Losartan hydrochlorothiazide krka

Package leaflet: Information for the user

Losartan Hydrochlorothiazide Krka, 100 mg + 12.5 mg, film-coated tablets
losartanum kalicum + hydrochlorothiazidum
Please read all of this leaflet carefully before taking this medicine because it contains
important information for you.

• Keep this leaflet as you may need to read it again.
• If you have any further questions, please ask your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others.
• It may harm other people, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Leaflet contents:

1. What Losartan Hydrochlorothiazide Krka is and what it is used for
2. What you need to know 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 narrow. 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 salts 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),
• if the patient is allergic to other sulfonamide-derived substances (e.g. other thiazide diuretics, certain antibacterial agents such as co-trimoxazole – consult a doctor in case of doubt),
• if the patient has severe liver function impairment,
• if the patient has low potassium levels, low sodium levels, or high calcium levels in the blood that cannot be corrected by treatment,
• if the patient has gout,
• if the patient is pregnant beyond the third month of pregnancy (use of Losartan Hydrochlorothiazide Krka should also be avoided during early pregnancy – see section “Pregnancy and breastfeeding”),
• if the patient has severe kidney function impairment or if the kidneys are not producing urine,
• if the patient has diabetes or kidney problems 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 a 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 cause severe harm to the unborn child if used during this period of
pregnancy (see “Pregnancy and breastfeeding”).
It is important to inform your doctor before taking Losartan Hydrochlorothiazide Krka:

• if the patient has ever experienced swelling of the face, lips, throat, or tongue,

• if the patient is taking diuretic medicines,

• 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 function disorders (see section “When not to use Losartan Hydrochlorothiazide Krka”),

• if the patient has narrowing of the blood vessels leading to the kidneys (renal artery stenosis), or if the patient has only one functioning kidney, or if the patient has recently received a kidney transplant,

• if the patient has narrowed blood vessels (arteriosclerosis), angina pectoris (chest pain due to reduced blood flow to the heart),

• if the patient has aortic or mitral valve stenosis (narrowing of heart valves) or hypertrophic cardiomyopathy (a disease causing thickening of the heart muscle),

• if the patient has diabetes,

• if the patient has had gout,

• if the patient has or has ever had 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 the blood, or if the patient is on a low-potassium diet,

• if the patient is to undergo anaesthesia (even at the dentist) or planned surgery, or if tests on parathyroid function are to be performed, the patient must inform the doctor or medical staff about taking Losartan Hydrochlorothiazide Krka,

• if the patient has primary hyperaldosteronism (a syndrome associated with increased secretion of the hormone aldosterone by the adrenal glands due to adrenal gland disease),

• if the patient is taking other medicines that may increase potassium levels in blood serum (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 and over a long period, may increase the risk of certain types of non-melanoma skin cancer and lip cancer. During treatment with Losartan Hydrochlorothiazide Krka, protect the skin from sunlight and UV radiation,

• if the patient has 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 a few hours to weeks after taking Losartan Hydrochlorothiazide Krka.
  The patient should stop taking Losartan Hydrochlorothiazide Krka and consult a doctor immediately.

• if the patient is taking any of the following medicines used to treat high blood pressure:

• an angiotensin-converting enzyme (ACE) inhibitor (e.g. enalapril, lisinopril, ramipril), particularly if the patient has kidney problems related to diabetes,

• aliskiren.

The treating doctor may monitor kidney function, blood pressure, and serum 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 further treatment.
Do not make independent decisions to stop taking Losartan Hydrochlorothiazide Krka.

Children and adolescents
There is no experience with the use of this medicine in children and adolescents. Therefore, Losartan
Hydrochlorothiazide Krka should not be given to these patient groups.

Losartan Hydrochlorothiazide Krka and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking, has recently taken, or
plans to take.
Inform your doctor about potassium supplements, salt substitutes containing potassium, potassium-sparing
agents, or other medicines that may increase serum potassium levels (e.g. medicines containing
trimethoprim), 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 preparations together with Losartan Hydrochlorothiazide Krka without strict medical
supervision.
Special precautions (e.g. blood tests) may be necessary if the patient is taking other diuretics, certain
laxatives, medicines used to treat gout, or medicines used to control heart rhythm or antidiabetic
medicines (oral preparations or insulin).
The treating doctor 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”).

