IRBESARTAN/HYDROCHLOROTHIAZIDE NORMON 300 mg/25 mg TABLETS

Introduction

PATIENT INFORMATION LEAFLET

Irbesartan/Hydrochlorothiazide NORMON 300 mg/25 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 produced, 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 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 medicine 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 levels or low potassium levels in your blood.
• if you have diabetes or kidney failure and are being treated with a blood pressure-lowering medicine that contains 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 taking Irbesartan/Hydrochlorothiazide NORMON

• if you have excessive vomiting or diarrhea,
• if you have kidney problemsor have had a kidney transplant,
• if you have heart problems,
• if you have liver problems,
• if you have diabetes,
• if you have systemic lupus erythematosus(also known as lupus or SLE),
• 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 for high blood pressure:

• an angiotensin-converting enzyme inhibitor (ACE inhibitor) (e.g., enalapril, lisinopril, ramipril), particularly if you have diabetic kidney disease.
• 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 and UV exposure while taking Irbesartan/Hydrochlorothiazide NORMON.
  • if you experience blurred vision or eye pain, these could be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or increased pressure in the eye, which can occur within hours to a week after taking Irbesartan/Hydrochlorothiazide NORMON. This can lead to permanent vision loss if not treated. 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. Irbesartan/Hydrochlorothiazide NORMON is not recommended during the first trimester of pregnancy (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 symptoms: feeling thirsty, dry mouth, weakness, feeling sleepy, muscle cramps, nausea, vomiting, or rapid heartbeat, as these may indicate an excessive effect of hydrochlorothiazide (contained in Irbesartan/Hydrochlorothiazide NORMON),
• if you experience an increased sensitivity of your skin to the sunwith symptoms of sunburn (such as redness, itching, swelling, blisters) that occurs more quickly than usual,
• if you are going to have surgery(surgical procedure) or if you are going to be given anesthetics.

Use in athletes

This medicine contains hydrochlorothiazide, which may produce 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 take any other medicines.

Diuretics, such as hydrochlorothiazide contained in Irbesartan/Hydrochlorothiazide NORMON, may interact with other medicines. You should not take preparations containing lithium with Irbesartan/Hydrochlorothiazide NORMON without your doctor's 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 that contain potassium,
• potassium-sparing diuretics 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 cholesterol in the blood.

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, if you drink alcohol while taking this medicine, you may experience increased dizziness when standing up, especially when getting up from a sitting position.

Pregnancy and breastfeeding

Pregnancy

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 medicine. 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 use during breastfeeding. Your doctor may decide to prescribe 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 medicine may cause stomach upset and diarrhea because it contains hydrogenated castor oil.

This medicine contains lactose. If your doctor has told you that you have an intolerance to some 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 instructions for administration of Irbesartan/Hydrochlorothiazide NORMON given by your doctor. Consult your doctor or pharmacist if you have any doubts.

Dose

The normal dose of Irbesartan/Hydrochlorothiazide NORMON is one tablet per day. In general, 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.

Method of administration

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. 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 to stop.

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

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

Children should not take Irbesartan/Hydrochlorothiazide NORMON

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 accidentally miss a dose, simply take your normal dose when it is due next. Do not take a double dose to make up for missed doses.

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

4. Possible Adverse Effects

Like all medicines, Irbesartan/Hydrochlorothiazide NORMON can have adverse effects, although not all people suffer from them.

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

Rarely, cases of allergic reactions on the 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 adverse effects reported in clinical studies for patients treated with irbesartan/hydrochlorothiazide were:

Frequent Adverse Effects(affecting between 1 and 10 out of 100 patients):

• nausea/vomiting,
• urination anomalies,
• fatigue,
• dizziness (including that which 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 a substance that measures kidney function (urea nitrogen in the blood, creatinine).

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

Infrequent Adverse Effects(affecting between 1 and 10 out of 1000 patients):

• 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 adverse effects cause you problems, consult your doctor.

Adverse Effects Since the Marketing of Irbesartan/Hydrochlorothiazide:

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

As with all combinations of two active principles, the adverse effects associated with each component cannot be excluded:

Adverse Effects Associated Only with Irbesartan:

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

Rarely: intestinal angioedema: swelling in the intestine that presents 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); pancreatitis characterized by severe upper stomach 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], lack of white blood cells which can lead to frequent infections, fever; decreased platelet count (blood cells essential for blood coagulation), decreased red blood cell count (anemia) characterized by fatigue, headaches, shortness of breath when exercising, dizziness, and paleness; kidney disease; pulmonary disorders 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 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; reduction of blood pressure after a change in body position; swelling of the salivary glands, high blood sugar levels; sugar in the urine; increases in some types of blood fat; 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 respiratory distress, fever, weakness, and confusion) with very rare frequency.

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

If you consider that any of the adverse effects you are experiencing is seriousor if you notice any adverse effect not mentioned in this prospectus, 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 that does not appear in this prospectus. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Conservation 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 shown on the packaging after CAD. The expiration date is the last day of the month indicated.

Medicines should not be thrown away through the sewage system or in the trash. Deposit the packaging and medicines you no longer need in the SIGRE Point of the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This way, you will help protect the environment.

6. Package Contents and Additional Information

Composition of Irbesartan/Hydrochlorothiazide NORMON 300 mg/25 mg Tablets

The active ingredients are irbesartan and hydrochlorothiazide.

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

Appearance of the Product and Package Contents

Irbesartan/Hydrochlorothiazide NORMON 300 mg/25 mg is presented in the form of tablets containing 300 mg of irbesartan and 25 mg of hydrochlorothiazide.

Irbesartan/Hydrochlorothiazide NORMON 300 mg/25 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 prospectus was approved in February 2025

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