IRBESARTAN/HYDROCHLOROTHIAZIDE VIATRIS 300 mg/25 mg TABLETS

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

Do not take Irbesartan/Hydrochlorothiazide Viatris:

• If you are allergicto irbesartan or any of the other ingredients of this medicine (listed in section 6).
• If you are allergicto hydrochlorothiazide or to any other medicine belonging to the sulphonamide group.
• If you are more than 3 months pregnant(in any case, it is better to avoid taking this medicine during the first few months of pregnancy - see section Pregnancy).
• If you have severe liver or kidney problems.
• If your doctor detects that you have persistently high levels of calcium or low levels of potassium in your blood.
• If you have diabetes mellitus or impaired kidney functionand are being treated with a medicine containing aliskiren.

Warnings and precautions

Consult your doctor or pharmacist before starting treatment with Irbesartan/Hydrochlorothiazide Viatris and in any of the following cases:

• If you have had respiratory or lung problems (such as inflammation or fluid in the lungs) after taking hydrochlorothiazide in the past. If you experience shortness of breath or severe difficulty breathing after taking Irbesartan/Hydrochlorothiazide Viatris, seek medical attention immediately.
• If you have had skin cancer or if you develop an unexpected skin lesion during treatment. Treatment with hydrochlorothiazide, particularly long-term use at high doses, may increase the risk of certain types of skin and lip cancer (non-melanoma skin cancer). Protect your skin from sun exposure and UV rays while taking irbesartan/hydrochlorothiazide.
• If you have excessive vomiting or diarrhoea.
• If you have kidney problems, including narrowing of the renal arteryor if you have had a kidney transplant.
• If you have heart problems, including narrowing of the heart valvesor enlargement or weakness of the heart muscle (heart failure).
• If you have a narrowing of the blood vessels of the heart, which can cause chest pain, for example angina.
• If you have other liver problems.
• If you have diabetes.
• If you experience low blood sugar levels (hypoglycaemia) (symptoms may include sweating, weakness, hunger, dizziness, trembling, headache, flushing or pallor, numbness, rapid or strong heartbeat), especially if you are being treated for diabetes.
• If you have systemic lupus erythematosus(also known as lupus or SLE).
• If you have a history of allergies or asthma.
• If you have primary aldosteronism(a condition related to excessive production of the hormone aldosterone, which causes sodium retention and, in turn, increased blood pressure).
• If you are on a low-salt diet.
• If you are taking diuretics.
• If you are taking any of the following medicines used to treat high blood pressure (hypertension):
• • An angiotensin-converting enzyme inhibitor (ACE inhibitor) (e.g. enalapril, lisinopril, ramipril), particularly if you have kidney problems related to diabetes.
  • Aliskiren.

Tell your doctor if you experience abdominal pain, nausea, vomiting, or diarrhoea after taking irbesartan/hydrochlorothiazide. Your doctor will decide whether to continue treatment. Do not stop taking irbesartan/hydrochlorothiazide 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 Irbesartan/Hydrochlorothiazide Viatris”.

If you think you might be pregnant or are planning to become pregnant, inform your doctor. Irbesartan/hydrochlorothiazide is not recommended during pregnancy and should not be taken after the third month of pregnancy, as it may cause serious harm to your baby (see section Pregnancy).

During treatment

You should also inform your doctor:

• If you experience any of the following signs: feeling of thirst, dry mouth, general weakness, feeling of sleepiness, muscle pain or cramps, nausea, vomiting, or rapid heartbeat, as these may indicate an excessive effect of hydrochlorothiazide (contained in irbesartan/hydrochlorothiazide).
• If you experience an increased sensitivity of the skin to the sunwith symptoms of sunburn (such as redness, itching, swelling, blisters) that occurs more quickly than usual.
• If you are going to have surgery(surgical intervention) or if you are going to be given anaesthetics.
• If you experience a decrease in vision or eye pain. These could be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or an increase in pressure in the eye and can occur within hours to weeks after taking irbesartan/hydrochlorothiazide. This can lead to permanent worsening of vision if left untreated. If you have previously had an allergy to penicillin or sulphonamide, you may be at greater risk of developing this.
• If you need to have a blood testto check how your parathyroid gland(a gland that helps maintain calcium levels) is working, tell your doctor or hospital staff that you are taking this medicine.

