Losartan/hydrochlorothiazide Tecnigen 50/12.5 mg film-coated tablets EFG

Patient Information Leaflet

Introduction

Patient Information Leaflet

Losartan/Hydrochlorothiazide TecniGen 50 mg/12.5 mg film-coated tablets EFG

Losartan/Hydrochlorothiazide

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

• Keep this leaflet, as you may need to refer to it again.
• If you have any questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you and should not be given to other people, even if they have the same symptoms as you, since it could harm them.
• If you experience any side effects, consult your doctor, pharmacist, or nurse, even if the side effects are not listed in this leaflet. See section 4.

Contents of the leaflet:

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

1. What LOSARTAN/HYDROCHLOROTHIAZIDE TECNIGEN is and what it is used for

Losartan/Hydrochlorothiazide TecniGen is a combination of an angiotensin II receptor antagonist (losartan) and a diuretic (hydrochlorothiazide).

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

2. BEFORE TAKING LOSARTAN/HYDROCHLOROTHIAZIDE TECNIGEN

Do not take Losartan/Hydrochlorothiazide TecniGen

• if you are allergic to losartan, hydrochlorothiazide, or any of the other ingredients of this medicine (listed in section 6).
• if you are allergic (hypersensitive) to other sulfonamide-derived substances (e.g., other thiazides, certain antibiotics such as cotrimoxazole; ask your doctor if you are unsure).
• if you are more than 3 months pregnant. (It is also advisable to avoid Losartan/Hydrochlorothiazide TecniGen during the first months of pregnancy (see Pregnancy section)).
• if you have severe liver impairment.
• if you have severe renal impairment or your kidneys are not producing urine.
• if you have low levels of potassium or sodium, or high levels of calcium that cannot be corrected with treatment.
• if you have gout.
• if you have diabetes or kidney impairment and are being treated with a blood pressure-lowering medicine containing aliskiren.

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting Losartan/Hydrochlorothiazide TecniGen

If you experience blurred vision or eye pain, these could be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or increased intraocular pressure, which may occur within hours to a week after taking losartan/hydrochlorothiazide.

Inform your doctor if you are pregnant (or suspect you may be). Use of Losartan/Hydrochlorothiazide TecniGen is not recommended during early pregnancy, and you must not take it after the third month of pregnancy, as it may cause serious harm to your baby when used from that point onward (see Pregnancy section).

It is important that you inform your doctor before taking Losartan/Hydrochlorothiazide TecniGen:

• if you have previously experienced swelling of the face, lips, tongue, or throat

• if you are taking diuretics (medicines to increase urine output)

• if you are on a low-salt diet

• if you have or have had excessive vomiting and/or diarrhea

• if you have heart failure

• if your liver function is impaired (see section 2. Do not take Losartan/Hydrochlorothiazide TecniGen)

• if you have narrowing of the arteries supplying the kidneys (renal artery stenosis), only one functioning kidney, or have recently undergone a kidney transplant

• if you have narrowed arteries (atherosclerosis), angina pectoris (chest pain due to poor heart function)

• if you have aortic or mitral valve stenosis (narrowing of heart valves) or hypertrophic cardiomyopathy (a condition causing thickening of the heart muscle)

• if you are diabetic

• if you have had gout

• if you have or have had an allergic disorder, asthma, or a condition causing joint pain, skin rash, and fever (systemic lupus erythematosus)

• if you have high calcium levels or low potassium levels, or if you are on a low-potassium diet

• if you require anesthesia (even at the dentist) or before surgery, or if you are undergoing tests to assess parathyroid function, you must inform the doctor or healthcare provider that you are taking losartan potassium and hydrochlorothiazide tablets

• if you have primary hyperaldosteronism (a syndrome associated with excessive secretion of the hormone aldosterone by the adrenal gland due to adrenal dysfunction)

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

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

• aliskiren

  • if you have had skin cancer or 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 sun exposure and UV radiation while taking this medicine.
  • if you have had respiratory or pulmonary problems (such as inflammation or fluid in the lungs) after taking hydrochlorothiazide in the past. If you develop shortness of breath or severe difficulty breathing after taking Losartan/Hydrochlorothiazide TecniGen, seek medical attention immediately.

