Patient Information Leaflet

Irbesartán/Hidroclorotiazida Pharma Combix 300 mg/25 mg Film-Coated Tablets

Read this 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. Do not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Irbesartán/Hidroclorotiazida Pharma Combix is an association of two active principles, irbesartan and hydrochlorothiazide.

Irbesartan belongs to a group of medications known as angiotensin-II receptor antagonists. Angiotensin II is a substance produced in the body that binds to blood vessel receptors, causing them to contract. This results in an increase in blood pressure. Irbesartan prevents the binding of angiotensin-II to these receptors, relaxing blood vessels and reducing blood pressure.

Hydrochlorothiazide belongs to a group of medications (called thiazide diuretics) that increase the amount of urine eliminated, reducing blood pressure.

The two active principles of Irbesartán/Hidroclorotiazida Pharma Combix act together to achieve a reduction in blood pressure greater than that obtained with each one separately.

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.

Do not take Irbesartán/Hidroclorotiazida Pharma Combix

· if you areallergicto irbesartan or to any of the other components of this medication (listed in section 6)

· if you areallergicto hydrochlorothiazide or to any other medication derived from sulfamides

· if you arepregnant for more than 3 months.(In any case, it is better to avoid taking this medication also at the beginning of your pregnancy – see Pregnancy section)

·if you havesevere liver problemsorkidney problems

·if you havedifficulty urinating

·if your doctor detects that you havepersistently elevated levels of calcium or low levels of potassium in your blood.

·if you have diabetes or kidney insufficiency and are being treated with a medication to lower blood pressure that contains aliskiren.

Pediatric use

Irbesartán/Hidroclorotiazida Pharma Combix should not be administered to children and adolescents (under 18 years).

Precautions and warnings

Consult your doctor or pharmacist before starting to take Irbesartán/Hidroclorotiazida Pharma Combix.

Inform your doctorin any of the following cases:

·if you havevomiting or excessive diarrhea

·if you havekidney problemsor have had akidney transplant

·if you haveheart problems

·if you haveliver problems

·if you havediabetes

· if you havelupus erythematosus(also known as lupus or SLE)

· if you haveprimary aldosteronism(a condition related to the excessive production of the hormone aldosterone, which causes sodium retention and, in turn, an increase in blood pressure).

· if you are taking any of the following medications 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. The treatment with hydrochlorothiazide, particularly its long-term use at high doses, may increase the risk of certain types of skin cancer and lip cancer (non-melanoma skin cancer). Protect your skin from sun exposure and UV rays while taking Irbesartán/Hidroclorotiazida Pharma Combix.

-if you have had respiratory or pulmonary problems (such as inflammation or fluid in the lungs) after taking hydrochlorothiazide in the past. If you experience severe shortness of breath or difficulty breathing after taking Irbesartán/Hidroclorotiazida, seek medical attention immediately

You may need to have your kidney function, blood pressure, and electrolyte levels (e.g. potassium) checked regularly by your doctor.

See also the information under the heading "Do not take Irbesartán/Hidroclorotiazida Pharma Combix".

If you are pregnant, think you may be pregnant or plan to become pregnant, inform your doctor. Irbesartán/Hidroclorotiazida Pharma Combix is not recommended for use at the beginning of pregnancy (first 3 months), and in any case, it should not be administered after the third month of pregnancy, as it may cause serious harm to your baby (see Pregnancy section).

You must also inform your doctor:

·if you are following alow-sodium diet

·if you experience any of the following symptoms:thirst, dry mouth, generalized weakness, feeling of drowsiness, muscle pain or cramps, nausea, vomiting, or rapid heartbeat, as they may indicate an excessive effect of hydrochlorothiazide (contained in Irbesartán/Hidroclorotiazida Pharma Combix)

· if you experience an increase insensitivity to the sunwith symptoms of sunburn (such as redness, itching, swelling, blisters) that occur more quickly than usual

· ifyou are to undergo surgery(surgical intervention) orif you are to receive anesthetics.

