Package Insert: Information for the User

Irbesartán Davur 150 mg Film-Coated Tablets

6. Contents of the pack and additional information

Irbesartán Davur belongs to a group of medications known as angiotensin-II receptor antagonists.Theangiotensin-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 Davur prevents the binding of angiotensin-II to these receptors, relaxing blood vessels and reducing blood pressure. Irbesartán Davur slows the deterioration of renal 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 altered renal function.

Do not take Irbesartán Davur

• if you areallergicto irbesartán or any of the other components of this medication (listed in section 6).
• if you aremore than 3 months pregnant(in any case, it is better to avoid taking Irbesartán Davur also at the beginning of your pregnancy – see pregnancy section)
• if you have diabetes or kidney failure and are being treated with a blood pressure medication that contains aliskirén

Warnings and precautions

Consult your doctor before starting to take Irbesartán Davur andif any of the following aspects affect you:

• if you haveexcessive vomiting or diarrhea
• if you havekidney problems
• if you haveheart problems
• if you are taking Irbesartán Davur fordiabetic nephropathy. In this case, your doctor may perform regular blood tests, especially to measure potassium levels in case of impaired renal function
• ifyou are to be operated(surgical intervention) or ifyou are to be administered anesthetics

• if you are takingany of the following medications used to treat high blood pressure (hypertension):

• a converting enzyme inhibitor (ACEI) (for example enalapril, lisinopril, ramipril), particularly if you have kidney problems related to diabetes.
• aliskirén

Your doctor may monitor your renal function, blood pressure, and electrolyte levels in the blood (such as 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 diarrhea 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, if you suspect you may beor if you plan to become pregnant, you must inform your doctor. It is generally recommended that you stop taking Irbesartán Davur before becoming pregnant or as soon as you become pregnant and your doctor will recommend taking another antihypertensive medication instead. Irbesartán Davur is not recommended for use at the beginning of pregnancy and should not be used in any case from the third month of pregnancy as it may cause serious harm to your baby, see Pregnancy and Breastfeeding section.

Children and adolescents

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

Taking Irbesartán Davur with other medications

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication.

Your doctor may need to adjust your dose and/or take other precautions:

If you are taking a converting enzyme inhibitor (ACEI) or aliskirén (see also the 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
• potassium-containing salt substitutes
• potassium-sparing medications (such as certain diuretics)
• medications containing lithium.

If you are using a type of analgesic, known as nonsteroidal anti-inflammatory drugs (NSAIDs), the effect of irbesartán may be reduced.

Taking Irbesartán Davur with food and drinks

Irbesartán Davur can be taken with or without food.

Pregnancy and breastfeeding

Pregnancy

You must inform your doctor if you are pregnant, if you suspect you may beor if you plan to become pregnant. It is generally recommended that you stop taking Irbesartán Davur before becoming pregnant or as soon as you become pregnant and your doctor will recommend taking another antihypertensive medication instead. Irbesartán Davur is not recommended for use at the beginning of pregnancy and should not be used in any case from the third month of pregnancy as it may cause serious harm to your baby when administered from that point onwards.

Breastfeeding

Inform your doctor if you are to initiate or are in the breastfeeding period as Irbesartán Davur is not recommended for administration to women during this period. Your doctor may decide to administer a more suitable treatment if you want to breastfeed, especially in newborns or premature babies.

Driving and operating machines

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

However, during hypertension treatment, occasional dizziness or fatigue may occur. If you experience these symptoms, discuss them with your doctor before driving or operating machines.

Irbesartán Davur contains lactose

If your doctor has indicated that you have an intolerance to certain sugars, consult with them before taking this medication.

Irbesartán Davur contains sodium

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

Follow exactly the administration instructions for this medication as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

Administration Method

Irbesartán Davur is administered byoral route. The tablets should be swallowed with a sufficient amount of liquid (e.g. a glass of water). Irbesartán Davur can be taken with or without food. You should try to take your daily dose at the same time every day. It is essential that you continue taking this medication until your doctor advises you otherwise.

• Patients with High Blood Pressure

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

Your doctor may advise a lower dose, especially at the beginning of treatment, in certain patients, such as those undergoinghemodialysisor thoseover 75 years old.

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

Use in Children and Adolescents

Irbesartán Davur should not be administered to children under 18 years old. 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 consult the Toxicology Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

If You Forget to Take Irbesartán Davur

If you accidentally forget to take a dose, simply take your normal dose when it is due again.Do nottake a double dose to compensate for the missed doses.

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

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

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

Like with similar medicines, in rare cases, skin allergic reactions (skin rash, urticaria) and localized inflammation in the face, lips, and/or tongue have been reported in patients treated with irbesartan. If you think you may have this type of reaction or experience shortness of breath,stop taking Irbesartán Davur and seek immediate medical attention.

The side effects mentioned below 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 side 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 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 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 (may affect up to 1 in 100 people): Tachycardia, skin redness, cough, diarrhea, indigestion/heartburn, sexual dysfunction (sexual function alterations), 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 observed with unknown frequency are: feeling of spinning, headache, altered taste, ringing in the ears, muscle cramps, muscle and joint pain, reduced platelet count, abnormal liver function, increased potassium levels in the blood, kidney function impairment, inflammation of small blood vessels, mainly in the skin area (condition known as leukocytoclastic vasculitis), and severe allergic reactions (anaphylactic shock). Cases of rare ictericia (yellowing of the skin and/or white of the eyes) have also been observed.

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through the Spanish System of Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

Do not use this medication after the expiration date that appears on the box and on the blister after CAD. The expiration date is the last day of the month indicated.

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

Medications should not be disposed of through drains or in the trash.Deposit the containers and medications you no longer need at the SIGRE point of your pharmacy.If in doubt, please ask your pharmacist how to dispose of the containers and medications you no longer need. By doing so, you will help protect the environment.

Composition of Irbesartán Davur

• The active ingredient is irbesartan. Each Irbesartán Davur 150 mg tablet contains 150 mg of irbesartan.
• The other components are lactose monohydrate, povidone, microcrystalline cellulose, sodium croscarmellose,colloidal anhydrous silica, sodium stearate fumarate, titanium dioxide (E-171)/cellulose derivative/propylene glycol and cellulose derivative/poloxyl-40 stearate.

Appearance of the product and content of the packaging

The film-coated tablets of Irbesartán Davur 150 mg are white or almost white, biconvex and cylindrical.

The tablets of Irbesartán Davur 150 mg are presented in blister-type packaging of 28 film-coated tablets.

Holder of the marketing authorization

Teva Pharma, S.L.U.

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

Alcobendas, 28108 Madrid (Spain)

Responsible for manufacturing

Teva Pharma, S.L.U.

Polígono Malpica C/ C, 4.

50016 Zaragoza

Last review date of this leaflet: January 2025

The detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http: //www.aemps.gob.es/