GLAUCOPT

Posology The dose is one drop of Glaucopt in the conjunctival sac of each affected eyetwice a day. Paediatric population The efficacy in paediatric patients has not been established. Safety in paediatric patients below 2 years of age has not been established.

1 but no recommendation on a posology can be made. Method of administration If another topical ophthalmic agent is being used, Glaucopt and the otheragent should be administered at least 10 minutes apart. Patients should wash their hands before use and prevent the tip of the dropperfrom coming into contact with the eye or surrounding areas.

Patients should also be informed that ophthalmic solutions, if handled improperly, can become contaminated by common bacteria that are known tocause eye infections. The use of infected solutions can cause serious damage to the eye and mayresult in subsequent loss of vision.

Single-dose-container This medicine is a sterile solution with no preservatives. The solution in each single-dose container must be used immediately after opening on the affected eye(s). Since sterility cannot be guaranteed after opening the single-dose container, any residues of the contents must be discarded immediately after use.

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

Summary of the safety profile In clinical trials with Glaucopt eye drops, the adverse reactions observed wereconsistent with those previously reported with dorzolamide hydrochloride and/or timolol maleate. During clinical trials, 1035 patients were treated with eye drops based on dorzolamide and timolol.

2% of all patients discontinued therapy due to local adverse reactions indicative of allergy or hypersensitivity (such as inflammation of theeyelid and conjunctivitis). Timolol maleate is absorbed into the systemic circulation. This can cause adverse reactions similar to those seen with systemic beta-blocking agents.

Theincidence of systemic adverse drug reactions after topical ophthalmic administration is lower than for systemic administration. Tabulated summary of adverse reactions The following adverse reactions have been reported with Glaucopt or one ofits active substances during clinical trials or in the post-marketing setting.

4) itching, tearing, redness, blurred vision, erosion of the cornea 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 atrioventricu lar block, heart failure dorzolamide hydrochloride eye drops, solution Palpitations , tachycardia Vascular diseases timolol maleate eye drops, solution hypotension *, claudication, Raynaud's phenomenon *, cold hands and feet * dorzolamide hydrochlorid e eye drops, solution hypertensio n Classification for systems and organs (MedDRA) Formulation Very common Common Uncommo n Rare Not Known ** Respiratory, thoracic and mediastinal disorders dorzolamide timolol eye drops, solution sinusitis shortness of breath, respiratory failure, rhinitis, rarely bronchospas m dyspnoea dorzolamide hydrochloride eye drops, solution epistaxis* timolol maleate eye drops, solution bronchospas m (mainly in patients with a history of pre-existing bronchospasti c disease) *, respiratory failure, cough * dyspnoea* Gastrointesti nal disorders dorzolamide timolol eye drops, solution dysgeusia dorzolamide hydrochloride eye drops, solution nausea* throat irritation, dry mouth * timolol maleate eye drops, solution nausea *, dyspepsia * diarrhoea, dry mouth * dysgeusia, abdominal pain, vomiting Skin and subcutaneous tissue disorders Dorzolamide Timolol eye drops, solution contact dermatitis, Stevens- Johnson syndrome, toxic epidermal necrolysis Classification for systems and organs (MedDRA) Formulation Very common Common Uncommo n Rare Not Known ** dorzolamide hydrochloride eye drops, solution skin rash * timolol maleate eye drops, solution alopecia *, psoriasiform rash or exacerbation of psoriasis * skin rash Musculoskele tal and connective tissue disorders timolol maleate eye drops, solution systemic lupus erythematosu s myalgia Renal and urinary disorders Dorzolamide Timolol eye drops, solution urolithiasi s Reproductive system and breast disorders timolol maleate eye drops, solution Peyronie’s disease *, decreased libido sexual dysfunction General disorders and administratio n site conditions dorzolamide hydrochloride eye drops, solution asthenia/ fatigue* timolol maleate eye drops, solution asthenia/ tiredness * * These adverse reactions were also observed with Dorzolamide Timolol eye drops solution during post-marketing experience.

Cardiovascular / respiratory reactions Timolol maleate is absorbed systemically. The active substance timolol maleate is a beta-blocker, therefore, with topical administration the same types of cardiovascular, pulmonary and other adverse reactions may occur with systemic administration of beta-blockers.

The incidence of systemic adverse drug reactions after topical ophthalmic administration is lower than for systemic administration. 2. , coronary heart disease, Prinzmetal angina and heart failure) and hypotension, beta-blocker therapy should be critically evaluated and therapy with other active substances should be considered.

Patients with cardiovascular disease should be monitored for signs of deterioration of these diseases and adverse reactions. Due to the adverse effect on conduction time, beta-blockers should always be administered 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 asthmatic patients, have been reported following administration of some ophthalmicbeta-blockers.

Glaucopt 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 Glaucopt has not been studied in patients with hepatic impairment andshould therefore be used with caution in such patients.

Immunology and Hypersensitivity Glaucopt may be absorbed systemically. Dorzolamide contains a sulfonamide group, which is also found 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.

1. • Reactive diseases of the airways, including bronchial asthma or a history of a bronchial asthma, or severe chronic obstructive pulmonary disease. • Sinus bradycardia, sick sinus syndrome, sino-atrial block, second or third degree non-controlled atrioventricular block not controlled with a pacemaker, overt cardiac failure, cariogenic shock.

• Severe renal impairment (creatinine clearance <30 ml/min) or hyperchloraemic acidosis. The contraindications listed above are based on the active substances and are not unique to the combination.