The most common undesirable reactions from the side of the organ of vision are allergic conjunctivitis, hyperemia of the conjunctiva, itching of the mucous membrane of the eyes and skin of the eyelids. Most of the undesirable reactions were of a rapidly passing character and a mild severity (not requiring discontinuation of treatment).
According to clinical Research Symptoms allergic reactions from the eyes were observed in 12.7 % cases (being the reason for termination of treatment in 11.5% of cases), while in most patients they were manifested after 3-6 months of application (according to the current information about the experience of using Alfagan in a concentration of 0.2%).
The incidence of adverse events observed during the study was evaluated as follows: very often (> 10%), often (> 1% and <10%); infrequently (> 0.1% and <1%), rarely (> 0.01% and <0.1%).
In clinical studies of the drug ALFAGAN® P, the following side effects were identified:
From the side of the organ of vision: very often - allergic conjunctivitis, congestion hyperemia, itching of the mucous membrane of the eyes and eyelid skin, blurring of vision; often burning sensation, conjunctival follicles or follicular conjunctivitis, local allergic reactions from the eyes (including keratoconjunctivitis), visual impairment, blepharitis, blepharoconjunctivitis, cataract, conjunctival edema, hemorrhage in the eye conjunctivitis, conjunctivitis, retinal lacrimation, epiphora, mucous discharge from the eyes, dryness and irritation of the eye mucosa, eye pain, eyelid edema, redness of the eyelids, foreign body sensation in the eyes, keratitis, eyelid lesions, photosensitivity, stitching in the eye, superficial keratopathy, lacrimation , loss of vision, vitreous detachment, vitreous hemorrhage, floating opacities in the vitreous body and reduced visual acuity; infrequently - corneal erosion, barley;
From the central nervous system: often - headache, drowsiness, insomnia, dizziness;
From the side of the cardiovascular system: often - increase or decrease in blood pressure;
On the part of the respiratory system: often - bronchitis, pharyngitis, cough, shortness of breath; infrequently - dryness of the nasal mucosa; apnea;
From the gastrointestinal side tract: often - gastrointestinal disorders - dyspepsia, dryness of the oral mucosa;
From the skin and subcutaneous fat: often - rash; Infectious and parasitic diseases: often - flu-like syndrome, infectious disease (chills and respiratory infection), rhinitis, sinusitis, incl. infectious; Laboratory indicators: often - hypercholesterolemia.
Other: often - general allergic reactions, asthenia, fatigue, taste disorder; infrequently perversion of taste.
In children (including newborn and infants): apnea, bradycardia, decrease in blood pressure (BP), hypothermia, muscle hypotension, pallor, drowsiness, decreased attention.
Separate serious side reactions such as coma, lethargy and respiratory depression in a newborn and infants, those. at an age in which the use of the drug is not approved, were observed when the drug was used at a concentration of 0.2%, exceeding the concentration of the drug.
In the postmarketing period, additional reports of the following side effects were received:
From the side of the organ of vision: frequency unknown - iritis, dry keratoconjunctivitis, miosis;
From the central nervous system: depression, syncope;
From the side of the cardiovascular system: bradycardia, tachycardia;
From the gastrointestinal tract: nausea;
From the skin and subcutaneous fat: local skin reactions (erythema, itchy eyelids, face swelling, rash and vasodilation of the skin of the eyelids and face), hypersensitivity.