Irbesartan Viatris 75 mg tablets EFG

Patient Information Leaflet

Introduction

Package Leaflet: Information for the Patient

Irbesartán Viatris 75 mg Tablets EFG

Read the entire leaflet carefully before you start taking this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult 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, since it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet Contents

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

1. What Irbesartan Viatris is and what it is 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 binds to receptors, causing blood vessels to constrict. This results in an increase in blood pressure. Irbesartan prevents angiotensin-II from binding to these receptors, relaxing blood vessels and thereby lowering blood pressure. Irbesartan slows the decline in renal function 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 clinical evidence of impaired kidney function.

2. What you need to know before taking Irbesartán Viatris

Do not take Irbesartán Viatris:

• 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 this medicine 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 or pharmacist before starting to take this medicine:

• If you have had or develop during treatment, excessive vomiting (feeling sick) or diarrhoea.

• If you have been taking diuretics or 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 heart valves, or enlargement or weakness of the heart muscle (heart failure).

• If you have narrowing of the blood vessels of the heart, which may 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 monitor potassium levels if kidney function is impaired.

• If you experience low blood sugar levels (symptoms may include sweating, weakness, hunger, dizziness, tremors, headache, flushing or paleness, numbness, rapid and strong heartbeat), especially if you are being treated for diabetes.

• If you have primary aldosteronism (a condition related to increased production of the hormone aldosterone, which causes sodium retention and leads to high blood pressure).

• If you are of Afro-Caribbean origin, irbesartan may be less effective in lowering blood pressure.

• If you are taking any of the following medicines used to treat high blood pressure (hypertension):

  • An ACE inhibitor (e.g., enalapril, lisinopril, ramipril), particularly if you have kidney problems related to diabetes.
  • Aliskiren.

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

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 Viatris”.

If you are pregnant, suspect you may be pregnant, or plan to become pregnant, you must inform your doctor. Use of irbesartan is not recommended during early pregnancy (first 3 months), and in no case should it be administered from the third month of pregnancy onwards, as it may cause serious harm to your baby (see section Pregnancy).

During treatment:

You should also inform your doctor:

• If you are going to undergo surgery or receive anaesthetics.

Children and adolescents

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

Other medicines and Irbesartán Viatris

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 ACE inhibitors or aliskiren (see also information under the headings “Do not take Irbesartán Viatris” and “Warnings and precautions”).

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

• Potassium supplements.
• Salt substitutes containing potassium.
• Potassium-sparing (diuretic) medicines or medicines that may increase potassium levels in the blood, for example, heparin.
• Medicines containing lithium (used to treat mental health conditions).
• Repaglinide (a medicine used to lower blood sugar levels).

If you are using a type of painkiller known as non-steroidal anti-inflammatory drugs (NSAIDs) or COX-2 inhibitors, for example, 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, consult your doctor before using this medicine. Generally, your doctor will advise you to stop taking irbesartan before becoming pregnant, or as soon as you become pregnant, and will recommend another antihypertensive medicine instead. Irbesartan 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 stage.

Breastfeeding

Inform your doctor if you are breastfeeding or about to start breastfeeding. Use of irbesartan is not recommended for breastfeeding mothers, and your doctor may choose an alternative treatment if you wish 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 operate machinery. However, during treatment for hypertension, dizziness or fatigue may occasionally occur. If you experience these symptoms, discuss them with your doctor before driving or operating machinery.

Irbesartán Viatris contains lactose and sodium

If your doctor has informed you that you have an intolerance to certain sugars (e.g., lactose), consult him before taking this medicine.

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

3. How to take Irbesartan Viatris

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

Method of administration

Irbesartan is administered orally. The tablets should be swallowed with a sufficient amount of liquid (for example, a glass of water). Irbesartan 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 irbesartan unless your doctor advises otherwise.

• Patients with high blood pressure

The recommended 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 advise a lower dose, especially when starting treatment, if you are undergoing haemodialysis or are aged 75 years or older.

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

Use in children and adolescents

Irbesartan 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 Irbesartan Viatris than you should

If you accidentally take too many tablets, contact your doctor immediately. You may feel dizzy or notice that your heart is beating faster or slower than normal.

In case of overdose or accidental ingestion, contact your doctor or pharmacist, or call the Toxicology Information Service at 91 562 04 20, indicating the medicine and the amount ingested. Take the packaging and any remaining tablets with you.

