Vividrin 20 mg EYE DROPS.

Allergic conjunctivitis.

Posology
For adults and children: 1-2 drops into each eye 4 times daily. Since therapy with sodium cromoglycate is essentially prophylactic, it is important to instruct patients to maintain regular dosage.

Hypersensitivity to the active substance sodium cromoglicate 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. Do not use if the bottle has been opened prior to receipt. Where concomitant steroid and sodium cromoglicate treatment has rendered it possible to reduce the steroid dose, precautions must be taken to prevent a severe attack if/when sodium cromoglicate is withdrawn from the treatment regime.
VIVIDRIN EYE DROPS contains benzalkonium chloride This medicinal product contains 0,00306 mg benzalkonium chloride in each drop (0,0306 ml) which is equivalent to 0,1 mg/ml.
Benzalkonium chloride may be absorbed by soft contact lenses and may change the colour of the contact lenses. Patients should remove contact lenses before using this medicine and put them back 15 minutes afterwards. Benzalkonium chloride has been reported to cause eye irritation, symptoms of dry eyes and may affect the tear film and corneal surface. VIVIDRIN EYE DROPS 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.

None known.

Safety in pregnancy has not been established.

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

Transient stinging and blurring may occur after instillation, other symptoms of local irritation have been reported rarely. Side effects in hypersensitive persons may include headache, skin rash, bronchospasm, breathlessness, anaphylaxis.
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicine is important. It allows continued monitoring of the benefit-risk of the medicine. Health care providers are asked to report any suspected adverse reactions to SAHPRA via the u201c6.04 Adverse Drug Reactions Reporting Formu201d, found online under SAHPRAu2019s publications: https://www.sahpra.org.za/Publications/Index/8 Suspected adverse reactions may also be reported directly to the Holder of the Certificate of registration using the following e-mail address: [email protected]

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.