Also inform your doctor if the patient is taking any of the following medicines:

• other medicines that lower blood pressure,
• corticosteroids,
• anticancer medicines,
• painkillers,
• antifungal medicines,
• medicines used to treat arthritis,
• bile acid sequestrants used to treat high cholesterol, such as cholestyramine,
• muscle relaxants,
• sleeping medicines,
• opioid medicines such as morphine,
• “pressor amines” such as adrenaline or other medicines in this group,
• oral antidiabetic medicines or insulin.

Also inform your doctor about taking Losartan Hydrochlorothiazide Krka if radiological examinations
with iodine-containing contrast agents are planned.

Losartan Hydrochlorothiazide Krka with food, drink, and alcohol
It is recommended that the patient does not drink alcohol while taking Losartan Hydrochlorothiazide
Krka, as alcohol and Losartan Hydrochlorothiazide Krka may enhance each other's effects.
Excessive salt intake in the diet may counteract the effect of Losartan Hydrochlorothiazide Krka.
Losartan Hydrochlorothiazide Krka may be taken with or without food.
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 a 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 stopping Losartan Hydrochlorothiazide Krka before planned pregnancy or as soon as
possible after pregnancy is confirmed, and will recommend another medicine instead of Losartan
Hydrochlorothiazide Krka. Use of Losartan Hydrochlorothiazide Krka is not recommended 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. Use of Losartan Hydrochlorothiazide
Krka is not recommended during breastfeeding – the doctor may choose an alternative treatment if the
patient intends to breastfeed.

Use in elderly patients
Losartan Hydrochlorothiazide Krka shows similar efficacy and is equally well tolerated in most adult
patients regardless of age. Most elderly patients require the same doses as younger patients.

Driving and using machines
During the initial phase of treatment with Losartan Hydrochlorothiazide Krka, do not perform tasks
requiring high concentration (e.g. driving a car or operating dangerous machinery) until you know how
you react to this medicine.

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

3. How to use Losartan Hydrochlorothiazyd Krka

This medicine should always be used as directed by the physician. If in doubt, consult a doctor or pharmacist.
The physician will determine the appropriate dose of Losartan Hydrochlorothiazyd Krka based on the patient's condition and other medications they are taking. To achieve proper blood pressure control, continue taking Losartan Hydrochlorothiazyd 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 containing 50 mg losartan and 12.5 mg hydrochlorothiazide once daily, which provides 24-hour blood pressure control. Your doctor may increase the dose to 2 tablets of the medicine containing 50 mg losartan and 12.5 mg hydrochlorothiazide once daily, or switch to 1 tablet containing 100 mg losartan and 25 mg hydrochlorothiazide (higher strength) once daily.
The maximum daily dose is either 2 tablets daily of the medicine containing 50 mg losartan and 12.5 mg hydrochlorothiazide, or 1 tablet of the medicine containing 100 mg losartan and 25 mg hydrochlorothiazide.
Losartan Hydrochlorothiazyd Krka 100 mg + 12.5 mg (100 mg losartan and 12.5 mg hydrochlorothiazide) is intended for patients already taking 100 mg losartan who require additional blood pressure control.

Taking more Losartan Hydrochlorothiazyd Krka than prescribed
If you take more than the prescribed dose, contact your doctor immediately to obtain urgent medical assistance.
Overdose may cause low blood pressure, rapid heartbeat, slowed heart function, changes in blood composition, and dehydration.

