LOSARTAN/HYDROCHLOROTHIAZIDE SANDOZ 50 mg/12.5 mg FILM-COATED TABLETS

Introduction

Patient Information Leaflet

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

Read the entire leaflet carefully before starting to take the medicine, as 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 to you only, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Contents of the leaflet

1. What is Losartan/Hydrochlorothiazide Sandoz and what is it 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. Storage of Losartan/Hydrochlorothiazide Sandoz
6. Package contents and additional information

1. What is Losartan/Hydrochlorothiazide Sandoz and what is it used for

Losartan potassium belongs to a group of medicines called angiotensin-II receptor antagonists. These cause the relaxation of blood vessels, which leads to a decrease in blood pressure.

Hydrochlorothiazide belongs to a group of medicines called diuretics.

Hydrochlorothiazide causes the kidneys to eliminate more salt. This also helps to reduce blood pressure.

The tablets are used to treat high blood pressure. The combination of losartan and hydrochlorothiazide is a suitable alternative for people who would otherwise be treated with losartan potassium and hydrochlorothiazide separately.

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

Do not take Losartan/Hydrochlorothiazide Sandoz:

• if you are allergicto losartan, hydrochlorothiazide, or any of the other ingredients of this medicine (listed in section 6),
• if you are allergicto other sulfonamide-derived substances(e.g., other thiazides, some antibacterial medicines such as cotrimoxazole; ask your doctor if you are unsure),
• if you are pregnant for more than 3 months. (It is also recommended to avoid losartan/hydrochlorothiazide at the beginning of pregnancy – see the Pregnancy section),
• if you have severe liver failure,
• if you have severe kidney failureor your kidneys do not produce urine,
• if you have low levels of potassium, sodium, or high levels of calcium that cannot be corrected with treatment,
• if you suffer from gout,
• if you have diabetesor kidney failure and are being treated with a blood pressure-lowering medicine that contains aliskiren.

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

Warnings and precautions

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

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

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

• if you have previously suffered from swelling of the face, lips, tongue, or throat,
• if you are taking diuretics(medicines that make you urinate),
• if you are on a low-salt diet,
• if you have had excessive vomitingand/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 that supply the kidneys(renal artery stenosis), if you only have one functioning kidney, or if you have recently had a kidney transplant,
• if you are on hemodialysis,
• if you have hardening of the arteries(atherosclerosis), chest pain(angina pectoris due to poor heart function),
• 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 disorder, asthma, or a condition that causes joint pain, skin rashes, and fever(systemic lupus erythematosus), 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 shortness of breath or severe difficulty breathing after taking losartan/hydrochlorothiazide, seek medical attention immediately,
• if you have high levels of calciumor potassiumor if you are on a low-potassium diet,
• if you need to have anesthesia(even at the dentist) or before surgery, or if you are going to have tests to determine your parathyroid function, you must inform your doctor or healthcare professional that you are taking losartan/hydrochlorothiazide tablets,
• if you have primary hyperaldosteronism(a syndrome associated with increased secretion of the hormone aldosterone by the adrenal gland, caused by a disorder of the gland),
• if you have had skin canceror if you develop an unexpected skin lesionduring 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 sun and UV radiation while taking Losartan/Hydrochlorothiazide Sandoz,
• 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 hours to a week after taking losartan/hydrochlorothiazide. This can lead to permanent vision loss if not treated. If you have had an allergy to sulfonamides or penicillins, you may be at higher risk of developing it,
• if you are taking any of the following medicines used to treat high blood pressure:
• • An ACE inhibitor(e.g., enalapril, lisinopril, ramipril), particularly 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 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 subject to doping control, as losartan/hydrochlorothiazide contains an active substance that may test positive.

Other medicines and Losartan/Hydrochlorothiazide Sandoz

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

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

• lithium (a medicine for the treatment of depressionor mania),
• potassium supplements,
• salt substitutes containing potassium,
• potassium-sparing medicines,
• other diuretics(water pills),
• some laxatives,
• medicines for the treatment of gout,
• medicines to control heart rhythm,
• medicines for diabetes(oral or insulin),
• medicines to lower blood pressure,
• corticosteroids,
• medicines for the treatment of cancer,
• medicines for pain relief,
• medicines for arthritis,
• medicines for the treatment of fungal infections,
• resins used for high cholesterol(e.g., colestyramine),
• medicines that relax muscles,
• sleeping pills,
• opioid medicines(e.g., morphine),
• medicines called pressor amines (e.g., adrenaline),
• licorice root extract(glycyrrhizin).
• An ACE inhibitoror aliskiren(see also the 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 going to undergo a radiographic procedure and need to take iodinated contrast media.

Losartan/Hydrochlorothiazide Sandoz with food and drinks

It is recommended that you do not drink alcohol while taking these tablets: alcohol and losartan/hydrochlorothiazide tablets may increase the effects of both.

Excessive salt in the diet may counteract the effect of losartan/hydrochlorothiazide.

Losartan/hydrochlorothiazide can be taken with or without food.

Pregnancy and breastfeeding

Pregnancy

You must inform your doctor if you think you are pregnant (or might be). Your doctor will normally advise you to stop taking losartan/hydrochlorothiazide before becoming pregnant or as soon as you know you are pregnant and will advise you to take a different medicine instead of losartan/hydrochlorothiazide. Losartan/hydrochlorothiazide is not recommended at the beginning of pregnancy and should not be taken if you are pregnant for more than 3 months, as it may cause serious harm to your baby if used from the third month of pregnancy onwards.

