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HSA Approval

PATANOL STERILE OPHTHALMIC SOLUTION 0.1%

SIN10485P

PATANOL STERILE OPHTHALMIC SOLUTION 0.1%

PATANOL STERILE OPHTHALMIC SOLUTION 0.1%

December 2, 1998

NOVARTIS (SINGAPORE) PTE LTD

NOVARTIS (SINGAPORE) PTE LTD

Regulatory Information

NOVARTIS (SINGAPORE) PTE LTD

NOVARTIS (SINGAPORE) PTE LTD

Therapeutic

Prescription Only

Formulation Information

SOLUTION

**4.2 Posology and method of administration** **Posology** 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 renal impairment No studies have been performed in patients with renal impairment. No dosage regimen adjustment is required for patients with renal impairment. Use in patients with hepatic impairment No studies have been performed in patients with hepatic impairment. No dosage regimen adjustment is required for patients with hepatic impairment. Use in patients 65 years of age or above No dosage regimen adjustment is required in patients 65 years of age or above. **Method of administration** For ocular use. After cap is removed, if tamper evident snap collar is loose, snap collar should be removed before using product. To avoid contamination, the dropper tip should not touch any surface. The dropper tip should also not come into contact with the eye as this may cause injury to the eye. The bottle should be kept tightly closed when not in use. When using nasolacrimal occlusion or closing the eyelids for 2 minutes, the systemic absorption is reduced. This may result in a decrease in systemic side effect and increase in local activity. 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. Patients should be advised not to wear a contact lens if their eye is red. Patanol should not be used to treat contact lens related irritation.

OPHTHALMIC

Medical Information

**4.1 Therapeutic indications** PATANOL eye drops is indicated for the treatment of the signs and symptoms of allergic conjunctivitis.

**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_.

S01GX09

olopatadine

Manufacturer Information

NOVARTIS (SINGAPORE) PTE LTD

ALCON-COUVREUR NV

ALCON SINGAPORE MANUFACTURING PTE. LTD.

Active Ingredients

OLOPATADINE HCl 11.1 mg/ml EQV OLOPATADINE

1mg/ml

Olopatadine

Documents

Package Inserts

PATANOL STERILE OPHTHALMIC SOLUTION 0.1 PI.pdf

Approved: May 2, 2023

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