Sodium Cromoglicate 2% W/V Eye Drops
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).
Excipients with known effect: 0.1mg benzalkonium chloride For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Eye Drops, Solution
A clear colourless to pale yellow solution for administration to the eye.
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
For the prophylaxis and symptomatic treatment of acute allergic conjunctivitis, chronic allergic conjunctivitis and vernal keratoconjunctivitis.
4.2 Posology and method of administration
Ocular use
Adults and Children:
One or two drops to be administered into each eye four times daily or as indicated by the doctor.
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 listed in section 6.1.
4.4 Special warnings and precautions for use
Discard any remaining contents four weeks after opening the bottle.
As with other ophthalmic solutions containing Benzalkonium chloride, soft contact lenses should not be worn during treatment period.
4.5 Interaction with other medicinal products and other forms of interaction
No interaction studies have been performed.
4.6 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 foetal 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 has a minor influence on the ability to drive and use machines.
As with all eye drops, 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.
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/ risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.
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: Opthalmologicals; Other antiallergics, ATC code: SO1GX01
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.
5.3 Preclinical safety data
None stated.
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
Low density polyethylene (LDPE) bottle with a low density polyethylene/ high density polyethylene tamper proof cap containing either 5ml or 10ml of solution.
LDPE bottle with a HDPE tamper proof cap containing 13.5ml of solution.
Pack sizes: 1x5ml, 1x10ml and 1 x 13.5ml
Not all pack sizes may be marketed.
6.6 Special precautions for disposal
No special requirements
Before using the medication for the first time, be sure that the tamper-proof seal on the bottle neck is unbroken. A gap between the bottle and the cap is normal for an unopened bottle.
7 MARKETING AUTHORISATION HOLDER
Aspire Pharma Ltd
Unit 4 Rotherbrook Court
Bedford Road
Petersfield
Hampshire
GU32 3QG
United Kingdom
8 MARKETING AUTHORISATION NUMBER(S)
PL 35533/0032
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
22/08/2014
10
DATE OF REVISION OF THE TEXT
23/09/2016