Maxitrol eye ointment

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Dexamethasone; Neomycin sulfate; Polymyxin B sulfate

Available from:

Novartis Pharmaceuticals UK Ltd

ATC code:

S01CA01

INN (International Name):

Dexamethasone; Neomycin sulfate; Polymyxin B sulfate

Dosage:

1mg/1gram ; 3500unit/1gram ; 6000unit/1gram

Pharmaceutical form:

Eye ointment

Administration route:

Ocular

Class:

No Controlled Drug Status

Prescription type:

Never Valid To Prescribe As A VMP

Product summary:

BNF: 11040100; GTIN: 5015664006317

Patient Information leaflet

1
PACKAGE LEAFLET - INFORMATION FOR THE USER
MAXITROL
® OINTMENT, EYE OINTMENT
DEXAMETHASONE, NEOMYCIN SULPHATE, POLYMYXIN B 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. Use of steroids may make
infections worse.
•
If you have a
STICKY DISCHARGE
from your eye.
•
If you are
ALLERGIC
to neomycin or any of the other ingredients listed in section 6.
Ask your doctor for advice.
TAKE SPECIAL CARE...
•
Do not inject or swallow this medicine.
•
Consult your doctor or pharmacist before using this medicine if you
have a disorder causing a
THINNING OF THE EYE TISSUES
.
•
You should have your
EYE PRESSURE CHECKED REGULARLY
while using this medicine. This is
especially important for children.
•
The risk of cataract formation is increased in patients with some
conditions such as diabetes.
•
Consult your doctor or pharmacist if your eye pain, redness, swelling
or irritation gets worse or
persists.
•
Ste

Summary of Product characteristics

OBJECT 1
MAXITROL OINTMENT
Summary of Product Characteristics Updated 14-Aug-2017 | Novartis
Pharmaceuticals UK Ltd
1. Name of the medicinal product
MAXITROL ointment
2. Qualitative and quantitative composition
1 gram ointment contains 1 mg dexamethasone, 6000 IU polymyxin B
sulphate, and 3500 IU neomycin
sulphate (as base).
For a full list of excipients, see section 6.1.
3. Pharmaceutical form
Eye ointment.
White to very pale yellow homogeneous 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.
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.
• Mycobacterial ocular infections.
4.4 Special warnings and precautions for use
• For topical ophthalmic use only. Not for injection or ingestion.
• As with all antibacterial preparation prolonged use may lead to
overgrowth of non-susceptible bacterial
strains or fungi. If superinfection occurs, appropriate therapy should
be initiated.
• Sensitivity to topically applied aminoglycosides may occur in some
patients. Cross-sensitivity to other
aminoglycosides may also occur. If signs of serious reactions or
hypersensitivity occur, discontinue use of
MAXITROL eye ointment.
• Patients using ophthalmic preparations containing neomycin
sulphate should be advised to consult a
physician if ocular pain, redness, swelling, or irritation worsens or
persists.
• Serious adverse reactions including neurotoxicity, ototoxicity an