IRBESARTAN DAVUR 300 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Irbesartan Davur 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 Davur and what is it used for
2. What you need to know before you take Irbesartan Davur
3. How to take Irbesartan Davur
4. Possible side effects
5. Storing Irbesartan Davur
6. Contents of the pack and other information

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

Irbesartan Davur 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 leads to an increase in blood pressure.

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

Irbesartan Davur is used in adult patients:

• 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 you take Irbesartan Davur

Do not take Irbesartan Davur

• if you are allergicto irbesartan or any of the other ingredients of this medicine (listed in section 6).
• if you are pregnant for more than 3 months(in any case, it is better to avoid taking Irbesartan Davur also at the start of your pregnancy – see section Pregnancy and Breastfeeding)
• if you have diabetes or kidney impairment and are being treated with a blood pressure-lowering medicine that contains aliskiren.

Warnings and precautions

Talk to your doctor before taking Irbesartan Davur and if any of the following apply to you:

• if you have excessive vomiting or diarrhea
• if you have kidney problems
• if you have heart problems
• if you are taking Irbesartan Davur 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:

• a converting enzyme inhibitor (e.g., enalapril, lisinopril, ramipril), especially if you have kidney problems related to diabetes.
• aliskiren

Your doctor may check 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 Davur”.

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

If you are pregnant, think you may be pregnant, or are planning to become pregnant, inform your doctor. Irbesartan Davur 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 Breastfeeding.

Children and adolescents

This medicine should not be used in children and adolescents as the safety and efficacy have not been fully established.

Taking Irbesartan Davur with 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 change your dose and/or take other precautions:

If you are taking a converting enzyme inhibitor (e.g., enalapril, lisinopril, ramipril) or aliskiren (see also the information under the headings “Do not take Irbesartan Davur” and “Warnings and precautions”).

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 Davur with food and drink

Irbesartan Davur can be taken with or without food.

Pregnancy and Breastfeeding

Pregnancy

Inform your doctor if you are pregnant, think you may be pregnant, or are planning to become pregnant. Your doctor will advise you to stop taking Irbesartan Davur before you become pregnant or as soon as you know you are pregnant and will recommend an alternative blood pressure-lowering medicine. Irbesartan Davur should not be used 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.

Breastfeeding

Inform your doctor if you are breastfeeding or plan to breastfeed. Irbesartan Davur is not recommended for use in breastfeeding women. Your doctor may decide to prescribe a different treatment if you want to breastfeed, especially for newborns or premature babies.

Driving and using machines

Irbesartan Davur is unlikely to 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, talk to your doctor before driving or using machines.

Irbesartan Davur contains lactose

If your doctor has told you that you have an intolerance to some sugars, talk to your doctor before taking this medicine.

Irbesartan Davur contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per film-coated tablet; this is essentially “sodium-free”.

3. How to take Irbesartan Davur

Always take this medicine exactly as your doctor has told you. If you are unsure, talk to your doctor or pharmacist.

Method of administration

Irbesartan Davur is taken by mouth. The tablets should be swallowed with a sufficient amount of liquid (e.g., a glass of water). Irbesartan Davur can be taken with or without food. Try to take your daily dose at the same time each day. It is important to continue taking this medicine until your doctor tells you to stop.

• Patients with high blood pressure

The usual dose is 150 mg once daily. Depending on the response to blood pressure, this dose may be increased to 300 mg once daily.

• Patients 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.

Your doctor may advise a lower dose, especially when starting treatment, in certain patients, such as those on hemodialysisor over 75 years of age.

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

Use in children and adolescents

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

If you take more Irbesartan Davur 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.

If you forget to take Irbesartan Davur

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 medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Some of these side effects can be serious and may need medical attention.

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

The following side effects are grouped by frequency:

Very common: may affect more than 1 in 10 people

Common: may affect up to 1 in 10 people

Uncommon: may affect up to 1 in 100 people

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

• Very common (may affect more than 1 in 10 people): if you have high blood pressure and type 2 diabetes with kidney damage, blood tests may show an increase in potassium levels.

• Common (may affect up to 1 in 10 people): 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 (may affect up to 1 in 100 people): rapid heartbeat, flushing, cough, diarrhea, indigestion/heartburn, sexual dysfunction (sexual function disorders), and chest pain.

• Rare (may affect up to 1 in 1,000 people): 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. The side effects with frequency not known are: feeling of spinning, headache, taste disturbance, ringing in the ears, muscle cramps, muscle and joint pain, reduced platelet count, abnormal liver function, increased potassium levels in the blood, impaired kidney function, inflammation of small blood vessels, mainly in the skin area (a condition known as leucocytoclastic vasculitis), and severe allergic reactions (anaphylactic shock). There have also been rare cases of jaundice (yellowing of the skin and/or whites of the eyes).

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist, even if it is possible that they are not listed in this leaflet. You can also report side effects directly through the Spanish Medicines and Healthcare Products Agency (AEMPS) https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storing Irbesartan Davur

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

Do not use this medicine after the expiry date which is stated on the carton and blister after EXP. The expiry date refers to the last day of the month shown.

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. This will help protect the environment.

6. Contents of the pack and other information / Other information

Composition of Irbesartan Davur

• The active substance is irbesartan. Each Irbesartan Davur 300 mg film-coated 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 and packaging

Irbesartan Davur 300 mg film-coated tablets are white or almost white, biconvex, and cylindrical.

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

Marketing authorization holder

Teva Pharma, S.L.U.

Anabel Segura 11, Edificio Albatros B, 1st floor,

Alcobendas, 28108 Madrid (Spain)

Manufacturer

Teva Pharma, S.L.U.

Malpica C/ C, 4.

50016 Zaragoza

Date of last revision of this leaflet: January 2025

Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency for Medicines and Healthcare Products (AEMPS) http://www.aemps.gob.es/