Irbesartan/hydrochlorothiazide Aurovitas 300 mg/25 mg film-coated tablets EFG

Patient Information Leaflet

Introduction

Patient Information Leaflet

Irbesartan/Hydrochlorothiazide Aurovitas 300 mg/25 mg film-coated tablets EFG

Read all of this leaflet carefully before you start taking this medicine, as it contains important information for you.

• Keep this leaflet as 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 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 side effects, talk to your doctor or pharmacist, even if it is a side effect not listed in this leaflet. See section 4.

Contents of the leaflet

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

1. What Irbesartán/Hidroclorotiazida Aurovitas is and what it is used for

Irbesartán/Hidroclorotiazida Aurovitas 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 results in an increase in blood pressure. Irbesartan prevents angiotensin-II from binding to these receptors, relaxing the blood vessels and thereby lowering 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 Irbesartán/Hidroclorotiazida Aurovitas 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 alone or hydrochlorothiazide alone does not provide adequate control of your blood pressure.

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

Do not take Irbesartan/Hydrochlorothiazide Aurovitas

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

Warnings and precautions

Talk to your doctor before starting to take Irbesartan/Hydrochlorothiazide Aurovitas and in 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 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 systemic lupus erythematosus (also known as lupus or SLE)

• if you have primary hyperaldosteronism (a condition involving 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 (ACE) inhibitor (e.g., enalapril, lisinopril, ramipril), particularly if you have kidney problems related to diabetes.

• aliskiren.

  • if you have had skin cancer or 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 sun exposure and UV rays while taking irbesartan/hydrochlorothiazide.
  • if you have previously experienced breathing or lung problems (such as inflammation or fluid in the lungs) after taking hydrochlorothiazide. If you develop severe shortness of breath or 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.

Talk to 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.

See also the information under the heading “Do not take Irbesartan/Hydrochlorothiazide Aurovitas”.

If you are pregnant, suspect you may be pregnant, or plan to become pregnant, you must inform your doctor. The use of irbesartan/hydrochlorothiazide is not recommended during early pregnancy, and must not be used from the third month of pregnancy onwards, as it may cause serious harm to your baby (see Pregnancy section).

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 Aurovitas)
• if you experience increased skin sensitivity to sunlight, with symptoms of sunburn (such as redness, itching, swelling, blisters) occurring more quickly than usual
• if you are going to have surgery (surgical procedure) or will be given anesthetics
• if you experience decreased vision or eye pain in one or both eyes while taking irbesartan/hydrochlorothiazide. These could be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or increased eye pressure (glaucoma), which may occur within hours to a week after taking irbesartan/hydrochlorothiazide. This may lead to permanent vision loss if not treated. If you previously had an allergy to penicillin or sulfonamides, you may be at higher risk. You must stop treatment with irbesartan/hydrochlorothiazide and seek immediate medical attention.

The hydrochlorothiazide contained in this medicine may cause positive results in doping tests.

Children and adolescents

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

Other medicines and Irbesartan/Hydrochlorothiazide Aurovitas

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

Diuretics such as hydrochlorothiazide contained in Irbesartan/Hydrochlorothiazide Aurovitas may interact with other medicines. You must not take preparations containing lithium together with irbesartan/hydrochlorothiazide without medical supervision.

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

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

You may need 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 blood pressure-lowering medicines, steroids, cancer treatments, painkillers, medicines for arthritis, or cholestyramine or colestipol resins to lower blood cholesterol.

Taking Irbesartan/Hydrochlorothiazide Aurovitas with food, drinks and alcohol

Irbesartan/hydrochlorothiazide can be taken with or without food.

Due to the hydrochlorothiazide contained in Irbesartan/Hydrochlorothiazide Aurovitas, if you drink alcohol while being treated with this medicine, you may feel more dizzy when standing up, especially after rising from a sitting position.

Pregnancy, breastfeeding and fertility

Pregnancy

Inform your doctor if you are pregnant, suspect you may be pregnant, or plan to become pregnant. Your doctor will usually 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 from the third month of pregnancy onwards, as it may cause serious harm to your baby when used from that point.

Breastfeeding

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

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

Driving and using machines

Irbesartan/hydrochlorothiazide is unlikely to 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, talk to your doctor before driving or operating machinery.

Irbesartan/Hydrochlorothiazide Aurovitas contains lactose

If your doctor has informed you that you have an intolerance to certain sugars, consult him before taking this medicine.

Sodium:

This medicine contains less than 1 mmol of sodium (23 mg) per film-coated tablet; this is essentially “sodium-free”.

3. How to take Irbesartán/Hidroclorotiazida Aurovitas

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

Dosage

The recommended dose of irbesartan/hydrochlorothiazide is one or two tablets daily. Generally, your doctor will prescribe irbesartan/hydrochlorothiazide when previous treatments 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 is administered 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 unless your doctor advises otherwise.

