IRBESARTAN/HYDROCHLOROTHIAZIDE PHARMA COMBIX 300 MG/25 MG FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the Patient

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

Read the entire package leaflet carefully before starting to take this medication, as it contains important information for you.

• Keep this package leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed to you only, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. See section 4.

Contents of the Package Leaflet:

1. What is Irbesartan/Hydrochlorothiazide Pharma Combix and what is it 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. Storage of Irbesartan/Hydrochlorothiazide Pharma Combix.
6. Package contents and additional information

1. What is Irbesartan/Hydrochlorothiazide Pharma Combix and what is it used for

Irbesartan/Hydrochlorothiazide 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 blood vessel receptors, causing them to contract. This leads to an increase in blood pressure. Irbesartan prevents angiotensin II from binding to these receptors, relaxing blood vessels and reducing blood pressure.

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

The two active substances in Irbesartan/Hydrochlorothiazide Pharma Combix work together to achieve a greater reduction in blood pressure than either substance alone.

Irbesartan/Hydrochlorothiazide Pharma Combix is used to treat high blood pressure, when treatment with only irbesartan or only hydrochlorothiazide does not provide adequate control of your blood pressure.

2. What you need to know before taking Irbesartan/Hydrochlorothiazide Pharma Combix

Do not take Irbesartan/Hydrochlorothiazide Pharma Combix

• if you are allergic to irbesartan or any of the other ingredients of this medication (listed in section 6)
• if you are allergic to hydrochlorothiazide or any other sulfonamide-derived medication
• if you are pregnant for more than 3 months. (In any case, it is best to avoid taking this medication during the beginning of your pregnancy – see section Pregnancy)
• if you have severe liver or kidney problems
• if you have difficulty urinating
• if your doctor detects that you have persistently elevated calcium levels or low potassium levels in your blood.
• if you have diabetes or kidney failure and are being treated with a blood pressure medication that contains aliskiren.

Children and adolescents

Irbesartan/Hydrochlorothiazide Pharma Combix should not be administered to children and adolescents (under 18 years of age).

Warnings and precautions

Consult your doctor or pharmacist before starting to take Irbesartan/Hydrochlorothiazide Pharma Combix.

Tell your doctorin 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 lupus erythematosus (also known as lupus or LES)
• if you have primary aldosteronism (a condition related to excessive production of the hormone aldosterone, leading to sodium retention and increased 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 diabetes-related kidney problems.
  • 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 skin and lip cancer (non-melanoma skin cancer). Protect your skin from sun and UV exposure while taking Irbesartan/Hydrochlorothiazide 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 shortness of breath or severe difficulty breathing after taking Irbesartan/Hydrochlorothiazide, 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 Irbesartan/Hydrochlorothiazide Pharma Combix".

If you are pregnant, think you may be pregnant, or plan to become pregnant, inform your doctor. It is not recommended to use Irbesartan/Hydrochlorothiazide Pharma Combix during pregnancy, and it should not be administered after the third month of pregnancy, 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 symptoms: feeling of thirst, dry mouth, generalized weakness, feeling of sleepiness, muscle pain or cramps, nausea, vomiting, or rapid heartbeat, as they may indicate an excessive effect of hydrochlorothiazide (contained in Irbesartan/Hydrochlorothiazide Pharma Combix)
• if you experience increased sensitivity of your skin to the sun with symptoms of sunburn (such as redness, itching, swelling, blisters) that occurs more quickly than usual
• if you are going to undergo surgery (surgical intervention) or if you are going to receive anesthetics.
• if you experience changes in your vision or pain in one or both eyes while taking Irbesartan/Hydrochlorothiazide 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 Irbesartan/Hydrochlorothiazide 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.

Using Irbesartan/Hydrochlorothiazide with other medications

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

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 the information under the headings "Do not take Irbesartan/Hydrochlorothiazide Pharma Combix" and "Warnings and precautions").

Diuretics, such as hydrochlorothiazide contained in Irbesartan/Hydrochlorothiazide Pharma Combix, may interact with other medications. You should not take preparations containing lithium with Irbesartan/Hydrochlorothiazide Pharma Combix without your doctor's supervision.

You may need to have blood tests if you take:

• potassium supplements
• salt substitutes that contain potassium
• potassium-sparing medications or other diuretics (tablets that increase urine production)
• certain laxatives
• medications used to treat gout
• vitamin D supplements
• medications to control heart rhythm
• medications for diabetes (oral agents or insulins)
• carbamazepine (a medication for the treatment of epilepsy)

It is also important to inform your doctor if you are taking other medications to lower your blood pressure, steroids, cancer medications, pain relievers, medications for arthritis, or cholestyramine or colestipol resins to reduce cholesterol in the blood.Taking Irbesartan/Hydrochlorothiazide Pharma Combix with food, drinks, and alcohol

Irbesartan/Hydrochlorothiazide Pharma Combix can be taken with or without food.

Due to the hydrochlorothiazide contained in Irbesartan/Hydrochlorothiazide Pharma Combix, if you drink alcohol while taking this medication, you may experience increased dizziness when standing up, especially when getting up from a seated position.

