Famvir Tablet, film coated 250mg

Țară: Malta

Limbă: engleză

Sursă: Medicines Authority

Ingredient activ:

FAMCICLOVIR

Disponibil de la:

Novartis Ireland Limited

Codul ATC:

J05AB09

INN (nume internaţional):

FAMCICLOVIR

Forma farmaceutică:

FILM-COATED TABLET

Compoziție:

FAMCICLOVIR 250 mg

Tip de prescriptie medicala:

POM

Zonă Terapeutică:

ANTIVIRALS FOR SYSTEMIC USE

Statutul autorizaţiei:

Authorised

Prospect

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PACKAGE LEAFLET
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PACKAGE LEAFLET: INFORMATION FOR THE USER
Famvir 125 mg film-coated tablets
Famvir 250 mg film-coated tablets
Famvir 500 mg film-coated tablets
Famciclovir
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 Famvir is and what it is used for
2.
What you need to know before you take Famvir
3.
How to take Famvir
4.
Possible side effects
5.
How to store Famvir
6.
Contents of the pack and other information
1. WHAT FAMVIR IS AND WHAT IT IS USED FOR
Famvir 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 Famvir
as soon as the first symptoms appear.
Famvir is 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). Famvir stops the virus
from spreading in
the body so that healing can occur faster.
-
Famvir 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. Famvir is used to treat
genital herpes
infections in adults. People who have frequent episodes of genital
herpes can also take
Famvir to help to prevent the attacks.

Caracteristicilor produsului

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SUMMARY OF PRODUCT CHARACTERISTICS
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1.
NAME OF THE MEDICINAL PRODUCT
Famvir 125 mg film-coated tablets
Famvir 250 mg film-coated tablets
Famvir 500 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film coated tablet contains 125 mg of famciclovir
Each film coated tablet contains 250 mg of famciclovir
Each film coated tablet contains 500 mg of famciclovir
Excipient with known effects: Each 125mg film coated tablet contains
26.85mg of lactose,
anhydrous
Excipient with known effects: Each 250mg film coated tablet contains
53.69mg of lactose,
anhydrous
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
White, round film-coated tablet, biconvex, bevelled edges, debossed
with “FV” on one side and
“125” on the reverse side.
Film-coated tablet.
White, round film-coated tablet, biconvex, bevelled edges, debossed
with “FV” on one side and
“250” on the reverse side.
Film-coated tablet.
White, oval film-coated tablet, biconvex, bevelled edges, debossed
with “FV 500” on one side and
plain on the reverse side
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Varicella zoster virus (VZV) infections – herpes zoster
Famvir 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
Famvir 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
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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 and ophthalmic zoster in immunocompetent a