Sofradex Ear/Eye Drops

देश: आयरलैंड

भाषा: अंग्रेज़ी

स्रोत: HPRA (Health Products Regulatory Authority)

सक्रिय संघटक:

Framycetin sulfate; Gramicidin; Dexamethasone

थमां उपलब्ध:

Sanofi-Aventis Ireland Limited T/A SANOFI

ए.टी.सी कोड:

S03CA; S03CA01

INN (इंटरनेशनल नाम):

Framycetin sulfate; Gramicidin; Dexamethasone

डोज़:

0.5 %w/v+0.005 %w/v+0.05 percent weight/volume

फार्मास्यूटिकल फॉर्म:

Ear/eye drops, solution

प्रिस्क्रिप्शन प्रकार:

Product subject to prescription which may not be renewed (A)

चिकित्सीय क्षेत्र:

Corticosteroids and antiinfectives in combination; dexamethasone and antiinfectives

प्राधिकरण का दर्जा:

Not marketed

प्राधिकरण की तारीख:

1977-04-01

सूचना पत्रक

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 6 below)
Signs of an allergic reaction include: a
rash,

उत्पाद विशेषताएं

Health Products Regulatory Authority
03 December 2019
CRN009FFS
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
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
(0.05 mg/ml), Dexamethasone sodium
metasulphobenzoate equivalent to Dexamethasone 0.05% w/v (0.5 mg/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 CONTRAINDICATIONS
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 (eardrum perforation), 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.
Health Products Regulatory Authority
03 December 2019
CRN009FFS
Page 2 of 5
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Prolonged use of an anti-infective may result in the development of
superinfection due to organisms,