Breastfeeding

Consult your doctor if you are breastfeeding or plan to start breastfeeding. 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, or think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

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 Sandoz contains lactose.

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

3. How to take Losartan/Hydrochlorothiazide Sandoz

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

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

Use in adults

The usual dose is one tablet once a day. If necessary, your doctor may increase the dose to a maximum of 2 tablets once a day or to one losartan/hydrochlorothiazide 100 mg/50 mg tablet once a day.

Use in elderly patients

Generally, no dose adjustment is necessary in elderly patients.

Use in hemodialysis and renal failure

In cases of moderate kidney problems, it is usually not necessary to adjust the dose. Do not take losartan/hydrochlorothiazide if you have severe kidney failure. Losartan/hydrochlorothiazide is not recommended in patients on hemodialysis.

Use in liver failure

Losartan/hydrochlorothiazide should be used with caution in patients with mild to moderate liver failure.

Do not take losartan/hydrochlorothiazide if your liver function is severely impaired (see section 2 "Do not take Losartan/Hydrochlorothiazide Sandoz").

Use in children and adolescents

Losartan/hydrochlorothiazide should not be administered to children and adolescents under 18 years of age.

Use in black patients

A dose adjustment may be necessary, as efficacy 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 for immediate medical attention. Overdose may cause a drop in blood pressure, palpitations, slow pulse, changes in blood composition, and dehydration.

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

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 want to stop taking this medicine. Although you may feel well, it may 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 all people suffer from them.

If you experience the following, stop taking losartan/hydrochlorothiazide 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 adverse effect, affecting more than 1 in 10,000 patients, but less than 1 in 1,000 patients. You may need urgent medical attention or hospitalization.

Acute respiratory distress (symptoms include severe difficulty breathing, 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:

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

• cough, upper respiratory infection, nasal congestion, sinusitis, nasal passage 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), decreased hemoglobin levels,
• changes in renal function including renal failure,
• low blood sugar levels (hypoglycemia).

Infrequent(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, altered blood electrolyte levels,
• anxiety, nervousness, panic disorders (recurrent panic attacks), confusion, depression, unusual dreams, sleep disorders, somnolence, memory impairment,
• tingling or similar sensations, pain in the limbs, tremor, migraine, fainting,
• blurred vision, itching or burning in the eyes, conjunctivitis, worsening vision, seeing things in yellow,
• tinnitus, 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 ischemic attack, "mini-stroke"), heart attack, palpitations,
• inflammation of blood vessels that is often associated with a skin rash or bruising,
• throat itching, shortness of breath, bronchitis, pneumonia, fluid in the lungs (which can cause difficulty breathing), nosebleeds, runny nose, congestion,
• constipation, obstructive 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, skin redness, sensitivity to light, Lyell syndrome (skin with a burned appearance and peeling), 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, altered renal 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 (liver inflammation), abnormal liver function tests.
• intestinal angioedema: swelling in the intestine that presents symptoms such as abdominal pain, nausea, vomiting, and diarrhea.

Frequency Not Known(frequency cannot be estimated from the available data):

• flu-like symptoms,
• muscle pain of unknown origin with dark-colored urine (tea-colored urine) (rhabdomyolysis),
• low sodium levels in the blood (hyponatremia)
• generally feeling unwell (malaise),
• taste disturbances (dysgeusia),
• skin and lip cancer (non-melanoma skin cancer),
• myopia,
• decreased vision or eye pain due to increased pressure (possible signs of fluid accumulation in the vascular layer of the eye (choroidal effusion) or acute angle-closure glaucoma).

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that is not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing 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 expiration date stated on the packaging after CAD. The expiration date is the last day of the month indicated.

Blister: store below 30°C.

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

Medicines should not be disposed of via wastewater or household waste. Deposit the packaging and any unused medicines in the pharmacy's SIGRE collection 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 Sandoz

• The active ingredients are losartan potassium and hydrochlorothiazide. Each Losartan/Hydrochlorothiazide Sandoz 50 mg/12.5 mg tablet contains 50 mg of losartan potassium and 12.5 mg of hydrochlorothiazide.

• The other ingredients are:

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

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

Appearance and Packaging of the Product

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

They are packaged in blisters with an aluminum foil or in plastic bottles with or without a child-resistant screw cap.

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

Blister (unit dose): 50 film-coated tablets.

Bottle: 100 and 250 film-coated tablets.

Only some 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 medicine is authorized in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:

Germany: Losartan-HCT Sandoz 50 mg/12.5 mg Filmtabletten

Austria: Losartan-HCT Sandoz 50 mg/12.5 mg Filmtabletten

Belgium: Co-Losartan Sandoz 50 mg/12.5 mg filmomhulde tabletten

Denmark: Ancozan Comp

Slovenia: Losartan/hidroklorotiazid Lek 50 mg/12.5 mg filmsko obložene tablete

France: LOSARTÁN/HYDROCHLOROTHIAZIDE Sandoz 50 mg/12.5 mg, comprimé pelliculé

Netherlands: KaliumLosartán/Hydrochloorthiazide Sandoz 50/12.5 mg, filmomhulde tabletten

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

Portugal: Losartán + Hidroclorotiazida SINTANO

Czech Republic: Sangona COMBI 50 mg/12.5 mg potahované tablety

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

Sweden: Losartan/ Hydrochlorothiazide Sandoz 50 mg/12.5 mg filmdragerade tabletter

Date of the 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