PREDMYCIN-P LIQUIFILM 5/3.5/10,0 Micromol Eye Drops Suspension

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

PREDNISOLONE ACETATE, NEOMYCIN SULFATE, POLYMYXIN B SULFATE

Available from:

Allergan Pharmaceuticals Ireland

ATC code:

S01CA02

INN (International Name):

PREDNISOLONE ACETATE, NEOMYCIN SULFATE, POLYMYXIN B SULFATE

Dosage:

5/3.5/10,0 Micromol

Pharmaceutical form:

Eye Drops Suspension

Prescription type:

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

Therapeutic area:

Corticosteroids and antiinfectives in combination

Authorization status:

Authorised

Authorization date:

1978-04-01

Patient Information leaflet

PREDMYCIN-P LIQUIFILM® 5MG/ML + 3.5MG/ML + 10,000U/ML EYE DROPS
SUSPENSION
(Prednisolone Acetate)
(Neomycin)
(Polymyxin B Sulphate)
Eyedrops Suspension
PATIENT INFORMATION LEAFLET
WHAT DOES THE MEDICINE CONTAIN?
This medicine contains 0.5% w/v (5 mg/ml) of Prednisolone Acetate,
Neomycin Sulphate equivalent to Neomycin base 0.35% w/v (3.5
mg/ml) and 10000 units/ml of Polymyxin B Sulphate, which are the three
active ingredients. It also contains Polyvinyl alcohol
(Liquifilm

), Thiomersal, Sodium Acetate Trihydrate, Polysorbate 80, Propylene
Glycol and Purified Water.
TYPE OF MEDICINE
Predmycin P

is an eye drop suspension and each bottle holds 5ml in a 10ml bottle.
WHO IS RESPONSIBLE FOR THE PRODUCT?
It is distributed by: Cahill May Roberts, Chapelizod, Dublin 20,
Ireland
It is manufactured by: Allergan Pharmaceuticals Ireland, Westport, Co.
Mayo, Ireland
Product Authorisation Holder: Allergan Pharmaceuticals Ireland,
Castlebar Road, Westport, Co. Mayo, Ireland
WHAT IS THE MEDICINE USED FOR?
Predmycin P

is used in the treatment of blepharitis and conjunctivitis including
those in which the inflammation is due to
micro-organisms sensitive to the anti-infective.
IMPORTANT INFORMATION ABOUT PREDMYCIN-P
This medicinal product contains thiomersal as a preservative and it is
possible that you may experience an allergic
reaction.
WHEN SHOULD THE MEDICINE NOT BE USED?
Predmycin P

should not be used if you are allergic to any of its ingredients.
Predmycin P

should not be used while wearing contact lenses.
BEFORE YOU USE THIS MEDICINE
Tell your doctor if
You are pregnant or are breast feeding.
You have any known allergies.
Please tell your doctor if you are taking or have recently taken any
other medicines, including medicines obtained without
a prescription.
Some medicines may increase the effects of PREDMYCIN-P and your doctor
may wish to monitor you carefully if you are
taking these medicines (including some medicines for HIV: ritonavir,
cobicistat).
DOSAGE
The following information represents the aver

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Predmycin-P Liquifilm 5mg/ml + 3.5mg/ml + 10,000U/ml Eye drops
suspension
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Excipients: contains thiomersal (10 microgram/ml)
For a full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Eye drops suspension
A white to creamy white microfine suspension.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
PREDMYCIN-P is indicated for the treatment of blepharitis and
conjunctivitis including those in which the
inflammation is due to micro-organisms sensitive to the
anti-infective.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
To Treat the Eye:
1 drop every 3 to 4 hours, or more frequently as required.
Intra-ocular instillation into conjunctival sac and topical
application to eyelids.
4.3 CONTRAINDICATIONS
Use in those individuals who have shown hypersensitivity to any of the
drug's ingredients.
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Warnings
Prolonged use of an anti-infective may result in the development of
superinfection due to organisms, including fungi,
resistant to that anti-infective.
The anti-infective present may be toxic if absorbed from open
surfaces.
Prolonged use may induce increased intraocular pressure corneal
thinning and perforation and subcapsular lenticular
opacities.
May cause allergic reactions.
Prolonged use may cause pigmentation of the lens and Keratopathy.
Active Ingredients
Percent (w/v)
mg/mL
Prednisolone acetate
0.50
5.0
Neomycin Sulphate (0.5% w/v) (equivalent
to Neomycin base)
0.35
3.5
Polymyxin B Sulphate
10,000 units/mL
10,000 units/mL
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