Zovirax 3% ophthalmic ointment

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Aciclovir

Available from:

GlaxoSmithKline UK Ltd

ATC code:

S01AD03

INN (International Name):

Aciclovir

Dosage:

30mg/1gram

Pharmaceutical form:

Eye ointment

Administration route:

Ocular

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 11030300; GTIN: 5010706003217

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
ZOVIRAX® EYE OINTMENT
ACICLOVIR
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING 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.
IN THIS LEAFLET:
1
What Zovirax is and what it is used for
2
What you need to know before you use Zovirax
3
How to use Zovirax
4
Possible side effects
5
How to store Zovirax
6
Contents of the pack and other information
1 WHAT ZOVIRAX IS AND WHAT IT IS USED FOR
Zovirax Eye Ointment (called ‘Zovirax’ in this leaflet) contains a
medicine called aciclovir. This belongs
to a group of medicines called antivirals. It is used to treat eye
infections caused by the Herpes
simplex virus. It works by killing or stopping the growth of viruses
on the front of your eyeball (cornea).
2 WHAT YOU NEED TO KNOW BEFORE YOU USE ZOVIRAX
DO NOT USE ZOVIRAX IF:
•
you are allergic (hypersensitive) to aciclovir or valaciclovir or any
of the other ingredients (listed in
Section 6).
If you are not sure, talk to your doctor or pharmacist before using
Zovirax.
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before using Zovirax if:
•
you wear contact lenses. Stop wearing them while using Zovirax.
If you are not sure, talk to your doctor or pharmacist before using
Zovirax.
OTHER MEDICINES AND ZOVIRAX
Please tell your doctor or pharmacist if you are taking or have
recently taken any other medicines.
This includes medicines obtained without prescription, including
herbal medicines.
PREGNANCY AND BREAST-FEEDING
Ask your doctor or pharmacist for advice before using any medicine.
DRIVING AND USING MACHINES
You may exp

Summary of Product characteristics

OBJECT 1
ZOVIRAX EYE OINTMENT
Summary of Product Characteristics Updated 08-Dec-2017 |
GlaxoSmithKline UK
1. Name of the medicinal product
Zovirax Eye Ointment
2. Qualitative and quantitative composition
Aciclovir 3.0% W/W
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Ophthalmic Ointment
4. Clinical particulars
4.1 Therapeutic indications
Treatment of herpes simplex keratitis.
4.2 Posology and method of administration
Topical administration to the eye.
ADULTS: 1cm ribbon of ointment should be placed inside the lower
conjunctival sac five times a day at
approximately four hourly intervals, omitting the night time
application. Treatment should continue for at
least 3 days after healing is complete.
CHILDREN: As for adults
USE IN THE ELDERLY: As for adults.
4.3 Contraindications
Zovirax eye ointment is contra-indicated in patients with a known
hypersensitivity to aciclovir or
valaciclovir, or any of the excipients listed in section 6.1.
4.4 Special warnings and precautions for use
Patients should be informed that transient mild stinging immediately
following application may occur.
Patients should avoid wearing contact lenses when using Zovirax Eye
Ointment.
4.5 Interaction with other medicinal products and other forms of
interaction
No clinically significant interactions have been identified.
4.6 Fertility, pregnancy and breast-feeding
_PREGNANCY_
A post-marketing aciclovir pregnancy registry has documented pregnancy
outcomes in women exposed to
any formulation of Zovirax. The registry findings have not shown an
increase in the number of birth
defects described amongst Zovirax exposed subjects compared with the
general population, and any birth
defects showed no uniqueness or consistent pattern to suggest a common
cause.
Systemic administration of aciclovir in internationally accepted
standard tests did not produce
embryotoxic or teratogenic effects in rabbits, rats or mice. In a
non-standard test in rats, foetal
abnormalities were observed but only following such high subcutaneous
doses t