Tobradex 3mg/ml / 1mg/ml eye drops

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Tobramycin; Dexamethasone

Available from:

Novartis Pharmaceuticals UK Ltd

ATC code:

S01CA01

INN (International Name):

Tobramycin; Dexamethasone

Dosage:

3mg/1ml ; 1mg/1ml

Pharmaceutical form:

Eye drops

Administration route:

Ocular

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 11040100; GTIN: 5015664127098

Patient Information leaflet

1
PACKAGE LEAFLET - INFORMATION FOR THE USER
TOBRADEX
® 3 MG/ML/1 MG/ML EYE DROPS, SUSPENSION
TOBRAMYCIN AND DEXAMETHASONE
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 your pharmacist.
•
This medicine has been prescribed for you.
DO NOT PASS IT ON TO OTHERS.
It may harm them,
even if their symptoms 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 PATIENT INFORMATION LEAFLET YOU WILL FIND INFORMATION ABOUT
1.
WHAT TOBRADEX IS AND WHAT IT IS USED FOR
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE TOBRADEX
3.
HOW TO USE TOBRADEX
4.
POSSIBLE SIDE EFFECTS
5.
HOW TO STORE TOBRADEX
6.
CONTENT OF THE PACK AND OTHER INFORMATION
1.
WHAT TOBRADEX
® IS AND WHAT IT IS USED FOR
TOBRADEX
contains dexamethasone a corticosteroid and tobramycin, an antibiotic
which is active
against a wide range of bacteria that may infect the eye.
IT IS USED TO PREVENT AND TREAT INFLAMMATION
and prevent possible infection of the eye after cataract
surgery in adults and children aged 2 years and older.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE TOBRADEX
DO NOT USE TOBRADEX...
•
If you have or think that you have any type of
INFECTION OF THE EYE.
Use of corticosteroids may
make infections worse.
•
If you have a
STICKY DISCHARGE
from your eye.
•
If you have a
RED EYE
that has not been seen by a doctor.
•
If you are
ALLERGIC
to tobramycin or dexamethasone or to any of the other ingredients
listed in
section 6.
If any of these apply ask your doctor for advice.
WARNINGS AND PRECAUTIONS
•
If you have a disorder causing a
THINNING OF THE EYE TISSUES,
such as
RHEUMATOID ARTHRITIS,
FUCH’S DYSTROPHY
or following a
CORNEAL TRANSPLANT
. Corticosteroids may cause further
thinning and possible perforation, and may delay the healing of your

Summary of Product characteristics

OBJECT 1
TOBRADEX EYE DROPS
Summary of Product Characteristics Updated 03-Oct-2017 | Novartis
Pharmaceuticals UK Ltd
1. Name of the medicinal product
TOBRADEX 3mg/ml/1mg/ml Eye Drops, Suspension
2. Qualitative and quantitative composition
Each ml contains: Tobramycin 3mg Dexamethasone 1mg.
For full list of excipients, see section 6.1.
3. Pharmaceutical form
Eye Drops, Suspension.
White to off-white suspension.
4. Clinical particulars
4.1 Therapeutic indications
Prevention and treatment of inflammation and prevention of infection
associated with cataract surgery in
adults and children aged 2 years and older.
4.2 Posology and method of administration
Adults:
One drop instilled into the conjunctival sac(s) every 4 to 6 hours
while the patient is awake. During the
initial 24 to 48 hours, the dosage may be increased to one drop every
two hours while the patient is
awake. Dosing should continue for 14 days not to exceed a maximum of
24 days. Frequency should be
decreased gradually as warranted by improvement in clinical signs.
Care should be taken not to
discontinue therapy prematurely.
Use in the Elderly:
Clinical studies have indicated dosage modifications are not required
for use in the elderly.
Paediatric population:
TOBRADEX may be used in children 2 years 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 2 years of age have
not been established, and no data is
available.
Use in hepatic and renal impairment:
TOBRADEX has not been studied in these patient populations
Shake the bottle well before use. To prevent contamination of the
dropper tip and suspension, care should
be taken not to touch the eyelids, surrounding areas, or other
surfaces with the dropper tip of the bottle.
Keep the bottle tightly closed when not in use. After cap is removed,
if tamper evident snap collar is
loose, remove before using product.
Gently closing the eyelid (s) and nasolacrimal occlusion for at least
1 minute after instillation is
rec