Adverse reactions : תופעות לוואי

4.8 Undesirable effects
Summary of safety profile
In clinical studies involving 1680 patients, PATANOL 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 PATANOL; 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 PATANOL 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,
PAT API MAY21 V3                                                                                EU update 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          Common             nasal dryness mediastinal disorders               Not known          dyspnoea, sinusitis Gastrointestinal disorders          Not known          nausea, vomiting, Skin and subcutaneous tissue        Uncommon           dermatitis contact, skin burning disorders                                              sensation, dry skin Not known          dermatitis, erythema
General disorders and               Common             fatigue administration site 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://sideeffecs.health.gov.il