Leaflet: information for the user

Irbesartán/Hidroclorotiazida Aurovitas 150 mg/12.5 mg film-coated tablets EFG

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 isIrbesartán/Hidroclorotiazida Aurovitasand what it is used for

2. What you need to know before you start takingIrbesartán/Hidroclorotiazida Aurovitas

3. How to takeIrbesartán/Hidroclorotiazida Aurovitas

4. Possible side effects

5. Storage ofIrbesartán/Hidroclorotiazida Aurovitas

6. Contents of the pack and additional information

Irbesartán/Hidroclorotiazida Aurovitas is an association of two active principles, irbesartan and hydrochlorothiazide.

Irbesartan belongs to a group of medications 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 medications (called thiazide diuretics) that increase the amount of urine eliminated, reducing blood pressure.

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

Irbesartán/Hidroclorotiazidais used to treat high blood pressure, when treatment with only irbesartan or only hydrochlorothiazide does not provide adequate control of your blood pressure.

Do not takeIrbesartán/Hidroclorotiazida Aurovitas

• if you areallergicto irbesartán or any of the other ingredients of this medicine (listed in section 6).
• if you areallergicto hydrochlorothiazide or any other sulfonamide-derived medicine.
• if you aremore than 3 months pregnant.(In any case, it is better to avoid taking irbesartán/hydrochlorothiazide at the beginning of your pregnancy – see Pregnancy section).
• if you havesevere liver or kidney problems.
• if you havedifficulty urinating.
• if your doctor detects that you havepersistently elevated calcium levels or low potassium levels in your blood.
• if you havediabetes 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 Irbesartán/Hidroclorotiazida Aurovitas andin any of the following cases:

• if you have hadskin canceror if you develop an unexpected skin lesion during treatment. The treatment with hydrochlorothiazide, particularly 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 irbesartán/hydrochlorothiazide
• if you haveexcessive vomiting or diarrhea.
• if you havekidney problemsor if you have had akidney transplant.
• if you haveheart problems.
• if you haveliver problems.
• if you havediabetes.

• if you experiencelow 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

• if you havelupus erythematosus(also known as lupus or LES)
• if you 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)
• if you are taking any of the following blood pressure-lowering medicines:

- an angiotensin-converting enzyme inhibitor (ACE inhibitor) (e.g. enalapril, lisinopril, ramipril), particularly if you have kidney problems related to diabetes.

- aliskiren.

• if you experience a decrease in vision or eye pain in one or both eyes while taking irbesartán/hydrochlorothiazide. These may be symptoms of fluid accumulation in the eye's vascular layer (choroidal effusion) or increased eye pressure (glaucoma) and can occur within a few hours to a week after taking irbesartán/hydrochlorothiazide. 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 a higher risk of developing it. You should discontinue treatment with irbesartán/hydrochlorothiazide and seek medical attention immediately
• 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 takingirbesartán/hydrochlorothiazide,seek medical attention immediately.

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 Aurovitas”.

If you are pregnant, think you may be pregnant, or plan to become pregnant, inform your doctor. Irbesartán/hydrochlorothiazide is not recommended for use at the beginning of pregnancy, and in no case should it be administered from the third month of pregnancy because it may cause serious harm to your baby (see Pregnancy section).

You should also inform your doctor:

• if you are following alow-sodium diet.
• if you experience any of these symptoms:thirst, dry mouth, generalized weakness, feeling sleepy, muscle pain or cramps, nausea, vomiting, orrapid heartbeat, as they may indicate excessive hydrochlorothiazide effect (contained in Irbesartán/Hidroclorotiazida Aurovitas)
• if you experience an increase insensitivity to the sunwith symptoms of sunburn (such as redness, itching, swelling, blisters) that occur more quickly than usual
• if you areabout to undergo surgery(surgical intervention) orif you are to receive anesthetics.

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

Children and adolescents

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

Other medicines and Irbesartán/Hidroclorotiazida Aurovitas

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medicine.

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

Your doctor may need to modify 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 Irbesartán/Hidroclorotiazida Aurovitas” 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

medicines used to treat gout

vitamin D supplements

medicines for heart rhythm control

diabetes medicines (oral agents such as repaglinide or insulin)

carbamazepine (a medicine for epilepsy).

It is also important to inform your doctor if you are taking other blood pressure-lowering medicines, steroids, cancer medicines, painkillers, arthritis medicines, or bile acid-binding resins or cholestyramine or colestipol to reduce cholesterol in the blood.

Taking Irbesartán/Hidroclorotiazida Aurovitas with food, drinks, and alcohol

Irbesartán/Hidroclorotiazida can be taken with or without food.

Due to the hydrochlorothiazide contained in Irbesartán/Hidroclorotiazida Aurovitas, if you drink alcohol while taking this medicine, you may experience a greater sense of 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 plan to become pregnant.

Generally, your doctor will advise you to stop taking irbesartán/hydrochlorothiazide before becoming pregnant or as soon as you become pregnant and recommend taking another blood pressure-lowering medicine instead. Irbesartán/hydrochlorothiazide is not recommended for use at the beginning of pregnancy, and in no case should it be administered from the third month of pregnancy because it may cause serious harm to your baby when administered from that point onwards.

