Irbesartan/hydrochlorothiazide Alter 300 mg/12.5 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Irbesartan/Hydrochlorothiazide Alter 300 mg/12.5 mg tablets EFG

Read the entire 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 questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Contents of the leaflet

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

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

3. How to take Irbesartan/Hydrochlorothiazide Alter

4. Possible adverse effects

5. How to store Irbesartan/Hydrochlorothiazide Alter

6. Contents of the pack and other 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 the blood vessels, causing them to constrict. This leads to an increase in blood pressure. Irbesartan blocks 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, which lower blood pressure by increasing the amount of urine produced.

The two active substances in irbesartan/hydrochlorothiazide work together to achieve a greater reduction in blood pressure than either of them alone.

Irbesartan/hydrochlorothiazide is used to treat high blood pressure when treatment with irbesartan alone or hydrochlorothiazide alone does not provide adequate control of blood pressure.

2. What you need to know before taking Irbesartán/Hidroclorotiazida Alter

Do not take Irbesartán/Hidroclorotiazida Alter

• 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 this medicine also during the early months of 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 calcium levels or low potassium levels in the blood
• if you have diabetes or renal insufficiency and are being treated with an antihypertensive medicine containing aliskiren.

Warnings and precautions

Talk to your doctor or pharmacist before starting to take Irbesartán/Hidroclorotiazida 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 non-melanoma skin cancer and lip cancer. Protect your skin from exposure to sunlight and UV rays while taking Irbesartán/Hidroclorotiazida Alter.
• if you have previously experienced breathing or lung problems (such as inflammation or fluid in the lungs) after taking hydrochlorothiazide. If you develop shortness of breath or severe difficulty breathing after taking Irbesartán/Hidroclorotiazida Alter, seek medical attention immediately.
• if you have excessive vomiting or diarrhea
• if you have kidney disorders or have had a kidney transplant
• if you have heart disorders
• if you have liver disorders
• if you have diabetes
• if you have 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, consequently, 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.

Talk to your doctor if you experience abdominal pain, nausea, vomiting, or diarrhea after taking Irbesartán/Hidroclorotiazida Alter. Your doctor will decide whether to continue treatment. Do not stop taking Irbesartán/Hidroclorotiazida Alter as monotherapy.

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 Irbesartán/Hidroclorotiazida Alter”.

If you are pregnant, suspect you may be pregnant, or plan to become pregnant, you must inform your doctor. Irbesartán/hydrochlorothiazide is not recommended during the first trimester of pregnancy and must not be used from the third month of pregnancy onwards, 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 signs: thirst, 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 Irbesartán/Hidroclorotiazida Alter)
• if you experience increased skin sensitivity to sunlight with sunburn symptoms (such as redness, itching, swelling, blisters) occurring more quickly than normal,
• if you are scheduled for surgery or if you will receive anesthetics,
• if you experience changes in vision or pain in one or both eyes while taking irbesartán/hydrochlorothiazide. This could be a sign of fluid accumulation in the vascular layer of the eye (choroidal effusion) or development of glaucoma, increased pressure in your eyes. You should stop treatment with irbesartán/hydrochlorothiazide and seek medical attention.

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

Children and adolescents

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

Taking Irbesartán/Hidroclorotiazida Alter with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

Diuretics such as hydrochlorothiazide contained in Irbesartán/Hidroclorotiazida Alter may interact with other medicines. You must not take lithium-containing preparations together with Irbesartán/Hidroclorotiazida Alter without medical 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 information under the headings “Do not take Irbesartán/Hidroclorotiazida Alter” and “Warnings and precautions”).

You may need blood tests if you take:

• 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 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 Irbesartán/Hidroclorotiazida Alter with food, drinks, and alcohol

Irbesartán/hydrochlorothiazide can be taken with or without food.

Due to the hydrochlorothiazide contained in Irbesartán/Hidroclorotiazida Alter, drinking alcohol while on this medicine may increase the sensation of dizziness upon standing, especially when 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. Generally, your doctor will advise you to stop taking irbesartán/hydrochlorothiazide before becoming pregnant or as soon as pregnancy is confirmed, and will recommend an alternative antihypertensive medicine. Irbesartán/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 time.

Breastfeeding

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

Driving and using machines

No studies on the ability to drive and use machines have been conducted. It is unlikely that irbesartán/hydrochlorothiazida affects your ability to drive vehicles or operate machinery. However, during treatment for hypertension, dizziness or fatigue may occasionally occur. If you experience these symptoms, talk to your doctor before driving or using machinery.

Irbesartán/Hidroclorotiazida Alter contains lactose

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

3. How to take Irbesartan/Hydrochlorothiazide Alter

Follow exactly the instructions for use provided by your doctor. If in doubt, consult your doctor or pharmacist again.

Dosage

The recommended dose of irbesartan/hydrochlorothiazide is one tablet daily. In general, 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 Alter.

Administration method

Irbesartan/hydrochlorothiazide is administered orally. Tablets should be swallowed with sufficient liquid (e.g. a glass of water). You may 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 advises otherwise.

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 at telephone number 91 562 04 20, indicating the medication and the amount ingested. It is recommended to bring the medication packaging and leaflet.

Children must not take Irbesartan/Hydrochlorothiazide Alter

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 Irbesartan/Hydrochlorothiazide Alter

If you forget to take a dose, simply take your next dose at the usual time. Do not take a double dose to make up for forgotten 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 will experience them.

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

Rarely (may affect up to 1 in 1,000 people), 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.

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
• abnormalities in urination
• fatigue
• dizziness (including dizziness upon 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 (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
• flushing
• swelling due to fluid retention (edema)
• sexual dysfunction (sexual performance disorders)
• blood tests may show low levels of sodium and potassium in your blood.

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

Adverse effects reported since marketing of Irbesartan/Hydrochlorothiazide Alter

Since the marketing of irbesartan/hydrochlorothiazide, some adverse effects have been reported. Adverse effects observed with unknown frequency (frequency cannot be estimated from available data) are: headache, tinnitus, cough, altered taste, indigestion, joint and muscle pain, liver function abnormalities and 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 (uncommon, may affect up to 1 in 100 people).

Adverse effects observed with rare frequency (may affect up to 1 in 1,000 people) are intestinal angioedema: swelling in the intestine presenting symptoms such as abdominal pain, nausea, vomiting, and diarrhea.

As with all fixed 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 and decreased platelet count (a blood cell essential for blood clotting) have also been observed.

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 characterized 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 (anemia) characterized by fatigue, headaches, 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 characterized 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; irregular heart rhythm; drop in blood pressure after a change in 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: Acute breathing difficulty (symptoms include severe shortness of breath, fever, weakness, and confusion).

Frequency not known: Skin and lip cancer (non-melanoma skin carcinoma); 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, pharmacist, or nurse, 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 Alter

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

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

Do not store above 30°C.

Keep in the original packaging to protect from moisture.

Medicines should not be disposed of via wastewater or household waste. Dispose of unused containers and medicines at the SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to properly dispose of unused containers and medicines. This will help protect the environment.

6. Contents of the pack and other information

Composition of Irbesartan/Hydrochlorothiazide Alter

• The active substances are irbesartan and hydrochlorothiazide. Each tablet contains 300 mg of irbesartan and 12.5 mg of hydrochlorothiazide.
• The other components are monohydrate lactose, 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 contents of the container

Oblong, film-coated tablets, yellowish in color and without a break 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 most recent review of this leaflet: February 2025.

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