Package Leaflet: Information for the Patient

Losartán/Hydrochlorothiazide Sandoz 50 mg/12.5 mg Film-Coated Tablets

Read the package leaflet carefully before you start taking the medicine because it contains important information for you.

• Keep this package 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. Do not pass it on to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, talk to your doctor or pharmacist. See section 4.

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

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

3.How to take Losartán/Hydrochlorothiazide Sandoz

4.Possible side effects

5.Storage of Losartán/Hydrochlorothiazide Sandoz

6.Contents of the pack and additional information

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.

Hidroclorotiazida belongs to a group of medicines called diuretics.

Hidroclorotiazida makes the kidneys eliminate a greater amount of salts. This also helps to reduce blood pressure.

The tablets are used to treat high blood pressure. The combination of losartan and hidroclorotiazida is an appropriate alternative for people who would otherwise need to be treated with losartan potassium and hidroclorotiazida separately.

Do not take Losartán/Hidroclorotiazida Sandoz:

• if you areallergictolosartan,hydrochlorothiazide, or any of the other ingredients of this medicine (listed in section 6),
• if you areallergicto othersulfonamide-derived substances(e.g. other thiazides, some antibacterial medicines such as cotrimoxazole, ask your doctor if you are unsure),
• if you are more than 3 months pregnant. (It is also best to avoid losartan/hydrochlorothiazide at the beginning of pregnancy – see Pregnancy section),
• if you havesevere liver disease,
• if you havesevere kidney diseaseor are unable to produce urine,
• if you havelow levels of potassium, sodium, or high levels of calcium that cannot be corrected with treatment,
• if you havegout,
• if you have diabetes or kidney disease and are being treated with a blood pressure medicine that contains aliskiren.

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

Warnings and precautions

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

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

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

• if you have previously experiencedswelling of the face, lips, tongue, or throat,
• if you are takingdiuretics (medicines that make you urinate),
• if you are following alow-sodium diet,
• if you have or have hadexcessive vomitingand/ordiarrhea,
• if you haveheart failure,
• if your liver function is impaired (see section 2 “Do not take Losartan/Hidroclorotiazida Sandoz”),
• if you havenarrowing of the arteries that supply the kidneys (renal artery stenosis),ifyou have only one functioning kidneyor if you have recently had akidney transplant,
• if you are onhaemodialysis,
• if you haveatherosclerosis (narrowing of the arteries),angina (chest pain due to heart failure),
• if you havestenosis of the aortic or mitral valveorhypertrophic cardiomyopathy (a disease that causes thethickening of the heart valves),
• if you arediabetic,
• if you have hadgout,
• if you have or have had anallergic reaction, asthmaor a condition that causes joint pain, skin rashes, and fever (systemic lupus erythematosus),if you have had respiratory or pulmonary 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 havehigh levels of calciumorpotassiumor if you are following alow-potassium diet,
• if you need to haveanaesthesia(including dental anaesthesia) or before surgery,or if you are to have tests to determine your parathyroid function,you must inform your doctor or healthcare professional that you are taking losartan potassium and hydrochlorothiazide tablets,
• if you haveprimary aldosteronism (a syndrome associated with an increase in the secretion of aldosterone hormone by the adrenal gland, caused by a glandular alteration),
• if you have hadskin canceror if you develop anunexpected skin lesionduring treatment. The treatment with hydrochlorothiazide, particularly long-term use at high doses, may increase the risk of certain types of skin cancer and lip cancer (non-melanoma skin cancer). Protect your skin from sun exposure and UV rays while taking Losartan/Hidroclorotiazida Sandoz,
• if you experience adecrease in vision or eye pain, which could be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or increased eye pressure and may occur within a few 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:
• • anACE 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 electrolyte levels in your blood (e.g. potassium) at regular intervals.

See also the information under the heading “Do not take Losartan/Hidroclorotiazida 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 subject to adrug testas losartan/hydrochlorothiazidecontains an active substance that may give a positive result in a drug test.

Other medicines and Losartan/Hidroclorotiazida Sandoz

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medicine.

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

• lithium (medicine for the treatment ofdepressionormania),
• potassium supplements,
• substitutesof salt that contain potassium,
• potassium-sparingmedicines,
• otherdiuretics (medicines that make you urinate),
• laxatives,
• medicines for the treatment ofgout,
• medicines to controlheart rhythm,
• medicines for the treatment ofdiabetes(oral medicines or insulin),
• medicines tolower your blood pressure,
• steroids,
• medicines for the treatment ofcancer,
• medicines forpain relief,
• medicines for the treatment ofarthritis,
• medicines to treatfungal infections,
• resins used forhigh cholesterol, (e.g. cholestyramine),
• medicines thatrelax muscles,
• sleeping pills,
• opioid medicines(e.g. morphine),
• medicines called amines (e.g. adrenaline),
• Glycyrrhizin(found in the root of licorice),
• anACE inhibitororaliskiren(see also the information under the headings “Do not take Losartan/Hidroclorotiazida Sandoz” and “Warnings and precautions”).

Please inform your doctor if you are taking losartan/hydrochlorothiazide and are to undergo a radiographic procedure and need to take a contrast agent containing iodine.

Losartán/Hidroclorotiazida Sandozwith 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 may be pregnant. Normally your doctor will 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 more than 3 months pregnant, as it may cause serious harm to your baby if used from the third month of pregnancy.

Lactation

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

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

Driving and operating machinery

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.

