Irbesartan/hydrochlorothiazide Normon 300 mg/25 mg tablets EFG

Package leaflet: Information for the user

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Irbesartan/Hydrochlorothiazide NORMON 300 mg/25 mg tablets EFG

Irbesartan and Hydrochlorothiazide

Read the entire 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, consult 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 you, since it could 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.

Contents of the leaflet:

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

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

Irbesartán/Hidroclorotiazida NORMON 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 by the body that binds to receptors in 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 NORMON work together to achieve a greater reduction in blood pressure than either of them alone.

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

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

Do not take Irbesartan/Hydrochlorothiazide NORMON

• if you are allergic (hypersensitive) to irbesartan or to any of the other components of Irbesartan/Hydrochlorothiazide NORMON (listed in section 6),
• 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 calcium levels or low potassium levels in the blood,
• if you have diabetes or renal insufficiency and are being treated with a blood pressure-lowering medicine containing aliskiren.

Irbesartan/Hydrochlorothiazide NORMON must not be administered to children and adolescents (under 18 years of age).

Warnings and precautions

Talk to your doctor or pharmacist before taking Irbesartan/Hydrochlorothiazide NORMON

• 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 related to excessive production of the hormone aldosterone, leading to sodium retention and, in turn, increased blood pressure),

• if you are taking any of the following medicines used to treat high blood pressure (hypertension):

• an angiotensin-converting enzyme (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 and UV exposure while taking Irbesartan/Hydrochlorothiazide NORMON.
  • if you experience a decrease in vision or eye pain, which could be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or increased eye pressure. These may occur within hours to a week after taking Irbesartan/Hydrochlorothiazide NORMON. This may lead to permanent vision loss if not treated. If you previously had an allergy to penicillin or sulfonamides, you may be at higher risk.
  • 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 Irbesartan/Hydrochlorothiazide NORMON, contact your doctor immediately.

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

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 NORMON”.

If you are pregnant, think you might be pregnant, or plan to become pregnant, you must inform your doctor. The use of Irbesartan/Hydrochlorothiazide NORMON is not recommended during early pregnancy (first 3 months), and must in no case be used during the last 6 months of pregnancy 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 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 NORMON),
• if you develop increased skin sensitivity to sunlight, with symptoms of sunburn (such as redness, itching, swelling, blisters) occurring more quickly than usual,
• if you are scheduled for surgery or if you will receive anaesthetics.

Use in athletes

This medicine contains hydrochlorothiazide, which may lead to a positive result in doping tests.

Taking Irbesartan/Hydrochlorothiazide NORMON 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 Irbesartan/Hydrochlorothiazide NORMON, may interact with other medicines. Do not take lithium-containing preparations together with Irbesartan/Hydrochlorothiazide NORMON without medical supervision.

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

If you are taking an angiotensin-converting enzyme (ACE) inhibitor or aliskiren (see also information under the headings “Do not take Irbesartan/Hydrochlorothiazide NORMON” 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 cholesterol-lowering resins such as cholestyramine or colestipol.

? Taking Irbesartan/Hydrochlorothiazide NORMON with food and drink

Irbesartan/Hydrochlorothiazide NORMON can be taken with or without food.

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

? Pregnancy and breastfeeding

Pregnancy

Inform your doctor if you are pregnant, think you might be pregnant, or plan to become pregnant. Generally, your doctor will advise you to stop taking Irbesartan/Hydrochlorothiazide NORMON before becoming pregnant or as soon as pregnancy is confirmed, and will recommend an alternative antihypertensive medicine. Irbesartan/Hydrochlorothiazide NORMON 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 point onward.

Breastfeeding

Inform your doctor if you are planning to breastfeed or are currently breastfeeding, as Irbesartan/Hydrochlorothiazide NORMON 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 NORMON affects your ability to drive or operate machinery. However, dizziness or fatigue may occasionally occur during antihypertensive treatment. If you experience these symptoms, consult your doctor before performing such activities.