Hydrochlorothiazide contained in this medicine may cause positive results in doping tests.

Children and adolescents

Irbesartan/hydrochlorothiazide should not be given to children and adolescents (under 18 years of age).

Other medicines and Irbesartan/Hydrochlorothiazide Viatris

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

Diuretics, such as hydrochlorothiazide contained in irbesartan/hydrochlorothiazide, may interact with other medicines.

Do not take irbesartan/hydrochlorothiazide with medicines containing lithium (used in mental health conditions) without your doctor's supervision.

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

• If you are taking an angiotensin-converting enzyme inhibitor (ACE inhibitor) or aliskiren (see also the information under the headings “Do not take Irbesartan/Hydrochlorothiazide Viatris” and “Warnings and precautions”.

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

• Potassium supplements.
• Salt substitutes that contain potassium.
• Potassium-sparing diuretics or other diuretics (tablets that increase urine production).
• Certain laxatives.
• Medicines used to treat gout, such as probenecid or sulfinpyrazone.
• Vitamin D or calcium supplements.
• Medicines to control heart rhythm, such as digoxin.
• Medicines for diabetes (oral agents such as repaglinide or insulins).
• Carbamazepine (a medicine used to treat epilepsy).
• Amphotericin (a medicine used to treat fungal infections).
• Sodium penicillin G (an antibiotic used to treat bacterial infections).
• Carbenoxolone (used for stomach and mouth ulcers).
• Medicines that may increase potassium levels in the blood, such as heparin (used to prevent blood clots).

It is also important to inform your doctor if you are taking other medicines to lower your blood pressure, steroids, medicines to treat cancer, such as cyclophosphamide, methotrexate, painkillers known as NSAIDs or COX-2 inhibitors, such as celecoxib or acetylsalicylic acid, amantadine (a medicine used to treat Parkinson's disease or influenza), allopurinol for gout, medicines that have the effect of emptying the stomach, such as atropine, biperiden, or resins like cholestyramine or colestipol, to reduce cholesterol in the blood.

Taking Irbesartan/Hydrochlorothiazide Viatris with alcohol

Due to the hydrochlorothiazide contained in irbesartan/hydrochlorothiazide, if you drink alcohol while taking this medicine, you may experience increased dizziness when standing up, especially when getting up from a sitting position.

Pregnancy and breastfeeding

Pregnancy

Tell your doctor if you think you might be pregnant or are planning to become pregnant. Your doctor will normally advise you to stop taking irbesartan/hydrochlorothiazide before you become pregnant or as soon as you find out you are pregnant and will recommend an alternative medicine. Irbesartan/hydrochlorothiazide is not recommended during pregnancy and should not be taken after the third month of pregnancy, as it may cause serious harm to your baby.

Breastfeeding

Tell your doctor if you are about to start or are already breastfeeding, as irbesartan/hydrochlorothiazide is not recommended for women during this period. Your doctor may decide to give you a different treatment that is more suitable if you want to breastfeed, especially for newborns or premature babies.

Driving and using machines

No studies have been performed on the ability to drive and use machines. It is unlikely that irbesartan/hydrochlorothiazide 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, talk to your doctor before driving or using machines.

Irbesartan/Hydrochlorothiazide Viatris contains lactose and sodium

This medicine contains lactose. If your doctor has told you that you have an intolerance to some sugars, consult your doctor before taking this medicine.

This medicinecontains less than 1 mmol of sodium (23 mg) per tablet; it isessentially “sodium-free”.

3. How to take Irbesartan/Hydrochlorothiazide Viatris

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

Dose

The recommended dose of irbesartan/hydrochlorothiazide is one tablet per day.

Generally, your doctor will prescribe irbesartan/hydrochlorothiazide when previous treatments you received did not sufficiently reduce your blood pressure. Your doctor will tell you how to switch from previous treatments to irbesartan/hydrochlorothiazide.

Method of administration

Irbesartan/hydrochlorothiazide is taken orally.

The tablets should be swallowed with a sufficient amount of liquid (e.g. a glass of water). You can take irbesartan/hydrochlorothiazide with or without food. Try to take your daily dose at the same time each day. It is important that you continue to take irbesartan/hydrochlorothiazide until your doctor tells you to stop.

