Adverse reactions : תופעות לוואי

4.8   Undesirable effects

In clinical studies, over 1,400 patients have been treated with preserved tafluprost either as monotherapy or as adjunctive therapy to timolol 0.5%. The most frequently reported treatment-related adverse event was ocular hyperaemia. It occurred in approximately 13% of the patients participating in clinical studies with preserved tafluprost in Europe and the US. It was mild in most cases and led to discontinuation on an average in 0.4% of patients participating in the pivotal studies. In a 3-month, phase III study in the US comparing the non-preserved formulation of tafluprost with the non-preserved timolol formulation, ocular hyperemia occurred in 4.1% (13/320) of patients treated with tafluprost.

The following undesirable effects related to treatment were reported during clinical trials with tafluprost in Europe and the US after a maximum follow-up of 24 months: Within each frequency grouping, adverse reactions are presented in order of decreasing frequency.

Nervous system disorders

Common (≥1/100 to <1/10): headache
Eye disorders

Common (≥1/100 to <1/10): eye pruritus, eye irritation, eye pain, conjunctival/ocular hyperaemia, changes in eyelashes (increased length, thickness and number of lashes), dry eye, foreign body sensation in eyes, eyelash discolouration, erythema of eye lid, superficial punctate keratitis (SPK), photophobia, increased lacrimation, blurred vision, reduced visual acuity and increased iris pigmentation.

Uncommon (≥1/1,000 to <1/100): blepharal pigmentation, eyelid oedema, asthenopia, conjunctival oedema, eye discharge, blepharitis, anterior chamber cells, ocular discomfort, anterior chamber flare, conjunctival pigmentation, conjunctival follicles, allergic conjunctivitis and abnormal sensation in eye.

Not known (cannot be estimated from the available data): iritis/uveitis, lid sulcus deepened macular oedema/cystoid macular oedema

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.

Respiratory, thoracic, and mediastinal disorders
Not known (cannot be estimated from the available data): exacerbation of asthma, dyspnea.

Skin and subcutaneous tissue disorders

Uncommon (≥1/1,000 to <1/100): hypertrichosis of eyelid
.

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