IRBESARTAN VIATRIS 300 mg TABLETS

Introduction

Package Leaflet: Information for the Patient

Irbesartan Viatris 300 mg film-coated tablets

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

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

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

Irbesartan Viatris contains irbesartan, which belongs to a group of medicines known as angiotensin-II receptor antagonists. Angiotensin-II is a substance produced in the body that causes blood vessels to narrow, leading to an increase in blood pressure. Irbesartan blocks the action of angiotensin-II, relaxing blood vessels and lowering blood pressure. Irbesartan slows the progression of kidney damage in patients with high blood pressure and type 2 diabetes.

Irbesartan Viatris 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 evidence of clinical kidney damage.

2. What you need to know before you take Irbesartan Viatris

Do not take Irbesartan Viatris:

• If you are allergicto irbesartan or 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 recommended to avoid taking this medicine during the first few months of pregnancy – see section Pregnancy).
• If you have diabetes or kidney problemsand are being treated with a blood pressure medicine containing aliskiren.

Warnings and precautions

Tell your doctor or pharmacist before starting to take this medicine:

• If you have had or have during treatment, excessive vomiting(being sick) or diarrhea.
• If you have been taking diureticsor have been on a low-sodium diet.
• If you have kidney problems, including narrowing of the kidney artery, or have had a kidney transplant.
• If you have heart problems, including narrowing of the heart valves, or enlargement or weakness of the heart muscle (heart failure).
• If you have narrowing of the blood vesselsof the heart, which can cause chest pain, for example, angina.
• If you are taking irbesartan 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 have low blood sugar levels(symptoms may include sweating, weakness, hunger, dizziness, trembling, headache, flushing, or pallor, numbness, rapid heartbeat), especially if you are being treated for diabetes.
• If you have primary aldosteronism(a disease related to increased production of the hormone aldosterone, which causes sodium retention and leads to increased blood pressure).
• If you are of Afro-Caribbean origin, irbesartan may not be as effective in lowering blood pressure.

• If you are taking any of the following medicines used to treat high blood pressure:
• • An ACE inhibitor (e.g., enalapril, lisinopril, ramipril), especially if you have kidney problems related to diabetes.
  • Aliskiren.

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

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 Viatris”.

If you are pregnant, think you may be pregnant, or plan to become pregnant, tell your doctor. It is not recommended to take irbesartan during the first few months of pregnancy, and in any case, it should not be taken after the third month of pregnancy, as it may harm your baby (see section Pregnancy).

During treatment:

Also, tell your doctor:

• If you are going to have surgery (including dental surgery)or are going to be given anesthetics.

Children and adolescents

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

Other medicines and Irbesartan Viatris

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

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

• If you are taking ACE inhibitors or aliskiren (see also the information under the heading “Do not take Irbesartan Viatris” and “Warnings and precautions”).

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

• Potassium supplements.
• Salt substitutes containing potassium.
• Potassium-sparing diuretics (water tablets) or medicines that may increase potassium levels in the blood, e.g., heparin.
• Medicines containing lithium (used to treat mental health problems).
• Repaglinide (a medicine used to lower blood sugar levels).

If you are using a type of painkiller called non-steroidal anti-inflammatory drugs (NSAIDs) or COX-2 inhibitors, e.g., celecoxib or acetylsalicylic acid, the effect of irbesartan may be reduced.

Pregnancy and breastfeeding

Pregnancy

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, ask your doctor for advice before taking this medicine. Your doctor will normally advise you to stop taking irbesartan before you become pregnant or as soon as you know you are pregnant and will advise you to take another medicine to treat your high blood pressure.

Irbesartan should not be used during the first few months of pregnancy and should not be taken after the third month of pregnancy, as it may harm your baby.

Breastfeeding

Tell your doctor if you are breastfeeding or about to start breastfeeding. It is not recommended to take irbesartan while breastfeeding, and your doctor may choose another treatment if you want to breastfeed, especially if your baby is a newborn or was born prematurely.

Driving and using machines

It is unlikely that irbesartan will 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, consult your doctor before driving or using machines.

Irbesartan Viatris contains lactose and sodium

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

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

3. How to take Irbesartan Viatris

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

Method of administration

Irbesartan is taken by mouth. The tablets should be swallowed with a sufficient amount of liquid (e.g., a glass of water). Irbesartan 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 irbesartan until your doctor tells you to stop.

• Patients with high blood pressure

The recommended 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 associated kidney damage is 300 mg once daily.

Your doctor may advise a lower dose, especially when starting treatment if you are on hemodialysis or are 75 years old or older.

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

Use in children and adolescents

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

If you take more Irbesartan Viatris than you should

If you accidentally take too many tablets, contact your doctor immediately. You may feel dizzy or your heart may beat faster or slower.

In case of overdose or accidental ingestion, contact your doctor or pharmacist or call the Toxicology Information Service, telephone 91 562 04 20, indicating the medicine and the amount taken. Bring the package and any remaining tablets with you.

