1. Name Of The Medicinal Product
Artelac 0.32% w/v Eye Drops Single Dose Unit
2. Qualitative And Quantitative Composition
Hypromellose, 0.32% w/v.
For excipients, see 6.1.
3. Pharmaceutical Form
Eye drops, solution.
Sterile clear solution.
4. Clinical Particulars
4.1 Therapeutic Indications
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.
4.2 Posology And Method Of Administration
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.
4.3 Contraindications
Hypersensitivity to the active substance (hypromellose) or to any of the excipients.
4.4 Special Warnings And Precautions For Use
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.
4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction
None.
4.6 Pregnancy And Lactation
Artelac can be used during pregnancy and lactation.
4.7 Effects On Ability To Drive And Use Machines
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.
4.8 Undesirable Effects
Brief blurred vision or a slight stinging sensation on instilling Artelac.
4.9 Overdose
No case of overdose has been reported.
5. Pharmacological Properties
5.1 Pharmacodynamic Properties
Pharmacotherapeutic group:
Ophthalmologicals: other ophthalmologicals
ATC code: S01X A20
Hypromellose prolongs adhesion, enhances moistening of the cornea and conjunctiva and allows for a smoother movement of the conjunctiva over the cornea.
5.2 Pharmacokinetic Properties
Hypromellose does not permeate the cornea or reach the systemic circulation via the ophthalmic vessels.
5.3 Preclinical Safety Data
There is no preclinical data of relevance to the prescriber.
6. Pharmaceutical Particulars
6.1 List Of Excipients
Disodium phosphate dodecahydrate
Sodium dihydrogen phosphate dihydrate
Sorbitol
Purified water
6.2 Incompatibilities
Not applicable.
6.3 Shelf Life
2 years.
6.4 Special Precautions For Storage
Do not store above 25°C.
6.5 Nature And Contents Of Container
0.5 ml single dose unit, composed of LDPE.
30, 60 or 120 single dose units.
6.6 Special Precautions For Disposal And Other Handling
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.
7. Marketing Authorisation Holder
Pharma Global Limited
Hudson Road
Sandycove
Co. Dublin
Republic of Ireland
8. Marketing Authorisation Number(S)
PL 11185/0002
9. Date Of First Authorisation/Renewal Of The Authorisation
25th January 2007
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