MINIMS PROXYMETACAINE HYDROCHLORIDE 0.5% W/V EYE DROPS SOLUTION

Active substance: PROXYMETACAINE HYDROCHLORIDE

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Art.76125 0504104/4

Art.76125 0504104/4

Minims*
Proxymetacaine hydrochloride 0.5% Eye Drops
0.5% w/v Proxymetacaine Hydrochloride BP

About Minims Proxymetacaine hydrochloride 0.5% The name of this medicine is Minims Proxymetacaine hydrochloride 0.5%. Each Minims unit is a sterile, single-use eye drops container which contains 0.5% w/v proxymetacaine hydrochloride solution. The solution also contains puried water and small amounts of hydrochloric acid and sodium hydroxide. Each Minims unit contains approximately 0.5ml of solution. Each carton contains 20 Minims units. Proxymetacaine hydrochloride is used as a local anaesthetic. Who makes Minims Proxymetacaine hydrochloride 0.5%? Minims Proxymetacaine hydrochloride 0.5% is manufactured by Laboratoire Chauvin S.A. Z.I. Ripotier, 07200/Aubenas, France. The Marketing Authorisations for Minims Proxymetacaine hydrochloride 0.5% (PL 0033/0151 & PA 118/46/1) are held by Chauvin Pharmaceuticals Ltd., 106 London Road, Kingston-UponThames KT2 6TN, England. What is it for ? Minims Proxymetacaine hydrochloride 0.5% is used to numb the eye temporarily. This could be necssary for a number of reasons. Most often, Minims Proxymetacaine hydrochloride 0.5% is used to allow your doctor or eye specialist to measure the pressure inside your eye or perform minor operations such as the removal of slitches and foreign bodies. This product is not intended to be used as a long term treatment for painful eye conditions.

Before using Minims Proxymetacaine hydrochloride 0.5% Are you allergic to Proxymetacaine hydrochloride? Do you suffer from heart disease? Do you have an overactive thyroid gland? Ih the answer to any of these questions is yes, tell your doctor or eye specialist before you use this product. When your eye has been numbed it is important not to rub it and to keep it free of dust and bacteria. Your doctor or eye specialist will make sure that your eye is properly protected. If you are pregnant (or if you think that you might be pregnant) you should tell your doctor or eye specialist before Minims Proxymetacaine hydrochloride 0.5% is used. It is possible that you still receive it, but it is also possible that an alternative may be used. Proxymetacaine hydrochloride is more comfortable for your eyes than some local anaesthetics but you may still feel some stinging when the drops are rst added. Your sight may also become blurred for a short time. Make sure that you do not try to drive or use machinery until your sight has returned to normal. Some eye examination involve the use of staining solutions as well as local anaesthetics. Proxymetacaine hydrochloride should not be given at the same time as a particular stain called uorescein. Your doctor or eye specialist will be aware of this and will make sure that a long enough time interval is allowed between the addition of Minims Proxymetacaine hydrochloride 0.5% and uorescein solution. The solution should be colourless or pale yellow. Minims Proxymetacaine hydrochloride 0.5% should not be used if it is darker than pale yellow in colour. This product should not be used in premature babies.

Using Minims Proxymetacaine hydrochloride 0.5% The amount of anaesthetic used will vary, depending on the procedure which is to be carried out: For measuring the pressure inside your eye, or for the removal of foreign bodies, 1 or 2 drops just before the procedure is sufcient. For the removal of stitches, 1 or 2 drops are applied 2 to 3 minutes before operating. If deep or prolonged anaesthesia is needed, 1 drop can be applied every 5 to 10 minutes. This can be repeated up to 7 times. The doctor or eye specialist will put the drops in your eye for you. You may be asked to press on the inner corners of your eyes for a minute to prevent the solution draining into your nose and throat. Your eye will remain numb for between 15 minutes and 1 hour, depending on how many drops you received. Avoid touching the eye until the anaesthetic has worn off. The Minims unit should be discarded after use. Local anaesthetic eye drops can damage the surface of the eye if they are used too much of too often. Your doctor or eye specialist will make sure that this does not happen. It is very unlikely that you will suffer an overdose from Minims Proxymetacaine hydrochloride 0.5%, but if you suddenly feel unwell after receiving the drops, tell your doctor or eye specialist. After using Minims Proxymetacaine hydrochloride 0.5% Minims Proxymetacaine hydrochloride 0.5% does not usually cause unwanted side effects, but allergic reactions have occasionally

occurred. These can affect the cornea (a transparent membrane covering the iris and pupil of the eye) and the iris. Your doctor or eye specialist will be able to tell if an allergic reaction occurs. Other reactions such as widening of the pupil, temporary paralysis of the lens or irritation of the conjunctiva (a mucous membrane which lines the inside of the eyelid) are very rare and will quickly wear off. If you do suddenly feel uncomfortable or unwell after reveiving Minims Proxymetacaine hydrochloride 0.5%, you should tell your doctor or eye specialist. Storing Minims Proxymetacaine hydrochloride 0.5% Minims Proxymetacaine hydrochloride 0.5% should be stored in a refrigerator at 2-8C. Do not allow it to freeze. The solution should not be used if it is more than pale yellow in colour. The expiry date for Minims Proxymetacaine hydrochloride 0.5% stored in a refrigerator at 2-8C is printed on each Minims unit overwrap and on the carton label. Do not use it after this date. If necessary, the product may be stored at temperature not exceeding 25C for up to 1 month only, in which case a label bearing the relevant expiry date will be afxed to the carton label. This leaet applies only to Minims Proxymetacaine hydrochloride 0.5%, but it does not contain all the information known about it. If you have any questions or are not sure about anything, ask a doctor, eye specialist or pharmacist. Date of (Partial) Revision of Text: September 2007. * Trade Mark

Chauvin Pharmaceuticals Ltd., 106 London Road, Kingston-Upon-Thames KT2 6TN, England. Tel : 020 8781 2900 Fax : 020 8781 2901

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

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