Missing a dose of Losartan Hydrochlorothiazyd Krka
Try to take Losartan Hydrochlorothiazyd Krka every day as directed by your doctor. If you miss a dose, do not take a double dose to make up for the missed dose. Continue taking the medicine according to the prescribed schedule.
If you have any further questions about the use of 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 the medicine
Losartan Hydrochlorothiazide Krka and consult a doctor immediately or go to
the emergency department of the nearest hospital:
Severe allergic reactions (rash, itching, swelling of the face, lips, mouth or throat, which
may cause difficulty in swallowing or breathing).
This is a serious, but rare adverse effect, occurring in more than 1 in 10,000 patients,
but in less than 1 in 1,000 patients. Urgent medical intervention or
hospitalization may be necessary.

The following adverse effects have been reported:

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

• Cough, upper respiratory tract infection, nasal 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 the blood (which may cause heart rhythm disturbances), decreased haemoglobin levels,
• Kidney function disorders, including kidney failure,
• Low blood sugar levels (hypoglycaemia).

Uncommon (may affect up to 1 in 100 people):

• Anaemia, red or brownish skin spots (usually mainly on the feet, legs, arms and buttocks, with joint pain, swelling of hands and feet, and stomach pain), easy bruising, decreased number of white blood cells, coagulation disorders, decreased platelet count,
• Loss of appetite, increased uric acid levels or overt gout, increased blood sugar levels, disturbances in blood electrolyte levels,
• Restlessness, nervousness, anxiety disorder with panic attacks (recurrent panic attacks), disorientation, depression, unusual dreams, sleep disturbances, drowsiness, memory disturbances,
• Tingling and numbness, limb pain, tremor, migraine, fainting,
• Blurred vision, burning or stinging sensation in the eyes, conjunctivitis, worsening of vision, yellow vision,
• Ringing, buzzing, humming or pulsating sounds in the ears, vertigo of labyrinthine origin,
• Low blood pressure, which may be related to changes in body position (feeling of dizziness or weakness upon standing), angina pectoris (chest pain), heart rhythm disturbances, cerebrovascular incident (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 in breathing), nosebleeds, runny nose, nasal congestion,
• Constipation, flatulence, gastritis, stomach cramps, vomiting, dryness of the oral mucosa, sialadenitis, toothache,
• Jaundice (yellowing of eyes and skin), pancreatitis,
• Urticaria, itching, dermatitis, rash, skin redness, photosensitivity, dry skin, sudden flushing (especially of the face), sweating, hair loss,
• Pain in arms, shoulders, hips, knees or other joints, joint swelling, stiffness, muscle weakness,
• Frequent urination, including at night, kidney function disorders, including nephritis, urinary tract infection, presence of glucose in urine,
• Decreased libido, impotence,
• Facial swelling, localised oedema (swelling), fever.

Rare (may affect up to 1 in 1,000 people):

• Hepatitis, abnormal liver function test results,
• Intestinal angioedema: intestinal swelling with symptoms such as abdominal pain, nausea, vomiting and diarrhoea.

Very rare (may affect up to 1 in 10,000 people):

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

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

• Malignant skin and lip tumours (non-melanoma skin cancers),
• Influenza-like symptoms,
• Unexplained muscle pain with dark (tea-coloured) urine (rhabdomyolysis),
• Low sodium levels in the blood (hyponatraemia),
• General malaise,
• Taste disturbances,
• Impaired vision or eye pain due to elevated pressure (possible symptoms of fluid accumulation in the vascular 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 adverse effects not listed
in this leaflet, inform your doctor or pharmacist. Adverse effects can be reported
directly to the Department for Monitoring Adverse Drug Reactions of 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.
By reporting adverse effects, additional information on the safety of the medicine can be collected.

5. How to store Losartan Hydrochlorothiazide Krka

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

6. Contents of the pack and other information

What Losartan Hydrochlorothiazide Krka contains

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

What Losartan Hydrochlorothiazide Krka looks like and contents of the pack
White, oval, biconvex film-coated tablets, 8 mm x 13 mm in size and 4.4 – 5.1 mm thick.
Pack sizes: 28, 30, 56 or 60 film-coated tablets in blister packs, packed in a cardboard box.

Marketing Authorisation Holder
KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8000 Novo mesto, Slovenia

Manufacturer
KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia
Genenpharm S.A., 18 km Marathon Anenue, 15351 Pallini, Greece

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