Losartan hydrochlorothiazide krka

Package leaflet: Information for the user

Losartan Hydrochlorothiazide Krka, 50 mg + 12.5 mg, film-coated tablets
Losartan Hydrochlorothiazide Krka, 100 mg + 25 mg, film-coated tablets
losartanum kalicum + hydrochlorothiazidum
Please read this leaflet carefully before taking the medicine, as it contains
important information for the patient.

• Keep this leaflet for future reference.
• If you have any questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not share it with others. This medicine may harm others, even if their symptoms are similar.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents:

1. What Losartan Hydrochlorothiazide Krka is and what it is used for
2. Important information before taking Losartan Hydrochlorothiazide Krka
3. How to take Losartan Hydrochlorothiazide Krka
4. Possible side effects
5. How to store Losartan Hydrochlorothiazide Krka
6. Contents of the pack and other information

1. What Losartan Hydrochlorothiazide Krka is and what it is 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 that binds to receptors in blood vessels, causing them to constrict. This leads to increased blood pressure. Losartan prevents angiotensin II from binding to these receptors, resulting in blood vessel dilation and lowering of blood pressure. Hydrochlorothiazide works by increasing the amount of water and salt excreted in the urine. This also contributes to lowering blood pressure.
Losartan Hydrochlorothiazide Krka is indicated for the treatment of essential hypertension (high blood pressure).

2. Important information before using Losartan Hydrochlorothiazide Krka

When not to use Losartan Hydrochlorothiazide Krka

• if the patient is allergic to losartan and (or) hydrochlorothiazide or any of the other ingredients of this medicine (listed in section 6.1),
• if the patient is allergic to other sulfonamide-derived substances (e.g. other thiazide diuretics, certain antibacterial agents such as co-trimoxazole; in case of doubt, consult a physician),
• if the patient is in pregnancy beyond the third month (Losartan Hydrochlorothiazide Krka should also be avoided during early pregnancy – see section "Pregnancy"),
• if the patient has severe liver dysfunction,
• if the patient has severe kidney dysfunction or is not producing urine,
• if the patient has low potassium levels, low sodium levels, or high calcium levels in blood that cannot be corrected by treatment,
• if the patient has gout,
• if the patient has diabetes or kidney dysfunction and is being treated with a blood pressure-lowering medicine containing aliskiren.

Warnings and precautions
Before starting treatment with Losartan Hydrochlorothiazide Krka, discuss this with your doctor or pharmacist.
Inform your doctor if you are pregnant, suspect you may be pregnant, or are planning pregnancy. Use of Losartan Hydrochlorothiazide Krka is not recommended during early pregnancy and must not be taken after the third month of pregnancy, as it may be highly harmful to the unborn child if used during this period of pregnancy (see section "Pregnancy and breastfeeding").

Before using Losartan Hydrochlorothiazide Krka, inform your doctor:

• if the patient has experienced facial, lip, throat or tongue swelling,
• if the patient is taking diuretics (water tablets),
• if the patient is on a low-salt diet,
• if the patient has or has had severe vomiting and/or diarrhoea,
• if the patient has heart failure,
• if the patient has liver dysfunction (see section 2. When not to use Losartan Hydrochlorothiazide Krka),
• if the patient has narrowing of the blood vessels leading to the kidneys (renal artery stenosis), if the patient has only one functioning kidney, or if the patient has recently undergone kidney transplantation,
• if the patient has narrowed blood vessels (arterial stenosis), angina pectoris (chest pain due to impaired heart function),
• if the patient has aortic or mitral valve stenosis (valve narrowing) or hypertrophic cardiomyopathy (a disease causing thickening of the heart muscle),
• if the patient has diabetes,
• if the patient has had an attack of gout,
• if the patient has had or has allergies, asthma, or a disease causing joint pain, skin rash and fever (systemic lupus erythematosus),
• if the patient has high calcium levels or low potassium levels in blood, or if the patient is on a low-potassium diet,
• if the patient is to undergo anaesthesia (even at the dentist), is scheduled for surgery, or is undergoing parathyroid function tests, it is essential to inform the doctor or medical staff about taking Losartan Hydrochlorothiazide Krka,
• if the patient has primary hyperaldosteronism (a disorder of the adrenal glands characterized by increased production of the hormone aldosterone),
• if the patient is taking other medicines that may increase serum potassium levels (see section 2 "Losartan Hydrochlorothiazide Krka and other medicines"),
• if the patient has previously had skin cancer or if unexpected skin changes occur during treatment. Treatment with hydrochlorothiazide, especially at high doses over a prolonged period, may increase the risk of certain types of skin and lip cancers (non-melanoma skin cancer). While taking Losartan Hydrochlorothiazide Krka, protect the skin from sunlight and UV radiation,
• if the patient previously experienced breathing or lung problems after taking hydrochlorothiazide (including pneumonia or fluid accumulation in the lungs). If severe shortness of breath or difficulty breathing occurs after taking Losartan Hydrochlorothiazide Krka, seek immediate medical help,
• if vision disturbances or pain in one or both eyes occur during treatment with Losartan Hydrochlorothiazide Krka. These may be symptoms of fluid accumulation in the vascular layer surrounding the eye (excessive fluid accumulation between choroid and sclera) or glaucoma, increased pressure in one or both eyes – which may occur from several hours to weeks after taking Losartan Hydrochlorothiazide Krka. Discontinue use of Losartan Hydrochlorothiazide Krka and consult a doctor immediately,
• if the patient is taking any of the following medicines for high blood pressure:
• an angiotensin-converting enzyme (ACE) inhibitor (e.g. enalapril, lisinopril, ramipril), particularly if the patient has kidney dysfunction related to diabetes,
• aliskiren.

