Cromobex 20 mg/ml Eye drops, solution.

Allergic conjunctivitis.

Adults and children: Instil 1 or 2 drops into each eye 4 times daily. It is important that the regular administration of CROMOBEX is maintained in the prevention and treatment of allergic conjunctivitis as therapy is essentially prophylactic.

Hypersensitivity to sodium cromoglycate, benzalkonium chloride or to any of the excipients listed in section 6.1.

The solution should be discarded 1 month after first opening the bottle or if any turbidity develops. CROMOBEX should not be used if the bottle has been opened prior to receipt. Patients should also be instructed that ocular solutions, if handled improperly can become contaminated by common bacteria known to cause ocular infections. Serious damage to the eye and subsequent loss of vision may result from using contaminated solutions. Patients should also be advised that if they develop any intercurrent ocular condition (e.g. trauma, ocular surgery or infection), they should immediately seek their medical practitioneru2019s advice concerning the continued use of CROMOBEX. There have been reports of bacterial keratitis associated with the use of topical ophthalmic products.

Where concomitant steroid and CROMOBEX treatment has rendered it possible to reduce the steroid dose, precautions must be taken to prevent a severe attack if/when CROMOBEX is withdrawn from the treatment regime. CROMOBEX contains benzalkonium chloride. This medicine contains 0,00306 mg benzalkonium chloride in each drop (0,0306 mL) which is equivalent to 0,1 mg/mL. As the possibility of adverse effects on the corneal permeability and the danger of disruption of the corneal epithelium with prolonged or repeated usage of benzalkonium chloride preserved ophthalmological preparations cannot be excluded, regular ophthalmological examination is required. Caution should be exercised in the use of benzalkonium chloride preserved topical medication over an extended period in patients with extensive ocular surface disease. Patients should be monitored in case of prolonged use. Benzalkonium chloride may be absorbed by soft contact lenses and may change the colour of the contact lenses. Soft contact lenses should not be worn during the treatment period. The lenses should be removed before instillation of the drops and not reinserted earlier than 15 minutes after use. Burning or stinging may occur following instillation of the drops.

None known.

Pregnancy: Safety in pregnancy has not been established.
Breastfeeding: It is not known whether sodium cromoglicate is excreted in human breast milk, but based on its physicochemical properties this is considered unlikely. Therefore, caution should be exercised when CROMOBEX eye drops are administered to breastfeeding mothers.
Fertility: It is not known whether sodium cromoglicate has any effect on fertility.

Transient stinging or blurred vision may occur on instillation. Patients should not drive or operate machinery until proper vision is restored.

Immune system disorders: Frequency unknown: anaphylaxis.
Nervous system disorders: Frequency unknown: headache.
Eye disorders: Less frequent: transient stinging and blurring of eyes after installation, eye irritation.
Respiratory, thoracic and mediastinal disorders: Frequency unknown: bronchospasm, breathlessness.
Skin and subcutaneous tissue disorders: Frequency unknown: skin rash.
Reporting of suspected adverse reactions: Reporting suspected adverse reactions after authorisation of CROMOBEX is important. It allows continued monitoring of the benefit/risk balance of CROMOBEX. Health care providers are asked to report any suspected adverse reactions to SAHPRA via the u201c6.04 Adverse Drug Reaction Reporting Formu201d, found online under SAHPRAu2019s publications: https://www.sahpra.org.za/Publications/Index/8

As sodium cromoglicate is absorbed only to a very limited extent from eye drops, no action other than medical observation should be necessary. In the event of accidental ingestion, symptomatic treatment is recommended. If a hypersensitive reaction occurs, withdraw treatment.