PROSPECTO: INFORMATION FOR THE USER

Irbesartán/hidroclorotiazida NORMON 150 mg/12,5 mg tablets EFG

Irbesartán and Hidroclorotiazida

Read this prospect carefully before starting to take this medicine, because it contains important information for you.

• Keep this prospect as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed only for you and should not be given to others, even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist even if they are not listed in this prospect. See section 4.

Irbesartán/hidroclorotiazida NORMON is an association of two active principles, 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 blood vessel receptors, causing them to contract. This results in an increase in blood pressure. Irbesartan prevents 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 eliminated, reducing blood pressure.

The two active principles of Irbesartán/hidroclorotiazida NORMON act together to achieve a decrease in blood pressure greater than that obtained with each one separately.

Irbesartán/hidroclorotiazida NORMON is used for the treatment of high blood pressure, when treatment with only irbesartan or only hydrochlorothiazide does not provide adequate control of your blood pressure.

Do not take Irbesartán/hidroclorotiazida NORMON:

• if you are allergic (hypersensitive) to irbesartán and hidroclorotiazida or to any of the other components of Irbesartán/hidroclorotiazida NORMON (listed in section 6),
• if you are allergic (hypersensitive) to hidroclorotiazida or to any other sulfonamide-derived medication,
• if you are more than 3 months pregnant (in any case, it is better to avoid taking this medication also at the beginning of your pregnancy - see Pregnancy section),
• if you have severe liver or kidney problems,
• if you have difficulty urinating,
• if your doctor detects persistently elevated calcium levels or low potassium levels in your blood,
• if you have diabetes or kidney insufficiency and are being treated with a blood pressure-lowering medication containing aliskirén.

Irbesartán/hidroclorotiazida NORMON should not be administered to children and adolescents (under 18 years).

Warnings and precautions:

Consult your doctor or pharmacist before starting to take Irbesartán/Hidroclorotiazida NORMON

• if you have excessive vomiting or diarrhea,
• if you have kidney problems or if you 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 the excessive production of aldosterone hormone, which causes sodium retention and, in turn, an increase in blood pressure),

-if you are taking any of the following blood pressure-lowering medications (hypertension):

-an angiotensin-converting enzyme inhibitor (ACEI) (for example, enalapril, lisinopril, ramipril), particularly if you have kidney problems related to diabetes.

-aliskirén.

• if you have had skin cancer or if you develop an unexpected skin lesion during treatment. The treatment with hidroclorotiazida, particularly its long-term use at high doses, may increase the risk of certain types of skin cancer and lip cancer (non-melanoma skin cancer). Protect your skin from sun exposure and UV rays while taking Irbesartán/Hidroclorotiazida.
• if you experience a decrease in vision or eye pain, which may be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or increased intraocular pressure, and may occur within a few hours to a week after taking Irbesartán/Hidroclorotiazida NORMON. This can lead to permanent vision loss if not treated. If you have previously had an allergy to penicillin or sulfonamide, you may be at a higher risk of developing it.
• if you have had respiratory or pulmonary problems (such as inflammation or fluid in the lungs) after taking hidroclorotiazida in the past. If you experience severe shortness of breath or difficulty breathing after taking Irbesartán/hidroclorotiazida NORMON, seek medical attention immediately.

Consult your doctor if you experience abdominal pain, nausea, vomiting, or diarrhea after taking Irbesartán/hidroclorotiazida NORMON. Your doctor will decide whether to continue treatment. Do not stop taking Irbesartán/hidroclorotiazida NORMON in monotherapy.

Your doctor may monitor your renal function, blood pressure, and electrolyte levels (such as potassium) at regular intervals.

See also the information under the heading “Do not take Irbesartán/Hidroclorotiazida NORMON”

If you are pregnant, if you suspect you may be pregnant, or if you plan to become pregnant, you must inform your doctor. Irbesartán/hidroclorotiazida NORMON is generally not recommended for use at the beginning of pregnancy (first 3 months) and should not be used in any case after the third month of pregnancy, as it may cause serious harm to your baby (see Pregnancy section).