The treating physician may monitor kidney function, blood pressure, and blood electrolyte levels (e.g. potassium) at regular intervals.
See also information under the heading: "When not to use Losartan Hydrochlorothiazide Krka".
If the patient experiences abdominal pain, nausea, vomiting or diarrhoea after taking Losartan Hydrochlorothiazide Krka, discuss this with the doctor. The doctor will decide on continuing treatment.
Do not make independent decisions about stopping Losartan Hydrochlorothiazide Krka.

Children and adolescents
There is no experience with the use of Losartan Hydrochlorothiazide Krka in children and adolescents; therefore, it should not be used in this patient group.

Use in elderly patients
Losartan Hydrochlorothiazide Krka is equally effective and well tolerated in most elderly patients as in younger patients. Most elderly patients receive the same dose as younger patients.

Losartan Hydrochlorothiazide Krka and other medicines
Inform your doctor about all medicines currently used, recently used, or planned for use.
Inform your doctor about potassium supplements, potassium-containing salt substitutes, potassium-sparing medicines, or other medicines that may increase serum potassium levels, as concomitant use with Losartan Hydrochlorothiazide Krka is not recommended.
Diuretics such as hydrochlorothiazide contained in Losartan Hydrochlorothiazide Krka may interact with other medicines.
Do not take lithium-containing preparations together with Losartan Hydrochlorothiazide Krka without strict medical supervision.
If the patient is taking other diuretics, certain laxatives, medicines used to treat gout, or medicines used to control heart rhythm or diabetes (oral antidiabetic medicines or insulin), special precautions (e.g. blood tests) may be necessary.
The treating physician may need to adjust the dose and/or take additional precautions:

• if the patient is taking an ACE inhibitor or aliskiren (see also information under the headings "When not to use Losartan Hydrochlorothiazide Krka" and "Warnings and precautions").

It is also important for the doctor to know if the patient is taking:

• other medicines to lower blood pressure,
• corticosteroids,
• cancer treatments,
• painkillers,
• antifungal medicines,
• anti-inflammatory medicines,
• bile acid sequestrants used to treat high cholesterol, such as cholestyramine,
• muscle relaxants,
• sleeping medicines,
• opioid medicines such as morphine,
• "pressors" such as adrenaline or other medicines in the same class,
• oral antidiabetic medicines or insulin.

If iodine-containing contrast agents are planned, inform the doctor about taking Losartan Hydrochlorothiazide Krka.

Losartan Hydrochlorothiazide Krka with food, drink and alcohol
Losartan Hydrochlorothiazide Krka may be taken with or without food.
It is recommended that the patient does not drink alcohol while taking Losartan Hydrochlorothiazide Krka, as alcohol and tablets containing potassium losartan with hydrochlorothiazide may mutually enhance their effects.
Excessive salt intake may counteract the effect of potassium losartan and hydrochlorothiazide.
Avoid drinking grapefruit juice while taking Losartan Hydrochlorothiazide Krka tablets.

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult her doctor or pharmacist before using this medicine.

Pregnancy
Inform your doctor if you are pregnant, suspect pregnancy, or are planning pregnancy. The doctor will usually advise discontinuation of Losartan Hydrochlorothiazide Krka before planned pregnancy or as soon as possible after pregnancy is confirmed, and will recommend an alternative medicine. Losartan Hydrochlorothiazide Krka is not recommended for use during early pregnancy and must not be used after the third month of pregnancy, as it may seriously harm the unborn child if taken during this period.

