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

Introduction

Package Leaflet: Information for the Patient

Losartan/Hydrochlorothiazide Krka 50 mg/12.5 mg Film-Coated Tablets EFG

losartan potassium/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 or pharmacist.
• 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 or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

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

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

Losartan/Hydrochlorothiazide Krka is a combination of an angiotensin II receptor antagonist (losartan) and a diuretic (hydrochlorothiazide). Angiotensin II is a substance produced in the body which binds to receptors in blood vessels, causing them to narrow. This leads to an increase in blood pressure. Losartan prevents the binding of angiotensin II to these receptors, resulting in the blood vessels relaxing, which in turn lowers the blood pressure. Hydrochlorothiazide works by making the kidneys remove more water and salts. This also helps to reduce blood pressure.

Losartan/Hydrochlorothiazide Krka is indicated for the treatment of essential hypertension (high blood pressure).

2. What you need to know before you take Losartan/Hydrochlorothiazide Krka

Do not takeLosartan/Hydrochlorothiazide Krka

• if you are allergic to losartan and/or hydrochlorothiazide or 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, some antibacterial drugs such as cotrimoxazole; ask your doctor if you are not sure);
• if you have severe hepatic impairment,
• if you have low potassium or sodium levels, or high calcium levels that cannot be corrected by treatment,
• if you have gout,
• if you are more than 3 months pregnant. (It is also recommended to avoid this medicine during the first trimester of pregnancy, see also pregnancy),
• if you have severe renal impairment or your kidneys are not producing urine,
• 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 or pharmacist before starting treatment with Losartan/Hydrochlorothiazide Krka.

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

• if you have previously suffered from 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 had excessive vomiting and/or diarrhoea,
• if you have heart failure,
• if your liver function is impaired (see section 2 “Do not take Losartan/Hydrochlorothiazide Krka”)
• if you have narrowings of the 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 have narrowing of the arteries (atherosclerosis), angina pectoris (chest pain due to poor heart function),
• if you have narrowing of the aortic or mitral valve (aortic or mitral stenosis) 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 disease that causes joint pain, skin rashes and fever (systemic lupus erythematosus),
• if you have high calcium or low potassium levels or if you are on a low-potassium diet,
• if you need to have anaesthesia (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 an alteration of this gland),
• if you are taking other medicines that may increase potassium levels in the blood (see section 2 “Other medicines and Losartan/Hydrochlorothiazide Krka”),
• if you have had skin cancer or if you develop an unexpected skin lesion during treatment. Treatment with hydrochlorothiazide, in particular long-term use at high doses, may increase the risk of some types of skin and lip cancer (non-melanoma skin cancer). Protect your skin from sun exposure and UV rays while taking Losartan/Hydrochlorothiazide Krka.
• 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 Krka, seek medical attention immediately,

• if you experience a decrease in vision or eye pain, these 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 weeks after taking losartan/hydrochlorothiazide. If left untreated, this can lead to permanent vision loss. You may be at greater risk if you have previously been allergic to penicillin or sulfonamides.
  • if you are taking any of these medicines used to treat high blood pressure:
  • ACE inhibitors (e.g. enalapril, lisinopril, ramipril), particularly if you have diabetes-related kidney problems,
  • aliskiren.

Your doctor may check 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 Krka”.

Consult your doctor if you experience abdominal pain, nausea, vomiting or diarrhoea after taking Losartan/Hydrochlorothiazide Krka. Your doctor will decide whether to continue treatment. Do not stop taking Losartan/Hydrochlorothiazide Krka on your own.

You should inform your doctor if you think you are pregnant (or might be). It is not recommended to take Losartan/Hydrochlorothiazide Krka at the start of pregnancy and it should not be taken if you are more than 3 months pregnant as it may cause serious harm to your baby if used during this period (see section pregnancy).

Other medicines and Losartan/Hydrochlorothiazide Krka

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

Tell your doctor if you are taking potassium supplements, salt substitutes that contain potassium, potassium-sparing medicines or other medicines that may increase potassium levels in the blood (e.g. trimethoprim-containing medicines), as this combination is not recommended with Losartan/Hydrochlorothiazide Krka.

Diuretics such as hydrochlorothiazide contained in Losartan/Hydrochlorothiazide Krka may interact with other medicines. Preparations containing lithium should not be taken with Losartan/Hydrochlorothiazide Krka without your doctor carrying out close monitoring. Special precautions may be necessary (e.g. blood tests) if you are taking diuretics (water tablets), certain laxatives, gout treatments, heart rate control medicines or diabetes medicines (oral or insulin).

It is also important that your doctor knows if you are taking:

• other medicines that lower blood pressure,
• corticosteroids,
• cancer treatments,
• analgesics,
• antifungal medicines,
• arthritis treatments,
• cholesterol-lowering resins such as cholestyramine,
• muscle relaxants,
• sleeping tablets,
• opioid medicines such as morphine,
• “pressor amines” such as adrenaline or other medicines of the same group,
• oral diabetes medicines or insulins.

Your doctor may need to change 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 Krka” and “Warnings and precautions”).

Please, when taking Losartan/Hydrochlorothiazide Krka, inform your doctor if you are going to have a radiographic test with an iodine-containing contrast medium.

TakingLosartan/Hydrochlorothiazide Krkawith food, drinks and alcohol

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

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

Losartan/Hydrochlorothiazide Krka tablets can be taken with or without food.

