Irbesartan/hydrochlorothiazide Sun 300/12.5 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

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

Irbesartan/hydrochlorothiazide

Read all of 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 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. It may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if such effects are not listed in this leaflet. See section 4.

Contents of this leaflet

1. What Irbesartan/Hydrochlorothiazide tablets are and what they are used for
2. What you need to know before taking Irbesartan/Hydrochlorothiazide tablets
3. How to take Irbesartan/Hydrochlorothiazide tablets
4. Possible side effects
5. How to store Irbesartan/Hydrochlorothiazide tablets
6. Contents of the pack and other information

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

Irbesartan/Hydrochlorothiazide tablets 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 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 Irbesartan/Hydrochlorothiazide tablets work together to achieve a greater reduction in blood pressure than either of them alone.

Irbesartan/Hydrochlorothiazide 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 taking Irbesartan/Hydrochlorothiazide tablets

Do not take Irbesartan/Hydrochlorothiazide tablets:

• if you are allergic to irbesartan or 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 Irbesartan/Hydrochlorothiazide 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 calcium levels or low potassium levels in your blood.
• if you have diabetes or renal insufficiency and are being treated with a blood pressure-lowering medicine containing aliskiren.

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting Irbesartan/Hydrochlorothiazide, and in any of the following cases:

• if you have excessive vomiting or diarrhoea.
• if you have kidney disorders or if you have had a kidney transplant.
• if you have heart disorders.
• if you have liver disorders.
• if you have diabetes.
• if you experience low blood sugar levels (symptoms may include sweating, weakness, hunger, dizziness, trembling, headache, flushing or paleness, numbness, rapid and strong heartbeat), especially if you are being treated for diabetes.
• if you have lupus erythematosus (also known as lupus or SLE).
• if you have primary hyperaldosteronism (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 for 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 Irbesartan/Hydrochlorothiazide SUN.
• if you have previously experienced respiratory or pulmonary problems (such as lung inflammation or fluid in the lungs) after taking hydrochlorothiazide. If you develop shortness of breath or severe difficulty breathing after taking Irbesartan/Hydrochlorothiazide SUN, seek medical help immediately.

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

If you are pregnant, suspect you may be pregnant, or plan to become pregnant, you must inform your doctor. Use of Irbesartan/Hydrochlorothiazide is not recommended during early pregnancy (first 3 months), and must not be used 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 the following signs: 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 Irbesartan/Hydrochlorothiazide tablets).
• if you experience increased skin sensitivity to sunlight with symptoms of sunburn (such as redness, itching, swelling, blisters) occurring more quickly than normal.
• if you are going to have surgery or will be given anaesthetics.
  • if you experience a decrease in vision or eye pain, these could be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or increased pressure in the eye (glaucoma), which may occur within hours to a week after taking Irbesartan/Hydrochlorothiazide SUN. This may lead to permanent vision loss if not treated. If you previously had an allergy to penicillin or sulfonamides, you may have a higher risk of developing this condition. You must stop treatment with Irbesartan/Hydrochlorothiazide and seek immediate medical attention.

Hydrochlorothiazide contained in this medicine may lead to positive doping test results.

Children and adolescents

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

Use of Irbesartan/Hydrochlorothiazide tablets with other medicines

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

Diuretics, such as hydrochlorothiazide contained in Irbesartan/Hydrochlorothiazide tablets, may interact with other medicines. You must not take products containing lithium together with Irbesartan/Hydrochlorothiazide unless under medical supervision.

Your doctor may need to adjust your dose and/or take additional precautions:

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

You may need to have 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 such as repaglinide or insulin)
• carbamazepine (a medicine used to treat 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 blood cholesterol.

Taking Irbesartan/Hydrochlorothiazide tablets with food and drink

Irbesartan/Hydrochlorothiazide tablets can be taken with or without food.

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

Pregnancy, breastfeeding, and fertility

Pregnancy

If you are pregnant, breastfeeding, 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 becoming pregnant or as soon as pregnancy is confirmed, and will recommend an alternative antihypertensive medicine. Irbesartan/Hydrochlorothiazide is not recommended during early pregnancy and must not be used after the third month of pregnancy, as it may cause serious harm to your baby when taken from that stage onward.

Breastfeeding

Inform your doctor if you are planning to breastfeed or are currently breastfeeding, as Irbesartan/Hydrochlorothiazide is not recommended during this period. Your doctor may decide to prescribe a more suitable treatment if you intend to breastfeed, especially if your baby is a newborn or premature.

Driving and use of machines

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

Irbesartan/Hydrochlorothiazide contains lactose and sodium. If your doctor has diagnosed you with an intolerance to certain sugars (e.g. lactose), consult him before taking this medicine.

