PRED-FORTE

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

PREDNISOLONE ACETATE

Available from:

ABBVIE BIOPHARMACEUTICALS LTD, ISRAEL

ATC code:

S01BA04

Pharmaceutical form:

OPHTHALMIC SUSPENSION

Composition:

PREDNISOLONE ACETATE 1 %W/V

Administration route:

OCULAR

Prescription type:

Required

Manufactured by:

ALLERGAN PHARMACEUTICALS IRELAND

Therapeutic group:

PREDNISOLONE

Therapeutic area:

PREDNISOLONE

Therapeutic indications:

For steroid responsive inflammation of the palpebral and bulbar conjunctiva, cornea and anterior segment of the globe.

Authorization date:

2020-04-30

Patient Information leaflet

PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS' REGULATIONS
(PREPARATIONS) - 1986
This medicine is dispensed w
ith a doctor’s prescription only
PRED FORTE
®
OPHTHALMIC SUSPENSION
ACTIVE INGREDIENT AND ITS CONCENTRATION:
prednisolone acetate 1% w/v
Inactive ingredients and allergens in the medicine: see section 2,
under
‘Important information about some of this medicine’s
ingredients’ and section 6
‘Additional information’.
READ THE ENTIRE LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE. This
leaflet contains concise information about the medicine. If you have
any further
questions, consult your doctor or pharmacist.
This medicine has been prescribed to treat your illness/for you. Do
not pass it on
to others. It may harm them, even if it seems to you that their
illness/medical
condition is similar to yours.
1.
WHAT IS THIS MEDICINE INTENDED FOR?
PRED FORTE is used to treat eye inflammation that responds to steroids
and
involves the conjunctiva, cornea or the anterior segment of the
eyeball.
THERAPEUTIC GROUP: corticosteroids
PRED FORTE belongs to a group of medicines known as steroidal anti-
inflammatory drugs. It reduces the irritation, burning, redness and
swelling of eye
inflammation caused by chemicals, heat, radiation, allergy, or foreign
objects in
the eye.
2.
BEFORE USING THIS MEDICINE
DO NOT USE THIS MEDICINE IF:
•
you are sensitive (allergic) to the substance prednisolone acetate,
benzalkonium chloride or any of the other ingredients of this medicine
(listed in sect
ion 6 ‘Addi
tional information
’)
.
•
you suffer from viral, fungal or bacterial eye infections.
•
you suffer from tuberculosis of the eye.
•
you have injuries or ulcers on the cornea.
•
you have previously had herpes simplex.
Page 2 of 6
SPECIAL WARNINGS ABOUT USING THIS MEDICINE
BEFORE TREATMENT WITH PRED FORTE, TELL YOUR DOCTOR IF:
-
you suffer from or have ever suffered from eye ulcers, or if you have
had a
disease or received treatment in the eye that caused the tissue to
become
thin
-
you have glauco

Summary of Product characteristics

PRE API JAN 24 CL
Page 1 of 5
1.
NAME OF THE MEDICINAL PRODUCT
Pred Forte
®
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
1% w/v prednisolone acetate.
Excipient(s) with known effect: Benzalkonium chloride 0.006% w/v.
Boric acid 1% w/v.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Ophthalmic suspension.
A dense white sterile microfine eye drops suspension.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
For steroid responsive inflammation of the palpebral and bulbar
conjunctiva, cornea and anterior segment
of the globe.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Adults_
One to two drops instilled into the conjunctival sac two to four times
daily. During the initial 24 to 48
hours the dosing frequency may be safely increased to 2 drops every
hour. Care should be taken not to
discontinue therapy prematurely.
No overall differences in safety or effectiveness have been observed
between elderly and younger patients.
_Paediatric population _
The safety and efficacy in paediatric population have not yet been
established.
No posology can be recommended.
Method of administration
Route of administration is by ocular instillation.
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.
Acute superficial herpes simplex (dendritic keratitis); vaccinia,
varicella and most other viral diseases of
the cornea and conjunctiva.
Fungal diseases of the eye.
Mycobacterial infection such as tuberculosis of the eye.
Hypersensitivity to the active substance or to any of the excipients
listed in section 6.1.
PRE API JAN 24 CL
Page 2 of 5
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Acute purulent infections of the eye may be masked or enhanced by the
use of topical steroids. Pred Forte
contains no antimicrobial agent. If infection is presen