Sodium Cromoglicate 2% w/v Eye drops, solution

Each ml of eye drops solution contains 20 mg of sodium cromoglicate.

Excipients with known effect

0.1 mg of benzalkonium chloride per ml of eye drops solution.

For the full list of excipients, see section 6.1.

Eye drops, solution (eye drops)

Sterile, clear, colourless to pale yellow solution without visible particulates.

For the prophylaxis and symptomatic treatment of acute allergic conjunctivitis, chronic allergic conjunctivitis and vernal kerato conjunctivitis.

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.

Hypersensitivity to the active substance(s) or to any of the excipients listed in section 6.1.

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.

This medicinal product contains 0.1mg benzalkonium chloride in each ml.

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.

No interaction studies have been performed.

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.

Breast-feeding

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

There are no fertility data available.

As with all eye drops, 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.

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.

No action other than medical observation should be necessary.

Pharmacotherapeutic group: Ophthalmologicals; Other antiallergics, ATC code: S01GX01

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.

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.

None stated.

Benzalkonium chloride

Disodium edetate

Water for injection

None known.

3 years.

The eye drops should be used within 4 weeks of opening the container. Any remaining after this time should be discarded.

Store below 30°C.

Store in the original package in order to protect from light.

Low Density Polyethylene (LDPE) bottles with a dropper 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.

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.

Neon Healthcare Ltd.

8 The Chase

John Tate Road, Hertford

SG13 7NN

United Kingdom

PL 45043/0133

26/04/2021

08/01/2024