LOSARTAN/HYDROCHLOROTHIAZIDE KRKA 100 MG/25 MG FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the Patient

Losartan/Hydrochlorothiazide Krka 100 mg/25 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 results in 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 causes the kidneys to remove more water and salts. This also helps to lower 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 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, some antibacterials such as cotrimoxazole; ask your doctor if you are not sure),
• if you are more than 3 months pregnant (it is also better to avoid this medicine during the first trimester of pregnancy, see also the section "Pregnancy and breast-feeding"),
• if you have severe hepatic impairment, cholestasis and biliary obstructive disorders,
• if you have severe renal impairment (e.g. creatinine clearance <30 ml/min),
• if your kidneys are not producing urine,
• if you have low potassium or low sodium levels, high calcium levels that cannot be corrected by treatment,
• if you have gout,
• if you have diabetes or renal impairment and are being treated with a blood pressure medicine that contains aliskiren.

Warnings and precautions

Consult your doctor or pharmacist before starting to take 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 diarrhea,
• 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 condition 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 anesthesia (even at the dentist) or before surgery, or if you are to undergo parathyroid function tests, 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 and UV exposure 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. 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 weeks after taking this medicine. This can lead to permanent visual impairment if left untreated. If you have previously been allergic to penicillin or sulfonamide, you may be at higher risk of developing it,
• if you are taking any of the following medicines used to treat high blood pressure (hypertension):
• • an angiotensin-converting enzyme inhibitor (ACE inhibitor) (e.g. enalapril, lisinopril, ramipril), particularly if you have kidney problems related to diabetes.
  • aliskiren.

Your doctor may need to 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 diarrhea after taking Losartan/Hydrochlorothiazide Krka. Your doctor will decide whether to continue treatment. Do not stop taking Losartan/Hydrochlorothiazide Krka on your own.

If you are pregnant, think you may be pregnant, or are planning to have a baby, inform your doctor. The use of Losartan/Hydrochlorothiazide Krka is not recommended at the start of pregnancy (first 3 months) and should not be taken after the third month of pregnancy as it may cause harm to your baby (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 the combination with Losartan/Hydrochlorothiazide Krka is not recommended.

Diuretics such as hydrochlorothiazide contained in losartan/hydrochlorothiazide may interact with other medicines. Preparations containing lithium should not be taken with losartan/hydrochlorothiazide without careful monitoring by your doctor. Special precautions (e.g. blood tests) may be necessary if you are taking other diuretics (water tablets), certain laxatives, medicines for treating gout, medicines for controlling heart rhythm or diabetes (oral medicines or insulins). It is also important that your doctor knows if you are taking other medicines to lower your blood pressure, steroids, medicines to treat cancer, painkillers, medicines to treat fungal infections, or medicines for arthritis, cholesterol-lowering medicines such as colestyramine, muscle relaxants, sleeping tablets; opioid medicines such as morphine, "pressor amines" such as adrenaline or other medicines of the same group; (oral medicines for diabetes or insulins).

Your doctor may need to adjust 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 inform your doctor when you are scheduled to undergo any procedure that uses iodine contrast media.

Losartan/Hydrochlorothiazide Krka with food, drinks, and alcohol

This medicine can be taken with or without food.

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.

Grapefruit juice should be avoided while taking losartan/hydrochlorothiazide tablets.

Pregnancyandbreast-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 before you become pregnant or as soon as you know you are pregnant and will advise you to take another medicine instead of losartan/hydrochlorothiazide. Losartan/hydrochlorothiazide is not recommended during pregnancy, and must 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

Inform your doctor if you are breast-feeding or about to start breast-feeding. The use of losartan/hydrochlorothiazide is not recommended for breast-feeding women, and your doctor may choose another treatment for you if you wish to breast-feed, especially if your baby is newborn or was born prematurely.

Use in children and adolescents

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

Use in elderly patients

Losartan/hydrochlorothiazide works as well and is as well tolerated by most elderly patients as by younger patients. Most elderly patients require the same dose as younger patients.

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 Krka contains lactose

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

3. How to take Losartan/Hydrochlorothiazide Krka

Take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.

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 while your doctor prescribes it for you to maintain constant control of your blood pressure.

High blood pressure

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

If you take more Losartan/Hydrochlorothiazide Krka than you should

In case of overdose, contact your doctor immediately or go 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

Try to take losartan/hydrochlorothiazide as prescribed each day. However, if you miss a dose, do not take an extra dose. Simply return to your normal 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 the 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 patient 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, upper respiratory tract 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 potassium levels (which can 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), reduced white blood cell count, coagulation problems, and reduced platelet count.
• Loss of appetite, high uric acid levels 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 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, often associated with a skin rash or hematoma.
• Sore throat, shortness of breath, bronchitis, pneumonia, fluid in the lungs (which can cause difficulty breathing), nasal bleeding, 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 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.
• Low sodium levels in the blood (hyponatremia).
• Generally feeling unwell (malaise).
• Skin and lip cancer (non-melanoma skin cancer).
• Muscle pain of unknown origin with dark-colored urine (tea-colored urine) (rhabdomyolysis).
• Taste disorder (dysgeusia).
• 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).

Reporting of Adverse Effects

If you experience any adverse effects, consult your doctor or pharmacist, even if they are possible adverse effects not listed in this leaflet. You can also report them directly through the 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 stated on the carton and blister after EXP. The expiration date is the last day of the month indicated.

Do not store above 30°C.

Store in the original packaging to protect from moisture.

HDPE bottle:

After the first opening of the container, the medicine should be used within the following 100 days.

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

6. Package Contents and Additional Information

Composition of Losartan/Hydrochlorothiazide Krka

• The active ingredients are losartan potassium and hydrochlorothiazide. Each Losartan/Hydrochlorothiazide Krka tablet contains 100 mg of losartan potassium, equivalent to 91.52 mg of losartan, and 25 mg of hydrochlorothiazide.
• The other ingredients are:

Core:pregelatinized corn starch, microcrystalline cellulose, lactose monohydrate, and magnesium stearate.

Coating:hypromellose, macrogol 4000, quinoline yellow (E104), talc, and titanium dioxide (E171). See section 2 "Losartan/Hydrochlorothiazide Krka contains lactose".

Appearance and Package Contents of the Product

Losartan/Hydrochlorothiazide Krka 100 mg/25 mg: film-coated tablets, yellow, oval, and slightly biconvex with dimensions of 8 mm x 15 mm and 5.1 – 6.1 mm in thickness.

The tablets are available in boxes containing:

• 7, 10, 14, 20, 28, 30, 50, 56, 60, 84, 90, 98, and 112 film-coated tablets in transparent Al/PVC/PVDC blisters.
• 100 film-coated tablets in a plastic bottle with a tamper-evident closure, in a box.

Not all pack sizes may be marketed.

Marketing Authorization Holder

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

Manufacturers

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

TAD Pharma GmbH, Heinz-Lohmann-Straße 5, 27472 Cuxhaven, Germany

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) under the following names:

This leaflet was approved in:June 2025

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