可普諾維膜衣錠 300 毫克/25 毫克

Ülke: Tayvan

Dil: Çince

Kaynak: 衛生福利部食品藥物管理署 (Ministry of Health and Welfare, Food And Drug Administration)

Aktif bileşen:

IRBESARTAN;;HYDROCHLOROTHIAZIDE (EQ TO 3,4-DIHYDROCHLOROTHIAZIDE)

Mevcut itibaren:

賽諾菲股份有限公司 台北市信義區松仁路3號7樓 (97168356)

ATC kodu:

C09DA04

Farmasötik formu:

膜衣錠

Kompozisyon:

HYDROCHLOROTHIAZIDE (EQ TO 3,4-DIHYDROCHLOROTHIAZIDE) (4028100600) MG; IRBESARTAN (9200038400) MG

Paketteki üniteler:

鋁箔盒裝

Sınıf:

製　劑

Reçete türü:

須由醫師處方使用

Tarafından üretildi:

Sanofi Clir 54 Avenue de la Boetie, 75008, Paris, France FR

Terapötik alanı:

irbesartan and diuretics

Terapötik endikasyonlar:

本態性高血壓。

Ürün özeti:

註銷日期: 2017/11/29; 註銷理由: 自請註銷; 有效日期: 2017/11/12; 英文品名: Coaprovel Film-Coated Tablets 300mg/25mg

Yetkilendirme durumu:

已註銷

Yetkilendirme tarihi:

2007-11-12

Bilgilendirme broşürü

1
1.
NAME OF THE MEDICINAL PRODUCT
CoAprovel 150 mg/12.5 mg film-coated tablets.
CoAprovel 300 mg/12.5 mg film-coated tablets.
CoAprovel 300 mg/25 mg film-coated tablets.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
CoAprovel 150 mg/12.5 mg:
Each film-coated tablet contains 150 mg of irbesartan and 12.5 mg of
hydrochlorothiazide.
Excipient: Each film-coated tablet contains 38.5 mg of lactose (as
lactose
monohydrate).
CoAprovel 300 mg/12.5 mg:
Each film-coated tablet contains 300 mg of irbesartan and 12.5 mg of
hydrochlorothiazide.
Excipient: Each film-coated tablet contains 89.5 mg of lactose (as
lactose
monohydrate).
CoAprovel 300 mg/25 mg:
Each
film-coated
tablet
contains
300 mg
of
irbesartan
and
25 mg
of
hydrochlorothiazide.
Excipient: Each film-coated tablet contains 53.3 mg of lactose (as
lactose
monohydrate).
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
CoAprovel 150 mg/12.5 mg:
Peach, biconvex, oval-shaped, with a heart debossed on one side and
the
number 2875 engraved on the other side.
CoAprovel 300 mg/12.5 mg:
Peach, biconvex, oval-shaped, with a heart debossed on one side and
the
number 2876 engraved on the other side.
CoAprovel 300 mg/25 mg:
Pink, biconvex, oval-shaped, with a heart debossed on one side and the
number 2788 engraved on the other side.
4.
CLINICAL PARTICULARS
4.1
Therapeutic indications
Treatment of essential hypertension.
This fixed dose combination is indicated in adult patients whose blood
pressure is not adequately controlled on irbesartan or
hydrochlorothiazide
alone (see section 5.1).
4.2
Posology and method of administration
CoAprovel can be taken once daily, with or without food.
Dose
titration
with
the
individual
components
(i.e.
irbesartan
and
hydrochlorothiazide) may be recommended.
When clinically appropriate direct change from monotherapy to the
fixed
combinations may be considered:
CoAprovel 150 mg/12.5 mg may be administered in patients whose blood
pressure
is
not
adequately
controlled
with
hydrochlorothiazide
or
irbesartan 150