Leaflet: Information for the user

Irbesartán/Hidroclorotiazida Kern Pharma 300 mg/12.5 mg film-coated tablets

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 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 Irbesartán/Hidroclorotiazida Kern Pharma is and what it is used for

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

3. How to take Irbesartán/Hidroclorotiazida Kern Pharma

4. Possible side effects

5. Storage of Irbesartán/Hidroclorotiazida Kern Pharma

6. Contents of the pack and additional information

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

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

Hydrochlorothiazide 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 Kern Pharma act together to achieve a reduction in blood pressure greater than that obtained with each one separately.

Irbesartán/Hidroclorotiazida Kern Pharma is used to treat high blood pressure, when treatment with irbesartan alone or hydrochlorothiazide alone does not provide adequate control of your blood pressure.

Do not takeIrbesartán/Hidroclorotiazida Kern Pharma

• if you areallergic(hypersensitive) to irbesartán, or to any of the other components of Irbesartán/Hidroclorotiazida Kern Pharma.
• if you areallergic(hypersensitive) to hydrochlorothiazide 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 calcium levels or low potassium levels in your blood
• if you have diabetes or kidney insufficiency and are being treated with a medication to lower blood pressure that contains aliskiren.

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

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting to take Irbesartán/Hidroclorotiazida Kern Pharma.

Inform your doctorin any of the following cases:

• if you haveexcessive vomiting or diarrhea
• if you havekidney problemsor if you have akidney 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 production of excessive aldosterone hormone, 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 converting enzyme inhibitor (ACEI) (for example enalapril, lisinopril, ramipril), particularly if you have kidney problems related to diabetes.

-aliskirén.

• 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 cancerand lips (non-melanoma skin cancer). Protect your skin from sun exposure and UV rays while taking Irbesartán/Hidroclorotiazida Kern Pharma.
• if you experience adecrease in vision or eye pain, which may be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or increased eye pressure and may occur within a few hours to a week after taking Irbesartán/Hidroclorotiazida Kern Pharma.
• 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 shortness of breath or severe difficulty breathing after taking Irbesartán/Hidroclorotiazida Kern Pharma, seek medical attention immediately.

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 Irbesartan/Hidroclorotiazida Kern Pharma”.

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

If you are pregnant, if you suspect you may be pregnantor if you plan to become pregnant, you must inform your doctor. It is generally recommended that you stop taking Irbesartán/Hidroclorotiazida Kern Pharma before becoming pregnant or as soon as you become pregnant and your doctor will recommend taking another antihypertensive medication instead. Irbesartán/Hidroclorotiazida Kern Pharma should not be used at the beginning of pregnancy and should not be administered at all from 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, feeling sleepy, muscle pain or cramps, nausea, vomiting, or rapid heartbeat, which may indicate excessive hydrochlorothiazide effect (contained in Irbesartán/Hidroclorotiazida Kern Pharma).
• if you experience an increase insensitivity to the sunwith symptoms of sunburn (such as redness, itching, swelling, blisters) that occur more quickly than usual.
• ifyou are to be operated(surgical intervention) orif you are to receive anesthetics.

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

Use of Irbesartán/Hidroclorotiazida Kern Pharma with other medications

Inform your doctor or pharmacist if you are using or have recently used other medications, including those purchased without a prescription.

Diuretics, such as hydrochlorothiazide contained in Irbesartán/Hidroclorotiazida Kern Pharma, may affect other medications. Do not take with Irbesartán/Hidroclorotiazida Kern Pharma 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 ACEI or aliskirén (see also the information under the headings “Do not take Irbesartan/Hidroclorotiazida Kern Pharma” 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).

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 Kern Pharma with food and beverages

Irbesartán/Hidroclorotiazida Kern Pharma can be taken with or without food.

Due to the hydrochlorothiazide contained in Irbesartán/Hidroclorotiazida Kern Pharma, 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 and lactation

Pregnancy

You must inform your doctor if you are pregnant, if you suspect you may be pregnantor if you plan to become pregnant. It is generally recommended that you stop taking Irbesartán/Hidroclorotiazida Kern Pharma before becoming pregnant or as soon as you become pregnant and your doctor will recommend taking another antihypertensive medication instead. Irbesartán/Hidroclorotiazida Kern Pharma should not be used at the beginning of pregnancy and should not be administered at all from the third month of pregnancy as it may cause serious harm to your baby (see Pregnancy section).

Lactation

You must inform your doctor if you plan to initiate or are in the lactation period as it is not recommended to administer Irbesartán/Hidroclorotiazida Kern Pharma to women during this period. Your doctor may decide to administer a more suitable treatment if you want to breastfeed, especially in newborns or premature babies.

Driving and operating machines

No studies have been conducted on the ability to drive and operate machines. It is unlikely that Irbesartán/Hidroclorotiazida Kern Pharma will affect your ability to drive vehicles or operate machines. However, during hypertension treatment, occasional dizziness or fatigue may occur. If you experience these symptoms, consult your doctor before driving or operating machines.

