PATIENT INFORMATION LEAFLET

SUN 300 mg/12.5 mg Film-Coated Tablets, Irbesartan/Hydrochlorothiazide

Irbesartan/Hydrochlorothiazide

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.

1. What Irbesartan/Hydrochlorothiazide tablets are and what they are used for

2. What you need to know before you start taking Irbesartan/Hydrochlorothiazide tablets

3. How to take Irbesartan/Hydrochlorothiazide tablets

4. Possible side effects

5. Storage of Irbesartan/Hydrochlorothiazide tablets

6. Contents of the pack and additional information

Irbesartán/Hidroclorotiazida tablets is an association of two active principles, 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 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 medicines (called thiazide diuretics) that increase the amount of urine eliminated, reducing blood pressure.

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

Irbesartán/Hidroclorotiazida 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 tablets:

• ifyouare allergicto irbesartan or any of the other ingredients of this medicine (listed in section 6).
• ifyou are allergicto hydrochlorothiazide or any other sulfonamide-derived medication
• ifyou are more than 3 months pregnant. (In any case, it is best to avoid taking Irbesartán/Hidroclorotiazida also at the beginning of your pregnancy – see Pregnancy section)
• ifyou have severe liver or kidney problems
• ifyou have difficulty urinating
• ifyour doctor detects thatyou havepersistently elevated calcium levels or low potassium levels in your blood
• ifyou havediabetes or kidney insufficiency and are being treated with a blood pressure-lowering medication containing aliskiren

Warnings and precautions

Consult your doctor, pharmacist, or nursebefore starting to take Irbesartán/Hidroclorotiazidaandin any of the following cases:

• ifyou have excessive vomiting or diarrhea

• ifyou have kidney problems or if you have had a kidney transplant
• ifyou havekidney problemsor if you have had akidney transplant
• ifyou haveheart problems
• ifyou haveliver problems
• ifyou havediabetes
• ifyou have low blood sugar levels(symptoms may include sweating, weakness, hunger, dizziness, tremors, headache, flushing, or pallor, numbness, rapid and strong heartbeats), especially if you are being treated for diabetes

• ifyou havelupus erythematosus(also known as lupus or LES)
• ifyou haveprimary aldosteronism(a condition related to the excessive production of the aldosterone hormone, which causes sodium retention and, in turn, an increase in blood pressure)
• ifyou are taking any of the following blood pressure-lowering medications:
• • an angiotensin-converting enzyme inhibitor (ACE inhibitor) (e.g. enalapril, lisinopril, ramipril), particularly if you have kidney problems related to diabetes
  • aliskiren
• ifyou have had skin canceror if you develop an unexpected skin lesion during treatment. The hydrochlorothiazide in this medication, particularly 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 SUN

• ifyou 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 SUN, seek medical attention immediately.

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

Your doctor may monitor your kidney function, blood pressure, and electrolyte levels (e.g. potassium) at regular intervals.

See also the information under the heading “Do not take Irbesartán/Hidroclorotiazida tablets”.

If you are pregnant, suspect you may be pregnant, or plan to become pregnant, inform your doctor. Irbesartán/Hidroclorotiazida 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 because it may cause serious harm to your baby (see Pregnancy section).

You must also inform your doctor:

-ifyou are on a low-sodium diet,

-ifyou experience any of these symptoms:sensation of thirst, dry mouth, generalized weakness, sensation of drowsiness, muscle pain or cramps, nausea, vomiting, or rapid heartbeat,as they may indicate excessive hydrochlorothiazide effect (contained in Irbesartan/Hidroclorotiazida tablets)

-ifyou experience increased skin sensitivity to the sunwith symptoms of sunburn (such as redness, itching, swelling, or blisters) that occur more quickly than usual

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

• ifyou experience a decrease in vision or eye pain, it may be a symptom of fluid accumulation in the vascular layer of the eye (choroidal effusion) or increased intraocular pressure (glaucoma) and may occur within a few hours to a week after taking Irbesartán/Hidroclorotiazida SUN. This can lead to permanent vision loss if not treated. If you have previously had an allergy to penicillin or sulfonamide, you may be at higher risk of developing it. You should interrupt treatment with Irbesartán/Hidroclorotiazida and seek medical attention immediately.

The hydrochlorothiazide in this medication may cause positive results in doping control.

Children and adolescents

Irbesartán/Hidroclorotiazidashould not be administered to children and adolescents (under 18 years old).

Use of Irbesartán/Hidroclorotiazida tablets with other medications

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication.

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

Your doctor may need to modify your dose and/or take other precautions:

ifyou are taking an angiotensin-converting enzyme inhibitor (ACE inhibitor) or aliskiren (see also the information under the headings “Do not take Irbesartan/Hidroclorotiazida tablets” and “Warnings and precautions”).