You should also inform your doctor:

• if you are following a low-sodium diet,
• if you experience any of these symptoms: excessive thirst, dry mouth, generalized weakness, drowsiness, muscle pain or cramps, nausea, vomiting, or rapid heartbeat, which may indicate excessive hidroclorotiazida (contained in Irbesartán/hidroclorotiazida NORMON) effects,
• if you experience increased skin sensitivity to the sun with symptoms of sunburn (such as redness, itching, swelling, or blisters) that occur more quickly than usual,
• if you are scheduled for surgery (surgical intervention) or if you are to receive anesthetics.

The hidroclorotiazida contained in this medication may cause positive results in doping control.

Irbesartán/hidroclorotiazida NORMON with other medications

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication.

Diuretics, such as the hidroclorotiazida contained in Irbesartán/hidroclorotiazida NORMON, may affect other medications. Do not take preparations containing lithium without your doctor's supervision.

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

If you are taking an ACEI or aliskirén (see also the information under the headings “Do not take Irbesartán/Hidroclorotiazida NORMON” and “Warnings and precautions”).

You may need to have blood tests if you take:

• potassium supplements,
• sodium-free substitutes that contain potassium,
• potassium-sparing medications or other diuretics (tablets that increase urine production),
• some laxatives,
• medications used to treat gout,
• vitamin D supplements,
• medications for heart rhythm control,
• diabetes medications (oral agents or insulin).

You should also inform your doctor if you are taking other blood pressure-lowering medications, steroids, cancer medications, analgesics, or arthritis medications.

Irbesartán/hidroclorotiazida NORMON with food and beverages

Irbesartán/hidroclorotiazida NORMON can be taken with or without food.

Due to the hidroclorotiazida contained in Irbesartán/hidroclorotiazida NORMON, if you drink alcohol while taking this medication, you may experience a greater sense of dizziness when standing up, especially when getting up from a seated position.

Pregnancy and lactation

Pregnancy

You must inform your doctor if you are pregnant, if you suspect you may be pregnant, or if you plan to become pregnant. Your doctor will generally advise you to stop taking Irbesartán/hidroclorotiazida NORMON before becoming pregnant or as soon as you become pregnant and recommend another blood pressure-lowering medication instead. Irbesartán/hidroclorotiazida NORMON is generally not recommended for use at the beginning of pregnancy (first 3 months) and should not be used in any case after the third month of pregnancy, as it may cause serious harm to your baby (see Pregnancy section).

Lactation

Inform your doctor if you plan to initiate or are in the lactation period, as it is not recommended to administer Irbesartán/hidroclorotiazida NORMON to women in this period. Your doctor may decide to administer a more suitable treatment if you want to breastfeed, especially for newborns or premature babies.

Driving and operating machinery

No studies have been conducted on the ability to drive and operate machinery. It is unlikely that Irbesartán/hidroclorotiazida NORMON will affect your ability to drive vehicles or operate machinery. However, during hypertension treatment, occasional dizziness or fatigue may occur. If you experience these symptoms, consult your doctor before engaging in these activities.

Irbesartán/hidroclorotiazida NORMON contains ricin oil, lactose, and sodium

This medication may cause stomach discomfort and diarrhea due to the presence of hydrogenated ricin oil.

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

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

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

The normal dose of Irbesartán/hidroclorotiazida NORMON is one or two tablets per day. In general, your doctor will prescribe Irbesartán/hidroclorotiazida NORMON when previous treatments you received did not sufficiently reduce your blood pressure. Your doctor will instruct you on how to switch from previous treatments to Irbesartán/hidroclorotiazida NORMON.

Irbesartán/hidroclorotiazida NORMON is administered orally. The tablets should be swallowed with a sufficient amount of liquid (e.g. a glass of water). You can take Irbesartán/hidroclorotiazida NORMON with or without food. You should try to take your daily dose at the same time every day. It is essential that you continue taking Irbesartán/hidroclorotiazida 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 Irbesartán/hidroclorotiazida NORMON than you should:

If you take more Irbesartán/hidroclorotiazida 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 bring the packaging and the medication leaflet.

Use in children:

Irbesartán/hidroclorotiazida 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 Irbesartán/hidroclorotiazida NORMON:

If you forget to take a dose, simply take your normal dose when it is due. Do not take a double dose to compensate for the missed doses.