Important information about some of the components of Irbesartán/Hidroclorotiazida Kern Pharma Irbesartán/Hidroclorotiazida Kern Pharma contains lactose. If your doctor has indicated that you have an intolerance to certain sugars (e.g. lactose), consult with him before taking this medication.

Follow exactly the administration instructions for Irbesartán/Hidroclorotiazida Kern Pharma as indicated by your doctor. Consult your doctor or pharmacist if you have any doubts.

Dose

The normal dose of Irbesartán/Hidroclorotiazida Kern Pharma is one tablet per day. In general, your doctor will prescribe Irbesartán/Hidroclorotiazida Kern Pharma 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 Kern Pharma.

Administration Form

Irbesartán/Hidroclorotiazida Kern Pharma is administered byoral route. The tablets should be swallowed with a sufficient amount of liquid (e.g., a glass of water). You can take Irbesartán/Hidroclorotiazida Kern Pharma 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 Irbesartán/Hidroclorotiazida Kern Pharma 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 Kern Pharma than you should

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 used. It is recommended to bring the packaging and the medication leaflet.

Children should not take Irbesartán/Hidroclorotiazida Kern Pharma

Irbesartán/Hidroclorotiazida Kern Pharma 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 Irbesartán/Hidroclorotiazida Kern Pharma

If you accidentally 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 product, ask your doctor or pharmacist.

Like all medications, Irbesartán/Hidroclorotiazida Kern Pharma may cause side effects, although not everyone will experience them.

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

Rarely, cases of skin allergic reactions (skin rash, urticaria) have been reported in patients treated with irbesartán, as well as localized inflammation in the face, lips, and/or tongue.If you experience any of the above symptoms or have difficulty breathing, stop taking Irbesartán/Hidroclorotiazida Kern Pharma and contact your doctor immediately.

The side effects reported in clinical studies for patients treated with Irbesartán/Hidroclorotiazida Kern Pharma were:

Frequent side effects(affect between 1 and 10 of every 100 patients):

• 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(affect less than 1 of every 1,000 patients)

- Intestinal angioedema: swelling in the intestine that presents symptoms such as abdominal pain, nausea, vomiting, and diarrhea.

As with all combinations of active ingredients, it cannot be ruled out that side effects associated with each component may occur.

Side effects associated only with irbesartán

Rare side effects(affect less than 1 of every 1,000 patients)

-Intestinal angioedema: swelling in the intestine that presents symptoms such as abdominal pain, nausea, vomiting, and diarrhea.

In addition to the side effects described above, chest pain and a reduction in the number of platelets have also been observed.

Side effects associated with hidroclorotiazida 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; 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]; low white blood cell count, which may lead to frequent infections, fever; decreased platelet count (essential blood cells for blood coagulation), decreased red blood cell count (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 on 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; alteration of heart rhythm; reduction of blood pressure after a change in body position; salivary gland swelling; high blood sugar levels; sugar in the urine; increases in some types of blood fats; high levels of uric acid in the blood, which may cause gout,skin and lip cancer (non-melanoma skin cancer), acute respiratory distress (symptoms include severe shortness of breath, fever, weakness, and confusion).

It is known that side effects associated with hidroclorotiazida may increase with higher doses of hidroclorotiazida.

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 Vigilance of Medications for Human Use:www.notificaRAM.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

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

Do not use Irbesartan/Hydrochlorothiazide Kern Pharma after the expiration date that appears on the carton and in the blister 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 light.

Medicines should not be disposed of through drains or in the trash. Deposit the containers and medicines 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 medicines you no longer need.By doing so, you will help protect the environment.

Composition of Irbesartán/Hidroclorotiazida Kern Pharma

-The active principles are irbesartan and hydrochlorothiazide. Each film-coated tablet of Irbesartán/Hidroclorotiazida Kern Pharma 300 mg/12.5 mg contains 300 mg of irbesartan and 12.5 mg of hydrochlorothiazide.

-The other components are lactose monohydrate, microcrystalline cellulose, sodium croscarmellose, anhydrous colloidal silica, povidone, and stearate and sodium fumarate, hypromellose, titanium dioxide, macrogol, iron oxide red and yellow.

Appearance of the product and contents of the package

The film-coated tablets of Irbesartán/Hidroclorotiazida Kern Pharma 300/12.5 mg are pink, round, and have a single scored face.

Irbesartán/Hidroclorotiazida Kern Pharma 300/12.5 mg is available in blister packs containing 28 tablets.

Holder of the marketing authorization and responsible for manufacturing

Kern Pharma, S.L.

Venus, 72 – Pol. Ind.Colón II

08228 Terrassa - Barcelona

Spain

Last review date of this package leaflet: February 2025

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