Package Insert: Information for the User

Irbesartán/Hidroclorotiazida TecniGen 300 mg/12.5 mg Film-Coated Tablets

Read this package insert carefully before starting to take the medication, as it contains important information for you.

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

1. What is Irbesartán/Hidroclorotiazida TecniGen and how is it used

2. What you need to know before starting to take Irbesartán/Hidroclorotiazida TecniGen

3. How to take Irbesartán/Hidroclorotiazida TecniGen

4. Possible adverse effects

5. Storage of Irbesartán/Hidroclorotiazida TecniGen

6. Contents of the package and additional information

Irbesartán/Hidroclorotiazida TecniGen is an association of two active principles, irbesartan and hydrochlorothiazide.

Irbesartan belongs to a group of medications known as angiotensin-II receptor antagonists. Angiotensin-II is a substance produced in 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 medications (called thiazide diuretics) that increase the amount of urine eliminated, reducing blood pressure. The two active principles of Irbesartán/Hidroclorotiazida TecniGen act together to achieve a reduction in blood pressure greater than that obtained with each one separately.

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

Do not take Irbesartán/Hidroclorotiazida TecniGen

• if you areallergicto irbesartan, or to any of the other ingredients of this medicine (listed in section 6).
• if you areallergicto hydrochlorothiazide or to any other sulfonamide-derived medicine.
• if you aremore than 3 months pregnant.(In any case, it is better to avoid taking this medicine also at the beginning of your pregnancy – see Pregnancy section)
• if you havesevere liver or kidney problems.
• if you havedifficulty urinating.
• if your doctor detects that you havepersistently 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 medicine that contains aliskiren.

Warnings and precautions

Consult your doctor, pharmacist or nurse before starting to take Irbesartán/Hidroclorotiazida TecniGen

Inform your doctorin any of the following cases:

• if you haveexcessive vomiting or diarrhea.
• if you havekidney problemsor if you have had akidney transplant.
• if you haveheart problems.
• if you haveliver problems.
• if you havediabetes.
• if you havelupus erythematosus(also known as lupus or LES).
• if you haveprimary aldosteronism(a condition related to the excessive production of the hormone aldosterone, which causes sodium retention and, in turn, an increase in blood pressure).
• if you are taking any of the following blood pressure-lowering medicines (hypertension):

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

- aliskiren

• if you have had respiratory or pulmonary 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 takingIrbesartán/Hidroclorotiazida TecniGen, see your doctor immediately.

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

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

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

- If you have had skin cancer or if you develop an unexpected skin lesion during treatment. The treatment with hydrochlorothiazide, particularly 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 takingIbersartán/Hidroclorotiazida TecniGen.

Inform your doctor if you are pregnant, suspect you may be pregnant or plan to become pregnant. Irbesartán/Hidroclorotiazida TecniGen is not recommended for use at the beginning of pregnancy (first 3 months), and in any case, it should not be administered from the third month of pregnancy as it may cause serious harm to your baby (see Pregnancy section).

You must also inform your doctor:

• if you are following alow-sodium diet.
• if you experience any of the following symptoms:thirst, dry mouth, generalized weakness, drowsiness, muscle pain or cramps, nausea, vomiting, orrapid heartbeat, as they may indicate excessive hydrochlorothiazide effect(contained in Irbesartán/Hidroclorotiazida TecniGen)
• if you experience an increase insensitivity to the sunwith symptoms of sunburn (such as redness, itching, swelling, blisters) that occur more quickly than usual.
• ifyou are to undergo surgery(surgical intervention) orif you are to receive anesthetics.
• if you experiencechanges in your vision or eye painwhile taking Irbesartán/Hidroclorotiazida. This could be a sign of glaucoma development, accumulation of fluid in the vascular layer of the eye (choroidal hemorrhage) or increased pressure in your eyes. You must interrupt treatment with Irbesartán/Hidroclorotiazida and seek medical attention.

Use in athletes:

This medicine contains hydrochlorothiazide, which may produce a positive result in doping control tests.

Children and adolescents

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

Use of other medicines

Inform your doctor or pharmacist that you are using, have used recently or may need to use any other medicine.

