Losartan/Hydrochlorothiazide Krka 100 mg/25 mg film-coated tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Losartan potassium; Hydrocholothiazide

Available from:

KRKA, d.d., Novo mesto

ATC code:

C09DA; C09DA01

INN (International Name):

Losartan potassium; Hydrocholothiazide

Dosage:

100 mg/25 milligram(s)

Pharmaceutical form:

Film-coated tablet

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic area:

Angiotensin II antagonists and diuretics; losartan and diuretics

Authorization status:

Marketed

Authorization date:

2013-11-08

Patient Information leaflet

15
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
LOSARTAN/HYDROCHLOROTHIAZIDE KRKA 100 MG/25 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.
WHAT IS IN THIS LEAFLET
1.
What Losartan/Hydrochlorothiazide Krka is and what it is 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.
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 which binds
to receptors in blood vessels, causing them to tighten. This results
in an increase in blood pressure.
Losartan prevents the binding of angiotensin II to these receptors,
causing the blood vessels to relax
which in turn lowers the blood pressure. Hydrochlorothiazide works by
making the kidneys pass more
water and salt. This also helps to reduce 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 TAKE LOSARTAN/HYDROCHLOROTHIAZIDE KRKA
-
if you are allergic to losartan and/or hydrochlorothiazide or any of
the other ingredients of this
medicine listed in section 6,
-
if you a

Summary of Product characteristics

Health Products Regulatory Authority
11 July 2023
CRN00DKRM
Page 1 of 15
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Losartan/Hydrochlorothiazide Krka 100 mg/25 mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 100 mg losartan potassium, equivalent
to 91.52 mg losartan and 25 mg hydrochlorothiazide.
Excipient with known effect: lactose 119.95 mg/tablet.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet.
Tablets are yellow, oval, slightly biconvex, film-coated tablets.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Losartan/Hydrochlorothiazide Krka is indicated for the treatment of
essential hypertension in patients, whose blood pressure is
not adequately controlled on losartan or hydrochlorothiazide alone.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Hypertension
Losartan and hydrochlorothiazide is not for use as initial therapy,
but in patients whose blood pressure is not adequately
controlled by losartan potassium or hydrochlorothiazide alone.
Dose titration with the individual components (losartan and
hydrochlorothiazide) is recommended.
When clinically appropriate direct change from monotherapy to the
fixed combination may be considered in patients whose
blood pressure is not adequately controlled.
The usual maintenance dose of Losartan/Hydrochlorothiazide Krka is one
tablet of Losartan/Hydrochlorothiazide Krka
50 mg/12.5 mg (losartan 50 mg/hydrochlorothiazide 12.5 mg) once daily.
For patients who do not respond adequately to
Losartan/Hydrochlorothiazide Krka 50 mg/12.5 mg, the dosage may be
increased to one tablet of
Losartan/Hydrochlorothiazide Krka 100 mg/25 mg (losartan 100
mg/hydrochlorothiazide 25 mg) once daily. The maximum
dose is one tablet of Losartan/Hydrochlorothiazide Krka 100 mg/25 mg
once daily. In general, the antihypertensive effect is
attained within three to four weeks after initiation of therapy.
Losartan/Hydrochlorothiazide Krka 100 mg/12.5 mg (losartan
100 mg/hydrochlorothiaz