Irbesartan/hydrochlorothiazide Kern Pharma 150 mg/12.5 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the user

Irbesartan/Hydrochlorothiazide Kern Pharma 150 mg/12.5 mg film-coated tablets EFG

Read the entire 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, and you should not give it to others, even if they have the same symptoms, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Leaflet contents:

1. What Irbesartan/Hydrochlorothiazide Kern Pharma is and what it is used for
2. What you need to know before taking Irbesartan/Hydrochlorothiazide Kern Pharma
3. How to take Irbesartan/Hydrochlorothiazide Kern Pharma
4. Possible side effects
5. How to store Irbesartan/Hydrochlorothiazide Kern Pharma
6. Contents of the pack and other information

1. What Irbesartán/Hidroclorotiazida Kern Pharma is and what it is used for

Irbesartán/Hidroclorotiazida Kern Pharma 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 on blood vessels, causing them to constrict. This leads to an increase in blood pressure. Irbesartan blocks angiotensin-II from binding to these receptors, relaxing blood vessels and thereby reducing blood pressure.

Hydrochlorothiazide belongs to a group of medicines (called thiazide diuretics) that lower blood pressure by increasing the amount of urine produced.

The two active substances in Irbesartán/Hidroclorotiazida Kern Pharma work together to achieve a greater reduction in blood pressure than either one alone.

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.

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

Do not take Irbesartan/Hydrochlorothiazide Kern Pharma

• if you are allergic (hypersensitive) to irbesartan or to any of the other ingredients of Irbesartan/Hydrochlorothiazide Kern Pharma.
• if you are allergic (hypersensitive) 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 early 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 levels of calcium or low levels of potassium in your blood.
• if you have diabetes or renal impairment and are being treated with a blood pressure-lowering medicine containing aliskiren.

Irbesartan/Hydrochlorothiazide Kern Pharma must not be given to children and adolescents (under 18 years of age).

Warnings and precautions

Talk to your doctor, pharmacist, or nurse before taking Irbesartan/Hydrochlorothiazide Kern Pharma.

Tell your doctor if any of the following apply to you:

• if you have excessive vomiting or diarrhea.

• if you have kidney problems or have had a kidney transplant.

• if you have heart problems.

• if you have liver problems.

• 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.

• if you have had skin cancer or develop an unexpected skin lesion during treatment. Treatment with hydrochlorothiazide, especially 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 sun exposure and UV radiation while taking Irbesartan/Hydrochlorothiazide Kern Pharma.

• If you experience vision loss or eye pain, these could be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or increased intraocular pressure, which may occur within hours to one week after taking Irbesartan/Hydrochlorothiazide Kern Pharma.

• If you have previously experienced respiratory or pulmonary problems (such as inflammation or fluid in the lungs) after taking hydrochlorothiazide. If you develop severe shortness of breath or difficulty breathing after taking Irbesartan/Hydrochlorothiazide Kern Pharma, contact your doctor immediately.

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 Kern Pharma”.

Consult your doctor if you experience abdominal pain, nausea, vomiting, or diarrhea after taking Irbesartan/Hydrochlorothiazide Kern Pharma. Your doctor will decide whether to continue treatment. Do not stop taking Irbesartan/Hydrochlorothiazide Kern Pharma without medical advice.

If you are pregnant, suspect you may be pregnant, or plan to become pregnant, inform your doctor. Use of Irbesartan/Hydrochlorothiazide Kern Pharma is not recommended during early pregnancy (first 3 months), and it must not be used from the third month of pregnancy onward, as it may cause serious harm to your baby (see Pregnancy section).

You should also inform your doctor:

• if you are on a low-salt diet.
• if you experience any of the following symptoms: 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 Irbesartan/Hydrochlorothiazide Kern Pharma).
• if you experience increased skin sensitivity to sunlight with symptoms of sunburn (such as redness, itching, swelling, blisters) occurring more quickly than usual.
• if you are going to have surgery or will be given anesthetics.

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

Use of Irbesartan/Hydrochlorothiazide Kern Pharma with other medicines

Inform your doctor or pharmacist if you are currently using, have recently used, or might use any other medicines, including those obtained without a prescription.

Diuretics such as hydrochlorothiazide contained in Irbesartan/Hydrochlorothiazide Kern Pharma may interact with other medicines. You must not take lithium-containing preparations together with Irbesartan/Hydrochlorothiazide Kern Pharma without medical supervision.

Your doctor may need to adjust your dose and/or take additional precautions:

If you are taking an angiotensin-converting enzyme inhibitor (ACE inhibitor) or aliskiren (see also information under the headings “Do not take Irbesartan/Hydrochlorothiazide Kern Pharma” 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 insulins).

It is also important to inform your doctor if you are taking other blood pressure-lowering medicines, steroids, cancer treatments, painkillers, arthritis medicines, or cholestyramine or colestipol resins to lower blood cholesterol.

Taking Irbesartan/Hydrochlorothiazide Kern Pharma with food and drink

Irbesartan/Hydrochlorothiazide Kern Pharma can be taken with or without food.

Due to the hydrochlorothiazide contained in Irbesartan/Hydrochlorothiazide Kern Pharma, drinking alcohol during treatment may increase the likelihood of dizziness upon standing, especially when rising from a sitting position.

Pregnancy and breastfeeding

Pregnancy

Inform your doctor if you are pregnant, suspect you may be pregnant, or plan to become pregnant. Your doctor will generally advise you to stop taking Irbesartan/Hydrochlorothiazide Kern Pharma before becoming pregnant or as soon as pregnancy is confirmed, and will recommend an alternative antihypertensive medicine. Irbesartan/Hydrochlorothiazide Kern Pharma is not recommended during early pregnancy and must not be used from the third month of pregnancy onward, as it may cause serious harm to your baby when used from that stage.

