Fusidic acid 1% modified-release eye drops

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Fusidic acid

Available from:

Advanz Pharma

ATC code:

S01AA13

INN (International Name):

Fusidic acid

Dosage:

10mg/1gram

Pharmaceutical form:

Modified-release drops

Administration route:

Ocular

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 11030100; GTIN: 5060337260770

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
FUSIDIC ACID 1% W/W
VISCOUS EYE DROPS
029067-01
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.
WHAT IS IN THIS LEAFLET:
1. What Fusidic acid Eye Drops are and
what they are used for
2. What you need to know before you use
Fusidic acid Eye Drops
3. How to use Fusidic acid Eye Drops
4. Possible side effects
5. How to store Fusidic acid Eye Drops
6. Contents
of
the
pack
and
other
information
1. WHAT FUSIDIC ACID EYE DROPS ARE
AND WHAT THEY ARE USED FOR
Fusidic acid Eye Drops belongs to a group
of medicines called antiinfectives. It is a
type of antibiotic.
Fusidic acid Eye Drops works by killing
germs (bacteria) that cause infections.
Fusidic acid Eye Drops is an eye drop
medicine used to treat infections of the
eyes
caused
by
germs
(bacterial
conjunctivitis).
2. WHAT YOU NEED TO KNOW BEFORE
YOU USE FUSIDIC ACID EYE DROPS
DO NOT USE FUSIDIC ACID EYE DROPS
•
If you are allergic to fusidic acid or any
of the other ingredients of this medicine
(listed in section 6).
WARNINGS AND PRECAUTIONS
Talk to your doctor, pharmacist or nurse
before using Fusidic acid Eye Drops
•
Do not use Fusidic acid eye drop for a
long time as the bacteria may no longer
be killed by the antibiotic
•
Do not wear any type of contact lenses
whilst using this medicine
•
Always use Fusidic acid eye drop for
the amount of time your doctor has
instructed you to use it for.
OTHER
MEDICINES
AND
FUSIDIC
ACID
EYE
DROPS
Tell your doctor or pharmacist if you are
using, have recently used or might us

Summary of Product characteristics

OBJECT 1
FUSIDIC ACID 1% VISCOUS EYE DROPS
Summary of Product Characteristics Updated 12-Apr-2018 | Concordia
International - formerly AMCo
1. Name of the medicinal product
Fucithalmic 1% w/w Viscous Eye Drops
Fusidic acid 1% w/w Viscous Eye Drops
2. Qualitative and quantitative composition
Each gram contains fusidic acid, hemihydrate 10mg.
Excipient with known effect: 0.01% w/w benzalkonium chloride
For the full list of excipients, see section 6.1
3. Pharmaceutical form
Sterile viscous eye drops.
4. Clinical particulars
4.1 Therapeutic indications
Fusidic acid eye drops are indicated for the topical treatment of
bacterial conjunctivitis where the
organism is known to be sensitive to the antibiotic.
4.2 Posology and method of administration
Posology:
For all ages: One Fusidic acid drop to be instilled into the eye twice
daily. Treatment should be continued
for at least 48 hours after the eye returns to normal.
Method of administration:
For ophthalmic use only.
4.3 Contraindications
Hypersensitivity to the active substance(s) or to any of the
excipients listed in section 6.1.
4.4 Special warnings and precautions for use
Contact lenses should not be worn/used when Fusidic acid eye drops are
used. The microcrystalline
fusidic acid may cause scratches in the contact lens or cornea.
Contact lenses are kept out until all
symptoms of the infection have gone.
Bacterial resistance has been reported to occur with the use of
fusidic acid. As with all antibiotics,
extended or recurrent use may increase the risk of developing
antibiotic resistance.
Excipients warning:
Fusidic acid eye drops contain benzalkonium chloride, which may cause
eye irritation and discolour soft
contact lenses.
4.5 Interaction with other medicinal products and other forms of
interaction
No interaction studies have been performed. Systemic interactions are
unlikely since systemic exposure
after application of Fusidic acid eye drops is negligible.
4.6 Fertility, pregnancy and lactation
Pregnancy
No effects during pregnancy are anticipated, since systemi