Package Insert: Information for the User

Losartán/Hidroclorotiazida TecniGen 50 mg/12.5 mg Film-Coated Tablets

Losartán/Hidroclorotiazida

Read this package insert carefully before starting to take the medicinebecause it contains important information for you:

• Keep this package insert, as you may need to read it again.
• If you have any doubts, consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed 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, pharmacist, or nurse, even if they are not listed in this package insert. See section 4.

5Storage of Losartán/Hidroclorotiazida TecniGen

6.Contents of the package and additional information

Losartán/Hidroclorotiazida TecniGen is a combination of an angiotensin II receptor antagonist (losartán) and a diuretic (hydrochlorothiazide).

Losartán/Hidroclorotiazida TecniGen is indicated for the treatment of essential hypertension (high blood pressure).

Do not take Losartán/Hidroclorotiazida TecniGen

• if you are allergic to losartan, hidroclorotiazida, or any of the other components of this medication (listed in section 6).
• if you are allergic (hypersensitive) to other sulfamida-derived substances (e.g. other thiazides, some antibacterians such as cotrimoxazol, ask your doctor if you are unsure).
• if you are more than 3 months pregnant. (It is better to avoid Losartán/Hidroclorotiazida TecniGen during the first months of pregnancy (see Pregnancy section).
• if you have severe liver failure.
• if you have severe kidney failure or your kidneys do not produce urine.
• if you have low levels of potassium or sodium, high levels of calcium that cannot be corrected with treatment.
• if you have gout.
• if you have diabetes or kidney failure and are being treated with a medication to lower blood pressure that contains aliskirén

Warnings and precautions

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

If you experience a decrease in vision or eye pain, they may be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or an increase in eye pressure and can occur within a few hours to a week after taking losartán/hidroclorotiazida.

Inform your doctor if you are pregnant (or if you suspect you may be). Losartán/Hidroclorotiazida TecniGen is not recommended for use at the beginning of pregnancy, and it should not be taken if you are more than 3 months pregnant as it may cause serious harm to your baby when administered from that point on (see Pregnancy section).

It is essential to inform your doctor before taking Losartán/Hidroclorotiazida TecniGen:

• if you have previously experienced swelling of the face, lips, tongue, or throat
• if you are taking diuretics (urine medications)
• if you follow a low-sodium diet
• if you have had excessive vomiting and/or diarrhea
• if you have heart failure
• if your liver function is altered (see section 2. Do not take Losartán/Hidroclorotiazida TecniGen)
• if you have narrowed arteries leading to the kidney (renal artery stenosis), if you only have one functioning kidney, or if you have recently had a kidney transplant
• if you have atherosclerosis (narrowing of the arteries), angina (chest pain due to heart dysfunction)
• if you have aortic or mitral valve stenosis (narrowing of the heart valves) or hypertrophic cardiomyopathy (a disease that causes thickening of the heart valves)
• if you are diabetic
• if you have had gout
• if you have or have had an allergic reaction, asthma, or a condition that causes joint pain, skin eruptions, and fever (systemic lupus erythematosus)
• if you have high levels of calcium or low levels of potassium or if you follow a low-potassium diet
• if you need anesthesia (even at the dentist) or before surgery, or if you are undergoing tests to determine your parathyroid function, inform your doctor or healthcare provider that you are taking losartan potassium and hydrochlorothiazide tablets
• if you have primary hyperaldosteronism (a syndrome associated with an elevated secretion of aldosterone hormone by the adrenal gland due to an alteration of this gland).
• if you are taking any of the following medications used to treat high blood pressure (hypertension):

- an angiotensin-converting enzyme inhibitor (ACE inhibitor) (e.g. 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 hydrochlorothiazide, 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 this medication.
• 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 taking Losartán/Hidroclorotiazida TecniGen, seek medical attention immediately.

Consult your doctor if you experience abdominal pain, nausea, vomiting, or diarrhea after taking losartán/hidroclorotiazida. Your doctor will decide whether to continue treatment. Do not stop taking losartán/hidroclorotiazida 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 Losartán/Hidroclorotiazida TecniGen”

Take Losartán/Hidroclorotiazida TecniGen with other medications

Inform your doctor or pharmacist if you are taking or have recently taken other medications, including those purchased without a prescription.

Diuretics like hydrochlorothiazide in Losartán/Hidroclorotiazida TecniGen may interact with other medications. Lithium preparations should not be taken with Losartán/Hidroclorotiazida TecniGen without your doctor's careful monitoring. Special precautions may be necessary (e.g. blood tests) if you take potassium supplements, salt substitutes containing potassium, or potassium-sparing medications, diuretics (urine tablets), some laxatives, medications for gout, medications to control heart rhythm or diabetes (oral medications or insulin). It is also essential for your doctor to know if you are taking other medications to lower your blood pressure, steroids, cancer medications, pain medications, fungal infection medications, or arthritis medications, cholesterol-lowering resins like cholestyramine, muscle relaxants, sleep aids; opioid medications like morphine, "pressor amines" like adrenaline, or other medications in the same group; (oral diabetes medications or insulin).

