TRAVATAN C EYE DROP SOLUTION 30MCG/ML [SIN15206P]

Product Info

TRAVATAN C EYE DROP SOLUTION 30MCG/ML

[SIN15206P]

4.1 Therapeutic indications

TRAVATAN C® eye drops contains travoprost, a prostaglandin analogue.

TRAVATAN C eye drops is indicated for the decrease of elevated intraocular pressure in adult patients with ocular hypertension or open-angle glaucoma (see section 5.1 – 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

Use in adults, including elderly patients

The dose is 1 drop of TRAVATAN C eye drops in the conjunctival sac of the affected eye(s) once daily. Optimal effect is obtained if the dose is administered in the evening.

TRAVATAN C eye drops may be used concomitantly with other topical ophthalmic drug products to lower intraocular pressure.

Use in patients with renal impairment

Travoprost 30 mcg/ml has not been studied in patients with renal impairment. However, travoprost 40 mcg/ml has been studied in patients with mild to severe renal impairment (creatinine clearance as low as 14 ml/min). No dosage adjustment is necessary in these patients (see section 5.2 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Therefore, no need for dose adjustment at the lower concentration of active ingredient is anticipated.

Use in patients with hepatic impairment

Travoprost 30 mcg/ml has not been studied in patients with hepatic. However, travoprost 40 mcg/ml has been studied in patients with mild to severe hepatic impairment.No dosage adjustment is necessary in these patients (see section 5.2 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Therefore, no need for dose adjustment at the lower concentration of active ingredient is anticipated.

Use in children and adolescents

The safety and efficacy of TRAVATAN C eye drops in children and adolescents below the age of 18 years has not been established. No data are available.

Method of administration

For ocular use.

For patients who wear contact lenses, please refer to section 4.4 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information.

The patient should remove the protective overwrap immediately prior to initial use.

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 of the bottle. Keep the bottle tightly closed when not in use. The dropper tip should also not come into contact with the eye as this may cause injury to the eye.

Nasolacrimal occlusion or gently closing the eyelid(s) for 2 minutes 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 a dose is missed, treatment should be continued with the next dose as planned. The dose should not exceed 1 drop in the affected eye(s) daily. Since it has been shown that more frequent administration of prostaglandin analogs may decrease the IOP lowering effect.

When substituting another ophthalmic antiglaucoma medicinal product with TRAVATAN C eye drops, the other medicinal product should be discontinued and TRAVATAN C eye drops should be started the following day.

If more than one topical ophthalmic medicinal product is being used, the medicinal 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.