Prospect: information for the patient

Irbesartan/Hydrochlorothiazide Viatris 300 mg/12.5 mg tablets EFG

Read this prospect carefully before starting to take this medicine, as it contains important information for you.

• Keep this prospect, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed only for you and should not be given to others, even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospect. See section 4.

1.What is Irbesartan/Hydrochlorothiazide Viatris and for what it is used

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

3.How to take Irbesartan/Hydrochlorothiazide Viatris

4.Possible adverse effects

5.Storage of Irbesartan/Hydrochlorothiazide Viatris

6.Contents of the package and additional information

Irbesartán/Hidroclorotiazida Viatris is a combination of two active ingredients, irbesartán and hidroclorotiazida.

Irbesartán belongs to a group of medicines 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. Irbesartán prevents angiotensin-II from binding to these receptors, relaxing blood vessels and reducing blood pressure.

Hidroclorotiazida belongs to a group of medicines (called thiazide diuretics) that increase the amount of urine eliminated, thereby reducing blood pressure.

The two active ingredients of irbesartán/hidroclorotiazida act together to achieve a decrease in blood pressure greater than that obtained with either one alone.

Irbesartán/hidroclorotiazida is used to treat high blood pressure,when treatment with irbesartán or hidroclorotiazida 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 aremore than 3 months pregnant(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 the 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 narrowingor if you have had akidney transplant.
• If you haveheart problems, including heart valve narrowing, heart enlargement or weakness (heart failure).
• If you havecoronary artery narrowing, 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 excessive production of the 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 the 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 sleepiness, 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 undergo surgery(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 loss 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 theparathyroid(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 old).

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 in mental health problems) without your doctor's supervision.

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

• Ifyou are takingan 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 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.
• Medications for diabetes (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 as for example, ciclofosfamida, metotrexato, analgesics known as NSAIDs or COX-2 inhibitors, such as celecoxib or acetylsalicylic acid, amantadina (a medication used to treat Parkinson's disease or the flu), alopurinol for gout, medications that have the effect of emptying the stomach, such as atropina, biperideno, or cholestyramine 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 intolerance to certain sugars, 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. In case of 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 (for example, 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 every 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 forgot to take Irbesartán/Hidroclorotiazida Viatris

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

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

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

Some of these side effects can be serious and may require medical attention.If you notice any of the following side effects, stop taking irbesartán/hidrochlorothiazide and inform 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.

Unknown frequency(cannot be estimated from available data)

• On rare occasions, cases of skin allergic reactions (skin rash, urticaria), as well as localized inflammation on the face, lips, and/or tongue and difficulty breathing have been reported.

• Fast and irregular heartbeat or a sensation of strong heartbeats (palpitations), pounding in the chest, sensation of dizziness and dizziness, 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 of fatigue, shortness of breath, especially after exercise, bruises 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 of fatigue or shortness 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).
• Increased frequency of urination, in large quantities, pale in color, or unable to urinate or requires effort to urinate, in this case, the urine may be darker in color or contain blood, which may be due to kidney problems.
• Severe upper stomach pain, feeling of nausea, 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 sensitivity of the skin 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/hidrochlorothiazide tablets were:

Common(may affect up to 1 in 10 people)

• Nausea/vomiting.
• Feeling of 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 affect up to 1 in 100 people)

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

Unknown frequency(cannot be estimated from available data)

• Headache.
• Tinnitus.
• Cough.
• Alteration of taste, indigestion.
• Pain in joints and muscles.
• Blood tests may show that the liver is not functioning correctly.
• Blood tests may show elevated 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 10,000 people)

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

Unknown frequency(cannot be estimated from available data)

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

Side effects associated with hidrochlorothiazide monotherapy

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

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

Unknown frequency(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.
• Fever.
• Weakness and muscle spasms.
• Prickling, pinching, or burning sensation "needles and pins" in the skin (paresthesia).
• Restlessness, dizziness.
• Reduced blood pressure after a change in body position.
• Swelling of salivary glands.
• Elevated blood sugar levels.
• Sugar in the urine.
• Increased levels of certain types of fats in the blood; elevated levels of uric acid in the blood, which may cause gout.

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

Reporting of 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 Irbesartan/Hydrochlorothiazide Viatris

• The active ingredients are irbesartan and hydrochlorothiazide.

Each tablet contains 300 mg of irbesartan and 12.5 mg of hydrochlorothiazide.

• The other components are: microcrystalline cellulose (E-460), anhydrous colloidal silica, sodium lauryl sulfate, pregelatinized cornstarch, magnesium stearate (E-470b), povidone (K-90), lactose monohydrate, sodium croscarmellose, yellow quinoline (E-104).See section 2 “Irbesartan/Hydrochlorothiazide Viatris contains lactose and sodium”.

Appearance of the product and contents of the package

The tablets are yellowish clear, oval, biconvex, marked with “M” on one face and “I34” on the other.

Irbesartan/Hydrochlorothiazide 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

H-2900 Komarom, Mylan utca 1

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:

SpainIrbesartan/Hydrochlorothiazide Viatris 300 mg/12.5 mg tablets EFG

FranceIrbesartan/Hydrochlorothiazide Mylan 300 mg/12.5 mg Compressed

ItalyIrbesartan and Hydrochlorothiazide Mylan 300 mg/12.5 mg Tablets

NorwayIrbesartan/Hydrochlorothiazide Mylan 300 mg/12.5 mg Tablets

NetherlandsIrbesartan/Hydrochloorthiazide Mylan 300 mg/12.5 mg tablets

PortugalIrbesartan/Hydrochlorothiazide Mylan 300 mg/12.5 mg Tablets

United KingdomIrbesartan/Hydrochlorothiazide Mylan 300 mg/12.5 mg Tablets

Czech RepublicIrbesartan/Hydrochlorothiazide Mylan 300 mg/12.5 mg Tablets

Last review date of this leaflet:January 2025

The 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/