Exocin 0.3% eye drops

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Ofloxacin

Available from:

AbbVie Ltd

ATC code:

S01AE01

INN (International Name):

Ofloxacin

Dosage:

3mg/1ml

Pharmaceutical form:

Eye drops

Administration route:

Ocular

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 11030100; GTIN: 5016007408331

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
EXOCIN
®
0.3% w/v
Eye drops, solution
Ofloxacin
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE.
•
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. Do not pass it on to
others. It may
harm them, even if their symptoms are the same as yours.
•
If any of the side effects gets serious, or if you notice any side
effects not listed in
this leaflet, please tell your doctor or pharmacist
IN THIS LEAFLET:
1.
WHAT EXOCIN IS AND WHAT IT IS USED FOR
2.
BEFORE YOU USE EXOCIN
3.
HOW TO USE EXOCIN
4.
POSSIBLE SIDE EFFECTS
5.
HOW TO STORE EXOCIN
6.
FURTHER INFORMATION
1.
WHAT EXOCIN IS AND WHAT IT IS USED FOR
EXOCIN is an eye-drop used to treat external eye infections such as
some types of
conjunctivitis.
EXOCIN belongs to a group of medicines called 4-quinolone
antibacterial agents.
EXOCIN IS NOT RECOMMENDED FOR USE IN INFANTS BELOW THE AGE OF ONE
YEAR.
2. BEFORE YOU USE EXOCIN
DO NOT USE EXOCIN
•
If you are
ALLERGIC
(hypersensitive) to OFLOXACIN
, BENZALKONIUM CHLORIDE,
any of
the other ingredients, or any other quinolones.
TAKE SPECIAL CARE WITH EXOCIN
This product should be used with caution in patients sensitive to
other quinolone
antibacterial agents.
Long term use may result in a new bacterial infection which does not
respond to
EXOCIN.
This product should be used with caution in patients with a defect or
ulceration of the
surface of the eye.
EXOCIN potentially increases sensitivity to sunlight. You should avoid
exposure to
direct sunlight or sun during use of EXOCIN.
HEART PROBLEMS:
Caution should be taken when using this kind of medicine, if you were
born with or
have family history of prolonged QT interval (seen on ECG, electrical
recording of
the heart), have salt imbalance in the blood (especially low level of
potassium or
magnesium in the blood), have a very slow heart rhythm (called
‘bradycardia’), have a
weak heart (heart

Summary of Product characteristics

OBJECT 1
EXOCIN
Summary of Product Characteristics Updated 27-Apr-2016 | Allergan Ltd
1. Name of the medicinal product
EXOCIN
®
3 mg/ml Eye Drops, Solution.
2. Qualitative and quantitative composition
One millilitre contains 3 mg ofloxacin.
For a full list of excipients, see section 6.1.
3. Pharmaceutical form
Eye drops, solution.
Clear, pale to light yellow-green solution, practically free from
visible particles.
4. Clinical particulars
4.1 Therapeutic indications
EXOCIN
®
is indicated for the topical treatment of external ocular infections
(such as conjunctivitis and
keratoconjunctivitis) in adults and children caused by ofloxacin -
sensitive organisms. Safety and efficacy
in the treatment of ophthalmia neonatorum has not been established.
4.2 Posology and method of administration
Topical ocular instillation.
For all ages: one to two drops in the affected eye(s) every two to
four hours for the first two days and then
four times daily. The length of treatment should not exceed ten days.
4.3 Contraindications
EXOCIN
®
is contra-indicated in individuals who have shown hypersensitivity to
ofloxacin, any of its
excipients or any other quinolones.
4.4 Special warnings and precautions for use
EXOCIN
®
is not for injection.
Safety and effectiveness in infants below the age of one year have not
been established.
Serious and occasionally fatal hypersensitivity
(anaphylactic/anaphylactoid) reactions, some following
the first dose, have been reported in patients receiving systemic
quinolones, including ofloxacin. Some
reactions were accompanied by cardiovascular collapse, loss of
consciousness, angioedema (including
laryngeal, pharyngeal or facial oedema), airway obstruction, dyspnoea,
urticaria, and itching.
If an allergic reaction to EXOCIN
®
occurs, discontinue the drug. Use EXOCIN
®
with caution in patients
who have exhibited sensitivities to other quinolones antibacterial
agents.
When using EXOCIN
®
the risk of rhinopharyngeal passage which can contribute to the
occurrence and
the diffusion of bacterial resista