AZYTER

Posology Adult population Instil one drop in the conjunctival fornix twice a day, morning and evening, during three days. It is unnecessary to prolong treatment beyond three days. Adherence to the dosing regimen is important for the success of treatment.

Elderly patients No dose adjustment is necessary. 1). Method of administration Ocular use. The patient should be advised to: - thoroughly wash hands before and after the instillation, - avoid touching the eye or eyelids with the dropper tip of the single-dose container, - discard the single-dose container after use, and not keep it for subsequent use.

During clinical trials and according to post-marketing safety data on Azyter eye drops solution, the following treatment-related signs and symptoms were reported: Immune system disorders Uncommon (≥1/1000, <1/100) Angioedema*, hypersensitivity.

Eye disorders Very common (≥1/10) Ocular discomfort (pruritus, burning, stinging) upon instillation. Common (≥1/100, <1/10) Blurred vision, sticky eye sensation, foreign body sensation upon instillation. Uncommon (≥1/1000, <1/100) Conjunctivitis*, allergic conjunctivitis*, keratitis*, eczema eyelids*, eyelid oedema*, eye allergy*, conjunctival hyperemia, lacrimation increased upon instillation, erythema of the eyelid.

Skin and subcutaneous tissue disorders Not known (cannot be estimated from the available data) Toxic epidermal necrolysis#, drug reaction with eosinophilia and systemic symptoms#, Stevens-Johnson syndrome#, dermatitis exfoliative#, acute generalised exanthematous pustulosis (AGEP)# * adverse event has not been observed during clinical studies with Azyter.

Inclusion of adverse event is based on post-marketing data. The frequency has been assigned based on 3/X, with X representing the total sample size summed up across all relevant clinical trials and studies, which is 3/879 resulting in “uncommon”.

# by extrapolation of systemic exposure Paediatric population In paediatric clinical trials, the safety profile was similar to that in adults and no new adverse events were identified. 1). 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. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

The eye drops solution should not be injected or be swallowed. The eye drops solution should not be used for peri- or intra-ocular injection. In the event of an allergic reaction, the treatment should be discontinued. The patient should be informed that it is not necessary to continue to instil the eye drops solution after the end of treatment on the third day, even if residual signs of bacterial conjunctivitis remain.

Symptomatic relief occurs generally within 3 days. If there are no signs of improvement after 3 days, diagnosis should be reconsidered. Contact lenses should not be worn by patients with bacterial conjunctivitis. With the systemic use of azithromycin cases of fulminant hepatitis potentially leading to life-threatening liver failure have been reported.

2). Hypersensitivity As with erythromycin and other macrolides, rare serious allergic reactions, including angioneurotic oedema and anaphylaxis (rarely fatal), dermatologic reactions including acute generalised exanthematous pustulosis (AGEP), Stevens Johnson syndrome (SJS), toxic epidermal necrolysis (TEN) (rarely fatal) and drug reaction with eosinophilia and systemic symptoms (DRESS) have been reported.

Some of these reactions with azithromycin have resulted in recurrent symptoms and required a longer period of observation and treatment. If an allergic reaction occurs, the drug should be discontinued and appropriate therapy should be instituted.

Physicians should be aware that reappearance of the allergic symptoms may occur when symptomatic therapy is discontinued. Paediatric population Regarding the treatment of trachomatous conjunctivitis, comparative safety and efficacy studies have not been performed with Azyter 15 mg/g eye drops in children younger than one year, but there are no known safety concerns or differences in disease process to exclude its use in children less than one year old in this indication taking into account clinical experience in children older than one year of age in the treatment of trachomatous conjunctivitis and considering Azyter experience in children from birth in the treatment of purulent bacterial conjunctivitis.

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