Maxitrol eye drops

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Dexamethasone; Hypromellose; Neomycin sulfate; Polymyxin B sulfate

Available from:

Novartis Pharmaceuticals UK Ltd

ATC code:

S01CA01

INN (International Name):

Dexamethasone; Hypromellose; Neomycin sulfate; Polymyxin B sulfate

Dosage:

1mg/1ml ; 5mg/1ml ; 3500unit/1ml ; 6000unit/1ml

Pharmaceutical form:

Eye drops

Administration route:

Ocular

Class:

No Controlled Drug Status

Prescription type:

Never Valid To Prescribe As A VMP

Product summary:

BNF: 11040100; GTIN: 5015664006300

Patient Information leaflet

Technical approval by Packaging Site not using
OneArt: electronic or handwritten signature.
(If handwritten, it must be legible, include the approver’s
full name and date of approval)
Artwork creator:
Ramurthy, Dubasi
Creation date:
29-Sep-2021
Proof No.:
1
Artwork Order No.:
300001397
$:LGHQWLÀHU1R1HZ
670094-GB
$:LGHQWLÀHU1R2OG
670093 GB
Artwork Order description:
LFT_DEXAC LDMO 6000IU/ML/3 LDPE 5ML(X)GB
Packaging site:
CM, ES, EL MASNOU, ALCON CUSI SA / SIEG
Dimension:
125 X 500 MM
Tech. Drawing No.:
MT0114-2
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Font type:
Helvetica Neue LT Pro
Minimum font size body text:
8pt
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670094 GB
PACKAGE LEAFLET - INFORMATION FOR THE USER
MAXITROL*
EYE DROPS, SUSPENSION
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 pharmacist.
• This medicine has been prescribed for you. DO NOT PASS IT ON TO
OTHERS.
It may harm them, even if their signs of illness 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.
WHAT IS IN THIS LEAFLET
1. WHAT MAXITROL IS AND WHAT IT IS
USED FOR
2. WHAT YOU NEED TO KNOW BEFORE
YOU USE MAXITROL
3. HOW TO USE MAXITROL
4. POSSIBLE SIDE EFFECTS
5. HOW TO STORE MAXITROL
6. CONTENTS OF THE PACK AND OTHER
INFORMATION
WHAT MAXITROL* IS AND WHAT IT
IS USED FOR
1.
MAXITROL 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,
where administration of an antibiotic is
also required to prevent an eye infection.
WHAT YOU NEED TO KNOW BEFORE
YOU USE MAX

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
MAXITROL EYE DROPS
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml suspension contains 1 mg dexamethasone, 6000 IU polymyxin B
sulphate,
3500 IU neomycin sulphate (as base).
Excipient(s) with known effect:
1 ml suspension contains 0.04 mg benzalkonium chloride.
For a full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Eye drops, suspension
White sterile suspension for topical ocular administration.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
MAXITROL eye drops, suspension 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 one or two drops to each affected eye up to six times daily or,
more frequently
if required.
Hepatic and renal impairment
Maxitrol Eye Drops has not been studied in these subject populations.
However, due
to low systemic absorption of the active substances after topical
administration of this
product, dose adjustment is not necessary.
Method of administration
For ocular use only. Not for injection or ingestion.
Shake the bottle well before use.
After cap is removed, if tamper evident snap collar is loose, remove
before using
product.
In order to prevent contamination of the dropper tip and the
suspension, caution
should be exercised to ensure that the dropper tip does not touch the
eyelids, the
surroundings of the eye, or any other surfaces.
Nasolacrimal occlusion or gently closing the eyelid after
administration is
recommended. This may reduce the systemic absorption of medicinal
products
administered via the ocular route and result in a decrease in systemic
adverse
reactions.
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