Leaflet: information for the user

Losartán/Hidroclorotiazida Krka 100 mg/12,5 mg film-coated tablets

losartán potassium/hydrochlorothiazide

Read this leaflet carefully before you start to take this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only, and you must not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Losartán/Hidroclorotiazida Krka is a combination of an angiotensin II receptor antagonist (losartán) and a diuretic (hidroclorotiazida).The angiotensin II is a substance produced in the body that binds to receptors present in blood vessels, causing them to constrict. This results in an increase in blood pressure. Losartán prevents the binding of angiotensin II to these receptors, causing blood vessels to relax, which in turn reduces blood pressure. Hidroclorotiazida causes the kidneys to eliminate a greater amount of water and salts. This also helps to reduce blood pressure.

Losartán/hidroclorotiazida is indicated for the treatment of essential hypertension (high blood pressure).

Do not takeLosartán/Hidroclorotiazida Krka

• if you are allergic to losartan, hydrochlorothiazide, or any of the other components of this medication (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 unsure)
• if you have severe liver failure
• if you have low levels of potassium or sodium or high levels of calcium that cannot be corrected with treatment
• if you have gout
• if you are more than three months pregnant (it is also recommended to avoid this medication in the first trimester of pregnancy, see Pregnancy section)
• if you have severe kidney failure or if your kidneys do not produce urine
• if you have diabetes or kidney failure and are being treated with a medication to lower blood pressure that contains aliskiren.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Losartán/Hidroclorotiazida Krka.

You should inform your doctor if you think you are pregnant (or may be pregnant). Losartán/Hidroclorotiazida Krka is not recommended in the first trimester of pregnancy and should not be used if you are more than three months pregnant, as it may cause serious harm to your baby if used at this stage (see Pregnancy section).

It is essential to inform your doctor before taking Losartán/Hidroclorotiazida Krka:

• if you have previously experienced swelling of the face, lips, tongue, or throat,
• if you are taking diuretics (medications to urinate),
• if you are following a low-sodium diet,
• if you have had excessive vomiting and/or diarrhea,
• if you have heart failure,
• if your liver function is altered (see section 2. “Do not take Losartán/Hidroclorotiazida Krka”),
• if you have narrowed arteries (arterial stenosis), angina pectoris (chest pain due to heart dysfunction),
• 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 reaction, asthma, or a condition that causes joint pain, skin eruptions, and fever (systemic lupus erythematosus),
• if you have high levels of calcium or low levels of potassium or if you are following a low-potassium diet,
• if you need anesthesia (even for dental procedures) or before surgery, or if you are undergoing tests to determine your parathyroid function, inform your doctor or healthcare professional that you are taking losartan potassium and hydrochlorothiazide tablets,
• if you have primary aldosteronism (a syndrome associated with an elevated secretion of aldosterone hormone by the adrenal gland due to a glandular alteration),
• if you are taking other medications that may increase serum potassium levels (see section 2 “Other medications and Losartán/Hidroclorotiazida Krka”),
• if you have had skin cancer or if you develop an unexpected skin lesion during treatment. The treatment with hydrochlorothiazide, particularly its 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 Losartán/Hidroclorotiazida Krka,
• 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 severe shortness of breath or difficulty breathing after taking Losartán/Hidroclorotiazida Krka, seek medical attention immediately,
• if you experience a decrease in vision or eye pain. These may be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or increased intraocular pressure and may occur within a few hours to several weeks after taking this medication. This can lead to permanent visual impairment if not treated. If you have previously had an allergy to penicillin or sulfonamide, you may be at a higher risk of developing it,

• if you are taking any of the following medications used to treat high blood pressure (hypertension):

• a converting enzyme inhibitor (ACE inhibitor) (e.g. enalapril, lisinopril, ramipril), particularly if you have kidney problems related to diabetes
• aliskiren

Your doctor may monitor your renal function, blood pressure, and electrolyte levels in the blood (e.g. potassium) at regular intervals.

See also the information under the heading “Do not take Losartán/Hidroclorotiazida Krka”.

