IRBESARTAN HYDROCHLOROTHIAZIDE ALTER 150 mg / 12.5 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the Patient

Irbesartan/Hydrochlorothiazide Alter 150 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 pack and other information

1. What is Irbesartan/Hydrochlorothiazide Alter and what is it used for
2. What you need to know before you take Irbesartan/Hydrochlorothiazide Alter
3. How to take Irbesartan/Hydrochlorothiazide Alter
4. Possible side effects
5. Storage of Irbesartan/Hydrochlorothiazide Alter

Contents of the pack and further information

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

Irbesartan/hydrochlorothiazide 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 reducing blood pressure.

Hydrochlorothiazide belongs to a group of medicines called thiazide diuretics, which increase the amount of urine excreted, reducing blood pressure.

The two active substances in irbesartan/hydrochlorothiazide 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 Alter

Do not take Irbesartan/Hydrochlorothiazide Alter

• if you are allergicto irbesartan or any of the other ingredients of this medicine (listed in section 6)
• if you are allergicto hydrochlorothiazide or to any other sulfonamide-derived medication
• if you are pregnant more than 3 months. (In any case, it is recommended to avoid taking this medicine during 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 failureand are being treated with a blood pressure-lowering medicine that contains aliskiren.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Irbesartan/Hydrochlorothiazide Alter 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 Alter
• if you have had respiratory or lung problems (such as inflammation or fluid in the lungs) after taking hydrochlorothiazide in the past. If you experience shortness of breath or severe difficulty breathing after taking Irbesartan/Hydrochlorothiazide Alter, seek medical attention immediately
• if you have excessive vomiting or diarrhea
• if you have kidney problemsor have had a kidney transplant
• if you have heart problems
• if you have liver problems
• if you have 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, which leads to sodium retention and, in turn, increased blood pressure).
• if you are taking any of the following medicines used to treat high blood pressure:
• an angiotensin-converting enzyme inhibitor (ACE inhibitor) (e.g., enalapril, lisinopril, ramipril), especially if you have kidney problems related to diabetes.
• aliskiren.

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

If you are pregnant, think you may be pregnant, or are planning to become pregnant, inform your doctor. The use of irbesartan/hydrochlorothiazide is not recommended during the first trimester of pregnancy and should not be administered from the third month of pregnancy onwards, as it may cause serious harm to your baby (see section Pregnancy).

You must 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, general weakness, feeling of sleepiness, muscle pain or cramps, nausea, vomiting, or rapid heartbeat, as they may indicate an excessive effect of hydrochlorothiazide (contained in Irbesartan/Hydrochlorothiazide Alter)
• 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 administered anesthetics,
• if you experience changes in your vision or pain in one or both eyeswhen taking irbesartan/hydrochlorothiazide. This could be a sign of fluid accumulation in the vascular layer of the eye (choroidal effusion) or the development of glaucoma, increased pressure in your eyes. You should discontinue treatment with irbesartan/hydrochlorothiazide and seek medical attention.

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

Children and adolescents

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

Taking Irbesartan/Hydrochlorothiazide Alter with other medicines

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 Alter, may have an effect on other medicines. You should not take preparations containing lithium with Irbesartan/Hydrochlorothiazide Alter 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 Alter” and “Warnings and precautions”).

You may need to have blood tests if you take:

• potassium supplements,
• salt substitutes that contain potassium,
• potassium-sparing diuretics 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 or insulins),
• carbamazepine (a medicine for the treatment of epilepsy).

It is also important to inform your doctor if you are taking: other medicines to lower your blood pressure, steroids, medicines to treat cancer, painkillers, medicines for arthritis, or cholestyramine or colestipol resins to reduce cholesterol in the blood.

Taking Irbesartan/Hydrochlorothiazide Alter with food, drinks, and alcohol

Irbesartan/hydrochlorothiazide can be taken with or without food.

Due to the hydrochlorothiazide contained in Irbesartan/Hydrochlorothiazide Alter, 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 anti-hypertensive medicine instead. The use of irbesartan/hydrochlorothiazide is not recommended during the first trimester of pregnancy and should not be administered from the third month of pregnancy onwards, 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 in women during this period. Your doctor may decide to administer a treatment that is more suitable if you wish to breastfeed, especially to newborns or premature babies.

