Aciclovir Agepha 30 mg/g eye ointment

Negara: Irlandia

Bahasa: Inggris

Sumber: HPRA (Health Products Regulatory Authority)

Bahan aktif:

Aciclovir

Tersedia dari:

AGEPHA Pharma s.r.o.

Kode ATC:

S01AD03

INN (Nama Internasional):

Aciclovir

Dosis:

30 milligram(s)/gram

Bentuk farmasi:

Eye ointment

Area terapi:

aciclovir

Status otorisasi:

Marketed

Tanggal Otorisasi:

2019-08-19

Selebaran informasi

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
ACICLOVIR AGEPHA 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.
WHAT IS IN THIS LEAFLET?
1.
What Aciclovir Agepha 30 mg/g eye ointment is and what it is used for?
2.
What you need to know before you use Aciclovir Agepha 30 mg/g eye
ointment ?
3.
How to use Aciclovir Agepha 30 mg/g eye ointment ?
4.
Possible side effects
5.
How to store Aciclovir Agepha 30 mg/g eye ointment ?
6.
Contents of the pack and other information
1.
WHAT ACICLOVIR AGEPHA 30 MG/G EYE OINTMENT IS AND WHAT IT IS USED FOR?
Aciclovir Agepha 30 mg/g Eye Ointment (called Aciclovir Agepha in this
leaflet) contains a medicine
called aciclovir, which 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 ACICLOVIR AGEPHA 30 MG/G EYE
OINTMENT?
DO NOT USE ACICLOVIR AGEPHA,
If you are allergic to aciclovir or valaciclovir or any of the other
ingredients of this medicine (listed in
Section 6).
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before using Aciclovir Agepha
•
Use Aciclovir Agepha 30 mg/g eye ointment only on eye
•
You may immediately experience a mild stinging and burning sensation
after the application.
•
Immediate hypersensitivity reactions, including angioedema, swelling
of the face etc. can
occur. Contact a doctor immediately in case of such hypersensitivi

Karakteristik produk

Health Products Regulatory Authority
22 April 2021
CRN00C61V
Page 1 of 4
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Aciclovir Agepha 30 mg/g eye ointment
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
1 g ointment contains 30 mg aciclovir.
For the full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Eye ointment
White to whitish grey, homogeneous eye ointment.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Aciclovir "Agepha" 30 mg/g eye ointment is indicated for the treatment
of herpes simplex keratitis.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Adults:
Unless otherwise prescribed, a 1cm ribbon of ointment should be placed
inside the lower conjunctival sac five times a day (at
approximately 4 hourly intervals). The treatment should continue for
at least 3 days after the healing is complete.
Paediatric population:
As for adults
Use in elderly people (≥ 65 years):
No adjustment in dosage is required.
Use in people with impaired renal and liver function:
No adjustment in dosage is required.
Method of administration:
Ocular use.
4.3 CONTRAINDICATIONS
- Hypersensitivity to the active substance or to any of the excipients
listed in section 6.1
- Hypersensitivity to Valaciclovir.
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
For ocular use only. Not for injection or oral intake.
There is insufficient clinical data on the use of Xorox eye ointment
for deep corneal defects and the combined use of Xorox eye
ointment with topical corticosteroids.
In case of a bacterial coinfection, an additional antibiotic therapy
must be carried out.
Patients should be informed that transient mild stinging immediately
following application may occur.
Health Products Regulatory Authority
22 April 2021
CRN00C61V
Page 2 of 4
Patients should avoid wearing contact lenses when using Aciclovir
"Agepha" eye ointment.
4.5 INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF
INTERACTIONS
No clinically significant interactions have been identified when
applied topically.
4.6 FERTILITY, PREGNANCY AND LACTATIO