Summary of Product Characteristics
last updated on the eMC:
20/09/2007
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SPC
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Artelac SDU preservative free hypromellose 0.32%
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Go to top of the page | Artelac 0.32% w/v Eye Drops Single Dose Unit | |
Go to top of the page | Hypromellose, 0.32% w/v.For excipients, see 6.1. | |
Go to top of the page | Eye drops, solution.Sterile clear solution. | |
Go to top of the pageGo to top of the page | Acts as a lubricant and artificial tear in the symptomatic treatment of dehydration of the cornea and conjunctiva due to impaired lacrimal secretion and functional disorders as a result of topical or systemic diseases, or caused by deficient or incomplete eyelid closure. | |
Go to top of the page | 4.2.1 Dosage Suitable for use in adults and children.Unless otherwise directed, instill 1 drop into the conjunctival sac (corner of the eye, nearest the nose) 3 to 5 times per day or as required, to provide sufficient lubrication.Therapy of dry eye syndrome requires an individual dosage regimen.Leave an interval of at least 5 minutes before instilling another ophthalmic medication.4.2.2 Administration For ocular use only. | |
Go to top of the page | Hypersensitivity to the active substance (hypromellose) or to any of the excipients. | |
Go to top of the page | Stop treatment and consult a physician if irritation persists or worsens or new eye signs or symptoms develop.Wearers of soft contact lenses should remove their lenses before Artelac is administered and should wait for at least 15 minutes before they insert them again. | |
Go to top of the pageGo to top of the page | Artelac can be used during pregnancy and lactation. | |
Go to top of the page | Artelac on instillation may cause a short term blurring of vision when first used. If affected wait until vision has cleared before driving or operating machinery. | |
Go to top of the page | Brief blurred vision or a slight stinging sensation on instilling Artelac. | |
Go to top of the page | No case of overdose has been reported. | |
Go to top of the pageGo to top of the page | Pharmacotherapeutic group:Ophthalmologicals: other ophthalmologicalsATC code: S01X A20Hypromellose prolongs adhesion, enhances moistening of the cornea and conjunctiva and allows for a smoother movement of the conjunctiva over the cornea. | |
Go to top of the page | Hypromellose does not permeate the cornea or reach the systemic circulation via the ophthalmic vessels. | |
Go to top of the page | There is no preclinical data of relevance to the prescriber. | |
Go to top of the pageGo to top of the page | Disodium phosphate dodecahydrateSodium dihydrogen phosphate dihydrateSorbitolPurified water | |
Go to top of the pageGo to top of the pageGo to top of the pageGo to top of the page | 0.5 ml single dose unit, composed of LDPE.30, 60 or 120 single dose units. | |
Go to top of the page | Avoid contamination during use. Artelac SDU eye drops are sterile until first opened. For single use only. Each carton contains a patient insert with instructions for use. | |
Go to top of the page | Pharma Global LimitedHudson RoadSandycoveCo. DublinRepublic of Ireland | |
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More information about this product
Link to this document from your website: http://www.medicines.org.uk/emc/medicine/20112/SPC/
