Ultracortenol 5mg/g eye ointment

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

PREDNISOLONE

Available from:

Agepha Pharma s.r.o Dialnicná cesta 5, Senec, 90301, Slovakia

ATC code:

S01BA04

INN (International Name):

PREDNISOLONE 5 mg/g

Pharmaceutical form:

EYE OINTMENT

Composition:

PREDNISOLONE 5 mg/g

Prescription type:

POM

Therapeutic area:

OPHTHALMOLOGICALS

Product summary:

Licence number in the source country: NOT APPLICAPABLE

Authorization status:

Authorised

Authorization date:

2020-11-11

Patient Information leaflet

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PACKAGE LEAFLET: INFORMATION FOR THE USER
ULTRACORTENOL 5 MG/G EYE OINTMENT
prednisolone pivalate
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.
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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.
THIS LEAFLET CONTAINS INFORMATION ON THE FOLLOWING:
1.
What Ultracortenol is and what it is used for
2.
What you need to know before using Ultracortenol
3.
How to use Ultracortenol
4.
Possible side effects
5.
How to store Ultracortenol
6.
Contents of the pack and other information
1. WHAT ULTRACORTENOL IS AND WHAT IT IS USED FOR
Ultracortenol is used in adults to treat:
A severe inflammation in the anterior part of the eye that has not
occurred due to an infection.
Ultracortenol contains the active substance Prednisolone pivalate.
Prednisolone pivalate is a glucocorticoid (a steroid) with a strong
anti-inflammatory effect. It inhibits
the release of inflammatory substances in the body, thereby preventing
signs of inflammation, e.g.
swelling, dilation of blood vessels and scarring.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE ULTRACORTENOL
DO NOT USE
ULTRACORTENOL:
-
If you are allergic to the active substance Prednisolone pivalate,
other glucocorticoids or any of the
other ingredients of this medicine (listed in Section 6).
-
If you have an eye infection caused by herpes virus (dendritic
keratitis) or any other viral infection
in the eye.
-
If you have an untreated bacterial or fungal infection in the eye.
-
If you have Narrow-angle glaucoma or advanced glaucoma and only
medication does not provide
sufficiently good effect.
WARNINGS AND PRECAUTIONS
Talk to your doc

Summary of Product characteristics

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SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Ultracortenol 5 mg/g eye ointment
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 g contains: prednisolone pivalate 5 mg.
1 cm string of ointment contains approx. 0.1 mg of prednisolone
pivalate.
Excipient(s) with known effect
1 gram of ointment contains 5 mg cetostearyl alcohol and 50 mg wool
fat.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Eye ointment
White to slightly yellowish, odourless.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Severe allergic eye inflammation and severe non-infectious
inflammatory conditions in the outer parts
of the eye and anterior segments.
Ultracortenol 5 mg/g eye ointment is indicated in adults.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Adults: _
A string of 3-5 mm ointment should be applied 2-4 times daily in the
conjunctival sac of the eye.
The maximum daily dose of ointment is a string of 5 mm,4 times daily.
If no improvement is seen within 2 days of initiation of treatment,
the indication should be re-
evaluated (see Section 4.4). Uncontrolled prolonged use should be
avoided. Do not interrupt treatment
abruptly but instead reduce the dose gradually over a period of
several days or weeks.
The duration of the treatment period should be adjusted individually.
If treatment is longer than 10 days, please see section 4.4
(“Special warnings and precautions for
use”).
Treatment with corticosteroids should generally not exceed 4 weeks
(see section 4.4). Uncontrolled
long-term use must be avoided.
_Paediatric population _
Safety and efficacy for children have not been established.
The lowest possible dose should be used. Long-term treatment should be
avoided in children (see
section 4.4).
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Method of administration
To be applied in the conjunctival sac of the eye.
Prior to application, contact lenses must be removed and may only be
inserted after 15 minutes.
In order to reduce possible systemic absorption, it is recommended
that the lacrimal sac at the me