Valaciclovir RBX

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Valaciclovir hydrochloride 556.275mg equivalent to valaciclovir 500 mg

Available from:

Douglas Pharmaceuticals Limited

INN (International Name):

Valaciclovir hydrochloride 556.275 mg (equivalent to valaciclovir 500 mg)

Dosage:

500 mg

Pharmaceutical form:

Film coated tablet

Composition:

Active: Valaciclovir hydrochloride 556.275mg equivalent to valaciclovir 500 mg Excipient: Crospovidone Indigo carmine aluminium lake Magnesium stearate Microcrystalline cellulose Opadry blue 02C50740 Povidone

Units in package:

Blister pack, PVC/PVDC/Al, 30 tablets

Class:

Prescription

Prescription type:

Prescription

Manufactured by:

Sun Pharmaceutical Industries Ltd

Therapeutic indications:

Valaciclovir RBX is indicated for the treatment of herpes zoster (shingles) and the reduction of zoster associated pain, which includes acute and post herpetic neuralgia, when given to immunocompetent patients in infection of less than 72 hours duration.

Product summary:

Package - Contents - Shelf Life: Blister pack, PVC/PVDC/Al - 30 tablets - 36 months from date of manufacture stored at or below 25°C - Blister pack, PVC/PVDC/Al - 42 tablets - 36 months from date of manufacture stored at or below 25°C - Blister pack, PVC/PVDC/Al - 100 tablets - 36 months from date of manufacture stored at or below 25°C

Authorization date:

2013-04-03

Patient Information leaflet

Consumer Medicine Information
VALACICLOVIR RBX
Valaciclovir 500 mg Tablets
WHAT IS IN THIS LEAFLET
This
leaflet
answers
some
common
questions
about
VALACICLOVIR
RBX
(valaciclovir).
It does not contain all the available information.
It does not take the place of talking to your doctor or pharmacist.
This leaflet was written on the date at the end of this leaflet. More
recent
information may be available. The latest Consumer Medicine Information
is
available
from
https://www.medsafe.govt.nz/
and
may
contain
important
information about the medicine and its use of which you should be
aware.
All medicines have risks and benefits. Your doctor has weighed the
risks of you
taking VALACICLOVIR RBX against the benefits it is expected to have
for you.
If you have any concerns about using/taking this medicine, ask your
doctor or
pharmacist.
Keep this leaflet with this medicine. You may need to read it again.
WHAT VALACICLOVIR RBX TABLET IS USED FOR
VALACICLOVIR
RBX
tablets
contain
valaciclovir
(as
hydrochloride).
VALACICLOVIR RBX tablets belong to a group of medicines called
anti-virals.
VALACICLOVIR RBX tablets are used for one or more of the following in
adults:
•
Treatment of Herpes zoster (shingles): Valaciclovir works by stopping
the
multiplication of the virus which causes shingles. It can reduce the
length and
severity of an outbreak of shingles and the duration of pain
associated with
shingles. It is important the treatment is started within the first
three days of
the shingles attack.
•
Treatment of Ophthalmic zoster (shingles affecting the eye region)
Valaciclovir RBX CMI Mar 2013
Page 1 of 10
•
Treatment of genital herpes infection: Valaciclovir works by stopping
the
multiplication of the virus which causes herpes. It can reduce the
length and
severity of an outbreak of herpes, the duration of pain and shorten
the time to
healing of crusts associated with herpes. They do not eliminate the
herpes
virus from the body. The herpes virus is also known as the Herpes
Simplex
Virus, or HSV.
VALACICLOVIR RBX tablets

Summary of Product characteristics

NEW ZEALAND DATA SHEET 

VALACICLOVIR RBX

 
_ VALACICLOVIR TABLETS 500 MG _

PHARMACEUTICAL FORM 

Film coated tablets. 

PRESENTATION 

VALACICLOVIR
RBX 500mg tablets are blue coloured, capsule shaped, 
biconvex, film coated tablets, debossed with “V”
and “5” on either side of the 
breakline on one side, notched on either side
along with the breakline and 
plain on the other side. 

USES 

ACTIONS 

Refer Pharmacological Properties 

INDICATIONS 

VALACICLOVIR RBX is indicated for the
treatment of herpes zoster (shingles) 
and the reduction of zoster - associated pain, which
includes acute and post 
herpetic neuralgia, when given to immunocompetent patients in
infection of 
less than 72 hours duration. 

VALACICLOVIR RBX is indicated for the
treatment of herpes simplex 
infections of the skin
and mucous membranes including initial and recurrent 
genital herpes in immunocompetent patients. 

VALACICLOVIR RBX can prevent lesion development when
taken at the first 
signs and symptoms of a
herpes simplex virus (HSV) recurrence. 

VALACICLOVIR RBX is indicated for the prevention
(suppression) of 
recurrent herpes simplex infections of the skin
and mucous membranes, 
including genital herpes in
immunocompetent and immunocompromised 
patients. 

VALACICLOVIR RBX is indicated for the
prophylaxis of cytomegalovirus 
(CMV) infection and disease, following organ
transplantation. CMV 
prophylaxis with VALACICLOVIR RBX reduces acute
graft rejection (renal 
transplant patients), opportunistic infections and
other herpes virus infections 
(herpes simplex virus (HSV), varicella zoster virus (VZV)). 

DOSAGE AND ADMINISTRATION 

TREATMENT OF VARICELLA ZOSTER VIRUS INFECTIONS: 

Herpes zoster (shingles) including ophthalmic zoster 

The dosage in adults is 1000mg of VALACICLOVIR RBX to be
t