Special Warning : אזהרת שימוש

4.4 Special warnings and precautions for use

Ocular
Before treatment is initiated, patients should be informed of the possibility of prostaglandin analogue periorbitopathy (PAP) and increased iris pigmentation, since these have been observed during treatment with bimatoprost. Some of these changes may be permanent, and may lead to impaired field of vision and differences in appearance between the eyes when only one eye is treated (see section 4.8).
Cystoid macular oedema has been uncommonly reported (≥1/1,000 to <1/100) following treatment with bimatoprost 0.3 mg/mL eye drops (multi-dose formulation). Therefore, BIMATOPROST S.K should be used with caution in patients with known risk factors for macular oedema (e.g. aphakic patients, pseudophakic patients with a torn posterior lens capsule).
There have been rare spontaneous reports of reactivation of previous corneal infiltrates or ocular infections with bimatoprost 0.3 mg/mL eye drops, solution (multi-dose formulation). BIMATOPROST S.K should be used with caution in patients with a prior history of significant ocular viral infections (e.g. herpes simplex) or uveitis/iritis.
bimatoprost has not been studied in patients with inflammatory ocular conditions, neovascular, inflammatory, angle-closure glaucoma, congenital glaucoma or narrow-angle glaucoma.
Skin
There is a potential for hair growth to occur in areas where BIMATOPROST S.K solution comes repeatedly in contact with the skin surface. Thus, it is important to apply BIMATOPROST S.K as instructed and avoid it running onto the cheek or other skin areas.
Respiratory bimatoprost has not been studied in patients with compromised respiratory function. While there is limited information available on patients with a history of asthma or COPD, there have been reports of exacerbation of asthma, dyspnoea and COPD, as well as reports of asthma, in post marketing experience. The frequency of these symptoms is not known.
Patients with COPD, asthma or compromised respiratory function due to other conditions should be treated with caution.
Cardiovascular bimatoprost has not been studied in patients with heart block more severe than first degree or uncontrolled congestive heart failure. There have been a limited number of spontaneous reports of bradycardia or hypotension with bimatoprost 0.3 mg/mL eye drops, solution (multi-dose formulation). BIMATOPROST S.K should be used with caution in patients predisposed to low heart rate or low blood pressure.
Other Information
In studies of bimatoprost 0.3 mg/ml in patients with glaucoma or ocular hypertension, it has been shown that the more frequent exposure of the eye to more than one dose of bimatoprost daily may decrease the IOP-lowering effect. Patients using BIMATOPROST S.K with other prostaglandin analogues should be monitored for changes to their intraocular pressure.
Bimatoprost 0.3 mg/mL has not been studied in patients wearing contact lenses.
Contact lenses should be removed prior to instillation and may be reinserted 15 minutes following administration.

Effects on Driving

4.7 Effects on ability to drive and use machines

BIMATOPROST S.K has negligible influence on the ability to drive and use machines. As with any ocular treatment, if transient blurred vision occurs at instillation, the patient should wait until the vision clears before driving or using machines.