Sofradex Ear/Eye Drops, solution

Quốc gia: Malta

Ngôn ngữ: Tiếng Anh

Nguồn: Malta Medicines Authority

Thành phần hoạt chất:

FRAMYCETIN SULFATE, DEXAMETHASONE, GRAMICIDIN

Sẵn có từ:

Sanofi Malta Limited

Mã ATC:

S03CA01

INN (Tên quốc tế):

FRAMYCETIN SULFATE, DEXAMETHASONE, GRAMICIDIN

Dạng dược phẩm:

EAR DROPS, SOLUTION, EYE DROPS, SOLUTION

Thành phần:

FRAMYCETIN SULFATE 0.5 percent weight/volume ; DEXAMETHASONE 0.05 percent weight/volume ; GRAMICIDIN 0.005 percent weight/volume

Loại thuốc theo toa:

POM

Khu trị liệu:

OPHTHALMOLOGICAL AND OTOLOGICAL PREPARATIONS

Tình trạng ủy quyền:

Authorised

Ngày ủy quyền:

2005-09-28

Tờ rơi thông tin

12/06/2017 08:36 - VISTAlink folder 2922892 - Page 1/4 PACKAGE LEAFLET:
INFORMATION FOR THE USER
SOFRADEX EAR/EYE DROPS
Framycetin sulphate 5mg/ml
Gramicidin 0.05mg/ml
Dexamethasone sodium
metasulphobenzoate 0.5mg/ml
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.
• Keep this leafl et. 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. Do not pass it on to others. It may
harm them, even if their symptoms are
the same as yours
• If any of the side effects gets serious,
or if you notice any side effects not listed
in this leafl et, please tell your doctor or
pharmacist
IN THIS LEAFL ET:
1. What Sofradex Drops are and what they
are used for
2. Before you use Sofradex Drops
3. How to use Sofradex Drops
4. Possible side effects
5. How to store Sofradex Drops
6. Further information
1. WHAT SOFRADEX DROPS ARE
AND WHAT THEY ARE USED FOR
WHAT SOFRADEX DROPS ARE
Sofradex Ear/Eye Drops (called Sofradex
Drops in this leafl et) contains three
medicines called Framycetin sulphate,
Gramicidin and Dexamethasone sodium
metasulphobenzoate.
• Framycetin sulphate and Gramicidin
belong to a group of medicines called
antibiotics. These work by killing the
bacteria that is causing the infection
• Dexamethasone sodium
metasulphobenzoate. This belongs to
a group of medicines called steroids. It
works by lowering infl ammation
WHAT SOFRADEX DROPS ARE USED FOR
IT IS USED IN THE EYE(S) FOR:
• Infl ammation in the eye when
prevention of bacterial infection is
also needed. Signs include sore, red or
swollen eyes
IT IS USED IN THE EAR(S) FOR:
• Infl ammation of the ear canal (otitis
externa)
2. BEFORE YOU USE SOFRADEX DROPS
DO NOT USE THIS MEDICINE AND TELL
YOUR DOCTOR IF:
You are allergic (hypersensitive) to
framycetin sulphate, dexamethasone
sodium metasulphobenzoate, gramicidin
or any of the other ingredients of Sofradex
Drops (listed in Section

Đặc tính sản phẩm

1.
NAME OF THE MEDICINAL PRODUCT
Sofradex Ear/Eye Drops.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Contains
Framycetin Sulphate 0.5%w/v (5mg/ml), Gramicidin 0.005%w/v
(0.05mg/ml),
Dexamethasone sodium metasulphobenzoate equivalent to Dexamethasone
0.05%w/v
(0.5mg/ml).
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Ear/Eye drops, solution.
Practically clear, colourless to slightly green-yellow aqueous
solution
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
In the eye: For the short-term treatment of steroid responsive
conditions of the eye, when
prophylactic antibiotic treatment is also required, after excluding
the presence of fungal
and viral disease.
In the ear:
Otitis externa.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Route of administration: Auricular and Ocular.
ADULTS (AND THE ELDERLY) AND CHILDREN:
In the eye: One or two drops applied to each affected eye up to six
times daily or more
frequently if required.
In the ear: Two or three drops instilled into the ear three or four
times daily.
Treatment duration should be short (not exceed 7 days) (see section
4.4).
4.3
CONTRA-INDICATIONS
Use in patients hypersensitive to the active ingredients.
Use in the presence of infections of viral, treponemal
, tuberculous or of non-sensitive fungal origin.
Use in infants.
The product should not be used if there is a perforation of the
tympanic membrane, as entry
into the middle ear could lead to ototoxicity.
Use is contraindicated if glaucoma is present or herpetic keratitis
(e.g. dendritic ulcer) is
considered a possibility. Use of topical steroids in the latter
condition can lead to extension
of the ulcer and marked visual deterioration.
4.4
SPECIAL WARNINGS AND SPECIAL PRECAUTIONS FOR USE
Prolonged use of an anti-infective may result in the development of
superinfection due to
organisms, including fungi, resistant to anti-infective.
Treatment with corticosteroid/antibiotic combinations should not be
continued for more
than 7 days in the absence of any clinical improvement, since
prolonge