Leaflet: information for the user

Irbesartan/Hydrochlorothiazide Cinfa 300 mg/25 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, consult your doctor or pharmacist.
• This medicine has been prescribed for you only, and you must 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.

irbesartan/hydrochlorothiazide cinfa is an association of two active principles, 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 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 medicines (called thiazide diuretics), which increase the amount of urine eliminated, reducing blood pressure.

The two active principles of irbesartan/hydrochlorothiazide act together to achieve a reduction 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 irbesartan/hydrochlorothiazide cinfa

• if you areallergicto irbesartan, hydrochlorothiazide, or any other sulfonamide-derived medication, or to any of the other components of this medication (listed in section 6).
• 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 section “Pregnancy”)
• if you havesevere liver or kidney problems
• if you havedifficulty urinating
• if your doctor detects that you havepersistently elevated calcium levels or low potassium levels in your blood.
• if you havediabetes or kidney insufficiencyand are being treated with a medication to lower blood pressure that contains aliskiren

Warnings and precautions

Consult your doctor or pharmacist before starting to takeirbesartan/hydrochlorothiazide cinfa

• if you have had skin cancer or if you develop an unexpected skin lesion during treatment. The treatment with hydrochlorothiazide, 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 irbesartan/hydrochlorothiazide.
• if you haveexcessive vomiting or diarrhea
• if you havekidney problems or if you have had a kidney transplant
• if you haveheart problems
• if you haveliver problems
• if you havediabetes
• if you experiencelow 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)
• 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 medications used to treat high blood pressure (hypertension):
• a renin-angiotensin-aldosterone system (RAAS) inhibitor (e.g., enalapril, lisinopril, ramipril), particularly if you have kidney problems related to diabetes
• aliskiren.
• 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 irbesartan/hydrochlorothiazide, seek medical attention immediately.

Your doctor may monitor your kidney function, blood pressure, and electrolyte levels (e.g., potassium) at regular intervals (see section “Do not take irbesartan/hydrochlorothiazide cinfa”).

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.

If you are pregnant, suspect you may be pregnant, or plan to become pregnant, inform your doctor. It is not recommended to use irbesartan/hydrochlorothiazide at the beginning of pregnancy (first 3 months) and in no case should it be administered from the third month of pregnancy, as it may cause serious harm to your baby (see section “Pregnancy”).

You must also inform your doctor:

• if you are following alow-sodium diet
• if you experience any of these symptoms: feeling thirsty, dry mouth, generalized weakness, feeling sleepy, muscle pain or cramps, nausea, vomiting, or rapid heartbeat,as they may indicate excessive hydrochlorothiazide effect (contained in irbesartan/hydrochlorothiazide cinfa)
• if you experience an increase insensitivity to the sunwith symptoms of sunburn (such as redness, itching, swelling, or blisters) that occur more quickly than usual,
• ifyou are to undergo surgery(surgical intervention) orif you are to receive anesthetics,
• if you experience adecrease in vision or eye pain, which 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 a week after taking irbesartan/hydrochlorothiazide. 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 must interrupt treatment with irbesartan/hydrochlorothiazide and seek medical attention immediately.

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

Children and adolescents

Irbesartan/hydrochlorothiazide should not be administered to children and adolescents (under 18 years old).

Other medications and irbesartan/hydrochlorothiazide cinfa

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

Diuretics, such as the hydrochlorothiazide contained in irbesartan/hydrochlorothiazide cinfa, may affect other medications. Do not take with irbesartan/hydrochlorothiazide preparations containing lithium without your doctor's 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 sections “Do not take irbesartan/hydrochlorothiazide cinfa” and “Warnings and precautions”).

You may need to have blood tests if you take:

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

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

Taking irbesartan/hydrochlorothiazide cinfa with food, drinks, and alcohol

Irbesartan/hydrochlorothiazide can be taken with or without food.