If you forget to take Irbesartan Viatris

If you accidentally miss a dose, simply take your next dose at the usual time. Do not take a double dose to make up for the missed dose.

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 can cause adverse effects, although not everyone experiences them.

Some of these adverse effects can be serious and may require immediate medical attention. If you experience any of the following adverse effects, stop taking this medicine immediately and contact your doctor or go straight to the nearest hospital emergency department:

Frequency not known (cannot be estimated from available data)

• Severe allergic reaction with symptoms such as red, itchy rash, feeling dizzy or faint, localized swelling of the face, lips and/or tongue, which could cause difficulty breathing.
• Yellowing of the skin and whites of the eyes, severe pain in the upper stomach, feeling sick and vomiting—this may be due to liver problems.
• Skin rash with purple spots and red patches caused by inflammation of small blood vessels (vasculitis).
• Increased frequency of urination, in large amounts, pale-colored urine, or difficulty or strain when urinating; alternatively, less frequent urination, in which case the urine may be darker or contain blood. This may be due to kidney problems.

Other possible adverse effects

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.

• Feeling sick or being sick (nausea or vomiting).

• Feeling tired (fatigue).

• Blood tests may show elevated levels of an enzyme that reflects how muscles and the heart are functioning (creatine kinase enzyme).

• In patients with high blood pressure and type 2 diabetes with kidney impairment:

• Dizziness upon standing up from a lying or sitting position.

• Low blood pressure upon standing up from a lying or sitting position.

• Muscle or joint pain.

• Blood tests may show decreased levels of a protein found in red blood cells (hemoglobin).

Uncommon (may affect up to 1 in 100 people)

• Feeling that your heart is beating faster than normal (tachycardia).
• Skin redness.
• Cough.
• Diarrhea.
• Indigestion/heartburn.
• Sexual dysfunction (disturbances in sexual function).
• Chest pain.

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

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

Frequency not known (cannot be estimated from available data)

• Appearance of bruises or bleeding more easily than usual, which may be due to a reduced number of platelets (blood cells that help with clotting).
• Fatigue, headaches, difficulty breathing during exercise, dizziness, or paleness, which may be caused by a reduced number of red blood cells (anemia).
• Sensation of spinning (vertigo).
• Headache.
• Taste disturbances.
• Ringing in the ears (tinnitus).
• Muscle cramps.
• Muscle and joint pain.
• Blood tests show abnormal liver function.
• Blood tests show increased levels of potassium in the blood.
• Low blood sugar levels.

Reporting of adverse effects

If you experience any type of adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report adverse effects directly via 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 Viatris

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

Do not use this medicine after the expiry date stated on the container, label or blisters, after EXP or CAD. The expiry date refers to the last day of the month indicated.

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 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 in doubt, ask your pharmacist how to dispose of containers and medicines you no longer need. This way, you 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 75 mg of irbesartan.

The other components are monohydrate lactose (see section 2 of the leaflet “Irbesartan Viatris contains lactose”), povidone, microcrystalline cellulose (E-460), sodium croscarmellose, magnesium stearate (E-572), and anhydrous colloidal silica.

Appearance of the product and contents of the pack

Round tablets, white to almost white, with convex sides, marked with an "M" on one side and "IN1" on the other.

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

Calendar blister packs of 14, 28, 56, 84 and 98 tablets.

Plastic bottles containing 500 and 1000 tablets.

Only certain 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

Further information on this medicinal product is available by contacting the local representative of the Marketing Authorization Holder:

Viatris Pharmaceuticals, S.L.U.
C/ General Aranaz, 86
28027 - Madrid
Spain

This medicinal product is authorized in the European Economic Area (EEA) Member States under the following names:

Germany Irbesartan Mylan 75 mg Tabletten
Belgium Irbesartan Mylan 75 mg tabletten
Spain Irbesartan Viatris 75 mg tablets EFG
France IRBESARTAN VIATRIS 75 mg comprimé
Greece Irbesartan/Mylan δισκ?α 75 mg/TAB
Italy Irbesartan Mylan 75 mg compresse
Luxembourg Irbesartan Mylan 75 mg comprimés
Norway Irbesartan Mylan 75 mg tabletter
Netherlands Irbesartan Mylan 75 mg tabletten
Portugal Irbesartan Mylan 75 mg comprimidos
United Kingdom Irbesartan 75 mg tablets
Romania Irbesartan Mylan 75 mg comprimate
Sweden Irbesartan Mylan 75 mg tabletter

Date of the most recent review of this leaflet: January 2025

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