Fucithalmic 1% eye drops
Country: United Kingdom
Language: English
Source: MHRA (Medicines & Healthcare Products Regulatory Agency)
Patient Information leaflet
(PIL)
06-11-2018
Summary of Product characteristics
(SPC)
06-06-2018
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: 5702191002041
Patient Information leaflet
Page 1 of 2
PACKAGE LEAFLET: INFORMATION FOR THE USER
FUCITHALMIC
® EYE DROPS
(fusidic acid)
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 Fucithalmic Eye Drops but it will be
referred to as Fucithalmic in
the rest of the leaflet.
WHAT IS IN THIS LEAFLET:
1.
WHAT FUCITHALMIC IS AND WHAT IT IS USED FOR
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE FUCITHALMIC
3.
HOW TO USE FUCITHALMIC
4.
POSSIBLE SIDE EFFECTS
5.
HOW TO STORE FUCITHALMIC
6.
CONTENTS OF THE PACK AND OTHER INFORMATION
1.
WHAT FUCITHALMIC IS AND WHAT IT IS USED FOR
Fucithalmic belongs to a group of medicines called anti-infectives. It
is a type of antibiotic.
Fucithalmic works by killing germs (bacteria) that cause infections.
Fucithalmic 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 FUCITHALMIC
DO NOT USE FUCITHALMIC
•
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 Fucithalmic
•
Do not use Fucithalmic 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 Fucithalmic for the amount of time your doctor has
instructed you to use it for.
OTHER MEDICINES AND FUCITHALMIC
Tell your doctor or pharmacist if you are using, have recently used or
might use any other
medicines. This include
Read the complete document
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
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