?Irbesartan/Hydrochlorothiazide NORMON contains hydrogenated castor oil, lactose, and sodium

This medicine may cause stomach discomfort and diarrhoea because it contains hydrogenated castor oil.

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

This medicine contains less than 23 mg of sodium (1 mmol) per tablet; this is essentially “sodium-free”.

3. How to take Irbesartan/Hydrochlorothiazide NORMON

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

Dosage

The usual dose of Irbesartan/Hydrochlorothiazide NORMON is one tablet daily. Generally, your doctor will prescribe Irbesartan/Hydrochlorothiazide NORMON when previous treatments have not sufficiently reduced your blood pressure. Your doctor will advise you on how to switch from previous treatments to Irbesartan/Hydrochlorothiazide NORMON.

Administration method

Irbesartan/Hydrochlorothiazide NORMON is administered orally. The tablets should be swallowed with an adequate amount of liquid (e.g. a glass of water). You may take Irbesartan/Hydrochlorothiazide NORMON 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 NORMON 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 NORMON than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist or call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medication and the amount ingested.

Children must not take Irbesartan/Hydrochlorothiazide NORMON

Irbesartan/Hydrochlorothiazide NORMON must not be given to children under 18 years of age. If a child accidentally swallows any tablets, contact your doctor immediately.

If you forget to take Irbesartan/Hydrochlorothiazide NORMON

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 missed doses.

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

4. Possible adverse effects

Like all medicines, Irbesartan/Hydrochlorothiazide NORMON can have adverse effects, although not everyone experiences them.

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

Rare cases of skin allergic reactions (rash, urticaria), as well as localized swelling of the face, lips and/or tongue, have been reported in patients treated with irbesartan. If you experience any of the above symptoms or develop shortness of breath, stop taking Irbesartan/Hydrochlorothiazide NORMON and contact your doctor immediately.

Adverse effects reported in clinical studies for patients treated with irbesartan/hydrochlorothiazide include:

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

• nausea/vomiting,
• abnormalities in urination,
• fatigue,
• dizziness (including when standing up from a 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 potassium and sodium in the blood.

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

Adverse effects reported since marketing of irbesartan/hydrochlorothiazide:

The frequency of occurrence of these effects is unknown. These adverse effects include: headache, tinnitus, cough, taste disturbance, 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.

As with all 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 previously described adverse effects, chest pain and decreased platelet count (a blood cell essential for blood clotting) have also been observed.

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

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; 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]; low white blood cell count which may lead to frequent infections, 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 paleness; 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 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; weakness and muscle spasms; irregular heartbeat; drop in blood pressure upon 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) with unknown frequency, acute breathing difficulty (symptoms include severe shortness of breath, fever, weakness and confusion) with very rare frequency.

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

If you consider any of the adverse effects you experience to be severe, or if you notice any adverse effects not listed in this leaflet, inform your doctor or pharmacist.

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: 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 NORMON

No special storage conditions are required.

Keep out of the reach and sight of children.

Do not use Irbesartan/Hydrochlorothiazide NORMON after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE Point in your pharmacy. If you are unsure, ask your pharmacist how to properly dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Irbesartán/Hidroclorotiazida NORMON 300 mg/25 mg tablets

The active substances are irbesartan and hydrochlorothiazide.

The other components (excipients) are: povidone, magnesium stearate, microcrystalline cellulose, monohydrate lactose, sodium croscarmellose, anhydrous colloidal silica, hydrogenated castor oil, and corn starch.

Appearance of the product and contents of the pack

Irbesartán/Hidroclorotiazida NORMON 300 mg/25 mg is presented as tablets containing 300 mg of irbesartan and 25 mg of hydrochlorothiazide.

Irbesartán/Hidroclorotiazida NORMON 300 mg/25 mg is available in packs of 28 tablets.

Marketing Authorization Holder and Manufacturer

LABORATORIOS NORMON, S.A.

Ronda de Valdecarrizo, 6 – 28760 Tres Cantos – Madrid (SPAIN)

This summary of product characteristics was approved in 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/