Adverse reactions : תופעות לוואי

4.8 Undesirable effects

TRUSOPT was evaluated in more than 1400 individuals in controlled and uncontrolled clinical studies. In long-term studies of 1108 patients treated with TRUSOPT as monotherapy or as adjunctive therapy with an ophthalmic beta- blocker, the most frequent cause of discontinuation (approximately 3%) from treatment with TRUSOPT was drug- related ocular adverse reactions, primarily conjunctivitis and lid reactions.

The following adverse reactions have been reported either during clinical trials or during post-marketing experience with dorzolamide:
[Very common: (≥ 1/10), Common: (≥ 1/100 to <1/10), Uncommon: (≥ 1/1,000 to <1/100), Rare: (≥ 1/10,000 to <1/1,000), Not known: (cannot be estimated from the available data)]
Nervous system disorders:
Common: headache
Rare: dizziness, paraesthesia
Eye disorders:
Very common: burning and stinging
Common: superficial punctate keratitis, tearing, conjunctivitis, eyelid inflammation, eye itching, eyelid irritation, blurred vision
Uncommon: iridocyclitis
Rare: irritation including redness, pain, eyelid crusting, transient myopia (which resolved upon discontinuation of therapy), corneal oedema, ocular hypotony, choroidal detachment following filtration surgery Not known: foreign body sensation in eye
Cardiac disorders:
Not known: palpitations, tachycardia
Vascular disorders:
Not known: hypertension
Respiratory, thoracic, and mediastinal disorders:
Rare: epistaxis
Not known: dyspnoea
Gastrointestinal disorders:
Common: nausea, bitter taste
Rare: throat irritation, dry mouth
Skin and subcutaneous tissue disorders:
Rare: contact dermatitis, Stevens-Johnson syndrome, toxic epidermal necrolysis Renal and urinary disorders:
Rare: urolithiasis
General disorders and administration site conditions:
Common: asthenia/fatigue
Rare: hypersensitivity: signs and symptoms of local reactions (palpebral reactions) and systemic allergic reactions, including angioedema, urticaria and pruritus, rash, shortness of breath, rarely bronchospasm Investigations:
Dorzolamide was not associated with clinically meaningful electrolyte disturbances.
Reporting 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/