Children and adolescents

There is no experience with the use of Losartán/Hidroclorotiazida Krka in children. Therefore, Losartán/Hidroclorotiazida Krka should not be administered to children.

Other medications and Losartán/Hidroclorotiazida Krka

Inform your doctor or pharmacist if you aretaking, havetakenrecentlyor may need to take any other medication.

Inform your doctor if you are taking potassium supplements, salt substitutes containing potassium, potassium-sparing medications, or other medications that may increase serum potassium levels (e.g. trimethoprim-containing medications), as the combination with Losartán/Hidroclorotiazida Krka is not recommended.

Diuretics such as hydrochlorothiazide in Losartán/Hidroclorotiazida Krka may interact with other medications. Lithium preparations should not be taken with Losartán/Hidroclorotiazida Krka without your doctor's careful monitoring. Special precautions may be necessary (e.g. blood tests) if you are taking diuretics (urine tablets), some laxatives, medications for gout, medications to control heart rhythm or diabetes (oral medications or insulin).

It is also essential to inform your doctor if you are taking:

• other medications that lower blood pressure,
• steroids,
• medications for cancer,
• analgesics,
• medications for fungal infections,
• medications for arthritis,
• resins used for high cholesterol, such as cholestyramine,
• muscle relaxants,
• sleeping pills,
• opioid medications such as morphine,
• pressor amines such as adrenaline or other drugs in the same group,
• oral diabetes medications or insulin.

Your doctor may need to adjust your dose and/or take other precautions:

-If you are taking an ACE inhibitor or aliskiren (see also the information under the headings “Do not take Losartán/Hidroclorotiazida Krka” and “Warnings and precautions”).

Please inform your doctor if you are taking losartan/hydrochlorothiazide and plan to undergo a radiographic procedure and will be given a contrast agent containing iodine.

Losartán/Hidroclorotiazida Krka with food, drinks, and alcohol

It is recommended not to drink alcohol while taking these tablets: alcohol and Losartán/Hidroclorotiazida Krka tablets may increase the effects of each other.

Excessive salt in the diet may counteract the effect of Losartán/Hidroclorotiazida Krka tablets.

Losartán/Hidroclorotiazida Krka can be taken with or without food.

The juice of a grapefruit should be avoided while taking losartan/hydrochlorothiazide tablets.

Pregnancy and lactation

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using this medication.

Pregnancy

You should inform your doctor if you think you are pregnant (or may be pregnant). Your doctor will usually advise you to stop taking Losartán/Hidroclorotiazida Krka before becoming pregnant or as soon as you know you are pregnant and recommend that you take another medication instead of Losartán/Hidroclorotiazida Krka. Losartán/Hidroclorotiazida Krka is not recommended during pregnancy, and it should not be taken if you are more than three months pregnant, as it may cause serious harm to your baby if used after the third month of pregnancy.

Lactation

Inform your doctor if you are breastfeeding or plan to start breastfeeding. Losartán/Hidroclorotiazida Krka is not recommended for breastfeeding mothers, and your doctor may choose another treatment for you if you wish to breastfeed.

Use in elderly patients

Losartán/Hidroclorotiazida Krka acts with equal efficacy and is equally well tolerated by most elderly patients and young patients. Most elderly patients require the same dose as younger patients.

Driving and operating machinery

When starting treatment with this medication, you should not perform tasks that require special attention (e.g. driving a car or operating hazardous machinery) until you know how you tolerate your medication.

Losartán/Hidroclorotiazida Krka contains lactose

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

Follow exactly the administration instructions of this medication indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again. Your doctor will decide on the appropriate dose oflosartán/hidroclorotiazida, depending on your condition and if you are taking other medications. It is essential to continue takinglosartán/hidroclorotiazidaas prescribed by your doctor to maintain a constant control of blood pressure.

Losartán/Hidroclorotiazida Krka is available inthreedoses:losartán/hidroclorotiazida 50 mg/12.5 mg film-coated tablets,losartán/hidroclorotiazida 100 mg/12.5 mg film-coated tablets andlosartán/hidroclorotiazida 100mg/25mg film-coated tablets.

