Famciclovir Teva 250 mg Film-coated Tablets

Land: Irland

Sprache: Englisch

Quelle: HPRA (Health Products Regulatory Authority)

Wirkstoff:

Famciclovir

Verfügbar ab:

Teva Pharma B.V.

ATC-Code:

J05AB; J05AB09

INN (Internationale Bezeichnung):

Famciclovir

Dosierung:

250 milligram(s)

Darreichungsform:

Film-coated tablet

Verschreibungstyp:

Product subject to prescription which may not be renewed (A)

Therapiebereich:

Nucleosides and nucleotides excl. reverse transcriptase inhibitors; famciclovir

Berechtigungsstatus:

Marketed

Berechtigungsdatum:

2008-02-15

Gebrauchsinformation

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

Fachinformation

Health Products Regulatory Authority
23 October 2020
CRN009V4T
Page 1 of 11
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Famciclovir Teva 250 mg Film-coated Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 250 mg of famciclovir.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet
White to off-white, round, film-coated tablets, engraved 8118 on one
side and 93 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
Posology
Herpes zoster and ophthalmic 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 or ophthalmic zoster.
Herpes zoster in immunocompromised adults
500 mg three times daily for ten days.
Treatment should be initiated as soon as possible after a diagnosis of
herpes zoster.
Genital herpes in immunocompetent adults
_First episode of genital herpes_: 250 mg three times daily for five
days. Initiation of treatment is recommended as soon as
possible after a diagnosis of first episode of genital herpes.
Episodic treatment of recurrent genital herpes: 125 mg twice daily for
five days. Initiation of treatment is