Brolene 0.1% w/v Eye Drops Solution

Страна: Ирландия

Език: английски

Източник: HPRA (Health Products Regulatory Authority)

Активна съставка:

PROPAMIDINE ISETIONATE

Предлага се от:

Sanofi-Aventis Ireland Limited T/A SANOFI

АТС код:

S01AX; S01AX15

INN (Международно Name):

PROPAMIDINE ISETIONATE

дозиране:

0.1 percent weight/volume

Лекарствена форма:

Eye drops, solution

Вид предписание :

Product not subject to medical prescription

Терапевтична област:

Other antiinfectives; propamidine

Статус Оторизация:

Marketed

Дата Оторизация:

1983-04-01

Листовка

P
ACKAGE
LEAFLET
:
I
NFORMATION
FOR
THE
USER
BROLENE® 0.1%W/V EYE
DROPS SOLUTION
Propamidine isetionate
IS THIS LEAFL ET HARD
TO SEE OR READ?
PHONE [phone]
FOR HELP
READ ALL OF THIS LEAFL ET CAREFULLY BEFORE
YOU START USING THIS MEDICINE BECAUSE IT
CONTAINS IMPORTANT INFORMATION FOR YOU.
Always use this medicine exactly as
described in this leafl et or as your doctor or
pharmacist have told you.
• Keep this leafl et. 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 or pharmacist. This
includes any possible side effects not
listed in this leafl et. 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 LEAFL ET:
1. What Brolene Eye Drops are and what
they are used for
2. What you need to know before you use
Brolene Eye Drops
3. How to use Brolene Eye Drops
4. Possible side effects
5. How to store Brolene Eye Drops
6. Contents of the pack and other
information
1. WHAT BROLENE EYE DROPS ARE AND
WHAT THEY ARE USED FOR
Brolene Eye Drops contain a medicine
called propamidine isetionate. This belongs
to a group of medicines called disinfectants
and antifungals. It works by stopping the
growth of bacteria, allowing your body to
fi ght off the infection.
It is used for minor infections of the eye or
eyelid. Signs include sore, red or infl amed
eyes, stickiness or a crust on the eyelids. 2. WHAT YOU NEED TO KNOW BEFORE YOU
USE BROLENE EYE DROPS
DO NOT USE THIS MEDICINE AND TELL
YOUR DOCTOR OR PHARMACIST IF:
 You are allergic (hypersensitive) to
propamidine isetionate or any of the
other ingredients of Brolene Eye Drops
(listed in Section 6 below)
Signs of an allergic reaction include:
a rash, swallowing or breathing
problems, swelling of your lips, face,
throat, tongue or around the eyes.
 You wear contact lenses. You should not
wear contact lenses while using these
drops.
Do not use this medicine if the above apply
to you. If you are not sure, talk to your
d

Данни за продукта

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Brolene 0.1% w/v Eye Drops Solution
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Propamidine isetionate 0.1% w/v.
Excipients: contains Benzalkonium Chloride solution 0.01% v/v
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Eye drops, solution (eye drops).
A clear, colourless, sterile, aqueous solution.
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.
The usual dosage is 1-2 drops into the affected eye up to four times
daily.
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 discontinue 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.
4.5 INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF
INTERACTION
None known.
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