Hypertension

For most patients with high blood pressure, the usual dose is 1 tablet of losartán/hidroclorotiazida 50 mg/12.5 mg per day to control blood pressure for 24 hours. Your doctor may increase the dose to 2 tablets of losartán/hidroclorotiazida 50 mg/12.5 mg per day or to 1 tablet of losartán/hidroclorotiazida 100 mg/25 mg per day (a higher dose). The maximum dose is 2 tablets of losartán/hidroclorotiazida 50 mg/12.5 mg per day or 1 tablet of losartán/hidroclorotiazida 100 mg/25 mg per day.

Losartán/hidroclorotiazida 100 mg/12.5 mg (100 mg of losartán/12.5 mg of hidroclorotiazida) is available for patients treated with 100 mg oflosartán, who need additional control of blood pressure.

Administration

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

If you take more Losartán/Hidroclorotiazida Krka than you should

In case of overdose or accidental ingestion, contact your doctor immediately, go directly to the hospital for immediate medical attention.The 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 Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

If you forgot to take Losartán/Hidroclorotiazida Krka

Try to take losartán/hidroclorotiazida daily as prescribed. Do not take a double dose to compensate for the missed doses. Simply return to your regular schedule.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

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

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

Severe allergic reaction (skin rash, itching, swelling of the face, lips, mouth, or throat that may cause difficulty swallowing or breathing).

This is a serious but rare side effect that can affect up to 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 serious but very rare side effect that can affect up to 1 in 10,000 patients. You may need urgent medical attention or hospitalization.You may need urgent medical attention or hospitalization.

The following side effects have been reported:

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

• Cough, respiratory infection, nasal congestion, sinusitis, breast 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 kidney function, including renal insufficiency
• Low blood sugar (hypoglycemia)

Occasional(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 cells, coagulation problems, reduced plateletsReduced platelets
• Loss of appetite, elevated uric acid levels or gout, elevated blood glucose levels, abnormal electrolyte levels in the blood
• Anxiety, nervousness, panic attacks (recurring panic attacks), confusion, depression, abnormal dreams, sleep disorders, drowsiness, memory alteration
• Tickling or similar sensations, pain in the extremities, tremor, migraine, fainting
• Blurred vision, eye itching or stinging, conjunctivitis, worsening vision, seeing things in yellow
• Ringing, buzzing, sounds or clicks 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 bleeding, runny nose, congestion
• Constipation, chronic constipation, gas, stomach disorders, stomach spasms, vomiting, dry mouth, salivary gland inflammation, tooth pain
• Jaundice (yellow discoloration of the eyes and skin), pancreatitis inflammation
• 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 kidney 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

Frequency unknown(cannot be estimated from available data):

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

• 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,

-Alteration of taste (dysgeusia),

• 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 experienceanytype of side effect, consultyour doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly to the Spanish System for the Vigilance of Medicinal Products for Human Use: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.

Do not store at a temperature above 30°C..

Store in the original packaging to protect it from moisture.

HDPE Bottle:

After the first opening of the packaging, the medication must be used within the next 100 days.

Medicines should not be thrown down the drains or in the trash. Dispose of the containers and medications you no longer need at the SIGRE point of the pharmacy. Ask your pharmacist how to dispose of the containers and medications you no longer need. In this way, you will help protect the environment.

Composition of Losartán/Hidroclorotiazida Krka

• The active principles 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 components are pregelatinized cornstarch, microcrystalline cellulose, lactose monohydrate, magnesium stearate in the core and hypromellose, macrogol 4000, talc, and titanium dioxide (E171) in the coating . See section 2 “Losartán/Hidroclorotiazida contains lactose”.

Appearance of the product and contents of the package

Losartán/Hidroclorotiazida Krka 100 mg/12.5 mg are film-coated tablets with a white film coating, oval, and biconvex. Dimensions of the tablet: 13 mm x 8 mm.

Package sizes :

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

Only some package 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

For further information about this medicinal product, please contact 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 medicinal product is authorized in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) with the following names:

Last revision date of this leaflet: September 2023

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