EYDELTO

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 as this could cause injury to the eye. 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. Eydelto eye 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).

Paediatric population Limited clinical data in paediatric patients with administration of dorzolamide (preserved formulation) three times a day are available. 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 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 backwards and hold the bottle above their eye.

3. The patient should pull the lower eyelid down 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. Patients should be instructed to seek advice from their doctor, pharmacist or nurse if they are not sure how to administer their medicine. 4. The patient should blink a few times so that the drop spreads over their eye.

When using nasolacrimal occlusion or closing the eyelid for 2 minutes, the systemic absorption is reduced. This may result in a decrease in systemic side effects and increase in local activity. 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 each 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. At the end of the 28-day in-use shelf life of the medicine, there will be some Eydelto left in the bottle. 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.

In a multiple-dose, double-masked, active-treatment (Dorzolamide multidose) controlled, two period crossover multiclinic study, the safety profile of Dorzolamide Preservative-Free was similar to that of Dorzolamide multidose. Dorzolamide multidose (preserved formulation) was evaluated in more than 1,400 individuals in controlled and uncontrolled clinical studies.

In long term studies of 1,108 patients treated with Dorzolamide multidose as monotherapy or as adjunctive therapy with an ophthalmic beta-blocker, the most frequent cause of discontinuations from treatment were drug-related ocular adverse effects in approximately 3% of patients primarily conjunctivitis and eyelid reactions.

The following adverse effects have been reported either during clinical trials or during post-marketing experience with dorzolamide: [Very Common: (≥ 1/10), Common: (≥ 1/100 to <1/10), Uncommon: (≥ 1/1,000 to <1/100), Rare: (≥ 1/10,000 to <1/1,000), Not known (frequency cannot be estimated from available data)] Very Common Common Uncommon Rare Not known Nervous system disorders headache dizziness, paraesthesia Eye disorders burning and stinging superficial punctate keratitis, tearing, conjunctivitis, eyelid inflammation, eye itching, eyelid irritation, blurred vision iridocyclitis irritation including redness, pain, eyelid crusting, transient myopia (which resolved upon discontinuation of therapy), corneal oedema, ocular hypotony, choroidal detachment following filtration surgery foreign body sensation in eye Cardiac disorders Palpitations Tachycardia Vascular disorder Hypertension Respiratory, thoracic, and mediastinal disorders epistaxis dyspnoea Gastrointestinal disorders nausea, bitter taste throat irritation, dry mouth Skin and subcutaneous tissue disorders contact dermatitis, Stevens-Johnson syndrome, toxic epidermal necrolysis Renal and urinary disorders urolithiasis General disorders and administration site conditions asthenia/fatigue Hypersensitivity: signs and symptoms of local reactions (palpebral reactions) and systemic allergic reactions including angioedema, urticaria and pruritus, rash, shortness of breath, rarely bronchospasm Laboratory Findings: dorzolamide was not associated with clinically meaningful electrolyte disturbances.

1. Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store).

Dorzolamide has not been studied in patients with hepatic impairment and should therefore be used with caution in such patients. The management of patients with acute angle-closure glaucoma requires therapeutic interventions in addition to ocular hypotensive agents.

Dorzolamide has not been studied in patients with acute angle-closure glaucoma. Dorzolamide contains a sulphonamido group, which also occurs in sulphonamides and although administered topically, is absorbed systemically. Therefore the same types of adverse reactions that are attributable to sulphonamides may occur with topical administration, including severe reactions such as Stevens-Johnson syndrome and toxic epidermal necrolysis.

If signs of serious reactions or hypersensitivity occur, discontinue the use of this preparation. Therapy with oral carbonic anhydrase inhibitors has been associated with urolithiasis as a result of acid-base disturbances, especially in patients with a prior history of renal calculi.

Although no acid-base disturbances have been observed with dorzolamide, urolithiasis has been reported infrequently. Because dorzolamide is a topical carbonic anhydrase inhibitor that is absorbed systemically, patients with a prior history of renal calculi may be at increased risk of urolithiasis while using dorzolamide.

g. conjunctivitis and eyelid reactions) are observed, treatment discontinuation should be considered. There is a potential for an additive effect on the known systemic effects of carbonic anhydrase inhibition in patients receiving an oral carbonic anhydrase inhibitor and dorzolamide.

The concomitant administration of dorzolamide and oral carbonic anhydrase inhibitors is not recommended. Corneal oedemas and irreversible corneal decompensations have been reported in patients with pre-existing chronic corneal defects and/or a history of intra-ocular surgery while using dorzolamide multidose (preserved formulation).

Topical dorzolamide should be used with caution in such patients. Choroidal detachment concomitant with ocular hypotony have been reported after filtration procedures with administration of aqueous suppressant therapies. Patients with a history of contact hypersensitivity to silver should not use this product as dispensed drops may contain traces of silver from the container closure.

This medicinal product has not been studied in patients wearing contact lenses. Paediatric population Dorzolamide has not been studied in patients less than 36 weeks gestational age and less than 1 week of age. Patients with significant renal tubular immaturity should only receive dorzolamide after careful consideration of the risk benefit balance because of the possible risk of metabolic acidosis.

1. Dorzolamide has not been studied in patients with severe renal impairment (CrCl < 30 ml/min) or with hyperchloraemic acidosis. Because dorzolamide and its metabolites are excreted predominantly by the kidney, dorzolamide is therefore contra-indicated in such patients.