Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2019 Publisher: Santen Oy, Niittyhaankatu 20, 33720, Tampere, Finland
Reduction of elevated intraocular pressure in open angle glaucoma and ocular hypertension.
As monotherapy in patients:
As adjunctive therapy to beta-blockers.
Saflutan is indicated in adults ≥18 years.
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.
No dosage alteration in elderly patients is necessary.
The safety and efficacy of tafluprost in children below age 18 has not yet been established. No data are available.
Tafluprost has not been studied in patients with renal/hepatic impairment and should therefore be used with caution in such patients.
Patients should be informed of the correct handling of the bottle. When using for the first time, before delivering a drop to the eye, the patient should first of all practise using the bottle by squeezing it slowly to deliver one drop away from the eye. The patient should practice until being confident to deliver one drop at a time. Otherwise the unpreserved alternative of the same medicinal product in single dose-units may be more appropriate.
To prevent potential contamination of the solution, the patients should not touch their eyelids, surrounding areas or any other surfaces with the applicator tip of the bottle. The residual liquid remaining at the dropper tip after application of the eye drops should immediately be removed by shaking the bottle once downwards. The dropper tip should not be touched or wiped.
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.
There will be a residual volume of approximately 1 ml, which cannot be dosed. The patient should not try to empty the bottle.
If more than one topical ophthalmic medicinal product is being used, each one should be administered at least 5 minutes apart.
Overdose is unlikely to occur after ocular administration.
If overdose occurs, treatment should be symptomatic.
Shelf life: 3 years.
After first opening the bottle: 28 days.
Store in a refrigerator (2°C-8°C). Do not freeze.
After opening: Store below 25°C.
Store in the original carton in order to protect from light.
Transparent low-density polyethylene (LDPE) bottles with white Aptar OSD (polyethylene, polypropylene, cyclic olefin copolymer) with blue polyethylene cap packed in a PET coated aluminium/polyethylene foil pouch. Each bottle has a fill volume of 3 ml.
The following pack sizes are available: cartons containing 1 or 3 bottles of 3 ml each packed in pouch.
Not all pack sizes may be marketed.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
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