The maximum blood pressure-lowering effect should be achieved 6-8 weeks after starting treatment.

If you take more Irbesartan/Hydrochlorothiazide Viatris than you should

If you accidentally take too many tablets, contact your doctor or pharmacist immediately, call the Toxicology Information Service (Tel. 91 562 04 20), indicating the medicine and the amount taken, or go to the emergency department of the nearest hospital. You may feel dizzy, weak, feel your heart beating faster or slower, feel sick, and sleepy or drowsy.

Children should not take Irbesartan/Hydrochlorothiazide Viatris

Irbesartan/hydrochlorothiazide should not be given to children under 18 years of age. If a child swallows some tablets, contact your doctor immediately.

If you forget to take Irbesartan/Hydrochlorothiazide Viatris

If you accidentally miss a dose, simply take your normal dose when it is due next. Do not take a double dose to make up for forgotten doses.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible Adverse Effects

Like all medicines, this medicine can cause adverse effects, although not all people suffer from them.

Some of these effects can be serious and may require medical attention. If you notice any of the following adverse effects, stop taking irbesartan/hydrochlorothiazide and inform your doctor or go immediately to the emergency department of the nearest hospital:

Uncommon(may affect up to 1 in 100 people)

• Yellowing of the skin and the whites of the eyes.

Frequency Not Known(cannot be estimated from the available data)

• Rarely, cases of allergic skin reactions (skin rash, hives) have been reported, as well as localized inflammation in the face, lips, and/or tongue and difficulty breathing.

• Faster and irregular heartbeat or sensation of strong heartbeats (palpitations), pounding in the chest, sensation of fainting and dizziness, which can be caused by problems with the heart rhythm. This can be detected by an ECG (a test used to show how the heart is beating).
• An increase in the number of infections, such as sore throat, mouth ulcers, pale appearance, feeling of tiredness, shortness of breath, especially after exercise, bruising or bleeding more easily, which may be due to a reduction in the number or type of blood cells in the blood. This can be caused by a problem with the bone marrow (where blood cells are produced).
• Pallor, feeling of tiredness or shortness of breath, which may be caused by the breakdown of red blood cells.
• Decreased vision or eye pain (possible signs of fluid accumulation in the vascular layer of the eye (choroidal effusion) or acute angle-closure glaucoma).
• Pain and difficulty breathing, fever, chest pain, and cough, caused by fluid in the lungs (pulmonary edema).
• Increased frequency of urination, in large quantities, pale in color, or difficulty urinating, which may be due to kidney problems.
• Severe pain in the upper abdomen, feeling of nausea, vomiting, which may be due to liver problems.
• Rash with raised purple spots and flat red areas caused by inflammation of the blood vessels (vasculitis).
• A severe allergic reaction in the skin that includes a rash with flat red areas, blisters, and large areas of skin peeling all over the body.
• Cutaneous lupus erythematosus - you may notice a rash that can appear on the face, neck, and scalp.
• Increased sensitivity of the skin to the sun.
• Pancreatitis - you may have severe stomach pain that radiates to the back and feeling of discomfort.
• Skin and lip cancer (non-melanoma skin cancer).

Other Possible Adverse Effects

Adverse effects reported in clinical studies in patients treated with irbesartan/hydrochlorothiazide combination tablets were:

Common(may affect up to 1 in 10 people)

• Feeling of nausea/vomiting.
• Feeling of tiredness (fatigue).
• Dizziness.
• Blood tests may show elevated levels of an enzyme that measures how the muscle and heart are working (creatine kinase) or elevated levels of substances that measure how the kidneys are working (urea nitrogen in the blood, creatinine).

Uncommon(may affect up to 1 in 100 people)

• Diarrhea.
• Low blood pressure.
• Fainting.
• Tachycardia.
• Flushing.
• Swelling.
• Sexual dysfunction (sexual function disorders).
• Blood tests may show low levels of sodium and potassium in the blood.
• Feeling of dizziness after standing up from lying down or sitting.

Frequency Not Known(cannot be estimated from the available data)

• Headache.
• Ringing in the ears.
• Cough.
• Taste disturbance, indigestion.
• Pain in joints and muscles.
• Blood tests may show that the liver is not working properly.
• Blood tests may show elevated levels of potassium in the blood.

