Fucithalmic 10mg/g viscous eye drops suspension

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

FUSIDIC ACID

Available from:

Amdipharm Limited Temple Chambers, 3 Burlington Road, Dublin 4, Ireland

ATC code:

S01AA13

INN (International Name):

FUSIDIC ACID 1 % (W/W)

Pharmaceutical form:

EYE DROPS, SUSPENSION

Composition:

FUSIDIC ACID 1 % (W/W)

Prescription type:

POM

Therapeutic area:

OPHTHALMOLOGICALS

Authorization status:

Authorised

Authorization date:

2005-01-19

Patient Information leaflet

Package leaflet: Information for the user
Fucithalmic
®
10 mg/g Viscous Eye Drops, Suspension
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
®
10 mg/g Viscous Eye Drops, Suspension 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 antibiotics.
The antibiotic in this product is called fusidic acid.
It works by killing germs (bacteria) that cause infections.
Fucithalmic is an eye drop medicine used to treat eye infections
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 wear any type of contact lenses while using this medicine.
• Do not use Fucithalmic for a long time as the bacteria may no
longer be killed by the
antibiotic.
• 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, or have recentl

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT
Fucithalmic 10mg/g Viscous Eye Drops, Suspension
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Contains 1 % w/w fusidic acid anhydrous (as the hemihydrate).
Excipient with known effect:
contains 0.011% w/w benzalkonium chloride.
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Eye drops, suspension (eye drops)
A white to off-white viscous suspension.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Treatment of ocular infection due to sensitive organisms.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology:
One drop of Fucithalmic viscous eye drop, should be applied to the
conjunctival sac every 12
hours. Treatment should be continued for 2 days after the eye appears
normal.
Method of administration:
For ophthalmic use only.
Direction for use for administration:
1.
As with any eye preparation, wash your hands before you administer
Fucithalmic viscous
eye-drops.
2.
Remove the cap from the tube. To administer Fucithalmic viscous
eye-drops, stand or sit
comfortably and tilt your head backwards. Hold the tube above your
eye.
3.
Gently pull down your lower eyelid and squeeze one drop from the tube
into your lower
eyelid as shown in the picture. You may find a mirror useful when
administering the drops.
4.
Be careful not to touch the tip of the tube to your eye or other
surface, so as to avoid
contamination of tube contents.
5.
Fucithalmic viscous eye-drops comes out of the tube as a single
viscous drop, which
quickly turns to liquid in your eye.
6.
If the drops are for children, you may put the drops in their eyes
when they are lying down
or asleep.
4.3 CONTRAINDICATIONS
Hypersensitivity to the active substance or to any of the excipients
listed in section 6.1.
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Bacterial resistance has been reported to occur with the use of
fusidic acid. As with all antibiotics,
extended or recurrent use of fusidic acid may increase the risk of
developing antibiotic resistance.
Contact lenses should