Diuretics, such as hydrochlorothiazide contained in Irbesartán/Hidroclorotiazida TecniGen, may affect other medicines. Do not take with Irbesartán/Hidroclorotiazida TecniGen 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 angiotensin-converting enzyme inhibitor (ACEI) or aliskiren (see also the information under the headings “Do not take Irbesartán/Hidroclorotiazida TecniGen” and “Warnings and precautions”)

You may need to have blood tests if you take:

• potassium supplements
• sodium-free salt substitutes containing potassium
• potassium-sparing diuretics (tablets that increase urine production)
• some laxatives
• medicines used to treat gout
• vitamin D supplements
• medicines to control heart rhythm
• diabetes medicines (oral agents or insulin)
• carbamazepine (a medicine for epilepsy treatment)

It is also important to inform your doctor if you are taking:

• other blood pressure-lowering medicines
• steroids
• medicines for cancer treatment
• analgesics
• medicines for arthritis
• cholestyramine or colestipol resins to reduce cholesterol in the blood.

Taking Irbesartán/Hidroclorotiazida TecniGen with food, drinks and alcohol

Irbesartán/Hidroclorotiazida TecniGen can be taken with or without food.

Due to the hydrochlorothiazide contained in Irbesartán/Hidroclorotiazida TecniGen, if you drink alcohol while taking this medicine, you may experience a greater sensation of dizziness when standing up, especially when getting up from a seated position.

Pregnancy, breastfeeding and fertility

If you are pregnant, breastfeeding or plan to become pregnant, consult your doctor or pharmacist before using this medicine

Pregnancy

You must inform your doctor if you are pregnant, suspect you may be pregnant or plan to become pregnant. Your doctor will usually advise you to stop taking Irbesartán/Hidroclorotiazida TecniGen before becoming pregnant or as soon as you become pregnant and recommend taking another blood pressure-lowering medicine instead. Irbesartán/Hidroclorotiazida TecniGen is not recommended for use at the beginning of pregnancy and should not be administered from the third month of pregnancy as it may cause serious harm to your baby when administered from that time.

Breastfeeding

Inform your doctor if you plan to start or are breastfeeding, as Irbesartán/Hidroclorotiazida TecniGen is not recommended for use during 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 TecniGen will affect your ability to drive vehicles or operate machinery. However, during hypertension treatment, you may occasionally experience dizziness or fatigue. If you experience these symptoms, speak with your doctor before driving or operating machinery.

Irbesartán/Hidroclorotiazida TecniGen contains lactose. If your doctor has told you that you have a certainsugar intolerance, consult with him before taking this medicine.

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

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

Dose

The recommended dose of Irbesartán/Hidroclorotiazida TecniGen is one or two tablets per day. In general, your doctor will prescribe Irbesartán/Hidroclorotiazida TecniGen 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 TecniGen.

Administration Form

Irbesartán/Hidroclorotiazida TecniGen is administered orally. via oral. The tablets should be swallowed with a sufficient amount of liquid (e.g. a glass of water). You can take Irbesartán/Hidroclorotiazida TecniGen 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 TecniGen until your doctor advises you otherwise.

The maximum blood pressure-lowering effect should be achieved within 6-8 weeks after starting treatment.

The groove is only for breaking the tablet if it is difficult to swallow it whole.

If you take more Irbesartán/Hidroclorotiazida TecniGen than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

Children should not take Irbesartán/Hidroclorotiazida TecniGen

Irbesartán/Hidroclorotiazida TecniGen should not be given to children under 18 years of age. If a child swallows some tablets, contact your doctor immediately.

If you forgot to take Irbesartán/Hidroclorotiazida TecniGen

If you accidentally forget to take a dose, simply take your regular 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 medication, ask your doctor, pharmacist, or nurse.

Like all medicines, this medicine can cause side effects, although not everyone will experience them. Some of these side effects may be serious and may require medical attention.

In rare cases, skin allergic reactions (skin rash, urticaria) have been reported in patients treated with irbesartan, as well as localized inflammation in the face, lips, and/or tongue.

If you experience any of the following symptoms or have difficulty breathing, stop taking Irbesartán/Hidroclorotiazida TecniGen and contact your doctor immediately.

