IRBESARTAN/HYDROCHLOROTHIAZIDE NORMON 300 mg/12.5 mg TABLETS

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Irbesartan/Hydrochlorothiazide NORMON

300 mg/12.5 mg film-coated tablets

Irbesartan and Hydrochlorothiazide

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack and other information

1. What is Irbesartan/Hydrochlorothiazide NORMON and what is it used for
2. What you need to know before you take Irbesartan/Hydrochlorothiazide NORMON
3. How to take Irbesartan/Hydrochlorothiazide NORMON

1. Possible side effects
2. Storage of Irbesartan/Hydrochlorothiazide NORMON
3. Contents of the pack and other information

1. What is Irbesartan/Hydrochlorothiazide NORMON and what is it used for

Irbesartan/Hydrochlorothiazide 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 results in an increase in blood pressure. Irbesartan blocks the binding of angiotensin-II to these receptors, relaxing blood vessels and reducing blood pressure.

Hydrochlorothiazide belongs to a group of medicines (called thiazide diuretics) that increase the amount of urine excreted, reducing blood pressure.

The two active substances in Irbesartan/Hydrochlorothiazide NORMON work together to achieve a greater reduction in blood pressure than either substance alone.

Irbesartan/Hydrochlorothiazide NORMON is used to treat high blood pressure, when treatment with irbesartan or hydrochlorothiazide alone does not provide adequate control of blood pressure.

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

Do not take Irbesartan/Hydrochlorothiazide NORMON:

• if you are allergic (hypersensitive) to irbesartan and hydrochlorothiazide or any of the other ingredients of Irbesartan/Hydrochlorothiazide NORMON (listed in section 6),
• if you are allergic (hypersensitive) to hydrochlorothiazide or any other sulfonamide-derived medication,
• if you are more than 3 months pregnant (in any case, it is recommended to avoid taking this medication during pregnancy - see section Pregnancy),
• if you have severe liver or kidney problems,
• if you have difficulty urinating,
• if your doctor detects that you have persistently elevated calcium or low potassium levels in your blood,
• if you have diabetes or kidney failure and are being treated with a blood pressure-lowering medication containing aliskiren.

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

Warnings and precautions:

Consult your doctor or pharmacist before starting to take Irbesartan/Hydrochlorothiazide NORMON

• 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 LES),
• if you have primary aldosteronism (a condition related to excessive production of the hormone aldosterone, leading to sodium retention and increased blood pressure),
• if you are taking any of the following medications used to treat high blood pressure (hypertension):
• an angiotensin-converting enzyme inhibitor (ACE inhibitor) (e.g., enalapril, lisinopril, ramipril), particularly if you have diabetes-related kidney problems.
• aliskiren.
• if you have had skin cancer or if you 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 skin and lip cancer (non-melanoma skin cancer). Protect your skin from sun exposure and UV rays while taking Irbesartan/Hydrochlorothiazide.
• 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 pressure in the eye, and can occur within hours to a week after taking Irbesartan/Hydrochlorothiazide NORMON. This can lead to permanent vision loss if left untreated. If you have previously been allergic to penicillin or sulfonamides, you may be at higher risk of developing this condition.
• if you have had respiratory or lung 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 Irbesartan/Hydrochlorothiazide NORMON, seek medical attention immediately.

Consult your doctor if you experience abdominal pain, nausea, vomiting, or diarrhea after taking Irbesartan/Hydrochlorothiazide NORMON. Your doctor will decide whether to continue treatment. Do not stop taking Irbesartan/Hydrochlorothiazide NORMON on your own.

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 may be pregnant, or are planning to become pregnant, inform your doctor. The use of Irbesartan/Hydrochlorothiazide NORMON is not recommended during the first trimester of pregnancy (the first 3 months) and should not be used during the last 6 months of pregnancy, as it may cause serious harm to your baby, see section Pregnancy.

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, weakness, feeling sleepy, 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 experience increased sensitivity of your skin to the sun with symptoms of sunburn (such as redness, itching, swelling, blisters) that occurs more quickly than usual,
• if you are going to have surgery (surgical intervention) or if you are going to be administered anesthetics.

