Summary of Product Characteristics (SmPC) - Sodium Cromoglicate 2% w/v eye drops solution
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 20 mg of sodium cromoglicate (one drop contains approximately 0.48 mg sodium cromoglicate).
Excipients with known effect
0.1 mg of benzalkonium chloride per ml of eye drops.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Eye drops, solution (eye drops)
Sterile, clear, colourless to pale yellow solution.
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
For the prophylaxis and symptomatic treatment of acute allergic conjunctivitis, chronic allergic conjunctivitis and vernal kerato conjunctivitis.
4.2 Posology and method of administration
Posology
Adults and children: one or two drops into each eye four times daily or as indicated by the doctor.
Elderly: no current evidence for alteration of the dose.
Method of administration
Ocular use.
4.3 Contraindications
Hypersensitivity to the active substance(s) 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. This medicine contains benzalkonium chloride
As with other ophthalmic solutions containing benzalkonium chloride, soft contact lenses should not be worn during treatment period.
From the limited data available, there is no difference in the adverse event profile in children compared to adults.
Generally, however, eyes in children show a stronger reaction for a given stimulus than the adult eye. Irritation may have an effect on treatment adherence in children. Benzalkonium chloride has been reported to cause eye irritation, symptoms of dry eyes and may affect the tear film and corneal surface. Should be used with caution in dry eye patients and in patients where the cornea may be compromised. Patients should be monitored in case of prolonged use.
4.5 Interaction with other medicinal products and other forms of interaction
No interaction studies have been performed.
4.6 Fertility, Pregnancy and lactation
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 clinical 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.
Fertility
It is not known whether sodium cromoglicate has any effect on fertility.
4.7 Effects on ability to drive and use machines
Instillation of Sodium Cromoglicate 2% w/v Eye drops, solution may cause a transient blurring of vision or local irritation that could impact driving or operating machinery. Do not drive or operate machinery if affected.
4.8 Undesirable effects
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 or search for ‘MHRA Yellow Card’ in the Google Play or Apple App Store.
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: Ophthalmologicals; Other antiallergics, ATC code: S01GX01
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
None stated.
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Benzalkonium chloride
Disodium edetate
Water for injection
6.2 Incompatibilities
None known.
6.3 Shelf life
3 years
The eye drops should be used within 4 weeks of opening the container. Any remaining after this time should be discarded.
6.4 Special precautions for storage
Store below 30°C.
Store in the original package in order to protect from light.
6.5 Nature and contents of container
Low Density Polyethylene (LDPE) bottle with a nozzle and a tamper evident Polypropylene (PP) screw cap. Each bottle contains 10 ml or 13.5 ml of the medicinal product.
Not all pack sizes may be marketed.
6.6 Special precautions for disposal
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
7 MARKETING AUTHORISATION HOLDER
Neon Healthcare Ltd.
8 The Chase
John Tate Road, Hertford
SG13 7NN
United Kingdom
8 MARKETING AUTHORISATION NUMBER(S)
PL 45043/0133
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
26/04/2021
10 DATE OF REVISION OF THE TEXT
08/01/2024