IRBESARTAN/HYDROCHLOROTHIAZIDE CINFA 300 mg/25 mg TABLETS

Introduction

Package Leaflet: Information for the User

Irbesartan/Hydrochlorothiazide Cinfa 300 mg/25 mg film-coated tablets

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

1. What is Irbesartan/Hydrochlorothiazide Cinfa and what is it used for
2. What you need to know before you take Irbesartan/Hydrochlorothiazide Cinfa
3. How to take Irbesartan/Hydrochlorothiazide Cinfa
4. Possible side effects
5. Storage of Irbesartan/Hydrochlorothiazide Cinfa
6. Contents of the pack and other information

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

Irbesartan/Hydrochlorothiazide Cinfa 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 receptors in blood vessels, causing them to narrow. This narrowing of blood vessels increases blood pressure. Irbesartan blocks the binding of angiotensin-II to these receptors, relaxing blood vessels and lowering blood pressure.

Hydrochlorothiazide belongs to a group of medicines called thiazide diuretics, which increase the amount of urine removed from the body, lowering blood pressure.

The two active substances in Irbesartan/Hydrochlorothiazide Cinfa work together to achieve a greater reduction in blood pressure than either substance alone.

Irbesartan/Hydrochlorothiazide Cinfa is used to treat high blood pressure, when treatment with irbesartan or hydrochlorothiazide alone has not provided adequate control of blood pressure.

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

Do not take Irbesartan/Hydrochlorothiazide Cinfa

• if you are allergicto irbesartan, hydrochlorothiazide, or any other sulfonamide-derived medication, or to any of the other ingredients of this medicine (listed in section 6).
• if you are more than 3 months pregnant. (In any case, it is recommended to avoid taking this medicine during the start of 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 insufficiencyand are being treated with a blood pressure-lowering medicine containing aliskiren

Warnings and precautions

Consult your doctor or pharmacist before starting to take Irbesartan/Hydrochlorothiazide Cinfa

• if you have had skin cancer or if you develop an unexpected skin lesion during treatment. Treatment with hydrochlorothiazide, particularly 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 Cinfa.
• if you have excessive vomiting or diarrhea
• if you have kidney problemsor if you 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, trembling, headache, flushing, or paleness, numbness, rapid 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 to treat high blood pressure (hypertension):
• an angiotensin-converting enzyme inhibitor (ACE inhibitor) (e.g., enalapril, lisinopril, ramipril), especially if you have kidney problems related to diabetes
• aliskiren.
• if you have had respiratory or lung 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 Cinfa, seek medical attention immediately.

Your doctor may monitor your kidney function, blood pressure, and blood 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 Cinfa. Your doctor will decide whether to continue treatment. Do not stop taking Irbesartan/Hydrochlorothiazide Cinfa on your own.

If you are pregnant, think you may be pregnant, or plan to become pregnant, inform your doctor. Your doctor will normally advise you to stop taking Irbesartan/Hydrochlorothiazide Cinfa before you become pregnant or as soon as you find out you are pregnant, and will recommend an alternative blood pressure-lowering medicine. Irbesartan/Hydrochlorothiazide Cinfa should not be used during the first three months of pregnancy and should not be used at all after the third month of pregnancy, as it may cause serious harm to your baby.

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, nausea, vomiting, or rapid heartbeat, as these may indicate an excessive effect of hydrochlorothiazide (contained in Irbesartan/Hydrochlorothiazide Cinfa)
• 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 procedure) or if you are going to be given anesthetics
• if you experience blurred vision or eye pain, which could be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or increased pressure in the eye, and can occur within hours to a week after taking Irbesartan/Hydrochlorothiazide Cinfa. This can lead to permanent vision loss if not treated. If you have previously been allergic to penicillin or sulfonamides, you may be at higher risk of developing this condition. You should discontinue treatment with Irbesartan/Hydrochlorothiazide Cinfa and seek immediate medical attention.

Hydrochlorothiazide contained in this medicine may cause positive results in doping tests.

Children and adolescents

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

Other medicines and Irbesartan/Hydrochlorothiazide Cinfa

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

Diuretics, such as hydrochlorothiazide contained in Irbesartan/Hydrochlorothiazide Cinfa, may interact with other medicines. You should not take preparations containing lithium with Irbesartan/Hydrochlorothiazide Cinfa 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 inhibitor (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
• potassium-containing salt substitutes
• potassium-sparing diuretics 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 the treatment of 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 Cinfa with food, drinks, and alcohol

Irbesartan/Hydrochlorothiazide Cinfa can be taken with or without food.

Due to the hydrochlorothiazide contained in Irbesartan/Hydrochlorothiazide Cinfa, if you drink alcohol while taking this medicine, you may experience increased dizziness when standing up, especially when getting up from a sitting or lying down position.

Pregnancy and breastfeeding

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

Pregnancy

You should inform your doctor if you are pregnant, think you may be pregnant, or plan to become pregnant. Your doctor will normally advise you to stop taking Irbesartan/Hydrochlorothiazide Cinfa before you become pregnant or as soon as you find out you are pregnant, and will recommend an alternative blood pressure-lowering medicine. Irbesartan/Hydrochlorothiazide Cinfa should not be used during the first three months of pregnancy and should not be used at all after the third month of pregnancy, as it may cause serious harm to your baby.

