Irbesartan/hydrochlorothiazide Viatris 300 mg/25 mg tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Irbesartan/Hydrochlorothiazide Viatris 300 mg/25 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, ask 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 side effects, talk to your doctor or pharmacist, even if they are side effects not listed in this leaflet. See section 4.

Leaflet contents

1. What Irbesartan/Hydrochlorothiazide Viatris is and what it is used for
2. What you need to know before taking Irbesartan/Hydrochlorothiazide Viatris
3. How to take Irbesartan/Hydrochlorothiazide Viatris
4. Possible side effects
5. How to store Irbesartan/Hydrochlorothiazide Viatris

Pack contents and other information

1. What is Irbesartán/Hidroclorotiazida Viatris and what is it used for?

Irbesartán/Hidroclorotiazida Viatris is a combination of two active substances, irbesartan and hydrochlorothiazide.

Irbesartan 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 in blood vessels, causing them 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.

Hydrochlorothiazide belongs to a group of medicines (called thiazide diuretics) that lower blood pressure by increasing the amount of urine produced.

The two active substances in irbesartan/hydrochlorothiazide work together to achieve a greater reduction in blood pressure than either substance alone.

Irbesartan/hydrochlorothiazide is used to treat high blood pressure when treatment with irbesartan alone or hydrochlorothiazide alone does not provide adequate control of blood pressure.

2. What you need to know before taking Irbesartán/Hidroclorotiazida Viatris

Do not take Irbesartán/Hidroclorotiazida Viatris:

• If you are allergic to irbesartán or any of the other components of this medicine (listed in section 6).
• If you are allergic to hydrochlorothiazide or to any other sulfonamide-derived medicines.
• 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 severe liver or kidney problems.
• If your doctor finds that you have persistently high levels of calcium or low levels of potassium in your blood.
• If you have diabetes mellitus or impaired kidney function 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 Irbesartán/Hidroclorotiazida Viatris and in any of the following cases:

• If you have previously experienced breathing or lung problems (such as inflammation or fluid in the lungs) after taking hydrochlorothiazide. If you develop shortness of breath or severe difficulty breathing after taking Irbesartán/Hidroclorotiazida 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 non-melanoma skin cancer and lip cancer. Protect your skin from exposure to sunlight and UV rays while taking irbesartan/hydrochlorothiazide.
• If you have excessive vomiting or diarrhea.
• If you have kidney disorders, including renal artery stenosis, or if you have had a kidney transplant.
• If you have heart disorders, including heart valve narrowing, or heart muscle enlargement or weakness (heart failure).
• If you have narrowing of the blood vessels in the heart, which may cause chest pain, for example angina.
• If you have other liver disorders.
• If you have diabetes.
• 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 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, causing 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 (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 diarrhea after taking irbesartan/hydrochlorothiazide. Your doctor will decide whether to continue treatment. Do not stop taking irbesartan/hydrochlorothiazida 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/Hidroclorotiazida Viatris”.

If you suspect you might be pregnant or plan to become pregnant, inform your doctor. The use of irbesartan/hydrochlorothiazide 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 (see Pregnancy section).

During treatment

You should also inform your doctor if:

• You experience any of the following signs: thirst, dry mouth, general weakness, drowsiness, muscle pain or cramps, nausea, vomiting, or rapid heartbeat, as these may indicate an excessive effect of hydrochlorothiazide (contained in irbesartan/hydrochlorothiazide).
• You experience increased skin sensitivity to sunlight, with sunburn symptoms (such as redness, itching, swelling, blisters) occurring more quickly than usual.
• You are going to have surgery or receive anesthetics.
• 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 increased eye pressure and may occur within hours to weeks after taking irbesartan/hydrochlorothiazide. This may lead to permanent vision impairment if not treated. If you previously had an allergy to penicillin or sulfonamides, you may be at higher risk of developing this condition.
• You need to have a blood test to assess how your parathyroid gland (a gland that helps maintain calcium levels) is functioning; inform your doctor or hospital staff that you are taking this medicine.

The hydrochlorothiazide contained in this medicine may cause positive results in doping controls.

Children and adolescents

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

Other medicines and Irbesartán/Hidroclorotiazida Viatris

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

Diuretics such as hydrochlorothiazide contained in irbesartan/hydrochlorothiazide may affect other medicines.

You must not take medicines containing lithium (used for mental health conditions) together with irbesartan/hydrochlorothiazide without medical supervision.

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

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

You may need blood tests if you are taking:

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

It is also important to inform your doctor if you are taking other blood pressure-lowering medicines, steroids, cancer treatments such as cyclophosphamide or methotrexate, painkillers known as NSAIDs or COX-2 inhibitors, for example, celecoxib or acetylsalicylic acid, amantadine (a medicine used to treat Parkinson’s disease or flu), allopurinol for gout, or medicines that delay stomach emptying such as atropine, biperiden, or cholestyramine or colestipol resins used to lower blood cholesterol.

Taking Irbesartán/Hidroclorotiazida Viatris with alcohol

Due to the hydrochlorothiazide contained in irbesartan/hydrochlorothiazide, drinking alcohol while taking this medicine may increase the sensation of dizziness when standing up, especially when rising from a sitting position.

Pregnancy and breastfeeding

Pregnancy

Inform your doctor if you suspect you might be pregnant or plan to become pregnant. Your doctor will generally advise you to stop taking irbesartan/hydrochlorothiazide before becoming pregnant or as soon as pregnancy is confirmed and will recommend an alternative treatment. Irbesartan/hydrochlorothiazide is not recommended during pregnancy and must not be used from the third month of pregnancy onward, as it may cause serious harm to your baby when used from that time.

