Risk Management Plan. Elements for a public summary. VI.2.1 Overview of disease epidemiology

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1 VI.2 Elements for a public summary VI.2.1 Overview of disease epidemiology Dorzolamide/Timolol is used to reduce pressure in the eye in relatively common conditions known as open angle glaucoma or pseudoexfoliative glaucoma which result from a build-up of fluid. Around 2% of people older than 40 years of age have long-term open angle glaucoma, a figure which rises to almost 10% in people older than 75 years. 1 Untreated open angle glaucoma leads to gradual vision loss. Hence, prevention or at least minimisation of ongoing damage is paramount to maintenance of vision. Pseudoexfoliative glaucoma is less common. 1

2 Risk factors for open-angle glaucoma include increased age, African ethnicity, family history and other eye disorders 1, for pseudoexfoliative glaucoma include sex (female gender), age (rarely seen before age 50) and Scandinavian origin 2. VI.2.2 Summary of treatment benefits In clinical studies, the effect of the dorzolamide and timolol eye drops prescribed in combination to reduce eye pressure has been shown to be greater than when either substance is administered alone. The eye pressure lowering effect has been demonstrated when measured at various time points throughout the day and has been maintained during long-term administration. The effect was also similar in patients given dorzolamide-timolol in a fixed combination compared to a group that received treatment with separate drops of dorzolamide and timolol. The benefit of dorzolamide timolol fixed combination lies in the simplification of the dosing regimen by reducing the prescribed number of doses per day. It has been documented that less frequent dosing regimens results in better adherence to the drug dosage regimen by patients 3 Use of the fixed combination also decreases the load of preservatives (chemicals that discourage the growth of bacteria that may irritate eyes once the bottle has been opened) to which the patient s eyes are exposed. In addition, it eliminates the effects of the need for the first instilled drug to be diluted or washed out by the second instilled drug, when two drugs are administered separately. 4 VI.2.3 Unknowns relating to treatment benefits Currently, there is a lack of data regarding the the use of dorzolamide/timolol in paediatric populations, in pregnant women/lactating mothers and patients with hepatic or severe renal impairment. VI.2.4 Summary of safety concerns Table 42 Important identified risks Important Identified Risk What is known Preventability Generalized effects in the body associated with a group of medicines known as betablockers in which timolol belongs (systemic beta-blockade associated side effects) Like other medicines applied into eyes, Dorzolamide/Timolol is absorbed into the blood. This may cause similar side effects as seen with systemic intra-venous and/or oral beta-blocking agents. Side effects after topical application into the eyes are lower than when medicines are, for example, taken by mouth or injected. Pressing the finger against the corner of the closed eye (the side where the eye meets the nose) and holding for 2 minutes. This helps to stop timolol getting into the rest of the body.

3 Heart (cardiac) disorders Circulatory (vascular) disorders Breathing (respiratory) disorders Low blood sugar (hypoglycaemia/diabetes) Interaction with surgical anaesthesia Drug interaction with other medicinal products that belong to the same group of medicines as timolol and dorzolamide ( betablocking agents ), and with other medicinal products (e.g. CYP2D6 inhibitors, adrenaline) This medicinal product can cause disturbances of heart rate such as slow heart beat (bradycardia), worsening of angina and awareness of heart rhythm (palpitations). This medicinal product can cause low blood pressure (hypotension), poor blood circulation disease (such as Raynaud s disease or Raynaud s syndrome) and cold hands and feet. This medicinal product can cause asthma, worsening of asthma, shortness of breath and worsening of pre-existing reactive respiratory diseases that can lead to a fatal outcome. Timolol may mask signs and symptoms of low blood sugar, which is a frequent sign of individuals with diabetes. Dorzolamide/Timolol may change the effect of some medicines used during anaesthesia. The medicinal product interacts with drugs used to treat high blood pressure such as oral calcium channel blockers, guanethidine, beta-blockers; antiarrhythmics (medications that normalise the heart rhythm); digitalis glycosides (used to treat heart failure); parasympathomimetic agents (e.g. for the treatment of high blood pressure); quinidine (used to treat heart conditions and some types of malaria); antidepressants known as monoamine oxidase inhibitors, fluoxetine and paroxetine. The interaction could lead to the hypotension (low blood pressure) and bradycardia (slow heart beat). The effect on the eye pressure or the known effects of generalised Patients with poor heart conditions (cardiac disorders) should be monitored closely by the attending physician. The doctor and/or pharmacist should be aware of this condition. Patients with poor blood circulation disease (such as Raynaud s disease or Raynaud s syndrome) should be monitored closely by the attending physician. The doctor and/or pharmacist should be aware of this condition. The medicinal product should not be used in patients that have or have a history of respiratory problems such as asthma, severe chronic obstructive bronchitis (severe lung disease which may cause wheeziness, difficulty in breathing and/or long-standing cough). Patients with low blood sugar (hypoglycaemia)/diabetes should be monitored closely by the attending physician. The doctor and/or pharmacist should be aware of this condition. The anaesthesiologist should be informed when the patient is receiving timolol. The doctor or pharmacist should be aware if the patient is taking any type of these medicinal products. This situation should be closely monitored by a healthcare professional.