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

If you are taking an ACE inhibitor or aliskirén (see also the information under the headings “Do not take Losartán/Hidroclorotiazida TecniGen” and “Warnings and precautions”)

Please inform your doctor when you plan to have a contrast agent with iodine.

Take Losartán/Hidroclorotiazida TecniGen with food, drinks, and alcohol

It is recommended that you do not drink alcohol while taking these tablets: alcohol and Losartán/Hidroclorotiazida TecniGen tablets may increase the effects of each other.

Excessive salt in the diet may counteract the effect of Losartán/Hidroclorotiazida TecniGen tablets.

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

Pregnancy, fertility, and breastfeeding

Pregnancy

You must inform your doctor if you are pregnant (or if you suspect you may be). Your doctor will usually recommend that you stop taking Losartán/Hidroclorotiazida TecniGen before becoming pregnant or as soon as you know you are pregnant and will recommend that you take another medication instead of Losartán/Hidroclorotiazida TecniGen. Losartán/Hidroclorotiazida TecniGen is not recommended for use at the beginning of pregnancy, and in any case, it should not be administered from the third month of pregnancy as it may cause serious harm to your baby when administered from that point on.

Lactation:

Inform your doctor if you are breastfeeding or plan to start. Losartán/Hidroclorotiazida TecniGen is not recommended for use during lactation, and your doctor will choose another treatment for you if you wish to breastfeed.

Consult your doctor or pharmacist before using any medication.

Use in pediatric and adolescent populations

There is no experience with the use of Losartán/Hidroclorotiazida in children. Therefore, Losartán/Hidroclorotiazida TecniGen should not be administered to children.

Use in elderly patients

Losartán/Hidroclorotiazida TecniGen acts with equal efficacy and is equally well tolerated by most elderly and young patients. Most elderly patients require the same dose as younger patients.

Driving and operating machinery

When starting treatment with this medication, you should not perform tasks that require special attention (e.g. driving a car or operating hazardous machinery) until you know how you tolerate your medication.

Losartán/Hidroclorotiazida TecniGen contains lactose

If your doctor has indicated that you have a lactose intolerance, consult with them before taking this medication.

Use in athletes:

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

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

Your doctor will decide the appropriate dose of Losartán/Hidroclorotiazida TecniGen, depending on your condition and if you are taking other medications. It is important to continue taking Losartán/Hidroclorotiazida TecniGen as prescribed by your doctor to maintain constant blood pressure control.

Hypertension

For most patients with high blood pressure, the usual dose is 1 tablet of losartán/hidroclorotiazida 50 mg/12.5 mg per day to control blood pressure for 24 hours. The dose can be increased to 2 tablets of losartán/hidroclorotiazida 50 mg/12.5 mg per day or changed to 1 tablet of losartán/hidroclorotiazida 100 mg/25 mg (a higher dose) per day. The maximum daily dose is 2 tablets of 50 mg losartán/12.5 mg hidroclorotiazida per day or 1 tablet of 100 mg losartán/25 mg hidroclorotiazida per day.

If you take more Losartán/Hidroclorotiazida TecniGen than you should

In case of an overdose, contact your doctor immediately or go directly to the hospital for immediate medical attention.

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.

An overdose may cause a drop in blood pressure, palpitations, slow pulse, changes in blood composition, and dehydration.

If you forgot to take Losartán/Hidroclorotiazida TecniGen

Try to take Losartán/Hidroclorotiazida TecniGen at the same time each day as prescribed. However, if you miss a dose, do not take an extra dose. Simply return to your regular schedule.

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

If you experience any of the following, stop taking Losartán/Hidroclorotiazida TecniGen tablets and inform your doctor immediately or go to the emergency service of your nearest hospital:

Severe allergic reaction (skin rash, itching, swelling of the face, lips, mouth, or throat that may cause difficulty swallowing or breathing).

This is a serious but rare side effect that affects more than 1 in 10,000 patients but fewer than 1 in 1,000. You may need urgent medical attention or hospitalization.

