Valaciclovir 500mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Valaciclovir hydrochloride

Available from:

Mawdsley-Brooks & Company Ltd

ATC code:

J05AB11

INN (International Name):

Valaciclovir hydrochloride

Dosage:

500mg

Pharmaceutical form:

Oral tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 05030201

Patient Information leaflet

ACCORD LOGO
VALACICLOVIR 500MG TABLETS_ _
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 VALACICLOVIR TABLETS ARE AND WHAT THEY ARE USED FOR
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE VALACICLOVIR TABLETS
3.
HOW TO TAKE VALACICLOVIR TABLETS
4.
POSSIBLE SIDE EFFECTS
5. HOW TO STORE VALACICLOVIR TABLETS
6.
CONTENTS OF THE PACK AND OTHER INFORMATION
1.
WHAT VALACICLOVIR TABLETS ARE AND WHAT THEY ARE USED FOR
Valaciclovir belongs to a group of medicines called antivirals. It
works by killing or stopping the growth of
viruses called herpes simplex (HSV), varicella zoster (VZV) and
cytomegalovirus (CMV).
Valaciclovir can be used to:
•
treat shingles (in adults).
•
treat HSV infections of the skin and genital herpes (in adults and
adolescents over 12 years old). It is also
used to help prevent these infections from returning.
•
treat cold sores (in adults and adolescents over 12 years old).
•
prevent infection with CMV after organ transplants (in adults and
adolescents over 12 years old).
•
treat and prevent HSV infections of the eye
that continue to come back (in adults and adolescents over 12
years old).
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE
VALACICLOVIR TABLETS
DO NOT TAKE VALACICLOVIR TABLETS
•
if you are
ALLERGIC
to valaciclovir or aciclovir or any of the other ingredients of -this
medicine (listed in
Section 6).
•
Do not take Valaciclovir Tablets if this applies to you. If you are
not sure, talk to your doctor or pharmacist
before taking Valaciclovir Tablets.
WARNINGS AND PRECAUTIO

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Valaciclovir 500mg Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 500mg, valaciclovir (as valaciclovir
hydrochloride
monohydrate).
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Film-coated tablet
500mg tablets: Oval, white, biconvex, film-coated tablets, 17.6 x 8.8
mm with VC2
on one side
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
_Varicella zoster virus (VZV) infections – herpes zoster _
Valaciclovir tablets are indicated for the treatment of herpes zoster
(shingles) and
ophthalmic zoster in immunocompetent adults (see sections 4.4).
Valaciclovir tablets are indicated for the treatment of herpes zoster
in adult patients
with mild or moderate immunosuppression (see section 4.4).
_Herpes simplex virus (HSV) infections _
Valaciclovir tablets are indicated
-
for the treatment and suppression of HSV infections of the skin and
mucous
membranes including
-
treatment of first-episode of genital herpes in immunocompetent adults
and
adolescents and in immunocompromised adults
-
treatment of recurrences of genital herpes in immunocompetent adults
and
adolescents, and in immunocompromised adults
-
suppression of recurrent genital herpes in immunocompetent adults and
adolescents and in immunocompromised adults
-
treatment and suppression of recurrent ocular HSV infections in
immunocompetent adults and adolescents and in immunocompromised adults
(see section 4.4).
Clinical studies have not been conducted in HSV-infected patients
immunocompromised for other causes than HIV-infection (see section
5.1).
_Cytomegalovirus (CMV) infections_:
Valaciclovir tablets are indicated for the prophylaxis of CMV
infection and disease
following solid organ transplantation in adults and adolescents (see
section 4.4)
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
_Varicella zoster virus (VZV) infections – herpes zoster and
ophthalmic zoster _
Patients should be advised to start treatment as soon as possible
af