ALCON ATROPINE SULFATE EYE DROPS 1% [SIN04140P]

Product Info

ALCON ATROPINE SULFATE EYE DROPS 1%

[SIN04140P]

4.1 Therapeutic Indications
ALCON ATROPINE SULFATE EYE DROPS contains atropine sulfate, a parasympatholytic agent which produces mydriasis and cycloplegia.

ALCON ATROPINE SULFATE EYE DROPS is used for refraction or for the iris dilation desired in acute inflammatory conditions of the iris and uveal tract.

4.2 Posology and method of administration
Posology

Use in adults:

• For uveitis: 1 drop in the eye(s), 3 times dally.

• For refraction: 1 drop in the eye(s), repeated 1 hour before the examination.

Children:
ALCON ATROPINE SULFATE EYE DROPS is contraindicated in children less than 12 years because of the risk of serious systemic side effects (see sections 4.3, 4.4, 4.8 and 4.9 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). When dosed in older children the lowest strength should be used:

• For uveitis: 1 drop of ALCON ATROPINE SULFATE EYE DROPS 0.5% in the eye(s), 3 times daily.

• For refraction: 1 drop of ALCON ATROPINE SULFATE EYE DROPS 0.5% in the eye(s), twice daily for 1 or 2 days before the examination and 1 hour before the examination.

Use in patients with hepatic or renal impairment
The safety and efficacy of ALCON ATROPINE SULFATE EYE DROPS in patients with hepatic and renal impairment have not been established.

Method of administration
For ocular use.

After cap is removed, if tamper evident snap collar is loose, remove before using product.
To prevent contamination of the dropper tip and solution, care must be taken not to touch the eyelids, surrounding areas or other surfaces with the dropper tip. Keep the bottle tightly closed when not in use.

Nasolacrimal occlusion or gently closing the eyelid after administration is recommended. This may reduce the systemic absorption of medicinal products administered via the ocular route and result in a decrease in systemic adverse reactions. This is particularly important in children.

If more than one topical ophthalmic product is being used, the products must be administered at least 5 minutes apart. Eye ointments should be administered last.

4.3 Contraindications

• Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information.

• Hypersensitivity to belladonna alkaloids.

• Patients with known or suspected glaucoma or a tendency towards glaucoma.

• Children less than 12 years (see section 4.4 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

• Children with Down’s syndrome, spastic paralysis or brain damage.