You may need to have blood tests if you take:

-potassium supplements

-sodium-free salt substitutes containing potassium

-potassium-sparing diuretics (tablets that increase urine production)

-some laxatives

-gout medications

-vitamin D supplements

-heart rate-controlling medications

-diabetes medications (oral agents such as repaglinide or insulin)

-carbamazepine (a medication for epilepsy treatment)

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

Taking Irbesartán/Hidroclorotiazida tablets with food and drinks

Irbesartán/Hidroclorotiazida tablets can be taken with or without food.

Due to the hydrochlorothiazide in Irbesartán/Hidroclorotiazida tablets, if you drink alcohol while taking this medication, you may experience increased dizziness when standing up, especially when getting up from a seated position.

Irbesartán/Hidroclorotiazidacontains lactose and sodium.If your doctor has told you that you have an intolerance to certain sugars (e.g. lactose), consult with them before taking this medication.

This medication contains less than 1 mmol of sodium (23 mg) per tablet, which is essentially “sodium-free”.

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

Dose

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

The recommended dose ofIrbesartán/Hidroclorotiazida300 mg/12.5 mg tablets andIrbesartán/Hidroclorotiazida300 mg/25 mg tablets is one tablet per day.

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

Your doctor will indicate how to switch from previous treatments to Irbesartán/Hidroclorotiazida.

Administration Form

Irbesartán/Hidroclorotiazida tablets are administered byoral route. The tablets should be swallowed with a sufficient amount of liquid (e.g., a glass of water).

You can take Irbesartán/Hidroclorotiazida 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 until your doctor advises you otherwise.

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

Children should not take Irbesartán/Hidroclorotiazida tablets

Irbesartán/Hidroclorotiazida tablets 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 Irbesartán/Hidroclorotiazida tablets 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 Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take Irbesartán/Hidroclorotiazida

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 following symptoms or have difficulty breathing, stop taking Irbesartán/Hidroclorotiazida and contact your doctor immediately.

The side effects reported in clinical studies for patients treated with Irbesartán/Hidroclorotiazida tablets were:

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

- Nausea, vomiting,

- Urinary abnormalities,

- 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 (blood urea nitrogen, creatinine).

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

Rare side effects(may affect up to 1 in 100 people)

- Diarrhea,

- Low blood pressure,

- Fainting,

- Tachycardia,

- Redness,

- 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.

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

Side effects since the marketing of Irbesartán/Hidroclorotiazida tablets

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

Rare:

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

Side effects associated with hidroclorotiazida in monotherapy:

Loss of appetite; stomach irritation; stomach cramps; diarrhea, 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;dizziness, tingling (paresthesia), drowsiness, restlessness, blurred vision; visual disturbances (color perception disorder, myopia; lack of white blood cells, which may lead to frequent infections, fever; decreased platelet count (blood cells essential for blood coagulation), decreased red blood cell count (anemia) characterized by fatigue, headaches, shortness of breath when exercising, dizziness, and paleness; kidney disease; respiratory disturbances 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; lupus erythematosus, which is identified by a rash that may appear on the face, neck, and scalp; allergic reactions; skin rash, urticaria; muscle weakness and spasms; alteration of heart rhythm; reduction of blood pressure after a change in body position; swelling of salivary glands; high blood sugar levels; sugar in the urine; electrolyte imbalance (including hypokalemia and hyponatremia) increases in some types of blood fats; high levels of uric acid in the blood, which may cause gout.

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

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

Unknown frequency (cannot be estimated from available data):

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

- Rapid deterioration of distant vision (acute myopia), decreased vision or eye pain due to high pressure [possible signs of fluid accumulation in the vascular layer of the eye (choroidal hemorrhage) or acute angle-closure glaucoma

It is known that the side effects associated with hidroclorotiazida may increase with higher doses of hidroclorotiazida.

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.

Do not use Irbesartán/Hidroclorotiazida 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 medication does not require special storage conditions.

Medicines should not be disposed of through drains or in the trash. Dispose of the packaging and the

medicines that 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 the medicines that you no longer need. By doing so, you will help protect the environment.

Composition of Irbesartan/Hydrochlorothiazide

- Irbesartan/Hydrochlorothiazide tablets contain two active ingredients: irbesartan and hydrochlorothiazide.

Cada Irbesartan/Hydrochlorothiazide SUN 300 mg/12.5 mg tablet 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).

Tablet coating:hypromellose, titanium dioxide (E-171), macrogol, talc, yellow iron oxide (E-172).

Appearance of the product and contents of the package

Yellow-coated, oval-shaped tablets, engraved with “IH 3” on one side and smooth on the other side.

This medication is marketed in blisters with packaging sizes 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.

Responsible for manufacturing

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 medication 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

Last review date of this leaflet: January 2025

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