IRBESARTAN / HYDROCHLOROTHIAZIDE SUN 300/12.5 mg FILM-COATED TABLETS

Introduction

PATIENT INFORMATION: SUMMARY OF PRODUCT CHARACTERISTICS

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

Irbesartan/Hydrochlorothiazide

Read this 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 further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack and other information

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

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

Irbesartan/Hydrochlorothiazide 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 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 produced, reducing blood pressure.

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

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

2. What you need to know before you take Irbesartan/Hydrochlorothiazide

Do not take Irbesartan/Hydrochlorothiazide:

• if you are allergicto irbesartan or any of the other ingredients of this medicine (listed in section 6).
• if you are allergicto hydrochlorothiazide or any other sulfonamide-derived medicine
• if you are pregnant more than 3 months. (In any case, it is recommended to avoid taking Irbesartan/Hydrochlorothiazide also at the beginning of 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 the blood.
• if you have diabetes or kidney failure and are being treated with a blood pressure-lowering medicine that contains aliskiren.

Warnings and precautions

Consult your doctor, pharmacist, or nursebefore starting to take Irbesartan/Hydrochlorothiazide andin 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 kidney problemsor have had a kidney transplant
• if you have heart problems
• if you have liver problems
• if you have diabetes
• if you experience low blood sugar levels(symptoms may include sweating, weakness, hunger, dizziness, trembling, headache, flushing or pallor, numbness, rapid and strong heartbeat), especially if you are being treated for diabetes

• if you have systemic lupus erythematosus(also known as lupus or SLE)
• if you have primary aldosteronism(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 canceror 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 exposure and UV rays while taking Irbesartan/Hydrochlorothiazide SUN

• 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 SUN, seek medical attention immediately.

Consult your doctor if you experience abdominal pain, nausea, vomiting, or diarrhea after taking Irbesartan/Hydrochlorothiazide. Your doctor will decide whether you should continue treatment. Do not stop taking Irbesartan/Hydrochlorothiazide on your own.

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”.

If you are pregnant, think you may be pregnant, or are planning to become pregnant, inform your doctor. It is not recommended to use Irbesartan/Hydrochlorothiazide at the start of pregnancy (first 3 months), and in no case should it be administered 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 these signs: feeling of thirst, dry mouth, weakness, feeling of sleepiness, muscle cramps or spasms, nausea, vomiting, or rapid heartbeat,as they may indicate an excessive effect of hydrochlorothiazide (contained in Irbesartan/Hydrochlorothiazide)

• if you experience increased sensitivity of the 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 have surgery (surgical intervention) or if you are going to be given anesthetics.
  • if you experience decreased vision or eye pain, they could be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or increased pressure in the eye (glaucoma) and can occur within a few hours to a week after taking Irbesartan/Hydrochlorothiazide SUN. This can lead to permanent vision loss if not treated. If you have previously been allergic to penicillin or sulfonamide, you may be at higher risk of developing it. You should discontinue treatment with Irbesartan/Hydrochlorothiazide and seek immediate medical attention.

Hydrochlorothiazide in this medicine may cause positive results in doping tests.

Children and adolescents

Irbesartan/Hydrochlorothiazideshould not be given to children and adolescents (under 18 years of age).

Use of Irbesartan/Hydrochlorothiazide with other medicines

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines.

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

Your doctor may need to change 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” and “Warnings and precautions”).

You may need to have blood tests if you take:

• potassium supplements
• salt substitutes that contain 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 such as repaglinide or insulins)
• carbamazepine (a medicine for the treatment of 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 cholesterol in the blood.

Taking Irbesartan/Hydrochlorothiazide with food and drinks

Irbesartan/Hydrochlorothiazide can be taken with or without food.

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

Pregnancy, breastfeeding, and fertility

Pregnancy

If you are pregnant, 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 Irbesartan/Hydrochlorothiazide before you become pregnant or as soon as you find out you are pregnant and will recommend that you take another anti-hypertensive medicine instead. It is not recommended to use Irbesartan/Hydrochlorothiazide at the start of pregnancy and in no case should it be administered from the third month of pregnancy onwards, as it may cause serious harm to your baby.

Breastfeeding

Tell your doctor if you are about to start or are breastfeeding, as Irbesartan/Hydrochlorothiazide is not recommended for use in women during this period. Your doctor may decide to give you a treatment that is more suitable if you want to breastfeed, especially newborns or premature babies.

Driving and using machines

It is unlikely that Irbesartan/Hydrochlorothiazide will affect your ability to drive or use machines. However, during treatment for high blood pressure, dizziness or fatigue may occasionally occur. If you experience these symptoms, talk to your doctor before driving or using machines.

Irbesartan/Hydrochlorothiazide contains lactose and sodium. If your doctor has told you that you have an intolerance to some sugars (e.g., lactose), consult your doctor before taking this medicine.

This medicine contains less than 1 mmol of sodium (23 mg) per tablet, i.e., it is essentially "sodium-free".

3. How to take Irbesartan/Hydrochlorothiazide

Follow exactly the instructions of administration of this medicine given by your doctor. If you are unsure, consult your doctor or pharmacist again.

Dose

This medicine is available in 2 doses: 300 mg/12.5 mg and 300 mg/25 mg film-coated tablets.

The recommended dose of Irbesartan/Hydrochlorothiazide 300 mg/12.5 mg and Irbesartan/Hydrochlorothiazide 300 mg/25 mg is one tablet per day.

Generally, your doctor will prescribe Irbesartan/Hydrochlorothiazide when previous treatments you received did not sufficiently reduce your blood pressure.

