Ketagex 0,25 mg Eye drops, solution

KETAGEX is indicated for the temporary prevention of itching of the eye due to seasonal allergic conjunctivitis. Safety and efficacy beyond 4 weeks have not been established.

Posology
Adults and children (age 3 years and older): Instil one drop into the lower conjunctival sac of the affected eye(s) twice daily, every 8-12 hours and no more than twice per day.
Paediatric population
The safety and efficacy of the use of KETAGEX in children younger than 3 years have not been established.
Method of administration
Contact lenses should be removed before instillation of the eye drops and may be reinserted after 15 minutes (see section 4.4). If more than one topical ophthalmic medicine is being used, they should be administered at least 5 minutes apart, in order to avoid washing out of the medicine. To avoid contamination, do not let the applicator tip touch the surface of the eye, fingers, or any other surface. Replace cap after each use.

Hypersensitivity to ketotifen fumarate or any other ingredients listed in section 6.1.

Use only for ocular instillation.
KETAGEX must not be used:

• if solution changes colour or becomes cloudy
• to treat contact lens related irritation.

No interaction studies have been performed. The use of KETAGEX may potentiate the effects of central nervous system depressants, antihistamines and alcohol.

Pregnancy: There are no adequate data from the use of KETAGEX eye drops in pregnant women. Animal studies using maternally toxic oral doses showed increased pre- and postnatal mortality, but no teratogenicity. Systemic levels after ocular administration are much lower than after oral use. However, the safety of KETAGEX in pregnancy has not been established.
Breastfeeding: Although animal data following oral administration show excretion into breast milk, topical administration to human is unlikely to produce detectable quantities in breast milk. However, the safety of KETAGEX in lactating women has not been established.
Fertility: There are no data available on the effect of KETAGEX on fertility in humans.

Instillation of eye drops may cause transient blurring of vision. Until this has resolved, patients should not drive or use machines.

a. Summary of the safety profile
In controlled clinical studies, conjunctival injection, headaches and rhinitis were reported at an incidence of 10 to 25 %. The occurrence of these side effects was generally mild. Some of these events were similar to the underlying ocular disease being studied.
b. Tabulated list of adverse reactions
Category Frequency Adverse reactions
Ocular Very common (u22651/10) , (10 u2013 25 %) conjunctival injection
Common (u22651/100; <1/10), (less than 5 %) allergic reactions, burning or stinging, conjunctivitis, discharge, dry eyes, eye pain, eyelid disorder, itching, punctate keratitis, punctate corneal epithelial erosion, lacrimation disorder, mydriasis, photophobia, rash
Non-ocular Very common (u22651/10) , (10 u2013 25 %) Headaches, rhinitis
Common (u22651/100; <1/10), (less than 5 %) flu syndrome, pharyngitis, drowsiness
Adverse drug reactions from post-marketing experience (Frequency not known): The following post marketing events have also been observed: hypersensitivity reactions including local allergic reaction (mostly contact dermatitis, eye swelling, eyelid pruritis and oedema), systemic allergic reactions including facial swelling/oedema (in some cases associated with contact dermatitis) and exacerbation of pre-existing allergic conditions such as asthma and eczema.
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]

Oral ingestion of the contents of a 10 ml bottle would be equivalent to 3,45 mg of ketotifen fumarate. Clinical results have shown no serious signs or symptoms after ingestion of up to 20 mg of ketotifen fumarate. In the event of an overdose, treatment should be symptomatic and supportive.