OPTILAST Eye drops Ref.[6238] Active ingredients: Azelastine

Optilast is not intended for treatment of eye infections. Further warnings see 4.5 and 4.6.

Optilast eye drops contains the preservative benzalkonium chloride. Benzalkonium chloride may cause eye irritation, especially with dry eyes or disorders of the cornea. Contact with soft contact lenses should be avoided. Contact lenses should be removed prior to application and the patient should wait at least 15 minutes before reinsertion. Known to discolour soft contact lenses.

No specific interaction studies with Optilast have been performed.

Interaction studies at high oral doses of Azelastine have been performed however they bear no relevance to Optilast, as systemic levels, after administration of the eye drops, are in the picogram range.

Fertility

Effects on human fertility have not been investigated

Pregnancy

There is insufficient information available to establish the safety of azelastine in human pregnancy. At high oral doses azelastine has shown to induce adverse effects (foetal death, growth retardation and skeletal malformation) in experimental animals. Local ocular application will result in minimal systemic exposure (picogram range). However, caution should be exercised when using Optilast during pregnancy.

Breast feeding

Azelastine is excreted into the milk in low quantities. For that reason Optilast is not recommended during lactation.

The mild, transient irritation which can be experienced after application of Optilast is unlikely to affect vision to any greater extent. However, if there are any transient effects on vision, the patient should be advised to wait until this clears before driving or operating machinery.

The assessment of undesirable effects is based on the following frequencies:

Very common (≥1/10)
Common (≥1/100 to <1/10)
Uncommon (≥1/1,000 to <1/100)
Rare (≥1/10,000 to <1/1,000)
Very rare (<1/10,000)
Not known (cannot be estimated from the available data)

Immune system disorders

Very rare: Allergic reactions (such as rash and pruritus).

Nervous system disorders

Uncommon: Bitter taste

Eye disorders

Common: Mild, transient irritation in the eye

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.

None known.