Brolene 0.15 % w/w Eye Ointment

País: Irlanda

Idioma: inglés

Fuente: HPRA (Health Products Regulatory Authority)

Ingredientes activos:

DIBROMPROPAMIDINE ISETIONATE

Disponible desde:

Clonmel Healthcare Ltd

Código ATC:

S01AX; S01AX14

Designación común internacional (DCI):

DIBROMPROPAMIDINE ISETIONATE

formulario farmacéutico:

Eye ointment

Área terapéutica:

Other antiinfectives; dibrompropamidine

Estado de Autorización:

Marketed

Fecha de autorización:

1983-04-01

Información para el usuario

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PACKAGE LEAFLET: INFORMATION FOR THE USER
BROLENE® 0.15% W/W EYE OINTMENT
dibrompropamidine isethionate
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.
ALWAYS USE THIS MEDICINE EXACTLY AS DESCRIBED IN THIS LEAFLET OR AS
YOUR DOCTOR OR PHARMACIST HAVE TOLD
YOU.
-
Keep this leaflet. You may need to read it again.
-
As your pharmacist if you need more information or advice.
-
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.
-
You must talk to a doctor if you do not feel better or if you feel
worse after 2 days.
IN THIS LEAFLET:
1. What Brolene Eye Ointment is and it is used for
2. What you need to know before you use Brolene Eye Ointment
3. How to use Brolene Eye Ointment
4. Possible side effects
5. How to store Brolene Eye Ointment
6. Contents of the pack and other information
1. WHAT BROLENE EYE OINTMENT IS AND WHAT IT IS USED FOR
Brolene Eye Ointment contains a medicine called dibrompropamidine
isetionate. This belongs to a group of
medicines called disinfectants and antifungals. It works by stopping
the growth of bacteria, allowing your
body to fight off the infection. It is used for minor infections of
the eye or eyelid. Signs include sore, red or
inflamed eyes, stickiness or a crust on the eyelids.
2. WHAT YOU NEED TO KNOW BEFORE YOU USE BROLENE EYE OINTMENT
DO NOT USE THIS MEDICINE AND TELL YOUR DOCTOR OR PHARMACIST IF:

You are allergic (hypersensitive) to dibrompropamidine isetionate or
any of the other ingredients of
Brolene Eye Ointment (listed in Section 6 below).
Signs of an allergic reaction include: a rash, swallowing or breathing
problems, swelling of your lips,
face, throat, tongue and worsening of redness, itching or swelling of
the eye or eyelid.

You wear contact lenses. You should not wear contact lenses while
using this ointment.
Do not use this medicine if this applies to you. If you are not sure,
talk t

Ficha técnica

Health Products Regulatory Authority
17 January 2022
CRN00CKYX
Page 1 of 3
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Brolene 0.15 % w/w Eye Ointment
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Dibrompropamidine Isetionate 0.15 % w/w.
Excipients: contains Wool fat 9.7% w/w.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Eye ointment.
A pale yellow, smooth, sterile ointment.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
As an anti-infective for use in local infections of the superficial
structures of the eye due to microorganisms sensitive to its
action.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
For ocular use.
Adults, elderly persons, and children: Cleanse the affected area and
apply the ointment topically to the eyelid or conjunctival
sac once or twice daily, for not more than 2 days.
4.3 CONTRAINDICATIONS
Hypersensitivity to any component of the preparation.
Use of contact lenses.
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
If there is no significant improvement within 2 days medical advice
should be sought.
There is always the possibility, although rare, of a sensitisation
reaction resulting from the use of Brolene preparations. In such
an event treatment should be discontinued immediately. Should erythema
or other evidence of increased inflammation occur
application should cease immediately and medical opinion should be
sought.
If problems of visual acuity occur or its symptoms are detected, the
doctor should be consulted immediately.
Brolene Ointment contains wool fat, which may cause local skin
reactions (e.g. contact dermatitis).
4.5 INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF
INTERACTIONS
None stated.
4.6 FERTILITY, PREGNANCY AND LACTATION
Health Products Regulatory Authority
17 January 2022
CRN00CKYX
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Safety of use in pregnancy and lactation has not been established. Use
during pregnancy and lactation only if considered
essential by the physician.
4.7 EFFECTS ON ABILITY TO DRIVE AND USE MACHINES
Brolene Eye Ointment may cause