As with all combinations of two active ingredients, the adverse effects associated with each component cannot be excluded.

Adverse Effects Associated with Irbesartan in Monotherapy

Uncommon(may affect up to 1 in 100 people)

• Chest pain.

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

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

Frequency Not Known(cannot be estimated from the available data)

• Formation of bruises and increased tendency to bleed, which may be due to a reduction in the number of platelets (blood clotting cells).
• Fatigue, headaches, difficulty breathing during exercise, and dizziness and pallor, which may be due to a reduced number of red blood cells (anemia).
• High blood sugar levels.
• Severe allergic reactions (anaphylactic shock).

Adverse Effects Associated with Hydrochlorothiazide in Monotherapy

Very Rare(may affect up to 1 in 10,000 people)

• Acute respiratory distress (signs include severe respiratory distress, fever, weakness, and confusion).

Frequency Not Known(cannot be estimated from the available data)

• Loss of appetite.
• Stomach irritation; stomach cramps; constipation.
• Sleep disorders.
• Depression.
• Blurred vision, color vision affected with objects appearing more yellow than they are (xanthopsia), myopia (acute myopia).
• Fever.
• Weakness and muscle spasms.
• Numbness, tingling, or burning sensation "pins and needles" in the skin (paresthesia).
• Restlessness, dizziness.
• Decrease in blood pressure after changing body position.
• Swelling of the salivary glands.
• High blood sugar levels.
• Sugar in the urine.
• Increases in some types of blood fats; high levels of uric acid in the blood, which can cause gout.

It is known that the adverse effects associated with hydrochlorothiazide can increase with higher doses of hydrochlorothiazide.

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 that is not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of Irbesartan/Hydrochlorothiazide Viatris

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

Do not use this medicine after the expiration date that appears on the packaging, label, or blister after CAD or EXP. The expiration date is the last day of the month indicated.

The shelf life of the product in the bottle is 90 days once opened.

This medicine does not require special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Deposit the packaging and medicines you no longer need at the SIGRE collection point in the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This way, you will help protect the environment.

6. Package Contents and Additional Information

Composition of Irbesartan/Hydrochlorothiazide Viatris

• The active ingredients are irbesartan and hydrochlorothiazide.

Each tablet contains 300 mg of irbesartan and 25 mg of hydrochlorothiazide.

• The other ingredients are: microcrystalline cellulose (E-460), anhydrous colloidal silica, sodium lauryl sulfate, pregelatinized corn starch, magnesium stearate (E-470b), povidone (K-90), lactose monohydrate, sodium croscarmellose. See section 2 "Irbesartan/Hydrochlorothiazide Viatris contains lactose and sodium".

Appearance of the Product and Package Contents

The tablets are white to off-white, oval, biconvex, marked with "M" on one side and "I35" on the other.

Irbesartan/Hydrochlorothiazide Viatris is available in blister packs of 14, 28, 30, 56, 90, 98, or 100 tablets, in single-dose blisters of 56 tablets, in calendar-type blister packs of 28 tablets, and in bottles of 500 tablets.

Only some 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 trading as Gerard Laboratories

35/36 Baldoyle Industrial Estate

Grange Road

Dublin 13

Ireland

or

Mylan Hungary Kft

H-2900 Komarom,

Mylan utca 1

Hungary

You can request more information about this medicine by contacting 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:

Spain Irbesartan/Hydrochlorothiazide Viatris 300 mg/25 mg tablets EFG

France Irbesartan/Hydrochlorothiazide Mylan 300 mg/25 mg tablets

Italy Irbesartan and Hydrochlorothiazide Mylan 300 mg/25 mg tablets

Norway Irbesartan/Hydrochlorothiazide Mylan 300 mg/25 mg tablets

Netherlands Irbesartan/Hydrochlorothiazide Mylan 300 mg/25 mg tablets

United Kingdom Irbesartan/Hydrochlorothiazide Mylan 300 mg/25 mg tablets

Czech Republic Irbesartan/Hydrochlorothiazide Mylan 300 mg/25 mg tablets

Date of the Last Revision of this Leaflet:January 2025

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