VIZIDOR Eye drops, solution Ref.[28007] Active ingredients: Dorzolamide

Posology

When used as monotherapy, the dose is one drop of dorzolamide in the conjunctival sac of the affected eye(s), three times daily.

When used as adjunctive therapy with an ophthalmic beta-blocker, the dose is one drop of dorzolamide in the conjunctival sac of the affected eye(s) two times daily.

When substituting dorzolamide for another ophthalmic anti-glaucoma agent, discontinue the other agent after proper dosing on one day, and start dorzolamide on the next day.

If more than one topical ophthalmic drug is being used, the drugs 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.

Vizidoreye drops solution is a sterile solution that does not contain a preservative. The solution from the multi-dose container can be used for up to 28 days after first opening for administration to the affected eye(s).

Pediatric population

Limited clinical data in pediatric patients with administration of dorzolamide (preserved formulation) three times a day are available. (For information regarding pediatric dosing see section 5.1).

Method of administration

Before instillation of the eye drops:

• Users should be instructed to wash their hands before opening the bottle.
• Users should also be instructed to not use this medicine if they notice that the tamper-proof seal on the bottle neck is broken before they first use it.
• When used for the first time, before delivering a drop to the eye, the patient should practise using the dropper bottle by squeezing it slowly to deliver one drop into the air, away from the eye.
• When the patient is confident they can deliver one drop at a time, the patient should adopt a position that is the most comfortable for the instillation of the drops (the patient can sit down, lie on their back, or stand in front of a mirror).

Instillation:

1. The bottle should be held directly below the cap and the cap should be turned to open the bottle. To avoid contamination of the solution, the tip of the bottle must not touch anything.

2. The patient should tilt their head back and hold the bottle above their eye.

3. The patient should pull the lower eyelid down slightly to form a pocket between the eyelid and eye and look up. The bottle should be squeezed gently in the middle and a drop should be allowed to fall into the patient’s eye. Please note that there might be a few seconds delay between squeezing and the drop coming out. The bottle must not be squeezed too hard.

4. The patient should instill one drop in the affected eye(s) as directed by the physician. The patient should blink a few times so that the drop spreads over their eye should be instructed to seek advice from their doctor, pharmacist or nurse if they are not sure how to administer their medicine.

5. Instructions 2. - 4. should be repeated for delivery into the other eye, if required. The patient should be clearly instructed if one eye only requires treatment, and if so, which eye is affected.

6. After use and prior to recapping, the bottle should be shaken once in a downwards direction, without touching the dropper tip, in order to remove any residual liquid on the tip. This is necessary in order to ensure delivery of subsequent drops.

7. After all doses have been used there will be some Vizidorleft in the bottle. The patient should not be concerned since an extra amount of Vizidorhas been added and the patient will get the full amount of Vizidor that their doctor has prescribed. Using the excess medicine remaining in the bottle after the patient has completed the course of treatment should not be attempted.

Patients must not use the eye drops for longer than 28 days after first opening the bottle.

Only limited information is available with regard to human overdose by accidental or deliberate ingestion of dorzolamide hydrochloride.

Symptoms

The following have been reported with oral ingestion: somnolence; topical application: nausea, dizziness, headache, fatigue, abnormal dreams, and dysphagia.

Treatment

Treatment should be symptomatic and supportive. Electrolyte imbalance, development of an acidotic state, and possible central nervous system effects may occur. Serum electrolyte levels (particularly potassium) and blood pH levels should be monitored.

30 months. After first opening, the product may be stored for a maximum of 28 days. No special storage conditions are required.

This medicinal product does not require any special storage conditions.

For storage conditions after first opening of the medicinal product, see section 6.3.

5 ml solution in a white opaque 11 ml LDPE bottle and white Novelia nozzle (HDPE and silicone) with a white HDPE cap.

Pack sizes: 1 or 3 bottles in cardbox.

Not all pack sizes may be marketed.

No special requirements for disposal.