IRBESARTAN HYDROCHLOROTHIAZIDE ALTER 300 mg/12.5 mg FILM-COATED TABLETS

Introduction

Patient Information Leaflet

Irbesartan/Hydrochlorothiazide Alter 300 mg/12.5 mg film-coated tablets

Read the entire 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. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you experience 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

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

2 What you need to know before you take Irbesartan/Hydrochlorothiazide Alter

1. How to take Irbesartan/Hydrochlorothiazide Alter
2. Possible side effects
3. Storage of Irbesartan/Hydrochlorothiazide Alter
4. 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 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 medicine
• if you are more than 3 months pregnant. (In any case, it is recommended to avoid taking this medicine during the first trimester of 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 high levels of calcium or low levels of potassium in your blood
• if you have diabetes or kidney problemsand are being treated with a blood pressure-lowering medicine containing 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, particularly 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, leading to sodium retention and increased blood pressure).
• if you are taking any of the following medicines used to treat 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.

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. Irbesartan/hydrochlorothiazide is not recommended during the first trimester of pregnancy and must not be taken after the third month of pregnancy, 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 thirsty, dry mouth, weakness, feeling sleepy, muscle 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 occur more quickly than usual,
• if you are going to have surgery(surgical procedure) or if you are going to be given anesthetics,
• if you experience changes in your vision or pain in one or both eyeswhile taking irbesartan/hydrochlorothiazide. This could be a sign of fluid accumulation in the vascular layer of the eye (choroidal effusion) or glaucoma, increased pressure in your eyes. You should stop taking 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 given 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 interact with 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 containing 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 taking this medicine, you may experience increased dizziness when standing up, especially when getting up from a sitting or lying 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 the first trimester of pregnancy and must 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 already breastfeeding, as irbesartan/hydrochlorothiazide is not recommended for use during breastfeeding. Your doctor may decide to prescribe a different treatment that is more suitable if you want to breastfeed, especially for newborns or premature babies.

Driving and using machines

No studies have been performed 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 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 Alter contains lactose

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

3. How to take Irbesartan/Hydrochlorothiazide Alter

Follow the instructions for administration of this medicine exactly as told by your doctor. If you are unsure, 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 tell you 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. Try to take your daily dose at the same time each day. It is important that you continue taking irbesartan/hydrochlorothiazide until your doctor tells 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 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.

Rarely (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 dizziness 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, 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
• fluid retention (edema)
• sexual dysfunction (sexual function disorders)
• blood tests may show low levels of sodium and potassium 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, altered taste, indigestion, muscle and joint pain, liver function disorders, kidney failure, high levels of potassium 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.

Rarely (may affect up to 1 in 1,000 people), cases of acute respiratory distress (symptoms include severe difficulty breathing, fever, weakness, and confusion) have been reported.

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.

Side effects associated only with irbesartan

In addition to the side effects described above, chest pain and decreased platelet count (a blood cell essential for blood clotting) have 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 whites of the eyes); pancreatitis characterized by severe stomach pain, often with nausea and vomiting; sleep disorders; depression; blurred vision; low white blood cell count, which can lead to frequent infections, fever; decreased platelet count (a blood cell essential for blood clotting), decreased red blood cell count (anemia) characterized by fatigue, headaches, shortness of breath when exercising, dizziness, and paleness; kidney disease; lung disorders, including pneumonia or fluid accumulation in the lungs; increased sensitivity of the skin 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; heart rhythm disorders; low blood pressure after changing body position; swelling of the salivary glands; high blood sugar levels; sugar in the urine; increased levels of certain blood fats; high levels of uric acid in the blood, which can cause gout.

Very rare: 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).

Reporting of side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects 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 medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton after "CAD". The expiry date is the last day of the month indicated.

Do not store above 30°C.

Store in the original packaging to protect from moisture.

Medicines should not be disposed of via wastewater or household waste. Dispose of the packaging and any unused medicine in the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medicine. 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 300 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

Film-coated, oblong tablets, yellow-ochre 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 up-to-date information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/.