MedPath
HSA Approval

ALERCHEK OPHTHALMIC SOLUTION 0.1%

SIN15527P

ALERCHEK OPHTHALMIC SOLUTION 0.1%

ALERCHEK OPHTHALMIC SOLUTION 0.1%

August 17, 2018

GOLDPLUS UNIVERSAL PTE LTD

GOLDPLUS UNIVERSAL PTE LTD

Regulatory Information

GOLDPLUS UNIVERSAL PTE LTD

GOLDPLUS UNIVERSAL PTE LTD

Therapeutic

Prescription Only

Formulation Information

SOLUTION, STERILE

**DOSAGE AND ADMINISTRATION** **Dosage** The recommended dose is 1 drop in each affected eye 2 times per day. Use in children Safety and effectiveness in paediatric patients below the age of 3 years have not been established. Use in patients with hepatic or renal impairment No clinical studies with ALERCHEK 0.1% eye drops have been conducted in patients with renal or hepatic impairment; therefore the efficacy and safety of ALERCHEK 0.1% eye drops in these patients have yet to be 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. 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.

OPHTHALMIC

Medical Information

**INDICATIONS** **ALERCHEK 0.1%** (olopatadine hydrochloride ophthalmic solution 0.1%) is indicated for the treatment of the signs and symptoms of allergic conjunctivitis.

**CONTRAINDICATIONS** Hypersensitivity to the active substance or to any of the excipients.

S01GX09

olopatadine

Manufacturer Information

GOLDPLUS UNIVERSAL PTE LTD

Indoco Remedies Limited

Active Ingredients

Olopatadine Hydrochloride 1.11mg/ml eqv Olopatadine

1.00mg/ml

Olopatadine

Documents

Package Inserts

1.4.3 Alerchek 0.1% leaflet - proposed clean.pdf

Approved: July 19, 2022

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