Adverse reactions : תופעות לוואי

4.8 Undesirable effects
Tabulated list of adverse reactions
The following adverse reactions have been reported following administration of DURATEARS eye ointment.
Frequencies cannot be estimated from the available data (not known).
System Organ Classification                 MedDRA Preferred Term (v. 14.1) Nervous system disorders                    Not known: Headache
Eye disorders                               Not known: Eye pain, eye swelling, eye pruritus, ocular discomfort, eye irritation, eye oedema,
foreign body sensation in eyes, ocular hyperaemia,
lacrimation increased, vision blurred.
Description of selected adverse reactions
DURATEARS eye ointment contains Lanolin (Wool Fat) which may cause local skin reactions (e.g. Contact dermatitis).
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. Any suspected adverse events should be reported to the Ministry of Health according to the National Regulation by using an online form: https://sideeffects.health.gov.il