IRBESARTAN/HYDROCHLOROTHIAZIDE STADA 150 mg/12.5 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the Patient

Irbesartan/Hydrochlorothiazide Stada 150 mg/12.5 mg film-coated tablets EFG

Irbesartan/Hydrochlorothiazide Stada 300 mg/12.5 mg film-coated tablets EFG

Irbesartan/Hydrochlorothiazide Stada 300 mg/25 mg film-coated tablets EFG

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you

• Keep this leaflet, you may need to read it again.

• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack and other information

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

1. Package contents and additional information

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

Irbesartan/Hydrochlorothiazide Stada 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 blood vessel receptors, causing them to constrict. This leads to an increase in blood pressure. Irbesartan prevents angiotensin-II from binding to these receptors, relaxing blood vessels and reducing blood pressure. Hydrochlorothiazide belongs to a group of medicines (called thiazide diuretics) that increase the amount of urine excreted, reducing blood pressure.

The two active substances in this medicine 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 or hydrochlorothiazide alone does not provide adequate control of your blood pressure.

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

Do not take Irbesartan/Hydrochlorothiazide Stada

• if you are allergicto irbesartan, or any of the other ingredients of this medicine (listed in section 6).

• if you are allergicto hydrochlorothiazide or any other sulfonamide-derived medicine
• if you are more than 3 months pregnant. (In any case, it is best to avoid taking this medicine during the start of your pregnancy - see section Pregnancy)

• if you have severe liver or kidney problems

• if you have difficulty urinating

• if your doctor detects that you have persistently elevated calcium or low potassium levels in your blood
• if you have diabetes or kidney failure and are being treated with a blood pressure-lowering medicine that contains aliskiren

Warnings and precautions

Consult your doctor before starting to take Irbesartan/Hydrochlorothiazide ifany of the following apply to you:

• if you have excessive vomiting or diarrhea
• if you have kidney problemsor have had a kidney transplant
• if you have heart problems
• if you have liver problems
• if you have diabetes
• if you experience low blood sugar levels(symptoms may include sweating, weakness, hunger, dizziness, tremors, headache, flushing or pallor, 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 primary aldosteronism(a condition related to excessive production of the hormone aldosterone, leading to sodium retention and increased blood pressure).
• if you are taking any of the following medicines used to treat high blood pressure:

• an angiotensin-converting enzyme inhibitor (ACE inhibitor) (e.g., enalapril, lisinopril, ramipril), particularly if you have kidney problems related to diabetes
• aliskiren

• if you have had skin cancer or if you develop an unexpected skin lesion during treatment. Treatment with hydrochlorothiazide, especially 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 had respiratory or pulmonary 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, seek medical attention immediately.

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 Stada”

If you think you may be pregnant (or might become pregnant), inform your doctor. Your doctor will normally advise you to stop taking irbesartan/hydrochlorothiazide before you become pregnant or as soon as you know you are pregnant and will recommend an alternative medicine instead of irbesartan/hydrochlorothiazide. Irbesartan/hydrochlorothiazide should not be used during the start of pregnancy and in no case should it be administered after the third month of pregnancy, as it may cause serious harm to your baby if used after this point.

You must also inform your doctor:

• if you are on a low-salt diet

• if you experience any of the following signs: feeling thirsty, dry mouth, weakness, feeling sleepy, muscle cramps or spasms, 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 your 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 anesthetics.
• if you experience reduced vision or eye painwhen taking irbesartan/hydrochlorothiazide. These could be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or increased pressure in the eye (glaucoma) and can occur within hours to weeks after taking irbesartan/hydrochlorothiazide. This can lead to permanent vision loss if not treated. If you have previously been allergic to penicillin or sulfonamide, you may be at higher risk. You should discontinue treatment with irbesartan/hydrochlorothiazide and seek immediate medical attention.

Consult 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/hydrochlorothiazide on your own.

Doping test: The hydrochlorothiazide contained in this medicine may cause positive results in doping tests.

Use in children and adolescents

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

Other medicines and Irbesartan/Hydrochlorothiazide Stada

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines.

Diuretics, such as hydrochlorothiazide contained in irbesartan/hydrochlorothiazide, may have an effect on other medicines. You should not take preparations containing lithium with irbesartan/hydrochlorothiazide 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 Stada" and "Warnings and precautions").

You may need to have blood tests if you take:

• potassium supplements

• salt substitutes that contain potassium
• potassium-sparing medicines or other diuretics (tablets that increase urine production)
• certain laxatives
• medicines used to treat gout
• vitamin D supplements
• medicines to control heart rhythm
• medicines for diabetes (oral agents such as repaglinide or insulins)
• carbamazepine (a medicine for treating epilepsy)

It is also important to inform your doctor if you are taking other medicines to lower your blood pressure, steroids, cancer treatments, painkillers, medicines for arthritis, or cholestyramine or colestipol resins to lower cholesterol in the blood.

Taking Irbesartan/Hydrochlorothiazide Stada with food and drinks

Irbesartan/hydrochlorothiazide can be taken with or without food.

