Patient Information Leaflet

Irbesartán/Hidroclorotiazida Viatris 150 mg/12.5 mg Tablets EFG

Read this 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. Do not give it to others, even if they have the same symptoms as you, as it may harm them.

-If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

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

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

3.How to take Irbesartán/Hidroclorotiazida Viatris

4.Possible side effects

5.Storage of Irbesartán/Hidroclorotiazida Viatris

6.Contents of the pack and additional information

Irbesartán/Hidroclorotiazida Viatris is an association of two active principles, irbesartan and hydrochlorothiazide.

Irbesartan belongs to a group of medications known as angiotensin-II receptor antagonists. Angiotensin-II is a substance produced in the body that binds to blood vessel receptors, causing them to contract. This results in an increase in blood pressure. Irbesartan prevents the binding of angiotensin-II to these receptors, relaxing blood vessels and reducing blood pressure.

Hydrochlorothiazide belongs to a group of medications (called thiazide diuretics) that, by increasing the amount of urine eliminated, decrease blood pressure.

The two active principles of irbesartan/hydrochlorothiazide act together to achieve a decrease in blood pressure greater than that obtained with each one separately.

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

Do not take Irbesartán/Hidroclorotiazida Viatris:

• If you areallergicto irbesartán or to any of the other components of this medication (listed in section 6).
• If you areallergicto hidroclorotiazida or to any other medication derived from sulfonamides.
• If you arepregnant for more than 3 months(in any case, it is better to avoid taking this medication also at the beginning of your pregnancy - see Pregnancy section).
• If you havesevere liver or kidney problems.
• If your doctor detects that you havepersistently elevated levels of calcium or low levels of potassium in your blood.
• If you have diabetes mellitus or damaged renal functionand are being treatedwith a medication to lower blood pressure that containsaliskirén.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Irbesartán/Hidroclorotiazida Viatris and in any of the following cases:

• If you have had respiratory or pulmonary problems (such as inflammation or fluid in the lungs) after taking hidroclorotiazida in the past. If you experience 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. The treatment with hidroclorotiazida, particularly its long-term use at high doses, may increase the risk of certain types of skin cancer and lip cancer (non-melanoma skin cancer). Protect your skin from sun exposure and UV rays while taking irbesartán/hidroclorotiazida.
• If you haveexcessive vomiting or diarrhea.
• If you havekidney problems, including renal artery stenosisor if you have had akidney transplant.
• If you haveheart problems, including heart valve narrowing, heart enlargement or weakness (heart failure).
• If you havecoronary artery stenosis, which may cause chest pain, for example angina.
• If you haveother liver problems.
• If you havediabetes.
• If you experience low blood sugar levels (symptoms may include sweating, weakness, hunger, dizziness, tremors, headache, flushing or pallor, numbness, rapid and strong heartbeats), especially if you are being treated for diabetes.
• If you havelupus erythematosus(also known as lupus or LES).
• Ifyou have a history ofallergies or asthma.
• If you haveprimary aldosteronism(a condition related to the production of excessive aldosterone hormone, which causes sodium retention and, in turn, an increase in blood pressure).
• If you are following alow-sodium diet.
• If you are takingdiuretics.
• Ifyou are takingany of the following medications used to treat high blood pressure (hypertension):
• • A converting enzyme inhibitor (ACEI) (for example, enalapril, lisinopril, ramipril), particularly if you have kidney problems related to diabetes.
  • Aliskirén.

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

Your doctor may monitor your renal function, blood pressure, and electrolyte levels in your blood (such as potassium), at regular intervals.

See also the information under the heading “Do not take Irbesartán/Hidroclorotiazida Viatris”.

If you suspect that you may be pregnant orif you plan to become pregnant, you must inform your doctor. It is generally recommended that you stop taking irbesartán/hidroclorotiazida before becoming pregnant or as soon as you become pregnant and your doctor will recommend taking another medication instead. Irbesartán/hidroclorotiazida should not be used during pregnancy and should not be administered after the third month of pregnancy, as it may cause serious harm to your baby (see Pregnancy section).

