TOBREX 3mg/ml eye drops, solution

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

TOBRAMYCIN

Available from:

Novartis Pharmaceuticals UK Limited

ATC code:

S01AA12

INN (International Name):

TOBRAMYCIN

Pharmaceutical form:

EYE DROPS, SOLUTION

Composition:

TOBRAMYCIN 3 mg/ml

Prescription type:

POM

Therapeutic area:

OPHTHALMOLOGICALS

Authorization status:

Authorised

Patient Information leaflet

BASIC PATIENT LEAFLET
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.
_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 personally and you should
not pass it on to _
_others. It may harm them, even if their symptoms are the same as
yours._
CONTENT OF THIS LEAFLET:
1.
What TOBREX is and what it is used for
2.
Before you use TOBREX
3.
How to use TOBREX
4.
Possible side effects
5
Storing TOBREX
6.
Further 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.
BEFORE YOU USE TOBREX
DO NOT USE TOBREX IF YOU:
-
If you are allergic to tobramycin, any other aminoglycosides or any of
the other
ingredients in TOBREX Eye Drops / Eye Ointment.
TAKE SPECIAL CARE WITH TOBREX:
-
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
TOBREX Eye Drops / Eye
Ointment, ask your doctor for advice.
-
If you use TOBREX Eye Drops / Eye Ointment for a long period of time
you may become
more susceptible to other eye infections.
-
If you are taking other medicines. Please, also read the section
“Using other medicines”.
1
Please consult

Summary of Product characteristics

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, IT TAMPER EVIDENT SNAP COLLAR IS LOOSE, REMOVE
BEFORE USING PRODUCT.
-
in mild disease: 1 or 2 drops in the eye(s) every 4 hours, or a small
amount of ointment 2 to 3
times per day,
-
in more severe infections: 2 drops 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, solution and ointment may be used in children 1 year
of age and older at the
same dose
as in adults. Currently available data is described in Section 5.1.
The safety and efficacy
in children younger than 1 year of age have not been established, and
no data are available.
Page 1 of 8
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 ingestion.
-
Sensitivity to topically administered aminoglycosides may occur in
some patients. Severity of
hypersensitivity reactions may vary from local effects to generalized
reactions su