Breastfeeding

Inform your doctor if you are breastfeeding or plan to breastfeed, as irbesartan/hydrochlorothiazide is not recommended for women during this period. Your doctor may decide to prescribe a more suitable treatment if you wish to breastfeed, especially if your baby is a newborn or premature.

Driving and using machines

No studies have been conducted on the ability to drive and use machines. It is unlikely that irbesartan/hydrochlorothiazide will affect your ability to drive or operate machinery. However, during treatment for high blood pressure, dizziness or fatigue may occasionally occur. If you experience these symptoms, speak with your doctor before driving or operating machinery.

Irbesartán/Hidroclorotiazida Viatris contains lactose and sodium

This medicine contains lactose. If your doctor has informed you that you have an intolerance to certain sugars, consult with him before taking this medicine.

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

3. How to take Irbesartan/Hydrochlorothiazide Viatris

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

Dosage

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

In general, your doctor will prescribe irbesartan/hydrochlorothiazide when previous treatments you have received have not sufficiently reduced your blood pressure. Your doctor will advise you on how to switch from previous treatments to irbesartan/hydrochlorothiazide.

Method of administration

Irbesartan/hydrochlorothiazide is administered orally.

The tablets should be swallowed with a sufficient amount of liquid (for example, a glass of water). You may take irbesartan/hydrochlorothiazide 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/hydrochlorothiazide unless your doctor advises otherwise.

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 medication and the amount ingested, or go to the nearest hospital emergency department. You may feel dizzy, weak, notice your heart beating faster or slower, feel nauseous, sleepy, or drowsy.

Children must not take Irbesartan/Hydrochlorothiazide Viatris

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

If you forget to take Irbesartan/Hydrochlorothiazide 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, ask 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 effects may be serious and may require immediate medical attention. If you notice any of the following adverse effects, stop taking irbesartan/hydrochlorothiazide and contact your doctor immediately or go straight to the nearest hospital emergency department:

Uncommon (may affect up to 1 in 100 people)

• Yellowing of the skin and whites of the eyes.

Frequency not known (cannot be estimated from available data)

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

• Faster or irregular heartbeat, or sensation of strong heartbeats (palpitations), pounding in the chest, feeling faint and dizziness, which may be caused by heart rhythm problems. This may be detected by 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 tired, 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. This may be caused by a problem with the bone marrow (where blood cells are produced).

• Paleness, feeling tired or short 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 amounts, pale-colored urine, or being unable to urinate or urinating less frequently, which may require effort; in this case, urine may be darker in color or contain blood, which may be due to kidney problems.

• Severe upper stomach pain, feeling unwell, nausea, which may be due to liver problems.

• Rash with raised purple spots and flat red areas caused by inflammation of blood vessels (vasculitis).

• A severe skin allergic reaction including rash with flat red areas, blisters, and large areas of skin peeling off 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 sunlight.

• Inflammation of the pancreas – you may have severe stomach pain radiating to the back, along with feeling unwell.

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

Uncommon (may affect up to 1 in 100 people)

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

Frequency not known (cannot be estimated from available data)

• Headache.
• Ringing in the ears.
• Cough.
• Taste disturbance, indigestion.
• Joint and muscle pain.
• Blood tests may show that the liver is not functioning properly.
• Blood tests may show high levels of potassium in the blood.

As with all fixed-dose combinations of two active substances, adverse effects associated with each individual 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, presenting with symptoms such as abdominal pain, nausea, vomiting, and diarrhea.

Frequency not known (cannot be estimated from available data)

• Bruising easily and increased tendency to bleed, which may be due to a reduced number of platelets (blood clotting cells).
• Tiredness, headache, shortness of breath during exercise, dizziness and paleness, 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 breathing difficulty (signs include severe shortness of breath, fever, weakness, and confusion).

Frequency not known (cannot be estimated from available data)

• Loss of appetite.
• Stomach irritation; stomach cramps; constipation.
• Sleep disorders.
• Depression.
• Blurred vision, altered color vision with objects appearing more yellow than they are (xanthopsia), myopia (acute myopia).
• Fever.
• Weakness and muscle cramps.
• Tingling, pricking or burning sensations like "pins and needles" on the skin (paresthesia).
• Restlessness, dizziness.
• Drop in blood pressure after a change in body position.
• Swelling of the salivary glands.
• High blood sugar levels.
• Sugar in the urine.
• Increases in certain types of blood fats; high levels of uric acid in the blood, which may lead to gout.

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

Reporting of adverse effects

If you experience any 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 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/Hydrochlorothiazide 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 blister after EXP or CAD. The expiry date refers to the last day of the month indicated.

The product's shelf life in the bottle 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 empty containers and any unused medicines to the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Irbesartan/Hydrochlorothiazide Viatris

• The active substances are irbesartan and hydrochlorothiazide.

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

• The other components 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 contents of the pack

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

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

Only certain pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation 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

Further information on this medicine is available from the local representative of the Marketing Authorisation Holder:

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

This medicine is authorised 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 e Idroclorotiazide Mylan 300 mg/25 mg Compresse
Norway: Irbesartan/Hydrochlorothiazide Mylan 300 mg/25 mg Tabletter
Netherlands: Irbesartan/Hydrochloorthiazide Mylan 300 mg/25 mg tabletten
United Kingdom: Irbesartan/Hydrochlorothiazide Mylan 300 mg/25 mg Tablets
Czech Republic: Irbesartan/Hydrochlorothiazid Mylan 300 mg/25 mg tablety

Date of latest revision of this leaflet: January 2025

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