Driving and using machines

No studies have been conducted on the ability to drive and use machines. It is unlikely that irbesartan/hydrochlorothiazide will affect your ability to drive or use machines. However, during the treatment of hypertension, dizziness or fatigue may occasionally occur. If you experience these symptoms, talk to your doctor before driving or using machines.

Irbesartan/Hydrochlorothiazide Alter contains lactose

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

3. How to take Irbesartan/Hydrochlorothiazide Alter

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

Dose

The recommended dose of irbesartan/hydrochlorothiazide is one tablet 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 indicate how to switch from previous treatments to Irbesartan/Hydrochlorothiazide Alter.

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 taking irbesartan/hydrochlorothiazide until your doctor advises you otherwise.

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

If you take more Irbesartan/Hydrochlorothiazide Alter than you should

If you accidentally take more irbesartan/hydrochlorothiazide than you should, consult your doctor or pharmacist.

In case of overdose or accidental ingestion, go to a Medical Center or call the Toxicology Information Service, phone 91 562 04 20, indicating the medicine and the amount ingested. It is recommended to bring the packaging and the leaflet of the medicine.

Children should not take Irbesartan/Hydrochlorothiazide Alter

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 Alter

If you forget to take 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 side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Some of these effects can be serious and may require medical attention.

In rare cases (may affect up to 1 in 1,000 people), cases of allergic skin 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 have any of the above symptoms or experience shortness of breath, stop taking irbesartan/hydrochlorothiazide and contact your doctor immediately.

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

Common side 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 seated 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 bother you, talk to your doctor.

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

• diarrhea
• low blood pressure
• fainting
• rapid heartbeat
• flushing
• swelling due to fluid retention (edema)
• sexual dysfunction (sexual function disorders)
• blood tests may show low sodium and potassium levels in your blood.

If any of these side effects bother you, talk to your doctor.

Side effects reported since the marketing of Irbesartan/Hydrochlorothiazide Alter

Since the marketing of irbesartan/hydrochlorothiazide, some side effects have been reported. The side effects observed with unknown frequency (frequency cannot be estimated from the available data) are: headache, ringing in the ears, cough, alteration of taste, indigestion, muscle and joint pain, liver function disorders, and kidney failure, high potassium levels in the blood, and allergic reactions such as skin rash, urticaria, swelling of the face, lips, mouth, tongue, or throat. Cases of intestinal angioedema have also been observed, with symptoms such as abdominal pain, nausea, vomiting, and diarrhea.

Rare side effects (may affect up to 1 in 1,000 people) include acute respiratory distress (symptoms include severe difficulty breathing, fever, weakness, and confusion).

Frequency not known: 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 glaucoma).

It is known that the side effects associated with hydrochlorothiazide can increase with higher doses of hydrochlorothiazide.

Reporting of side effects

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

5. Storage of Irbesartan/Hydrochlorothiazide Alter

Keep this medication out of sight and reach of children.

Do not use this medication after the expiration date shown on the packaging after "CAD". The expiration date is the last day of the month indicated.

Do not store at a temperature above 30°C.

Store in the original packaging to protect it from moisture.

Medicines should not be disposed of via wastewater or household waste. Deposit the packaging and any unused medication at the SIGRE collection point in your pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medication. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Irbesartan/Hydrochlorothiazide Alter

• The active ingredients are irbesartan and hydrochlorothiazide. Each tablet contains 150 mg of irbesartan and 12.5 mg of hydrochlorothiazide.
• The other ingredients are lactose monohydrate, microcrystalline cellulose, sodium croscarmellose, hypromellose, anhydrous colloidal silica, magnesium stearate, titanium dioxide (E171), triacetin, red iron oxide (E172), and yellow iron oxide (E172).

Appearance of the Product and Package Contents

Round, film-coated tablets, pink-salmon in color and without a score line.

The tablets are presented in blister packs containing 28 tablets.

Marketing Authorization Holder and Manufacturer

Laboratorios Alter, S.A.

C/ Mateo Inurria 30

28036 Madrid

Spain

Date of the Last Revision of this Leaflet: February 2025.

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