IRBESARTAN/HYDROCHLOROTHIAZIDE TECNIGEN 300 mg/12.5 mg FILM-COATED TABLETS

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

Do not take Irbesartan/Hydrochlorothiazide TecniGen

• if you are allergicto irbesartan or any of the other ingredients of this medicine (listed in section 6).
• if you are allergicto hydrochlorothiazide or any other sulfonamide-derived medication
• if you are pregnant more than 3 months. (In any case, it is best to avoid taking this medicine at the start of your 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

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting to take Irbesartan/Hydrochlorothiazide TecniGen

Tell your doctorin any of the following cases:

• 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 medicines used to treat high blood pressure:

• an angiotensin-converting enzyme inhibitor (ACE inhibitor) (e.g., enalapril, lisinopril, ramipril), particularly if you have kidney problems related to diabetes.
• aliskiren
  • 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 TecniGen, seek medical attention 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 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 TecniGen”

• If you have had skin cancer or if you develop an unexpected skin lesion during treatment. Treatment with hydrochlorothiazide, particularly 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 TecniGen.

If you are pregnant, think you may be pregnant, or are planning to become pregnant, inform your doctor. It is not recommended to use Irbesartan/Hydrochlorothiazide TecniGen at the start of pregnancy (first 3 months), and in no case should it be administered after the third month of pregnancy, as it may cause serious harm to your baby (see section Pregnancy).

You must also inform your doctor:

• if you are on a low-salt diet
• if you experience any of the following symptoms: feeling of thirst, dry mouth, weakness, feeling of sleepiness, muscle pain or cramps, nausea, vomiting, or rapid heartbeat, as they may indicate an excessive effect of hydrochlorothiazide (contained in Irbesartan/Hydrochlorothiazide TecniGen)
• 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 intervention) or if you are going to be given anesthetics.
• if you experience changes in your vision or pain in one or both eyeswhile taking Irbesartan/Hydrochlorothiazide. This could be a sign of glaucoma, fluid accumulation in the vascular layer of the eye (choroidal effusion), or increased pressure in your eyes. You should stop taking Irbesartan/Hydrochlorothiazide and seek medical attention.

Athletes:

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

Children and adolescents

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

Use of other medicines

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

Diuretics, such as hydrochlorothiazide contained in Irbesartan/Hydrochlorothiazide TecniGen, may interact with other medicines. You should not take preparations containing lithium with Irbesartan/Hydrochlorothiazide TecniGen 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 TecniGen” 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)
• carbamazepine (a medicine for the treatment of epilepsy)

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

• other medicines to lower your blood pressure
• corticosteroids
• medicines to treat cancer
• analgesics
• medicines for arthritis
• cholestyramine or colestipol resins to reduce blood cholesterol levels.

Taking Irbesartan/Hydrochlorothiazide TecniGen with food, drinks, and alcohol

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

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

Pregnancy, breastfeeding, and fertility

If you are pregnant, breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using this medicine.

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 TecniGen before you become pregnant or as soon as you find out you are pregnant and will recommend that you take a different blood pressure-lowering medicine instead. It is not recommended to use Irbesartan/Hydrochlorothiazide TecniGen at the start of pregnancy and in no case should it be administered after the third month of pregnancy, as it may cause serious harm to your baby when administered after this time.

Breastfeeding

Tell your doctor if you are about to start or are breastfeeding, as it is not recommended to administer Irbesartan/Hydrochlorothiazide TecniGen to women during this period. Your doctor may decide to give you a treatment that is more suitable if you want to breastfeed, especially 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 TecniGen 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, talk to your doctor before driving or using machines.

Irbesartan/Hydrochlorothiazide TecniGen contains lactose. If your doctor has told you that you have an intolerance to some sugars, consult them 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 TecniGen

Follow exactly the instructions of administration of this medicine given by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist again.

Dose

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

Method of administration

Irbesartan/Hydrochlorothiazide TecniGen 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 TecniGen 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 TecniGen until your doctor advises you to stop.

