Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
TROPICAMIDE
Bausch & Lomb UK Limited
S01FA06
TROPICAMIDE
1.0 % %w/v
Eye Drops Solution
Product subject to prescription which may be renewed (B)
tropicamide
Marketed
1987-11-01
MINIMS® TROPICAMIDE 0.5% W/V MINIMS® TROPICAMIDE 1% W/V EYE DROPS, SOLUTION TROPICAMIDE IN THIS LEAFLET: 1. What Minims® Tropicamide eye drops are and what they are used for 2. Before you use your eye drops 3. How to use your eye drops 4. Possible side effects 5. How to store your eye drops 6. Further information 1. WHAT MINIMS® TROPICAMIDE EYE DROPS ARE AND WHAT THEY ARE USED FOR Minims® Tropicamide contains a mydriatic and cycloplegic agent. It is used to enlarge the pupil of your eye and temporarily paralyse the lens. Your doctor or eye specialist may use it to examine your eye. 2. BEFORE YOU USE YOUR EYE DROPS DO NOT USE THESE DROPS IF • you are allergic to the active substance (tropicamide) or any of the other ingredients (refer to the end of this leaflet). • you have history of closed angle glaucoma with your eyes likely to develop sudden increased internal pressure when the pupil is enlarged Consult your doctor for advice; use of this product may cause: - Increase in the pressure of your eye. You should have your eye pressure checked before initiation of therapy, especially in elderly. TAKE SPECIAL CARE Ask yourself the following questions: • Is this product to be used in a small child? • Are your eyes red or inflamed? If the answer to any of these questions is yes, tell your doctor or eye specialist. IF YOU ARE PREGNANT, MAY BE PREGNANT, OR ARE BREASTFEEDING Tell your doctor or eye specialist, he/she may decide to use these drops or to prescribe you an alternative. CONTACT LENSES Your doctor will ask you to remove your contact lenses prior to the administration of the drops. There is no information on the effect of this product on contact lenses. Therefore, do not wear your contact lenses until the effects of the drops have completely worn off. DRIVING AND USING MACHINES Some people find bright light (such as daylight) uncomfortable for a few hours after receiving Minims® Tropicamide. This may make it difficult for you to drive. As with all eye drops, your vision may be blurred after putting Read the complete document
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Minims Tropicamide 1% w/v Eye drops, solution 2 QUALITATIVE AND QUANTITATIVE COMPOSITION The solution contains 1.0% w/v tropicamide. Each unit (0.5ml) contains 5mg tropicamide. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Eye drops, solution. (eye drops) A clear, colourless solution. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS As a topical mydriatic and cycloplegic. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION _Adults (including the elderly):_ 1 drop followed by a second drop after an interval of 5 minutes. A further 1 drop 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, or 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 on 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 drops via the naso-lacrimal duct to the wide absorptive area of the nasal and pharyngeal mucosa. It is especially advisable in children.) H E A L T H P R O D U C T S R E G U L A T O R Y A U T H O R I T Y ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ __ Read the complete document