Losartan/hydrochlorothiazide Sandoz 100 mg/25 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Losartan/Hydrochlorothiazide Sandoz 100 mg/25 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 or pharmacist.
• This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents

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

1. What Losartán/Hidroclorotiazida Sandoz is and what it is used for

Losartán potásico belongs to a group of medicines called angiotensin-II receptor antagonists. These cause the blood vessels to relax, resulting in a reduction in blood pressure.

Hidroclorotiazida belongs to a group of medicines called diuretics. Hidroclorotiazida causes the kidneys to eliminate more salts. This also helps reduce blood pressure.

Losartán/Hidroclorotiazida 100 mg/25 mg is used to treat high blood pressure in patients who do not respond adequately to treatment with losartán/hidroclorotiazida 50 mg/12.5 mg.

2. What you need to know before taking Losartan/Hydrochlorothiazide Sandoz

Do not take Losartan/Hydrochlorothiazide Sandoz:

• if you are allergic to losartan, to hydrochlorothiazide, or to any of the other ingredients of this medicine (listed in section 6),
• if you are allergic to other sulfonamide-derived substances (e.g., other thiazides, certain antibacterial medicines 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 in early pregnancy – see section “Pregnancy”),
• if you have severe liver failure,
• if you have severe renal failure or your kidneys are not producing urine,
• if you have low levels of potassium or sodium, or high calcium levels that cannot be corrected with treatment,
• if you suffer from gout,
• if you have diabetes or kidney failure and are being treated with a blood pressure-lowering medicine containing aliskiren.

If you think any of the above conditions may apply to you, consult your doctor or pharmacist.

Warnings and precautions

Talk to your doctor or pharmacist before starting to take Losartan/Hydrochlorothiazide Sandoz.

You should inform your doctor if you think you are pregnant (or could be). Losartan/hydrochlorothiazide is not recommended in early pregnancy and must not be used if you are more than 3 months pregnant, as it may cause serious harm to your baby if used at this stage (see section “Pregnancy”).

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

• if you have previously had swelling of the face, lips, tongue, or throat,
• if you are taking diuretics (water tablets),
• 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 Sandoz”),
• if you have narrowed arteries to the kidney (renal artery stenosis), if you only have one functioning kidney, or if you have recently undergone kidney transplantation,
• if you are on hemodialysis,
• 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 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 rashes, and fever (systemic lupus erythematosus),
• if you have had respiratory or pulmonary problems (such as lung 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, seek medical help immediately,
• if you have high levels of calcium or potassium, 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 your doctor or healthcare provider that you are taking losartan potassium and hydrochlorothiazide tablets,
• if you have primary hyperaldosteronism (a syndrome associated with increased secretion of the hormone aldosterone by the adrenal gland due to a glandular abnormality),
• 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 and lip cancer. Protect your skin from sun exposure and UV rays while taking Losartan/Hydrochlorothiazide Sandoz,
• if you experience vision loss or eye pain, which could be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or increased eye pressure, occurring within hours to a week after taking losartan/hydrochlorothiazide. This may lead to permanent vision loss if not treated. If you have had an allergy to sulfonamides or penicillins, you may be at higher risk,
• if you are taking any of the following medicines for high blood pressure:
  • An ACE inhibitor (e.g., enalapril, lisinopril, ramipril), especially if you have kidney problems related to diabetes,
  • Aliskiren.

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 Sandoz”.

Children and adolescents

The safety and efficacy of losartan/hydrochlorothiazide have not been established in children and adolescents under 18 years of age. Losartan/hydrochlorothiazide should not be given to children and adolescents.

Ask your doctor if you are undergoing anti-doping control, as losartan/hydrochlorothiazide contains an active substance that may result in a positive anti-doping test.

Other medicines and Losartan/Hydrochlorothiazide Sandoz

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

Your doctor may need to adjust your dose and/or take other precautions if you are taking:

• lithium (a medicine used to treat depression or mania),
• potassium supplements,
• potassium-containing salt substitutes,
• potassium-sparing medicines,
• other diuretics (water tablets),
• some laxatives,
• medicines used to treat gout,
• medicines to control heart rhythm,
• medicines for diabetes (oral antidiabetics or insulin),
• medicines to lower your blood pressure,
• steroids,
• medicines to treat cancer,
• medicines for pain,
• medicines for arthritis,
• medicines to treat fungal infections,
• resins used for high cholesterol (e.g., cholestyramine),
• medicines that relax muscles,
• sleeping tablets,
• opioid medicines (e.g., morphine),
• medicines called pressor amines (e.g., adrenaline),
• glycyrrhizin (found in licorice root),
• an ACE inhibitor or aliskiren (see also information under the headings “Do not take Losartan/Hydrochlorothiazide Sandoz” and “Warnings and precautions”).