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

Pregnancy, breastfeeding, and fertility

Pregnancy

If you think you may be pregnant (or might become pregnant), inform your doctor. Your doctor will normally advise you to stop taking irbesartan/hydrochlorothiazide before you become pregnant or as soon as you know you are pregnant and will recommend an alternative medicine instead of irbesartan/hydrochlorothiazide. Irbesartan/hydrochlorothiazide should not be used during the start of pregnancy and in no case should it be administered after the third month of pregnancy, as it may cause serious harm to your baby if used after this point.

Breastfeeding

Tell your doctor if you are about to start or are already breastfeeding. Irbesartan/hydrochlorothiazide is not recommended for mothers who are breastfeeding, and your doctor may decide to prescribe a different treatment that is more suitable if you wish to breastfeed, especially if your baby is newborn or premature.

Driving and using machines

Irbesartan/hydrochlorothiazide is unlikely to 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 Stada contains lactose and sodium.

If your doctor has told you that you have an intolerance to some sugars (e.g., lactose), consult your doctor 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 Stada

Always take this medicine exactly as your doctor has told you. If you are not sure, check with your doctor or pharmacist.

Dose

Irbesartan/Hydrochlorothiazide Stada 150 mg/12.5 mg film-coated tablets EFG

The recommended dose of irbesartan/hydrochlorothiazide is one or two tablets a day. In general, your doctor will prescribe irbesartan/hydrochlorothiazide when previous treatments you received did not sufficiently reduce your blood pressure. Your doctor will advise you on how to switch from previous treatments to irbesartan/hydrochlorothiazide.

Irbesartan/Hydrochlorothiazide Stada 300 mg/12.5 mg film-coated tablets EFG and Irbesartan/Hydrochlorothiazide Stada 300 mg/25 mg film-coated tablets EFG

The recommended dose of irbesartan/hydrochlorothiazide is one tablet a day. In general, your doctor will prescribe irbesartan/hydrochlorothiazide when previous treatments you received did not sufficiently reduce your blood pressure. Your doctor will advise you on how to switch from previous treatments to irbesartan/hydrochlorothiazide.

Method of administration

This medicine 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 taking irbesartan/hydrochlorothiazide until your doctor tells you to stop.

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

If you take more Irbesartan/Hydrochlorothiazide Stada than you should

If you accidentally take too many tablets, consult your doctor or pharmacist immediately, go to a healthcare center, or call the Toxicology Information Service, phone: 91 5620420, indicating the medicine and the amount taken. It is recommended to take the package and the package leaflet of the medicine with you.

Children should not take Irbesartan/Hydrochlorothiazide Stada

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 Stada

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.

Rarely, cases of allergic skin reactions (skin rash, hives) have been reported in patients treated with irbesartan, as well as localized inflammation in the face, lips, and/or tongue.

Very rare (may affect up to 1 in 10,000 people): acute respiratory distress (symptoms include severe respiratory distress, fever, weakness, and confusion).

If you experience any of the above symptoms or have shortness of breath, stop taking irbesartan/hydrochlorothiazide and contact your doctor immediately.

The adverse effects reported in clinical studies for patients treated with the combination of irbesartan and hydrochlorothiazide were:

Frequent Adverse Effects(may affect up to 1 in 10 people):

• nausea/vomiting
• urination anomalies
• fatigue
• dizziness (including that which occurs when standing up from a lying or sitting position)
• blood tests may show elevated levels of an enzyme that measures muscle and heart function (creatine kinase) or elevated levels of substances that measure kidney function (urea nitrogen in the blood, creatinine).

If any of these adverse effects cause you problems, consult your doctor.

Uncommon Adverse Effects(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 your blood.

If any of these adverse effects cause you problems, consult your doctor.

Adverse Effects Reported Since the Marketing of the Irbesartan/Hydrochlorothiazide Combination

Some undesirable effects have been reported since the marketing of irbesartan/hydrochlorothiazide. Adverse reactions whose frequency is unknown are: headache, ringing in the ears, cough, altered taste, indigestion, joint and muscle pain, abnormal liver function, and kidney function problems, high levels of potassium in your blood, and allergic reactions such as skin rash, hives, swelling of the face, lips, mouth, tongue, or throat. Additionally, rare cases of jaundice (yellowing of the skin and/or whites of the eyes) have been reported.

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

Adverse Effects Associated Only with Irbesartan

In addition to the adverse effects described above, chest pain, severe allergic reactions (anaphylactic shock), decreased red blood cell count (anemia – symptoms may include fatigue, headaches, difficulty breathing when exercising, dizziness, and paleness), and decreased platelet count (a blood cell essential for blood clotting) and low blood sugar levels have also been observed.

