Irbesartan/hydrochlorothiazide Combix 150 mg/12.5 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

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

Read the entire leaflet carefully before you start taking this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms as you, since it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Leaflet contents:

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

1. What Irbesartán/Hidroclorotiazida Combix is and what it is used for

Irbesartán/Hidroclorotiazida Combix 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 Combix work together to achieve a greater reduction in blood pressure than either substance alone.

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

2. What you need to know before taking Irbesartán/Hidroclorotiazida Combix

Do not take Irbesartán/Hidroclorotiazida Combix

• if you are allergic to the active substances or to any of the other components 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 Pregnancy section)
• 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.

Irbesartán/Hidroclorotiazida Combix must not be given to children and adolescents (under 18 years of age).

Warnings and precautions

Talk to your doctor or pharmacist before taking Irbesartán/Hidroclorotiazida Combix.

Tell your doctor if any of the following apply to you:

• 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 lupus erythematosus (also known as lupus or SLE)

• if you have primary hyperaldosteronism (a condition related to excessive production of the hormone aldosterone, leading to sodium retention and, in turn, increased blood pressure)

• if you are taking any of the following medicines used to treat 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 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 non-melanoma skin cancer and lip cancer. Protect your skin from exposure to sunlight and UV rays while taking Irbesartán/Hidroclorotiazida Combix.

• if you experience a decrease in vision or eye pain, as these could be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or increased intraocular pressure, which may occur within hours to a week after taking Irbesartán/Hidroclorotiazida Combix.

• if you have previously experienced breathing or lung problems (such as inflammation or fluid in the lungs) after taking hydrochlorothiazide. If you develop dyspnea or severe difficulty breathing after taking Irbesartán/Hidroclorotiazida, 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 Irbesartán/Hidroclorotiazida Combix”.

If you are pregnant, suspect you may be pregnant, or plan to become pregnant, inform your doctor. Use of Irbesartán/Hidroclorotiazida Combix is not recommended during early pregnancy (first 3 months), and must in no case 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
• if you experience any of the following signs: feeling thirsty, 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 Irbesartán/Hidroclorotiazida Combix)
• if you experience increased skin sensitivity to sunlight with symptoms of sunburn (such as redness, itching, swelling, blisters) occurring more quickly than usual
• if you are going to have surgery or will receive anesthetics.

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.

The hydrochlorothiazide contained in this medicine may lead to positive doping test results.

Taking Irbesartán/Hidroclorotiazida with other medicines

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 Irbesartán/Hidroclorotiazida Combix may interact with other medicines. You must not take lithium-containing preparations together with Irbesartán/Hidroclorotiazida Combix 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 also information under the headings “Do not take Irbesartán/Hidroclorotiazida Combix” and “Warnings and precautions”).

You may need blood tests if you are taking:

• potassium supplements
• salt substitutes containing 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 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 Irbesartán/Hidroclorotiazida Combix with food and drink

Irbesartán/Hidroclorotiazida Combix can be taken with or without food.

Due to the hydrochlorothiazide contained in Irbesartán/Hidroclorotiazida Combix, if you drink alcohol while taking this medicine, you may experience increased dizziness upon standing, especially when rising from a sitting position.

Pregnancy and breastfeeding

Pregnancy

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. Generally, your doctor will advise you to stop taking Irbesartán/Hidroclorotiazida Combix before becoming pregnant or as soon as pregnancy is detected, and will recommend an alternative antihypertensive medicine. Use of Irbesartán/Hidroclorotiazida Combix 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 used from that time.

Breastfeeding

Inform your doctor if you are planning to breastfeed or are currently breastfeeding, as Irbesartán/Hidroclorotiazida Combix 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

No studies have been conducted on the ability to drive and use machines. It is unlikely that Irbesartán/Hidroclorotiazida Combix will affect your ability to drive or operate machinery. However, dizziness or fatigue may occasionally occur during antihypertensive treatment. If you experience these symptoms, speak with your doctor before driving or operating machinery.

Irbesartán/Hidroclorotiazida Combix contains lactose. If your doctor has diagnosed you with an intolerance to certain sugars, consult him before taking this medicine.

3. How to take Irbesartan/Hydrochlorothiazide

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

Dosage

The usual dose of Irbesartan/Hydrochlorothiazide Combix is one or two tablets daily. Generally, your doctor will prescribe Irbesartan/Hydrochlorothiazide Combix 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 Combix.