The following side effects have been reported:

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

• Cough, respiratory infection, nasal congestion, sinusitis, breast disorder,
• Diarrhea, abdominal pain, nausea, indigestion,
• Muscle pain or cramps, leg pain, back pain,
• Insomnia, headache, dizziness,
• Weakness, fatigue, chest pain,
• Elevated potassium levels (which may cause an abnormal heart rhythm), decreased hemoglobin levels
• Changes in renal function, including renal insufficiency
• Low blood sugar (hypoglycemia)

Poorly frequent (may affect up to 1 in 100 people):

• Anemia, red or brown spots on the skin, (sometimes especially on the feet, legs, arms, and buttocks, with joint pain, swelling of the hands and feet, and abdominal pain), hematoma, reduced white blood cell count, coagulation problems, reduced platelet count,

• Loss of appetite, elevated uric acid levels or manifest gout, elevated blood glucose levels, abnormal electrolyte levels in the blood,
• Anxiety, nervousness, panic disorders (recurrent panic attacks), confusion, depression, abnormal dreams, sleep disorders, drowsiness, memory alteration,
• Tingling or similar sensations, pain in the extremities, tremor, migraine, fainting,
• Blurred vision, eye itching or stinging, conjunctivitis, worsening of vision, seeing things in yellow,
• Ringing, buzzing, sounds, or crackling in the ears, vertigo
• Low blood pressure that may be associated with changes in posture (feeling dizzy or weak when standing up), angina (chest pain), abnormal heartbeats, transient ischemic attack (mini-stroke), heart attack, palpitations,
• Inflammation of blood vessels that often occurs with a skin rash or hematoma,
• Sore throat, shortness of breath, bronchitis, pneumonia, fluid in the lungs (which may cause difficulty breathing), nasal bleeding, runny nose, congestion,
• Constipation, chronic constipation, gas, stomach disorders, stomach spasms, vomiting, dry mouth, salivary gland inflammation, tooth pain,
• Jaundice (yellow discoloration of the eyes and skin), pancreatitis inflammation,
• Urticaria, itching, skin inflammation, skin rash, skin redness, light sensitivity, dry skin, flushing, sweating, hair loss,
• Pain in the arms, shoulders, hips, knees, or other joints, joint swelling, stiffness, muscle weakness,
• Frequent urination even at night, abnormal renal function, including kidney inflammation, urinary tract infection, sugar in the urine,
• Decreased sexual appetite, impotence,
• Localized swelling (edema), fever.

Rare (may affect up to 1 in 1,000 people):

• Hepatitis (liver inflammation), abnormal liver function tests.
• Intestinal angioedema: swelling in the intestine that presents symptoms such as abdominal pain, nausea, vomiting, and diarrhea.

Very rare (may affect up to 1 in 10,000 people):

• Acute respiratory distress (symptoms include severe difficulty breathing, fever, weakness, and confusion).

Unknown (frequency cannot be estimated from available data):

• Muscle pain of unknown origin with dark-colored urine (tea-colored urine) (rhabdomyolysis),
• 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].

Reporting 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: https://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 packaging after CAD. The expiration date is the last day of the month indicated.

Do not store at a temperature above 30°C.

Store Losartán/Hidroclorotiazida TecniGen in the original packaging.

Keep the blister in the outer packaging. Do not open the blister until ready to take the tablet.

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

Composition of Losartán/Hidroclorotiazida TecniGen

The active principles are losartan potassium and hydrochlorothiazide.

Each Losartán/Hidroclorotiazida TecniGen 50 mg/12.5 mg coated tablet contains, as active principles, 50 mg of losartan (potassium) and 12.5 mg of hydrochlorothiazide.

Losartán/Hidroclorotiazida TecniGen 50 mg/12.5 mg coated tablets with film coating contain the following inactive ingredients: lactose monohydrate (lactose), microcrystalline cellulose, hydroxypropyl cellulose, pregelatinized cornstarch (cornstarch) and magnesium stearate.

Losartán/Hidroclorotiazida TecniGen 50 mg/12.5 mg contains 4.24 mg (0.108 mEq) of potassium.

Losartán/Hidroclorotiazida TecniGen 50 mg/12.5 mg coated tablets also contain:

Opadry Y-1-7000 White:hypromellose, titanium dioxide (E-171), polyethylene glycol 400.

Appearance of the product and contents of the package

Losartán/Hidroclorotiazida TecniGen 50 mg/12.5 mg tablets are supplied as coated tablets with film, white, oblong, and scored on one side.

Losartán/Hidroclorotiazida TecniGen 50 mg/12.5 mg coated tablets are supplied in packages of 28 tablets.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Tecnimede España Industria Farmacéutica, S.A.

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

28108 Alcobendas (Madrid) SPAIN

Responsible for manufacturing:

Atlantic Pharma – Produções Farmacêuticas SA

Rua da Tapada Grande nº 2, Abrunheira. 2710 – 089 Sintra (Portugal).

Date of the last review of this prospectus:February 2025

The detailed and updated information of this medication is available on the webpage of the Spanish Agency of Medicaments and Health Products (AEMPS)http://www.aemps.gob.es/