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

• intestinal angioedema: swelling in the intestine that presents symptoms such as abdominal pain, nausea, vomiting, and diarrhea

Adverse Effects Associated with Hydrochlorothiazide in Monotherapy

Loss of appetite; stomach irritation; stomach cramps; constipation; jaundice (yellowing of the skin and/or whites of the eyes); pancreatitis characterized by severe upper stomach pain, often with nausea and vomiting; sleep disorders; depression; blurred vision, lack of white blood cells, which can lead to frequent infections, fever; decreased platelet count (blood cells essential for blood clotting), decreased red blood cell count (anemia) characterized by fatigue, headaches, shortness of breath when exercising, dizziness, and paleness; kidney disease; pulmonary disorders including pneumonia or fluid accumulation in the lungs; increased skin sensitivity to the sun; inflammation of blood vessels; a skin disease characterized by peeling of the skin all over the body; cutaneous lupus erythematosus, which is identified by a rash that can appear on the face, neck, and scalp; allergic reactions; weakness and muscle spasms; altered heart rhythm; reduced blood pressure after a change in body position; swelling of the salivary glands; high blood sugar levels; sugar in the urine; increased levels of certain types of blood fats; high levels of uric acid in the blood, which can cause gout

Frequency not known (cannot be estimated from available data): skin and lip cancer (non-melanoma skin cancer), decreased vision or eye pain due to high pressure (possible signs of fluid accumulation in the vascular layer of the eye (choroidal effusion) or acute angle-closure glaucoma).

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 does not appear in this prospectus. You can also report them 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 Stada

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

Do not use this medicine after the expiration date that appears on the carton and on the blister pack after CAD. The expiration date is the last day of the month indicated.

Do not store above 30°C.

Medicines should not be thrown away through wastewater or household waste. Deposit the packaging and medicines you no longer need at the SIGRE Point in the pharmacy. Ask your pharmacist how to dispose of the packaging and medicines you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Irbesartan/Hydrochlorothiazide Stada

• The active ingredients are irbesartan and hydrochlorothiazide.

Irbesartan/Hydrochlorothiazide Stada 150 mg/12.5 mg film-coated tablets EFG

Each film-coated tablet contains 150 mg of irbesartan and 12.5 mg of hydrochlorothiazide.

Irbesartan/Hydrochlorothiazide Stada 300 mg/12.5 mg film-coated tablets EFG

Each film-coated tablet contains 300 mg of irbesartan and 12.5 mg of hydrochlorothiazide.

Irbesartan/Hydrochlorothiazide Stada 300 mg/25 mg film-coated tablets EFG

Each film-coated tablet contains 300 mg of irbesartan and 25 mg of hydrochlorothiazide.

• The other components are lactose monohydrate, pregelatinized corn starch, copovidone, croscarmellose sodium (E468), colloidal anhydrous silica (E551), magnesium stearate (E470b), hypromellose (E464), titanium dioxide (E171), talc, macrogol 8000, yellow iron oxide (E172), red iron oxide (E172), and black iron oxide (E172).

Appearance of the Product and Package Contents

Irbesartan/Hydrochlorothiazide Stada film-coated tablets are pink, oblong, and biconvex.

Irbesartan/Hydrochlorothiazide Stada 150 mg/12.5 mg

Package sizes of 7, 10, 14, 28, 30, 50, 56, 90, 98, and 100 film-coated tablets.

Irbesartan/Hydrochlorothiazide Stada 300 mg/12.5 mgand Irbesartan/Hydrochlorothiazide Stada 300 mg/25 mg

Package sizes of 7, 10, 14, 28, 30, 50, 56, 90, 98, 100, 126, and 154 film-coated tablets.

Not all package sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Laboratory STADA, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern

(Barcelona) Spain

[email protected]

Manufacturer

STADA Arzneimittel AG,

Stadastr. 2-18,

D-61118 Bad Vilbel,

Germany

or

Centrafarm Services B.V.

Van de Reijtstraat 31-E

4814 NE Breda

Netherlands

or

STADA M&D SRL

Str. Trascaului nr. 10,

Municipiul Turda,

Judet Cluj 401135,

Romania

This medicine is authorized in the Member States of the European Economic Area under the following names:

Germany: Irbesartan/HCT STADA 150 mg/12.5 mg; 300 mg/12.5 mg; 300 mg/25 mg film-coated tablets

Belgium: Irbesartan/HCT EG 150 mg/12.5 mg; 300 mg/12.5 mg; 300 mg/25 mg film-coated tablets

Denmark: Irbesartan/Hydrochlorothiazide STADA 150 mg/12.5 mg; 300 mg/12.5 mg; 300 mg/25 mg film-coated tablets

Spain: Irbesartan/Hydrochlorothiazide STADA 150 mg/12.5 mg; 300 mg/12.5 mg; 300 mg/25 mg film-coated tablets EFG

France: Irbesartan/Hydrochlorothiazide EG 150 mg/12.5 mg; 300 mg/12.5 mg; 300 mg/25 mg film-coated tablets

Luxembourg: Irbesartan/HCT EG 150 mg/12.5 mg; 300 mg/12.5 mg; 300 mg/25 mg film-coated tablets

Netherlands: Irbesartan/Hydrochlorothiazide STADA 150mg/12.5mg; 300 mg/12.5 mg; 300 mg/25 mg film-coated tablets

Portugal: Irbesartan + Hydrochlorothiazide STADA

Sweden: Irbesartan/Hydrochlorothiazide STADA 150 mg/12.5 mg; 300 mg/12.5 mg; 300 mg/25 mg film-coated tablets

Date of the Last Revision of this Prospectus:February 2025

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