Adverse Events

Vizidor 20 mg/ml eye drops solution Prescribing Information

Please refer to Summary of Product Characteristics before prescribing. Further information about this product can be requested from the Marketing Authorisation Holder or may be found in the Summary of Product Characteristics.

Contains: Each ml contains 20 mg of dorzolamide (as dorzolamide hydrochloride).

Main Indications and Dosage: as adjunctive therapy to beta-blockers, as monotherapy in patients unresponsive to beta-blockers or in whom beta- blockers are contraindicated, in the treatment of elevated intra-ocular pressure in ocular hypertension, open-angle glaucoma and pseudoexfoliative glaucoma.
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. 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. Vizidor 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 pediatric patients with administration of dorzolamide (preserved formulation) three times a day are available. (For information regarding pediatric dosing see section 5.1 of the SmPC).

Administration: Before instillation of the eye drops users should be instructed to wash their hands before opening the bottle and 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). Please see section 4.2 of the SmPC for the full method of administration and accompanying diagrams.

Patients must not use the eye drops for longer than 28 days after first opening the bottle.

Contraindications, Precautions and Warnings: 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. If allergic reactions (e.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. Vizidor 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.

Fertility, Pregnancy and Lactation: Dorzolamide should not be used during pregnancy. There are no or limited amount of data from the use of dorzolamide in pregnant women. It is unknown whether dorzolamide metabolites are excreted in human milk. Available pharmacodynamic/toxicological data in animals have shown excretion of dorzolamide/metabolites in milk. See section 4.6 of the SmPC for more detail.

Undesirable effects: Nervous system disorders: Common: headache. Rare: dizziness and paraesthesia. Eye disorders: Very Common: burning and stinging. Common: superficial punctate keratitis, tearing, conjunctivitis, eyelid inflammation, eye itching, eyelid irritation, blurred vision. Uncommon: iridocyclitis. Rare: irritation including redness, pain, eyelid crusting, transient myopia (which resolved upon discontinuation of therapy), corneal oedema, ocular hypotony, choroidal detachment following filtration surgery. Not Known: foreign body sensation in eye. Cardiac disorders: Not Known: palpitations. Respiratory, thoracic, and mediastinal disorders: Rare: epistaxis. Not Known: dyspnoea. Gastrointestinal disorders: Common: nausea, bitter taste. Rare: throat irritation, dry mouth. Skin and subcutaneous tissue disorders: Rare: dermatitis, Stevens-Johnson syndrome, toxic epidermal necrolysis. Renal and urinary disorders: Rare: urolithiasis. General disorders and administration site conditions: Common: asthenia/ fatigue. Please see section 4.8 of the SmPC for more details on undesirable effects.
For information regarding the paediatric population see section 5.1 of the SmPC.

Legal Category: POM.
Vizidor 20 mg/ml eye drops solution UK PL No: PL 03468/0087
Basic NHS Price: £ 7.09
Marketing Authorisation Holder:
Bausch & Lomb UK Ltd., Bausch & Lomb House, 106 London Road, Kingston-upon-Thames, Surrey, KT2 6TN, UK
Date of Revision: June 2023
PIP Code: 4180337

Vizidor Duo 20 mg/ml + 5 mg/ml eye drops solution Prescribing Information

Please refer to Summary of Product Characteristics before prescribing. Further information about this product can be requested from the Marketing Authorisation Holder or may be found in the Summary of Product Characteristics.

Contains: Each ml contains 20 mg of dorzolamide (as dorzolamide hydrochloride) and 5 mg of timolol (as maleate). Main Indications and Dosage: Indicated in the treatment of elevated intraocular pressure (IOP) in patients with open-angle glaucoma or pseudoexfoliative glaucoma when topical beta-blocker monotherapy is not sufficient. 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.

Administration: Before instillation of the eye drops users should be instructed to wash their hands before opening the bottle and 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). Please see section 4.2 of the SmPC for the full method of administration and accompanying diagrams. Patients must not use the eye drops for longer than 28 days after first opening the bottle. Paediatric population: Efficacy in paediatric patients has not been established.

Safety in paediatric patients below the age of 2 years has not been established. (For information regarding safety in paediatric patients ≥ 2 and < 6 years of age, see section 5.1 of the SmPC). Contraindications, Precautions and Warnings: Vizidor Duo eye drops solution is contraindicated in patients with reactive airway disease, including bronchial asthma or a history of bronchial asthma, or severe chronic obstructive pulmonary disease; sinus bradycardia, sick sinus syndrome, sino-atrial block, second or third degree atrioventricular block not controlled with pacemaker, overt cardiac failure, cardiogenic shock; severe renal impairment (CrCl < 30 ml/min) or hyperchloraemic acidosis and hypersensitivity to one or both active substances or to any of the excipients listed in section 6.1 of the SmPC. 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. To reduce the systemic absorption, see section 4.2 of the SmPC. Cardiac disorders: In patients with cardiovascular diseases (e.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. Vascular disorders:
Patients with severe peripheral circulatory disturbance/disorders (i.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 betablockers, 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. The use of two topical beta-adrenergic blocking agents is not recommended (see section 4.5 of the SmPC). 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. Surgical anaesthesia: Beta-blocking ophthalmological preparations may block systemic beta-agonist effects e.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. Choroidal detachment has been reported with administration of aqueous suppressant therapies (e.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 stabilisation. Patients with a history of contact hypersensitivity to silver should not use this product as dispensed drops may contain traces of silver. Contact Lens Use: This medicinal product has not been studied in patients wearing contact lenses Paediatric population: See section 5.1 of the SmPC.

