LOSARTAN/HYDROCHLOROTHIAZIDE KRKA 100 MG/12.5 MG FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Losartan/Hydrochlorothiazide Krka 100 mg/12.5 mg film-coated tablets

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. Storing 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 relaxation of blood vessels, which in turn lowers blood pressure. Hydrochlorothiazide increases the amount of urine removed from the body, which also helps to lower blood pressure.

Losartan/hydrochlorothiazide 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, 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 better to avoid this medicine during the first trimester of pregnancy; see section Pregnancy)
• if you have severe renal impairment or if your kidneys are not producing urine
• if you have diabetes or renal impairment and are treated with a blood pressure lowering medicine containing aliskiren.

Warnings and precautions

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

You should inform your doctor if you think you are pregnant (or might become pregnant). Losartan/Hydrochlorothiazide Krka is not recommended during the first trimester of pregnancy and must not be used 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.

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 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 narrowing of the arteries that supply the kidneys (renal artery stenosis), if you have only 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 anaesthesia (even at the dentist) or before surgery, or if you are to have tests to check your parathyroid function, you must inform your doctor or hospital that you are taking losartan/hydrochlorothiazide tablets,
• if you have primary hyperaldosteronism (a syndrome associated with high secretion of aldosterone by the adrenal gland due to an adrenal gland disorder),
• if you are taking other medicines that may increase potassium levels in your 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, particularly 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 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 increased pressure in the eye 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:

• 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 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.

Children and adolescents

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

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 your blood (e.g. trimetoprim-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 monitoring you closely. Special precautions may be necessary (e.g. blood tests) if you are taking diuretics (water tablets), certain laxatives, medicines for treating gout, medicines for controlling heart rhythm or for diabetes (oral medicines or insulins).

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

• other medicines that lower blood pressure,
• steroids,
• cancer medicines,
• painkillers,
• medicines for treating fungal infections,
• 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 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 also inform your doctor if you are taking losartan/hydrochlorothiazide and are scheduled for a radiographic procedure and will be given a contrast agent containing iodine.

Losartan/Hydrochlorothiazide Krka with 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 your diet may counteract the effect of Losartan/Hydrochlorothiazide Krka tablets.

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

You should avoid grapefruit juice while taking losartan/hydrochlorothiazide tablets.

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 become pregnant). 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 Krka. Losartan/Hydrochlorothiazide Krka 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

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

Use in elderly patients

Losartan/Hydrochlorothiazide Krka 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 you start taking this medicine, do not perform tasks that require special attention (e.g. driving a car or using dangerous 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, contact them before taking this medicine.

3. How to take Losartan/Hydrochlorothiazide Krka

Take this medicine exactly 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.

Losartan/Hydrochlorothiazide Krka is available in three strengths: losartan/hydrochlorothiazide 50 mg/12.5 mg film-coated tablets, losartan/hydrochlorothiazide 100 mg/12.5 mg film-coated tablets and losartan/hydrochlorothiazide 100 mg/25 mg film-coated tablets.

High blood pressure

For most patients with high blood pressure, the usual dose is one losartan/hydrochlorothiazide 50 mg/12.5 mg tablet per day to control blood pressure over 24 hours. Your doctor may increase the dose to two losartan/hydrochlorothiazide 50 mg/12.5 mg tablets per day or one losartan/hydrochlorothiazide 100 mg/25 mg tablet per day (a higher dose). The maximum dose is two losartan/hydrochlorothiazide 50 mg/12.5 mg tablets per day or one losartan/hydrochlorothiazide 100 mg/25 mg tablet per day.

Losartan/hydrochlorothiazide 100 mg/12.5 mg (100 mg losartan/12.5 mg hydrochlorothiazide) is available for patients treated with 100 mg losartan, who require additional blood pressure control.

Administration

The tablets should be swallowed whole with a glass of water.

If you take more Losartan/Hydrochlorothiazide Krka than you should

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

If you forget to take Losartan/Hydrochlorothiazide Krka

Try to take losartan/hydrochlorothiazide daily as prescribed by your doctor. Do not take a double dose to make up for forgotten doses. 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 that can affect up to 1 in 1,000 patients. You may need urgent medical attention or hospitalization.

Acute respiratory distress (signs include severe breathing difficulties, fever, weakness, and confusion).

This is a serious but very rare adverse effect that can affect up to 1 in 10,000 patients. You may need 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 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), bruising, reduced white blood cell count, coagulation problems, 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
• Tingling or similar sensations, pain in the limbs, tremors, 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 ischemic attack, "mini-stroke"), heart attack, palpitations
• Inflammation of blood vessels that is often associated with a skin rash or bruising
• Sore throat, shortness of breath, bronchitis, pneumonia, fluid in the lungs (which can cause breathing difficulties), 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 that occurs with symptoms such as abdominal pain, nausea, vomiting, and diarrhea.

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

• Skin and lip cancer (non-melanoma skin cancer),

• Flu-like symptoms,

• Muscle pain of unknown origin with dark-colored urine (tea-colored), (rhabdomyolysis),
• Low sodium levels in the blood (hyponatremia),
• Generally feeling unwell (malaise),
• Taste disturbance (dysgeusia),
  • 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 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 is 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 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.

HDPE Bottle:

After the first opening of the packaging, the medicine must be used within 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. Packaging Contents and Additional Information

Composition of Losartan/Hydrochlorothiazide Krka

• The active ingredients are losartan potassium and hydrochlorothiazide. Each tablet contains 100 mg of losartan potassium (equivalent to 91.52 mg of losartan) and 12.5 mg of hydrochlorothiazide.
• The other ingredients are pregelatinized corn starch, microcrystalline cellulose, lactose monohydrate, magnesium stearate in the core, and hypromellose, macrogol 4000, talc, and titanium dioxide (E171) in the coating. See section 2 "Losartan/Hydrochlorothiazide contains lactose".

Appearance and Packaging of the Product

Losartan/Hydrochlorothiazide Krka 100 mg/12.5 mg are film-coated tablets that are white, oval, and biconvex. Tablet dimensions: 13 mm x 8 mm.

Packaging Sizes:

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

Not all packaging sizes may be marketed.

Marketing Authorization Holder

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

Manufacturer

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) 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/).