Special Warning : אזהרת שימוש

4.4     Special warnings and precautions for use

Eye colour change

TRAVATAN may gradually change the eye colour by increasing the number of melanosomes (pigment granules) in melanocytes. Before treatment is instituted, patients must be informed of the possibility of a permanent change in eye colour. Unilateral treatment can result in permanent heterochromia. The long- term effects on the melanocytes and any consequences thereof are currently unknown. The change in iris colour occurs slowly and may not be noticeable for months to years. The change in eye colour has predominantly been seen in patients with mixed coloured irides, i.e., blue-brown, grey-brown, yellow-brown and green-brown; however, it has also been observed in patients with brown eyes.
Typically, the brown pigmentation around the pupil spreads concentrically towards the periphery in affected eyes, but the entire iris or parts of it may be become more brownish. After discontinuation of therapy, no further increase in brown iris pigment has been observed.

Periorbital and eye lid changes

In controlled clinical trials, periorbital and/or eyelid skin darkening in association with the use of TRAVATAN has been reported in 0.4% of patients. Periorbital and lid changes including deepening of the eyelid sulcus have also been observed with prostaglandin analogues.

TRAVATAN may gradually change eyelashes in the treated eye(s); these changes were observed in about half of the patients in clinical trials and include: increased length, thickness, pigmentation, and/or number of lashes. The mechanism of eyelash changes and their long-term consequences are currently unknown.

TRAVATAN has been shown to cause slight enlargement of the palpebral fissure in studies in the monkey. However, this effect was not observed during the clinical trials and is considered to be species specific.


TRA API APR22 V3                                                                          EU SmPC SEP21 There is no experience of TRAVATAN in inflammatory ocular conditions; nor in neovascular, angle-closure, narrow-angle or congenital glaucoma and only limited experience in thyroid eye disease, in open-angle glaucoma of pseudophakic patients and in pigmentary or pseudoexfoliative glaucoma.
TRAVATAN should therefore be used with caution in patients with active intraocular inflammation.

Aphakic patients

Macular oedema has been reported during treatment with prostaglandin F2a analogues. Caution is recommended when using Travatan in aphakic patients, pseudophakic patients with a torn posterior lens capsule or anterior chamber lenses, or in patients with known risk factors for cystoid macular oedema.

Iritis/uveitis

In patients with known predisposing risk factors for iritis/uveitis, TRAVATAN should be used with caution.

Contact with the skin

Skin contact with TRAVATAN must be avoided as transdermal absorption of travoprost has been demonstrated in rabbits.

Prostaglandins and prostaglandin analogues are biologically active materials that may be absorbed through the skin. Women who are pregnant or attempting to become pregnant should exercise appropriate precautions to avoid direct exposure to the contents of the bottle. In the unlikely event of coming in contact with a substantial portion of the contents of the bottle, thoroughly cleanse the exposed area immediately.

Contact lenses

Patients must be instructed to remove contact lenses prior to application of TRAVATAN and wait 15 minutes after instillation of the dose before reinsertion.

Excipients

TRAVATAN contains propylene glycol which may cause skin irritation.
TRAVATAN contains polyoxyethylene hydrogenated castor oil 40 which may cause skin reactions.

Effects on Driving

4.7         Effects on ability to drive and use machines

TRAVATAN has no or negligible influence on the ability to drive and use machines, however as with any eye drop, temporary blurred vision or other visual disturbances may affect the ability to drive or use machines. If blurred vision occurs at instillation, the patient must wait until the vision clears before driving or using machines.