Pred Mild Sterile Ophthalmic Suspension, 0.12% w/v, Eye Drops, Suspension

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Prednisolone acetate

Available from:

Allergan Pharmaceuticals Ireland

ATC code:

S01BA; S01BA04

INN (International Name):

Prednisolone acetate

Dosage:

0.12 percent weight/volume

Pharmaceutical form:

Eye drops, suspension

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic area:

Corticosteroids, plain; prednisolone

Authorization status:

Marketed

Authorization date:

1977-04-01

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
PRED MILD STERILE OPHTHALMIC SUSPENSION 0.12% W/V EYE DROPS,
SUSPENSION
PREDNISOLONE ACETATE
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 PRED MILD is and what it is used for
2.
What you need to know before you use PRED MILD
3.
How to use PRED MILD
4.
Possible side effects
5.
How to store PRED MILD
6.
Contents of the pack and other information
1.
WHAT PRED MILD IS AND WHAT IT IS USED FOR
PRED MILD belongs to a group of medicines known as steroidal
anti-inflammatory
drugs and is used in adults for the short term treatment of eye
inflammation. It reduces
the irritation, burning, redness and swelling of the eye caused by
chemicals, heat,
radiation, allergy, or foreign objects in the eye.
2.
DO NOT USE PRED MILD
-
If you are allergic to prednisolone acetate or any of the other
ingredients of this
medicine (listed in Section 6).
(Symptoms of an allergic reaction may include swelling of the face,
lips and throat,
itching, redness or rash around the eye, body rash, hives, wheeziness,
feeling faint or
shortness of breath. Contact your doctor or seek medical attention
immediately if you
experience any of these symptoms).
-
If you are suffering from, or have in the past suffered from viral,
fungal or bacterial
eye infections or tuberculosis of the eye.
WARNINGS AND PRECAUTIONS
Talk to your doctor before using PRED MILD if you suffer from, or have
in the past
suffered from:
-
Eye ulcers or have had a disease or treatment to the eye that caused
the tissue to
beco

Summary of Product characteristics

Health Products Regulatory Authority
29 March 2021
CRN00C5LV
Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Pred Mild Sterile Ophthalmic Suspension, 0.12% w/v, Eye Drops,
Suspension
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Contains prednisolone acetate 0.12% w/v.
Excipient(s) with known effect: benzalkonium chloride 0.004% w/v.
boric acid 1% w/v.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Eye drops suspension.
Off-white microfine suspension.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Mild to moderate non-infectious allergic and inflammatory disorders of
the lid, conjunctiva, cornea and sclera (including
chemical and thermal burns) in adults.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
One to two drops instilled into the conjunctival sac two to four times
daily.
During the initial 24 to 48 hours, the dosage may be safely increased
to two drops every hour.
Care should be taken not to discontinue therapy prematurely.
_Paediatric population_
The safety and efficacy of Pred Mild in paediatric patients have not
been established. No posology can be recommended.
Method of administration
To reduce possible systemic absorption, it may be recommended that the
lacrimal sac be compressed at the medial canthus
(punctal occlusion) for 1 minute. This should be performed immediately
following the instillation of each drop.
Shake well before use.
4.3 CONTRAINDICATIONS
Acute untreated purulent ocular infections, such as superficial (or
epithelial) herpes simplex keratitis (dendritic keratitis),
vaccinia, varicella, fungal infections of the ocular structures,
mycobacterial infection such as tuberculosis of the eye.
Hypersensitivity to the active substance or to any of the excipients
listed in section 6.1.
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Eye drops containing corticosteroids, should not be used for more than
one week except under strict ophthalmic supervision
with regular checks for intraocular pressure.
Health Products Regulatory Authority
29 M