Grapefruit juice should be avoided while taking losartan/hydrochlorothiazide.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy

You should inform your doctor if you think you are pregnant (or might be). Your doctor will normally advise you to stop taking Losartan/Hydrochlorothiazide Krka 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. Losartan/Hydrochlorothiazide Krka is not recommended during 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 after the third month of pregnancy.

Breast-feeding

Tell your doctor if you are breast-feeding or about to start breast-feeding. It is not recommended to take Losartan/Hydrochlorothiazide Krka if you are breast-feeding, and your doctor may choose another treatment for you if you want to continue breast-feeding.

Children and adolescents

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

Use in elderly patients

Losartan/Hydrochlorothiazide Krka works in the same way and is equally well tolerated by most elderly and young patients. Most elderly patients require the same dose as younger patients.

Driving and using machines

When you start 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 Krkacontains lactose

If your doctor has told you that you have an intolerance to some sugars, contact 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 Krka

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 depending on your condition and whether you are taking other medicines. It is important to keep taking this medicine while your doctor prescribes it to maintain constant blood pressure control.

High blood pressure

For most patients with high blood pressure, the usual dose is 1 tablet of Losartan/Hydrochlorothiazide Krka 50 mg/12.5 mg per day to control blood pressure over 24 hours. This can be increased to 2 tablets of Losartan/Hydrochlorothiazide Krka 50 mg/12.5 mg per day or changed to 1 tablet of Losartan/Hydrochlorothiazide 100 mg/25 mg (a stronger dose) per day. The maximum daily dose is 2 tablets of Losartan/Hydrochlorothiazide Krka 50 mg/12.5 mg per day or 1 tablet of Losartan/Hydrochlorothiazide 100 mg/25 mg per day.

Administration

The tablets should be swallowed with a glass of water.

If you take more Losartan/Hydrochlorothiazide Krka than you should

In case of overdose, contact your doctor immediately or go directly to the hospital for immediate medical attention. Overdose may cause a drop in blood pressure, palpitations, slow pulse, changes in blood composition and dehydration.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, telephone: 91 562 04 20, indicating the medicine and the amount taken.

If you forget to take Losartan/Hydrochlorothiazide Krka

Do not take a double dose to make up for forgotten doses.

Try to take this medicine at the same time each day as prescribed by your doctor. However, if you miss a dose, do not take an extra dose. Simply return to your regular schedule.

If you have any further questions on 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 Krka 50 mg/12.5 mg 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 may affect more than 1 person in 10,000, but less than 1 patient in 1,000. It may require urgent medical attention or hospitalization.

The following adverse effects have been reported:

Frequent (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 levels of potassium (which can cause an abnormal heart rhythm), decrease in 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), hematoma, reduction of white blood cells, coagulation problems, reduced platelet count.
• Loss of appetite, high levels of uric acid or gout, high blood glucose 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, itching or burning in the eyes, 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 cerebral stroke, "mini-stroke"), heart attack, palpitations.
• Inflammation of blood vessels that is often associated with a skin rash or hematoma.
• 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 renal function including kidney inflammation, urinary tract infection, sugar in the urine.
• Decreased sexual appetite, 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 occurs with 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 difficulty breathing, fever, weakness, and confusion).

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

• Flu-like symptoms.
• Muscle pain of unknown origin with dark-colored urine (tea-colored) (rhabdomyolysis).
• Low sodium levels in the blood (hyponatremia).
• General feeling of being unwell (malaise).
• Altered taste (dysgeusia).
• 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].

If you consider that any of the adverse effects you are experiencing is serious or if you notice any adverse effect not mentioned in this leaflet, inform your doctor or pharmacist.

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 that does not appear in this leaflet. You can also report them directly through the national reporting system: Spanish Pharmacovigilance System for Human Use Medicines: 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 Krka

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 above 30°C. Store in the original packaging to protect it from moisture.

Medicines should not be disposed of through wastewater or household waste. Deposit the packaging and medicines you no longer need at the SIGRE collection point in the pharmacy. Ask your pharmacist how to dispose of the packaging and medicines you no longer need. This way, you will help protect the environment.

6. Package Contents and Additional Information

Composition of Losartan/Hydrochlorothiazide Krka 50 mg/12.5 mg

• The active ingredients are losartan potassium and hydrochlorothiazide.

Each film-coated tablet contains 50 mg of losartan potassium (equivalent to 45.76 mg of losartan) and 12.5 mg of hydrochlorothiazide.

• The other ingredients are pregelatinized corn starch, microcrystalline cellulose, lactose monohydrate, and magnesium stearate in the tablet core, and hypromellose, macrogol 4000, quinoline yellow (E104), talc, and titanium dioxide (E171) in the film coating.

Appearance of the Product and Package Contents

The film-coated tablets are yellow, oval, moderately biconvex with a score line on one side, and have dimensions of 6 mm x 12 mm (oval shape) and a thickness of 3.8 - 4.7 mm.

The score line is only for breaking and facilitating swallowing, but not for dividing into equal doses.

Package size:28 film-coated tablets in a PVC/PVDC//Al blister pack and carton.

Marketing Authorization Holder and Manufacturer

KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

You can request more information about this medicine by contacting the local representative of the marketing authorization holder:

KRKA Farmacéutica, S.L., C/ Anabel Segura 10, Pta. Baja, Oficina 1, 28108 Alcobendas, Madrid, Spain

This medicine is authorized in the member states of the European Economic Area and in the United Kingdom (Northern Ireland) with the following names:

Date of the last revision of this leaflet:June 2025

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