Friday, October 21, 2016

Lidocaine Hydrochloride Injection BP 1% w / v






LIDOCAINE HYDROCHLORIDE INJECTION 1%


This leaflet will provide you with important information about your medicine. Please read it carefully before your medicine is administered. If, after reading it, you still have some questions, please speak to your doctor, nurse or pharmacist.





What’s in your medicine?



The active ingredient in this medicine is lidocaine hydrochloride. This is the new name for lignocaine hydrochloride. The ingredient itself has not changed.


Lidocaine Hydrochloride Injection 1% is a clear, colourless, sterile solution in a clear glass ampoule containing 2, 5, 10 or 20 ml. It contains 10 mg of the active ingredient lidocaine hydrochloride in each 1 ml of solution.


It also contains the following inactive ingredients: hydrochloric acid, sodium hydroxide and water for injections.





About your medicine


Lidocaine hydrochloride is a local anaesthetic. It numbs the area of the body where it is administered. It may also be used after heart attacks.



Holder of Product Licence:



hameln pharmaceuticals ltd

Gloucester

United Kingdom




Manufacturer:



hameln pharmaceuticals gmbh

Langes Feld 13

31789 Hameln

Germany



PL 01502/0002R





Uses


Lidocaine Hydrochloride Injection 1% may be used to:


  • Produce local anaesthesia and stop pain being felt in the area of the body where it is administered.

  • Suppress extra heartbeats and racing heart especially after a heart attack.




Before you receive your medicine


Lidocaine hydrochloride should not be used in patients who are allergic to lidocaine hydrochloride, or to one or more of the ingredients of Lidocaine Hydrochloride Injection 1%.


Tell your doctor if you ever had an allergic or bad reaction, for example, skin rash or breathlessness, to any local anaesthetic medicines.



Before you receive this medicine, you should also tell your doctor if:


  • you suffer from heart, lung or breathing disorder

  • you have kidney or liver disease

  • you are feeling unwell or run down for any reason

  • you suffer from epilepsy or have fits

  • you are pregnant or breast-feeding

  • you have inflammation or infection in the area to be injected



You should also tell your doctor if you are taking any other medication, in particular any of the following:


  • cimetidine (for stomach ulcer or heartburn)

  • beta-blockers, for example, propranolol, (for angina, high blood pressure or other heart problems).



Driving and Operating Machinery:


Depending on where and how lidocaine hydrochloride is used, it may affect your ability to drive or operate machinery. Ask your doctor about when it would be safe to drive or operate machines.






How your medicine is administered


Lidocaine hydrochloride may be given by injection into a vein, a muscle or under the skin, by drip into a vein, or into the epidural space near the spinal cord.



Adults:


As a guide, 20 ml is the usual maximum dose. Your doctor will decide on the most appropriate dose for you. A smaller dose may be used if you are elderly or weak.




Children:


A smaller dose is usually used for children depending on their age, physical condition and the procedure to be performed.






After you receive your medicine


Like all medicines, Lidocaine Hydrochloride Injection 1% can have side effects:


Lidocaine is generally well tolerated, but along with its needed effects, all medicine can cause unwanted effects. Lidocaine may occasionally cause the following side effects:


  • pain, inflammation or numbness at the site of injection after the effects of the injection should
    have worn off

  • nervousness

  • tremor

  • blurred or double vision

  • dizziness or drowsiness

  • convulsions (seizures)

  • nausea or vomiting

  • slowed heart beat or low blood pressure

Allergic reactions to lidocaine hydrochloride are rare, but tell your doctor immediately if you get any difficulty with your breathing, a rash or itchy skin.


After spinal injection of lidocaine, you should tell your doctor if you experience any of the following
side effects:


  • pain or numbness in the back or lower legs

  • difficulty in walking

  • problems with controlling your bladder or bowels

  • faintness or lightheaded feeling

  • slow heart rate or pulse rate

If you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.


For patients going home before the numbness or loss of feeling caused by a local anaesthetic wears off:


During the time that the injected area feels numb, serious injury can occur without your knowing about it. Be especially careful to avoid injury until the anaesthetic wears off or feeling returns to the area.





Storing your medicine


The ampoules should be stored protected from light, at less than 25°C and out of reach of children. Your doctor will not use the drug after the expiry date shown on the ampoule and carton. If only part of an ampoule is used, the remainder should be discarded.





This leaflet was prepared on August 6th 2004.


43829/18/04





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