COSOPT-S OPHTHALMIC SOLUTION [SIN15435P]

Product Info

COSOPT-S OPHTHALMIC SOLUTION

[SIN15435P]

4.1 Therapeutic indications
COSOPT-S is indicated in the treatment of elevated intraocular pressure (IOP) in patients with ocular hypertension, open-angle glaucoma, pseudoexfoliative glaucoma or other secondary open-angle glaucomas when concomitant therapy is appropriate.

4.2 Posology and method of administration

Posology
The dose is one drop of COSOPT-S in the (conjunctival sac of the) affected eye(s) two times daily.

If another topical ophthalmic agent is being used, COSOPT-S and the other agent should be administered at least ten minutes apart.

This medicinal product is a sterile solution that does not contain a preservative. The solution from one individual single-dose container is to be used immediately after opening for administration to the affected eye(s). Since sterility cannot be maintained after the individual single-dose container is opened, any remaining contents must be discarded immediately after administration.

Patients should be instructed to wash their hands before use and avoid allowing the container to come into contact with the eye or surrounding structures as this could cause injury to the eye (see instructions for use).

Patients should also be instructed that ocular solutions, if handled improperly, can become contaminated by common bacteria known to cause ocular infections. Serious damage to the eye and subsequent loss of vision may result from using contaminated solutions.

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 effects and an increase in local activity.

Instructions for use
Patients should be informed of the correct handling of the single-dose container. Please see section 6.6 for specific diagrams and instructions for use – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information.

Paediatric population
Efficacy in paediatric patients has not been established. Safety in paediatric patients below the age of 2 years has not been established (For information regarding safety in paediatric patients ≥ 2 and < 6 years of age, see section 5.1 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

4.3 Contraindications
COSOPT-S is contraindicated in patients with:

• 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 not controlled with pacemaker, overt cardiac failure, cardiogenic shock

• severe renal impairment (CrCl < 30 ml/min) or hyperchloraemic acidosis

• hypersensitivity to one or both 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.

The above are based on the components and are not unique to the combination.