LOSARTAN/HYDROCHLOROTHIAZIDE TECNIGEN 100/25 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Losartan/Hydrochlorothiazide TecniGen 100 mg/25 mg film-coated tablets EFG

Losartan/Hydrochlorothiazide

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.:

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack:

1. What is Losartan/Hydrochlorothiazide TecniGen and what is it used for
2. What you need to know before you take Losartan/Hydrochlorothiazide TecniGen
3. How to take Losartan/Hydrochlorothiazide TecniGen
4. Possible side effects

5 Storage of Losartan/Hydrochlorothiazide TecniGen

1. Contents of the pack and further information

1. What is Losartan/Hydrochlorothiazide TecniGen and what is it 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. What you need to know before you take 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, some antibacterials such as cotrimoxazole, ask your doctor if you are not sure).
• If you are pregnant for more than 3 months. (It is also best to avoid Losartan/Hydrochlorothiazide TecniGen during the first months of pregnancy (see section on Pregnancy).
• if you have severe hepatic impairment.
• if you have severe renal impairment or your kidneys do not produce urine.
• if you have low potassium or sodium levels, high calcium levels that cannot be corrected with treatment.
• if you have gout.
• if you have diabetes or renal impairment and are being treated with a blood pressure-lowering medicine that contains aliskiren

Warnings and precautions

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

If you experience a decrease in vision or eye pain, they could 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 losartan/hydrochlorothiazide.

Inform your doctor if you are pregnant (or if you think you may be). Losartan/Hydrochlorothiazide TecniGen is not recommended during the first trimester of pregnancy, and it must not be taken if you are pregnant for more than 3 months as it may cause serious harm to your baby when administered from that time on (see section on Pregnancy).

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

• if you have previously suffered from swelling of the face, lips, tongue, or throat
• if you are taking diuretics (water pills)
• if you are on a low-salt 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 Losartan/Hydrochlorothiazide TecniGen)
• if you have narrowed arteries supplying the kidneys (renal artery stenosis), if you only have one functioning kidney, or if you have recently had a kidney transplant
• if you have narrowing of the arteries (arteriosclerosis), angina pectoris (chest pain due to poor heart function)
• if you have narrowing of the aortic or mitral valve (heart valve narrowing) or hypertrophic cardiomyopathy (a disease that causes thickening of the heart valves)
• if you are diabetic
• if you have had gout
• if you have had an allergic disorder, asthma, or a condition that causes 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 need to be given anesthesia (even at the dentist) or before surgery, or if you are going to have tests to determine your parathyroid function, you should inform your doctor or healthcare professional that you are taking losartan potassium and hydrochlorothiazide tablets
• if you have primary hyperaldosteronism (a syndrome associated with high secretion of the hormone aldosterone by the adrenal gland due to a disorder of this gland).
• if you are taking any of the following medicines used to treat high blood pressure (hypertension):

• an angiotensin-converting enzyme inhibitor (ACE inhibitor) (e.g., enalapril, lisinopril, ramipril), particularly if you have diabetic-related kidney problems.
• aliskiren
  • if you have had skin cancer or if you develop an unexpected skin lesion during treatment. Treatment with hydrochlorothiazide, especially 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 this medicine.
  • 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 severe shortness of breath or 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 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 Losartan/Hydrochlorothiazide TecniGen”

Taking Losartan/Hydrochlorothiazide TecniGen with other medicines

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

Diuretics like hydrochlorothiazide contained in Losartan/Hydrochlorothiazide TecniGen may interact with other medicines. Preparations containing lithium should not be taken with Losartan/Hydrochlorothiazide TecniGen without your doctor's careful monitoring. Special precautions may be necessary (e.g., blood tests) if you take potassium supplements, salt substitutes that contain potassium, or potassium-sparing medicines, diuretics (water pills), certain laxatives, medicines for treating gout, medicines for controlling heart rhythm or diabetes (oral or insulin), or other blood pressure-lowering medicines.

It is also important that your doctor knows if you are taking other medicines to lower your blood pressure, steroids, cancer medicines, painkillers, antifungal medicines, or arthritis medicines, cholesterol-lowering medicines such as colestyramine, muscle relaxants, sleeping pills; opioid medicines like morphine, "pressor amines" like adrenaline or other medicines in the same group; (oral diabetes medicines or insulins).

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 Losartan/Hydrochlorothiazide TecniGen” and “Warnings and precautions”)

Please, when taking Losartan/Hydrochlorothiazide TecniGen, inform your doctor when you are scheduled to have a contrast medium with iodine.

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

It is recommended that you do not drink alcohol while taking these tablets: alcohol and Losartan/Hydrochlorothiazide TecniGen tablets may increase each other's effects.

Excessive salt in the diet may counteract the effect of Losartan/Hydrochlorothiazide TecniGen tablets.

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

Pregnancy, fertility, and breastfeeding

Pregnancy

You should inform your doctor if you are pregnant (or if you think you may be). Your doctor will generally advise you to stop taking Losartan/Hydrochlorothiazide TecniGen before you become pregnant or as soon as you know you are pregnant and will recommend that you take another medicine instead of Losartan/Hydrochlorothiazide TecniGen. Losartan/Hydrochlorothiazide TecniGen is not recommended during the first trimester of pregnancy, and it must not be taken if you are pregnant for more than 3 months as it may cause serious harm to your baby when administered from that time on.

