Provist-Opto 5 mg/ml eye drops, solution in single-dose container

Country: Malta

Language: English

Source: Medicines Authority

Available from:

Uni-Pharma Kleon Tsetis Pharmaceutical Laboratories S.A. 14th Km National Road Athens - Lamia 1, GR-145 64 Kifissia, Greece

ATC code:

S01BA04

INN (International Name):

PREDNISOLONE 5 mg/ml

Pharmaceutical form:

EYE DROPS, SOLUTION

Composition:

PREDNISOLONE 5 mg/ml

Prescription type:

POM

Therapeutic area:

OPHTHALMOLOGICALS

Product summary:

Licence number in the source country: NOT APPLICAPABLE

Authorization status:

Authorised

Authorization date:

2023-03-21

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
PROVIST-OPTO 5 MG/ML EYE DROPS, SOLUTION IN SINGLE-DOSE CONTAINER
prednisolone sodium phosphate
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING 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 Provist-Opto is and what it is used for
2.
What you need to know before you use
Provist-Opto
3.
How to use Provist-Opto
4.
Possible side effects
5.
How to store Provist-Opto
6.
Contents of the pack and other information
1.
WHAT PROVIST-OPTO IS AND WHAT IT IS USED FOR
Provist-Opto is an eye drops, solution in single-dose containers. It
contains prednisolone
sodium phosphate, which belongs to a group of medicines called
corticosteroids; these
medicines have an anti-inflammatory action.
Provist-Opto is used in adults for the short-term treatment of
inflammatory eye diseases
of the
anterior part of the eye
that has not occurred due to an infection and which respond to
corticosteroid treatment.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE PROVIST-OPTO
DO NOT USE PROVIST-OPTO
•
If you are allergic to prednisolone sodium phosphate or any of the
other ingredients of
this medicine (listed in section 6).
•
If you are suffering from an eye infection which is not being treated
with appropriate co-
therapy.
•
If you have an eye ulcer which is not being treated with appropriate
co-therapy.
•
If you have increased eye pressure (glaucoma) which cannot be
sufficiently controlled by
medicinal products.
•
If you have an acute herpes simplex infection (dendritic keratitis).
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharma

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Provist-Opto 5 mg/ml eye drops, solution in single-dose container
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml of eye drops, solution contains 5 mg prednisolone sodium
phosphate.
Excipient(s) with known effect:
This medicinal product contains 0.07 mg phosphates in each drop.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Eye drops, solution in single-dose container.
Clear, colourless solution.
pH: 7.3-8.3; Osmolarity: 220-300 mOsmol/ kg H
2
O (approx.)
4.
CLINICAL PARTICULARS
4.1.
THERAPEUTIC INDICATIONS
For the short-term, symptomatic treatment of steroid-responsive,
non-infectious
inflammatory diseases of the anterior part of the eye in adults.
4.2.
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Adults _
Depending on the severity of inflammation, 1-2 drops be instilled 3 to
4 times daily
in the conjunctival sac of the eye. If needed, the dosing frequency
may be increased
up to every 1 to 2 hours
during the first 24 - 48 hours
as initial therapy. When a
favourable response is observed, reduce dosage slowly
in the following days or
weeks.
To ensure the therapeutic effect, treatment should not be discontinued
prematurely.
Duration of treatment generally varies from a few days to several
weeks, according
to therapeutic response. Treatment with corticosteroids should
generally not exceed
a duration of 4 weeks (see section 4.4). Uncontrolled prolonged use
must be
avoided.
If no improvement occurs within two days after the start of treatment,
the indication
should be reexamined.
_Paediatric population _
The safety and efficacy in the paediatric population have not yet been
established.
Currently
available
data
are
described
in
sections
4.4
and
4.8,
but
no
recommendation on a posology can be made.
Method of administration
[Invented name] 5 mg/ml, eye drops, solution in single-dose container
is for ocular
use only.
To reduce possible systemic absorption, it is recommended that the
lacrimal sac be
compressed at the media