IRBESARTAN/HYDROCHLOROTHIAZIDE AUROVITAS 300 MG/12.5 MG FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Irbesartan/Hydrochlorothiazide Aurovitas 300 mg/12.5 mg Film-Coated Tablets EFG

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 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 Package Leaflet

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

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

Irbesartan/Hydrochlorothiazide 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 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 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 or hydrochlorothiazide alone does not provide adequate control of blood pressure.

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

Do not takeIrbesartan/Hydrochlorothiazide Aurovitas

• 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 medication.
• if you are pregnant more than 3 months. (In any case, it is best to avoid taking irbesartan/hydrochlorothiazide also at the start 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 or low potassium levels in your blood.
• if you have diabetes or kidney insufficiencyand are being treated with a blood pressure-lowering medicine that contains aliskiren.

Warnings and Precautions

Consult your doctor before starting to take Irbesartan/Hydrochlorothiazide Aurovitas and in any of the following cases:

• if you have had skin cancer or if you develop an unexpected skin lesion during treatment. Treatment with hydrochlorothiazide, in particular its 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.
• if you have excessive vomiting or diarrhea
• if you have kidney problemsor if you 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 heartbeats), 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 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 experience decreased vision or eye pain when taking irbesartan/hydrochlorothiazide. These 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 hours to a week after taking irbesartan/hydrochlorothiazide. 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 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 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.

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

If you are pregnant, think you may be pregnant, or are planning to become pregnant, inform your doctor. Irbesartan/hydrochlorothiazide is not recommended during pregnancy and should not be taken 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, weakness, feeling of sleepiness, 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 an increased sensitivity of your skin to the sunwith 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.

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

Children and Adolescents

Irbesartan/Hydrochlorothiazide should 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 taking, have recently taken, or might take any other medicines.

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

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 Aurovitas” and “Warnings and Precautions”).

You may need to have blood tests if you take:

• potassium supplements
• potassium-containing salt substitutes
• potassium-sparing diuretics or other diuretics (tablets that increase urine production)

• certain laxatives
• medicines used in the treatment of gout
• vitamin D supplements
• medicines for controlling heart rhythm
• medicines for diabetes (oral agents such as repaglinide or insulins)
• carbamazepine (a medicine for treating 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 levels.

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 experience increased dizziness when standing up, especially when getting up from a seated position.

Pregnancy, Breastfeeding, and Fertility

Pregnancy

You should inform your doctor if you are pregnant, think you may be pregnant, or are planning to become pregnant. Your doctor will normally 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 a different blood pressure-lowering medicine instead. Irbesartan/hydrochlorothiazide is not recommended during pregnancy and should not be taken after the third month of pregnancy as it may cause serious harm to your baby.

Breastfeeding

Inform your doctor if you are about to start or are breastfeeding, as irbesartan/hydrochlorothiazide is not recommended for use during breastfeeding. Your doctor may decide to prescribe a treatment that is more suitable if you wish to breastfeed, especially for newborns or premature babies.

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

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 Aurovitas Contains Lactose

If your doctor has told you that you have an intolerance to some sugars, consult them before taking this medicine.

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

3. How to Take Irbesartan/Hydrochlorothiazide Aurovitas

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

Dose

The recommended dose of irbesartan/hydrochlorothiazide is one or two tablets per day. In general, your doctor will prescribe irbesartan/hydrochlorothiazide when previous treatments you received did not sufficiently reduce 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 can 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 to take irbesartan/hydrochlorothiazide until your doctor advises you to stop.

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

If You Take More Irbesartan/Hydrochlorothiazide 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, telephone 91 562 04 20, indicating the medicine and the amount used. It is recommended to carry the packaging and the package leaflet of the medicine.

Children Should Not Take Irbesartan/Hydrochlorothiazide Aurovitas

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 Forget to Take Irbesartan/Hydrochlorothiazide Aurovitas

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, hives) 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 frequency of the adverse effects listed below is defined using the following convention:

Common: may affect up to 1 in 10 people.

Uncommon: may affect up to 1 in 100 people.

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

Common 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 (creatinine 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.

Uncommon Adverse Effects(may affect up to 1 in 100 people):

• diarrhea
• low blood pressure
• fainting
• rapid heartbeat
• redness
• swelling
• sexual dysfunction (sexual function disorders)
• 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 distant vision (acute myopia).

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

Adverse Effects 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, taste alteration, indigestion, joint and muscle pain, liver function disorders, and kidney failure, high levels of potassium in your blood, and allergic reactions such as skin rash, hives, 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 combinations of two active ingredients, 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 - characterized by fatigue, headaches, shortness of breath 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.

Adverse Effects Associated with Hydrochlorothiazide in Monotherapy:

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; 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; 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; increased levels of certain types of blood fats; high levels of uric acid 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 available data): skin and lip cancer (non-melanoma skin cancer), 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).

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 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. Storage of Irbesartan/Hydrochlorothiazide Aurovitas

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

Do not use this medicine after the expiration date that appears on the packaging and blister after CAD. The expiration date is the last day of the month indicated.

Store below 30°C.

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. Ask your pharmacist how to dispose of the packaging and medicines you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Irbesartan/Hydrochlorothiazide Aurovitas

• The active ingredients are irbesartan and hydrochlorothiazide. Each film-coated tablet contains 300 mg of irbesartan and 12.5 mg of hydrochlorothiazide.
• The other components are:

Core of the tablet: lactose monohydrate, sodium carboxymethyl starch (Type A) (derived from potato starch), povidone K-30, colloidal anhydrous silica, talc, sodium stearyl fumarate.

Coating of the tablet: lactose monohydrate, hypromellose (E464), titanium dioxide (E171), macrogol 4000, yellow iron oxide (E172), and red iron oxide (E172).

Appearance of the Product and Package Contents

Film-coated tablet.

Peach-colored, biconvex, oval-shaped film-coated tablets, marked with "H 36" on one side and smooth on the other.

The tablets are available in blister packs.

Package sizes:14 and 28 film-coated tablets.

Not all package 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 medicine is authorized in the Member States of the European Economic Area under the following names:

Spain: Irbesartan/Hydrochlorothiazide Aurovitas 300 mg/12.5 mg film-coated tablets EFG

Portugal: Irbesartan + Hydrochlorothiazide Aurovitas

Date of the Last Revision of this Prospectus: September 2024

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