Fertility, Pregnancy and Lactation: Vizidor Duo should not be used during pregnancy. There is no adequate clinical data from the use of dorzolamide and timolol in pregnant women. See section 4.6 of the SmPC for more detail.

Undesirable effects (Dorzolamide/Timolol Preservative-Free): Immune system disorders: Rare: signs and symptoms of systemic allergic reactions, including angioedema, urticaria, pruritus, rash, anaphylaxis. Eye disorders: Very Common: burning and stinging. Common: conjunctival injection, blurred vision, corneal erosion, ocular itching, tearing. Respiratory, thoracic, and mediastinal disorders: Common: sinusitis. Rare: shortness of breath, respiratory failure, rhinitis, rarely bronchospasm. Gastrointestinal disorders: Very Common: dysgeusia. Skin and subcutaneous tissue disorders: Rare: contact dermatitis, Stevens-Johnson syndrome, toxic epidermal necrolysis. Renal and urinary disorders: Uncommon: urolithiasis. Undesirable effects (Timolol maleate eye drops, solution): Immune system disorders: Rare: signs and symptoms of allergic reactions including angioedema, urticaria, localised and generalised rash, anaphylaxis. Not Known: pruritus. Metabolism and nutrition disorders: Not Known: Hypoglycaemia. Psychiatric disorders: Uncommon: depression. Rare: insomnia, nightmares, memory loss. Not Known: hallucination. Nervous system disorders: Common: headache. Uncommon: dizziness, syncope. Rare: paraesthesia, increase in signs and symptoms of myasthenia gravis, decreased libido, cerebrovascular accident, cerebral ischaemia. Eye disorders: Common: signs and symptoms of ocular irritation including blepharitis, keratitis, decreased corneal sensitivity, and dry eyes. Uncommon: visual disturbances including refractive changes (due to withdrawal of miotic therapy in some cases). Rare: ptosis, diplopia, choroidal detachment following filtration surgery (see section 4.4 of the SmPC). Not Known: itching, tearing, redness, blurred vision, corneal erosion. Ear and labyrinth disorders: Rare: tinnitus. Cardiac disorders: Uncommon: bradycardia. Rare: chest pain, palpitation, oedema, arrhythmia, congestive heart failure, cardiac arrest, heart block. Unknown: atrioventricular block, cardiac failure. Vascular disorders: Rare: hypotension, claudication, Raynaud’s phenomenon, cold hands and feet. Respiratory, thoracic, and mediastinal disorders: Uncommon: dyspnoea. Rare: bronchospasm (predominantly in patients with preexisting bronchospastic disease), respiratory failure, cough. Gastrointestinal disorders: Uncommon: nausea, dyspepsia. Rare: diarrhoea, dry mouth. Not Known: dysgeusia, abdominal pain, vomiting. Skin and subcutaneous tissue disorders: Rare: alopecia, psoriasiform rash or exacerbation of psoriasis. Not Known: skin rash. Musculoskeletal and connective tissue disorders: Rare: systemic lupus erythematosus. Not Known: myalgia. Reproductive system and breast disorders: Rare: Peyronie’s disease, decreased libido. Not Known: sexual dysfunction. General disorders and administration site conditions: Uncommon: asthenia/ fatigue. Undesirable effects (Dorzolamide hydrochloride eye drops, solution): Nervous system disorders: Common: headache. Rare: dizziness, paraesthesia. Eye disorders: Common: eyelid inflammation, eyelid irritation. Uncommon: iridocyclitis. Rare: irritation including redness, pain, eyelid crusting, transient myopia (which resolved upon discontinuation of therapy), corneal oedema, ocular hypotony, choroidal detachment (following filtration surgery). Not Known: foreign body sensation in eye. Cardiac disorders: Not Known: palpitations, tachycardia. Vascular disorders: Not Known: hypertension. Respiratory, thoracic, and mediastinal disorders: _Rare: epistaxis. Not Known: dyspnoea. Gastrointestinal disorders: Common: nausea. Rare: throat irritation, dry mouth. Skin and subcutaneous tissue disorders: Rare: rash. General disorders and administration site conditions: Common: asthenia/ fatigue. Please see section 4.8 of the SmPC for more details on undesirable effects.

Legal Category: POM.
Vizidor Duo 20 mg/ml + 5 mg/ml UK PL No: PL 03468/0088
Basic NHS Price: £ 8.14
Marketing Authorisation Holder:
Bausch & Lomb U.K. Ltd., Bausch & Lomb House, 106 London Road, Kingston-upon-Thames, Surrey, KT2 6TN, UK
Date of Revision: June 2023
PIP Code: 4180345