Irbesartan Viatris 300 mg tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Irbesartán Viatris 300 mg tablets EFG

Read the entire 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, 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, because it could harm them.
• If you experience any adverse reactions, consult your doctor or pharmacist, even if they are adverse reactions 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 Irbesartán Viatris is and what it is used for

Irbesartán 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 leads to an increase in blood pressure. Irbesartan prevents angiotensin-II from binding to these receptors, relaxing the blood vessels and thereby lowering blood pressure. Irbesartan slows the decline in renal function in patients with high blood pressure and type 2 diabetes.

Irbesartán 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 taking 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 in 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 measure potassium levels if kidney function is impaired.

• If you experience low blood sugar levels (symptoms may include sweating, weakness, hunger, dizziness, trembling, 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, causing sodium retention and leading to increased 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.

Consult 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 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 onward, 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 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 pregnancy is confirmed, and will recommend an alternative antihypertensive medicine. Irbesartan is not recommended during early pregnancy and must not be used from the third month of pregnancy onward, as it may cause serious harm to your baby when administered from that time.

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 another treatment if you wish to breastfeed, especially if your baby is a newborn or was born prematurely.

Driving and use of 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 Irbesartán Viatris

Always follow exactly the instructions given by your doctor or pharmacist when taking this medicine. If in doubt, consult your doctor or pharmacist again.

Method of administration

Irbesartán is administered orally. The tablets should be swallowed with a sufficient amount of liquid (for example, a glass of water). Irbesartán 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 irbesartán unless your doctor advises you 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 at the start of treatment, if you are undergoing haemodialysis or are 75 years of age or older.

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

Use in children and adolescents

Irbesartán 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 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 Irbesartán 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 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 can cause adverse effects, although not everyone will experience them.

Some of these adverse effects may be serious and may require medical attention. If you notice any of the following adverse effects, stop taking this medicine and contact your doctor immediately 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.
• 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 or effort in urinating, or less frequent urination—in this case, urine may be darker in color 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/vomiting.

• Feeling tired (fatigue).

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

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

• 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 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 (tachycardia).
• Skin redness.
• Cough.
• Diarrhea.
• Indigestion/heartburn.
• Sexual dysfunction (changes in sexual function).
• Chest pain.

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

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

Frequency not known (cannot be estimated from available data)

• Appearance of bruises or more frequent bleeding than normal, which may be due to a reduced number of platelets (blood cells that help with clotting).
• Tiredness, headaches, difficulty breathing during exercise, dizziness, and 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, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them 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 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. Return unused medicines and their containers to the SIGRE Point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of unused medicines and containers. This 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 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

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

Available in blister packs 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.

HDPE bottles containing 30, 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

For further information regarding this medicinal product, please contact 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 member states 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 the most recent revision 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/