Method of administration

Irbesartan/Hydrochlorothiazide Combix 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 Combix 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 Combix until your doctor advises otherwise.

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

If you take more Irbesartan/Hydrochlorothiazide Combix than you should

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medicine and the amount ingested.

Children must not take Irbesartan/Hydrochlorothiazide Combix

Irbesartan/Hydrochlorothiazide Combix must not be given to children under 18 years of age. If a child swallows any tablets, contact your doctor immediately.

If you forget to take Irbesartan/Hydrochlorothiazide Combix

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

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, Irbesartan/Hydrochlorothiazide Combix may cause adverse effects, although not everyone experiences them.

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

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

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

Frequent adverse effects (affect between 1 and 10 out of every 100 patients):

• Nausea/vomiting
• Urination abnormalities
• Fatigue
• Dizziness (including dizziness upon 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 (affect between 1 and 10 out of every 1,000 patients):

• Diarrhea
• Low blood pressure
• Fainting
• 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.

Rare adverse effects (may affect up to 1 in 10,000 people):

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

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

Adverse effects reported since marketing of irbesartan/hydrochlorothiazide

Since the marketing of irbesartan/hydrochlorothiazide, some adverse effects have been reported. The adverse effects observed with unknown frequency include: headache, tinnitus, cough, altered taste, indigestion, joint and muscle pain, liver function abnormalities, kidney failure, elevated potassium levels in the 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-dose combination products, adverse effects associated with each individual component cannot be excluded.

Adverse effects associated solely with irbesartan

In addition to the previously described adverse effects, chest pain and reduced platelet count have also been observed.

Rare adverse effects (may affect up to 1 in 1,000 people):

• 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 abdominal pain, often accompanied by nausea and vomiting; sleep disorders; depression; blurred vision; low white blood cell count, which may lead to frequent infections and fever; reduced platelet count (blood cells essential for blood clotting), reduced red blood cell count (anemia) characterized by fatigue, headaches, shortness of breath during exercise, dizziness, and pallor; 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 disorder 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; irregular heart rhythm; drop in blood pressure upon changing body position; decreased vision or eye pain due to increased pressure [possible signs of fluid accumulation in the vascular layer of the eye (choroidal effusion) or acute angle-closure glaucoma]; swelling of the salivary glands; high blood sugar levels; sugar in the urine; increases in certain types of blood fats; elevated levels of uric acid in the blood, which may cause gout.

Frequency not known

• Skin and lip cancer (non-melanoma skin cancer)

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 is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Irbesartan/Hydrochlorothiazide Combix

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.

No special storage conditions are required.

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

6. Contents of the pack and other information

Composition of Irbesartan/Hydrochlorothiazide Combix

• The active substances are irbesartan and hydrochlorothiazide. Each film-coated tablet of Irbesartan/Hydrochlorothiazide Combix 150 mg/12.5 mg contains 150 mg of irbesartan and 12.5 mg of hydrochlorothiazide.
• The other components are monohydrate lactose, microcrystalline cellulose, sodium croscarmellose, pregelatinized maize starch, yellow iron oxide (E172), red iron oxide (E172), calcium stearate and Opadry II Pink 30F84515, composed of: monohydrate lactose, hypromellose, macrogol, titanium dioxide (E171), red iron oxide (E172), yellow iron oxide (E172) and black iron oxide (E172).

Appearance of the product and contents of the pack

Film-coated tablets, pink in colour, biconvex, capsule-shaped, marked “ZF1” on one side and smooth on the other.

PVC/PVDC/Aluminium blisters.

Irbesartan/Hydrochlorothiazide Combix is also available in packs of 28 tablets containing 300 mg of irbesartan and 12.5 mg of hydrochlorothiazide.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Laboratorios Combix, S.L.U.

C/ Badajoz, 2. Edificio 2

28223 Pozuelo de Alarcón (Madrid)

Spain

Manufacturer

Zydus France

25, parc d’activités des Peupliers, Bâtiment L

92000 Nanterre

France

or

Centre Spécialités Pharmaceutiques

ZAC des Suzots

35 rue de la Chapelle

63450 Saint Amant Tallende

France

Date of the most recent revision of this leaflet: February 2025

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