VIZIDOR DUO

Posology The dose is one drop of Vizidor Duo eye drops solution in the (conjunctival sac of the) affected eye(s) two times daily. If another topical ophthalmic agent is being used, Vizidor Duo eye drops solution and the other agent should be administered at least ten minutes apart.

Vizidor Duo 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). 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.

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 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 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.

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 Vizidor Duo left in the bottle. The patient should not be concerned since an extra amount of Vizidor Duo has been added and the patient will get the full amount of Vizidor Duo 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. Safety in paediatric patients below the age of 2 years has not been established.

1).

In a clinical study for dorzolamide/timolol preservative-free the observed adverse reactions have been consistent with those that were reported previously with dorzolamide/timolol (preserved formulation), dorzolamide hydrochloride and/or timolol maleate.

During clinical studies, 1035 patients were treated with dorzolamide/timolol (preserved formulation). 2% of all patients discontinued because of local adverse reactions suggestive of allergy or hypersensitivity (such as lid inflammation and conjunctivitis).

Dorzolamide/Timolol preservative-free has been shown to have a similar safety profile to dorzolamide/timolol (preservative containing formulation) in a repeat dose double-masked, comparative study. Like other topically applied ophthalmic medicines, timolol is absorbed into the systemic circulation.

This may cause similar undesirable effects as seen with systemic beta-blocking agents. Incidence of systemic ADRs after topical ophthalmic administration is lower than for systemic administration. 4) itching, tearing, redness, blurred vision, corneal erosion Ear and labyrinth disorders Timolol maleate eye drops, solution tinnitus* Cardiac disorders Timolol maleate eye drops, solution bradycardia * chest pain*, palpitation*, oedema*, arrhythmia*, congestive heart failure*, cardiac arrest*, heart block atrioventric ular block, cardiac failure Dorzolamide hydrochlorid e eye drops, solution palpitations Vascular disorders Timolol maleate eye drops, solution hypotension*, claudication, Raynaud's phenomenon*, cold hands and feet* Dorzolamide/ Timolol Preservative- Free sinusitis shortness of breath, respiratory failure, rhinitis, rarely bronchospasm Dorzolamide hydrochlorid e eye drops, solution epistaxis* dyspnoea Respiratory, thoracic, and mediastinal disorders Timolol maleate eye drops, solution dyspnoea* bronchospasm (predominantly in patients with pre-existing bronchospastic disease)*, respiratory failure, cough* Dorzolamide/ Timolol Preservative- Free dysgeusia Dorzolamide hydrochlorid e eye drops, solution nausea* throat irritation, dry mouth* Gastrointestinal disorders Timolol maleate eye drops, solution nausea*, dyspepsia* diarrhoea, dry mouth* dysgeusia, abdominal pain, vomiting Dorzolamide/ Timolol Preservative- Free contact dermatitis, Stevens-Johnson syndrome, toxic epidermal necrolysis Skin and subcutaneous tissue disorders Dorzolamide hydrochlorid e eye drops, solution rash* Timolol maleate eye drops, solution alopecia*, psoriasiform rash or exacerbation of psoriasis* skin rash Musculoskeletal and connective tissue disorders Timolol maleate eye drops, solution systemic lupus erythematosus myalgia Renal and urinary disorders Dorzolamide/ Timolol Preservative- Free urolithiasis Reproductive system and breast disorders Timolol maleate eye drops, solution Peyronie's disease*, decreased libido sexual dysfunction Dorzolamide hydrochlorid e eye drops, solution asthenia/ fatigue* General disorders and administration site conditions Timolol maleate eye drops, solution asthenia/ fatigue* *These adverse reactions were also observed with Dorzolamide/ Timolol (preserved formulation) during post-marketing experience.

**Additional adverse reactions have been seen with ophthalmic beta-blockers and may potentially occur with dorzolamide/timolol preservative-free. 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. Healthcare professionals are asked to report any suspected adverse reactions via the […]

Cardiovascular/Respiratory Reactions Like other topically applied ophthalmic agents timolol is absorbed systemically. Due to beta- adrenergic component, timolol, the same types of cardiovascular, pulmonary and other adverse reactions seen with systemic beta-adrenergic blocking agents may occur.

