Gentamicin 0.3% ear/eye drops

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Gentamicin sulfate

Available from:

FDC International Ltd

ATC code:

S03AA06

INN (International Name):

Gentamicin sulfate

Dosage:

3mg/1ml

Pharmaceutical form:

Ear/eye drops solution

Administration route:

Auricular; Ocular

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 11030100; GTIN: 05050135001064

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
GENTAMICIN
EYE/EAR DROPS 0.3% W/V
Gentamicin Sulphate
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 or pharmacist.

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 or pharmacist. This
includes any possible
side effects not listed in this leaflet. See section 4.

Your medicine, Gentamicin Eye/Ear Drops 0.3% w/v will be referred to
as gentamicin in
this leaflet.
WHAT IS IN THIS LEAFLET
1. What Gentamicin is and what it is used for
2. What you need to know before you use Gentamicin
3. How to use Gentamicin
4. Possible side effects
5. How to store Gentamicin
6. Contents of the pack and other information
1.
WHAT GENTAMICIN IS AND WHAT IT IS USED FOR
Gentamicin is a sterile, preserved, aqueous solution used as eye/ear
drops. The active
ingredient Gentamicin is an antibiotic. Gentamicin is used in adults
and children to kill
bacteria which cause infection. It is used for the management of
infection in injured eye and
ear.
2. WHAT YOU NEED TO KNOW BEFORE YOU USE GENTAMICIN
DO NOT USE GENTAMICIN IF

you are ALLERGIC to Gentamicin or any of the other ingredients of this
medicine (listed in section 6).

you have or suspect you have a burst ear drum, if you are being
treated
for a problem with your ear.

you suffer from myasthenia gravis, a disease causing muscle weakness.
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before using Gentamicin if you

have any problems with your kidneys or liver;

have open wounds or damaged skin;

are using this medicine for a long period of time.

know (or think you have) a mitochondrial disease (mutations in the
parts of your cells
which help make energy); certain mitochond

Summary of Product characteristics

Gentamicin Eye/Ear Drops 0.3% w/v
Summary of Product Characteristics Updated 24-Nov-2020 | FDC
International Ltd
1. Name of the medicinal product
Gentamicin Eye/Ear Drops 0.3% w/v
2. Qualitative and quantitative composition
Active Ingredient
Gentamicin sulphate equivalent to 30mg gentamicin base in 10ml of
solution
Excipient(s) with known effect:
Benzalkonium chloride 0.10mg/ml
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Eye/Ear Drops Solution
4. Clinical particulars
4.1 Therapeutic indications
Treatment of infections of the external structures of the eye and its
adnexa caused by susceptible bacteria. Such
infections include conjunctivitis, keratitis, kerato-conjunctivitis,
corneal ulcers, blepharitis and blepharo-conjunctivitis,
acute meibomianitis, episcleritis and dacryocystitis. It may be used
for the prevention of ocular infection after: removal of
a foreign body, burns or lacerations of the conjunctiva; damage from
chemical or physical agents and after ocular
surgery.
Also indicated for the treatment of otitis externa.
4.2 Posology and method of administration
Posology
Adults, including the elderly and children
Eyes: Instill 1-2 drops into the affected eye up to six times a day,
or more frequently if required. (severe infections may
require 1 or 2 drops every fifteen to twenty minutes initially,
reducing the frequency of instillation gradually as the
infection is controlled).
Ears: The area should be cleansed and 2-3 drops instilled in the
affected ear 3-4 times a day and at night or more
frequently if required.
4.3 Contraindications
Hypersensitivity to active substance, Gentamicin or to any of the
excipient listed in section 6.1.
Should not be administered to patients with a known allergy to
gentamicin and other aminoglycosides. Evidence exists
that gentamicin may cause neuromuscular blockade and is therefore
contra-indicated in myasthenia gravis and related
conditions.
Perforated tympanic membrane.
4.4 Special warnings and precautions for use
Avoid prolonged use. Prolonged use