Valaciclovir 500mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Valaciclovir hydrochloride

Available from:

Sandoz 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; GTIN: 5050650067019

Patient Information leaflet

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)
DO NOT TAKE VALACICLOVIR:
•
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 if the above applies to you. If
you are not sure, talk to your doctor or pharmacist
before taking Valaciclovir.
WARNINGS AND PRECAUTIONS
Check with your doctor or pharmacist before taking
Valaciclovir if:
•
you have kidney problems
•
you have liver problems
•
you are over 65 years of age
•
your immune system is weak
If you are not sure if the above apply to you, talk to your
doctor or pharmacist before taking Valaciclovir.
PREVENT PASSING GENITAL HERPES ON TO OTHERS
If you are taking Valaciclovir to treat or prevent genital
herpes, or you have had genital herpes in the past, you
should still practice safe sex, including the use of
condoms. This is important to prevent you passing the
infection on to others. You should not have sex if you
have genital sores or blisters.
OTHER MEDICINES AND VALACICLOVIR
Tell your doctor or pharmacist if you are taking or have
recently taken any other medicines. This includes
medicines obtained without a prescription, including
herbal medicines.
Tell your doctor or pharmacist if you are taking any other
medicines that affect the kidneys. These include:
aminoglycosides, organoplatinum compounds, iodin

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Valaciclovir 500mg film-coated tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 556.275 mg valaciclovir hydrochloride equivalent
to 500
mg valaciclovir.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Film-coated tablet.
White to off-white capsule shaped film coated tablets with “500”
debossed on one
side and plain on other side.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
_Varicella zoster virus (VZV) infections – herpes zoster _
Valaciclovir is indicated for the treatment of herpes zoster
(shingles) and
ophthalmic zoster in immunocompetent adults (see section 4.4).
Valaciclovir is 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 is 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 is 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
after a