Gentamicin 0.3% ear/eye drops

Country: United Kingdom

Bahasa: Inggeris

Sumber: MHRA (Medicines & Healthcare Products Regulatory Agency)

Bahan aktif:

Gentamicin sulfate

Boleh didapati daripada:

Advanz Pharma

Kod ATC:

S03AA06

INN (Nama Antarabangsa):

Gentamicin sulfate

Dos:

3mg/1ml

Borang farmaseutikal:

Ear/eye drops solution

Laluan pentadbiran:

Ocular; Auricular

Kelas:

No Controlled Drug Status

Jenis preskripsi:

Valid as a prescribable product

Ringkasan produk:

BNF: 11030100; GTIN: 5060337260831

Risalah maklumat

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
GENTAMICIN 0.3% W/V EYE/EAR DROPS
gentamicin
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.
WHAT IS IN THIS LEAFLET
1. What Gentamicin 0.3% w/v Eye/Ear Drops are and what they are used
for
2. What you need to know before you use Gentamicin 0.3% w/v Eye/Ear
Drops
3. How to use Gentamicin 0.3% w/v Eye/Ear Drops
4. Possible side effects
5. How to store Gentamicin 0.3% w/v Eye/Ear Drops
6. Contents of the pack and other information
1. WHAT GENTAMICIN 0.3% W/V EYE/EAR DROPS
ARE AND WHAT THEY ARE USED FOR
The name of your medicine is Gentamicin 0.3% w/v Eye/Ear Drops.
Gentamicin 0.3% w/v Eye/Ear
Drops contain the active ingredient gentamicin which belongs to a
group of medicines called
antibiotics.
Gentamicin 0.3% w/v Eye/Ear Drops are used in adults and children to
treat bacterial infections in
the eye or ear and to prevent infections in an injured eye or ear.
2. WHAT YOU NEED TO KNOW BEFORE YOU USE GENTAMICIN 0.3% W/V EYE/EAR
DROPS
DO NOT USE GENTAMICIN 0.3% W/V EYE/EAR DROPS:
•
if you are allergic
to gentamicin, any of the other ingredients of this medicine (listed
in section
6)
•
if you are allergic
to a similar medicine containing an aminoglycoside antibiotic
• if you have or suspect you have a burst ear drum, if you are being
treated for a problem with your
ear
• if you suffer from myasthenia gravis, a disease causing muscle
weakness.
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before using Gentamicin 0.3% w/v
Eye/Ear Drops:
•
if you have any problems with

Ciri produk

Genticin (Gentamicin 0.3% w/v) Eye/Ear Drops
Summary of Product Characteristics Updated 13-Jun-2021 | ADVANZ Pharma
1. Name of the medicinal product
Genticin 0.3% w/v Eye/Ear Drops.
Gentamicin 0.3% w/v Eye/Ear Drops
2. Qualitative and quantitative composition
Each bottle contains gentamicin sulfate equivalent to 30 mg gentamicin
base in 10 ml of solution
Excipients with known effect:
Benzalkonium chloride 50% w/v solution (0.020% w/v per 10 ml)
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Eye/Ear drops.
Sterile, isotonic solution in dropper bottles.
4. Clinical particulars
4.1 Therapeutic indications
Genticin eye/ear drops are indicated in adults and children:
1. For the treatment of superficial eye and ear infections caused by
organisms sensitive to gentamicin.
2. For prophylaxis against infection in trauma of the eye or ear.
4.2 Posology and method of administration
Posology
Adults, the elderly and the paediatric population
Eyes: 1 or 2 drops should be instilled in 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 cleaned and 2 - 3 drops instilled in the
affected ear three to four times a day and at night, or
more frequently if required.
Method of administration
Auricular and ocular use.
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 gentamicin should be supplemented
with appropriate systemic antibiotic treatment.
Gentamicin may cause irreversible partial