Consult your doctor if you experience abdominal pain, nausea, vomiting, or diarrhea after taking losartan/hydrochlorothiazide. Your doctor will decide whether to continue treatment. Do not stop taking losartan/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 information under the heading “Do not take Losartan/Hydrochlorothiazide TecniGen”

Taking Losartan/Hydrochlorothiazide TecniGen with other medicines

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

Diuretics such as hydrochlorothiazide contained in Losartan/Hydrochlorothiazide TecniGen can interact with other medicines. Lithium-containing preparations should not be taken with Losartan/Hydrochlorothiazide TecniGen unless your doctor performs careful monitoring. Special precautionary measures (e.g., blood tests) may be necessary if you are taking potassium supplements, potassium-containing salt substitutes, potassium-sparing diuretics, other diuretics (water tablets), certain laxatives, gout medications, medicines to control heart rhythm, or diabetes medications (oral agents or insulin). It is also important that your doctor knows if you are taking other blood pressure-lowering medicines, steroids, cancer treatments, painkillers, antifungal medicines, arthritis medications, cholesterol-lowering resins such as cholestyramine, muscle relaxants, sleeping tablets, opioid medicines such as morphine, pressor amines such as adrenaline, or other medicines in the same class, or oral antidiabetic medicines or insulin.

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 information under the headings “Do not take Losartan/Hydrochlorothiazide TecniGen” and “Warnings and precautions”)

Please inform your doctor when undergoing iodinated contrast media procedures while taking Losartan/Hydrochlorothiazide TecniGen.

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

You are advised not to drink alcohol while taking these tablets: alcohol and Losartan/Hydrochlorothiazide TecniGen tablets may enhance each other's effects.

Excessive dietary salt intake may counteract the effect of Losartan/Hydrochlorothiazide TecniGen tablets.

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

Pregnancy, fertility, and breastfeeding

Pregnancy

Inform your doctor if you are pregnant (or suspect you may be). Your doctor will usually advise you to stop taking Losartan/Hydrochlorothiazide TecniGen before becoming pregnant or as soon as you know you are pregnant, and will recommend an alternative medicine. Use of Losartan/Hydrochlorothiazide TecniGen is not recommended during early pregnancy, and must not be used after the third month of pregnancy, as it may cause serious harm to your baby from that stage onward.

Breastfeeding:

Inform your doctor if you are breastfeeding or planning to breastfeed. Use of Losartan/Hydrochlorothiazide TecniGen is not recommended during breastfeeding, and your doctor will choose an alternative treatment if you intend to breastfeed.

Consult your doctor or pharmacist before using any medicine.

Use in pediatric and adolescent populations

There is no experience with the use of Losartan/Hydrochlorothiazide in children. Therefore, Losartan/Hydrochlorothiazide TecniGen must not be administered to children.

Use in elderly patients

Losartan/Hydrochlorothiazide TecniGen is equally effective and well tolerated in most elderly and younger patients. Most elderly patients require the same dosage as younger patients.

Driving and use of machines

When starting treatment with this medicine, do not perform tasks that require special attention (e.g., driving a car or operating dangerous machinery) until you know how you react to the medicine.

Losartan/Hydrochlorothiazide TecniGen contains lactose

If your doctor has informed you that you have an intolerance to certain sugars, consult with him before taking this medicine.

Use in athletes:

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

3. HOW TO TAKE LOSARTAN/HYDROCHLOROTHIAZIDE TECNIGEN

Follow exactly the instructions for use of this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Your doctor will decide the appropriate dose of Losartan/Hydrochlorothiazide TecniGen based on your condition and whether you are taking other medications. It is important to continue taking Losartan/Hydrochlorothiazide TecniGen as prescribed by your doctor to maintain consistent blood pressure control.

High blood pressure

For most patients with high blood pressure, the usual dose is 1 tablet of losartan/hydrochlorothiazide 50 mg/12.5 mg once daily to control blood pressure over 24 hours. This dose may be increased to 2 film-coated tablets of losartan/hydrochlorothiazide 50 mg/12.5 mg per day or switched to 1 film-coated tablet of losartan/hydrochlorothiazide 100 mg/25 mg (a stronger dose) per day. The maximum daily dose is 2 tablets of 50 mg losartan/12.5 mg hydrochlorothiazide per day or 1 tablet of 100 mg losartan/25 mg hydrochlorothiazide per day.

