MAXITROL %w/v Eye Drops Suspension

Land: Irland

Sprog: engelsk

Kilde: HPRA (Health Products Regulatory Authority)

Aktiv bestanddel:

DEXAMETHASONE, POLYMYXIN B SULFATE, NEOMYCIN SULFATE

Tilgængelig fra:

Novartis Pharmaceuticals UK Ltd

ATC-kode:

S01CA01

INN (International Name):

DEXAMETHASONE, POLYMYXIN B SULFATE, NEOMYCIN SULFATE

Dosering:

%w/v

Lægemiddelform:

Eye Drops Suspension

Recept type:

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

Terapeutisk område:

Corticosteroids and antiinfectives in combination

Autorisation status:

Authorised

Autorisation dato:

2017-05-05

Indlægsseddel

1
PACKAGE LEAFLET - INFORMATION FOR THE USER
MAXITROL
® 0.1% W/V, 6000 IU/ML, 3500 IU/ML EYE DROPS, SUSPENSION
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 IS AND WHAT IT IS USED FOR
2.
BEFORE YOU USE MAXITROL
3.
HOW TO USE MAXITROL
4.
POSSIBLE SIDE EFFECTS
5.
HOW TO STORE MAXITROL
6.
FURTHER INFORMATION
1.
WHAT MAXITROL IS AND WHAT IT IS USED FOR
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.
2.
BEFORE YOU USE MAXITROL
DO NOT USE MAXITROL...
•
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 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
.
•
If you experience
ALLERGIC REACTIONS
with MAXITROL, 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 anti

Produktets egenskaber

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Maxitrol 0.1% w/v, 6000 IU/ml, 3500 IU/ml eye drops, suspension.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml suspension contains 1 mg Dexamethasone, 6000 IU Polymyxin B
Sulphate, 3500 IU Neomycin Sulphate (as base)
Excipients:
1ml suspension contains 0.04 mg Benzalkonium Chloride
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Eye drops, suspension
White to pale yellow opaque suspension.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Maxitrol Eye Drops 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.
Heptic and renal impairment
Maxitrol Eye Drops has not been studied in these subject populations.
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 diseases of ocular structures or untreated parasitic eye
infections.
Mycobacterial ocular infections.
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