Summary of Product Characteristics (SmPC) - Cromolux 2% eye drops
1 NAME OF THE MEDICINAL PRODUCT
Cromolux 2% Eye Drops
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each one ml of solution contains 20 mg of Sodium Cromoglicate.
Pack size: 13.5 ml.
For excipients, see section 6.1
3 PHARMACEUTICAL FORM
Eye drops solution
A clear, colourless solution
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
Cromolux 2% Eye drops are indicated for the prophylaxis and symptomatic treatment of acute allergic conditions such as hay fever, chronic allergic conjunctivitis and vernal kerato conjunctivitis. Sodium cromoglicate inhibits mediator release from sensitised mast cells in the allergic response.
4.2 Posology and method of administration
Adults (including elderly) and children: One or two drops in each eye four times daily
4.3 Contraindications
Sodium cromoglicate eye drops are contraindicated in patients with sensitivity to any ingredient, including sodium cromoglicate, benzalkonium chloride and sodium edetate.
4.4 Special warnings and precautions for use
Soft contact lenses should not be worn during treatment.
Sodium cromoglicate is to be used prophylactically. Therefore patients should be advised not to discontinue use of the product unless advised to do so.
4.5 Interaction with other medicinal products and other forms of interaction
None Known
4.6 Pregnancy and lactation
As with all medications during pregnancy, this product should be used with caution especially during the first trimester. There do not appear to be foetal abnormalities in toxicity studies, but this should not mitigate the care to be used with this product. The product should therefore only be used in pregnancy where there is a clear need.
There is no information to indicate that the use of sodium cromoglicate has any undesirable effects on the baby.
It is unlikely that this product would be excreted in breast milk but this has not been fully investigated
4.7 Effects on ability to drive and use machines
Instillation of drops may cause transient alteration of vision. Patients should be advised not to drive or operate machinery until clarity of vision is restored.
4.8 Undesirable effects
Stinging, blurring of vision and burning may occur briefly after instillation, as may local irritation.
4.9 Overdose
Sodium cromoglicate is poorly absorbed through the gastrointestinal tract. In cases of overdosage, no action other than medical observation should be necessary.
5 PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
Both in-vitro and in-vivo studies suggest that sodium cromoglicate prevents the release of granules that produce allergen-mediated inflammatory reaction in the eye. Sodium cromoglicate appears to inhibit reactions caused by both antigenic and non antigenic stimuli. Sodium cromoglicate has no intrinsic antihistaminic or anti-inflammatory action. Evidence suggests that the effects of the drug may be due to mast cell membrane stabilisation, although the precise mechanism is not known.
5.2 Pharmacokinetic properties
Sodium cromoglicate is poorly absorbed from the gastrointestinal tract, with less than 1% being made available by this route.
Systemically absorbed sodium cromoglicate is not metabolised and drug is excreted unchanged in the bile and urine. The drug does not cross the blood- brain barrier.
5.3 Preclinical safety data
There is no published information on either mutagenicity or carcinogenicity testing with this drug.
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Benzalkonium Chloride
Disodium Edetate
Purified Water
6.2 Incompatibilities
None known
6.3 Shelf life
3 years unopened.
28 days once opened.
6.4 Special precautions for storage
Do not store above 25º C.
6.5 Nature and contents of container
Bottle and tip are made of low density Polyethylene with white coloring.
Pack size 13.5 ml.
6.6 Special precautions for disposal
None
7 MARKETING AUTHORISATION HOLDER
Bausch & Lomb (UK) Ltd
Bausch &Lomb House
106 London Road
Kingston-Upon-Thames
Surrey KT2 6TN
UK
8 MARKETING AUTHORISATION NUMBER(S)
PL 03468/0022
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
29/09/2008
10 DATE OF REVISION OF THE TEXT
29/09/2008