Pred Forte 1% eye drops

Riik: Suurbritannia

keel: inglise

Allikas: MHRA (Medicines & Healthcare Products Regulatory Agency)

Toimeaine:

Prednisolone acetate

Saadav alates:

Necessity Supplies Ltd

ATC kood:

S01BA04

INN (Rahvusvaheline Nimetus):

Prednisolone acetate

Annus:

10mg/1ml

Ravimvorm:

Eye drops

Manustamisviis:

Ocular

Klass:

No Controlled Drug Status

Retsepti tüüp:

Valid as a prescribable product

Toote kokkuvõte:

BNF: 11040100

Infovoldik

Insert - Pred Forte
®
- Great Britain - MoH Submission
Artwork created at 100%
Drop all keylines and notes before printing
Part Number: 72064MD066K
Drawing Number: 0106901
PACKAGE LEAFLET:
INFORMATION FOR THE USER
PRED FORTE
®
1% W/V EYE DROPS, SUSPENSION
Prednisolone acetate
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.
TURN OVER
WARNINGS AND PRECAUTIONS
Talk to your doctor before
using PRED FORTE 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 become thin
▪
You have glaucoma or are
being treated for raised
pressure within the eye
▪
You have had surgery for
cataracts
▪
Bacterial, viral or fungal eye
infections
Contact your doctor if you
experience blurred vision or
other visual disturbances.
TELL YOUR DOCTOR BEFORE USING
PRED FORTE, IF YOU ARE:
Using or have used other
steroid eye drops, as frequent
or long-term use of steroids can
result in additional side effects.
OTHER MEDICINES AND
PRED FORTE
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 PRED
FORTE and your doctor may
wish to monitor you carefully
if you are taking these
medicines (including some
medicines for HIV: ritonavir,
cobicistat).
WHAT IS IN THIS LEAFLET:
1. What PRED FORTE is and
what it is used for
2. What you need

Toote omadused

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Pred Forte 1% w/v, Eye Drops Suspension
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
1% w/v prednisolone acetate.
Excipient(s) with known effect: Benzalkonium chloride 0.006% w/v.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Eye drops, suspension.
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. 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.
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 age