Cosartal Plus 100 mg/25 mg Film-coated tablets

国: アイルランド

言語: 英語

ソース: HPRA (Health Products Regulatory Authority)

有効成分:

Losartan potassium; Hydrochlorothiazide

から入手可能:

Actavis Group PTC ehf

ATCコード:

C09DA; C09DA01

INN（国際名）:

Losartan potassium; Hydrochlorothiazide

投薬量:

100/25 milligram(s)

医薬品形態:

Film-coated tablet

処方タイプ:

Product subject to prescription which may be renewed (B)

治療領域:

Angiotensin II antagonists and diuretics; losartan and diuretics

認証ステータス:

Marketed

承認日:

2010-06-04

情報リーフレット

Cosartal Plus FCTs
v015
PA1380/98/1-3
PACKAGE LEAFLET: INFORMATION FOR THE USER
COSARTAL PLUS 50 MG/ 12.5 MG FILM-COATED TABLETS
COSARTAL PLUS 100 MG/ 12.5 MG FILM-COATED TABLETS
COSARTAL PLUS 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 Cosartal Plus is and what it is used for
2.
What you need to know before you take Cosartal Plus
3.
How to take Cosartal Plus
4.
Possible side effects
5.
How to store Cosartal Plus
6.
Contents of the pack and other information
1.
WHAT COSARTAL PLUS IS AND WHAT IT IS USED FOR
Cosartal Plus is a combination of an angiotensin II receptor
antagonist (losartan) and a diuretic
(hydrochlorothiazide).
Cosartal Plus is indicated for the treatment of essential hypertension
(high blood pressure).
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE COSARTAL PLUS
DO NOT TAKE COSARTAL PLUS:
-
if you are allergic to losartan, hydrochlorothiazide or to any of the
other ingredients of this
medicine (listed in section 6).
-
if you are allergic (hypersensitive) to other sulfonamide-derived
substances (e.g. other thiazides,
some antibacterial drugs such as co-trimoxazole, ask your doctor if
you are not sure)
-
if you have severely impaired liver function
-
if you are more than 3 months pregnant (it is also better to avoid
Cosartal Plus in early pregnancy
– see pregnancy section)
- if you have severely impaired kidney function or your kidneys are
not producing any urine
-
if you have low potassium, low sodium or high

製品の特徴

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Cosartal Plus 100mg/25mg Film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 100 mg losartan potassium and 25 mg
hydrochlorothiazide.
For the full list of excipients see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet.
White, round, biconvex, 10 mm film-coated tablets, scored on both
sides, with side scores. Marked LH2 on one side.
The tablet can be divided into equal doses.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Cosartal Plus 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 of Cosartal Plus is one tablet of Cosartal
Plus 50 mg/12.5 mg (losartan 50 mg/HCTZ 12.5
mg) once daily.
For patients who do not
respond adequately to Cosartal
Plus 50 mg/12.5 mg,
the dosage may be
increased to one tablet of Cosartal Plus 100 mg/25 mg (losartan 100
mg/ HCTZ 25 mg) once daily. The maximum dose
is one tablet of Cosartal Plus 100 mg/25 mg once daily. In general,
the antihypertensive effect is attained within three to
four weeks after initiation of therapy.
Other tablets containing losartan 100 mg/
HCTZ 12.5 mg may be available for those patients titrated to 100 mg of
losartan who require additional blood pressure control.
_Use in patients with renal impairment and haemodialysis patients_
No initial dosage adjustment is necessary in patients with moderate
renal i