Posiforlid 20 mg/g eye ointment

Country: Malta

Language: English

Source: Malta Medicines Authority

Active ingredient:

BIBROCATHOL

Available from:

Ursapharm Arzeneitmittel GmbH Industriestrasse, 66129 Saarbrucken, Germany

ATC code:

S01AX05

INN (International Name):

BIBROCATHOL 20 mg/g

Pharmaceutical form:

EYE OINTMENT

Composition:

BIBROCATHOL 20 mg/g

Prescription type:

OTC

Therapeutic area:

OPHTHALMOLOGICALS

Product summary:

Licence number in the source country: NOT APPLICAPABLE

Authorization status:

Authorised

Authorization date:

2021-11-05

Patient Information leaflet

Page 1 of 5
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
POSIFORLID 20 MG/G EYE OINTMENT
Active substance: Bibrocathol
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
Always use this medicine exactly as described in this leaflet or as
your doctor has told you.
-
Keep this leaflet. You may need to read it again.
-
Ask your pharmacist if you need more information or advice.
-
If you get any side effects, talk to your doctor. This includes any
possible side effects not listed
in this leaflet. See section 4.
-
You must talk to a doctor if you do not feel better or if you feel
worse after 7 days.
WHAT IS IN THIS LEAFLET
1.
What Posiforlid 20 mg/g is and what it is used for
2.
What you need to know before you use Posiforlid 20 mg/g
3.
How to use Posiforlid 20 mg/g
4.
Possible side effects
5.
How to store Posiforlid 20 mg/g
6.
Contents of the pack and other information
1.
WHAT POSIFORLID 20 MG/G IS AND WHAT IS USED FOR
Posiforlid 20 mg/g is a disinfecting, adstringent und secretion
inhibiting eye ointment.
Posiforlid 20 mg/g is used in chronic (long lasting) inflammation of
the eye lid margin that are not
caused by bacteria.
You must talk to a doctor if you do not feel better or if you feel
worse after seven days.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE POSIFORLID 20 MG/G
DO NOT USE POSIFORLID 20 MG/G
-
if you are allergic to bibrocathol or any of the other ingredients of
this medicine (listed in
section 6).
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before using Posiforlid 20 mg/g.
Wool fat may cause local skin reactions (e.g. contact dermatitis).
Do not wear contact lenses during the use of Posiforlid 20 mg/g.
Page 2 of 5
CHILDREN AND ADOLESCENTS
Posiforlid 20 mg/g is recommended in adolescents and children 6 years
and older.
OTHER MEDICINES AND POSIFORLID 20 MG/G
No interaction studies have been performed.
Tell your doctor or pharmacist if you are using, have recently used or
might use any other
medicines.
Note: If you apply ot

Summary of Product characteristics

Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Posiforlid 20 mg/g eye ointment
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 g of eye ointment contains 20 mg Bibrocathol.
Excipient(s) with known effect: Contains wool fat.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Eye ointment.
Ochre, homogenous ointment.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Chronic inflammation of the lid margin (Blepharitis chronica) not
requiring antibiotic treatment.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Adults _
If not otherwise prescribed, a 0.5 cm strip of eye ointment should be
applied in adults 3 to 5 times
daily into the conjunctival sac or on the affected position of the eye
lid for a maximum of 14 days.
_Adolescents and Children 6 years and older _
If not otherwise prescribed, a 0.5 cm strip of eye ointment should be
applied in children aged 6 to
less than 18 years 3 times daily into the conjunctival sac or on the
affected position of the eye lid for
a maximum of 10 days.
_ _
_ _
_Paediatric population _
The safety and efficacy of Posiforlid in children less than 6 years of
age have not been established.
No data are available.
Posiforlid 20 mg/g may be applied until relief of the symptoms. When
the complaints persist or the
symptoms do not improve a physician should be consulted after 7 days.
Page 2 of 6
Method of administration
For ocular use.
A contact between the tip of the tube and eye or facial skin should be
avoided.
4.3
CONTRAINDICATIONS
Hypersensitivity to the active substance or to any of the excipients
listed in section 6.1.
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Woolfat may cause local skin reactions (e.g. contact dermatitis).
Contact lenses should not be worn during use of Posiforlid 20 mg/g.
4.5
INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF
INTERACTION
No interaction studies have been performed.
Note: In concomitant treatment with other eye drops/eye ointments an
interval of at least 1 hour
should be between th