EXFORGE 5 MG160 MG

Quốc gia: Israel

Ngôn ngữ: Tiếng Anh

Nguồn: Ministry of Health

Thành phần hoạt chất:

AMLODIPINE AS BESYLATE; VALSARTAN

Sẵn có từ:

NOVARTIS ISRAEL LTD

Mã ATC:

C08CA01

Dạng dược phẩm:

FILM COATED TABLETS

Thành phần:

AMLODIPINE AS BESYLATE 5 MG; VALSARTAN 160 MG

Tuyến hành chính:

PER OS

Loại thuốc theo toa:

Required

Sản xuất bởi:

SIEGFRIED BARBERA, S.L., SPAIN

Nhóm trị liệu:

AMLODIPINE

Khu trị liệu:

AMLODIPINE

Chỉ dẫn điều trị:

Treatment of essential hypertension. Exforge is indicated for patients whose blood pressure is not adequately controlled on monotherapy.

Ngày ủy quyền:

2023-04-30

Tờ rơi thông tin

)قوف امو ةنس 65 رمع نم( نينسملا ىدل
جروفسكيإ
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لأسإ ،ءاودلا لامعتسإ لوح ةيفاضإ ةلئسأ
كيدل ترفوت اذإ
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اطرفم
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يف لئاوسلا
.لوانتلا دعب ةعاس 24-48 ىتح روطتي دق
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ءاودلا لوانت تيسن اذإ
يئاودلا رادقملا لوانت بجي ،كلذ دعب
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لوانت دعوم
ً
ابيرقت ناح اذإ ،ﻦكل .يدايتعلإا تقولا
يف مداقلا
يئاودلا رادقملا لوانت زوجي لاف
،مداقلا يئاودلا رادقملا
ضيوعتلل فعاضم يئاود رادقم لوانت زوجي
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.بيبطلا تايصوت بسحب جلاعلا ىلع
ةبظاوملا بجي
،بيبطلا ةراشتسإ نودب ءاودلاب جلاعلا
ﻦع فقوتلا زوجي لا
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ءاودلا لوانت نع كفقوت لاح يف
.كضرم مقافتل يدؤي دق جروفسكيإ ـب
جلاعلا ﻦع فقوتلا نإ
.بيبطلا تاميلعتب لاإ ءاودلا لوانت ﻦع
فقوتت لا عباط صيخشت بجي !

Đặc tính sản phẩm

EXF API FEB23 V1
1
EU SmPC 11.2022
1.
NAME OF THE MEDICINAL PRODUCT
EXFORGE
® 5 MG/80 MG
EXFORGE
® 5 MG/160 MG
EXFORGE
® 10 MG/160 MG
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Exforge
®
5 mg/80 mg film-coated tablets
Each film-coated tablet contains 5 mg of amlodipine (as amlodipine
besylate) and
80 mg of valsartan.
Exforge
®
5 mg/160 mg film-coated tablets
Each film-coated tablet contains 5 mg of amlodipine (as amlodipine
besylate) and
160 mg of valsartan.
Exforge
®
10 mg/160 mg film-coated tablets
Each film-coated tablet contains 10 mg of amlodipine (as amlodipine
besylate) and
160 mg of valsartan.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet
Exforge 5 mg/80 mg film-coated tablets
Dark yellow, round shaped film-coated tablet with bevelled edges,
debossed with “NVR” on
one side and “NV” on the other side. Approximate size: diameter
8.20 mm.
Exforge 5 mg/160 mg film-coated tablets
Dark yellow, ovaloid shaped film-coated tablet with bevelled edges,
debossed with “NVR” on
one side and “ECE” on the other side. Approximate size: 14.2 mm
(length) x 5.7 mm (width).
Exforge 10 mg/160 mg film-coated tablets
Light yellow, ovaloid shaped film-coated tablet with bevelled edges,
debossed with “NVR” on
one side and “UIC” on the other side. Approximate size: 14.2 mm
(length) x 5.7 mm (width).
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Treatment of essential hypertension.
Exforge is indicated for patients whose blood pressure is not
adequately controlled on
monotherapy.
EXF API FEB23 V1
2
EU SmPC 11.2022
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
GENERAL TARGET POPULATION
A patient whose blood pressure is not adequately controlled on
monotherapy may be
switched to combination therapy with Exforge. The recommended dose is
one tablet per day
(see section 2).
Individual dose titration with the components (i.e. amlodipine and
valsartan) is recommended
before changing to the fixed dose combination. When clinically
appropriate direct chang