Irbesartan Davur 300 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Irbesartán 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 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 must not be given to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any side effects, talk to your doctor or pharmacist, even if they are side effects not listed in this leaflet. See section 4.

Contents of the leaflet:

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

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

Irbesartán 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.

Irbesartán Davur prevents angiotensin-II from binding to these receptors, relaxing blood vessels and thereby lowering blood pressure. Irbesartán Davur slows down the decline in kidney function in patients with high blood pressure and type 2 diabetes.

Irbesartán 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 taking Irbesartán Davur

Do not take Irbesartán Davur

• if you are allergic to irbesartan or to any of the other ingredients of this medicine (listed in section 6).
• if you are more than 3 months pregnant (in any case, it is better to avoid taking Irbesartán Davur also during early pregnancy – see Pregnancy section)
• if you have diabetes or kidney failure and are being treated with a blood pressure-lowering medicine containing aliskiren.

Warnings and precautions

Talk to your doctor before starting to take Irbesartán Davur and if any of the following apply to you:

• if you have excessive vomiting or diarrhoea

• if you have kidney problems

• if you have heart problems

• if you are taking Irbesartán Davur for diabetic kidney disease. In this case, your doctor may perform regular blood tests, especially to monitor potassium levels if kidney function is impaired

• if you are going to have surgery or will 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 Davur”.

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

If you are pregnant, think you might be pregnant, or plan to become pregnant, you must inform your doctor. The use of Irbesartán Davur is not recommended during early pregnancy (first 3 months), and should in no case be used during the last 6 months of pregnancy, as it may cause serious harm to your baby; see section Pregnancy and Breast-feeding.

Children and adolescents

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

Taking Irbesartán Davur with other medicines

Tell 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 information under the headings “Do not take Irbesartán Davur” and “Warnings and precautions”).

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 Davur with food and drink

Irbesartán Davur may be taken with or without food.

Pregnancy and breast-feeding

Pregnancy

Inform your doctor if you are pregnant, think you might be pregnant, or plan to become pregnant. Your doctor will usually advise you to stop taking Irbesartán Davur before becoming pregnant or as soon as pregnancy is confirmed, and will recommend an alternative antihypertensive medicine. Irbesartán Davur is not recommended during early pregnancy and must not be used from the third month of pregnancy onwards, as it may cause serious harm to your baby when used from that time.

Breast-feeding

Inform your doctor if you are planning to breast-feed or are currently breast-feeding, as Irbesartán Davur is not recommended for women during this period. Your doctor may choose a treatment more suitable for you if you intend to breast-feed, especially if the baby is a newborn or premature.

Driving and using machines

It is unlikely that Irbesartán Davur will affect your ability to drive or operate machinery.

However, during treatment for hypertension, dizziness or fatigue may occasionally occur. If you experience these symptoms, talk to your doctor before driving or operating machinery.

Irbesartán Davur contains lactose

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

Irbesartán Davur contains sodium

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

3. How to take Irbesartán Davur

Follow exactly the instructions for use of this medicine as given by your doctor. If in doubt, consult your doctor or pharmacist again.

Method of administration

Irbesartán Davur is administered orally. The tablets should be swallowed with a sufficient amount of liquid (e.g. a glass of water). Irbesartán Davur may 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.

• 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.

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

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

Use in children and adolescents

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

If you take more Irbesartán 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 contact the Toxicology Information Service, telephone 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Irbesartán Davur

If you accidentally miss a dose, simply take your next scheduled 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 medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everyone will experience them.

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 Irbesartán Davur and seek immediate medical attention.

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

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

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

• Very common (may affect more than 1 in 10 people): If you have high blood pressure and type 2 diabetes with kidney impairment, blood tests may show increased levels of potassium.

• 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 enzyme). In patients with high blood pressure and type 2 diabetes with kidney impairment, dizziness (especially upon standing), low blood pressure (especially upon standing), 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): tachycardia, skin redness, cough, diarrhea, indigestion/acid reflux, sexual dysfunction (alterations in sexual function), and chest pain.

• Rare (may affect up to 1 in 1,000 people): Intestinal angioedema: swelling in the intestine presenting symptoms such as abdominal pain, nausea, vomiting, and diarrhea.

Additional adverse effects have been reported since irbesartan has been marketed. Adverse effects observed with unknown frequency include: sensation of spinning, headache, taste disturbances, tinnitus, muscle cramps, muscle and joint pain, reduced platelet count, abnormal liver function, increased blood potassium levels, kidney function impairment, inflammation of small blood vessels, primarily in the skin (a condition known as leukocytoclastic vasculitis), and severe allergic reactions (anaphylactic shock). Uncommon cases of jaundice (yellowing of the skin and/or whites of the eyes) have also been observed.

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 through the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Irbesartan Davur

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

Do not use this medicine after the expiry date stated on the carton 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 packaging.

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

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

Composition of Irbesartan Davur

• The active substance is irbesartan. Each Irbesartan Davur 300 mg tablet 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

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

Irbesartan Davur 300 mg tablets are supplied in blister packs containing 28 film-coated tablets.

Marketing Authorization Holder

Teva Pharma, S.L.U.

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

Alcobendas, 28108 Madrid (Spain)

Manufacturer

Teva Pharma, S.L.U.

Polígono Malpica C/ C, 4.

50016 Zaragoza

Date of the most recent 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 Health Products (AEMPS) http://www.aemps.gob.es/