EYZEETAN

Posology Recommended dosage in adults (including older people) The recommended dose is one drop of Eyzeetan in the affected eye(s) once daily, administered either in the morning or in the evening. It should be administered at the same time each day.

3mg/ml + 5mg/ml eye drops, solution (preserved formulation) suggest that evening dosing may be more effective in IOP lowering than morning dosing. 1). If one dose is missed, treatment should continue with the next dose as planned. The dose should not exceed one drop in the affected eye(s) daily.

Eyzeetan eye drops solution is a sterile solution that does not contain a preservative. Renal and hepatic impairment Eyzeetan has not been studied in patients with hepatic or renal impairment. Therefore caution should be used in treating such patients.

Paediatric population The safety and efficacy of Eyzeetan in children aged less than 18 years has not been established. No data are available. Method of administration If more than one topical ophthalmic medicinal product is to be used, each one should be instilled at least 5 minutes apart.

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. Eyzeetan eye drops solution is a sterile solution that does not contain a preservative.

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 and contaminate the solution.

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.

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.

5. After using Eyzeetan, the patient should press a finger into the corner of their eye, by the nose, for 2 minutes. This helps to stop Eyzeetan getting into the rest of the body. 6. Instructions 2. – 5. 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. 7. 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. 8. At the end of the 28-day in-use shelf life of the medicine, there will be some Eyzeetan 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.

3 mg/ml + 5 mg/ml eye drops, solution (preserved formulation) or for of the single active substances bimatoprost and timolol. No new adverse reactions specific for bimatoprost/timolol have been observed in clinical studies. 3mg/ml +5mg/ml eye drops, solution were ocular, mild in severity and none were serious.

4% of patients. 3mg/ml +5mg/ml eye drops, solution (within each frequency grouping, adverse reactions are presented in order of decreasing seriousness) or in the post-marketing period. The frequency of possible adverse reactions listed below is defined using the following convention: 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 Very rare <1/10,000 Not known Frequency cannot be estimated from available data Table 1 System Organ Class Frequency Adverse reaction Immune system disorders Not known hypersensitivity reactions including signs or symptoms of allergic dermatitis, angioedema, eye allergy Psychiatric disorders Not known Insomnia2, nightmare2 Common headache,Nervous system disorders Not known dysgeusia2, dizziness2 Eye disorders Very common conjunctival hyperaemia, prostaglandin analogue periorbitopathy Common punctuate keratitis, corneal erosion2, burning sensation2, conjunctival irritation1, eye pruritus, stinging sensation in the eye2, foreign body sensation, dry eye, erythema of eyelid, eye pain, photophobia, eye discharge2, visual disturbance2, eyelid pruritus, visual acuity worsened2, blepharitis2, eyelid oedema, eye irritation, lacrimation increased, growth of eyelashes Uncommon iritis2, conjunctival oedema2, eyelid pain2, abnormal sensation in the eye1, asthenopia, trichiasis2, iris hyperpigmentation2, periorbital and lid changes associated with periorbital fat atrophy and skin tightness resulting in deepening of eyelid sulcus, eyelid ptosis, enophthalmos, lagophthalmos and eyelid retraction1&2, eyelash discolouration (darkening)1.

Not known cystoid macular oedema2, eye swelling, vision blurred2. 3mg/ml +5mg/ml eye drops, solution preserved formulations Like other topically applied ophthalmic drugs, Eyzeetan is absorbed into the systemic circulation. Absorption of timolol may cause similar undesirable effects as seen with systemic beta-blocking agents.

The incidence of systemic ADRs after topical ophthalmic administration is lower than for systemic administration. 2. Additional adverse reactions that have been seen with either of the active substances (bimatoprost or timolol), and may potentially occur also with Eyzeetan are listed below in Table 2.

