Ribavirin 200mg Capsules
Country: United Kingdom
Language: English
Source: myHealthbox
Patient Information leaflet
(PIL)
20-04-2024
Summary of Product characteristics
(SPC)
20-04-2024
Active ingredient:
ribavirin
Available from:
Milpharm Limited
ATC code:
J05AB04
INN (International Name):
ribavirin
Dosage:
200mg
Pharmaceutical form:
Capsule, hard
Administration route:
Oral use
Units in package:
84, 112, 140 and 168 capsules
Prescription type:
POM - Prescription Only Medicine
Manufactured by:
APL Swift Services (Malta) Limited
Therapeutic group:
Direct acting antivirals, nucleosides and nucleotides (excl.reverse transcriptase inhibitors)
Therapeutic indications:
Adult patients: Ribavirin is indicated, in combination with interferon alfa-2b, for the treatment of adult patients with all types of chronic hepatitis C except genotype 1, not previously treated, without liver decompensation, with elevated alanine aminotransferase (ALT), who are positive for hepatitis C viral ribonucleic acid HCV-RNA Children 3 years of age and older and adolescents: Ribavirin is intended for use, in a combination regimen with interferon alfa-2b, for the treatment of children and adolescents 3 years of age and older, who have all types of chronic hepatitis C, except genotype 1, not previously treated, without liver decompensation, and who are positive for HCV-RNA. When deciding to not to defer treatment until adulthood, it is important to consider that the combination therapy induced a growth inhibition. The reversibility of growth inhibition is uncertain. The decision to treat should be made on a case by case basis
Authorization status:
Authorised
Authorization date:
2012-03-23
Patient Information leaflet
PACKAGE LEAFLET: INFORMATION FOR THE USER
RIBAVIRIN 200 MG CAPSULES
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 side effects 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
Ribavirin contain the active ingredient ribavirin. Ribavirin stops
the
multiplication of many types of viruses, including hepatitis C virus.
Ribavirin
must not be used without interferon alfa-2b, i.e. Ribavirin must not
be used
alone.
_Previously untreated patients:_
The combination of Ribavirin with interferon alfa-2b is used to treat
patients
3 years of age and older who have chronic hepatitis C (HCV) infection.
For
children and adolescents weighing less than 47 kg a solution
formulation is
available.
_Previously treated adult patients:_
The combination of Ribavirin with interferon alfa-2b is used to treat
adult
patients with chronic hepatitis C, who have previously responded to
treatment
with an alfa interferon alone, but whose condition has recurred.
There is no safety or efficacy information on the use of Ribavirin
with
pegylated or other forms of interferon (i.e., not alfa-2b).
Ribavirin is not recommended for use in patients under the age of 3
years.
DO NOT TAKE RIBAVIRIN
If any of the following apply to you or your child you are caring
for, DO NOT
TAKE this medicine, and TELL YOU
Read the complete document
Summary of Product characteristics
Ribavirin 200mg Capsules
Summary of Product Characteristics Updated 16Sep2015 | Aurobindo Pharma Milpharm Ltd.
1. Name of the medicinal product
Ribavirin 200 mg capsules, hard
2. Qualitative and quantitative composition
Each hard capsule contains 200 mg of ribavirin.
Excipient with known effect: Ribavirin contains 45 mg of lactose monohydrate.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Capsule, hard
White/white, size '1' hard gelatine capsule filled with white to offwhite granular powder and imprinted with 'E” on white
cap and '81' on white body with black ink.
4. Clinical particulars
4.1 Therapeutic indications
Ribavirin is indicated for the treatment of chronic hepatitis C virus (HCV) infection in adults, children 3 years of age and
older and adolescents and must only be used as part of a combination regimen with interferon alfa2b. Ribavirin
monotherapy must not be used.
There is no safety or efficacy information on the use of Ribavirin with other forms of interferon (i.e., not alfa2b).
Naïve patients
_Adult patients: _Ribavirin is indicated, in combination with interferon alfa2b, for the treatment of adult patients with all
types of chronic hepatitis C except genotype 1, not previously treated, without liver decompensation, with elevated
alanine aminotransferase (ALT), who are positive for hepatitis C viral ribonucleic acid HCVRNA (see section 4.4).
_Children 3 years of age and older and adolescents_: Ribavirin is intended for use, in a combination regimen with
interferon alfa2b, for the treatment of children and adolescents 3 years of age and older, who have all types of chronic
hepatitis C, except genotype 1, not previously treated, without liver decompensation, and who are positive for HCV
RNA.
When deciding to
Read the complete document
