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

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

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

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 questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, talk to your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Contents of this leaflet

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

Losartan potassium belongs to a group of medicines known as angiotensin-II receptor antagonists. These cause blood vessels to relax, resulting in a reduction in blood pressure.

Hydrochlorothiazide belongs to a group of medicines called diuretics.

Hydrochlorothiazide causes the kidneys to eliminate more salts. This also helps lower blood pressure.

The tablets are used to treat high blood pressure (hypertension). The combination of losartan and hydrochlorothiazide is an appropriate alternative for people who would otherwise be treated with separate tablets of potassium losartan and hydrochlorothiazide.

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. (Losartan/hydrochlorothiazide should also be avoided in early pregnancy – see section “Pregnancy”),
• 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, or high levels of calcium that cannot be corrected with treatment,
• if you suffer from gout,
• if you have diabetes or kidney disease and are being treated with a blood pressure-lowering medicine containing aliskiren.

If you think any of the conditions listed above 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 might be). Losartan/hydrochlorothiazide 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 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 (angioedema),
• 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 supplying the kidneys (renal artery stenosis), if you only have one functioning kidney, or if you have recently undergone a kidney transplant,
• 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 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), or if you have had respiratory or lung 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 disorder),
• 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 skin and lip cancer (non-melanoma skin cancer). Protect your skin from exposure to sunlight 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. Your risk may be higher if you have had allergies to sulfonamides or penicillins,
• if you are taking any of the following medicines used to treat high blood pressure:
  • An ACE inhibitor (e.g., enalapril, lisinopril, ramipril), especially if you have kidney problems related to diabetes,
  • Aliskiren.

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

Ask your doctor if you are undergoing anti-doping testing, 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,
• salt substitutes containing potassium,
• potassium-sparing medicines,
• other diuretics (water tablets),
• some laxatives,
• medicines for treating gout,
• medicines to control heart rhythm,
• medicines for diabetes (oral medications or insulin),
• medicines to lower your blood pressure,
• steroids,
• medicines used 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 increase each other's effects.

Excessive dietary salt intake may reduce the effectiveness 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 the third month of pregnancy, as it may cause serious harm to your baby if used from the third month of pregnancy onward.

Breastfeeding

Talk to 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, 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 that require 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 diagnosed you with 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 determine 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 is one tablet once daily. If necessary, your doctor may increase the dose up to a maximum of two tablets once daily or one tablet of losartan/hydrochlorothiazide 100 mg/25 mg once daily.

Use in elderly patients

Dosage adjustment is generally not required in elderly patients.

Use in hemodialysis 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 failure. Losartan/hydrochlorothiazide is not recommended in patients undergoing hemodialysis.

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

A dose 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 forgotten doses. 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, you may still need 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 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 feet, legs, arms and buttocks, with joint pain, swelling of hands and feet and abdominal pain), bruising, reduction in white blood cells, coagulation 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 disturbance,
• tingling or similar sensations, limb pain, tremor, migraine, fainting,
• blurred vision, burning or itching eyes, conjunctivitis, worsening of vision, seeing things in yellow,
• ringing, buzzing, noise 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), irregular heartbeat, stroke (transient ischaemic attack, "mini-stroke"), heart attack, palpitations,
• inflammation of blood vessels often associated with a skin rash or bruising,
• sore throat, breathlessness, bronchitis, pneumonia, fluid in the lungs (which may cause difficulty breathing), nosebleed, runny nose, congestion,
• constipation, obstructive constipation, flatulence, stomach disorders, stomach spasms, vomiting, dry mouth, inflammation of a salivary gland, toothache,
• jaundice (yellowing of eyes and skin), inflammation of the pancreas,
• urticaria, itching, skin inflammation, skin rash, redness of the skin, photosensitivity, Lyell's syndrome (skin appears burned and peels), dry skin, flushing, sweating, hair loss,
• pain in arms, shoulders, hips, knees or other joints, joint swelling, stiffness, muscle weakness,
• frequent urination even at night, altered kidney function including kidney inflammation, urinary tract infection, sugar in urine,
• decreased sexual appetite, impotence,
• facial swelling, localized swelling (oedema), 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 diarrhoea.

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

• flu-like symptoms,
• unexplained muscle pain 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, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may 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 Sandoz

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.

Blister pack: store below 30°C.

Bottle: store below 30°C. Keep the bottle tightly closed to protect from moisture.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE point at your pharmacy. If you are unsure, 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 Losartán/Hidroclorotiazida Sandoz

• The active substances are losartan potassium and hydrochlorothiazide. Each Losartán/Hidroclorotiazida Sandoz 50 mg/12.5 mg tablet contains 50 mg of losartan potassium and 12.5 mg of hydrochlorothiazide.

• The other components are:

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

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

Nature of the product and pack sizes

Film-coated tablets, light yellow in colour, round, biconvex, with a diameter of 8 mm.

Packaged in aluminium foil blisters or in plastic bottles with or without child-resistant screw caps.

Blister packs: 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 Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:

Austria: Losartán-HCT Sandoz 50 mg/12,5 mg - Filmtabletten

Belgium: Co-Losartán Sandoz 50 mg/ 12,5 mg filmomhulde tabletten

Denmark: Ancozan Comp

France: LOSARTÁN/HYDROCHLOROTHIAZIDE Sandoz 50 mg/12,5 mg, comprimé pelliculé

Netherlands: KALIUMLOSARTAN/HYDROCHLOORTHIAZIDE SANDOZ 50/12,5 MG, filmomhulde tabletten

Italy: LOSARTÁN IDROCLOROTIAZIDE SANDOZ 50 mg + 12.5 mg compresse rivestite con film

Portugal: LOSARTAN + HIDROCLOROTIAZIDA SINTANO

Czech Republic: Sangona COMBI 50 mg/12,5 mg potahované tablety

United Kingdom (Northern Ireland): Losartán Potassium/Hydrochlorothiazide 50 mg/12.5 mg Film-coated Tablets

Date of the most recent revision 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