Breast-feeding

Inform your doctor if you are planning to breastfeed or are currently breastfeeding, as Irbesartan/Hydrochlorothiazide Kern Pharma is not recommended for women during this period. Your doctor may choose a treatment more suitable for breastfeeding, especially if feeding a newborn or premature infant.

Driving and using machines

No studies on the ability to drive and operate machinery have been performed. It is unlikely that Irbesartan/Hydrochlorothiazide Kern Pharma will affect your ability to drive or use machines. However, dizziness or fatigue may occasionally occur during antihypertensive treatment. If you experience these symptoms, speak with your doctor before driving or operating machinery.

Important information on some of the ingredients of Irbesartan/Hydrochlorothiazide Kern Pharma Irbesartan/Hydrochlorothiazide Kern Pharma contains lactose. If your doctor has diagnosed you with an intolerance to certain sugars (e.g., lactose), consult with your doctor before taking this medicine.

3. How to take Irbesartan/Hydrochlorothiazide Kern Pharma

Follow exactly the administration instructions for Irbesartan/Hydrochlorothiazide Kern Pharma given by your doctor. Consult your doctor or pharmacist if you have any doubts.

Dosage

The usual dose of Irbesartan/Hydrochlorothiazide Kern Pharma is one or two tablets per day. In general, your doctor will prescribe Irbesartan/Hydrochlorothiazide Kern Pharma 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 Kern Pharma.

Method of administration

Irbesartan/Hydrochlorothiazide Kern Pharma is administered orally. The tablets should be swallowed with a sufficient amount of liquid (e.g., a glass of water). You may take Irbesartan/Hydrochlorothiazide Kern Pharma 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 Kern Pharma unless 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 Kern Pharma than you should

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

Children must not take Irbesartan/Hydrochlorothiazide Kern Pharma

Irbesartan/Hydrochlorothiazide Kern Pharma 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 Kern Pharma

If you accidentally miss a dose, simply take your next dose at the usual time. Do not take a double dose to make up for missed doses.

If you have any further questions about the use of this product, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, Irbesartan/Hydrochlorothiazide Kern Pharma can cause adverse effects, although not everyone experiences them.

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

Rarely, 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 Kern Pharma and contact your doctor immediately.

Adverse effects reported in clinical studies for patients treated with Irbesartan/Hydrochlorothiazide Kern Pharma were:

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

• nausea/vomiting
• urinary abnormalities
• 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 (affect between 1 and 10 out of every 1,000 patients):

• diarrhea
• low blood pressure
• fainting
• tachycardia
• flushing
• 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 adverse effects cause you problems, consult your doctor.

Adverse effects reported since marketing of Irbesartan/Hydrochlorothiazide

The frequency of these effects is unknown. These adverse effects are: headache, tinnitus, cough, taste disturbance, 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 adverse effects (affect fewer than 1 out of every 1,000 patients)

• Intestinal angioedema: swelling in the intestine presenting symptoms such as abdominal pain, nausea, vomiting and diarrhea.

As with all combinations of two active substances, adverse effects associated with each component cannot be ruled out.

Adverse effects associated solely with irbesartan

Rare adverse effects (affect fewer than 1 out of every 1,000 patients)

• Intestinal angioedema: swelling in the intestine presenting symptoms such as abdominal pain, nausea, vomiting and diarrhea.

In addition to the adverse effects described above, chest pain and reduction in platelet count 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; decreased vision or eye pain due to elevated pressure [possible signs of fluid accumulation in the vascular layer of the eye (choroidal effusion) or acute angle-closure glaucoma]; lack of white blood cells, which may lead to frequent infections, fever; reduction in platelet count (blood cells essential for blood clotting), reduction in red blood cell count (anemia) characterized by tiredness, headaches, shortness of breath during exercise, dizziness and paleness; kidney disease; lung disorders including pneumonia or fluid accumulation in the lungs; increased skin sensitivity to sunlight; inflammation of blood vessels; a skin disease 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; weakness and muscle spasms; irregular heartbeat; drop in blood pressure after changing body position; swelling of the salivary glands; high blood sugar levels; sugar in urine; increases in certain 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 breathing difficulty (signs include severe shortness of breath, fever, weakness and confusion).

It is known that adverse effects associated with hydrochlorothiazide may increase with higher doses of hydrochlorothiazide.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Irbesartán/Hidroclorotiazida Kern Pharma

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

Do not use Irbesartán/Hidroclorotiazida Kern Pharma after the expiry date stated on the carton and blister 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 light.

Medicines must 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 containers and unused medicines. This will help protect the environment.

6. Package contents and other information

Composition of Irbesartan/Hydrochlorothiazide Kern Pharma

• The active substances are irbesartan and hydrochlorothiazide. Each film-coated tablet of Irbesartan/Hydrochlorothiazide Kern Pharma 150 mg/12.5 mg contains 150 mg of irbesartan and 12.5 mg of hydrochlorothiazide.

• The other components are monohydrate lactose, microcrystalline cellulose, sodium croscarmellose, anhydrous colloidal silica, stearil fumarate and sodium, hypromellose, titanium dioxide, macrogol, and red and yellow iron oxides.

Appearance of the product and contents of the pack

The film-coated tablets of Irbesartan/Hydrochlorothiazide Kern Pharma 150/12.5 mg are pink-colored, round, and have a single-scored line.

Irbesartan/Hydrochlorothiazide Kern Pharma 150/12.5 mg is available in blister packs containing 28 tablets.

Marketing Authorization Holder

Kern Pharma, S.L.

Venus, 72 – Pol. Ind. Colón II

08228 Terrassa - Barcelona

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/