Artelac 3.2 Mg/Ml Eye Drops Solution
Out of date information, search anotherSUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Artelac 3.2 mg/ml Eye Drops Solution
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Hypromellose 3.2 mg/ml
For full list of excipients, see section 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
Dosage
Suitable for use in adults and children.
Unless otherwise directed, instil 1 drop into the conjunctival sac (comer 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.
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 Hypromellose 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
Hypromellose can be used during pregnancy and lactation.
Hypromellose 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 Hypromellose.
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.
Preclinical safety data
5.3
Hypromellose has proved to be very well tolerated in local toxicity studies.
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Cetrimide
Disodium Phosphate Dodecahydrate Sodium Dihydrogen Phosphate Dihydrate Disodium Edetate Sorbitol
Water for Injections in Bulk
6.2 Incompatibilities
Not applicable.
6.3 Shelf life
3 years. Discard within 28 days of first opening.
6.4 Special precautions for storage
Protect from light. Store below 25°C.
Sterile until opened. Avoid contamination during use.
6.5
Nature and contents of container
10 ml round transparent white bottle (LDPE) with white dropper plug (LDPE) and white cap (HDPE).
6.6 Special precautions for disposal
Avoid contamination during use. Hypromellose 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
Bausch & Lomb (UK) Ltd
Bausch &Lomb House 106 London Road Kingston-Upon-Thames Surrey KT2 6TN
UK
8 MARKETING AUTHORISATION NUMBER(S)
PL 03468/0032
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
02/09/2009
10 DATE OF REVISION OF THE TEXT
28/03/2011