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

If you take more Irbesartán/Hidroclorotiazida Aurovitas than you should

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

In case of overdose or accidental ingestion, consult your doctor or pharmacist, go to a Medical Center, or call the Toxicology Information Service at 91 562 04 20, indicating the medicine and the amount taken. It is recommended to bring the medicine's packaging and leaflet.

Children must not take Irbesartán/Hidroclorotiazida Aurovitas

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

If you forget to take Irbesartán/Hidroclorotiazida Aurovitas

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 missed 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 experiences 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.

The frequency of the adverse effects listed below is defined using the following convention:

• Frequent: may affect up to 1 in 10 people.
• Uncommon: may affect up to 1 in 100 people.
• Rare: may affect up to 1 in 1,000 people.
• Very rare: may affect up to 1 in 10,000 people.
• Frequency not known: cannot be estimated from available data.

Adverse effects reported in clinical studies for patients treated with irbesartan/hydrochlorothiazide were:

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

• Nausea/vomiting
• Abnormal urination
• Fatigue
• Dizziness (including dizziness upon standing up from a lying or sitting position)
• Blood tests may show elevated levels of an enzyme measuring muscle and heart function (creatine kinase), or elevated levels of substances measuring 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):

• Diarrhea
• Low blood pressure
• Fainting
• Tachycardia
• Redness
• Swelling
• Sexual dysfunction (changes in sexual function)
• Blood tests may show low levels of sodium and potassium in your blood.

Frequency not known (cannot be estimated from available data):

• Sudden decrease in distance vision (acute myopia).

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

Adverse effects reported since marketing of irbesartan/hydrochlorothiazide

Since the marketing of irbesartan/hydrochlorothiazide, some adverse effects have been reported. The adverse effects observed with frequency not known are: headache, tinnitus (ringing in the ears), cough, altered taste, indigestion, joint and muscle pain, liver function abnormalities, kidney failure, elevated potassium levels in your 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.

As with all fixed-dose combinations of two active substances, 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 – characterised by fatigue, headache, shortness of breath during exercise, dizziness and pallor), decreased platelet count (a blood cell essential for blood clotting), and low blood sugar levels have also been observed.

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

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

Adverse effects associated with hydrochlorothiazide in monotherapy:

Loss of appetite; stomach irritation; stomach cramps; 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; blurred vision; lack of white blood cells, which may lead to frequent infections and fever; decreased platelet count (blood cells essential for blood clotting), decreased red blood cell count (anaemia) characterised by fatigue, headache, shortness of breath during exercise, dizziness and pallor; kidney disease; lung disorders including pneumonia or fluid accumulation in the lungs; increased sensitivity of the skin 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; muscle weakness and spasms; changes in heart rhythm; drop in blood pressure upon changing body position; swelling of the salivary glands; high blood sugar levels; sugar in the urine; 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 (symptoms include severe shortness of breath, fever, weakness and confusion).

Frequency not known (cannot be estimated from available data): skin and lip cancer (non-melanoma skin cancer), 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).

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

Reporting of adverse effects

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

5. Storage of Irbesartan/Hydrochlorothiazide Aurovitas

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

Do not use this medicine after the expiry date stated on the outer packaging and blister after EXP. The expiry date refers to the last day of the month indicated.

Store below 30°C.

Medicines should not be disposed of via wastewater or household waste. Dispose of unused medicines and their packaging at the SIGRE collection point at your pharmacy. Ask your pharmacist how to properly dispose of any unused medicines and their packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Irbesartán/Hidroclorotiazida Aurovitas

• The active substances are irbesartan and hydrochlorothiazide. Each film-coated tablet contains 300 mg of irbesartan and 25 mg of hydrochlorothiazide.
• The other components are:

Tablet core: monohydrate lactose, sodium carboxymethylstarch (Type A) (derived from potato starch), povidone K-30, colloidal anhydrous silica, talc and sodium stearyl fumarate.

Tablet coating: hypromellose (E464), titanium dioxide (E171), macrogol 4000, red iron oxide (E172) and black iron oxide (E172).

Appearance of the product and contents of the pack

Film-coated tablet.

Pink, biconvex, oval-shaped film-coated tablets, marked with “H 37” on one side and plain on the other.

The tablets are available in blister packs.

Pack sizes: 14 and 28 film-coated tablets.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16-D

28036 Madrid

Spain

Manufacturer:

APL Swift Services (Malta) Limited

HF26, Hal Far Industrial Estate, Hal Far

Birzebbugia, BBG 3000

Malta

This medicinal product is authorized in the European Economic Area member states under the following names:

Spain: Irbesartán/Hidroclorotiazida Aurovitas 300 mg/25 mg film-coated tablets EFG

Portugal: Irbesartan + Hidroclorotiazida Aurovitas

Date of the most recent review of this leaflet: March 2026.

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