Please inform your doctor if you are taking losartan/hydrochlorothiazide and are scheduled for a radiographic procedure requiring iodinated contrast medium.

Losartan/Hydrochlorothiazide Sandoz with food and drink

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

Excessive dietary salt intake may counteract the effect of losartan/hydrochlorothiazide.

Losartan/hydrochlorothiazide may be taken with or without food.

Grapefruit juice should be avoided while taking losartan/hydrochlorothiazide.

Pregnancy and breastfeeding

Pregnancy

Inform your doctor if you think you are pregnant (or could be). Your doctor will usually advise you to stop taking losartan/hydrochlorothiazide before becoming pregnant or as soon as you know you are pregnant, and will recommend an alternative medicine. Losartan/hydrochlorothiazide is not recommended in early pregnancy and must not be taken after 3 months of pregnancy, as it may cause serious harm to your baby if used from the third month of pregnancy onward.

Breastfeeding

Consult your doctor if you are breastfeeding or planning to breastfeed. Losartan/hydrochlorothiazide is not recommended for breastfeeding mothers, and your doctor may choose a different treatment if you wish to breastfeed.

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.

Driving and using machines

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

Losartan/Hydrochlorothiazide Sandoz contains lactose.

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

3. How to take Losartan/Hydrochlorothiazide Sandoz

Follow exactly the instructions given by your doctor or pharmacist for taking this medicine. If in doubt, consult your doctor or pharmacist again. Your doctor will decide the appropriate dose of losartan/hydrochlorothiazide depending on your condition and whether you are taking other medicines. It is important to keep taking losartan/hydrochlorothiazide as prescribed by your doctor to maintain consistent blood pressure control.

Take the tablet with a glass of water. It may be taken with or without food.

Use in adults

The usual dose of losartan/hydrochlorothiazide 100 mg/25 mg is one tablet once daily.

Use in elderly patients

Dosage adjustment is generally not required in elderly patients.

Use in haemodialysis and renal impairment

In cases of moderate kidney problems, dosage adjustment is generally not required. Do not take losartan/hydrochlorothiazide if you have severe renal impairment. Losartan/hydrochlorothiazide is not recommended in patients undergoing haemodialysis.

Use in hepatic impairment

Losartan/hydrochlorothiazide should be used with caution in patients with a history of mild to moderate hepatic impairment.

Do not take losartan/hydrochlorothiazide if you have severely impaired liver function (see section 2 “Do not take Losartan/Hydrochlorothiazide Sandoz”).

Use in children and adolescents

Losartan/hydrochlorothiazide must not be given to children and adolescents under 18 years of age.

Use in black patients

Dosage adjustment may be necessary as effectiveness may be reduced in black patients compared to non-black patients.

If you take more Losartan/Hydrochlorothiazide Sandoz than you should

In case of overdose, contact your doctor immediately to receive immediate medical attention. Overdose may cause low blood pressure, palpitations, slow pulse, changes in blood composition, and dehydration.

If you have taken more Losartan/Hydrochlorothiazide Sandoz than you should, contact your doctor, pharmacist, or call the Toxicology Information Service at telephone number: 91 562 04 20, indicating the medicine and the amount taken.

If you forget to take Losartan/Hydrochlorothiazide Sandoz

Do not take a double dose to make up for a missed dose. Take your next dose as usual.

If you stop taking Losartan/Hydrochlorothiazide Sandoz

Always consult your doctor if you wish to stop taking this medicine. Even if you feel well, it may still be necessary for you to continue taking this medicine.

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

4. Possible adverse effects

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

If you experience any of the following, stop taking losartan/hydrochlorothiazide tablets immediately and contact your doctor right away 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 patients. It may require urgent medical attention or hospitalization.

Acute breathing difficulty (symptoms include severe shortness of breath, fever, weakness, and confusion) – this is a very rare adverse reaction (may affect up to 1 in 10,000 people).

The following adverse effects have been reported:

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

• cough, upper respiratory tract infection, nasal congestion, sinusitis, nasal sinus disorder,
• diarrhoea, 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 haemoglobin levels,
• changes in kidney function including kidney failure,
• blood sugar levels too low (hypoglycaemia).