Incidence of systemic ADRs after topical ophthalmic administration is lower than for systemic administration. 2. g. coronary heart disease, Prinzmetal's angina and cardiac failure) and hypotension therapy with beta-blockers should be critically assessed and the therapy with other active substances should be considered.

Patients with cardiovascular diseases should be watched for signs of deterioration of these diseases and of adverse reactions. Due to its negative effect on conduction time, beta-blockers should only be given with caution to patients with first degree heart block.

e. severe forms of Raynaud's disease or Raynaud's syndrome) should be treated with caution.

Respiratory disorders:

Respiratory reactions, including death due to bronchospasm in patients with asthma have been reported following administration of some ophthalmic beta-blockers. Vizidor Duo eye drops solution should be used with caution, in patients with mild/moderate chronic obstructive pulmonary disease (COPD) and only if the potential benefit outweighs the potential risk.

Hepatic Impairment This medicinal product has not been studied in patients with hepatic impairment and should therefore be used with caution in such patients. Immunology and Hypersensitivity As with other topically-applied ophthalmic agents, this medicinal product may be absorbed systemically.

Dorzolamide contains a sulfonamido group, which also occurs in sulfonamides. Therefore, the same types of adverse reactions found with systemic administration of sulfonamides 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 use of this preparation. Local ocular adverse effects, similar to those observed with dorzolamide hydrochloride eye drops, have been seen with this medicinal product.

If such reactions occur, discontinuation of Vizidor Duo eye drops solution should be considered. While taking beta-blockers, patients with a history of atopy or a history of severe anaphylactic reaction to a variety of allergens may be more reactive to repeated challenge with such allergens and may be unresponsive to the usual doses of adrenaline used to treat anaphylactic reactions.

Concomitant Therapy The effect on intra-ocular pressure or the known effects of systemic beta-blockade may be potentiated when timolol is given to the patients already receiving a systemic beta-blocking agent. The response of these patients should be closely observed.

5). The use of dorzolamide and oral carbonic anhydrase inhibitors is not recommended. Withdrawal of Therapy As with systemic beta-blockers, if discontinuation of ophthalmic timolol is needed in patients with coronary heart disease, therapy should be withdrawn gradually.

Additional Effects of Beta-Blockade Hypoglycaemia/diabetes:

Beta-blockers should be administered with caution in patients subject to spontaneous hypoglycaemia or to patients with labile diabetes, as beta-blockers may mask the signs and symptoms of acute hypoglycaemia. Beta-blockers may also mask the signs of hyperthyroidism.

Abrupt withdrawal of beta-blocker therapy may precipitate a worsening of symptoms.

Corneal diseases:

Ophthalmic beta-blockers may induce dryness of eyes. Patients with corneal diseases should be treated with caution. g. of adrenaline. The anaesthesiologist should be informed when the patient is receiving timolol. Therapy with beta-blockers may aggravate symptoms of myasthenia gravis.

Additional Effects of Carbonic Anhydrase Inhibition 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/timolol (preserved formulation), urolithiasis has been reported infrequently. Dorzolamide + Timolol eye drops solution contains 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 this medicinal product.

Other The management of patients with acute angle-closure glaucoma requires therapeutic interventions in addition to ocular hypotensive agents. This medicinal product has not been studied in patients with acute angle-closure glaucoma.

Corneal oedema and irreversible corneal decompensation have been reported in patients with pre- existing chronic corneal defects and/or a history of intraocular surgery while using dorzolamide. There is an increased potential for developing corneal oedema in patients with low endothelial cell counts.

Precautions should be used when Vizidor Duo eye drops solution to these groups of patients. g. timolol, acetazolamide) after filtration procedures. As with the use of other antiglaucoma medicines, diminished responsiveness to ophthalmic timolol maleate after prolonged therapy has been reported in some patients.

However, in clinical studies in which 164 patients have been followed for at least three years, no significant difference in mean intraocular pressure has been observed after initial […]

1. The above are based on the components and are not unique to the combination. Paediatric population Efficacy in paediatric patients has not been established.