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

3. How to take Irbesartan/Hydrochlorothiazide tablets

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

Dosage

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

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

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

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

Method of administration

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

You may take Irbesartan/Hydrochlorothiazide 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 until your doctor advises otherwise.

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

Children must not take Irbesartan/Hydrochlorothiazide tablets

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

If you take more Irbesartan/Hydrochlorothiazide tablets than you should

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

In case of overdose or accidental ingestion, contact your doctor or call the Poison Information Service immediately at telephone number: 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Irbesartan/Hydrochlorothiazide

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 can cause adverse effects, although not everyone will experience 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 Irbesartan/Hydrochlorothiazide and contact your doctor immediately.

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,
• abnormalities in urination,
• fatigue,
• dizziness (including 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 adverse effects cause you problems, consult your doctor.

Uncommon adverse effects (may affect up to 1 in 100 people):

• diarrhoea,
• low blood pressure,
• fainting,
• tachycardia,
• flushing,
• swelling due to fluid retention (oedema),
• 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 reported since marketing of Irbesartan/Hydrochlorothiazide tablets

Since the marketing of Irbesartan/Hydrochlorothiazide tablets, some adverse effects have been reported. Adverse effects observed at an unknown frequency include: headache, tinnitus (ringing in the ears), 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.

Rare:

Intestinal angioedema: swelling in the intestine presenting with symptoms such as abdominal pain, nausea, vomiting and diarrhoea.

As with all fixed combination products, 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, severe allergic reactions (anaphylactic shock), decreased number of red blood cells (anaemia; symptoms may include tiredness, headache, shortness of breath on exertion, dizziness and pallor), decreased number of platelets (a blood cell essential for blood clotting), and low blood sugar levels have also been observed.

Rare:

Intestinal angioedema: swelling in the intestine presenting with symptoms such as abdominal pain, nausea, vomiting and diarrhoea.

Adverse effects associated with hydrochlorothiazide in monotherapy:

Loss of appetite; stomach irritation; stomach cramps; diarrhoea, constipation; jaundice (yellowing of the skin and/or whites of the eyes); inflammation of the pancreas characterised by severe upper abdominal pain, often with nausea and vomiting; sleep disorders; depression; dizziness, tingling (paraesthesia), drowsiness, restlessness, blurred vision; visual disturbances (colour vision disorders, myopia); lack of white blood cells, which may lead to frequent infections and fever; decreased number of platelets (blood cells essential for blood clotting), decreased number of red blood cells (anaemia) characterised by fatigue, headache, shortness of breath on exertion, dizziness and pallor; kidney disease; pulmonary disorders including pneumonia or fluid accumulation in the lungs; increased skin sensitivity to sunlight; inflammation of blood vessels; a skin disorder characterised 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; skin rash, urticaria; muscle weakness and muscle spasms; changes in heart rhythm; drop in blood pressure upon changing position; swelling of the salivary glands; high blood sugar levels; sugar in the urine; electrolyte imbalance (including hypokalaemia and hyponatraemia); increases in certain 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 breathing difficulty (signs include severe shortness of breath, 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 blurred distance vision (acute myopia), decreased 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]

Adverse effects associated with hydrochlorothiazide are known to increase with higher doses of hydrochlorothiazide.

Reporting of adverse reactions

If you experience any adverse reaction, consult your doctor or pharmacist, even if it is a possible adverse reaction not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse reactions, you can help provide more information on the safety of this medicine.

5. Storage of Irbesartan/Hydrochlorothiazide Tablets

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

Do not use Irbesartan/Hydrochlorothiazide SUN after the expiry date which is stated on the packaging after the abbreviation EXP. The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage conditions.

Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE collection 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

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

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

The other components (excipients) are:

Tablet core: Monohydrate lactose, 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 pack

Yellow, oval, film-coated tablets, engraved with "IH 3" on one side and smooth on the other.

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

Only certain pack sizes may be commercially available.

Marketing Authorization Holder

Sun Pharmaceutical Industries Europe B.V.,
Polarisavenue 87,
2132JH Hoofddorp,
The Netherlands.

Manufacturer

Sun Pharmaceutical Industries Europe B.V.,
Polarisavenue 87,
2132JH Hoofddorp,
The Netherlands.

or

TERAPIA S.A.,
124 Fabricii Street,
400 632 Cluj Napoca,
Romania

or

DEMO SA PHARMACEUTICAL INDUSTRY,
21st km National Road Athens – Lamia, Krioneri Attiki,
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 European Economic Area member states under 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: 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 most recent revision of this leaflet: January 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/