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

Like all medications, Irbesartán/hidroclorotiazida NORMON may have side effects, although not everyone will experience them.

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

Rare cases of skin reactions (skin rash, urticaria) have been reported in patients treated with irbesartán, as well as localized inflammation in the face, lips, and/or tongue. If you experience any of the previous symptoms or have difficulty breathing, stop taking Irbesartán/hidroclorotiazida NORMON and contact your doctor immediately.

The side effects reported in clinical studies for patients treated with irbesartán/hidroclorotiazida were:

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

• nausea/vomiting,
• urination abnormalities,
• 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 (creatinine-cinase) or elevated levels of a substance that measures kidney function (urea nitrogen in the blood, creatinine).

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

Less frequent side effects(affect between 1 and 10 of every 1000 patients):

• diarrhea,
• low blood pressure,
• syncope,
• tachycardia,
• flushing,
• 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 cause you problems, consult your doctor.

Side effects from the commercialization of irbesartán/hidroclorotiazida:

The frequency of these side effects is unknown. These side effects are: headache, tinnitus, cough, alteration of taste, indigestion, joint and muscle pain, liver function alterations, and kidney insufficiency, elevated levels of potassium in the blood, and allergic reactions such as skin rash, urticaria, facial swelling, lip, mouth, tongue, or throat swelling.

As with all combinations of two active principles, the side effects associated with each component cannot be ruled out:

Side effects associated only with irbesartán:

In addition to the side effects described above, chest pain and a decrease in the number of platelets (an essential blood cell for blood coagulation) 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 hidroclorotiazida in monotherapy:

• loss of appetite; stomach irritation; stomach cramps; constipation; jaundice (yellowing of the skin and/or white of the eyes); pancreatitis characterized by severe upper stomach pain, often with nausea and vomiting; sleep disturbances; depression; blurred vision; decreased vision or eye pain due to high pressure [possible signs of fluid accumulation in the vascular layer of the eye (choroidal hemorrhage) or acute angle-closure glaucoma], low white blood cell count which may lead to frequent infections, fever; low platelet count (essential blood cells for blood coagulation), low red blood cell count (anemia) characterized by fatigue, headaches, shortness of breath during exercise, dizziness, and pallor; kidney disease; pulmonary alterations 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 over the entire body; cutaneous lupus erythematosus, identified by a rash that may appear on the face, neck, and scalp; allergic reactions; muscle weakness and spasms; alteration of heart rhythm; reduction of blood pressure after a change in body position; salivary gland swelling, high blood sugar levels; sugar in the urine; increases in some types of blood fat; high levels of uric acid in the blood, which may cause gout; skin and lip cancer (non-melanoma skin cancer) with unknown frequency,acute respiratory distress (symptoms include severe shortness of breath, fever, weakness, and confusion) with very rare frequency.

It is known that the side effects associated with hidroclorotiazida may increase with higher doses of hidroclorotiazida.

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

Reporting of side effects:

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through the Spanish System of Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

No special storage conditions are required.

Keep out of the reach and sight of children.

Do not use Irbesartán/hidroclorotiazida NORMON after the expiration date that appears on the packaging after "Cad." The expiration date is the last day of the month indicated.

Medicines should not be disposed of through drains or in the trash. Dispose of the packaging and medicines you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. In this way, you will help protect the environment.

Composition of Irbesartán/hidroclorotiazida NORMON 150 mg/12.5 mg tablets

The active principles are irbesartan and hidroclorotiazida.

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

Appearance of the product and contents of the packaging

Irbesartán/hidroclorotiazida NORMON 150 mg/12.5 mg is presented in the form of tablets containing 150 mg of irbesartan and 12.5 mg of hidroclorotiazida.

Irbesartán/hidroclorotiazida NORMON 150 mg/12.5 mg is presented in packs of 28 tablets.

Holder of the marketing authorization and Responsible for manufacturing

LABORATORIOS NORMON, S.A.

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

OTHER PRESENTATIONS

Irbesartán/hidroclorotiazida NORMON 300 mg/12.5 mg TABLETS EFG

This prospectus was approved in February 2025

The detailed information of this medicine is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/