Losartán/Hidroclorotiazida Sandozcontains lactose.

If your doctor has told you that you are intolerant to certain sugars, consult with him before taking this medicine.

Follow exactly the administration instructions for this medication 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 if you are taking other medications. It is essential to continue taking losartan/hydrochlorothiazide as prescribed by your doctor to maintain constant blood pressure control.

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 two tablets once a day or one tablet of losartan/hydrochlorothiazide 100 mg/50 mg once a day.

Use in elderly patients

Generally, no dose adjustment is necessary in elderly patients.

Use in hemodialysis and renal insufficiency

In cases of moderate kidney problems, generally no dose adjustment is necessary. Do not take losartan/hydrochlorothiazide if you have severe kidney insufficiency. Losartan/hydrochlorothiazide is not recommended in patients undergoing hemodialysis.

Use in liver insufficiency

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

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 the effectiveness may be reduced in black patients compared to patients who are not black.

If you take moreLosartan/Hydrochlorothiazide Sandozthan you should

In case of an overdose, contact your doctor immediately for immediate medical attention. An 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 Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount used.

If you forgot to takeLosartan/Hydrochlorothiazide Sandoz

Do not take a double dose to compensate for the missed doses. Take your next dose as usual.

If you interrupt the treatment withLosartan/Hydrochlorothiazide Sandoz

Always consult your doctor if you want to stop taking this medication. Although you may feel well, it may be necessary to continue taking this medication.

If you have any other questions about the use of thismedication, ask your doctor, orpharmacist.

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

If you experience any of the following, stop taking losartan/hydrochlorothiazide tablets and inform your doctor immediately or go to the nearest hospital emergency service:

This is a severe but rare side effect that affects 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 respiratory difficulty, fever, weakness, and confusion), this is a very rare side effect (it may affect up to 1 in 10,000 people).

The following side effects have been reported:

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

• Cough, upper respiratory tract infection, nasal congestion, sinusitis, nasal septum 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 an abnormal heart rhythm), decreased hemoglobin levels,
• Changes in renal function including renal failure,
• Low blood sugar (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), hematoma, reduced white blood cell count, coagulation problems, reduced platelet count,
• Loss of appetite, elevated uric acid levels or manifest gout, elevated blood sugar levels, altered electrolyte levels in the blood,
• Anxiety, nervousness, panic disorder (recurrent panic attacks), confusion, depression, strange dreams, sleep disorders, drowsiness, memory alteration,
• Tickling or similar sensations, limb pain, tremor, migraine, fainting,
• Blurred vision, eye itching or stinging, conjunctivitis, worsening vision, seeing things in yellow,
• Ringing, buzzing, sounds or crackling in the ears, vertigo,
• Low blood pressure that may be associated with changes in posture (feeling dizzy or weak when standing up), angina (chest pain), abnormal heartbeats, transient ischemic attack (mini-stroke), heart attack, palpitations,
• Inflammation of blood vessels that often occurs with a skin rash or hematoma,
• Throat itching, shortness of breath, bronchitis, pneumonia, fluid in the lungs (which may cause difficulty breathing), nasal hemorrhage, runny nose, congestion,
• Constipation, obstructive constipation, gas, stomach disorders, stomach spasms, vomiting, dry mouth, salivary gland inflammation, tooth pain,
• Jaundice (yellow discoloration of the eyes and skin), pancreatitis inflammation,
• Urticaria, itching, skin inflammation, skin rash, skin redness, light sensitivity, 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 libido, impotence,
• Swelling of the face, 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.

Unknown frequency(the frequency cannot be estimated from available data):

• Symptoms similar to the flu,
• Muscle pain of unknown origin with dark-colored urine (rhabdomyolysis),
• Low sodium levels in the blood (hyponatremia)
• Generally feeling unwell,
• Alterations in taste (dysgeusia),
• Skin and lip cancer (non-melanoma skin cancer),
• Myopia,
• Decreased vision or eye pain due to high pressure (possible signs of fluid accumulation in the vascular layer of the eye (choroidal hemorrhage) or acute angle-closure glaucoma).

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through theSpanish System for the Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears 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 perfectly closed to protect it from moisture.

Medicines should not be thrown into the drains or trash. Dispose of the packaging and medicines you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. By doing so, you will help protect the environment.

Composition of Losartán/Hidroclorotiazida Sandoz

• The active principles are losartan potassium and hydrochlorothiazide. Cada comprimido de Losartán/Hidroclorotiazida Sandoz 50 mg/12.5 mg contains 50 mg of losartan potassium and 12.5 mg of hydrochlorothiazide.

• The other components are:

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

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

Appearance of the product and contents of the package

Yellowish-colored, round, biconvex film-coated tablets with a diameter of 8 mm.

It is packaged in aluminum blisters or plastic bottles with or without child-resistant caps.

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

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

Bottle: 100 and 250 film-coated tablets.

Only some package sizes may be marketed.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder

Sandoz Farmacéutica, S.A.

Centro Empresarial Parque Norte

Edificio Roble

C/ Serrano Galvache, 56

28033 Madrid

Spain

Responsible 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) with the following names:

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

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

Belgium: Co-Losartán 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): Losartán Potassium/Hydrochlorothiazide 50 mg/12.5 mg Film-coated Tablets

Sweden: Losartan/ Hydrochlorothiazide Sandoz 50 mg/12,5 mg filmdragerade tabletter

Last review date of this leaflet: February 2025

The detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es