Cosartal Plus 100 mg/12.5 mg Film-coated tablets

Negara: Irlandia

Bahasa: Inggris

Sumber: HPRA (Health Products Regulatory Authority)

Bahan aktif:

Hydrochlorothiazide; Losartan potassium

Tersedia dari:

Actavis Group PTC ehf

Kode ATC:

C09DA; C09DA01

INN (Nama Internasional):

Hydrochlorothiazide; Losartan potassium

Dosis:

100/12.5 milligram(s)

Bentuk farmasi:

Film-coated tablet

Jenis Resep:

Product subject to prescription which may be renewed (B)

Area terapi:

Angiotensin II antagonists and diuretics; losartan and diuretics

Status otorisasi:

Marketed

Tanggal Otorisasi:

2012-03-02

Selebaran informasi

BBBA0879
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
PACKAGE LEAFLET:
INFORMATION FOR THE USER
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 calcium levels
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Karakteristik produk

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Cosartal Plus 100mg/12.5mg Film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 100 mg losartan potassium and 12.5 mg
hydrochlorothiazide
For the full list of excipients see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet.
Cosartal Plus 100 mg/12.5 mg film-coated tablets: yellow, round,
biconvex, 10 mm film-coated tablets. Marked LH3
on one side. The tablets are not scored.
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.
Cosartal
Plus 100 mg /
12.5 mg is 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 impairment (i.e.
creatinine clear