Breastfeeding
Inform your doctor if you are breastfeeding or intend to breastfeed. Losartan Hydrochlorothiazide Krka is not recommended during breastfeeding, and the doctor may prescribe an alternative treatment if the patient wishes to breastfeed.

Driving and operating machinery
When starting treatment with Losartan Hydrochlorothiazide Krka, the patient should not perform tasks requiring high concentration (e.g. driving a car or operating dangerous machinery) until it is known how the patient tolerates this medicine.

Losartan Hydrochlorothiazide Krka contains lactose. If the patient has been diagnosed with an intolerance to certain sugars, he or she should consult a doctor before starting treatment with this medicine.

3. How to use Losartan Hydrochlorothiazide Krka

This medicine should always be used exactly as directed by your doctor or pharmacist. If in doubt,
consult your doctor or pharmacist.
Your doctor will determine the appropriate dose of Losartan Hydrochlorothiazide Krka based on
your condition and other medications you may be taking. To achieve proper control of blood
pressure, continue taking Losartan Hydrochlorothiazide Krka for as long as your doctor has instructed.

High blood pressure
The recommended dose for most patients with high blood pressure is 1 tablet of Losartan Hydrochlorothiazide Krka 50 mg + 12.5 mg once daily, which provides blood pressure control over a 24-hour period. Your doctor may increase the dose to 2 tablets of losartan + hydrochlorothiazide 50 mg + 12.5 mg once daily or switch you to 1 tablet of losartan + hydrochlorothiazide 100 mg + 25 mg (a higher strength) once daily. The maximum daily dose is either 2 tablets daily of losartan + hydrochlorothiazide 50 mg + 12.5 mg or 1 tablet daily of losartan + hydrochlorothiazide 100 mg + 25 mg.

Taking more Losartan Hydrochlorothiazide Krka than prescribed
If you take more than the prescribed amount, contact your doctor immediately so that appropriate measures can be taken without delay. Overdose may cause low blood pressure, palpitations, slowed heart rate, changes in blood composition, and dehydration.

If you miss a dose of Losartan Hydrochlorothiazide Krka
Do not take a double dose to make up for a missed dose.
Losartan Hydrochlorothiazide Krka should be taken every day as directed by your doctor.
If you miss a dose, do not take a double dose to compensate. Instead, continue taking the medicine according to your prescribed schedule.

If you have any further doubts about using this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
If any of the following adverse effects occur, stop taking Losartan Hydrochlorothiazide Krka and consult a doctor immediately or go to the emergency department at the nearest hospital:
Severe allergic reactions (rash, itching, swelling of the face, lips, mouth or throat, which may cause difficulty swallowing or breathing).
This is a serious, although rare, adverse effect that may occur in no more than 1 in 1,000 patients. Urgent medical intervention or hospitalization may be required.

The following adverse effects have been reported:

Common (may occur in up to 1 in 10 patients):

• Cough, upper respiratory tract infection, nasal mucosa congestion, sinusitis, sinus disorders,
• Diarrhoea, abdominal pain, nausea, indigestion,
• Muscle pain or cramps, leg pain, back pain,
• Insomnia, headache, dizziness,
• Weakness, fatigue, chest pain,
• Increased potassium levels in blood (which may cause heart rhythm disturbances), decreased haemoglobin levels,
• Kidney function impairment, including kidney failure,
• Low blood sugar levels (hypoglycaemia).

Uncommon (may occur in up to 1 in 100 patients):

