Irbesartan/hydrochlorothiazide CINFA 300 mg/25 mg tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

irbesartan/hydrochlorothiazide cinfa 300 mg/25 mg 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 other people, even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, talk to your doctor or pharmacist, even if they are side effects not listed in this leaflet. See section 4.

Contents of the leaflet

1. What irbesartan/hydrochlorothiazide cinfa is and what it is used for
2. What you need to know before taking irbesartan/hydrochlorothiazide cinfa
3. How to take irbesartan/hydrochlorothiazide cinfa
4. Possible side effects
5. How to store irbesartan/hydrochlorothiazide cinfa
6. Contents of the pack and other information

1. What irbesartán/hidroclorotiazida cinfa is and what it is used for

irbesartán/hidroclorotiazida 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 constrict. This results in an increase in blood pressure. Irbesartan blocks angiotensin-II from binding to these receptors, relaxing blood vessels and thereby reducing blood pressure.

Hydrochlorothiazide belongs to a group of medicines (called thiazide diuretics) that lower blood pressure by increasing the amount of urine produced.

The two active substances in irbesartán/hidroclorotiazida cinfa work together to achieve a greater reduction in blood pressure than either substance alone.

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

2. What you need to know before taking irbesartan/hydrochlorothiazide cinfa

Do not take irbesartan/hydrochlorothiazide cinfa

• if you are allergic to irbesartan, hydrochlorothiazide, or any other sulfonamide-derived medicine, 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 better to avoid taking this medicine also during early pregnancy—see section “Pregnancy”)
• if you have severe liver or kidney problems
• if you have difficulty urinating
• if your doctor finds that you have persistently high calcium levels or low potassium levels in the blood
• if you have diabetes or renal insufficiency and are being treated with a blood pressure-lowering medicine containing aliskiren

Warnings and precautions

Talk to your doctor or pharmacist before starting irbesartan/hydrochlorothiazide cinfa

• if you have had skin cancer or 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 non-melanoma skin cancer and lip cancer. Protect your skin from sun exposure and UV rays while taking irbesartan/hydrochlorothiazide.
• if you have excessive vomiting or diarrhea
• if you have kidney problems or have had a kidney transplant
• if you have heart problems
• if you have liver problems
• if you have diabetes
• if you have low blood sugar levels (symptoms may include sweating, weakness, hunger, dizziness, trembling, headache, flushing or paleness, numbness, rapid and strong heartbeat), especially if you are being treated for diabetes
• if you have lupus erythematosus (also known as lupus or SLE)
• if you have primary hyperaldosteronism (a condition related to excessive production of the hormone aldosterone, causing sodium retention and, in turn, increased blood pressure)
• if you are taking any of the following medicines for high blood pressure (hypertension):
• 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 previously experienced breathing or lung problems (such as inflammation or fluid in the lungs) after taking hydrochlorothiazide. If you develop shortness of breath or severe difficulty breathing after taking irbesartan/hydrochlorothiazide cinfa, seek medical help 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”).

Talk to 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 might be pregnant, or plan to become pregnant, inform your doctor. The use of irbesartan/hydrochlorothiazide is not recommended during early pregnancy (first 3 months), and must not be used from the third month of pregnancy onward, as it may cause serious harm to your baby (see section “Pregnancy”).

You should also inform your doctor if:

• you are on a low-salt diet
• you experience any of the following signs**: excessive thirst, dry mouth, general weakness, drowsiness, muscle pain or cramps, nausea, vomiting, or rapid heartbeat**, as these may indicate an excessive effect of hydrochlorothiazide (contained in irbesartan/hydrochlorothiazide cinfa)
• you develop increased skin sensitivity to sunlight, with symptoms of sunburn (such as redness, itching, swelling, blisters) occurring more quickly than usual
• you are scheduled for surgery (operation) or will receive anesthetics
• you experience vision changes or eye pain, which could be signs of fluid accumulation in the vascular layer of the eye (choroidal effusion) or increased eye pressure, occurring within hours to a week after taking irbesartan/hydrochlorothiazide. This may lead to permanent vision loss if not treated. If you previously had an allergy to penicillin or sulfonamides, you may have a higher risk. You must stop treatment with irbesartan/hydrochlorothiazide and seek immediate medical attention.

The hydrochlorothiazide contained in this medicine may cause positive results in doping controls.

Children and adolescents

Irbesartan/hydrochlorothiazide must 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 need to take any other medicines.

Diuretics such as hydrochlorothiazide (contained in irbesartan/hydrochlorothiazide cinfa) may interact with other medicines. You must not take lithium-containing preparations together with irbesartan/hydrochlorothiazide without medical 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 blood tests if you are taking:

• potassium supplements
• potassium-containing salt substitutes
• 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 insulin)
• carbamazepine (a medicine used to treat epilepsy)

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

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

Irbesartan/hydrochlorothiazide can be taken with or without food.

Due to the hydrochlorothiazide contained in irbesartan/hydrochlorothiazide cinfa, drinking alcohol during treatment may increase the likelihood of dizziness when standing up, especially when rising from a sitting position.

Pregnancy and breastfeeding

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

Pregnancy

Inform your doctor if you are pregnant, suspect you might be pregnant, or plan to become pregnant. Your doctor will generally advise you to stop taking irbesartan/hydrochlorothiazide before becoming pregnant or as soon as pregnancy occurs, and will recommend an alternative antihypertensive medicine. Irbesartan/hydrochlorothiazide is not recommended during early pregnancy and must not be used from the third month of pregnancy onward, as it may cause serious harm to your baby when taken from that point.

