Famciclovir 250mg tablets

Land: Bretland

Tungumál: enska

Heimild: MHRA (Medicines & Healthcare Products Regulatory Agency)

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Download Vara einkenni (SPC)
25-06-2014
Download Opinber matsskýrsla (PAR)
20-04-2020

Virkt innihaldsefni:

Famciclovir

Fáanlegur frá:

Alliance Healthcare (Distribution) Ltd

ATC númer:

J05AB09

INN (Alþjóðlegt nafn):

Famciclovir

Skammtar:

250mg

Lyfjaform:

Oral tablet

Stjórnsýsluleið:

Oral

Tegund:

No Controlled Drug Status

Gerð lyfseðils:

Valid as a prescribable product

Vörulýsing:

BNF: 05030201

Upplýsingar fylgiseðill

                                FAMCICLOVIR 125 MG, 250 MG AND 500 MG
FILM-COATED TABLETS
PACKAGE LEAFLET: INFORMATION FOR THE USER
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 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.
1.
WHAT FAMCICLOVIR IS AND WHAT IT IS USED FOR
2.
BEFORE YOU TAKE FAMCICLOVIR
3.
HOW TO TAKE FAMCICLOVIR
4.
POSSIBLE SIDE EFFECTS
5.
HOW TO STORE FAMCICLOVIR
6.
FURTHER INFORMATION
WHAT FAMCICLOVIR IS AND WHAT IT IS 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 as soon as
the
first symptoms appear.
Famciclovir 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 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 Famciclovir to help to prevent the attacks.
BEFORE YOU TAKE FAMCICLOVIR
DO NOT TAKE FAMCICLOVIR
•
if you are allergic (hypersensitive) to famciclovir, to any of the
other
ingredients of Famciclovir listed in s
                                
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                                SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Famciclovir 250mg Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each Famciclovir 250mg tablet contains 250mg of famciclovir.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Film-coated tablet.
250mg film-coated tablets: white, round, biconvex, film-coated
tablets, scored on one
side with diameter of 10.6mm approximately.
Famciclovir 250mg film-coated tablets:
The tablet can be divided into equal doses. Use lower dosage strength
tablets, where
these are available.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Varicella zoster virus (VZV) infections – herpes zoster
Famciclovir tablets are 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 tablets are 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 g
                                
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