Hydrochlorothiazide contained in this medication may cause positive results in doping tests.

Taking Irbesartan/Hydrochlorothiazide NORMON with other medicines

Inform your doctor or pharmacist if you are using, have recently used, or might use any other medication.

Diuretics, such as hydrochlorothiazide contained in Irbesartan/Hydrochlorothiazide NORMON, may interact with other medications. Do not take preparations containing lithium with Irbesartan/Hydrochlorothiazide NORMON without medical supervision.

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

If you are taking an angiotensin-converting enzyme inhibitor (ACE inhibitor) or aliskiren (see also the information under the headings "Do not take Irbesartan/Hydrochlorothiazide NORMON" and "Warnings and precautions").

You may need to have blood tests if you take:

• potassium supplements,
• salt substitutes containing potassium,
• potassium-sparing diuretics or other diuretics (tablets that increase urine production),
• certain laxatives,
• medications used to treat gout,
• vitamin D supplements,
• medications to control heart rhythm,
• medications for diabetes (oral agents or insulins).

It is also important to inform your doctor if you are taking other medications to lower your blood pressure, steroids, medications to treat cancer, painkillers, or medications for arthritis.

Taking Irbesartan/Hydrochlorothiazide NORMON with food and drinks

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

Due to the hydrochlorothiazide contained in Irbesartan/Hydrochlorothiazide NORMON, if you drink alcohol while being treated with this medication, you may experience increased dizziness when standing up, especially when getting up from a seated position.

Pregnancy and breastfeeding

Pregnancy

You should inform your doctor if you are pregnant, think you may be pregnant, or are planning to become pregnant. Your doctor will normally advise you to stop taking Irbesartan/Hydrochlorothiazide NORMON before you become pregnant or as soon as you find out you are pregnant and will recommend an alternative blood pressure-lowering medication instead. The use of Irbesartan/Hydrochlorothiazide NORMON is not recommended during the first trimester of pregnancy and should not be used during the last 6 months of pregnancy, as it may cause serious harm to your baby.

Breastfeeding

Inform your doctor if you are about to start or are breastfeeding, as Irbesartan/Hydrochlorothiazide NORMON is not recommended for women during this period. Your doctor may decide to administer a treatment that is more suitable if you wish to breastfeed, especially for newborns or premature babies.

Driving and using machines

No studies have been performed on the ability to drive and use machines. It is unlikely that Irbesartan/Hydrochlorothiazide NORMON will affect your ability to drive or use machines. However, during treatment for high blood pressure, dizziness or fatigue may occasionally occur. If you experience these symptoms, consult your doctor before performing these activities.

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

This medication may cause stomach upset and diarrhea because it contains hydrogenated castor oil.

This medication contains lactose. If your doctor has told you that you have an intolerance to some sugars, consult with them before taking this medication.

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

3. How to take Irbesartan/Hydrochlorothiazide NORMON

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

The normal dose of Irbesartan/Hydrochlorothiazide NORMON is one tablet per day. In general, your doctor will prescribe Irbesartan/Hydrochlorothiazide NORMON when previous treatments you received did not sufficiently reduce your blood pressure. Your doctor will indicate how to switch from previous treatments to Irbesartan/Hydrochlorothiazide NORMON.

Irbesartan/Hydrochlorothiazide NORMON is administered orally. The tablets should be swallowed with a sufficient amount of liquid (e.g., a glass of water). You can take Irbesartan/Hydrochlorothiazide NORMON 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 NORMON until your doctor advises you otherwise.

The 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:

If you take more Irbesartan/Hydrochlorothiazide NORMON than you should, consult your doctor or pharmacist.

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

Use in children:

Irbesartan/Hydrochlorothiazide NORMON 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 Irbesartan/Hydrochlorothiazide NORMON:

If you forget to take a dose, simply take your normal dose when it is due next. Do not take a double dose to make up for forgotten doses.

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

4. Possible side effects

Like all medicines, Irbesartan/Hydrochlorothiazide NORMON can cause side effects, although not everybody gets them.

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

On rare occasions, cases of allergic reactions in the skin (skin rash, hives) 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 above symptoms or experience shortness of breath, stop taking Irbesartan/Hydrochlorothiazide NORMON and contact your doctor immediately.

