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BIOCAINE 3% PLAIN SOLUTION FOR INJECTION

Active substance(s): MEPIVACAINE HYDROCHLORIDE

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Biocaine 3% Plain
Solution for injection
Mepivacaine hydrochloride
PATIENT INFORMATION LEAFLET
Read all of this leaflet carefully before you start using this medicine.
‐ Keep this leaflet. You may need to read it again.
‐ If you have any further questions, ask your dentist.
‐ This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if
their symptoms are the same as yours.
‐ If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please
tell your dentist.

In this leaflet:
1.What BIOCAINE 3% PLAIN is and what it is used for
2.Before you use BIOCAINE 3% PLAIN
3.How to use BIOCAINE 3% PLAIN
4.Possible side effects
5.How to store BIOCAINE 3% PLAIN
6.Further information

1.What BIOCAINE 3% PLAIN is and what it is used for
BIOCAINE 3% PLAIN is given by injection to cause loss of feeling before and during chiropody and dental
procedures.
It contains one active ingredient: mepivacaine hydrochloride, a local anaesthetic which prevents the pain.
BIOCAINE 3% PLAIN is for children over 4 years old and adults.
Only a dentist can administer this product.

2.Before you use BIOCAINE 3% PLAIN
Do not use BIOCAINE 3% PLAIN
ƒ if you are allergic (hypersensitive) to the active ingredient (mepivacaine hydrochloride) or to any of the
other ingredients (refer to section 6).
ƒ if you are allergic to local anaesthetics called amide type anaesthetics,
ƒ in children under 4 years old.
Take special care with BIOCAINE 3% PLAIN
Before receiving this medicine, tell your dentist if:
ƒ you have problems with your heart,
ƒ you have problems with your liver,
ƒ you have problems with your kidneys,
ƒ you have a severe infection or an inflammation in the area where the injection will be done.
Using other medicines
Please tell your dentist if you are taking or have recently taken any other medicines, including medicines
obtained without a prescription.
Your dentist should take special attention if you are taking the following medicines:
ƒ medicines used to reduce patient apprehension (e.g. sedatives). In that case, the dosage of anaesthetic
should be reduced.

Pregnancy and breast‐feeding
This medicine should be used with caution during pregnancy or breast‐feeding.
Ask your dentist for advice before taking any medicine.
Driving and using machines
If you experience side effects, including dizziness or blurred vision, you should not drive or operate
machinery until these effects have disappeared.
Important information about some ingredients of BIOCAINE 3% PLAIN
BIOCAINE 3% PLAIN contains less than 1 mmol (23mg) sodium per cartridge, i.e. essentially "sodium free".

3.How to use BIOCAINE 3% PLAIN
Your dentist will explain to you why you are being treated with BIOCAINE 3% PLAIN. He will choose the
formula and adjust the dosage according to your age, your health and the dental procedure.
One cartridge is usually sufficient but your dentist may give you a greater quantity.
BIOCAINE 3% PLAIN is injected between two teeth. It should not be injected into a blood vessel.
If your dentist uses more BIOCAINE 3% PLAIN than he should
If you think you may have been given too much of this injection and feel unwell (see section 4, possible side
effects), tell your dentist.

4.Possible side effects
Like all medicines, BIOCAINE 3% PLAIN, can cause side effects, although not everybody gets them.
While you are in your dentist office, your dentist will carefully follow the effects of BIOCAINE 3% PLAIN.
However, some effects may not be noticed or appear later. Check with your dentist, doctor or pharmacist if
any of the following side effects occur:
ƒ General effects: feeling nervous, nausea, vomiting, headache, dizziness, twitching, apprehension, feeling
of well‐being commonly exaggerated, confusion, drowsiness, malaise, agitation, convulsions,
unconsciousness, faint
ƒ Effects on your senses: trembling, light headedness, buzzing in the ears, blurred or double vision,
sensation of heat, cold or numbness,
ƒ Effects on your lung: difficulty in breathing
ƒ Effects on your heart and blood vessels: slow heartbeats, low blood pressure,
ƒ Effects on your skin: skin rash, hives or itching or severe allergic reaction (including swelling of the
face, lips and/or tongue, difficulty in breathing).
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.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your
dentist.

5.How to store BIOCAINE 3% PLAIN
Keep out of the reach and sight of children.
It is most unlikely that you will be asked to look after this medicine.
Your dentist will not use this medicine after the expiry date which is stated on the package. The expiry date
refers to the last day of that month.
Your dentist will keep it up to 25°C, stored in the original container (protected from light).

6.Further information
What BIOCAINE 3% PLAIN contains
ƒ Active substance: each ml of solution for injection contains 30 mg of mepivacaine hydrochloride.
ƒ The other ingredients are: sodium chloride, sodium hydroxide solution and water for injection.
What BIOCAINE 3% PLAIN looks like and content of the pack
It is a clear and colourless solution for injection.
BIOCAINE 3% PLAIN is available in boxes containing 50 cartridges of 1.8 ml or of 2.2 ml.
Marketing authorisation holder
Septodont Ltd, Units R & S
Orchard Business Centre
St Barnabas Close
Allington, Maidstone
Kent ME16 0JZ ‐ UK
Manufacturer
Septodont
58 rue du Pont de Créteil
94100 Saint‐Maur‐des‐Fossés
France
This leaflet was last approved on: 02/2011
If more PILs are necessary, call free number 0800435155.

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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 combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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