Breastfeeding

Inform your doctor if you are planning to start or are currently breastfeeding, as irbesartan/hydrochlorothiazide is not recommended for women during this period. Your doctor may choose a treatment more suitable for breastfeeding, especially if the infant is a newborn or premature.

Driving and using machines

Irbesartan/hydrochlorothiazide is unlikely to affect your ability to drive or operate machinery. However, dizziness or fatigue may occasionally occur during treatment for hypertension. 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 diagnosed you with an intolerance to certain sugars, consult him/her before taking this medicine.

irbesartan/hydrochlorothiazide cinfa contains sodium.

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

3. How to take irbesartan/hydrochlorothiazide cinfa

Follow exactly the instructions for use of this medicine given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Dosage

The recommended dose of irbesartan/hydrochlorothiazide is one tablet daily. Generally, your doctor will prescribe irbesartan/hydrochlorothiazide when previous treatments have not sufficiently reduced your blood pressure. Your doctor will advise you on how to switch from previous treatments to irbesartan/hydrochlorothiazide cinfa.

Method of administration

Irbesartan/hydrochlorothiazide is administered orally. The tablets should be swallowed with a sufficient amount of liquid (e.g. a glass of water). You may take irbesartan/hydrochlorothiazide 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 unless your doctor advises otherwise.

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

Use in children and adolescents

Irbesartan/hydrochlorothiazide must not be given to children or adolescents under 18 years of age. If a child or adolescent swallows any 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 Poison Information Service at telephone number 91 562 04 20, indicating the medication and the amount taken.

If you forget to take irbesartan/hydrochlorothiazide cinfa

If you accidentally miss a dose, simply take your usual dose at the next scheduled time. Do not take a double dose to make up for missed doses.

If you have any further questions about 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 everyone will experience them.

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

Rare cases of skin allergic 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 experience any of the above symptoms or have difficulty breathing, stop taking irbesartán/hydrochlorothiazide and contact your doctor immediately.

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

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

• nausea/vomiting
• abnormalities in urination
• fatigue
• dizziness (including 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 adverse effects cause you problems, consult your doctor.

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

• diarrhea
• low blood pressure
• fainting
• palpitations
• flushing
• swelling due to fluid retention (edema)
• sexual dysfunction (disturbances in sexual function)
• 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 marketing of irbesartan/hydrochlorothiazide cinfa

Since the marketing of irbesartan/hydrochlorothiazide, some adverse effects have been reported. The adverse effects observed with unknown frequency include: headache, tinnitus (ringing in the ears), cough, taste disturbance, indigestion, joint and muscle pain, liver function abnormalities and kidney failure, elevated potassium levels in your blood, and allergic reactions such as rash, urticaria, swelling of the face, lips, mouth, tongue or throat.

Rare cases of jaundice (yellowing of the skin and/or whites of the eyes) have also been observed.

As with all fixed combinations of two active substances, adverse effects associated with each individual component cannot be excluded.

Adverse effects associated solely with irbesartan

In addition to the adverse effects described above, chest pain, severe allergic reactions (anaphylactic shock), reduction in the number of red blood cells (anemia – symptoms may include tiredness, headaches, shortness of breath on exertion, dizziness and paleness), reduction in the number of platelets (a blood cell essential for blood clotting), and low blood sugar levels have also been observed.

Rare frequency

Intestinal angioedema: swelling in the intestine presenting 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); inflammation of the pancreas characterized by severe upper stomach pain, often with nausea and vomiting; sleep disorders; depression; blurred vision; lack of white blood cells, which may lead to frequent infections and fever; reduction in platelet count (blood cells essential for blood clotting), reduction in red blood cells (anemia) characterized by fatigue, headaches, shortness of breath during exercise, dizziness, and paleness; kidney disease; lung disorders including pneumonia or fluid accumulation in the lungs; increased sensitivity of the skin to sunlight; inflammation of blood vessels; a skin disease characterized by peeling of the skin over the entire body; cutaneous lupus erythematosus, identified by a rash that may appear on the face, neck, and scalp; allergic reactions; muscle weakness and muscle spasms; changes in heart rhythm; reduction in blood pressure after a change in body position; swelling of the salivary glands; high blood sugar levels; sugar in the urine; increases in certain types of blood fats; high levels of uric acid in the blood, which may cause gout.

Very rare frequency

• Acute breathing difficulty (signs include severe shortness of breath, fever, weakness, and confusion).

Frequency not known (cannot be estimated from available data)

• Skin and lip cancer (non-melanoma skin cancer).
• Decreased vision or eye pain due to elevated pressure [possible signs of fluid accumulation in the vascular layer of the eye (choroidal effusion) or acute angle-closure glaucoma].

It is known that adverse effects associated with hydrochlorothiazide may 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 involves possible adverse effects not listed in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of irbesartan/hydrochlorothiazide cinfa

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

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date is the last day of the month indicated.

This medicine does not require any special storage conditions.

Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of irbesartan/hydrochlorothiazide cinfa

• The active substances are irbesartan and hydrochlorothiazide. Each tablet contains 300 mg of irbesartan and 25 mg of hydrochlorothiazide.
• The other components are povidone, microcrystalline cellulose, sodium croscarmellose, lactose monohydrate, magnesium stearate, colloidal anhydrous silica, corn starch (does not contain gluten), and hydrogenated castor oil.

Appearance of the product and contents of the pack

irbesartan/hydrochlorothiazide cinfa 300 mg/25 mg tablets EFG are presented as white, oblong, biconvex tablets marked with the code “IH25”.

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

Each pack 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 most recent revision of this leaflet: February 2025

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

You can access detailed and up-to-date information on this medicine by scanning with your mobile phone (smartphone) the QR code included in the package leaflet and outer packaging. You may also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/72310/P_72310.html

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