Sodium Cromoglicate 2% W/V Eye Drops Solution
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Sodium Cromoglicate 2% w/v Eye Drops, Solution
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml of eye drops contains
Active substance: 20 mg sodium cromoglicate (2.0% w/v), (one drop contains 0.7mg sodium cromoglicate).
Excipient: 0.1mg benzalkonium chloride For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Eye Drops, Solution
Clear colourless to pale yellow solution
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
For the relief and treatment of seasonal and perennial allergic conjunctivitis.
4.2 Posology and method of administration
Ocular use
Adults and Children over 6 years:
One or two drops to be administered into each eye four times daily.
Children under 6 years
There is no relevant indication for use of sodium cromoglicate in children. Sodium cromoglicate is contraindicated in children under 2 years of age.
Elderly
There is no evidence to suggest that dosage alteration is required for elderly patients.
4.3 Contraindications
Hypersensitivity to the active substance or to any of the excipients
4.4 Special warnings and precautions for use
Discard any remaining contents four weeks after opening the bottle.
Sodium cromoglicate eye drops contains benzalkonium chloride.
May cause eye irritation.
Avoid contact with soft contact lenses.
Remove contact lenses prior to application and wait at least 15 minutes before reinsertion.
Known to discolour soft contact lenses.
4.5 Interaction with other medicinal products and other forms of interaction
No interaction studies have been performed.
4.6 Fertility, pregnancy and lactation
Fertility:
It is not known whether sodium cromoglicate has any effect on fertility.
Pregnancy:
As with all medication, caution should be exercised especially during the first trimester of pregnancy. Cumulative experience with sodium cromoglicate suggests that it has no adverse effects on fetal development. It should be used in pregnancy only where there is a clear need.
Lactation:
It is not known whether sodium cromoglicate is excreted in human breast milk but, on the basis of its physicochemical properties, this is considered unlikely. There is no information to suggest the use of sodium cromoglicate has any undesirable effects on the baby.
4.7 Effects on ability to drive and use machines
Sodium cromoglicate may interfere with the ability to drive and use machines.
Instillation of these eye drops may cause a transient blurring of vision. Patients are advised not to drive or operate machinery if affected, until their vision returns to normal.
4.8 Undesirable effects
Eye disorders
Transient stinging and burning may occur after instillation. Other symptoms of local irritation have been reported rarely.
4.9 Overdose
Overdosage is very unlikely. In the event of accidental ingestion, symptomatic treatment is recommended.
5 PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
Pharmacotherapeutic group: , ATC code: under application/pending
The solution exerts its effect locally in the eye.
In vitro and in vivo animal studies have shown that sodium cromoglicate inhibits the degranulation of sensitised mast cells which occurs after exposure to specific antigens. sodium cromoglicate acts by inhibiting the release of histamine and various membrane derived mediators from the mast cell.
Sodium cromoglicate has demonstrated the activity in vitro to inhibit the degranulation of non-sensitised rat mast cells by phospholipase A and subsequent release of chemical mediators. sodium cromoglicate did not inhibit the enzymatic activity of released phospholipase A on its specific substrate.
Sodium cromoglicate has no intrinsic vasoconstrictor or antihistamine activity.
5.2 Pharmacokinetic properties
Sodium cromoglicate is poorly absorbed. When multiple doses of sodium cromoglicate ophthalmic solution are instilled into normal rabbit eyes, less than 0.07% of the administered dose of sodium cromoglicate is absorbed into the systemic circulation (presumably by way of the eye, nasal passages, buccal cavity and gastrointestinal tract). Trace amounts (less than 0.01%) of the sodium cromoglicate does penetrate into the aqueous humour and clearance from this chamber is virtually complete within 24 hours after treatment is stopped.
In normal volunteers, analysis of drug excretion indicates that approximately 0.03% of sodium cromoglicate is absorbed following administration to the eye.
Sodium cromoglicate is not metabolised.
5.3 Preclinical safety data
There are no data of relevance to the prescriber that are not already included elsewhere in the SmPC.
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Disodium edetate
Benzalkonium chloride Water for Injections
6.2 Incompatibilities
Not applicable.
6.3 Shelf life
30 months.
After first opening the bottle: 4 weeks
Discard any remaining solution four weeks after first opening.
6.4 Special precautions for storage
Before first opening the bottle: This medicinal product does not require any special storage conditions
After first opening the bottle: Do not store above 25°C.
6.5 Nature and contents of container
LDPE Blow Fill Seal (BFS) container with white polypropylene spiked screw cap having tamper-proof base ring. LDPE Blow Fill Seal (BFS) container with white polypropylene spiked screw cap having a tamper-proof base ring.
Pack sizes: 1x5ml and 1x10ml
Not all pack sizes may be marketed.
6.6 Special precautions for disposal and other handling
No special requirements
Using the drops for the first time: You must not use the bottle if the tamper-proof base ring with cap is broken before you first use it. These eye drops come in a bottle with a screw cap. The inside of the screw cap contains a spike. The screw cap is fitted to the bottle in such a way that there is no contact between the spike and the top of the bottle. In order to open the bottle it is necessary to tighten the screw cap further, so that the tamper-proof base ring will break. Remove the tamper-proof base ring.
Further, tighten the screw cap so that the edge of the screw cap and the edge of bottle neck are totally aligned. At this point the screw cap spike will pierce the top of the bottle which will open the bottle. Once the bottle has been opened in this way, unscrew the screw cap fully to remove it from the bottle and apply the eye drops.
MARKETING AUTHORISATION HOLDER
Brown & Burk UK Ltd 5, Marryat Close Hounslow West Middlesex TW4 5DQ UK
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MARKETING AUTHORISATION NUMBER(S)
PL 25298/0033
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
29/03/2012
DATE OF REVISION OF THE TEXT
13/05/2013