Losartan/Hydrochlorothiazide 50 mg/ 12.5 mg film-coated tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Losartan potassium; Hydrochlorothiazide

Available from:

Rowex Ltd

ATC code:

C09DA; C09DA01

INN (International Name):

Losartan potassium; Hydrochlorothiazide

Dosage:

50 mg/12.5 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:

Not marketed

Authorization date:

2009-03-20

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
LOSARTAN/HYDROCHLOROTHIAZIDE 50 MG/ 12.5 MG FILM-COATED TABLETS
LOSARTAN/HYDROCHLOROTHIAZIDE 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 is and what it is used for
2. What you need to know before you take Losartan/Hydrochlorothiazide
3. How to take Losartan/Hydrochlorothiazide
4. Possible side effects
5. How to store Losartan/Hydrochlorothiazide
6. Contents of the pack and other information
1. WHAT LOSARTAN/HYDROCHLOROTHIAZIDE IS AND WHAT IT IS USED FOR_ _
_Losartan_
potassium belongs to a group of medicines called angiotensin-II
receptor antagonists. These
cause the blood vessels to relax which in turn lowers the blood
pressure.
_Hydrochlorothiazide_
belongs to a group of medicines called diuretics (water tablets).
Hydrochlorothiazide works by making the kidneys pass more water and
salt. This also helps to reduce
blood pressure.
_Losartan/Hydrochlorothiazide 50 mg/12.5 mg film-coated tablets: _
These tablets are used to treat high blood pressure. The combination
of losartan and
hydrochlorothiazide is a suitable alternative for those people who
would otherwise have to be treated
with losartan potassium and hydrochlorothiazide given as separate
tablets.
_Losartan/Hydrochlorothiazide 100 mg/ 25 mg film-coated tablets: _
These tablets are used to treat high blood pressure in patients who
have not responded sufficiently to
treatment with Losartan/Hy

Summary of Product characteristics

Health Products Regulatory Authority
30 June 2021
CRN00CD2Q
Page 1 of 15
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Losartan/Hydrochlorothiazide 50 mg/ 12.5 mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 50 mg of losartan potassium and 12.5
mg hydrochlorothiazide.
Excipient with known effect
Each film-coated tablet contains 25.6 mg of lactose (as monohydrate).
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet
Light yellow, round, biconvex film-coated tablet with a diameter of 8
mm.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Losartan/Hydrochlorothiazide 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
Posology
_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 is one tablet of
Losartan/Hydrochlorothiazide 50 mg/ 12.5 mg (losartan 50 mg/HCTZ 12.5
mg)
once daily. For patients who do not respond adequately to
Losartan/Hydrochlorothiazide 50 mg/ 12.5 mg, the dose may be
increased to maximum 2 tablets daily of Losartan/Hydrochlorothiazide
50 mg/ 12.5 mg or one tablet of
Losartan/Hydrochlorothiazide 100 mg/ 25 mg (losartan 100 mg/ HCTZ 25
mg) once daily. In general, the antihypertensive
effect is attained within three to four weeks after initiation of
therapy.
_Renal impairment and haemodialysis_
No initial dose adjustment is necessary in patients with moderate
renal impairment (i.e. creatinine clearance 30-50 ml/mi