During treatment

You must also inform your doctor:

• Ifyou experience any of these symptoms:thirst, dry mouth, generalized weakness, feeling of drowsiness, muscle pain or cramps, nausea, vomiting or rapid heartbeat, as they may indicate excessive hidroclorotiazida effect (contained in irbesartán/hidroclorotiazida).
• Ifyou experience an increasedsensitivity to the sunwith symptoms of sunburn (such as redness, itching, swelling, blisters) that occur more quickly than usual.
• Ifyou are to be operated(surgical intervention) orif you are to receive anesthetics.
• If you experience a decrease in vision or eye pain. These may be symptoms of fluid accumulation in the vascular layer of the eye (choroidal hemorrhage) or increased eye pressure and may occur within a few hours to weeks after taking irbesartán/hidroclorotiazida. This may lead to permanent vision impairment if not treated.If you have previously had an allergy to penicillin or sulfonamide, you may have a higher risk of developing this.
• Ifyou need to have blood tests to check how yourparathyroid(a gland that helps maintain calcium levels) is working, tell your doctor or hospital staff that you are taking this medication.

The hidroclorotiazida contained in this medication may cause positive results in doping control.

Children and adolescents

Irbesartán/hidroclorotiazida should not be administered to children and adolescents (under 18 years).

Other medications and Irbesartán/Hidroclorotiazida Viatris

Inform your doctor or pharmacist if you are taking, have taken recently or may need to take any other medication.

Diuretics, such as hidroclorotiazida contained in irbesartán/hidroclorotiazida, may affect other medications.

You should not take it with irbesartán/hidroclorotiazida the medications that contain lithium (used for mental health problems) without your doctor's supervision.

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

• Ifyou are takinga converting enzyme inhibitor (ACEI) oraliskirén(see also the information under the headings “Do not take Irbesartán/Hidroclorotiazida Viatris” and “Warnings and precautions”.

You may need to have blood tests if you take:

• Potassium supplements.
• Sodium-free salt substitutes that contain potassium.
• Medications that conserve potassium or other diuretics (tablets that increase urine production).
• Some laxatives.
• Medications used to treat gout, for example, probenecid, sulfinpirazona.
• Vitamin D or calcium supplements.
• Medications to control heart rhythm, for example, digoxina.
• Diabetes medications (oral agents such as repaglinida or insulins).
• Carbamazepine (a medication used to treat epilepsy).
• Anfotericina (a medication used to treat fungal infections).
• Penicilina G-sódica (an antibiotic used to treat bacterial infections).
• Carbenoxolona (used to treat stomach and mouth ulcers).
• Medications that may increase potassium levels in the blood, for example, heparina (used to prevent blood clots).

It is also important to inform your doctor if you are taking other medications to lower your blood pressure, steroids, medications to treat cancer, such asciclofosfamida, metotrexato, analgésicos known as AINEs or COX-2 inhibitors, such as celecoxib or ácido acetilsalicílico, amantadina (a medication used totreating Parkinson's disease or the flu), alopurinol for gout, medications that have the effect of emptying the stomach, such as atropina, biperideno, or resins of colestiramina or colestipol, to reduce cholesterol in the blood.

Irbesartán/Hidroclorotiazida Viatris with alcohol

Due to the hidroclorotiazida contained in irbesartán/hidroclorotiazida, if you drink alcohol while taking this medication, you may experience a greater sensation of dizziness when standing up, especially when getting up from a seated position.

Pregnancy and breastfeeding

Pregnancy

You must inform your doctor if you suspect that you may be pregnant or if you plan to become pregnant. It is generally recommended that you stop taking irbesartán/hidroclorotiazida before becoming pregnant or as soon as you become pregnant and your doctor will recommend taking another medication instead. Irbesartán/hidroclorotiazida should not be used during pregnancy and should not be administered after the third month of pregnancy, as it may cause serious harm to your baby when administered from that point on.