· if you experiencechanges in your vision or eye pain while takingIrbesartán/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 should discontinue treatment with Irbesartán/Hidroclorotiazida Pharma Combix and seek medical attention.

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.

Use of Irbesartán/Hidroclorotiazida with other medications

Inform your doctor or pharmacist if you are using or have used recently or may need to use any other medication.

You may need to have your doctor adjust your dose and/or take other precautions:

If you are taking an angiotensin-converting enzyme inhibitor (ACE inhibitor) or aliskiren (see also the headings "Do not take Irbesartán/Hidroclorotiazida Pharma Combix" and "Precautions and warnings").

Diuretics, such as hydrochlorothiazide contained in Irbesartán/Hidroclorotiazida Pharma Combix, may affect other medications. Do not take with Irbesartán/Hidroclorotiazida Pharma Combix preparations containing lithium without your doctor's supervision.

You may need to have blood tests if you take:

· potassium supplements

· potassium-sparing salt substitutes

· potassium-sparing medications or other diuretics (tablets that increase urine production)

· some laxatives

· medications used to treat gout

· vitamin D supplements

· medications to control heart rhythm

· diabetes medications (oral agents or insulin)

· carbamazepine (a medication for epilepsy treatment)

You should also inform your doctor if you are taking other medications to lower your blood pressure, steroids, cancer medications, painkillers, medications for arthritis, or cholestyramine or colestipol resins to reduce cholesterol in the blood.

Taking Irbesartán/Hidroclorotiazida 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 medication, you may experience a greater sense of dizziness when standing up, especially when getting up from a seated position.

Pregnancy, lactation, 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 medication.

Pregnancy

You should inform your doctor if you are pregnant, think you may be pregnant or plan to become pregnant. Your doctor will usually advise you to stop taking Irbesartán/Hidroclorotiazida Pharma Combix before becoming pregnant or as soon as you become pregnant and recommend taking another antihypertensive medication instead. Irbesartán/Hidroclorotiazida Pharma Combix is not recommended for use during pregnancy and should not be administered after the third month of pregnancy, as it may cause serious harm to your baby when administered from that point onwards.

Lactation

You should inform your doctor if you plan to start or are breastfeeding, as Irbesartán/Hidroclorotiazida Pharma Combix is not recommended for use during this period. Your doctor may decide to administer a more suitable treatment if you want to breastfeed, especially for newborns or premature babies.

Driving and operating machinery

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

Irbesartán/Hidroclorotiazida Pharma Combix contains lactose. If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication.

Use in athletes

This medication contains hydrochlorothiazide, which may produce a positive result in doping control tests.

Follow exactly the administration instructions for this medication as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

Dosage

The recommended dose of Irbesartán/Hidroclorotiazida Pharma Combix is one tablet per day. In general, your doctor will prescribe Irbesartán/Hidroclorotiazida Pharma Combix when previous treatments you received have not sufficiently reduced your blood pressure. Your doctor will indicate how to switch from previous treatments to Irbesartán/Hidroclorotiazida Pharma Combix.

Administration Form

Irbesartán/Hidroclorotiazida Pharma Combix is administered byoral route.Swallow the tablets with a sufficient amount of liquid (e.g., a glass of water). You can take Irbesartán/Hidroclorotiazida Pharma Combix with or without food. You should try to take your daily dose at the same time every day. It is essential that you continue taking Irbesartán/Hidroclorotiazida Pharma Combix until your doctor advises you otherwise.

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

If you take more Irbesartán/Hidroclorotiazida Pharma Combix than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, Telephone 91 562 04 20, indicating the medication and the amount ingested.

Use in children and adolescents

Children should not take Irbesartán/Hidroclorotiazida Pharma Combix

Irbesartán/Hidroclorotiazida Pharma Combix should not be given to children under 18 years of age. If a child swallows some tablets, contact your doctor immediately.