4)1, keratitis1, blepharospasm2, retinal haemorrhage2, uveitis2 Cardiac disorder atrioventricular block1, cardiac arrest1, arrhythmia1, cardiac failure1, congestive heart failure1, chest pain1, palpitations1, oedema1 Vascular disorders hypotension1, hypertension2, Raynaud’s phenomenon1, cold hands and feet1 Respiratory, thoracic and mediastinal disorders asthma exacerbation2, COPD exacerbation2, cough1 Gastrointestinal disorders nausea1,2, diarrhoea1, dyspepsia1, dry mouth1, abdominal pain1, vomiting1 Skin and subcutaneous tissue disorders psoriasiform rash1 or exacerbation of psoriasis1, skin rash1 Musculoskeletal and connective tissue disorders myalgia1 Reproductive system and breast disorders sexual dysfunction1, decreased libido1 General disorders and administration site conditions asthenia1,2 Investigations liver function tests (LFT) abnormal1 1 adverse reactions observed with timolol 2 adverse reactions observed with bimatoprost monotherapy Description of selected adverse reactions: Prostaglandin analogue periorbitopathy (PAP) Prostaglandin analogues including Eyzeetan can induce periorbital lipodystrophic changes which can lead to deepening of the eyelid sulcus, ptosis, enophthalmos, eyelid retraction, involution of dermatochalasis and inferior scleral show.

Changes are typically mild, can occur as early as one […]

Like other topically applied ophthalmic medicinal products, the active substances (timolol/ bimatoprost) in Eyzeetan may be absorbed systemically. 3mg/ml + 5mg/ml eye drops, solution (preserved formulation). Due to the beta-adrenergic component, timolol, the same types of cardiovascular, pulmonary and other adverse reactions as seen with systemic beta-blockers 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 receiving hypotension therapy with beta-blockers should be critically assessed and 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 the 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.

Eyzeetan 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. Endocrine disorders Beta-adrenergic blocking medicinal products should be administered with caution in patients subject to spontaneous hypoglycemia or to patients with labile diabetes as beta-blockers may mask the signs and symptoms of acute hypoglycemia.

Beta-blockers may also mask the signs of hyperthyroidism. Corneal diseases Ophthalmic beta-blockers may induce dryness of eyes. Patients with corneal diseases should be treated with caution. Other beta-blocking agents 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). Anaphylactic reactions 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 unresponsive to the usual dose of adrenaline used to treat anaphylactic reactions.

g. timolol, acetazolamide) after filtration procedures. g. of adrenaline. The anaesthesiologist should be informed when the patient is receiving timolol. Hepatic In patients with a history of mild liver disease or abnormal alanine aminotransferase (ALT), aspartate aminotransferase (AST) and/or bilirubin at baseline, bimatoprost had no adverse reactions on liver function over 24 months.

There are no known adverse reactions of ocular timolol on liver function. Ocular Before treatment is initiated, patients should be informed of the possibility of prostaglandin analogue periorbitopathy (PAP) during treatment with Eyzeetan.

3 mg/ml + 5 mg/ml eye drops, solution (preserved formulation). 8). 3 mg/ml + 5 mg/ml eye drops, solution (preserved formulation). g. intraocular surgery, retinal vein occlusions, ocular inflammatory disease and diabetic retinopathy). g.

uveitis) because the inflammation may be exacerbated. Skin There is a potential for hair growth to occur in areas where Eyzeetan solution comes repeatedly in contact with the skin surface. Thus, it is important to apply Eyzeetan as instructed and avoid it running onto the cheek or other skin areas.

Other conditions Eyzeetan has not been studied in patients with inflammatory ocular conditions, neovascular, inflammatory, angle-closure glaucoma, congenital glaucoma or narrow- angle glaucoma. 3 mg/ml in patients with glaucoma or ocular hypertension, it has been shown that more frequent exposure of the eye to more than 1 dose of bimatoprost daily may decrease the IOP-lowering effect.

Patients using Eyzeetan with other prostaglandin analogs should be monitored for changes to their intraocular pressure. Patients with a history of contact hypersensitivity to silver should not use this product as dispensed drops may contain traces of silver.

1. • Reactive airway disease including bronchial asthma or a history of bronchial asthma, severe chronic obstructive pulmonary disease. • Sinus bradycardia, sick sinus syndrome, sino-atrial block, second or third degree atrioventricular block, not controlled with pace-maker.

Overt cardiac failure, cardiogenic shock.