Breastfeeding

Inform your doctor if you are about to start or are breastfeeding, as Irbesartan/Hydrochlorothiazide Cinfa is not recommended for use in women during this period. Your doctor may decide to administer a treatment that is more suitable if you wish to breastfeed, especially newborns or premature babies.

Driving and using machines

It is unlikely that Irbesartan/Hydrochlorothiazide Cinfa will 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 Cinfa contains lactose.

This medicine contains lactose. If your doctor has told you that you have an intolerance to some sugars, consult your doctor before taking this medicine.

Irbesartan/Hydrochlorothiazide Cinfa contains sodium.

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

3. How to take Irbesartan/Hydrochlorothiazide Cinfa

Follow exactly the instructions of administration of this medicine given by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist again.

Dose

The recommended dose of Irbesartan/Hydrochlorothiazide Cinfa is one tablet per day. In general, your doctor will prescribe Irbesartan/Hydrochlorothiazide Cinfa when previous treatments have not sufficiently lowered your blood pressure. Your doctor will indicate how to switch from previous treatments to Irbesartan/Hydrochlorothiazide Cinfa.

Method of administration

Irbesartan/Hydrochlorothiazide Cinfa 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 Cinfa with or without food. You should try to take your daily dose at the same time each day. It is important that you continue taking Irbesartan/Hydrochlorothiazide Cinfa until your doctor advises you to stop.

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

Use in children and adolescents

Irbesartan/Hydrochlorothiazide Cinfa should not be given to children and 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 Toxicology Information Service, telephone 91 562 04 20, indicating the medicine and the amount taken.

If you forget to take Irbesartan/Hydrochlorothiazide Cinfa

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 side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

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

Rarely, cases of allergic skin reactions (rash, urticaria) have been reported in patients treated with irbesartan, as well as localized swelling of the face, lips, and/or tongue. If you have any of the above symptoms or experience shortness of breath,stop taking Irbesartan/Hydrochlorothiazide Cinfa and contact your doctor immediately.

The side effects reported in clinical studies for patients treated with Irbesartan/Hydrochlorothiazide Cinfa were:

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

• nausea/vomiting
• urination anomalies
• fatigue
• dizziness (including dizziness 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, creatinine in the blood).

If any of these side effects bother you, talk to your doctor.

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

• diarrhea
• low blood pressure
• fainting
• rapid heartbeat
• flushing
• fluid retention (edema)
• sexual dysfunction (sexual function disorders)
• blood tests may show low sodium and potassium levels in your blood

If any of these side effects bother you, talk to your doctor.

Side effects reported since the marketing of Irbesartan/Hydrochlorothiazide Cinfa

Since the marketing of Irbesartan/Hydrochlorothiazide Cinfa, some side effects have been reported. The side effects with frequency not known are: headache, ringing in the ears, cough, altered taste, indigestion, joint and muscle pain, liver function disorders, kidney failure, elevated potassium levels in the blood, and allergic reactions such as rash, urticaria, 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 observed.

As with all combinations of two active substances, it cannot be excluded that side effects associated with each component may occur.

Side effects associated with irbesartan alone

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

Rare Frequency

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

Adverse Effects Associated with Hydrochlorothiazide in Monotherapy

Lack of appetite; stomach irritation; stomach cramps; constipation; jaundice (yellowish coloration 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; decrease in the number of platelets (blood cells essential for blood clotting), decrease in the number of red blood cells (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 sensitivity of the skin 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; alteration of heart rhythm; reduction of blood pressure after a change in body position; swelling of the 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 can cause gout.

Very Rare Frequency

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

Frequency Not Known(cannot be estimated from the 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 directly 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 medication.

5. Conservation of Irbesartan/Hydrochlorothiazide Cinfa

Keep this medication out of 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.

Medicines should not be thrown away through drains or into the trash. Deposit the packaging and medications you no longer need at the SIGRE Point in the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This way, you will help protect the environment.

6. Packaging Content and Additional Information

Composition of Irbesartan/Hydrochlorothiazide Cinfa

• The active ingredients are irbesartan and hydrochlorothiazide. Each tablet contains 300 mg of irbesartan and 25 mg of hydrochlorothiazide.
• The other components are povidone, microcrystalline cellulose, croscarmellose sodium, lactose monohydrate, magnesium stearate, colloidal anhydrous silica, cornstarch (gluten-free), and hydrogenated ricin oil.

Appearance of the Product and Packaging Content

Irbesartan/Hydrochlorothiazide Cinfa 300 mg/25 mg EFG tablets 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 EFG tablets are presented in PVC/PVDC-Aluminum blisters.

Each package contains 28 tablets.

Marketing Authorization Holder and Manufacturer:

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Polígono Industrial Areta

31620 Huarte (Navarra) – Spain

Date of the Last Revision of this Prospectus:February 2025

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

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

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