If you take more Losartan/Hydrochlorothiazide TecniGen than you should

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

In the event of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medication and the amount ingested.

Overdose may cause low blood pressure, palpitations, slow pulse, changes in blood composition, and dehydration.

If you forget to take Losartan/Hydrochlorothiazide TecniGen

Try to take Losartan/Hydrochlorothiazide TecniGen daily as prescribed. However, if you miss a dose, do not take an extra dose. Simply return to your regular dosing schedule.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

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

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

This is a serious but rare adverse effect, affecting more than 1 in 10,000 patients but less than 1 in 1,000. It may require urgent medical attention or hospitalization.

The following adverse effects have been reported:

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

• Cough, respiratory infection, nasal congestion, sinusitis, sinus 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 abnormal heart rhythm), decreased hemoglobin levels,
• Changes in kidney function including kidney failure,
• Blood sugar too low (hypoglycemia)

Uncommon (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 hands and feet and abdominal pain), bruising, reduction in white blood cells, bleeding problems, reduced platelet count,
• Loss of appetite, elevated uric acid levels or overt gout, elevated blood glucose levels, abnormal blood electrolyte levels,
• Anxiety, nervousness, panic disorders (recurrent panic attacks), confusion, depression, abnormal dreams, sleep disorders, drowsiness, memory disturbance,
• Tingling or similar sensations, limb pain, tremor, migraine, fainting,
• Blurred vision, burning or itching in the eyes, conjunctivitis, worsening of vision, seeing things in yellow,
• Ringing, buzzing, noises or crackling in the ears, vertigo,
• Low blood pressure which may be associated with postural changes (feeling dizzy or weak when standing up), angina (chest pain), abnormal heartbeats, stroke (transient ischemic attack, "mini-stroke"), heart attack, palpitations,
• Inflammation of blood vessels often associated with a skin rash or bruising,
• Sore throat, shortness of breath, bronchitis, pneumonia, fluid in the lungs (which may cause difficulty breathing), nosebleed, runny nose, congestion,
• Constipation, chronic constipation, flatulence, stomach disorders, stomach spasms, vomiting, dry mouth, inflammation of a salivary gland, toothache,
• Jaundice (yellowing of the eyes and skin), inflammation of the pancreas,
• Urticaria, itching, skin inflammation, skin rash, skin redness, photosensitivity, dry skin, flushing, sweating, hair loss,
• Pain in arms, shoulders, hips, knees or other joints, joint swelling, stiffness, muscle weakness,
• Frequent urination including at night, abnormal kidney function including kidney inflammation, urinary tract infection, sugar in the urine,
• Decreased sexual appetite, impotence,
• Facial swelling, localized swelling (edema), fever.

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

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

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

• Acute breathing difficulty (signs include severe shortness of breath, fever, weakness and confusion).

Not known (frequency cannot be estimated from available data):

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

Reporting of adverse effects:

If you experience any 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: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of LOSARTAN/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 packaging after EXP. The expiry date refers to the last day of the month indicated.

Do not store above 30°C.

Store Losartan/Hydrochlorothiazide TecniGen in the original packaging.

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

Medicines must not be disposed of via wastewater or household waste. Return unused medicines and their containers to the SIGRE point at your pharmacy. If you are in doubt, ask your pharmacist how to dispose of medicines and containers you no longer need. This helps protect the environment.

6. ADDITIONAL INFORMATION

Composition of Losartán/Hidroclorotiazida TecniGen

The active substances are losartan potassium and hydrochlorothiazide.

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

Losartán/Hidroclorotiazida TecniGen 50 mg/12.5 mg film-coated tablets contain the following inactive ingredients: monohydrate lactose (lactose), microcrystalline cellulose, hydroxypropyl cellulose, pregelatinized corn starch (corn starch), 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 film-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 white, oblong, film-coated tablets, scored on one side.

Losartán/Hidroclorotiazida TecniGen 50 mg/12.5 mg film-coated tablets are supplied in packs of 28 tablets.

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 SA

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

Date of the most recent review of this leaflet: February 2025

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