If you forget to take Irbesartan Viatris

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 product, 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. If you notice any of the following side effects, stop taking this medicine and tell your doctor or go to the emergency department at your nearest hospital:

Frequency not known(cannot be estimated from the available data)

• Severe allergic reaction with symptoms such as redness, itching, feeling dizzy or fainting, swelling of the face, lips, and/or tongue, which may cause difficulty breathing.
• Yellowing of the skin and the white part of the eyes, severe pain in the upper abdomen, feeling sick, and being sick, which may be due to liver problems.
• Rash with purple spots and red patches caused by inflammation of small blood vessels (vasculitis).
• Increased frequency of urination, in large amounts, pale in color, or difficulty urinating, which may be due to kidney problems.

Other possible side effects

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.
• Feeling sick/being sick (vomiting).
• Feeling tired (fatigue).
• Blood tests may show elevated levels of an enzyme that measures how muscles and the heart work (creatine kinase).
• In patients with high blood pressure and type 2 diabetes with kidney damage:

• Dizziness when standing up from a lying or sitting position.
• Low blood pressure when standing up from a lying or sitting position.
• Muscle or joint pain.
• Blood tests may show a decrease in the levels of a protein present in red blood cells (hemoglobin).

Uncommon(may affect up to 1 in 100 people)

• Feeling that your heart is beating faster (tachycardia).
• Redness of the skin.
• Cough.
• Diarrhea.
• Indigestion/heartburn.
• Sexual dysfunction (sexual function disorders).
• Chest pain.

Rare(may affect up to 1 in 1,000 people)

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

Frequency not known(cannot be estimated from the available data)

• Appearance of bruises or bleeding more frequently than usual, which may be due to a reduction in the number of platelets (blood cells that help blood clot).
• Feeling tired, headaches, difficulty breathing when exercising, or dizziness and paleness, which may be caused by a reduced number of red blood cells (anemia).
• Feeling of spinning.
• Headache.
• Taste disturbance.
• Ringing in the ears.
• Muscle cramps.
• Muscle and joint pain.
• Blood tests show that the liver is not working properly.
• Blood tests show elevated potassium levels in the blood.
• Low blood sugar levels.

Reporting of side effects

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

5. Storage of Irbesartan Viatris

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, label, or blister after EXP. The expiry date refers to the last day of that month.

The shelf life of the product when stored in plastic bottles is 90 days after opening.

This medicine does not require any special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

Composition of Irbesartan Viatris:

The active substance is irbesartan. Each tablet contains 300 mg of irbesartan. The other ingredients are lactose monohydrate (see section 2 of the leaflet “Irbesartan Viatris contains lactose”), povidone, microcrystalline cellulose (E-460), croscarmellose sodium, magnesium stearate (E-572), and anhydrous colloidal silica.

Appearance of the product and pack contents

Oval, white to almost white tablets, with curved sides, marked with an "M" on one side and "IN3" on the other.

Available in blisters of 10, 14, 28, 30, 56, 57, 58, 60, 84, 90, 98, and 100 tablets.

Calendar blisters of 14, 28, 56, 84, and 98 tablets.

HDPE bottles containing 30, 500, and 1000 tablets.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Viatris Limited

Damastown Industrial Park

Mulhuddart, Dublin 15

Dublin

Ireland

Manufacturer:

McDermott Laboratories Limited trading as Gerard Laboratories

35/36 Baldoyle Industrial Estate

Grange Road, Dublin 13

Ireland

or

Mylan Hungary Kft.

H-2900 Komárom

Mylan utca 1

Hungary

or

Generics [UK] Limited

Station Close, Potters Bar,

Hertfordshire,

EN6 1TL

United Kingdom

You can ask for more information about this medicine from the local representative of the marketing authorization holder:

Viatris Pharmaceuticals, S.L.U.

C/ General Aranaz, 86

28027 - Madrid

Spain

This medicine is authorized in the Member States of the European Economic Area under the following names:

Germany Irbesartan Mylan 300 mg Tabletten

Belgium Irbesartan Mylan 300 mg tabletten

Slovakia Irbesartan Mylan 300 mg

Spain Irbesartán Viatris 300 mg comprimidos EFG

France IRBESARTAN VIATRIS 300 mg comprimé

Greece Irbesartan/Mylan δισκ?α 300 mg/TAB

Italy Irbesartan Mylan 300 mg compresse

Luxembourg Irbesartan Mylan 300 mg comprimés

Norway Irbesartan Mylan 300 mg tabletter

Netherlands Irbesartan Mylan 300 mg tabletten

Portugal Irbesartan Mylan 300 mg comprimidos

United Kingdom Irbesartan 300 mg tablets

Czech Republic Irbesartan Mylan 300 mg tablety

Romania Irbesartan Mylan 300 mg comprimate

Sweden Irbesartan Mylan 300 mg tabletter

Date of last revision of this leaflet:January 2025

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