Land: Australia
Språk: engelsk
Kilde: Department of Health (Therapeutic Goods Administration)
dorzolamide hydrochloride,timolol maleate
Apotex Pty Ltd
Dorzolamide hydrochloride,Timolol maleate
Registered
APO-DORZOLAMIDE/ TIMOLOL _Contains the active dorzolamide (as hydrochloride) 2.0% and timolol (as maleate) 0.5%_ CONSUMER MEDICINE INFORMATION _FOR A COPY OF A LARGE PRINT LEAFLET, PH: 1800 195 055_ WHAT IS IN THIS LEAFLET READ THIS LEAFLET CAREFULLY BEFORE TAKING YOUR MEDICINE. This leaflet answers some common questions about dorzolamide/timolol. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist. The information in this leaflet was last updated on the date listed on the last page. More recent information on this medicine may be available. ASK YOUR DOCTOR OR PHARMACIST: • if there is anything you do not understand in this leaflet, • if you are worried about taking your medicine, or • to obtain the most up-to-date information. You can also download the most up to date leaflet from www.apotex.com.au. All medicines have risks and benefits. Your doctor has weighed the risks of you using this medicine against the benefits they expect it will have for you. Pharmaceutical companies cannot give you medical advice or an individual diagnosis. Keep this leaflet with your medicine. You may want to read it again. WHAT THIS MEDICINE IS USED FOR The name of your medicine is APO- Dorzolamide/Timolol eye drops. It contains the active ingredients dorzolamide (22.3 mg of dorzolamide hydrochloride) and timolol (6.8 mg of timolol maleate). It is used to treat 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 r Les hele dokumentet
1 AUSTRALIAN PRODUCT INFORMATION APO- DORZOLAMIDE/TIMOLOL 20/5 DORZOLAMIDE (AS HYDROCHLORIDE) AND TIMOLOL (AS MALEATE) EYE DROPS, SOLUTION 1 NAME OF THE MEDICINE Dorzolamide hydrochloride and Timolol maleate 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each millilitre of dorzolamide/timolol combination eye drops contains 20.0 mg (2% w/v) dorzolamide (22.3 mg of dorzolamide hydrochloride) and 5.0 mg (0.5% w/v) timolol (6.8 mg of timolol maleate) as the active ingredients. It is a sterile, isotonic, buffered, slightly viscous, aqueous solution. 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 to nearly colourless, slightly viscous solution. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Dorzolamide/timolol combination eye drops is indicated in the treatment of elevated intraocular pressure (IOP) in patients with ocular hypertension or open-angle glaucoma when concomitant therapy is appropriate. 4.2 DOSE AND METHOD OF ADMINISTRATION APO-Dorzolamide/Timolol 20/5 Eye Drops are intended for ophthalmic administration and for individual patient use only. DOSAGE The dose is one drop of dorzolamide/timolol combination (2.0%/0.5%) eye drops in the affected eye(s) two times daily. When substituting dorzolamide/timolol combination eye drops for another ophthalmic antiglaucoma agent(s), discontinue the other agent(s) after proper dosing on one day, and start dorzolamide/timolol combination eye drops on the next day. If another topical ophthalmic agent is being used, dorzolamide/timolol combination eye drops and the other agent should be administered at least ten minutes apart. Systemic absorption can be minimised by pressure on the tear duct immediately after application of the eye drop. 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 ≥ Les hele dokumentet