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

国家: 爱尔兰

语言: 英文

来源: HPRA (Health Products Regulatory Authority)

有效成分:

Losartan potassium; Hydrochlorothiazide

可用日期:

Rowex Ltd

ATC代码:

C09DA; C09DA01

INN（国际名称）:

Losartan potassium; Hydrochlorothiazide

剂量:

100 mg/25 milligram(s)

药物剂型:

Film-coated tablet

处方类型:

Product subject to prescription which may be renewed (B)

治疗领域:

Angiotensin II antagonists and diuretics; losartan and diuretics

授权状态:

Not marketed

授权日期:

2009-03-20

资料单张

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

产品特点

Health Products Regulatory Authority
04 August 2021
CRN00CGK0
Page 1 of 15
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Losartan/Hydrochlorothiazide 100 mg/25 mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 100 mg of losartan potassium and 25
mg hydrochlorothiazide.
Excipient with known effect
Each film-coated tablet contains 51.1 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 10
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 maximum dose is one tablet of Losartan/Hydrochlorothiazide 100 mg/
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/min).
Losartan and hydrochlorothiazide tablets are not recommended for
haemodialysis patients. Losartan/HCTZ tablets must not be
used in patients with severe renal impairment (i.e. creatinine
clearance <30 ml/min) (see section 4.3).
_Intravascular volume depletion_
Volume and/or sodium depletion should be corrected prior to
administra