Irbesartan/hydrochlorothiazide Combix 300 mg/12.5 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Irbesartan/Hydrochlorothiazide Combix 300 mg/12.5 mg film-coated tablets EFG

Read the entire 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, 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, because it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if such effects are 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 adverse effects
5. How to store Irbesartan/Hydrochlorothiazide Combix
6. Contents of the pack and other information

1. What is Irbesartán/Hidroclorotiazida Combix and what is it 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 leads to an increase in blood pressure. Irbesartan blocks angiotensin II from binding to these receptors, relaxing the 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 either irbesartan or hydrochlorothiazide alone does not provide adequate control of 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 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 Pregnancy section)
• if you have severe liver or kidney problems
• if you have difficulty passing urine
• if your doctor finds that you have persistently high levels of calcium or low levels of potassium in your 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 diarrhoea

• 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 systemic 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 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 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, which could be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or increased eye pressure; these 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 dyspnoea 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 not be used from the third month of pregnancy onwards, 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 be given anaesthetics.

Consult your doctor if you develop abdominal pain, nausea, vomiting, or diarrhoea after taking irbesartan/hydrochlorothiazide. Your doctor will decide whether to continue treatment. Do not stop taking irbesartan/hydrochlorothiazide on your own.

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

Use of 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 to have blood tests if you take:

• 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 medicines to lower your blood pressure, steroids, cancer treatments, painkillers, medicines for arthritis, or cholestyramine or colestipol resins to reduce blood cholesterol.

Use of Irbesartán/Hidroclorotiazida Combix with food and drink

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

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

Pregnancy and breast-feeding

Pregnancy

If you are pregnant or breast-feeding, think you may be pregnant, or are planning 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 occurs, and will recommend an alternative antihypertensive medicine. Irbesartán/Hidroclorotiazida Combix is not recommended during early pregnancy and must not be used from the third month of pregnancy onwards, as it may cause serious harm to your baby when used from that stage.

Breast-feeding

Inform your doctor if you are breastfeeding or intend to breastfeed, as Irbesartán/Hidroclorotiazida Combix is not recommended for women during this period. Your doctor may decide to prescribe a more suitable treatment if you wish to breastfeed, especially if your baby is a newborn or premature.

Driving and using machines

No studies on the ability to drive and use machines have been conducted. It is unlikely that Irbesartán/Hidroclorotiazida Combix will affect your ability to drive or use machines. 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 told you that you have 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 given 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. In general, your doctor will prescribe Irbesartan/Hydrochlorothiazide Combix when previous treatments have not sufficiently lowered 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 unless 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 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, Irbesartan/Hydrochlorothiazide Combix may cause adverse effects, although not everyone experiences them.

Some of these effects may be serious and may require 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 in 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 measuring muscle and heart function (creatine kinase) or elevated levels of substances measuring 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. Adverse effects observed with unknown frequency include: headache, tinnitus, cough, taste disturbances, indigestion, joint and muscle pain, liver function abnormalities and kidney failure, elevated potassium levels in the blood, and allergic reactions such as skin 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-combination products, 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 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 with nausea and vomiting; sleep disorders; depression; blurred vision; lack of white blood cells, which may lead to frequent infections and fever; decreased platelet count (blood cells essential for blood clotting), decreased 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 skin sensitivity 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 spasms; irregular heartbeat; drop in blood pressure upon changing body position; 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]; swelling of the salivary glands; high blood sugar levels; sugar in urine; increases in certain types of blood lipids; high levels of uric acid in the blood, which may cause gout.

Frequency unknown

• 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 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 refers to 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 containers and unused medicines at the SIGRE point located at your pharmacy. If in doubt, 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 Combix

• The active substances are irbesartan and hydrochlorothiazide. Each film-coated tablet of Irbesartan/Hydrochlorothiazide Combix 300 mg/12.5 mg contains 300 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 “ZF7” on one side and smooth on the other.

PVC/PVDC/Aluminum blisters.

Irbesartan/Hydrochlorothiazide Combix is also available in packs of 28 tablets containing 150 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 review of this leaflet: February 2025

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