MINIMS PREDNISOLONE SODIUM PHOSPHATE

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

PREDNISOLONE SODIUM PHOSPHATE

Available from:

Bausch & Lomb UK Limited

ATC code:

S01BA04

INN (International Name):

PREDNISOLONE SODIUM PHOSPHATE

Dosage:

0.5 %w/v

Pharmaceutical form:

Eye Drops Solution

Prescription type:

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

Therapeutic area:

prednisolone

Authorization status:

Marketed

Authorization date:

1982-02-18

Patient Information leaflet

Graphics&Packing
Technology Section
ICN POLFA RZESZÓW S.A.
ULOTKA PIL
Nazwa produktu
Product Name
MINIMS PREDNISOLONE
SODIUM PHOSPHATE 0.5 %
W/V DRP 20 SDU
Kolor nadruku Colours
Black
Kraj
Country (ISO)
UNITED KINGDOM (UK),
IRELAND (IE)
Nr wykrojnika
Spec No
5338
Opracowane przez
Designed by
Kod Wytwórcy
Manufacturer code
77002
Nr korekty
Proof No
2
Data
Date
09.05.2017
Kod farmaceutyczny
Pharmacode
-
Kod wersji
Valeant version code
P1UKIE05
Inny kod
Other code
77002 (DATA MATRIX)
Rozmiar czcionki
Font size
MINIMUM 8 PT
Wymiar ulotki
PIL size
160 X 240 MM
Krój czcionki
Font used
Frutiger Neue LT W1G
Condensed
FRUTIGER NEUE LT W1G
CONDENSED BOLD
Gramatura papieru
Paper weight
60 G/M
2
Komentarze Comments (Reason for the change)
IMPLEMENTATION OF PRAC - RESUBMISSION
PMR_ICN-17-0514-A
PACKING SITE: LABORATOIRE CHAUVIN, AUBENAS, FRANCE
Akceptacja Techniczna Technical Approval
Akceptacja Działu ds. Rejestracji Regulatory Affairs Dept. Approval
MINIMS® PREDNISOLONE SODIUM PHOSPHATE 0.5%W/V
EYE DROPS, SOLUTION
PREDNISOLONE SODIUM PHOSPHATE
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU.
•
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 only. Do not pass it on to
others. It may harm them, even if their signs of illness are the
same as yours.
•
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side effects not listed in this leaflet. See
section 4.
WHAT IS IN THIS LEAFLET:
1. What Minims® Prednisolone Sodium Phosphate eye drops are and what
they are used for
2. What you need to know before you use your eye drops
3. How to use your eye drops
4. Possible side effects
5. How to store your eye drops
6. Contents of the pack and other information
1.
WHAT MINIMS® PREDNISOLONE SODIUM PHOSPHATE EYE DROPS ARE AND WHAT ARE
THEY USED FOR
Minims® Prednisolone Sodium Phosphate contains a cortic

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Minims Prednisolone Sodium Phosphate 0.5% w/v Eye Drops, Solution
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Prednisolone sodium phosphate 0.5 % w/v.
For full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Eye drops, solution
Clear, colourless, aqueous, single-use eye drops, solution.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Non-infected inflammatory conditions of the eye.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
_Adults and the elderly_
One or two drops applied topically to the eye as required.
_Paediatric population_
At the discretion of the physician.
4.3 CONTRAINDICATIONS
Use of this medicine is contraindicated in patients with a known
hypersensitivity to the active ingredient.
Use is also contraindicated in viral, fungal, tuberculosis and other
bacterial infections.
Prolonged application to the eye of preparations containing
corticosteroids has caused increased intra-ocular pressure
and, therefore, the drops should not be used in patients with
glaucoma.
In children, long-term, continuous topical corticosteroid therapy
should be avoided due to possible adrenal suppression.
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Care should be taken to ensure that the eye is not infected before
Minims Prednisolone is used.
Topical corticosteroids should not be used for longer than one week,
except under ophthalmic supervision with regular
checks of intra-ocular pressure.
Systemic absorption may be reduced by compressing the lacrimal sac at
the medial canthus for a minute during and
following the instillation of the drops. (This blocks the passage of
drops via the naso-lacrimal duct to the wide
absorptive area of the nasal and pharyngeal mucosa. It is especially
advisable in children).
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