Nazione: Australia
Lingua: inglese
Fonte: Department of Health (Therapeutic Goods Administration)
tropicamide, Quantity: 5 mg/mL
Bausch & Lomb Australia Pty Ltd
Eye Drops, solution
Excipient Ingredients: hydrochloric acid; sodium hydroxide; purified water
Ophthalmic
20 X 0.5mL
Medicine Registered
(S4) Prescription Only Medicine
To produce mydriasis and cycloplegia.
Visual Identification: A clear, colourless solution, reasonably free from visible particulate matter; Container Type: Tube; Container Life Time: 30 Months; Container Temperature: Store at 2 to 8 degrees Celsius
Registered
1991-10-30
MINIMS ® TROPICAMIDE _Tropicamide Eye Drops_ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Minims Tropicamide, including how to use the eye drops. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist. All medicines have benefits and risks. Your doctor has weighed the risks of you using Minims Tropicamide 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 MINIMS TROPICAMIDE IS USED FOR Minims Tropicamide belongs to a class of medicines called antimuscarinic agents. It is used to enlarge the pupil of the eye and to temporarily paralyse the lens so that your doctor can examine your eye. It is usually used at the beginning of an eye examination. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY THIS MEDICINE HAS BEEN PRESCRIBED TO YOU. Your doctor may have prescribed it for another reason. BEFORE YOU USE MINIMS TROPICAMIDE _WHEN YOU MUST NOT USE IT_ DO NOT USE MINIMS TROPICAMIDE IF YOU HAVE AN ALLERGY TO: • any medicine containing tropicamide • any of the ingredients listed at the end of this leaflet. Some of the symptoms of an allergic reaction may include: • shortness of breath • wheezing or difficulty breathing • swelling of the face, lips, tongue or other parts of the body • rash, itching or hives on the skin. DO NOT USE MINIMS TROPICAMIDE IF YOU HAVE NARROW ANGLE GLAUCOMA (HIGH PRESSURE IN THE EYE). Tropicamide can increase the pressure in the eye. DO NOT USE THIS MEDICINE AFTER THE EXPIRY DATE PRINTED ON THE PACK OR IF THE PACKAGING IS TORN OR SHOWS SIGNS OF TAMPERING. If it has expired or is damaged, return it to your pharmacist for disposal. IF YOU ARE NOT SURE WHETHER YOU SHOULD START USING THIS MEDICINE, TALK TO YOUR DOCTOR. _BEFORE YOU START TO USE IT_ TELL YOUR DOCTOR IF YOU HAVE HAD AN ALLERGY TO ANY OTHER MEDICI Leggi il documento completo
Minims Tropicamide PI-A20200602 v4 Page 1 of 6 AUSTRALIAN PRODUCT INFORMATION – MINIMS TROPICAMIDE (TROPICAMIDE) EYE DROPS 1 NAME OF THE MEDICINE Tropicamide 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Minims Tropicamide Eye Drops contain tropicamide 0.5% and 1% w/v. No preservatives are contained in the formulation. For the full list of excipients, see Section 6.1 List of excipients. 3 PHARMACEUTICAL FORM A single-use eye drops, solution. Minims Tropicamide are clear, colourless sterile ophthalmic solution. No preservatives are contained in the formulation. 4 CLINICAL PARTICULARS 4.1 T HERAPEUTIC INDICATIONS Minims Tropicamide Eye Drops is one of the antimuscarinics used to produce mydriasis and cycloplegia. 4.2 D OSE AND METHOD OF ADMINISTRATION Adults (including the elderly): To produce mydriasis, 1 or 2 drops of a 0.5% solution are instilled 15 to 20 minutes before examination of the eye. To produce cycloplegia 1 or 2 drops of a 1% solution are required, repeated after 5 minutes. A further drop may be necessary to prolong the effect after 20 to 30 minutes. Systemic absorption can be minimised by pressure on the tear duct immediately after application. 4.3 C ONTRAINDICATIONS Hypersensitivity to tropicamide or any other component listed in the formulation. Narrow angle glaucoma. Minims Tropicamide PI-A20200602 v4 Page 2 of 6 4.4 S PECIAL WARNINGS AND PRECAUTIONS FOR USE IDENTIFIED PRECAUTIONS For topical ophthalmic use only. Not for injection. Tropicamide should not be used in patients with a narrow angle glaucoma since it may raise intra- ocular pressure and precipitate an acute attack. As with other antimuscarinic agents, tropicamide should be used with caution in conditions characterised by tachycardia such as thyrotoxicosis, heart failure and in cardiac surgery where it may further accelerate the heart rate. Care is required in patients with acute myocardial infarction as ischaemia and infarction may be made worse. Tropicamide may significantly increase intraocular pressure. Use with caution in an inflamed Leggi il documento completo