Irbesartan/hydrochlorothiazide Kern Pharma 300 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 300 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 other people, even if they have the same symptoms, as it may harm them.
• If you experience any adverse reactions, consult your doctor or pharmacist, even if they are adverse reactions 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 adverse 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 in blood vessels, causing them to constrict. This results in an increase in blood pressure. Irbesartan blocks angiotensin-II from binding to these receptors, relaxing the 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 substance 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 medicines.
• 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 passing urine.
• 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 diarrhoea.

• 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 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 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 a 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, seek medical attention immediately.

Your doctor may monitor your kidney function, blood pressure, and blood levels of electrolytes (e.g. potassium) at regular intervals.

See also the information under the heading “Do not take Irbesartan/Hydrochlorothiazide Kern Pharma”.

Contact your doctor if you experience abdominal pain, nausea, vomiting, or diarrhoea 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, you must inform your doctor. The use of Irbesartan/Hydrochlorothiazide Kern Pharma is not recommended during the first trimester of pregnancy, and it must not be used from the third month of pregnancy onwards, as it may cause severe harm to your baby (see Pregnancy section).

You should also inform your doctor if:

• you are on a low-salt diet.
• you experience any of the following signs: feeling thirsty, 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).
• you develop increased skin sensitivity to sunlight with symptoms of sunburn (such as redness, itching, swelling, blisters) occurring more rapidly than usual.
• you are going to undergo surgery or receive anaesthetics.

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

Taking Irbesartan/Hydrochlorothiazide Kern Pharma with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might take 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 are taking:

• 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).

It is also important to inform your doctor if you are taking other blood pressure-lowering medicines, steroids, cancer treatments, painkillers, arthritis medicines, or bile acid sequestrants such as cholestyramine or colestipol for lowering blood cholesterol.

Taking Irbesartan/Hydrochlorothiazide Kern Pharma with food and drink

Irbesartan/Hydrochlorothiazide Kern Pharma may 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 onwards, as it may cause severe harm to your baby when administered from this stage.

Breastfeeding

Inform your doctor if you are breastfeeding or plan to breastfeed, as Irbesartan/Hydrochlorothiazide Kern Pharma is not recommended for women during this period. Your doctor may choose a more suitable treatment if you wish to breastfeed, 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 Irbesartan/Hydrochlorothiazide Kern Pharma will affect your ability to drive or operate machinery. 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 about some of the ingredients of Irbesartan/Hydrochlorothiazide Kern Pharma Irbesartan/Hydrochlorothiazide Kern Pharma contains lactose. If your doctor has informed you that you have an intolerance to certain sugars (e.g. lactose), consult with him 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. If you have any doubts, consult your doctor or pharmacist.

Dosage

The usual dose of Irbesartan/Hydrochlorothiazide Kern Pharma is one tablet daily. In general, your doctor will prescribe Irbesartan/Hydrochlorothiazide Kern Pharma when previous treatments you have received have not sufficiently lowered your blood pressure. Your doctor will advise you on how to switch from previous treatments to Irbesartan/Hydrochlorothiazide Kern Pharma.

Administration method

Irbesartan/Hydrochlorothiazide Kern Pharma is administered orally. Tablets must 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 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 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 number 91 562 04 20, indicating the medication and the amount taken. It is recommended to bring the medication's 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 scheduled 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 product, ask your doctor or pharmacist.

4. Possible adverse effects

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

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

Rare 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
• abnormalities in urination
• fatigue
• dizziness (including dizziness upon standing up from lying or sitting position)
• blood tests may show elevated levels of an enzyme measuring muscle and heart function (creatine kinase) or elevated levels of substances measuring 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 include: headache, tinnitus, cough, altered taste, indigestion, joint and muscle pain, liver function abnormalities and kidney failure, elevated potassium levels in the blood, and allergic reactions such as rash, urticaria, swelling of the face, lips, mouth, tongue or throat.

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

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

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

Adverse effects associated solely with irbesartan

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

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

In addition to the adverse effects described above, chest pain and reduced 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 and fever; reduced platelet count (blood cells essential for blood clotting), reduced 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 heart rhythm; reduction in blood pressure after changing 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; non-melanoma skin and lip cancer; acute breathing difficulty (symptoms 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 Medicinal Products: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Irbesartan/Hydrochlorothiazide Kern Pharma

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

Do not use Irbesartan/Hydrochlorothiazide 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 should not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE collection point in your pharmacy. In case of doubt, ask your pharmacist how to properly dispose of unused containers and medicines. This will help protect the environment.

6. Package leaflet contents and additional information

Composition of Irbesartan/Hydrochlorothiazide Kern Pharma

• The active substances are irbesartan and hydrochlorothiazide. Each film-coated tablet of Irbesartan/Hydrochlorothiazide Kern Pharma 300 mg/12.5 mg contains 300 mg of irbesartan and 12.5 mg of hydrochlorothiazide.

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

Appearance of the medicinal product and contents of the container

The film-coated tablets of Irbesartan/Hydrochlorothiazide Kern Pharma 300/12.5 mg are pink-colored, round, and with a single-scored line.

Irbesartan/Hydrochlorothiazide Kern Pharma 300/12.5 mg is available in blister packs containing 28 tablets.

Marketing Authorization Holder and Manufacturer

Kern Pharma, S.L.

Venus, 72 – Pol. Ind. Colón II

08228 Terrassa - Barcelona

Spain

Date of the most recent revision 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 Health Products (AEMPS) http://www.aemps.gob.es/