If you forgot to take Irbesartán/Hidroclorotiazida Pharma Combix

If you accidentally forget to take a dose, simply take your regular dose when it is due next. Do not take a double dose to compensate for the missed doses.

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

Like all medicines, this medicine can cause side effects, although not everyone will experience them. Some of these side effects can be serious and may require medical attention.

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

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

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

• nausea/vomiting,
• urination abnormalities,
• fatigue,
• dizziness (including dizziness that occurs 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 side effects cause you problems, consult your doctor

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

• diarrhea,
• low blood pressure,
• syncope,
• tachycardia,
• flushing,
• fluid retention (edema),
• sexual dysfunction (alterations in sexual function),
• blood tests may show low levels of sodium and potassium in your blood.

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

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

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

Side effects reported since the marketing of Irbesartan/Hidroclorotiazida

Since the marketing of Irbesartan/Hidroclorotiazida, some side effects have been reported. The side effects observed with unknown frequency are: headache, tinnitus, cough, alteration of taste, indigestion, joint and muscle pain, liver function alterations, kidney insufficiency, elevated potassium levels in your blood, and allergic reactions such as skin rash, urticaria, facial swelling, lip, mouth, tongue, or throat swelling. Also, cases of jaundice (yellowing of the skin and/or white of the eyes) have been observed.

As with all combinations of two active principles, the side effects associated with each component cannot be ruled out.

Side effects associated only with irbesartan

In addition to the side effects described above, chest pain and a reduction in the number of platelets have also been observed.

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

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

Side effects associated only with hydrochlorothiazide

Loss of appetite; stomach irritation; stomach cramps; constipation; jaundice (yellowing of the skin and/or white of the eyes); pancreatitis characterized by severe upper abdominal pain, often with nausea and vomiting; sleep disturbances; depression; blurred vision; lack of white blood cells, which can lead to frequent infections, fever; decreased platelet count (essential blood cells for blood coagulation), decreased red blood cell count (anemia) characterized by fatigue, headaches, shortness of breath during exercise, dizziness, and pallor; kidney disease; pulmonary alterations including pneumonia or fluid accumulation in the lungs; increased skin sensitivity to the sun; 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 can appear on the face, neck, and scalp; allergic reactions; muscle weakness and spasms; alteration of heart rhythm; reduction of blood pressure after a change in body position; decreased vision or eye pain due to increased pressure [possible signs of fluid accumulation in the vascular layer of the eye (choroidal hemorrhage) or acute angle-closure glaucoma]; salivary gland swelling; 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.

It is known that the side effects associated with hydrochlorothiazide can increase with higher doses of hydrochlorothiazide.

Unknown frequency

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

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

No special storage conditions are required.

Do not use this medication after the expiration date that appears on the packagingafterCAD. The expiration date is the last day of the month indicated.

Medications should not be disposed of through drains or in the trash. Dispose of the packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Irbesartán/Hidroclorotiazida Pharma Combix

• The active principles are irbesartan and hydrochlorothiazide. Each film-coated tablet contains 300 mg of irbesartan and 25 mg of hydrochlorothiazide.
• The other components (excipients) are: lactose monohydrate, maize pregelatinized 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: hydroxypropylmethylcellulose (E464), lactose monohydrate, 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 packaging

Film-coated tablets, pink in color, biconvex, capsule-shaped, with the mark “ZF 17” on one face and smooth on the other.

PVC/PVDC-Aluminium blisters.

Irbesartán/Hidroclorotiazida Pharma Combix 300 mg/25 mg is available in packs of 28 tablets.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Laboratorios Combix, S.L.U.

C/ Badajoz 2, Edificio 2

28223– Pozuelo de Alarcon (Madrid)

Spain

Responsible for manufacturing

Zydus france

Zac Les Hautes Pâturages

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

Last review date of this leaflet: February 2025

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/.