Adverse reactions : תופעות לוואי

4.8 Undesirable effects

Summary of safety profile
In clinical studies involving 1680 patients, Olopatadine was administered one to four times daily in both eyes for up to four months as monotherapy or adjunctive therapy to loratadine 10 mg. Approximately 4.5% of patients can be expected to experience adverse reactions associated with the use of Olopatadine ; however, only 1.6% of patients discontinued from the clinical studies due to these adverse reactions. No serious ophthalmic or systemic adverse reactions related to Olopatadine were reported in clinical studies. The most frequent treatment-related adverse reaction was eye pain, reported at an overall incidence of 0.7%.
Tabulated list of adverse reactions
The following adverse reactions have been reported during clinical studies and post-marketing data and are classified according to the following convention: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1000)very rare (<1/10,000) or not known (cannot be estimated from the available data).
Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.


System Organ Classification                     Frequency                Adverse Reactions 
Infections and infestations                     Uncommon                 rhinitis 
Immune system disorders                         Not known                hypersensitivity, swelling face 
Nervous system disorders                        Common                   headache, dysgeusia 
Uncommon                 dizziness, hypoaesthesia

Not known                somnolence
Eye disorders                                 Common                  eye pain, eye irritation, dry eye, abnormal  sensation in eyes

Uncommon                corneal erosion, corneal epithelium defect, corneal epithelium disorder, punctate keratitis, keratitis,
corneal staining, eye discharge, photophobia,
vision blurred, visual acuity reduced,
blepharospasm, ocular discomfort, eye pruritus,
conjunctival follicles, conjunctival disorder, foreign body sensation in eyes, lacrimation increased,
erythema of eyelid, eyelid oedema, eyelid disorder,
ocular hyperaemia

Not known               corneal oedema, eye oedema, eye swelling,
conjunctivitis, mydriasis, visual disturbance, eyelid margin crusting

Respiratory, thoracic, and mediastinal        Common                  nasal dryness disorders
Not known               dyspnoea, sinusitis

Gastrointestinal disorders                    Not known               nausea, vomiting, 
Skin and subcutaneous tissue disorders        Uncommon                dermatitis contact, skin burning sensation, dry skin 
Not known               dermatitis, erythema

General disorders and administration site     Common                  fatigue conditions
Not known               asthenia, malaise

Cases of corneal calcification have been reported very rarely in association with the use of phosphate containing eye drops in some patients with significantly damaged corneas.
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorization 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 http://sideeffects.health.gov.il