Irbesartan/hydrochlorothiazide Tecnigen 300 mg/12.5 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Irbesartan/Hydrochlorothiazide TecniGen 300 mg/12.5 mg film-coated tablets EFG

Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms of illness, as it may harm them.
• If you experience any adverse reactions, consult your doctor, pharmacist, or nurse, even if they are adverse reactions not listed in this leaflet. See section 4.

Leaflet contents:

1. What Irbesartan/Hydrochlorothiazide TecniGen is and what it is used for
2. What you need to know before taking Irbesartan/Hydrochlorothiazide TecniGen
3. How to take Irbesartan/Hydrochlorothiazide TecniGen
4. Possible side effects
5. How to store Irbesartan/Hydrochlorothiazide TecniGen
6. Contents of the pack and other information

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

Irbesartan/Hydrochlorothiazide TecniGen 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 in the body that binds to receptors in blood vessels, causing them to constrict. This leads to an increase in blood pressure.

Irbesartan prevents angiotensin-II from binding to these receptors, relaxing blood vessels and thereby reducing blood pressure.

Hydrochlorothiazide belongs to a group of medicines (called thiazide diuretics) that lower blood pressure by increasing the amount of urine produced. The two active substances in Irbesartan/Hydrochlorothiazide TecniGen work together to achieve a greater reduction in blood pressure than either of them alone.

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

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

Do not take Irbesartan/Hydrochlorothiazide TecniGen

• if you are allergic to irbesartan or any of the other ingredients of this medicine (listed in section 6).
• if you are allergic to hydrochlorothiazide or to any other sulfonamide-derived medicine
• if you are more than 3 months pregnant. (In any case, it is better to avoid taking this medicine also during early pregnancy – see Pregnancy section)
• if you have severe liver or kidney problems
• if you have difficulty urinating
• if your doctor finds you have persistently high levels of calcium or low levels of potassium in your blood
• if you have diabetes or renal failure and are being treated with a blood pressure-lowering medicine containing aliskiren

Warnings and precautions

Talk to your doctor, pharmacist, or nurse before taking Irbesartan/Hydrochlorothiazide TecniGen

Tell your doctor if any of the following apply to you:

• if you have excessive vomiting or diarrhoea

• 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 SLE)

• if you have primary hyperaldosteronism (a condition involving excessive production of the hormone aldosterone, leading to sodium retention and, consequently, increased blood pressure).

• if you are taking any of the following medicines used to treat high blood pressure (hypertension):

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

• aliskiren

  • if you have previously experienced respiratory or lung problems (such as inflammation or fluid in the lungs) after taking hydrochlorothiazide. If you develop 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 diarrhoea after taking irbesartan/hydrochlorothiazide. Your doctor will decide whether to continue treatment. Do not stop taking irbesartan/hydrochlorothiazide monotherapy without medical advice.

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 non-melanoma skin cancer and lip cancer. Protect your skin from exposure to sunlight and UV rays while taking Irbesartan/Hydrochlorothiazide TecniGen.

If you are pregnant, suspect you may be pregnant, or plan to become pregnant, you must inform your doctor. The use of Irbesartan/Hydrochlorothiazide TecniGen is not recommended during early pregnancy (first 3 months), and must not be used from the third month of pregnancy onwards, as it may cause severe harm to your baby (see Pregnancy section).

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, generalised weakness, drowsiness, muscle pain or cramps, nausea, vomiting, or rapid heartbeat, as these may indicate an excessive effect of hydrochlorothiazide (contained in Irbesartan/Hydrochlorothiazide TecniGen)
• if you experience increased skin sensitivity to sunlight with sunburn symptoms (such as redness, itching, swelling, blisters) occurring more quickly than usual
• if you are going to have surgery (operation) or will be given anaesthetics.
• if you experience changes in vision or pain in one or both eyes while taking Irbesartan/Hydrochlorothiazide. This could be a sign of developing glaucoma, fluid accumulation in the vascular layer of the eye (choroidal effusion), or increased eye pressure. You must stop treatment with Irbesartan/Hydrochlorothiazide and seek medical help immediately.

Use in athletes:

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

Children and adolescents

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

Taking other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

Diuretics such as hydrochlorothiazide contained in Irbesartan/Hydrochlorothiazide TecniGen may affect other medicines. You must not take preparations containing lithium together with Irbesartan/Hydrochlorothiazide TecniGen without medical supervision.

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

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

You may need blood tests if you are taking:

• potassium supplements
• salt substitutes containing potassium
• potassium-sparing medicines 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 insulin)
• carbamazepine (a medicine used to treat epilepsy)

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

• other medicines to lower your blood pressure
• steroids
• cancer treatment medicines
• painkillers
• medicines for arthritis
• cholestyramine or colestipol resins to reduce blood cholesterol.

Taking Irbesartan/Hydrochlorothiazide TecniGen with food, drink, 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 taking this medicine, you may experience increased dizziness upon standing, especially when rising from a sitting position.