Breastfeeding

Inform your doctor if you plan to start or are breastfeeding, as it is not recommended to administer irbesartán/hidroclorotiazida to women during this period. Your doctor may decide to administer a more suitable treatment if you want to breastfeed, especially to newborns or premature babies.

Driving and operating machinery

No studies have been conducted on the ability to drive and operate machinery. It is unlikely that irbesartán/hidroclorotiazida will affect your ability to drive vehicles or operate machinery. However, during hypertension treatment, you may occasionally experience dizziness or fatigue. If you experience these symptoms, speak with your doctor before driving or operating machinery.

Irbesartán/Hidroclorotiazida Viatris contains lactose and sodium

This medication contains lactose. If your doctor has indicated that you have a lactose intolerance, consult with him before taking this medication.

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

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Dose

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

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

Administration Form

Irbesartan/hidroclorotiazida is administered byoral route.

Tablets should be swallowed with a sufficient amount of liquid (e.g., a glass of water). You can take irbesartan/hidroclorotiazida with or without food. You should try to take your daily dose at the same time each day. It is essential that you continue taking irbesartan/hidroclorotiazida until your doctor advises you otherwise.

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

If you take more Irbesartán/Hidroclorotiazida Viatris than you should

If you accidentally take too many tablets, contact your doctor or pharmacist immediately, call the Toxicological 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, feel your heart beating faster or slower, feel nauseous, and drowsy.

Children should not take Irbesartán/Hidroclorotiazida Viatris

Irbesartan/hidroclorotiazida 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 Irbesartán/Hidroclorotiazida Viatris

If you accidentally forget to take a dose, simply take your regular dose when it is next due. Do not take a double dose to make up for the missed dose.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medicines,this medicinecan cause side effects, although not everyone will experience them.

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

Rare(may affect up to 1 in 100 people)

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

Frequency unknown(cannot be estimated from available data)

• Occasional cases of skin allergic reactions (skin rash, urticaria), as well as localized inflammation on the face, lips, and/or tongue and difficulty breathing.

• Irregular or rapid heartbeat or a sensation of strong heartbeats (palpitations), pounding in the chest, dizziness, and fainting, which may be caused by heart rhythm problems. 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 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 in the blood. This may be caused by a problem with the bone marrow (where blood cells are produced).
• Pale appearance, feeling tired or short of breath, which may be caused by the rupture of red blood cells.
• Decreased vision or eye pain (possible signs of fluid accumulation in the vascular layer of the eye (choroidal hemorrhage) or acute angle-closure glaucoma).
• Chest pain and difficulty breathing, fever, chest pain, and cough, caused by fluid in the lungs (pulmonary edema).
• Frequent urination, in large quantities, pale in color, or unable to urinate or requires a great effort to urinate, in this case, the urine may be darker or contain blood, which may be due to kidney problems.
• Severe upper stomach pain, feeling sick, vomiting, 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 that includes 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 skin sensitivity to the sun.
• Pancreatitis inflammation - you may have severe stomach pain that radiates and wraps around the back, as well as a feeling of discomfort.
• Skin and lip cancer (non-melanoma skin cancer).

Other possible side effects

The side effects reported in clinical studies in patients treated with irbesartan/hydrochlorothiazide tablets were:

Common(may affectup to 1 in 10people)

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

Rare(may affectup to 1 in 100people)

• Diarrhea.
• Low blood pressure.
• Syncope.
• Tachycardia.
• Flush.
• Swelling.
• Sexual dysfunction (alterations in sexual function).
• Blood tests may show low levels of sodium and potassium in the blood.
• Dizziness after getting up from lying down or sitting.

Frequency unknown(cannot be estimated from available data)

• Headache.
• Tinnitus in the ears.
• Cough.
• Alteration of taste, indigestion.
• Pain in joints and muscles.
• Blood tests may show that the liver is not functioning correctly.
• Blood tests may showelevated levels of potassium in the blood.

As with all combinations of two active principles, the side effects associated with each component cannot be ruled out.

