Land: Australia
Språk: engelsk
Kilde: Department of Health (Therapeutic Goods Administration)
timolol maleate, Quantity: 3.42 mg/mL (Equivalent: timolol, Qty 2.5 mg/mL)
Mundipharma Pty Ltd
Eye Drops, solution
Excipient Ingredients: benzalkonium chloride; monobasic sodium phosphate; dibasic sodium phosphate dodecahydrate; water for injections; sodium hydroxide
Ophthalmic
5mL
Medicine Registered
(S4) Prescription Only Medicine
TIMOPTOL Ophthalmic Solution is indicated for the reduction of elevated intraocular pressure. In clinical trials it has been shown to reduce intraocular pressure in: Patients with ocular hypertension - Patients with chronic open-angle glaucoma - Aphakic patients with glaucoma.
Visual Identification: Clear colourless solution; Container Type: Bottle; Container Material: HDPE; Container Life Time: 3 Years; Container Temperature: Store below 30 degrees Celsius; Container Closure: Restricted flow insert
Registered
1991-10-30
TIMOPTOL ® EYE DROPS 1 TIMOPTOL ® Timolol maleate Consumer Medicine Information What is in this leaflet This leaflet answers some common questions about TIMOPTOL. 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 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 is used for TIMOPTOL 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 helps control your glaucoma it does not cure it. For more information about glaucoma, contact Glaucoma Australia Inc., PO Box 420, Crows Nest 1585, telephone 1800 500 88 read_full_document
TIMOPTOL® EYE DROPS Page 1 of 12 AUSTRALIAN PRODUCT INFORMATION – TIMOPTOL ® [TIMOLOL (AS MALEATE)] EYE DROPS 1 NAME OF THE MEDICINE Timolol maleate 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each mL of TIMOPTOL 0.25% contains 2.5 mg of timolol (3.4 mg of timolol maleate). Each mL of TIMOPTOL 0.5% contains 5.0 mg of timolol (6.8 mg of timolol maleate). List of excipient(s) with known effect: benzalkonium chloride. For the full list of excipients, see Section 6.1 List of excipients. 3 PHARMACEUTICAL FORM Eye drops, solution. Clear, colourless sterile solution. 4 CLINICAL PARTICULARS 4.1 T HERAPEUTIC INDICATIONS TIMOPTOL is indicated for the reduction of elevated intraocular pressure. In clinical trials it has been shown to reduce intraocular pressure in: Patients with ocular hypertension Patients with chronic open-angle glaucoma Aphakic patients with glaucoma 4.2 D OSE AND METHOD OF ADMINISTRATION Recommended therapy is one drop of 0.25% solution in the affected eye twice a day. If clinical response is not adequate, dosage may be changed to one drop of 0.5% solution in each affected eye twice a day. If needed, concomitant therapy with miotics, adrenaline (epinephrine) and systemically administered carbonic anhydrase inhibitors may be instituted. The use of two topical beta-adrenergic blocking agents is not recommended (see Section 4.4 Special Warnings and Precautions for Use). Since in some patients the pressure-lowering response to TIMOPTOL may require a few weeks to stabilise, evaluation should include a determination of intraocular pressure after approximately 4 weeks of treatment with TIMOPTOL. If the intraocular pressure is maintained at satisfactory levels, many patients can be placed on once-a-day therapy. Because of naturally occurring diurnal variations in intraocular pressure, TIMOPTOL® EYE DROPS Page 2 of 12 satisfactory response is best determined by measuring the intraocular pressure at different times during the day. Systemic absorption of drugs from ophthalmic solutions may be minimised by pres read_full_document