No case of overdose has been reported.
Hypersensitivity to the active substance or to any of the excipients.
Not for use with soft contact lenses.
None known.
The following undesirable effects have been reported since Lacril Tears was marketed.
Frequency:
Not known: the incidence cannot be determined from available information.
Eye disorders:
Not known: Eye irritation, eye pain, ocular hyperaemia, lacrimation increased, foreign body sensation, eye pruritus.
Immune system disorders:
Not known: hypersensitivity
The constituents of Lacril Tears have been used safely in pharmaceutical products for many years. Topical administration in animal studies showed no untoward effects.
As an ocular lubricant for the relief of dry eye and dry eye symptoms.
Pharmacotherapeutic group: Artificial tears and other indifferent preparations, ATC code: S01AX20.
Not applicable. Lacril Tears contains no pharmacologically active ingredient.
Not applicable. Lacril Tears contains no pharmacologically active ingredient.
If irritation, pain, redness and changes in vision occur or worsen or persist for more than 72 hours, treatment should be discontinued and a new assessment considered.
To avoid contamination, the dropper tip should not be allowed to touch the eye or any other surface.
Contact lenses should be removed before each application and may be reinserted after 15 minutes.
Lacril Tears contain benzalkonium chloride which is irritant to the eye and could cause discolouration of soft lenses. Avoid contact with soft contact lenses. Remove contact lenses before Lacril Tears is used and wait for at least 15 minutes before reinsertion.
Concomitant ocular medication should be administered 15 minutes prior to the instillation of Lacril Tears.
No studies on the effects on the ability to drive and use machines have been performed.
Based upon the information available, Lacril Tears has no or negligible influence on the ability to drive and use machines. However, it may cause transient blurring of vision. Do not drive or use hazardous machinery unless vision is clear.
Dosage schedule: One to two drops as required or directed for all ages.
Route of administration: Topical instillation into conjunctival sac.
No special requirements.
