Patient Information Leaflet

Irbesartán/Hidroclorotiazida Stada 150 mg/12,5 mg Film-Coated Tablets

Irbesartán/Hidroclorotiazida Stada 300 mg/12,5 mg Film-Coated Tablets

Irbesartán/Hidroclorotiazida Stada 300 mg/25 mg Film-Coated Tablets

Read this leaflet carefully before you start to take this medicine because it contains important information for you

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

• If you have any doubts, consult 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.

6. Contents of the pack Information for additional information

Irbesartán/Hidroclorotiazida Stada 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 increase the amount of urine eliminated, reducing blood pressure.

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

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

Do not take Irbesartán/Hidroclorotiazida Stada

• if you areallergicto irbesartán, or to any of the other ingredients of this medicine (listed in section 6).

• if you areallergicto hydrochlorothiazide or any other sulfonamide-derived medication
• if you aremore than 3 months pregnant.(In any case, it is better to avoid taking this medicine also at the beginning of your pregnancy - see Pregnancy section)

• if you havesevere liver problemsorkidney problems

• if you havedifficulty urinating

• if your doctor detects that you havepersistently elevated calcium levels or low potassium levels in your blood
• if you have diabetes or kidney insufficiency and are being treated with a blood pressure-lowering medication containing aliskiren

Warnings and precautions

Consult your doctor before starting to take Irbesartán/Hidroclorotiazidaif any of the following cases affect you:

• if you haveexcessive vomiting or diarrhea
• if you havekidney problemsor have had akidney transplant
• if you haveheart problems
• if you haveliver problems
• if you havediabetes
• if you experiencelow blood sugar(symptoms may include sweating, weakness, hunger, dizziness, tremors, headache, flushing, pallor, numbness, rapid and strong heartbeats), especially if you are being treated for diabetes
• if you havelupus erythematosus(also known as lupus or SLE)
• if you haveprimary aldosteronism(a condition related to the excessive production of the hormone aldosterone, which causes sodium retention and, in turn, an increase in blood pressure).
• if you are taking any of the following blood pressure-lowering medications:

• 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. The treatment with hydrochlorothiazide, particularly 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 have had respiratory or pulmonary problems (such as inflammation or fluid in the lungs) after taking hydrochlorothiazide in the past. If you experience severe shortness of breath or difficulty breathing after taking irbesartán/hidroclorotiazida, seek medical attention immediately.

Your doctor may monitor your kidney function, blood pressure, and electrolyte levels (e.g. potassium) at regular intervals.

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

If you think you may be pregnant (or could be), you must inform your doctor. Irbesartán/hidroclorotiazida is not recommended for use at the beginning of pregnancy, and in any case, it should not be administered after the third month of pregnancy, as it may cause serious harm to your baby if used at this stage (see Pregnancy section).

You must also inform your doctor:

• if you are following alow-sodium diet

• if you experience any of the following symptoms:thirst, dry mouth, generalized weakness,sleepiness, muscle pain or cramps, nausea, vomiting, orrapid heartbeats, as they may indicate excessive hydrochlorothiazide effect (contained inirbesartán/hidroclorotiazida)

• if you experience an increase insensitivity to the sunwith symptoms of sunburn (such as redness, itching, swelling, blisters) that occur more quickly than usual
• if you areabout to undergo surgery(surgical intervention) orif you are to receive anesthetics.
• if you experiencevision loss or eye pain in one or both eyeswhile taking irbesartán/hidroclorotiazida.These may be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or an increase in eye pressure (glaucoma) and can occur within a few hours to several 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 be at a higher risk of developing it. You should discontinue treatment with irbesartán/hidroclorotiazida and seek medical attention immediately.

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.

Drug testing: The hydrochlorothiazide contained in this medicine may cause positive results in doping control.

Use in children and adolescents

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

Other medicines and Irbesartán/Hidroclorotiazida Stada

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medicine.

The diuretics, such as the hydrochlorothiazide contained in irbesartán/hidroclorotiazida, may affect other medicines. Do not take with irbesartán/hidroclorotiazida preparations containing lithium without your doctor's supervision.

Your doctor may need to modify 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 Irbesartán/Hidroclorotiazida Stada" and "Warnings and precautions").

You may need to have blood tests if you take:

• potassium supplements

• sodium-free salt substitutes containing potassium
• potassium-sparing diuretics (tablets that increase urine production)
• some laxatives
• medicines used to treat gout
• vitamin D supplements
• medicines to control heart rhythm
• diabetes medications (oral agents such as repaglinide or insulin)
• carbamazepine (a medicine for epilepsy treatment)

It is also important to inform your doctor if you are taking other blood pressure-lowering medications, steroids, cancer medications, painkillers, arthritis medications, or cholestyramine or colestipol resins to reduce cholesterol in the blood.

Taking Irbesartán/Hidroclorotiazida Stada with food and drinks

Irbesartán/hidroclorotiazida can be taken with or without food.

Due to the hydrochlorothiazide contained in irbesartán/hidroclorotiazida, if you drink alcohol while taking this medicine, you may experience a greater sense of 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 could be), you must inform your doctor. Your doctor will usually advise you to stop taking irbesartán/hidroclorotiazida before becoming pregnant or as soon as you become pregnant and recommend taking another medicine instead of irbesartán/hidroclorotiazida. Irbesartán/hidroclorotiazida is not recommended for use at the beginning of pregnancy, and in any case, it should not be administered after the third month of pregnancy, as it may cause serious harm to your baby if used at this stage.

Breastfeeding

Inform your doctor if you are about to start or are breastfeeding. Irbesartán/hidroclorotiazida is not recommended for use in breastfeeding mothers and your doctor may decide to administer another treatment that is more suitable if you want to breastfeed, especially if your baby is newborn or premature.