Side effects associated with irbesartan monotherapy

Rare(may affect up to 1 in 100 people)

• Chest pain.

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

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

Frequency unknown(cannot be estimated from available data)

• Formation of bruises and increased bleeding, which may be due to a reduction in the number of platelets (blood clotting cells).
• Tiredness, headaches, difficulty breathing after exercise or dizziness, and pale appearance, which may be due to a reduced number of red blood cells (anemia).
• Low blood sugar levels.
• Severe allergic reactions (anaphylactic shock).

Side effects associated with hydrochlorothiazide monotherapy

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

• Acute respiratory distress (symptoms include severe difficulty breathing, fever, weakness, andconfusion).

Frequency unknown(cannot be estimated from 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), acute myopia (acute myopia).
• Fever.
• Weakness and muscle spasms.
• Prickling, pinching, or burning sensation "needles and pins" in the skin (paresthesia).
• Restlessness, dizziness.
• Low blood pressure after a change in body position.
• Swelling of the salivary glands.
• Elevated blood sugar levels.
• Sugar in the urine.
• Increases in some types of blood fats; elevated levels of uric acid in the blood, which may cause gout.

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

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

Do not use this medication 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 product shelf life in the bottle is 90 days once opened.

This medication does not require special storage conditions.

Medications should not be disposed of through drains or in the trash. Dispose of the containers and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medications you no longer need. By doing so, you will help protect the environment.

Composition of Irbesartán/Hidroclorotiazida Viatris

• The active ingredients are irbesartán and hidroclorotiazida.
• Each tablet contains 150 mg of irbesartán and 12.5 mg of hidroclorotiazida.
• The other components are: microcrystalline cellulose (E-460), anhydrous colloidal silica, sodium laurilsulfate, pregelatinized cornstarch, magnesium stearate (E-470b), povidone (K-90), lactose monohydrate, croscarmellose sodium. See section 2 “Irbesartán/Hidroclorotiazida Viatris contains lactose and sodium”.

Appearance of the product and contents of the package

The tablets are white to off-white, oval, biconvex, marked with “M” on one face and “I33” on the other.

Irbesartán/Hidroclorotiazida Viatris is available in blister packs of 14, 28, 30, 56, 90, 98 or 100 tablets, in unit dose blister packs of 56 tablets, in calendar blister packs of 28 tablets, and in bottles of 500 tablets.

Only some package sizes may be marketed.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder:

Viatris Limited

Damastown Industrial Park

Mulhuddart, Dublin 15

Dublin

Ireland

Responsible manufacturer:

McDermott Laboratories trading as Gerard Laboratories

35/36 Baldoyle Industrial Estate

Grange Road

Dublin 13

Ireland

or

Mylan Hungary Kft

Mylan utca 1

2900 Komárom

Hungary

You can request more information about this medication by contacting the local representative of the marketing authorization holder:

Viatris Pharmaceuticals, S.L.U.

C/ General Aranaz, 86

28027 - Madrid

Spain

This medication is authorized in the member states of the European Economic Area with the following names:

SpainIrbesartán/Hidroclorotiazida Viatris 150 mg/12.5 mg tablets EFG

FranceIrbesartan/Hydrochlorothiazide Mylan 150 mg/12.5 mg Comprimés

ItalyIrbesartan e Idroclorotiazide Mylan 150 mg/12.5 mg Compresse

NorwayIrbesartan/Hydrochlorothiazide Mylan 150 mg/12.5 mg Tabletter

NetherlandsIrbesartan/Hydrochloorthiazide Mylan 150 mg/12,5 mg tabletten

PortugalIrbesartan/Hydrochlorothiazide Mylan 150 mg/12.5 mg Comprimidos

United KingdomIrbesartan/Hydrochlorothiazide Mylan 150 mg/12.5 mg Tablets

Czech RepublicIrbesartan/Hydrochlorothiazid Mylan 150 mg/12.5 mg tablety

Last review date of this leaflet:January 2025

More detailed information about this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) https://www.aemps.gob.es/