Isopto tears

Overdose

No case of overdose has been reported.

Contraindications

Hypersensitivity to the active substance (Isopto Tears) or to any of the excipients.

Incompatibilities

Not applicable.

Undesirable effects

The following adverse reactions have been reported following administration of Artelac 3.2 mg/ml Eye Drops Solution.

Eye disorder:

Very rare (<1/10,000):

Cases of corneal calcification have been reported very rarely in association with the use of phosphate containing eye drops in some patients with significantly damaged corneas.

Not known: Brief blurred vision or a slight stinging sensation on instilling Artelac 3.2 mg/ml Eye Drops Solution.

Reporting of suspected adverse reactions:

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via Yellow Card Scheme; Website: www.mhra.gov.uk/yellowcard.

Preclinical safety data

Isopto Tears has proved to be very well tolerated in local toxicity studies.

Therapeutic indications

This medicinal product 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. Artelac 3.2 mg/ml Eye Drops Solution is indicated in adults and children.

Pharmacotherapeutic group

Ophthalmologicals: other ophthalmologicals

Pharmacodynamic properties

Pharmacotherapeutic group: Ophthalmologicals: other ophthalmologicals

ATC code: S01X A20

Isopto Tears prolongs adhesion, enhances moistening of the cornea and conjunctiva and allows for a smoother movement of the conjunctiva over the cornea.

Pharmacokinetic properties

Isopto Tears does not permeate the cornea or reach the systemic circulation via the ophthalmic vessels.

Name of the medicinal product

Isopto Tears

Qualitative and quantitative composition

Hypromellose

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 3.2 mg/ml Eye Drops Solution is administered and should wait for at least 15 minutes before they insert them again. Ensure the dropper tip does not touch any surface including the eye surface.

Effects on ability to drive and use machines

Artelac 3.2 mg/ml Eye Drops Solution 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.

Dosage (Posology) and method of administration

Posology

Suitable for use in adults and children. Unless otherwise directed, instil 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.

Method of administration

For ocular use only.

Special precautions for disposal and other handling

Avoid contamination during use. Isopto Tears SDU eye drops are sterile until first opened. For single use only. Each carton contains a patient insert with instructions for use.