TOBREX 3mg/g eye ointment

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

TOBRAMYCIN

Available from:

Novartis Ireland Limited Vista Building, Elm Park, Merrion Road, Ballsbridge, Dublin 4,, Ireland

ATC code:

S01AA12

INN (International Name):

TOBRAMYCIN 3 mg/g

Pharmaceutical form:

EYE OINTMENT

Composition:

TOBRAMYCIN 3 mg/g

Prescription type:

POM

Therapeutic area:

OPHTHALMOLOGICALS

Authorization status:

Authorised

Authorization date:

2005-08-01

Patient Information leaflet

1
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
TOBREX® 3 MG/ML, EYE DROPS,
SOLUTION
TOBREX® 3 MG/G, EYE
OINTMENT
tobramycin
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 further questions, please ask your doctor or your
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 Tobrex is and what it is used for
2.
What you need to know before you use Tobrex
3.
How to use Tobrex
4.
Possible side effects
5
How to store Tobrex
6.
Contents of the pack and other information
1.
WHAT TOBREX IS AND WHAT IT IS USED FOR
Tobrex is an antibiotic indicated in the treatment of eye infections.
Tobrex is indicated for topical treatment of infections of the eye and
the surrounding
tissues, caused by susceptible bacteria sensitive to tobramycin, in
adults and children
aged 1 year and older.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE TOBREX
DO NOT USE TOBREX:
-
If you are allergic to tobramycin, any other aminoglycosides or any of
the
other ingredients in Tobrex Eye Drops / Eye Ointment.
WARNINGS AND PRECAUTIONS
-
Only use Tobrex Eye Drops / Eye Ointment in your eye(s).
-
If you experience allergic reactions with Tobrex Eye Drops / Eye
Ointment,
discontinue use and consult your doctor. Allergic reactions may vary
from localized
itching or skin redness to severe allergic reactions (anaphylactic
reaction) or serious
skin reactions. These allergic reactions may occur with other topical
or systemic
antibiotics of the same family (aminoglycosides).
-
If your symptoms get worse or suddenly return, please consult your
doctor.
-
If you are using other antibiotic treatment, including oral, with

Summary of Product characteristics

Page 1 of 8
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Tobrex® 3 mg/mL eye drops, solution
Tobrex® 3 mg/g eye ointment
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Eye drops:
1 mL solution contains 3.0 mg tobramycin.
Excipients: 1 mL solution contains 0.1 mg benzalkonium chloride
Eye ointment:
1 gram ointment contains 3.0 mg tobramycin.
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
-
Eye drops, solution
-
Eye ointment
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Treatment of external infections of the eye and its adnexa, caused by
bacteria susceptible to
tobramycin in adults and children aged 1 year and older.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
AFTER CAP IS REMOVED, IF TAMPER EVIDENT SNAP COLLAR IS LOOSE, REMOVE
BEFORE USING PRODUCT.
_Adults _
-
For mild infections: 1 or 2 drops instilled in the eye(s) every 4
hours, or a small amount of ointment
2 to 3 times per day,
-
For more severe infections: 2 drops instilled in the eye(s) hourly or
a small amount of ointment
every 3 to 4 hours until improvement, following which treatment should
be reduced prior to
discontinuation.
The length of the treatment is dependent on the origin of the
infection and may vary between a couple
of days up to some weeks.
Clinical studies have demonstrated that tobramycin is also efficacious
and harmless for children.
_Paediatric population_
:
Tobrex eye drops and Tobrex eye ointment may be used in children 1
year of age and older at the
same dose
as in adults. The maximum dose of Tobrex eye drops is 14 drops/day in
children 1 to <2 years
and 46 drops/day in children 2 to <12 years of age. Currently
available data is described in Section 5.1.
Page 2 of 8
The safety and efficacy in children younger than 1 year of age have
not been established, and no data
are available.
4.3 CONTRAINDICATIONS
Hypersensitivity to tobramycin, any other aminoglycosides, or any of
the excipients.
4.4
SPECIAL WARNINGS AND SPECIAL PRECAUTIONS FOR USE
-
For ocular use only. Not for injection or inges