Breastfeeding:

Inform your doctor if you are breastfeeding or plan to start breastfeeding. Losartan/Hydrochlorothiazide TecniGen is not recommended during breastfeeding, and your doctor will choose another treatment for you if you want to breastfeed.

Consult your doctor or pharmacist before using any medicine.

Use in pediatric population and adolescents

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

Use in elderly patients

Losartan/Hydrochlorothiazide TecniGen works as effectively and is as well tolerated by most elderly patients as it is by younger patients. Most elderly patients require the same dose as younger patients.

Driving and using machines

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

Losartan/Hydrochlorothiazide TecniGen contains lactose

If your doctor has told you that you have an intolerance to some sugars, consult them before taking this medicine.

Use in athletes:

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

3. How to take Losartan/Hydrochlorothiazide TecniGen

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

Your doctor will decide the appropriate dose of Losartan/Hydrochlorothiazide TecniGen, depending on your condition and whether you are taking other medicines. It is essential to keep taking Losartan/Hydrochlorothiazide TecniGen as long as your doctor prescribes it to maintain constant control of your blood pressure.

High blood pressure

For most patients with high blood pressure, the usual dose is one losartan/hydrochlorothiazide 50 mg/12.5 mg tablet per day to control blood pressure for 24 hours. It can be increased to two losartan/hydrochlorothiazide 50 mg/12.5 mg film-coated tablets per day or changed to one losartan/hydrochlorothiazide 100 mg/25 mg film-coated tablet (a stronger dose) per day. The maximum daily dose is two losartan 50 mg/hydrochlorothiazide 12.5 mg tablets per day or one losartan 100 mg/hydrochlorothiazide 25 mg tablet 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 for immediate medical attention.

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 ingested.

Overdose may cause a drop in 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 as prescribed every day. However, if you forget a dose, do not take an extra dose. Simply return to your regular schedule.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

If you experience the following, stop taking Losartan/Hydrochlorothiazide TecniGen tablets and inform your doctor immediately or go to the emergency department of your nearest hospital:

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

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

The following side 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,
• High potassium levels (which can cause an abnormal heart rhythm), decrease in hemoglobin levels
• Changes in kidney function including kidney failure
• Low blood sugar (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 the hands and feet, and abdominal pain), bruising, reduced white blood cell count, coagulation problems, reduced platelet count,

• Loss of appetite, high uric acid levels or gout, high blood sugar levels, abnormal blood electrolyte levels,
• Anxiety, nervousness, panic disorders (recurrent panic attacks), confusion, depression, abnormal dreams, sleep disorders, somnolence, memory impairment,
• Numbness or similar sensations, pain in the limbs, tremor, migraine, fainting,
• Blurred vision, eye irritation or itching, conjunctivitis, worsening of vision, seeing things in yellow,
• Ringing, buzzing, noises, or clicking in the ears, vertigo
• Low blood pressure that may be associated with postural changes (feeling dizzy or weak when standing up), angina (chest pain), abnormal heartbeats, stroke (transient stroke, "mini-stroke"), heart attack, palpitations,
• Inflammation of blood vessels that is often associated with a skin rash or bruising,
• Sore throat, shortness of breath, bronchitis, pneumonia, fluid in the lungs (which can cause difficulty breathing), nosebleeds, runny nose, congestion,
• Constipation, chronic constipation, gas, stomach disorders, stomach spasms, vomiting, dry mouth, inflammation of a salivary gland, toothache,
• Jaundice (yellowing of the eyes and skin), pancreatitis,
• Hives, itching, skin inflammation, skin rash, redness of the skin, sensitivity to light, 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 kidney function including kidney inflammation, urinary tract infection, sugar in the urine,
• Decreased sexual desire, impotence,
• Swelling of the face, 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 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 (signs include severe shortness of breath, fever, weakness, and confusion).

Not known (frequency cannot be estimated from the 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 effusion) or acute angle-closure glaucoma].

Reporting of side effects:

If you experience any side effects, talk to your doctor, pharmacist, or nurse, even if it is possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side 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 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 Losartan/Hydrochlorothiazide TecniGen in its original packaging.

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

Medicines should not be disposed of via wastewater or household waste. Deposit the packaging and any unused medicines at the pharmacy's SIGRE point. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medicines. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Losartan/Hydrochlorothiazide TecniGen

The active ingredients are losartan potassium and hydrochlorothiazide.

Each Losartan/Hydrochlorothiazide TecniGen 100 mg/25 mg film-coated tablet contains, as active ingredients, 100 mg of losartan (potassium) and 25 mg of hydrochlorothiazide.

Losartan/Hydrochlorothiazide TecniGen 100 mg/25 mg film-coated tablets contain the following inactive ingredients: lactose monohydrate (lactose), microcrystalline cellulose, hydroxypropyl cellulose, pregelatinized corn starch (corn starch), and magnesium stearate.

Losartan/Hydrochlorothiazide TecniGen 100 mg/25 mg film-coated tablets contain 8.48 mg (0.216 mEq) of potassium.

Losartan/Hydrochlorothiazide TecniGen 100 mg/25 mg film-coated tablets also contain:

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

Product Appearance and Packaging Contents

Losartan/Hydrochlorothiazide TecniGen 100 mg/25 mg film-coated tablets are supplied as white, oblong, and scored film-coated tablets.

Losartan/Hydrochlorothiazide TecniGen 100 mg/25 mg film-coated tablets are supplied in packages 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 Last Revision of this Leaflet: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/