Patient Information Leaflet

Irbesartán/Hidroclorotiazida Alter 300 mg/12.5 mg Tablets EFG

Read this 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 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 is Irbesartán/Hidroclorotiazida Alter and what is it used for

2What you need to know before starting to take Irbesartán/Hidroclorotiazida Alter

3.How to take Irbesartán/Hidroclorotiazida Alter

4.Possible side effects

5.Storage of Irbesartán/Hidroclorotiazida Alter

6.Contents of the pack and additional information

Irbesartán/hidroclorotiazida is an association of two active principles, irbesartán and hidroclorotiazida.

Irbesartán belongs to the 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. Irbesartán prevents the binding of angiotensin-II to these receptors, relaxing blood vessels and reducing blood pressure.

Hidroclorotiazida belongs to the group of medications called thiazide diuretics that increase the amount of urine eliminated, reducing blood pressure.

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

Irbesartán/hidroclorotiazida is used to treat high blood pressure, when treatment with only irbesartán or only hidroclorotiazida does not provide adequate control of your blood pressure.

Do not take Irbesartán/Hidroclorotiazida Alter

• if you areallergicto irbesartán or to any of the other components of this medication (listed in section 6)
• if you areallergicto hidroclorotiazida or to any other medication derived from sulfonamides
• if you aremore than 3 months pregnant. (In any case, it is better to avoid taking this medication also 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 levels of calcium or low levels of potassium in the blood
• if you havediabetes or kidney insufficiencyand are being treated with a medication to lower blood pressure that contains aliskirén.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Irbesartán/Hidroclorotiazida Alter andin any of the following cases:

• if you have had skin cancer or if you develop an unexpected skin lesion during treatment. The treatment with hidroclorotiazida, particularly its long-term use at high doses, may increase the risk of certain types of skin cancer and lip cancer (non-melanoma skin cancer). Protect your skin from sun exposure and UV rays while taking Irbesartán/Hidroclorotiazida Alter.
• ifyou have had respiratory or pulmonary problems (such as inflammation or fluid in the lungs) after taking hidroclorotiazida in the past. If you experience severe shortness of breath or difficulty breathing after taking Irbesartán/Hidroclorotiazida Alter, seek medical attention immediately.
• if you haveexcessive vomiting or diarrhea
• if you havekidney problemsor have had a kidney transplant
• if you haveheart problems
• if you haveliver problems
• if you havediabetes
• if you havelupus erythematosus(also known as lupus or LES)
• if you haveprimary aldosteronism(a condition related to the excessive production of the hormone aldosterona, which causes sodium retention and, in turn, an increase in blood pressure).
• if you are taking any of the following medications used to treat high blood pressure (hypertension):
• a renin-angiotensin-aldosterone system (RAAS) inhibitor (for example enalapril, lisinopril, ramipril), particularly if you have kidney problems related to diabetes.
• aliskirén.

Consult 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 in monotherapy.

Your doctor may monitor your renal function, blood pressure, and electrolyte levels (such as potassium) at regular intervals.

See also the information under the heading “Do not take Irbesartán/Hidroclorotiazida Alter”.

If you are pregnant, if you suspect you may beor if you plan to become pregnant, you must inform your doctor. Irbesartán/hidroclorotiazida is not recommended for use at the beginning of pregnancy (first 3 months) and should not be administered after the third month of pregnancy, as it may cause serious harm to your baby (see Pregnancy section).

You must also inform your doctor:

• if you are following alow-sodium diet
• if you experience any of the following symptoms:thirst, dry mouth, generalized weakness, drowsiness, muscle pain or cramps, nausea, vomiting, or rapid heartbeat, which may indicate excessive hidroclorotiazida effect (contained in Irbesartán/Hidroclorotiazida Alter)
• 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 are to be operated(surgical intervention) orif you are to receive anesthetics,
• if you experiencechanges in vision or eye painwhile taking irbesartán/hidroclorotiazida. 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 must interrupt treatment with irbesartán/hidroclorotiazida and seek medical attention.

The hidroclorotiazida contained in this medication may cause positive results in doping control.

Children and adolescents

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

Taking Irbesartán/Hidroclorotiazida Alter with other medications

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication.

Diuretics, such as the hidroclorotiazida contained in Irbesartán/Hidroclorotiazida Alter, may affect other medications. Do not take with Irbesartán/Hidroclorotiazida Alter 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 (ACE) inhibitor or aliskirén (see also the information under the headings “Do not take Irbesartán/Hidroclorotiazida Alter” and “Warnings and precautions”).

You may need to have blood tests if you take:

• potassium supplements,
• sodium substitutes containing potassium,
• potassium-sparing medications or other diuretics (tablets that increase urine production),
• some laxatives,
• medications used to treat gout,
• vitamin D supplements,
• medications to control heart rhythm,
• diabetes medications (oral agents or insulin),
• carbamazepine (a medication for epilepsy treatment).

