AZARGA 10MG/ML + 5MG/ML EYE DROPS, SUSPENSION [SIN13802P]

Product Info

AZARGA 10MG/ML + 5MG/ML EYE DROPS, SUSPENSION

[SIN13802P]

4.1 Therapeutic indications

Decrease of intraocular pressure (IOP) in adult patients with open-angle glaucoma or ocular hypertension for whom monotherapy provides insufficient IOP reduction. (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 the elderly
The dose is one drop of AZARGA® eye drops in the conjunctival sac of the affected eye(s) twice daily.

If a dose is missed, treatment should be continued with the next dose as planned. The dose should not exceed one drop in the affected eye(s) twice daily.

If more than 1 topical ophthalmic medicinal product is used, the medicines must be administered at least 5 minutes apart.

When substituting another ophthalmic antiglaucoma agent with AZARGA® eye drops, the other agent should be discontinued and AZARGA eye drops should be started the following day.

Use in paediatric patients
AZARGA® eye drops is not recommended for use in children below 18 years due to a lack of data on safety and efficacy.

Use in geriatric patients
No overall differences in safety and effectiveness have been observed between elderly and other adult populations.

Use in patients with hepatic or renal impairment
No studies have been conducted with AZARGA® eye drops or with timolol 5 mg/ml eye drops in patients with hepatic or renal impairment. No dosage adjustment is necessary in patients with hepatic impairment or in patients with mild to moderate renal impairment.

AZARGA® eye drops has not been studied in patients with severe renal impairment (creatinine clearance <30 ml/min) or in patients with hyperchloraemic acidosis. Since brinzolamide and its main metabolite are excreted predominantly by the kidney, AZARGA eye drops is therefore contraindicated in patients with severe renal impairment (see section 4.3).

Method of administration
For ocular use.

Patients should be instructed to shake the bottle well before use.

Nasolacrimal occlusion and closing the eyelids for 2 minutes after instillation is recommended. This may result in a decrease in systemic side effects and an increase in local activity.

Patients must be instructed to remove soft contact lenses prior to application of AZARGA® and to wait 15 minutes after instillation of the dose before reinsertion.

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. Patients should be instructed to keep the bottle tightly closed when not in use.

After the cap is removed, if the tamper evident snap collar is loose, this should be removed before using the product.

4.3 Contraindications

• Hypersensitivity to the active substances 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 other beta-blockers.

• Hypersensitivity to sulphonamides (see section 4.4 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

• Reactive airway disease including bronchial asthma or a history of bronchial asthma, or severe chronic obstructive pulmonary disease.

• Sinus bradycardia, sick sinus syndrome, sino-atrial block, second or third degree atrioventricular block, overt cardiac failure or cardiogenic shock.

• Severe allergic rhinitis.

• Severe renal impairment (see section 4.2).

• Hyperchloraemic acidosis (see section 4.2).