Gentisone HC ear drops

מדינה: הממלכה המאוחדת

שפה: אנגלית

מקור: MHRA (Medicines & Healthcare Products Regulatory Agency)

מרכיב פעיל:

Gentamicin sulfate; Hydrocortisone acetate

זמין מ:

Advanz Pharma

קוד ATC:

S02CA03

INN (שם בינלאומי):

Gentamicin sulfate; Hydrocortisone acetate

כמות:

3mg/1ml ; 10mg/1ml

טופס פרצבטיות:

Ear drops

מסלול נתינה (של תרופות):

Auricular

סיווג:

No Controlled Drug Status

סוג מרשם:

Valid as a prescribable product

leaflet_short:

BNF: 12010100; GTIN: 5060064171714

עלון מידע

GENTAMICIN 0.3% W/V AND
HYDROCORTISONE ACETATE 1% W/V
EAR DROPS
Gentamicin and Hydrocortisone acetate
Package leaflet: Information for the user
LF-102455-01
31026731-03
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU
START USING THIS MEDICINE BECAUSE IT
CONTAINS IMPORTANT INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it
again.
-
If you have any further questions, ask
your doctor, pharmacist or nurse.
-
This medicine has been prescribed for
you only. Do not pass it on to others. It
may harm them, even if their signs of
illness are the same as yours.
-
If you get any side effects, talk to your
doctor, pharmacist or nurse. This
includes any possible side effects not
listed in this leaflet. See section 4.
The name of your medicine is Gentamicin
0.3% w/v and Hydrocortisone acetate 1% w/v
Ear Drops; it will be called Gentamicin and
Hydrocortisone Ear Drops for ease here after.
WHAT IS IN THIS LEAFLET
1.
What Gentamicin and Hydrocortisone Ear
Drops are and what they are used for
2.
What you need to know before you use
Gentamicin and Hydrocortisone Ear Drops
3.
How to use Gentamicin and
Hydrocortisone Ear Drops
4.
Possible side effects
5.
How to store Gentamicin and
Hydrocortisone Ear Drops
6.
Contents of the pack and other information
1.
WHAT GENTAMICIN AND HYDROCORTISONE
EAR DROPS ARE AND WHAT THEY ARE USED
FOR
The name of your medicine is Gentamicin
and Hydrocortisone Ear Drops. Gentamicin
and Hydrocortisone Ear Drops contain the
active ingredients gentamicin which belongs
to a group of medicines called antibiotics and
hydrocortisone acetate which is a steroid.
Gentamicin and Hydrocortisone Ear Drops are
used in adults and children to treat eczema
and bacterial infections in the external ear, to
prevent infections in an injured ear and to
treat infected bone cavities (mastoid) behind
the ear after an operation.
2.
WHAT YOU NEED TO KNOW BEFORE YOU
USE GENTAMICIN AND HYDROCORTISONE
EAR DROPS
DO NOT USE THIS GENTAMICIN AND
HYDROCORTISONE EAR DROPS:
•
if you are allergic to gentamicin,
hydrocortisone or s

מאפייני מוצר

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Gentisone HC Ear Drops.
_ _
Gentamicin 0.3% w/v and Hydrocortisone acetate 1% w/v Ear Drops
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
This
medicine
is
a
sterile
aqueous
suspension
in
10
ml
dropper
bottles
containing
gentamicin sulphate, equivalent to 0.3% w/v gentamicin base and 1.0%
w/v hydrocortisone
acetate.
Excipients with known effect:
Benzalkonium chloride 50% w/v solution (0.02% w/v per 10ml)
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Sterile, isotonic solution in dropper bottles.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
This medicine is indicated in adults and children:
1. For the treatment of eczema and infection of the outer ear (otitis
externa).
2. For prophylaxis against otitis externa following trauma.
3. For post-operative local use in surgery to infected mastoid
cavities.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Adults, the elderly and the paediatric population
The area should be cleaned and 2 - 4 drops instilled in the affected
ear three to four times a
day and at night. Alternatively, wicks medicated with this medicine
may be placed in the
external ear or mastoid cavity.
Method of administration
_ _
Auricular use only.
4.3
CONTRAINDICATIONS
Hypersensitivity to the active substance or to any of the excipients
listed in section 6.1.
Myasthenia gravis.
_ _
Known or suspected perforation of the ear drum.
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Long-term continuous topical therapy should be avoided. Prolonged use
may lead to skin
sensitisation
and
the
emergence
of
resistant
organisms.
Cross
sensitivity
with
other
aminoglycoside antibiotics may occur.
In severe infections, topical use of this medicine should be
supplemented with appropriate
systemic antibiotic treatment.
The condition of the ear drum must always be checked before this
medicinal product is
prescribed. The medicinal product must not be used if the integrity of
the ear drum cannot be
guaranteed.
Gentamicin may cause