Package Leaflet: Information for the User

Irbesartán Tarbis Farma 75 mg Film-Coated Tablets

Irbesartán Tarbis Farma 150 mg Film-Coated Tablets

Irbesartán Tarbis Farma 300 mg Film-Coated Tablets

Read 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. Do not pass it on to others even if their symptoms are the same as yours. It may harm them.
• If you experience any side effects, talk to your doctor or pharmacist. See section 4.

1. What Irbesartán Tarbis Farma is and what it is used for

2. What you need to know before you start taking Irbesartán Tarbis Farma

3. How to take Irbesartán Tarbis Farma

4. Possible side effects

5. Storage of Irbesartán Tarbis Farma

6. Contents of the pack and additional information

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

Irbesartán 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 with clinical evidence of altered renal function.

Do not take Irbesartán Tarbis Farma

• if you areallergicto irbesartán or to 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 this medication also at the beginning of your pregnancy – see section “Pregnancy”)
• if you havediabetes or kidney failureand are being treated with a medication to lower blood pressure that contains aliskiren.

Warnings and precautions

Consult your doctor before starting to take irbesartán 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 fordiabetic nephropathy. In this case, your doctor may perform regular blood tests, especially to measure potassium levels in case of impaired renal function
• if you presentlow blood sugar levels(symptoms may include sweating, weakness, hunger, dizziness, tremors, headache, flushing or pallor, numbness, rapid and strong heartbeats), especially if you are being treated for diabetes
• if you are to be operated(surgical intervention) orif you are to be administered anesthetics
• if you are taking any 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.
• aliskiren.

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 Tarbis Farma”.

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

If you are pregnant, if you suspect you may be, or if you plan to become pregnant, you must inform your doctor. It is generally recommended that you stop taking irbesartán before becoming pregnant or as soon as you become pregnant and your doctor will recommend taking another antihypertensive medication instead. Irbesartán is not recommended for use at the beginning of pregnancy and should not be administered after the third month of pregnancy as it may cause serious harm to your baby (see section “Pregnancy”).

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 Tarbis Farma 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 an ACEI or aliskiren (see also the information under the headings “Do not take Irbesartán Tarbis Farma” and “Warnings and precautions”).

You may need to have blood tests if you are taking:

• potassium supplements
• potassium-sparing salt substitutes
• potassium-sparing medications (such as certain diuretics)
• litium-containing medications
• repaglinide (a medication used to reduce blood sugar levels).

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

Taking Irbesartán Tarbis Farma with food and drinks

Irbesartán Tarbis Farma 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 be, or if you plan to become pregnant.Generally, your doctor will advise you to stop taking irbesartán before becoming pregnant or as soon as you become pregnant and recommend taking another antihypertensive medication instead. Irbesartán is not recommended for use at the beginning of pregnancy and should not be administered after the third month of pregnancy as it may cause serious harm to your baby when administered from that point on.

Breastfeeding

Inform your doctor if you plan to start or are breastfeeding as irbesartán is not recommended for use during this period. Your doctor may decide to administer a more suitable treatment if you want to breastfeed, especially for newborns or premature babies.

Driving and operating machinery

It is unlikely that irbesartán will affect your ability to drive vehicles or operate machinery. However, during hypertension treatment, occasional dizziness or fatigue may occur. If you experience these symptoms, discuss them with your doctor before driving or operating machinery.

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 Tarbis Farma is administeredorally. The tablets should be swallowed with a sufficient amount of liquid (e.g. a glass of water). Irbesartán Tarbis Farma 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.

• 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.

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 Tarbis Farma 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 Tarbis Farma Than You Should

If you accidentally take too many tablets, contact your doctor immediately.

In case of overdose or accidental ingestion, consult your doctor or pharmacist or call the Toxicology Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

If You Forget to Take Irbesartán Tarbis Farma

If you accidentally forget to take a dose, simply take your regular dose when it is due next. Do not take a double dose to compensate for the missed doses.

If you have any other questions about the use of this medication, ask 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, cases of skin allergic reactions (skin rash, urticaria) have been reported in patients treated with irbesartán, as well as localized inflammation in the face, lips, and/or tongue. If you think you may have this type of reaction or experience shortness of breath,stop taking Irbesartán Tarbis Farma 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

Rare:may affect up to 1 in 1000 people

The side effects reported in clinical trials conducted in patients treated with irbesartán 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 1000 people):Intestinal angioedema: intestinal swelling that presents symptoms such as abdominal pain, nausea, vomiting, and diarrhea.

Since the marketing of irbesartán, some side effects have been reported. The side effects observed with unknown frequency are: feeling of spinning, headache, taste alteration, ringing in the ears, muscle cramps, muscle and joint pain, decreased number of red blood cells (anemia - symptoms may include fatigue, headaches, difficulty breathing during exercise, dizziness, and paleness), reduced number of platelets, abnormal liver function, increased potassium levels in blood, kidney function impairment, inflammation of small blood vessels, mainly in the skin area (condition known as leukocytoclastic vasculitis), severe allergic reactions (anaphylactic shock), and low blood sugar levels. Cases of rare icterus (yellowing of the skin and/or white of the eyes) have also been observed.

Reporting of side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, 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 for Pharmacovigilance of Medicines for Human Use: 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/EXP. The expiration date is the last day of the month indicated.

This medication does not require special conditions for conservation.

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

Composition of Irbesartán Tarbis Farma

The active ingredient is irbesartan.

Each film-coated tablet contains 75 mg of irbesartan.

Each film-coated tablet contains 150 mg of irbesartan.

Each film-coated tablet contains 300 mg of irbesartan.

The other components are

Core:microcrystalline cellulose, sodium croscarmellose, povidone (kollidon 30), colloidal silica, calcium stearate.

Coating:hypromellose, titanium dioxide, talc (E553b).

Appearance of the product and contents of the package

Irbesartán Tarbis Farma 75 mg film-coated tablets EFG

Film-coated tablets, white to off-white in color (approximately 9.10 mm x 4.60 mm), capsule-shaped, biconvex, engraved with "158" on one face and "H" on the other.

Irbesartán Tarbis Farma 150 mg film-coated tablets EFG

Film-coated tablets, white to off-white in color (approximately 11.59 mm x 5.58 mm), capsule-shaped, biconvex, engraved with "159" on one face and "H" on the other.

Irbesartán Tarbis Farma 300 mg film-coated tablets EFG

Film-coated tablets, white to off-white in color (approximately 15.12 mm x 6.58 mm), capsule-shaped, biconvex, engraved with "160" on one face and "H" on the other.

Irbesartán Tarbis Farma film-coated tablets are supplied in blisters of 28, 30, 56, 90, 98, and 500 film-coated tablets.

Only some package sizes may be commercially available.

Marketing Authorization Holder

Tarbis Farma S.L.

Gran Vía Carlos III, 94

08028 Barcelona

Spain

Responsible for manufacturing

Amarox Pharma B.V.

Rouboslaan 32

Voorschoten, 2252TR

Netherlands

This medicinal product is authorized in the member states of the European Economic Area with the following names:

Germany:Irbesartan Amarox 75 mg/150 mg/300 mg Filmtabletten

Netherlands:Irbesartan Amarox 75 mg/150 mg/300 mg, filmomhulde tabletten

Spain:Irbesartán Tarbis Farma 75 mg/150 mg/300 mg film-coated tablets EFG

Last review date of this leaflet: December 2024

For detailed and updated information on this medicinal product, please visit the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/