Breastfeeding

Inform your doctor if you plan to start or are breastfeeding, as Irbesartán/Hidroclorotiazida is not recommended for use during this period. Your doctor may decide to administer a more suitable treatment if you want to breastfeed, especially in newborns or premature babies.

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

It is unlikely that irbesartán/hydrochlorothiazide will affect your ability to drive vehicles or use machines. However, during hypertension treatment, you may occasionally experience dizziness or fatigue. If you experience these symptoms, speak with your doctor before driving or using machines.

Irbesartán/Hidroclorotiazida Aurovitas contains lactose

If your doctor has told you that you have a certain sugar intolerance, consult with them before taking this medicine.

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

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

Dose

The recommended dose of irbesartan/hidroclorotiazida is one or two tablets per day. In general, your doctor will prescribe irbesartan/hidroclorotiazida when previous treatments you received did not sufficiently reduce your blood pressure. Your doctor will indicate how to switch from previous treatments to irbesartan/hidroclorotiazida.

Administration Form

Irbesartan/hidroclorotiazida is administered orally.via oral.The tablets should be swallowed with a sufficient amount of liquid (e.g. a glass of water). You can take irbesartan/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 irbesartan/hidroclorotiazida until your doctor advises you otherwise.

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

If you take moreIrbesartán/Hidroclorotiazida Aurovitasthan 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, visit a Medical Center or call the Toxicology Information Service, phone 91 562 04 20, indicating the medication and the amount used. It is recommended to bring the packaging and the medication leaflet.

Children should not takeIrbesartán/Hidroclorotiazida Aurovitas

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

If you forgot to takeIrbesartán/Hidroclorotiazida Aurovitas

If you accidentally forget to take a dose, simply take your regular dose when it is due. 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, 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 irbesartan/hydrochlorothiazide and contact your doctor immediately.

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

Frequent: may affect up to 1 in 10 people.

Rare: may affect up to 1 in 100 people.

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

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

• nausea/vomiting
• urinary abnormalities
• fatigue
• dizziness (including dizziness that 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 side effects cause you problems, consult your doctor.

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

• diarrhea
• low blood pressure
• syncope
• tachycardia
• flushing
• swelling
• sexual dysfunction (alterations in sexual function)
• blood tests may show low levels of sodium and potassium in your blood.

Unknown frequency(cannot be estimated from available data):

• sudden decrease in distant vision (acute myopia).

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

Side effects since the marketing ofirbesartan/hydrochlorothiazide

Since the marketing of irbesartan/hydrochlorothiazide, some side effects have been reported. The side effects observed with unknown frequency are: headache, tinnitus, cough, alteration of taste, indigestion, joint and muscle pain, liver function alterations, kidney insufficiency, elevated levels of potassium in your blood, and allergic reactions such as skin rash, urticaria, facial swelling, lip, mouth, tongue, or throat swelling. Also, rare cases of jaundice (yellowing of the skin and/or white of the eyes) have been observed.

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 - characterized by fatigue, headaches, shortness of breath on exertion, dizziness, and paleness), and decreased platelet count (a blood cell essential for blood coagulation), and low blood sugar levelshave also been observed.

Side effects associated with hydrochlorothiazide in monotherapy:

Loss of appetite; stomach irritation; stomach cramps; constipation; jaundice (yellowing of the skin and/or white of the eyes); pancreatitis characterized by severe upper stomach pain, often with nausea and vomiting; sleep disturbances; depression; blurred vision; 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 on exertion, dizziness, and paleness; kidney disease; 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; muscle weakness and spasms; alteration of heart rhythm; reduction of blood pressure after a change in body position; swelling of salivary glands; high levels of sugar in the blood; sugar in the urine; 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), 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 hydrochlorothiazide may increase with higher doses of hydrochlorothiazide.

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 this medication after the expiration date that appears on the carton and blister packaging after CAD. The expiration date is the last day of the month indicated.

Store below 30°C.

Medicines should not be disposed of through drains or in the trash. Dispose of packaging and medications you no longer need at the SIGRE collection point at the pharmacy.Ask your pharmacist how to dispose of packaging and medications you no longer need. This will help protect the environment.

Composition ofIrbesartán/Hidroclorotiazida Aurovitas

• The active principles are irbesartan and hydrochlorothiazide. Each film-coated tablet contains 150 mg of irbesartan and 12.5 mg of hydrochlorothiazide.
• The other components are:

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

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

Appearance of the product and contents of the packaging

Film-coated tablet.

Orange-colored, biconvex, oval-shaped tablets, marked with “H 35” on one side and smooth on the other.

The tablets are available in blister-type packaging.

Packaging sizes:14 and 28 film-coated tablets.

Only some packaging sizes may be commercially available.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder:

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16-D

28036 Madrid

Spain

Responsible manufacturer:

APL Swift Services (Malta) Limited

HF26, Hal Far Industrial Estate, Hal Far

Birzebbugia, BBG 3000

Malta

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

Spain:Irbesartán/Hidroclorotiazida Aurovitas 150 mg/12.5 mg film-coated tablets EFG

Portugal:Irbesartan + Hidroclorotiazida Aurovitas

Last review date of this leaflet: September 2024

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