Your doctor will advise you how to switch from previous treatments to Irbesartan/Hydrochlorothiazide.

Method of administration

Irbesartan/Hydrochlorothiazide is taken orally. The tablets should be swallowed with a sufficient amount of liquid (e.g., a glass of water).

You can take Irbesartan/Hydrochlorothiazide with or without food.

Try to take your daily dose at the same time each day.

It is important that you continue taking Irbesartan/Hydrochlorothiazide until your doctor tells you to stop.

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

Children should not take Irbesartan/Hydrochlorothiazide

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

If you take more Irbesartan/Hydrochlorothiazide than you should

If you accidentally take too many tablets, contact your doctor immediately.

In case of overdose or accidental ingestion, consult your doctor immediately or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medicine and the amount taken.

If you forget to take Irbesartan/Hydrochlorothiazide

If you accidentally miss a dose, simply take your normal dose when it is due next.

Do not take a double dose to make up for forgotten doses.

If you have any further questions on the use of this medicine, 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, 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/Hydrochlorothiazide and contact your doctor immediately.

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

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

• 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 people)

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

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

Adverse Effects Since the Marketing of Irbesartan/Hydrochlorothiazide Tablets

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

Rare:

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

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, severe allergic reactions (anaphylactic shock), decreased red blood cell count (anemia; symptoms may include fatigue, headaches, difficulty breathing when exercising, dizziness, and paleness), and decreased platelet count (a blood cell essential for blood clotting) and low blood sugar levels have also been observed.

Rare:

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

Adverse Effects Associated with Hydrochlorothiazide in Monotherapy:

Lack of appetite; stomach irritation; stomach cramps; diarrhea, 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; dizziness, tingling (paresthesia), drowsiness, restlessness, blurred vision; vision alterations (color vision disorder, myopia; 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 alterations including pneumonia or fluid accumulation in the lungs; increased skin sensitivity to the sun; blood vessel inflammation; 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; skin rash, urticaria; weakness and muscle spasms; alteration of heart rhythm; reduction of blood pressure after a change in body position; swelling of the salivary glands; high blood sugar levels; sugar in the urine; electrolyte imbalance (including hypokalemia and hyponatremia) increases in some types of blood fats; high uric acid levels in the blood, which can cause gout.

Very Rare: may affect up to 1 in 10,000 people

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

Frequency Not Known (cannot be estimated from the available data):

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

• Rapid onset of deterioration of distant vision (acute myopia), 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]

It is known that the adverse effects associated with hydrochlorothiazide can 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 that does not appear in this leaflet. 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 Tablets

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

Do not use Irbesartan/Hydrochlorothiazide SUN after the expiration date that appears on the packaging after the abbreviation CAD. The expiration date is the last day of the month indicated.

This medicine does not require special storage conditions.

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

• Irbesartan/Hydrochlorothiazide tablets contain two active principles: irbesartan and hydrochlorothiazide.

Each coated tablet of Irbesartan/Hydrochlorothiazide SUN 300 mg/12.5 mg contains 300 mg of irbesartan and 12.5 mg of hydrochlorothiazide.

The other components (excipients) are:

Core of the tablet: lactose monohydrate, microcrystalline cellulose, sodium croscarmellose, hypromellose, anhydrous colloidal silica, magnesium stearate, yellow iron oxide (E-172).

Coating of the tablet:hypromellose, titanium dioxide (E-171), macrogol, talc, yellow iron oxide (E-172).

Appearance of the Product and Package Contents

Coated tablets with a yellow film, oval, engraved with "IH 3" on one side and smooth on the other side.

This medicine is marketed in blisters with packages of 7, 10, 14, 15, 20, 28, 30, 49, 50, 56, 60, 84, 90, 98, and 100 tablets.

Only some package sizes may be marketed.

Marketing Authorization Holder

Sun Pharmaceutical Industries Europe B.V,

Polarisavenue 87,

2132JH Hoofddorp,

Netherlands.

Manufacturer

Sun Pharmaceutical Industries Europe B.V,

Polarisavenue 87,

2132JH Hoofddorp,

Netherlands.

or

TERAPIA S.A.

124 Fabricii Street,

400 632 Cluj Napoca

Romania

or

DEMO SA PHARMACEUTICAL INDUSTRY,

21st km National Road Athens – Lamia, KrioneriAttiki,

14568, Greece

Local Representative

Sun Pharma Laboratorios, S.L.

Rambla de Catalunya 53-55

08007 – Barcelona

Spain

Tel: +34 93 342 78 90

This medicine is authorized in the member states of the European Economic Area with the following names:

Hungary: Irbesartan Hydrochlorothiazide Ranbaxy 300 mg /12, 5 mg

Greece: Irbesartan Hydrochlorothiazide Ranbaxy 300 mg /12, 5 mg

Ireland: Irbesartan/Hydrochlorothiazide Ranbaxy 300 mg /12, 5 mg Film-coated tablets

France: Irbesartan Hydrochlorothiazide Ranbaxy 300 mg /12, 5 mg comprimé pelliculé

Belgium: France: Irbesartan Hydrochlorothiazide Ranbaxy 300 mg /12, 5 mg

Luxembourg: Irbesartan Hydrochlorothiazide 300 mg / 12, 5 mg

Germany: Irbesartan Comp Basics 300 mg / 12, 5 mg Filmtabletten

Romania: Irbesartan Hidroclorotiazida Ranbaxy 300 mg / 12, 5 mg Comprimate filmate

Spain: Irbesartán / Hidroclorotiazida SUN 300 mg / 12, 5 mg comprimidos recubiertos con película EFG

Date of the Last Revision of this Leaflet: January 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/