Famciclovir 500mg tablets

Țară: Regatul Unit

Limbă: engleză

Sursă: MHRA (Medicines & Healthcare Products Regulatory Agency)

Ingredient activ:

Famciclovir

Disponibil de la:

Sandoz Ltd

Codul ATC:

J05AB09

INN (nume internaţional):

Famciclovir

Dozare:

500mg

Forma farmaceutică:

Oral tablet

Calea de administrare:

Oral

Clasă:

No Controlled Drug Status

Tip de prescriptie medicala:

Valid as a prescribable product

Rezumat produs:

BNF: 05030201; GTIN: 5050650052879

Prospect

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
FAMCICLOVIR 125MG, 250MG OR 500MG 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 Tablets are and what they are used for
2.
What you need to know before you take Famciclovir Tablets
3.
How to take Famciclovir Tablets
4.
Possible side effects
5.
How to store Famciclovir Tablets
6.
Contents of the pack and other 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 frequent episodes of genital
herpes can also take
fam

Caracteristicilor produsului

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Famciclovir 500mg Film-coated Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 500mg of famciclovir.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Film-coated Tablet.
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
POSOLOGY
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.
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 recommended as soon as possible after
onset of
prodromal symptoms (e.g. tingling, itching, burning, pain) or lesions.
Rec