Uncommon (may affect up to 1 in 100 people):

• anaemia, 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 disorders, reduction in platelet count,
• loss of appetite, elevated uric acid levels or overt gout, elevated blood sugar levels, altered blood electrolyte levels,
• anxiety, nervousness, panic disorders (recurrent panic attacks), confusion, depression, strange dreams, sleep disorders, drowsiness, memory impairment,
• 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 clicking 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 ischaemic 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), nosebleeds, runny nose, congestion,
• constipation, obstructive 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, Lyell's syndrome (skin appears burnt and peels), 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, altered kidney function including kidney inflammation, urinary tract infection, sugar in the urine,
• decreased sexual appetite, impotence,
• facial swelling, localized swelling (oedema), fever.

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

• hepatitis (liver inflammation), abnormal liver function tests,
• intestinal angioedema: swelling in the intestine presenting symptoms such as abdominal pain, nausea, vomiting and diarrhoea.

Frequency not known (frequency cannot be estimated from available data):

• flu-like symptoms,
• muscle pain of unknown origin with dark-coloured urine (tea-coloured urine) (rhabdomyolysis),
• low sodium levels in the blood (hyponatraemia),
• generally feeling unwell (malaise),
• taste disturbances (dysgeusia),
• skin and lip cancer (non-melanoma skin cancer),
• myopia,
• 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 type of adverse effect, talk to your doctor or pharmacist, 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 Medicinal Products: 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 Sandoz

Keep this medicine out of 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.

Alu/Alu blister: store below 30 °C.

Aclar/Alu blister: store below 30 °C.

Bottle: keep the bottle tightly closed to protect it from moisture.

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

6. Contents of the pack and other information

Composition of Losartan/Hydrochlorothiazide Sandoz

• The active substances are losartan potassium and hydrochlorothiazide. Each Losartan/Hydrochlorothiazide Sandoz 100 mg/25 mg tablet contains 100 mg of losartan potassium and 25 mg of hydrochlorothiazide.

• The other components are:

Core: lactose monohydrate, microcrystalline cellulose, pregelatinized maize starch, magnesium stearate, colloidal anhydrous silica.

Coating: hypromellose, hydroxypropylcellulose, yellow iron oxide (E172), titanium dioxide (E171), macrogol (400), talc.

Appearance of the product and contents of the pack

Losartan/Hydrochlorothiazide Sandoz 100 mg/25 mg is presented as film-coated tablets, light yellow in colour, round, biconvex, with a diameter of 10 mm.

It is packed in aluminium blisters or in plastic bottles with or without child-resistant screw caps.

Blister: 7, 10, 14, 28, 30, 50, 56, 60, 84, 90, 98 and 100 film-coated tablets.

Unit dose blister: 50 film-coated tablets.

Bottle: 100 and 250 film-coated tablets.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Sandoz Farmacéutica, S.A.

Centro Empresarial Parque Norte

Edificio Roble

C/ Serrano Galvache, 56

28033 Madrid

Spain

Manufacturer

Lek Pharmaceuticals d.d.

Verovskova 57

SI-1526 Ljubljana

Slovenia

or

Lek S.A.,

Ul. Domaniewska 50 C

02-672 Warsaw

Poland

or

Salutas Pharma GmbH

Otto von Guericke Allee 1

39179 Barleben, Germany

or

Salutas Pharma GmbH

Dieselstrasse 5

70839 Gerlingen

Germany

This medicinal product is authorized in the European Economic Area countries and in the United Kingdom (Northern Ireland) under the following names:

Austria: Losartán-HCT Sandoz 100 mg/25 mg - Filmtabletten

Belgium: Co-Losartán Sandoz 100 mg/25 mg filmomhulde tabletten

Denmark: Ancozan Comp

France: LOSARTÁN/ HYDROCHLOROTHIAZIDE Sandoz 100 mg/25 mg, comprimé pelliculé

Netherlands: KALIUMLOSARTAN/HYDROCHLOORTHIAZIDE SANDOZ 100/25 MG, filmomhulde tabletten

Italy: LOSARTÁN IDROCLOROTIAZIDE SANDOZ 100 mg + 25 mg compresse rivestite con film

Portugal: LOSARTAN + HIDROCLOROTIAZIDA SINTANO

United Kingdom (Northern Ireland): Losartán Potassium/Hydrochlorothiazide 100 mg/25 mg Film-coated Tablets

Czech Republic: Sangona Combi 100 mg/ 25 mg

Date of the most recent review of this leaflet: March 2026.

Detailed information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es