Pred Forte 1% w/v, Eye Drops Suspension

Quốc gia: Ai-len

Ngôn ngữ: Tiếng Anh

Nguồn: HPRA (Health Products Regulatory Authority)

Thành phần hoạt chất:

Prednisolone acetate

Sẵn có từ:

AbbVie Limited

Mã ATC:

S01BA; S01BA04

INN (Tên quốc tế):

Prednisolone acetate

Dạng dược phẩm:

Eye drops, suspension

Khu trị liệu:

Corticosteroids, plain; prednisolone

Tình trạng ủy quyền:

Marketed

Ngày ủy quyền:

1978-04-01

Tờ rơi thông tin

PACKAGE LEAFLET: INFORMATION FOR THE USER
PRED FORTE 1% 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 Forte is and what it is used for
2. What you need to know before you use Pred Forte
3. How to use Pred Forte
4. Possible side effects
5. How to store Pred Forte
6. Contents of the pack and other information
1. WHAT PRED FORTE IS AND WHAT IT IS USED FOR
Pred Forte belongs to a group of medicines known as steroidal
(anti-inflammatory drugs).
Pred Forte is used in adults for the short-term treatment of eye
inflammation when the
presence of viral, fungal and bacterial agents have been ruled out.
It reduces the irritation, burning, redness and swelling of the eye
caused by chemicals,
heat, radiation, allergy, or foreign objects in the eye.
2. WHAT YOU NEED TO KNOW BEFORE YOU USE PRED FORTE
DO NOT USE PRED FORTE
:
- If you are allergic to prednisolone, benzalkonium chloride 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 suffer from tuberculosis of the eye
- If you have previously had herpes simplex
WARNINGS AND PRECAUTIONS
Talk to your doctor before using Pred Forte if you suffer from, or
have in the past
suffered from:
- eye ul

Đặc tính sản phẩm

Health Products Regulatory Authority
01 April 2022
CRN00CNGC
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Pred Forte 1% w/v, Eye Drops Suspension
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Prednisolone acetate 1.0 % w/v.
Excipients 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
Eye drops, suspension (eye drops)
A dense white sterile microfine eye drops suspension.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
For short-term treatment of steroid-responsive inflammatory conditions
of the eye, after excluding the presence of viral, fungal
and bacterial pathogens in adults.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Adults_
One to two drops instilled into the conjunctival sac two to four times
daily. Initially dosage may be 2 drops every hour. Care
should be taken not to discontinue therapy prematurely.
_Elderly patients_
No adjustment in the adult dosage regimen is recommended.
_Paediatric population_
The safety and efficacy of Pred Forte in paediatric patients have not
yet been established. No posology can be recommended.
Method of Administration
Topical by instillation into the conjunctival sac.
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 ocular infections, such as superficial (or epithelial)
herpes simplex keratitis (dendritic keratitis), vaccinia,
varicella, and most other viral diseases of the cornea and
conjunctiva, fungal or treponemal 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.
Health Products Regulatory Authority
01 April 2022
CRN00CNGC
Page 2 of 5
4.4 SPECIAL WARNINGS AND PRECAUTIO