The frequency of the side effects listed below is defined using the following convention:

Frequent: may affect up to 1 in 10 people

Rare: may affect up to 1 in 100 people

The side effects reported in clinical studies for patients treated with Irbesartán/Hidroclorotiazida TecniGen were:

Frequent side effects(may affect up to 1 in 10 people):

• nausea/vomiting,
• urinary 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 (creatine kinase) or elevated levels of substances that measure kidney function (urea nitrogen in the blood, creatinine).

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

Rare side effects(may affect up to 1 in 100 people)

• diarrhea,
• low blood pressure,
• syncope,
• 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 side effects cause you problems, consult your doctor.

Side effects from the marketing of Irbesartán/Hidroclorotiazida TecniGen

Since the marketing of Irbesartán/Hidroclorotiazida TecniGen, some side effects have been reported. The side effects observed with unknown frequency are: headache, tinnitus, cough, alteration of taste, indigestion, joint and muscle pain, liver function alterations, kidney insufficiency, elevated levels of potassium in your blood, and allergic reactions such as skin rash, urticaria, swelling of the face, lips, mouth, tongue, or throat. Also, rare cases of jaundice (yellowing of the skin and/or white of the eyes) have been observed.

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

Side effects associated only with irbesartan

Intestinal angioedema: swelling in the intestine that presents symptoms such as abdominal pain, nausea, vomiting, and diarrhea (rare).

In addition to the side effects described above, intestinal angioedema has also been observed, as well as chest pain and a reduction in the number of platelets (unknown frequency).

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 abdominal pain, often with nausea and vomiting; sleep disturbances; depression; blurred vision; lack of white blood cells, which can lead to frequent infections, fever; decreased platelet count (essential blood cells for blood coagulation), decreased red blood cell count (anemia) characterized by fatigue, headaches, shortness of breath during exercise, dizziness, and paleness; 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; lupus erythematosus, which is identified by a rash that can appear on the face, neck, and scalp; allergic reactions; muscle weakness and spasms; alteration of heart rhythm; decreased blood pressure after a change in body position; swelling of salivary glands; high blood sugar levels; sugar in the urine; increases in some types of blood fats; high levels of uric acid in the blood, which can cause gout.

Rare (may affect up to 1 in 10,000 people):Acute respiratory distress (symptoms include severe difficulty breathing, fever, weakness, andconfusion).

Unknown frequency: Skin and lip cancer (non-melanoma skin cancer).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].

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

Reporting of side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, 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 for the Pharmacovigilance of Medicines for Human Use. Website: www.notificaram.es.

By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

Do not use this medication after the expiration date that appears on the carton and on the blister pack after CAD.

The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

Medicines should not be disposed of through drains or in the trash. Dispose of the packaging and unused medications at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist where to dispose of unused medications. By doing so, you will help protect the environment.

Composition of Irbesartán/Hidroclorotiazida TecniGen

• The active principles are irbesartan and hydrochlorothiazide. Each Irbesartán/Hidroclorotiazida TecniGen 300 mg/12.5 mg tablet contains 300 mg of irbesartan and 12.5 mg of hydrochlorothiazide.
• The other components are lactose monohydrate, microcrystalline cellulose, hypromellose, sodium croscarmellose, and magnesium stearate (core). Lactose monohydrate, hypromellose 15 cP, macrogol 3350, titanium dioxide (E171), yellow and red iron oxides (E172) (coating).

Appearance of the product and content of the container

The Irbesartán/Hidroclorotiazida TecniGen 300 mg/12.5 mg tablets are pink/pale pink, convex, and oblong.

Irbesartán/Hidroclorotiazida TecniGen 300 mg/12.5 mg tablets are available in blister packs with 14, 28, or 56 tablets.

Only some package sizes may be commercially available.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder

Tecnimede España Industria Farmacéutica, S.A.

Avda. de Bruselas, 13, 3rd floor. Edificio América. Polígono Arroyo de la Vega,

28108 Alcobendas (Madrid) SPAIN

Responsible manufacturer

Atlantic Pharma – Produções Farmacêuticas, S.A.

Rua da Tapada Grande, n.º 2, Abrunheira, 2710-089 Sintra, Portugal

Last review date of this leaflet: February 2025

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