Zovirax 30 mg/g Eye Ointment

Krajina: Írsko

Jazyk: angličtina

Zdroj: HPRA (Health Products Regulatory Authority)

Aktívna zložka:

Aciclovir

Dostupné z:

GlaxoSmithKline (Ireland) Limited

ATC kód:

S01AD; S01AD03

INN (Medzinárodný Name):

Aciclovir

Dávkovanie:

30 milligram(s)/gram

Forma lieku:

Eye ointment

Typ predpisu:

Product subject to prescription which may not be renewed (A)

Terapeutické oblasti:

Antivirals; aciclovir

Stav Autorizácia:

Not marketed

Dátum Autorizácia:

1981-08-26

Príbalový leták

(GSK LOGO)
PACKAGE LEAFLET: INFORMATION FOR THE USER
ZOVIRAX
® 30 MG/G 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.
WHATS 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 30 mg/g 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 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 to aciclovir or valaciclovir or any of the other
ingredients of this medicine (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
Tell your doctor or pharmacist if you are taking, have recently taken
or might take any other
medicines. This includes medicines obtained without prescription,
including herbal medicines.
ZOVIRAX WITH FOOD AND DRINK
Food and drink should not affect the absorption of your medicine.
PREGNANCY AN

Súhrn charakteristických

Health Products Regulatory Authority
08 October 2019
CRN009D41
Page 1 of 4
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Zovirax 30 mg/g Eye Ointment
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each gram of ointment contains 30 mg aciclovir equivalent to 3 %w/w
aciclovir.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Eye ointment
Soft, homogenous, white to off-white, slightly translucent, unctuous
mass.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Zovirax eye ointment is indicated in the treatment of Herpes simplex
keratitis.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
For ophthalmic administration
Method of administration.
_Adults and children:_ A l cm ribbon of the ointment should be placed
inside the lower conjunctival sac five times a day at
approximately four-hourly intervals. Treatment should continue for at
least 3 days after healing is complete.
4.3 CONTRAINDICATIONS
Zovirax eye Ointment is contraindicated in patients known to be
hypersensitive to aciclovir or valaciclovir, or any of the
excipients as 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
INTERACTIONS
No clinically significant interactions have been identified.
4.6 FERTILITY, PREGNANCY AND LACTATION
_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 amongst Zovirax exposed subjects
compared with the general population, and any birth defects showed no
uniqueness or consistent pattern to suggest a
common cause.
Health Products Regulatory Authority
08 October 2019
CRN009D41
Page 2 of 4
Systemic administration of aciclovir in internationally accepted
standard tests did not p