Driving and operating 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, consult your doctor before driving or operating machinery.

Irbesartán/Hidroclorotiazida Stada contains lactose and sodium.

If your doctor has told you that you have anintolerance to certain sugars (e.g. lactose), consult your doctor before taking this medicine.

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

Follow exactly the administration instructions of this medication as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

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 indicate 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 indicate how to switch from previous treatments to irbesartan/hydrochlorothiazide.

Administration form

This medication is administered 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. You should try to take your daily dose at the same time every day. It is essential that you continue taking irbesartan/hydrochlorothiazide until your doctor advises you otherwise.

The maximum blood pressure-reducing 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 Toxicological Information Service, phone: 91 5620420, indicating the medication and the amount ingested. It is recommended to bring the packaging and the medication leaflet.

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 forgot to take Irbesartan/Hydrochlorothiazide Stada

If you accidentally forget to take a dose, simply take your regular dose when it is due. 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 may cause side effects, although not everyone will experience them.

Some of these side effects may be serious and may require medical attention.

Rarely, cases of skin allergic reactions (skin rash, urticaria) 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 difficulty breathing, fever, weakness, and confusion).

If you experience any of the above symptoms or have difficulty breathing, stop takingirbesartan/hydrochlorothiazide and contact your doctor immediately.

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

Frequent side effects(may affect up to 1 in 10 people):

• nausea/vomiting
• urinary abnormalities
• 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 side effects cause you problems, consult your doctor.

Infrequent side effects(may affect up to 1 in 100 people):

• diarrhea
• low blood pressure
• syncope
• tachycardia
• anxiety
• swelling
• sexual dysfunction (alterations in sexual function)
• blood tests may show low levels of sodium and potassium in your blood.

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

Side effects reported since the marketing of the irbesartan/hydrochlorothiazide combination

Some unwanted effects have been reported since the marketing of irbesartan/hydrochlorothiazide. The frequency of adverse reactions that is not known is: headache, tinnitus, cough, alteration of taste, indigestion, pain in joints and muscles, abnormal liver function, and renal function problems, elevated levels of potassium in your blood, and allergic reactions such as skin rash, urticaria, swelling of the face, lips, mouth, tongue, or throat. Also, there have been reported cases of jaundice (yellowing of the skin and/or white of the eyes).

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

Side effects associated only with irbesartan

In addition to the side 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 been observed.

Rare side 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

Side effects associated with hydrochlorothiazide in monotherapy

Loss of appetite; stomach irritation; stomach cramps; constipation; jaundice (yellowing of the skin and/or white of the eyes); pancreatitis characterized by severe upper abdominal pain, often with nausea and vomiting; sleep disturbances; depression; blurred vision, lack of white blood cells, which may 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 accumulation of fluid 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; lupus erythematosus, which is identified by a rash that may appear on the face, neck, and scalp; allergic reactions; muscle weakness and spasms; alteration of heart rhythm; reduction of blood pressure after a change in body position; swelling of 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 may cause gout

Unknown frequency (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 hemorrhage) or acute angle-closure glaucoma).

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

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 prospectus. You can also report them through the Spanish System for the Pharmacovigilance of Medicines for Human Usehttps://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 carton and on the blister pack after CAD. The expiration date is the last day of the month indicated.

Do not store at a temperature above 30°C.

Medicines should not be disposed of through drains or in the trash. Dispose of the containers and medicines you no longer need at the SIGRE collection point at the pharmacy. Ask your pharmacist how to dispose of the containers and medicines you no longer need. This will help protect the environment.

Composition of Irbesartan/Hydrochlorothiazide Stada

The active principles are irbesartan and hydrochlorothiazide.

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

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

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

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

• The other components are lactose monohydrate, maize pregelatinized starch, copovidone, sodium croscarmellose (E468), anhydrous colloidal 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 contents of the package

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

Irbesartan/Hydrochlorothiazide Stada 150 mg/12.5 mg

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

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

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

Only some pack sizes may be marketed.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

STADA, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern

(Barcelona) Spain

[email protected]

Responsible for manufacturing

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

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

Germany:Irbesartan/HCT STADA 150 mg/12.5 mg; 300 mg/12.5 mg; 300 mg/25 mg Filmtabletten

Belgium:Irbesartan/HCT EG 150 mg/12.5 mg; 300 mg/12.5 mg; 300 mg/25 mg filmomhulde tabletten

Denmark:Irbesartan/Hydrochlorthiazid STADA 150 mg/12.5 mg; 300 mg/12.5 mg; 300 mg/25 mg filmovertrukne tabletter

Spain:Irbesartan/Hidroclorotiazida STADA 150 mg/12.5 mg; 300 mg/12.5 mg; 300 mg/25 mg comprimidos recubiertos con película EFG

France:Irbesartan/Hydrochlorothiazide EG 150 mg/12.5 mg; 300 mg/12.5 mg; 300 mg/25 mg comprimé pelliculé

Luxembourg:Irbesartan/HCT EG 150 mg/12.5 mg; 300 mg/12.5 mg; 300 mg/25 mg comprimés pelliculés

Netherlands:Irbesartan/ Hydrochlorothiazide STADA 150mg/12.5mg; 300 mg/12.5 mg; 300 mg/25 mgfilmomhulde tabletten

Portugal:Irbesartan + Hidroclorotiazida STADA

Sweden:Irbesartan/Hydrochlorothiazid STADA 150 mg/12.5 mg; 300 mg/12.5 mg; 300 mg/25 mg filmdragerade tabletter

Last review date of this leaflet:February 2025

Further information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/