MAXITROL Eye Ointment

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

NEOMYCIN SULFATE, POLYMYXIN B SULFATE, DEXAMETHASONE

Available from:

Novartis Pharmaceuticals UK Ltd

ATC code:

S01CA01

INN (International Name):

NEOMYCIN SULFATE, POLYMYXIN B SULFATE, DEXAMETHASONE

Pharmaceutical form:

Eye Ointment

Prescription type:

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

Therapeutic area:

Corticosteroids and antiinfectives in combination

Authorization status:

Authorised

Authorization date:

2017-05-05

Patient Information leaflet

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
MAXITROL
®
0.1% W/W, 6000 IU/G, 3500 IU/G EYE OINTMENT
Dexamethasone, Polymyxin B sulphate, Neomycin sulphate
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 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 ANY OF THE SIDE EFFECTS GET SERIOUS,
or if you notice any side effects not listed in this leaflet,
please tell your doctor or pharmacist.
IN THIS LEAFLET
1.
WHAT MAXITROL OINTMENT IS AND WHAT IT IS USED FOR
2.
BEFORE YOU USE MAXITROL OINTMENT
3.
HOW TO USE MAXITROL OINTMENT
4.
POSSIBLE SIDE EFFECTS
5.
HOW TO STORE MAXITROL OINTMENT
6.
FURTHER INFORMATION
1.
WHAT MAXITROL OINTMENT IS AND WHAT IT IS USED FOR
MAXITROL OINTMENT
contains a steroid, dexamethasone and two antibiotics, neomycin
sulphate
and polymyxin B sulphate.
IT IS USED FOR THE SHORT TERM TREATMENT
of inflammation of the eye, when it is also considered that a
bacterial eye infection could develop.
2.
BEFORE YOU USE MAXITROL OINTMENT
DO NOT USE MAXITROL OINTMENT…

If you have
ANY TYPE OF INFECTION
of the eye that is not being treated
including viral, fungal or
untreated
parasitic eye infections or Tuberculosis
of the eye. Use of steroids may make
infections worse.

If you are
ALLERGIC
to dexamethasone,
polymyxin B, neomycin or to any of
the other
ingredients listed in section 6.
Ask your doctor for advice.
TAKE SPECIAL CARE …

Only use MAXITROL Ointment in your eye(s).

Consult your doctor or pharmacist before using this medicine if you
have a disorder causing a
THINNING
OF THE EYE TISSUES.

I
f you experience
ALLERGIC REACTIONS
with MAXITROL, discontinue use any consult your
doctor. Allergic reactions may vary from localized itching or skin
redness to severe allergic
reactions (anaphylactic reaction) or serious skin reactions. These
al

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Maxitrol 0.1% w/w, 6000 IU/g, 3500 IU/g eye ointment.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Dexamethasone 1mg/g (0.1% w/w).
Polymyxin B Sulphate 6,000 IU/g.
Neomycin Sulphate (as Base) 3,500 IU/g.
Also contains:
Methyl parahydroxybenzoate (E218) 0.05% w/w
Propyl parahydroxybenzoate (E216) 0.01% w/w
Liquid Lanolin 3.0% w/w
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Eye Ointment
A white to very pale yellow homogenous translucent ointment.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
MAXITROL eye ointment is indicated for the short-term treatment of
steroid responsive conditions of the eye when
prophylactic antibiotic treatment is also required, after excluding
the presence of fungal and viral disease.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Children and Adults (including the Elderly)
Apply a small amount
into the conjunctival sac(s) up to three to four times daily or,
may be used adjunctively with
drops at bedtime.
Do not let the tip of the tube touch your eye
For topical ophthalmic use only. Not for injection or ingestion.
Hepatic and renal impairment
Maxitrol Eye Ointment has not been studied in these subject
populations.
4.3 CONTRAINDICATIONS
Hypersensitivity to the active substances or to any of the excipients.
Herpes simplex keratitis.
Vaccinia, varicella, and other viral infection of cornea or
conjunctiva
Fungal diseases of ocular structures or untreated parasitic eye
infections.
Mycobacterial ocular infections.
H
E
A
L
T
H
P
R
O
D
U
C
T
S
R
E
G
U
L
A
T
O
R
Y
A
U
T
H
O
R
I
T
Y
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___