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58. rue du Pont de CrOteil 94107 Saint-Maur-des-FossOs France
Enrocaine 2%
Solution for Inieetion Lidoeaine hydrochloride 2% and adrenaline (epinephrine) injection 1:80,004
PATIENT INFORMATION LEAFLET
Please read this leaflet carefully before you start using this medicine It tells you the important points you should know about EUROCAINE 2 %.
WHATS IN YOUR MEDICINE
Each ml ol solution contains 20.00 mg of lidoeaine hydrochloride and 12.5 micrograms of adrenaline (epinephrine) as the acid tartrate expressed as base.
It also includes the excipients: potassium metabisulphite (E224). sodium chloride, sodium edetate. sodium hydroxide solution and water for injection.
EUROCAINE 2 % is available in boxes oontamlng 50 cartridges of 2.2 ml.
Name of marketing authorisation holder: Deproco UK Ltd.. Units R & S. Orchard Business Centre. St. Barnabas Close. Allington, Maidstone. Kent ME16 0JZ. England
Name of manufacturer:
Laboratoire Biodica. 58, rue du Pont de Crdteil 94107 Saint-Maur-des-Foss6s, France
ABOUT YOUR MEDICINE
EUROCAINE 2 % is given by injection to cause loss of feeling before and during dental procedures. It contains two active ingredients lidoeaine hydrochloride, a local anaesthetic which prevents pain, and adrenaline tartrate, a vasoconstrictor which makes it last longer (adrenaline narrows the blood vessels at the site of injection, which keeps the anaesthetic where needed for a longer time).
BEFORE THIS MEDICINE IS USED
Before receiving this medicine, tell your dentist if:
- you are allergic to local anaesthetics or any particular ingredients,
• you are asthmatic or have bronchoepasmic allergic reactions induced by sulphites.
- you are taking antidepressant treatment, phenothiazines. beta-
blockers (e g atenolol), and medicines which contain ergotamine tartrate, .
- you have cardiovascular, hepatic or renal affections.
• you are pregnant or breast-feeding
It is recommended to tell your dentist which medicines you are taking even those you have bought without any prescription
HOW THIS MEDICINE WILL BE USED
Your dentist will explain to you why you are being treated with EUROCAINE 2 % and tell you what dose you will be administered. One cartridge is usually sufficient but your dentist may give you a greater quantity He adjusts the dosage according to your age. to your health and to the dental work.
WHAT TO DO IF AN OVERDOSE IS TAKEN
if unusual reactions develop, adapted measures will be taken promptly by your dentist
AFTER TAKING YOUR MEDICINE
EUROCAINE 2 %. like most other medicines, may cause side effects in some patients Although not all of these side effects may occur, If they do occur they may need medical attention While you are in your dentist office, your dentist will carefully follow the effects of EUROCAINE 2 %. However, some effects may not be noticed until later Check with your dentist if any of the following side effects occur:
- If you are feeling nervous or nauseous, if you have headache if you
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are trembling, or have twltchmgs.
- If you have any abnormal feeling as light headness, apprehension, feeling of well-being commonly exaggerated, confusion, drowsiness, buzzing In the ears, blurred or double vision, sensation of heat, cold or numbness.
- If your breathing is difficult
• If your heart is beating an abnormal way, slows down or gets a low blood pressure.
- If you have skin rash, hives or itching,
Very occasionally you may develop more severe reactions such as convulsions and reduced level of consciousness with possible arrest of breathing or heart. Emergency medical help should immediately be called.
WARNING
EUROCAINE 2% contains less than 1 mmol sodium (0 255 mmol’ 2.2 ml), i.e. essentially ’sodium free".
STORING YOUR MEDICINE
It is most unlikely that you will be asked to look after this medicine. Your dentist will keep it below 25° C and protected from light. He will not use this medicine after the expiry date printed on the package All medicines must be kept in a safe place out of the reach of children
FURTHER INFORMATION
Remember this medicine is only for you. Only a denlisl can administer this product.
This leaflet provides only a summary of the information known about EUROCAINE 2 %. If you have any questions, want to know more about this medicine, or have some doubts, ask your dentist
This information applies only to EUROCAINE 2 %.
Date of preparation: September 2004.
If more PILs are necessary, call free number 0600 435155.
