Country: New Zealand
Bahasa: Inggeris
Sumber: Medsafe (Medicines Safety Authority)
Tropicamide 0.5%{relative};
Bausch & Lomb (NZ) Ltd
Tropicamide 0.5% w/v
0.5% w/v
Eye drops, solution
Active: Tropicamide 0.5%{relative} Excipient: Hydrochloric acid Purified water Sodium hydroxide
Single use dropper, 0.5mL, 20 dose units
Prescription
Prescription
Uquifa Mexico SA de CV
Latest Regulatory Activity
Package - Contents - Shelf Life: Single use dropper, 0.5mL - 20 dose units - 30 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze)
1981-09-24
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 MEDICINES, FOOD Baca dokumen lengkap
NEW ZEALAND DATA SHEET 1 MINIMS Tropicamide, eye drops solution 0.5% w/v MINIMS Tropicamide, eye drops solution 1% w/v 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each 0.5 mL unit contains 2.5 mg or 5 mg of Tropicamide. For full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Clear, colourless, single-use, sterile eye drops. 4 CLINICAL PARTICULARS 4.1 Therapeutic indications As a topical mydriatic and cycloplegic. 4.2 Dose and method of administration Adults (including the elderly): 1 drop followed by a second drop after an interval of 5 minutes. A further 1drop may be instilled after 30 minutes, if required. Children: At the discretion of the physician. 4.3 Contraindications Do not use in patients with a known hypersensitivity to tropicamide. Tropicamide is contraindicated in narrow angle glaucoma and in eyes where the filtration angle is narrow, as an acute attack of angle closure glaucoma may be precipitated. 4.4 Special warnings and precautions for use Use with caution in an inflamed eye, as hyperaemia greatly increases the rate of systemic absorption through the conjunctiva. Care should be exercised in small children. Systemic absorption may be reduced by compressing the lacrimal sac at the medial canthus for a minute during and following the instillation of the drops. (This blocks the passage of the drops via the naso-lacrimal duct to the wide absorptive area of the nasal and pharyngeal mucosa. It is especially advisable in children.) 4.5 Interaction with other medicaments and other forms of interaction None known. NEW ZEALAND DATA SHEET 4.6 Fertility, pregnancy and lactation There is no evidence as to the drug's safety in human pregnancy, nor is there evidence from animal work that it is free from hazard. This product should only be used in pregnancy if considered essential by the physician. 4.7 Effects on ability to drive and use machines Patient warning: Patients who receive a mydriatic may suffer from photophobia and this may impair their ability to drive under certain circumstances. 4.8 Undesi Baca dokumen lengkap