4 Severe sudden life-threatening allergic reaction (anaphylactic reaction) Eye (ophthalmic) disorders (including corneal disorders and choroidal detachment) effects may be potentiated when timolol is given to the patients already receiving a beta-blocking agent. The use of two local betablockers is not recommended. Allergic reactions include swelling beneath the skin that can occur in areas such as the face and limbs and can obstruct the airway which may cause difficulty swallowing or breathing, (angioedema) hives or itchy rash, localized and generalized rash, itchiness, severe sudden life-threatening allergic reaction (anaphylactic reaction). These allergic reactions can be associated with the use of Dorzolamide/Timolol. Signs and symptoms of eye irritation (e.g. burning, stinging, itching, tearing, redness), inflammation of the eyelid, inflammation in the cornea, blurred vision, choroidal detachment (detachment of the layer below the retina that contains blood vessels following filtration surgery which may cause visual disturbances), decreased corneal sensitivity, dry eyes, corneal erosion (damage to the front layer of the eyeball), drooping of the upper eyelid (making the eye stay half closed) and double vision are effects that can be associated with use of Dorzolamide/Timolol. The medicinal product should not be used in the patients that are allergic to dorzolamide or timolol or beta-blockers (group of medicines which timolol belongs), or any of the other ingredients of Dorzolamide/Timolol. The doctor or pharmacist should be aware if the patient has now or has had in the past suffering from severe allergic reactions that would usually require hospital treatment. The doctor or pharmacist should be aware if the patient has any kind of eye surgery (including cataract surgery) or has had any kind of eye surgery in the past), if the patient suffer from eye problems (such as eye pain, eye irritation, eye inflammation or blurred vision) or if the patient suffers from dry eyes. These situations should be closely monitored by the healthcare professionals. Table 43 Important potential risks Important Potential Risk Severe hypersensitivity reactions (undesirable reaction produced by the immune system) associated with sulfonamide group (part of the dorzolamide molecule) What is known (including reason why it is considered a potential risk) Dorzolamide molecule contains a sulfonamide group, which also occurs in sulphonamides (several groups of drugs used e.g. as antibacterial drugs, anti-diabetic drugs and drugs against high blood pressure). The same types of adverse reactions found with systemic administration (into the circulatory system, the entire body is affected) of sulphonamides may occur with local administration (e.g. eye drops), including severe reactions such as Stevens-Johnson syndrome and toxic

5 Urinary tract stones (urolithiasis) epidermal necrolysis (rare, potentially deadly skin diseases in which the skin and mucous membranes react severely with the loosing of outer layer). Causal relationship with medicinal product is identified as an area requiring confirmation or further investigation. Oral therapy with the similar drugs as dorzolamide (oral carbonic anhydrase inhibitors) is associated with urinary tract stones (urolithiasis), especially in patients with a prior history of kidney stone. Causal relationship between dorzolamide administration into eyes and urinary tract stones (urolithiasis) required further investigations. Table 44 Missing information Missing Information Use in children and adolescents (from birth to 18 years of age) Use in pregnancy/breast-feeding Use in patients with liver or severe kidney problems What is known Efficacy in children and adolescent patients has not been established. Safety in children under the age of two years has not been established. Dorzolamide/Timolol is not recommended for children or adolescents. There are no adequate data from the use of Dorzolamide/Timolol in pregnant or breast-feeding women. Studies in animals have shown reproductive toxicity. The potential risk for humans is unknown. If Dorzolamide/Timolol is administered until delivery, the neonate should be carefully monitored during the first days of life. Consequently Dorzolamide/Timolol should not be used during pregnancy and lactation. If treatment with Dorzolamide/Timolol is required, then breast feeding is not recommended. Dorzolamide/Timolol has not been study in patients with liver impairment and should therefore be used with caution in such patients. VI.2.5 Summary of risk minimisation measures by safety concern All medicines have a Summary of Product Characteristics (SmPC) which provides physicians, pharmacists and other health care professionals with details on how to use the medicine, the risks and recommendations for minimising them. An abbreviated version of this in lay language is provided in the form of the package leaflet (PL). The measures in these documents are known as routine risk minimisation measures.

6 The Summary of Product Characteristics and the Package leaflet for Dorzolamide/Timolol Eye Drops, Solution can be found attached to this document. This medicine has no additional risk minimisation measures. VI.2.6 Planned post-authorisation development plan (if applicable) Not applicable. VI.2.7 Summary of changes to the risk management plan over time Table 45 Major changes to the Risk Management Plan over time Version Date Safety concerns Comment Not applicable. Not applicable. Not applicable. Not applicable.

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