Pregnancy, breastfeeding, and fertility

If you are pregnant, breastfeeding, or think you may be 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 Irbesartan/Hydrochlorothiazide Pharma Combix before becoming pregnant or as soon as you become pregnant and recommend taking another blood pressure medication instead. It is not recommended to use Irbesartan/Hydrochlorothiazide Pharma Combix during pregnancy, and it should not be administered after the third month of pregnancy, as it may cause serious harm to your baby.

Breastfeeding

Tell your doctor if you are breastfeeding or plan to start breastfeeding, as it is not recommended to administer Irbesartan/Hydrochlorothiazide Pharma Combix to women during this period. Your doctor may decide to administer a treatment that is more suitable if you want to breastfeed, especially to newborns or premature babies.

Driving and using machines

No studies have been conducted on the ability to drive and use machines. It is unlikely that Irbesartan/Hydrochlorothiazide Pharma Combix will affect your ability to drive vehicles or use machines. However, during hypertension treatment, dizziness or fatigue may occasionally occur. If you experience these symptoms, talk to your doctor before driving or using machines.

Irbesartan/Hydrochlorothiazide 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 tests.

3. How to take Irbesartan/Hydrochlorothiazide Pharma Combix

Follow the administration instructions for this medication exactly as indicated by your doctor. If you are unsure, consult your doctor or pharmacist again.

Dosage

The recommended dose of Irbesartan/Hydrochlorothiazide Pharma Combix is one tablet per day. In general, your doctor will prescribe Irbesartan/Hydrochlorothiazide Pharma Combix when previous treatments have not sufficiently reduced your blood pressure. Your doctor will indicate 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 can take Irbesartan/Hydrochlorothiazide Pharma Combix with or without food. Try to take your daily dose at the same time each day. It is essential that you continue taking Irbesartan/Hydrochlorothiazide Pharma Combix until your doctor advises you to stop.

The maximum blood pressure-reducing 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, consult your doctor or pharmacist immediately or call the Toxicology Information Service, Telephone 91 562 04 20, indicating the medication and the amount ingested.

Use in children and adolescents

Children should not take Irbesartan/Hydrochlorothiazide Pharma Combix

Irbesartan/Hydrochlorothiazide 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 forget to take Irbesartan/Hydrochlorothiazide Pharma Combix

If you accidentally miss a dose, simply take your normal dose when it is time for your next dose. Do not take a double dose to make up for missed doses.

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

4. Possible Adverse Effects

Like all medicines, this medicine can cause adverse effects, although not all people suffer from them. Some of these effects can be serious and may require medical attention.

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

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

Frequent Adverse Effects(may affect up to 1 in 10 patients):

• nausea/vomiting,
• urination anomalies,
• fatigue,
• dizziness (including that which 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 (urea nitrogen in the blood, creatinine).

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

Infrequent Adverse Effects(may affect up to 1 in 100 patients):

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

Very Rare Adverse Effects (may affect up to 1 in 10,000 people):

• Acute respiratory distress (signs include severe respiratory distress, fever, weakness, and confusion).

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

Adverse Effects Reported Since the Marketing of Irbesartan/Hydrochlorothiazide

Since the marketing of Irbesartan/Hydrochlorothiazide, some adverse effects have been reported. The adverse effects observed with unknown frequency are: headache, ringing in the ears, cough, altered taste, indigestion, joint and muscle pain, liver function disorders, and kidney failure, high levels of potassium in the blood, and allergic reactions such as skin rash, hives, swelling of the face, lips, mouth, tongue, or throat. Cases of jaundice (yellowing of the skin and/or whites of the eyes) have also been observed.

As with all combinations of two active principles, the adverse effects associated with each component cannot be excluded.

Adverse Effects Associated Only with Irbesartan

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

Rare Adverse 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.

Adverse Effects Associated Only with Hydrochlorothiazide

Lack of appetite; stomach irritation; stomach cramps; constipation; jaundice (yellowing of the skin and/or whites of the eyes); pancreatitis characterized by severe upper stomach pain, often with nausea and vomiting; sleep disorders; depression; blurred vision; lack of white blood cells, which can lead to frequent infections, fever; decreased platelet count (blood cells essential for blood clotting), decreased red blood cell count (anemia) characterized by fatigue, headaches, shortness of breath when exercising, dizziness, and paleness; kidney disease; pulmonary disorders 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 all over the body; cutaneous lupus erythematosus, which is identified by a rash that can appear on the face, neck, and scalp; allergic reactions; weakness and muscle spasms; alteration of heart rhythm; decrease in blood pressure after a change in body position; decreased vision or eye pain due to high 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 some types of blood fats; high levels of uric acid in the blood, which can cause gout.

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

Unknown Frequency

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

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 that does not appear in this prospectus. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Conservation 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 expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Medicines should not be thrown away through wastewater or household waste. Deposit the packaging and medicines you no longer need at the SIGRE point in the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This way, you will help protect the environment.

6. Package Contents and Additional Information

Composition of Irbesartan/Hydrochlorothiazide Pharma Combix

• The active ingredients 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, 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: hydroxypropyl methylcellulose (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 Package Contents

Film-coated tablets, pink, biconvex, capsule-shaped, with the mark "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 packages 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 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

Date of the Last Revision of this Prospectus: February 2025

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