SAFLUTAN

Posology The recommended dose is one drop of SAFLUTAN in the conjunctival sac of the affected eye(s) once daily in the evening. The dose should not exceed once daily as more frequent administration may lessen the intraocular pressure lowering effect.

For single use only, one container is sufficient to treat both eyes. Any unused solution should be discarded immediately after use. Use in elderly No dosage alteration in elderly patients is necessary. Paediatric population The safety and efficacy of tafluprost in children below age 18 has not yet been established.

No data are available. Use in renal/hepatic impairment Tafluprost has not been studied in patients with renal/hepatic impairment and should therefore be used with caution in such patients. Method of administration To reduce the risk of darkening of the eyelid skin the patients should wipe off any excess solution from the skin.

As with any other eye drops, nasolacrimal occlusion or gently closing the eyelid after administration is recommended. This may reduce the systemic absorption of medicinal products administered via the ocular route. If more than one topical ophthalmic medicinal product is being used, each one should be administered at least 5 minutes apart.

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. 4% of patients participating in the pivotal studies.

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 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 of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.

Before treatment is initiated, patients should be informed of the possibility of eyelash growth, darkening of the eyelid skin and increased iris pigmentation. Some of these changes may be permanent, and may lead to differences in appearance between the eyes when only one eye is treated.

The change in iris pigmentation occurs slowly and may not be noticeable for several months. g. blue-brown, grey-brown, yellow-brown and green-brown. The risk of lifelong heterochromia between the eyes in unilateral cases is obvious. There is a potential for hair growth to occur in areas where tafluprost solution comes repeatedly in contact with the skin surface.

There is no experience with tafluprost in neovascular, angle-closure, narrow-angle or congenital glaucoma. There is only limited experience with tafluprost in aphakic patients and in pigmentary or pseudoexfoliative glaucoma. Caution is recommended when using tafluprost in aphakic patients, pseudophakic patients with torn posterior lens capsule or anterior chamber lenses, or in patients with known risk factors for cystoid macular oedema or iritis/uveitis.

There is no experience in patients with severe asthma. Such patients should therefore be treated with caution.

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