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

The score line is only to facilitate breaking the tablet if you have difficulty swallowing it whole.

If you take more Irbesartan/Hydrochlorothiazide TecniGen than you should

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

Children should not take Irbesartan/Hydrochlorothiazide TecniGen

Irbesartan/Hydrochlorothiazide TecniGen 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 TecniGen

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 forgotten doses.

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

4. Possible Adverse Effects

Like all medicines, this medicine can cause 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 skin reactions (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 experience any of the above symptoms or have difficulty breathing, stop taking Irbesartan/Hydrochlorothiazide TecniGen and contact your doctor immediately.

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

Common: may affect up to 1 in 10 people

Uncommon: may affect up to 1 in 100 people

Adverse effects reported in clinical studies for patients treated with Irbesartan/Hydrochlorothiazide TecniGen were:

Common Adverse Effects(may affect up to 1 in 10 people):

• 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 substances that measure kidney function (urea nitrogen in the blood, creatinine).

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

Uncommon Adverse Effects(may affect up to 1 in 100 people)

• diarrhea,
• low blood pressure,
• fainting,
• tachycardia,
• flushing,
• fluid retention (edema)
• sexual dysfunction (sexual function disorders).
• Blood tests may show low levels of sodium and potassium in your blood.

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

Adverse Effects Since the Marketing of Irbesartan/Hydrochlorothiazide TecniGen

Since the marketing of Irbesartan/Hydrochlorothiazide TecniGen, some adverse effects have been reported. Adverse effects with unknown frequency are: headache, ringing in the ears, cough, altered taste, indigestion, joint and muscle pain, liver function disorders, and kidney failure, high potassium levels in the blood, and allergic reactions such as skin rash, hives, swelling of the face, lips, mouth, tongue, or throat. Rare cases of jaundice (yellowing of the skin and/or whites of the eyes) have also been observed.

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

Adverse 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 adverse effects described above, chest pain and reduced platelet count (unknown frequency) have also been observed.

Adverse 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 stomach pain, often with nausea and vomiting; sleep disorders; depression; blurred vision; lack of white blood cells, which can lead to frequent infections, fever; decreased platelet count (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; blood vessel inflammation; 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; heart rhythm disorders; decreased 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 uric acid levels in the blood, which can cause gout.

Very rare (may affect up to 1 in 10,000 people): Acute respiratory distress (signs include severe respiratory distress, fever, weakness, and confusion).

Frequency "not known": 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 effusion) or acute angle-closure glaucoma].

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

Reporting of Adverse Effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, 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. Website: 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 TecniGen

Keep this medicine out of sight and reach of children.

Do not use this medicine 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 medicine does not require special storage conditions.

Medicines should not be thrown away through wastewater or household waste. Deposit the packaging and unused medicines in the SIGRE Point of the pharmacy. In case of doubt, ask your pharmacist where to throw away unused medicines. This way, you will help protect the environment.

6. Package Contents and Additional Information

Composition of Irbesartan/Hydrochlorothiazide TecniGen

• The active ingredients are irbesartan and hydrochlorothiazide. Each tablet of Irbesartan/Hydrochlorothiazide TecniGen 300 mg/12.5 mg 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 Package Contents

The tablets of Irbesartan/Hydrochlorothiazide TecniGen 300 mg/12.5 mg are pink/light pink, convex, and oblong.

Irbesartan/Hydrochlorothiazide TecniGen 300 mg/12.5 mg tablets are available in blister packs of 14, 28, or 56 tablets.

Only some package sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Tecnimede España Industria Farmacéutica, S.A.

Avda. de Bruselas, 13, 3º D. Edificio América. Polígono Arroyo de la Vega,

28108 Alcobendas (Madrid) SPAIN

Manufacturer

Atlantic Pharma – Produções Farmacêuticas, S.A.

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

Date of the Last Revision of this Prospectus: 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/