You should also inform your doctor if you are taking: other medications to lower your blood pressure, steroids, cancer medications, analgesics, medications for arthritis, or bile acid-binding resins (cholestyramine or colestipol) to reduce cholesterol in the blood.

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

Irbesartán/hidroclorotiazida can be taken with or without food.

Due to the hidroclorotiazida contained in Irbesartán/Hidroclorotiazida Alter, if you drink alcohol while taking this medication, you may experience a greater sensation of dizziness when standing up, especially when getting up from a seated position.

Pregnancy, breastfeeding, and fertility

Pregnancy

You must inform your doctor if you are pregnant, if you suspect you may beor if you plan to become pregnant. Your doctor will usually advise you to stop taking irbesartán/hidroclorotiazida before becoming pregnant or as soon as you become pregnant and recommend taking another antihypertensive medication instead. Irbesartán/hidroclorotiazida is not recommended for use at the beginning of pregnancy and should not be administered after the third month of pregnancy, as it may cause serious harm to your baby when administered from that point on.

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 for newborns or premature babies.

Driving and operating machinery

No studies have been conducted on the ability to drive and operate machinery. It is unlikely that irbesartán/hidroclorotiazida will affect your ability to drive vehicles or operate machinery. However, during hypertension treatment, you may occasionally experience dizziness or fatigue. If you experience these symptoms, speak with your doctor before driving or operating machinery.

Irbesartán/Hidroclorotiazida Alter contains lactose

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

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 tablet 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 Irbesartán/Hidroclorotiazida Alter.

Administration Form

Irbesartan/hidroclorotiazida is administered byoral route. 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 more Irbesartán/Hidroclorotiazida Alter than you should

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

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

Children should not take Irbesartán/Hidroclorotiazida Alter

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 take Irbesartán/Hidroclorotiazida Alter

If you forget to take a dose, simply take your regular dose when it is due next. 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 may cause side effects, although not everyone will experience them.

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

In rare cases (may affect up to 1 in 1,000 people), cases of 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 have any of the previous 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:

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

• Nausea/vomiting
• Urination abnormalities
• 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 (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
• Fainting
• Tachycardia
• Redness
• Swelling due to fluid retention (edema)
• Sexual dysfunction (alterations in sexual function)
• Blood tests may show low levels of sodium and potassium in your blood.

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

Side effects since the commercialization of Irbesartan/Hidrochlorothiazide Alter

Since the commercialization of irbesartan/hydrochlorothiazide, some side effects have been reported. The side effects observed with unknown frequency (the frequency cannot be estimated from the available data) are:Headache, buzzing in the ears, 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, cases of jaundice (yellowing of the skin and/or white of the eyes) have been observed in rare cases (may affect up to 1 in 100 people).

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

As with all combinations of two active principles, the side effects associated with each component cannot be excluded.

Side effects associated only with irbesartan

In addition to theside effectsdescribed above, chest pain anddecreasein the number of platelets(an essential blood cell for blood coagulation) 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 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; decrease in the number of platelets (essential blood cells for blood coagulation), decrease in the number of red blood cells (anemia) characterized by fatigue, headaches, shortness of breath during exercise, dizziness, and paleness; kidney disease; pulmonary alterations including pneumonia or fluid accumulation in the lungs; increased skin sensitivity to the sun; inflammation of blood vessels; a skin disease characterized by peeling of the skin all over the body; cutaneous lupus erythematosus, 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:Acute respiratory distress (signs include severe difficulty breathing, fever, weakness, and confusion).

Unknown frequency: Skin and lip cancer (non-melanoma skin cancer); decrease in 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, pharmacist, or nurse, 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 packaging after “CAD”. The expiration date is the last day of the month indicated.

Do not store above 30°C.

Store in the original packaging to protect it from moisture.

Medications should not be disposed of through drains or in the trash. Deposit the containers and medications you no longer need at the SIGRE collection point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medications you no longer need. By doing so, you will help protect the environment.

Composition of Irbesartán/Hidroclorotiazida Alter

• The active principles are irbesartan and hydrochlorothiazide. Each tablet contains 300 mg of irbesartan and 12.5 mg of hydrochlorothiazide.
• The other components are lactose monohydrate, microcrystalline cellulose, sodium croscarmellose, hypromellose, anhydrous colloidal silica, magnesium stearate, titanium dioxide (E171), triacetin, iron oxide red (E172), and iron oxide yellow (E172).

Appearance of the product and contents of the packaging

Coated tablets, oblong in shape, yellow ochre in color, and without a groove.

The tablets are presented in blister-type packaging with 28 tablets.

Holder of the marketing authorization and responsible for manufacturing

Laboratorios Alter, S.A.

C/ Mateo Inurria 30

28036 Madrid

Spain

Last review date of this leaflet: February 2025.

The detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/.