Irbesartan/hydrochlorothiazide Pharma Combix 300 mg/25 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Irbesartan/Hydrochlorothiazide Pharma Combix 300 mg/25 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; 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 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 Pharma Combix is and what it is used for.
2. What you need to know before taking Irbesartan/Hydrochlorothiazide Pharma Combix.
3. How to take Irbesartan/Hydrochlorothiazide Pharma Combix.
4. Possible side effects.
5. How to store Irbesartan/Hydrochlorothiazide Pharma Combix.
6. Contents of the pack and other information.

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

Irbesartán/Hidroclorotiazida Pharma 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 contract. This leads to an increase in blood pressure. Irbesartan prevents 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 Pharma Combix work together to achieve a greater reduction in blood pressure than either of them alone.

Irbesartán/Hidroclorotiazida Pharma 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 starting to take Irbesartán/Hidroclorotiazida Pharma Combix

Do not take Irbesartán/Hidroclorotiazida Pharma Combix

• if you are allergic to irbesartan or to any of the other ingredients of this medicine (listed in section 6)
• if you are allergic to hydrochlorothiazide or to any other sulfonamide-derived medicine
• 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 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.

Children and adolescents

Irbesartán/Hidroclorotiazida Pharma 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 Pharma Combix.

Tell your doctor in any of the following cases:

• 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 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 cancer and lip cancer. Protect your skin from exposure to sunlight and UV rays while taking Irbesartán/Hidroclorotiazida Pharma Combix.
  • 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 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 Pharma Combix".

If you are pregnant, think you might be pregnant, or plan to become pregnant, you must inform your doctor. Use of Irbesartán/Hidroclorotiazida Pharma Combix is not recommended during early pregnancy (first 3 months), and must in no case be used after the third month of pregnancy, as it may cause serious harm to your baby (see section Pregnancy).

You should also tell your doctor:

• if you are on a low-salt diet
• if you experience any of the following symptoms: 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 Pharma Combix)
• if you experience increased skin sensitivity to sunlight with sunburn symptoms (such as redness, itching, swelling, blisters) occurring more quickly than usual
• if you are going to have surgery or if you are to be given anaesthetics
• if you experience changes in vision or pain in one or both eyes while taking Irbesartán/Hidroclorotiazida Pharma Combix. This could be a sign of fluid accumulation in the vascular layer of the eye (choroidal effusion) or development of glaucoma, increased pressure in your eyes. You must stop treatment with Irbesartán/Hidroclorotiazida Pharma Combix and seek medical help.

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.

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.

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 Pharma Combix" and "Warnings and precautions").

Diuretics, such as hydrochlorothiazide contained in Irbesartán/Hidroclorotiazida Pharma Combix, may affect other medicines. You must not take lithium-containing preparations together with Irbesartán/Hidroclorotiazida Pharma Combix without medical supervision.

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 tell 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.

Taking Irbesartán/Hidroclorotiazida Pharma Combix with food, drinks and alcohol

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

Due to the hydrochlorothiazide contained in Irbesartán/Hidroclorotiazida Pharma Combix, if you drink alcohol while taking this medicine, you may feel more dizzy when standing up, especially when rising from a sitting position.

Pregnancy, breastfeeding and fertility

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 must inform your doctor if you are pregnant, think you might be pregnant, or plan to become pregnant. Generally, your doctor will advise you to stop taking Irbesartán/Hidroclorotiazida Pharma Combix before becoming pregnant or as soon as pregnancy occurs, and will recommend an alternative antihypertensive medicine. Use of Irbesartán/Hidroclorotiazida Pharma Combix is not recommended during pregnancy and must in no case be used after the third month of pregnancy, as it may cause serious harm to your baby when used from that point onward.

Breastfeeding

Inform your doctor if you are planning to breastfeed or are currently breastfeeding, as Irbesartán/Hidroclorotiazida Pharma 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 the 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 Pharma Combix will affect your ability to drive or operate machinery. However, during treatment for hypertension, dizziness or fatigue may occasionally occur. If you experience these symptoms, speak with your doctor before driving or operating machinery.

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

Use in athletes

This medicine contains hydrochlorothiazide, which may lead to a positive result in doping control tests.

3. How to take Irbesartan/Hydrochlorothiazide Pharma Combix

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

Dosage

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

Method of administration

Irbesartan/Hydrochlorothiazide Pharma Combix is administered orally. Swallow the tablets with a sufficient amount of liquid (e.g. a glass of water). You may take Irbesartan/Hydrochlorothiazide Pharma 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 Pharma 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 Pharma 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.

Use in children and adolescents

Children must not take Irbesartan/Hydrochlorothiazide Pharma Combix.

Irbesartan/Hydrochlorothiazide Pharma 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 Pharma 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 forgotten 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 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) 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/Hidroclorotiazida Pharma Combix and contact your doctor immediately.

The adverse effects reported in clinical studies for patients treated with Irbesartán/Hidroclorotiazida Pharma Combix were:

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

• nausea/vomiting,
• abnormalities in urination,
• 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 (may affect up to 1 in 100 patients):

• diarrhea,
• low blood pressure,
• fainting,
• tachycardia,
• flushing,
• swelling due to fluid retention (edema),
• sexual dysfunction (changes 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 (signs 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 Irbesartán/Hidroclorotiazida

Since the marketing of Irbesartán/Hidroclorotiazida, some adverse effects have been reported. The adverse effects observed with unknown frequency are: headache, tinnitus, cough, altered taste, indigestion, joint and muscle pain, liver function abnormalities and 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 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 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 solely with hydrochlorothiazide

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; pulmonary 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 spasms; irregular heartbeat; drop in blood pressure upon changing body position; reduced 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; high levels of uric acid in the blood, which may cause gout.

It is known that adverse effects associated with hydrochlorothiazide may increase with higher doses of hydrochlorothiazide.

Frequency not known

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

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: 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 Pharma Combix

Keep this medicine out of sight and reach of children.

No special storage conditions are required.

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.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused containers and medicines at the SIGRE point at your pharmacy. If you have any doubts, 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 Pharma Combix

• The active substances are irbesartan and hydrochlorothiazide. Each film-coated tablet contains 300 mg of irbesartan and 25 mg of hydrochlorothiazide.
• The other components (excipients) are: monohydrate lactose, pregelatinized corn starch, sodium croscarmellose (E468), microcrystalline cellulose (E460i), yellow iron oxide (E172), red iron oxide (E172), calcium stearate (E470a) and Opadry II Pink 30F84515, composed of: hypromellose (E464), monohydrate lactose, titanium dioxide (E171), polyethylene glycol 3350 (E1521), yellow iron oxide (E172), red 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 "ZF 17" on one side and smooth on the other.

PVC/PVDC-Aluminum blisters.

Irbesartan/Hydrochlorothiazide Pharma Combix 300 mg/25 mg is available in packs of 28 tablets.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Laboratorios Combix, S.L.U.

C/ Badajoz 2, Edificio 2

28223– Pozuelo de Alarcon (Madrid)

Spain

Manufacturer

Zydus France

Zac Les Hautes Pâtures

Parc d'Activités des Pleupliers

25 rue des Pleupliers

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 medicine is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/.