Country: New Zealand
Language: English
Source: Medsafe (Medicines Safety Authority)
Timolol maleate 3.42 mg/mL equivalent to 2.5 mg/mL timolol
Mundipharma New Zealand Ltd
Timolol maleate 3.42 mg/mL (=2.5 mg/mL timolol)
0.25 %
Eye drops, solution
Active: Timolol maleate 3.42 mg/mL equivalent to 2.5 mg/mL timolol Excipient: Benzododecinium bromide Gelrite Mannitol Trometamol Water for injection
Bottle, plastic, 2.5mL sample pack, 2.5 mL
Prescription
Prescription
Fareva La Vallee
Package - Contents - Shelf Life: Bottle, plastic, sample pack - 2.5 mL - 36 months from date of manufacture stored at or below 30°C - Bottle, plastic, Occumeter Plus-HDPE(Lupolen) - 2.5 mL - 36 months from date of manufacture stored at or below 30°C
1993-07-07
CONSUMER MEDICINE INFORMATION 1 TIMOPTOL-XE ® _timolol maleate_ 2.5 mL ophthalmic solution WHAT IS IN THIS LEAFLET This leaflet answers some common questions about TIMOPTOL-XE. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits. Your doctor has weighed the risks of you using TIMOPTOL-XE against the benefits they expect it will have for you. If you have any concerns about using this medicine, ask your doctor or pharmacist. Keep this leaflet with the medicine. You may need to read it again. WHAT TIMOPTOL-XE IS USED FOR TIMOPTOL-XE is used to lower raised pressure in the eye and to treat glaucoma. Glaucoma is a condition in which the pressure of fluid in the eye may be high. However, some people with glaucoma may have normal eye pressure. Also, some people with raised eye pressure may not have glaucoma. Glaucoma is usually caused by a build up of the fluid, which flows through the eye. This build up occurs because the fluid drains out of your eye more slowly than it is being pumped in. Since new fluid continues to enter the eye, joining the fluid already there, the pressure continues to rise. This raised pressure may damage the back of the eye resulting in gradual loss of sight. Damage can progress so slowly that the person is not aware of this gradual loss of sight. Sometimes even normal eye pressure is associated with damage to the back of the eye. There are usually no symptoms of glaucoma. The only way of knowing that you have glaucoma is to have your eye pressure, optic nerve and visual field checked by an eye specialist or optometrist. If glaucoma is not treated it can lead to serious problems. You may have no symptoms but eventually glaucoma can lead to total blindness. In fact, untreated glaucoma is one of the most common causes of blindness. Although TIMOPTOL-XE helps control your glaucoma it does not cure it. For more information about glaucoma, contact Glaucoma New Zealand, Department of Ophthalmology Read the complete document
NEW ZEALAND DATA SHEET TIMOPTOL-XE® TIM-XE002 18 Mar 2020 Page 1 of 14 TIMOPTOL-XE® OPHTHALMIC GEL FORMING SOLUTION Timolol maleate 1 PRODUCT NAME TIMOPTOL-XE® 0.25% Ophthalmic Gel Forming Solution TIMOPTOL-XE® 0.5% Ophthalmic Gel Forming Solution 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each mL of TIMOPTOL-XE 0.25% contains 2.5 mg of timolol (3.4 mg of timolol maleate). Each mL of TIMOPTOL-XE 0.5% contains 5.0 mg of timolol (6.8 mg of timolol maleate). Excipient(s) with known effect: Benzododecinium bromide 0.012% is added as preservative. For full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Eye drops solution. A colourless to nearly colourless, slightly opalescent, slightly viscous, aqueous ophthalmic solution. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS TIMOPTOL-XE is indicated for the reduction of elevated intraocular pressure in patients with: ocular hypertension chronic open-angle glaucoma aphakic glaucoma secondary glaucoma (some cases) narrow angles and a history of spontaneous or iatrogenically induced narrow-angle closure in the opposite eye in whom reduction of intraocular pressure is necessary (see section 4.4) 4.2 DOSE AND METHOD OF ADMINISTRATION The usual starting dose is one drop of 0.25% TIMOPTOL-XE in the affected eye(s) once a day. If the clinical response is not adequate, the dosage may be changed to one drop of 0.5% TIMOPTOL-XE in the affected eye(s) once a day. Invert the closed container and shake once before each use. It is not necessary to shake the container more than once. If needed, concomitant therapy with other agent(s) for lowering intraocular pressure may be given with TIMOPTOL-XE. The use of two topical beta-adrenergic blocking agents is not recommended (see section 4.4). Other topically applied medications should be administered no less than 10 minutes before TIMOPTOL-XE. NEW ZEALAND DATA SHEET TIMOPTOL-XE® TIM-XE002 18 Mar 2020 Page 2 of 14 When using nasolacrimal occlusion or closing the eyelids for 2 minutes, the systemic absorpt Read the complete document