Famciclovir 125mg Film-coated Tablets

Land: Malta

Sprache: Englisch

Quelle: Medicines Authority

Wirkstoff:

FAMCICLOVIR

Verfügbar ab:

Actavis Group PTC ehf Revkjavikurvegi 76-78, 220 Hafnarfjordur, Iceland

ATC-Code:

J05AB09

INN (Internationale Bezeichnung):

FAMCICLOVIR 125 mg

Darreichungsform:

FILM-COATED TABLET

Zusammensetzung:

FAMCICLOVIR 125 mg

Verschreibungstyp:

POM

Therapiebereich:

ANTIVIRALS FOR SYSTEMIC USE

Berechtigungsstatus:

Withdrawn

Berechtigungsdatum:

2009-03-09

Gebrauchsinformation

PACKAGE LEAFLET: INFORMATION FOR THE USER 

FAMCICLOVIR 125MG, 250MG OR 500MG FILM-COATED TABLETS 
(Famciclovir) 

READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE. 
- 
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. Do NOT pass it on
to others. It may harm them, 
even if their symptoms are the same as yours. 
- 
If any of the side effects get serious, or if you notice any side
effects not listed in this leaflet, 
please tell your doctor or pharmacist. 

IN THIS LEAFLET:  
1. 
What Famciclovir Tablets are and what they are used for 
2. 
Before you take Famciclovir Tablets  
3. 
How to take Famciclovir Tablets 
4. 
Possible side effects 
5. 
How to store Famciclovir Tablets 
6. 
Further information 

1.  WHAT FAMCICLOVIR TABLETS ARE AND WHAT THEY ARE USED FOR 

Famciclovir is an antiviral medicine. It stops the infecting virus
from reproducing. Since the virus 
reproduces very early in the infection, you will benefit most
from treatment if you take Famciclovir 
Tablets as soon as the first symptoms appear. 

Famciclovir Tablets are used to treat two types of viral infections in
adults: 
-   Shingles (herpes zoster), which is a viral infection caused by a
virus called varicella zoster (the 

same virus that causes chickenpox). Famciclovir stops the virus
from spreading in the body so that 

healing can occur faster. 
-   Famciclovir is also used for the treatment of shingles in the
area around the eye or of the eye 

itself (ophthalmic zoster). 
-   Genital herpes. Genital herpes is a viral infection caused
by herpes simplex virus type 1 or 2. It is 

normally spread by sexual contact. It causes blisters and burning
or itching around the genitals, 

which may be painful. Famciclovir is used to treat genital herpes
infections in adults. People who 

have

Fachinformation

1. 
NAME OF THE MEDICINAL PRODUCT  

Famciclovir 125mg Film-coated Tablets 
FAMCICLOVIR 250MG FILM-COATED TABLETS 
FAMCICLOVIR 500MG FILM-COATED TABLETS 

2.  
QUALITATIVE AND QUANTITATIVE COMPOSITION  

Each film-coated tablet contains 125mg of famciclovir. 
EACH FILM-COATED TABLET CONTAINS 250MG OF FAMCICLOVIR. 
EACH FILM-COATED TABLET CONTAINS 500MG OF FAMCICLOVIR. 

For a full list of excipients, see section 6.1.  

3.  
PHARMACEUTICAL FORM  

Film-coated Tablet. 
White, round, coated tablet with ‘FC’ over “125” on one side
and ‘>’ on the other side. 
WHITE, ROUND, COATED TABLET WITH ‘FC’ OVER “250” ON ONE SIDE
AND ‘>’ ON THE OTHER SIDE. 
WHITE, CAPSULE-SHAPED, COATED TABLET WITH ‘FC 500” ON ONE SIDE
AND ‘>’ ON THE OTHER SIDE. 

4. 
CLINICAL PARTICULARS  

4.1   THERAPEUTIC INDICATIONS  

Varicella zoster virus (VZV) infections – herpes zoster 
Famciclovir is indicated for 
-   the treatment of herpes zoster and ophthalmic zoster
in immunocompetent adults (see section 4.4) 
-  the treatment of herpes zoster in immunocompromised adults (see
section 4.4) 

Herpes simplex virus (HSV) infections – genital herpes 
Famciclovir is indicated for 
-  the treatment of first and recurrent episodes of genital herpes
in immunocompetent adults 
-  the treatment of recurrent episodes of genital herpes in
immunocompromised adults 
-  the suppression of recurrent genital herpes in immunocompetent
and immunocompromised adults 

Clinical studies have not been conducted in HSV-infected patients
immunocompromised for other 
causes than HIV-infection (see section 5.1). 

4.2 
POSOLOGY AND METHOD OF ADMINISTRATION  

Herpes zoster in immunocompetent adults 
500 mg three times daily for seven days. 

Treatment should be initiated as soon as possible after a diagnosis
of herpes zoster. 

Herpes zoster in immunocompromised adults 
500 mg three times daily for ten days.