GLAUCOL

25% solution in the affected eye(s) twice a day. 5% solution in the affected eye(s) twice daily. If required Timolol Maleate ophthalmic solution may be used with miotics, adrenaline or systemically-administered carbonic anhydrase inhibitors.

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. Intra-ocular pressure should be reassessed approximately four weeks after starting treatment because response to Timolol Maleate eye-drops may take a few weeks to stabilise.

25% eye-drops started the next day with one drop twice daily in the affected eye(s). 5% solution twice daily. 25% Timolol solution in the affected eye(s) twice daily. On the following day the previous agent should be discontinued and Timolol Maleate continued.

5% solution twice daily if the clinical response is inadequate.

Use in the elderly:

There is a wide difference with the usage of this product in elderly patients. The dosage recommendations above reflect the clinical data derived from this experience.

Use in children:

Due to limited data, Timolol could only be recommended for use in Primary congenital and primary juvenile glaucoma for a transitional period while decision is made on a surgical approach and in case of failed surgery while awaiting further options.

Posology:

Clinicians should strongly evaluate the risks and benefits when considering medical therapy with Timolol in paediatric patients. A detailed paediatric history and examination to determine the presence of systemic abnormalities should precede the use of Timolol.

1). However, if benefit outweighs the risk, it is recommended to use the lowest active agent concentration available once daily. If IOP could not be sufficiently controlled, a careful up titration to a maximum of two drops daily per affected eye has to be considered.

If applied twice daily, an interval of 12 hours should be preferred. Furthermore the patients, especially neonates, should be strongly observed after the first dose for one to two hours in the office and closely monitored for ocular and systemic side effects until surgery is performed.

1% active agent concentration might already be sufficient.

Method of administration:

To limit potential adverse effects only one drop should be instilled per dosing time. g. for 3 - 5 minutes) after instillation of drops. 2.

Duration of treatment:

For a transient treatment in the paediatric population Route of Administration: topical eye-drops.

Timolol Maleate ophthalmic solution is usually well tolerated. Like other topically applied ophthalmic drugs, 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. Listed adverse reactions include reactions seen within the class of ophthalmic beta-blockers.

Immune system disorders:

Systemic allergic reactions including angioedema, urticaria, localised and generalised rash, pruritus, anaphylactic reaction.

Metabolism and nutrition disorders:

Hypoglycaemia Psychiatric disorders: Insomnia, depression, nightmares, memory loss Nervous system disorders: Syncope, cerebrovascular accident, cerebral ischemia, increases in signs and symptoms of myasthenia gravis, dizziness, paraesthesia, and headache.

g. 4 Special warnings and special precautions for use), decreased corneal sensitivity, dry eyes, corneal erosion, ptosis, diplopia Cardiac disorders: Bradycardia, chest pain, palpitations, oedema, arrhythmia, congestive heart failure, atrioventricular block, cardiac arrest, cardiac failure Vascular disorders: Hypotension, Raynaud's phenomenon, cold hands and feet Respiratory, thoracic, and mediastinal disorders: Bronchospasm (predominantly in patients with pre-existing bronchospastic disease), dyspnoea, cough Gastrointestinal disorders: Dysgeusia, nausea, dyspepsia, diarrhoea, dry mouth, abdominal pain, vomiting Skin and subcutaneous tissue disorders: Alopecia, psoriasiform rash or exacerbation of psoriasis, skin rash Musculoskeletal and connective tissue disorders: Myalgia Reproductive system and breast disorders: Sexual dysfunction, decreased libido General disorders and administration site conditions: Asthenia/fatigue

Like other topically applied ophthalmic drugs, Timolol Maleate ophthalmic solution may be absorbed systemically and due to the beta-adrenergic component, timolol, the same types of cardiovascular, pulmonary and other adverse reactions seen with systemically administered beta-blockers may occur.

Incidence of systemic ADRs after topical ophthalmic administration is lower than for system 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 closely observed 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. Timolol ophthalmic 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.

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.

Corneal diseases:

Ophthalmic β-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 exaggerated when Timolol Maleate ophthalmic solution is given to patients already receiving an oral beta-blocking agent. The response of these patients should be closely watched.

5).

Anaphylactic reactions:

While taking beta-blockers, patients with 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. 2). It is important to notify the parents of potential side effects so they can immediately discontinue the drug therapy. Signs to look for are for example coughing and wheezing.

Because of the possibility of apnoea and Cheyne-Stokes breathing, the drug should be used with extreme caution in neonates, infants and younger children. A portable apnoea monitor may also be helpful for neonates on Timolol. If Timolol Maleate ophthalmic solution is used to reduce elevated intra-ocular pressure in angle closure glaucoma it should be used with a miotic and not alone.

There have been reports of skin rashes and/or dry eyes associated with the use of beta-adrenergic receptor blocking drugs. The reported incidence is small and in most cases the symptoms have cleared when treatment was withdrawn. Discontinuation of the drug should be considered if any such reaction is not otherwise explicable.

Cessation of therapy involving beta-blockade should be gradual.

• Reactive airway disease including bronchial asthma, history of bronchial asthma, or severe chronic obstructive pulmonary disease • sinus bradycardia, sick sinus syndrome sino-artial block, second and third degree AV block not controlled with a pace-maker, overt cardiac failure, cardiogenic shock • hypersensitivity to the active substance (Timolol Maleate), or other beta-blocking agents, or to any of the excipients