Pregnancy, breastfeeding, and fertility

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

Pregnancy

Inform your doctor if you are pregnant, suspect you may be pregnant, or plan to become pregnant. Your doctor will generally advise you to stop taking Irbesartan/Hydrochlorothiazide TecniGen before becoming pregnant or as soon as pregnancy occurs, and will recommend an alternative antihypertensive medicine. Irbesartan/Hydrochlorothiazide TecniGen is not recommended during early pregnancy and must not be used from the third month of pregnancy onwards, as it may cause severe harm to your baby when used from that stage.

Breastfeeding

Inform your doctor if you are planning to breastfeed or are currently breastfeeding, as Irbesartan/Hydrochlorothiazide TecniGen is not recommended for women during this period. Your doctor may choose a treatment more suitable for breastfeeding, especially if the infant is a newborn or premature.

Driving and using machines

No studies have been conducted on the ability to drive or operate machinery. It is unlikely that Irbesartan/Hydrochlorothiazide TecniGen affects your ability to drive or use machines. However, dizziness or fatigue may occasionally occur during antihypertensive treatment. If you experience these symptoms, speak with your doctor before driving or operating machinery.

Irbesartan/Hydrochlorothiazide TecniGen contains lactose. If your doctor has diagnosed you with an intolerance to certain sugars, consult him 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 for use of this medicine as provided by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Dosage

The recommended dose of Irbesartan/Hydrochlorothiazide TecniGen is one or two tablets daily. Generally, your doctor will prescribe Irbesartan/Hydrochlorothiazide TecniGen when previous treatments have not sufficiently lowered your blood pressure. Your doctor will advise you on 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 may 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 otherwise.

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

The tablet score is intended solely for splitting the tablet if you find it difficult to swallow it whole.

If you take more Irbesartan/Hydrochlorothiazide TecniGen than you should

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

Children must not take Irbesartan/Hydrochlorothiazide TecniGen

Irbesartan/Hydrochlorothiazide TecniGen must not be given to children under 18 years of age. If a child swallows any tablets, contact your doctor immediately.

If you forget to take Irbesartan/Hydrochlorothiazide TecniGen

If you accidentally miss a dose, simply take your next dose at the usual time. Do not take a double dose to make up for missed doses.

If you have any further questions about 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 everyone will experience them. Some of these effects may be serious and may require immediate medical attention.

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

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

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

Frequent: 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 Irbesartán/Hidroclorotiazida TecniGen were:

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

• nausea/vomiting,
• abnormalities in urination,
• fatigue,
• dizziness (including dizziness upon 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 (blood urea nitrogen, 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,
• swelling due to fluid retention (edema),
• sexual dysfunction (disturbances in sexual function).
• 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 reported since marketing of Irbesartán/Hidroclorotiazida TecniGen

Since the marketing of Irbesartán/Hidroclorotiazida TecniGen, some adverse effects have been reported. The adverse effects observed with unknown frequency include: headache, tinnitus, cough, altered taste, indigestion, joint and muscle pain, liver function abnormalities and kidney failure, elevated potassium levels in the blood, and allergic reactions such as rash, urticaria, 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 fixed-dose combinations of two active substances, adverse effects associated with each individual component cannot be excluded.

Adverse effects associated solely with irbesartan

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

In addition to the adverse effects described above, chest pain and reduced platelet count have also been observed (frequency not known).

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); inflammation of the pancreas characterized by severe upper abdominal pain, often with nausea and vomiting; sleep disorders; depression; blurred vision; low white blood cell count, which may lead to frequent infections and fever; reduced platelet count (blood cells essential for blood clotting), reduced red blood cell count (anaemia) characterized by fatigue, headaches, shortness of breath during exercise, dizziness and paleness; kidney disease; lung disorders including pneumonia or fluid accumulation in the lungs; increased skin sensitivity to sunlight; 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; weakness and muscle cramps; irregular heartbeat; drop in blood pressure after a change in body position; swelling of the salivary glands; high blood sugar levels; sugar in urine; increases in certain types of blood fats; high levels of uric acid in the blood, which may cause gout.

Very rare (may affect up to 1 in 10,000 people): Acute breathing difficulty (symptoms include severe shortness of breath, fever, weakness and confusion).

Frequency not known: Skin and lip cancer (non-melanoma skin cancer). 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].

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

Reporting of adverse effects

If you experience any type of adverse effect, talk to your doctor, pharmacist or nurse, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines. Website: www.notificaram.es.

By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Irbesartan/Hydrochlorothiazide TecniGen

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

Do not use this medicine after the expiry date stated on the carton and on the blister pack after EXP.

The expiry date refers to the last day of the stated month.

This medicine does not require any special storage conditions.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their packaging at the SIGRE Point in your pharmacy. If in doubt, ask your pharmacist where to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

Composition of Irbesartan/Hydrochlorothiazide TecniGen

• The active substances 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 monohydrate lactose, microcrystalline cellulose, hypromellose, sodium croscarmellose and magnesium stearate (core). Monohydrate lactose, hypromellose 15 cP, macrogol 3350, titanium dioxide (E171), yellow and red iron oxides (E172) (coating).

Appearance of the medicine and contents of the pack

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

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

Only certain pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation 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 most recent revision of this leaflet: February 2025

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