Due to the hydrochlorothiazide contained inirbesartan/hydrochlorothiazide cinfa, if you drink alcohol while taking this medication, you may experience a greater sense of dizziness when standing up, especially when getting up from a seated position.

Pregnancy and breastfeeding

If you are pregnant, breastfeeding, or suspect you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medication.

Pregnancy

You must inform your doctor if you are pregnant, suspect you may be pregnant, or plan to become pregnant. Your doctor will usually advise you to stop taking irbesartan/hydrochlorothiazide before becoming pregnant or as soon as you become pregnant and recommend taking another antihypertensive medication instead. It is not recommended to use irbesartan/hydrochlorothiazide at the beginning of pregnancy and in no case should it be administered from 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 irbesartan/hydrochlorothiazide 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

It is unlikely that irbesartan/hydrochlorothiazide 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.

Irbesartan/hydrochlorothiazide cinfa contains lactose.

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

Irbesartan/hydrochlorothiazide cinfa contains sodium.

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

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

Dose

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

Administration form

Irbesartan/hydrochlorothiazide 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.

Use in children and adolescents

Irbesartan/hydrochlorothiazide should not be given to children or adolescents under 18 years of age. If a child or adolescent swallows some tablets, contact your doctor immediately.

If you take more irbesartan/hydrochlorothiazide cinfa than you should

In case of overdose or accidental ingestion, consult your doctor immediately or call the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount taken.

If you forget to take irbesartan/hydrochlorothiazide cinfa

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

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

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

• nausea/vomiting
• urinary abnormalities
• fatigue
• dizziness (including dizziness that 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 (blood urea nitrogen, creatinine).

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

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

• diarrhea
• low blood pressure
• syncope
• tachycardia
• flushing
• swelling due to fluid retention (edema)
• 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 since the marketing of irbesartan/hydrochlorothiazide cinfa

Since the marketing of irbesartan/hydrochlorothiazide, some side effects have been reported. The side effects observed with unknown frequency are: headache, tinnitus, cough, alteration of taste, indigestion, joint and muscle pain, liver function alterations, kidney insufficiency, elevated levels of potassium in your blood, and allergic reactions such as skin rash, urticaria, facial swelling, lip, mouth, tongue, or throat swelling.

Also, cases of jaundice (yellowing of the skin and/or white of the eyes) have been observed.

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

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 frequency

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; respiratory 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 over the entire 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.

Very rare frequency

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

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 directly through the Spanish System for the 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 after CAD. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

Medications should not be disposed of through drains or in the trash. Dispose of the packaging 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 packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of irbesartan/hydrochlorothiazide cinfa

• The active principles are irbesartan and hydrochlorothiazide. Each tablet contains 300 mg of irbesartan and 25 mg of hydrochlorothiazide.
• The other components are microcrystalline cellulose, croscarmellose sodium, lactose monohydrate, magnesium stearate, colloidal anhydrous silica, and hydrogenated ricin oil.

Appearance of the product and contents of the packaging

irbesartan/hydrochlorothiazide cinfa 300 mg/25 mg tablets EFG are presented in the form of oblong, biconvex tablets, white in color, and marked with the code “IH25”.

irbesartan/hydrochlorothiazide cinfa 300 mg/25 mg tablets EFG are presented in PVC/PVDC-Aluminum blisters.

Each package contains 28 tablets.

Holder of the marketing authorization and responsible for manufacturing:

Cinfa Laboratories, S.A.

Carretera Olaz-Chipi, 10. Industrial Estate Areta

31620 Huarte (Navarra) – Spain

Date of the last review of this leaflet:February 2025

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

You can access detailed and updated information about this medicine by scanning with your smartphone the QR code included in the leaflet and packaging. You can also access this information at the following internet address:https://cima.aemps.es/cima/dochtml/p/72310/P_72310.html

QR code to:https://cima.aemps.es/cima/dochtml/p/72310/P_72310.html