Ribavirin 400mg Film-coated Tablets

国: マルタ

言語: 英語

ソース: Malta Medicines Authority

有効成分:

RIBAVIRIN

から入手可能:

Aurobindo Pharma (Malta) Limited Vault 14, Level 2, Valletta Waterfront, Floriana FRN 1913, Malta

ATCコード:

J05AB04

INN（国際名）:

RIBAVIRIN 400 mg

医薬品形態:

FILM-COATED TABLET

構図:

RIBAVIRIN 400 mg

処方タイプ:

POM

治療領域:

ANTIVIRALS FOR SYSTEMIC USE

認証ステータス:

Withdrawn

承認日:

2015-02-23

情報リーフレット

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
RIBAVIRIN 200 MG FILM-COATED TABLETS
RIBAVIRIN 400 MG FILM-COATED TABLETS
Ribavirin
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
sideeffects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET:
1.
What Ribavirin is and what it is used for
2.
What you need to know before you take Ribavirin
3.
How to take Ribavirin
4.
Possible side effects
5.
How to store Ribavirin
6.
Contents of the pack and other information
1.
WHAT RIBAVIRIN IS AND WHAT IT IS USED FOR
Ribavirin, which is the antiviral active substance of Ribavirin,
inhibits the multiplication of
manytypesof viruses, including the hepatitis C viruses(which can cause
an infection of the liver called
hepatitis C).
Ribavirinis used in combination with other medicines except
peginterferon alfa-2a and peginterferon
alfa-2b to treat certain chronic forms of hepatitis C to treat
certainchronicforms of hepatitis C
Ribavirin should only be used in combination withother medicines
except peginterferon alfa-2a and
peginterferon alfa-2b to treat hepatitis C. Itshould not be taken
alone.
Refer also to the package leaflets of the other medicines except
peginterferon alfa-2a and
peginterferon alfa-2b that are used in combination with Ribavirin.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE RIBAVIRIN
DO NOT TAKE RIBAVIRIN:

if you are allergic to ribavirin or to any of the other ingredients of
this medicine (listed insection
6).

if you are pregnant or breast-feeding (see section “Pregnancy,
breast-feeding and fertility”).

if you have had a heart attack or have suffered from any

製品の特徴

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Ribavirin 200 mg film-coated tablets
Ribavirin 400 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 200 mg of ribavirin.
Each film-coated tablet contains 400 mg of ribavirin.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
_Ribavirin 200 mg: _
Light pink colored, capsule shaped, film-coated tablets debossed with
‘F’ on one side and ‘10’ on the
other side. The size is 13.1 mm x 6.1 mm.
_ _
_Ribavirin 400 mg:_
Reddish brown colored, oval shaped, beveled biconvex, film-coated
tablets debossed with ‘F’ on one
side and ‘11’ on the other side. The size is 17.6 mm x 7.6 mm.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Ribavirin is indicated in combination with other medicinal products
except peginterferon alfa-2a and
peginterferon alfa-2b, for the treatment of chronic hepatitis C.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Treatment should be initiated and monitored by a physician experienced
in the management of
chronic hepatitis C.
Refer also to the SmPC of the medicinal products that are used in
combination with Ribavirin for the
treatment of hepatitis C.
_Method of Administration _
Ribavirin film-coated tablets are administered orally in two divided
doses with food (morning and
evening). Due to the teratogenic potential of ribavirin, the tablets
should not be broken or crushed.
Ribavirin is available in a 200 mg tablet, there is no need for
dividing or cutting the 400 mg tablet in
half.
_Posology _
_Dose to be administered _
The dose of Ribavirin is based on patient body weight, and the
medicinal product that is used in
combination (see Table1). Ribavirin tablets are to be administered
orally each day in two divided
doses (morning and evening) with food.
_ _
Table 1. Ribavirin dosing recommendation according to the medicinal
product used in combination
Medicinal product used in
combination
Daily Ribavirin Dose
Number of 200/400mg tab