The side effects reported in clinical studies for patients treated with irbesartan/hydrochlorothiazide were:

Common side effects(affect 1 to 10 users in 100):

• nausea/vomiting,
• urination anomalies,
• fatigue,
• dizziness (including dizziness when standing up from a lying or seated position),
• blood tests may show elevated levels of an enzyme that measures muscle and heart function (creatine kinase) or elevated levels of a substance that measures kidney function (urea nitrogen in blood, creatinine).

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

Uncommon side effects(affect 1 to 10 users in 1,000):

• diarrhea,
• low blood pressure,
• fainting,
• rapid heartbeat,
• 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 side effects bother you, consult your doctor.

Side effects reported since the marketing of irbesartan/hydrochlorothiazide:

The frequency of these effects is unknown. These side effects are: headache, ringing in the ears, cough, alteration of taste, indigestion, joint and muscle pain, liver function alterations, and kidney failure, high levels of potassium in the blood, and allergic reactions such as skin rash, hives, swelling of the face, lips, mouth, tongue, or throat.

As with all combinations of two active substances, it cannot be excluded that side effects associated with each component may occur:

Side effects associated only with irbesartan:

In addition to the side effects described above, pain in the chest and a decrease in the number of platelets (a blood cell essential for blood clotting) have also been observed.

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

Side effects associated with hydrochlorothiazide in monotherapy:

• Lack of appetite; stomach irritation; stomach cramps; constipation; jaundice (yellowing of the skin and/or whites of the eyes); pancreatitis characterized by severe upper stomach pain, often with nausea and vomiting; sleep disorders; depression; blurred vision; decreased vision or eye pain due to increased 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 can lead to frequent infections, fever; decreased number of platelets (blood cells essential for blood clotting), decreased number of red blood cells (anemia) characterized by fatigue, headaches, shortness of breath when exercising, dizziness, and paleness; kidney disease; lung disorders including pneumonia or fluid accumulation in the lungs; increased sensitivity of the skin to the sun; inflammation of blood vessels; a skin disease characterized by peeling of the skin all over the body; cutaneous lupus erythematosus, which is identified by a rash that can appear on the face, neck, and scalp; allergic reactions; weakness and muscle spasms; alteration of heart rhythm; decrease in blood pressure after a change in body position; swelling of the salivary glands, high blood sugar levels; sugar in the urine; increased levels of certain blood fats; high levels of uric acid in the blood, which can cause gout; skin and lip cancer (non-melanoma skin cancer) with unknown frequency, acute respiratory distress (signs include severe difficulty breathing, fever, weakness, and confusion) with very rare frequency.

It is known that side effects associated with hydrochlorothiazide can increase with higher doses of hydrochlorothiazide.

If you consider any of the side effects you are experiencing to be serious or if you notice any side effect not mentioned in this leaflet, inform your doctor or pharmacist.

Reporting of side effects:

If you experience any side effects, consult your doctor or pharmacist, even if it is possible side effects not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medication.

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 expiration date stated on the packaging after Exp. The expiration date is the last day of the indicated month.

Medicines should not be disposed of via wastewater or household waste. Deposit the packaging and any unused medicines at the SIGRE collection point in your pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medicines. By doing so, you will help protect the environment.

6. Packaging contents and additional information

Composition of Irbesartan/hydrochlorothiazide NORMON 300 mg/12.5 mg tablets

The active ingredients are irbesartan and hydrochlorothiazide.

The other ingredients are: povidone, magnesium stearate, microcrystalline cellulose, lactose monohydrate, sodium croscarmellose, anhydrous colloidal silica, hydrogenated ricin oil, and corn starch.

Appearance of the product and packaging contents

Irbesartan/hydrochlorothiazide NORMON 300 mg/12.5 mg is presented in the form of tablets containing 300 mg of irbesartan and 12.5 mg of hydrochlorothiazide.

Irbesartan/hydrochlorothiazide NORMON 300 mg/12.5 mg is presented in packages of 28 tablets.

Marketing authorization holder and manufacturer

LABORATORIOS NORMON, S.A.

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

This leaflet was approved in February 2025

Detailed information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/