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PATANOL STERILE OPHTHALMIC SOLUTION 0.1%

Prescription Only
Drug type: Therapeutic
ATC code: S01GX09
Dosage form: SOLUTION
Route of administration: OPHTHALMIC
Active ingredient: OLOPATADINE HCl 11.1 mg/ml EQV OLOPATADINE; OLOPATADINE HCl 11.1 mg/ml EQV OLOPATADINE

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.

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.

Registrant
NOVARTIS (SINGAPORE) PTE LTD
Approval Date
1998-12-02
Approval Number
SIN10485P
Manufacturer
ALCON-COUVREUR NV ALCON SINGAPORE MANUFACTURING PTE. LTD.
Licence Holder
NOVARTIS (SINGAPORE) PTE LTD