COSOPT Eye drops, solution Ref.[50805] Active ingredients: Dorzolamide Timolol

Posology

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

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

Patients should be instructed to wash their hands before use and avoid allowing the tip of the container to come into contact with the eye or surrounding structures.

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.

Patients should be informed of the correct handling of the containers.

Method of administration

1. Wash your hands
2. Open the container. Take special care that the tip of the dropper container does not touch your eye, the skin around your eye or your fingers.
3. Tilt your head backwards and hold the container upside down over the eye.
4. Pull the lower eyelid downwards and look up. Hold and gently squeeze the container on the flattened sides of the container and let one drop fall into the space between the lower eyelid and the eye.
5. Press a finger into the corner of your eye, by the nose, or close your eyelids for 2 minutes. This helps to stops the medicine from getting into the rest of the body.
6. Repeat steps 3 to 5 with the other eye if instructed to do so by your doctor.
7. Put the cap back on and close the container tightly.

[OCUMETER PLUS containers only]

1. Before using the medication for the first time, be sure the Safety Strip on the front of the container is unbroken. A gap between the container and the cap is normal for an unopened container.
2. First, wash your hands, and then tear off the Safety Strip to break the seal.
3. To open the container, unscrew the cap by turning as indicated by the arrows on the top of the cap. Do not pull the cap directly up and away from the container. Pulling the cap directly up will prevent your dispenser from operating properly.
4. Tilt your head back and pull your lower eyelid down slightly to form a pocket between your eyelid and your eye.
5. Invert the container, and press lightly with the thumb or index finger over the “Finger Push Area” until a single drop is dispensed into the eye as directed by your doctor. DO NOT TOUCH YOUR EYE OR EYELID WITH THE DROPPER TIP.
6. 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.
7. If drop dispensing is difficult after opening for the first time, replace the cap on the container and tighten (Do not overtighten) and then remove by turning the cap in the opposite directions as indicated by the arrows on the top of the cap.
8. Repeat steps 4 & 5 with the other eye if instructed to do so by your doctor.
9. Replace the cap by turning until it is firmly touching the container. The arrow on the left side of the cap must be aligned with the arrow on the left side of the container label for proper closure. Do not overtighten or you may damage the container and cap.
10. The dispenser tip is designed to provide a single drop; therefore, do NOT enlarge the hole of the dispenser tip.
11. After you have used all doses, there will be some medicine left in the container. You should not be concerned since an extra amount of medicine has been added and you will get the full amount of COSOPT that your doctor prescribed. Do not attempt to remove the excess medicine from the container.

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).

No data are available in humans in regard to overdose by accidental or deliberate ingestion of COSOPT.

Symptoms

There have been reports of inadvertent overdoses with timolol maleate ophthalmic solution resulting in systemic effects similar to those seen with systemic beta-adrenergic blocking agents such as dizziness, headache, shortness of breath, bradycardia, bronchospasm, and cardiac arrest. The most common signs and symptoms to be expected with overdoses of dorzolamide are electrolyte imbalance, development of an acidotic state, and possibly central nervous system effects.

Only limited information is available with regard to human overdose by accidental or deliberate ingestion of dorzolamide hydrochloride. With oral ingestion, somnolence has been reported. With topical application the following have been reported: nausea, dizziness, headache, fatigue, abnormal dreams, and dysphagia.

Treatment

Treatment should be symptomatic and supportive. Serum electrolyte levels (particularly potassium) and blood pH levels should be monitored. Studies have shown that timolol does not dialyze readily.

3 years.

COSOPT should be used no longer than 28 days after first opening the container.

This medicinal product does not require any special temperature storage conditions.

Keep the container in the outer carton, in order to protect from light.

COSOPT containers contain 5 ml of solution. Two alternate containers may be marketed.

White translucent low-density polyethylene container, a transparent dropper tip and a white cap

or

OCUMETER Plus Ophthalmic Dispenser consisting of a translucent, high-density polyethylene container with a sealed dropper tip, a flexible fluted side area which is depressed to dispense the drops, and a 2-piece cap assembly. The 2-piece cap mechanism punctures the sealed dropper tip upon initial use, then locks together to provide a single cap during the usage period. Tamper evidence is provided by a safety strip on the container label.

COSOPT is available in the following packaging configurations:

1 × 5 ml (single 5 ml container)
3 × 5 ml (three 5 ml containers)
6 × 5 ml (six 5 ml containers)

Not all pack sizes may be marketed

No special requirements.