• Anaemia, red or brownish skin spots (usually mainly on feet, legs, arms and buttocks, with joint pain, swelling of hands and feet, and stomach pain), bruising, decreased white blood cell count, coagulation disorders, decreased platelet count,
• Loss of appetite, increased uric acid levels or gout, increased blood sugar levels, disturbances in blood electrolyte levels,
• Anxiety, nervousness, panic disorder (recurrent panic attacks), disorientation, depression, unusual dreams, sleep disturbances, drowsiness, memory disturbances,
• Tingling and numbness, limb pain, tremors, migraine, fainting,
• Blurred vision, burning or stinging sensation in the eyes, conjunctivitis, worsening of vision, yellow vision,
• Sensation of ringing, buzzing, roaring or pulsating sounds in the ears, vertigo,
• Low blood pressure, which may be related to postural changes (dizziness or weakness upon standing), angina (chest pain), heart rhythm disturbances, stroke (transient ischaemic attack, "mini-stroke"), myocardial infarction, palpitations,
• Vasculitis, often accompanied by skin rash or bruising,
• Sore throat, shortness of breath, bronchitis, pneumonia, pulmonary oedema (causing difficulty breathing), nosebleeds, nasal congestion, rhinitis, nasal mucosa congestion,
• Constipation, flatulence, upset stomach, stomach cramps, vomiting, dry mouth, sialadenitis, toothache,
• Jaundice (yellowing of eyes and skin), pancreatitis,
• Urticaria, itching, dermatitis, rash, skin redness, photosensitivity, dry skin, hot flushes, sweating, hair loss,
• Pain in arms, shoulders, hips, knees or other joints, joint swelling, stiffness, decreased muscle strength,
• Frequent urination (including at night), kidney function disorders, including nephritis, urinary tract infection, presence of glucose in urine,
• Decreased libido, impotence,
• Facial swelling, localized facial oedema, fever.

Rare (may occur in up to 1 in 1,000 patients):

• Hepatitis, abnormal liver function test results,
• Angioedema of the intestine: intestinal swelling with symptoms such as abdominal pain, nausea, vomiting and diarrhoea.

Very rare (may occur in up to 1 in 10,000 patients):

• Acute respiratory failure (symptoms include severe shortness of breath, fever, fatigue and confusion).

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

• Malignant skin and lip tumours (non-melanoma skin cancers),
• Influenza-like symptoms,
• Unexplained muscle pain and dark-coloured (tea-coloured) urine (rhabdomyolysis),
• Low sodium levels in blood (hyponatraemia),
• General malaise (apathy),
• Taste disturbances,
• Visual impairment or eye pain due to increased pressure (possible symptoms of fluid accumulation in the avascular membrane surrounding the eye – excessive fluid accumulation between choroid and sclera – or acute angle-closure glaucoma).

Reporting of adverse effects
If any adverse effects occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Al. Jerozolimskie 181C, 02-222 Warsaw,
Tel.: +48 22 49 21 301, Fax: +48 22 49 21 309,
Website: https://smz.ezdrowie.gov.pl
Adverse effects can also be reported to the marketing authorization holder.
Reporting adverse effects helps provide more information on the safety of this medicine.

5. How to store Losartan Hydrochlorothiazide Krka

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging following EXP. The expiry date refers to the last day of the stated month.
Do not store above 30°C. Store in the original packaging to protect from moisture.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures will help protect the environment.

6. Contents of the packaging and other information

What Losartan Hydrochlorothiazide Krka contains

• The active substances in this medicinal product are losartan potassium and hydrochlorothiazide.
  50 mg + 12.5 mg: Each coated tablet contains 50 mg of losartan potassium, equivalent to 45.76 mg of losartan, and 12.5 mg of hydrochlorothiazide.
  100 mg + 25 mg: Each coated tablet contains 100 mg of losartan potassium, equivalent to 91.52 mg of losartan, and 25 mg of hydrochlorothiazide.
• Other ingredients are: pregelatinized starch, corn starch, microcrystalline cellulose, lactose monohydrate, magnesium stearate in the tablet core; hypromellose, macrogol 4000, quinoline yellow (E 104), talc, titanium dioxide (E 171) in the tablet coating. See section 2: "Losartan Hydrochlorothiazide Krka contains lactose".

What Losartan Hydrochlorothiazide Krka looks like and contents of the pack
50 mg + 12.5 mg: yellow, oval, moderately biconvex coated tablets, with a break line on one side; tablet dimensions 6 mm x 12 mm (oval shape), thickness 3.8 – 4.7 mm. The break line on the tablet is intended only to facilitate breaking for ease of swallowing and does not ensure equal dose division.
100 mg + 25 mg: yellow, oval, slightly biconvex coated tablets; tablet dimensions 8 mm x 15 mm (oval shape), thickness 5.1 – 6.1 mm.
Pack sizes: 28, 30, 56, 60 or 90 coated tablets in blister packs, packed in cardboard boxes.

Marketing Authorisation Holder and Manufacturer
KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

This medicinal product is authorised in the Member States of the European Economic Area under the following names:

For further information about this medicinal product, please contact
the local representative of the marketing authorisation holder:
KRKA-POLSKA Sp. z o.o.
Równoległa 5 Street
02-235 Warsaw
Poland
tel.: + 48 22 573 75 00