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2%W/V LIDOCAINE INJECTION BP

Active substance(s): LIDOCAINE HYDROCHLORIDE

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PACKAGE LEAFLET: INFORMATION FOR THE USER

577/13600133R/R608

B. Braun Melsungen AG 34209 Melsungen, Germany

2% w/v Lidocaine Injection solution for injection
Lidocaine hydrochloride
Your doctor should know if you have any of the following conditions: certain heart or respiratory conditions shock diseases of the liver and kidneys low blood pressure or blood volume any condition which may lead to an increased risk of fits and seizures. TAKING OR USING OTHER MEDICINES Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. In particular, tell your doctor if you are taking any of the following: some heart medicines, namely beta blockers (e.g. propranolol, metoprolol) cimetidine, a medicine for treatment of stomach disorders diazepam, a tranquilliser/sleeping pill noradrenaline, a medicine for treatment heart weakness phenytoin, a medicine for treatment of epilepsy phenobarbital, which is used in general anaesthesia to induce sleep medicines used to relax muscles in general anaesthesia, especially suxamethonium chloride. PREGNANCY AND BREAST-FEEDING Ask your doctor or pharmacist for advice before taking any medicine. Your doctor or dentist will only administer this medicine while you are pregnant if he/ she considers it essential. The dose may be reduced. Lidocaine is secreted into breast milk. Your doctor or dentist will therefore be particularly careful if you are breast feeding. In general, however, it will not be necessary to discontinue breast feeding. DRIVING AND USING MACHINES This medicine can occasionally cause effects such as drowsiness or confusion. If affected you should not drive or operate machinery.

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 doctor or pharmacist. This medicine has been prescribed for you. Do not pass it on to others. If any of the side effects become serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. In this leaflet: 1.What 2% w/v Lidocaine Injection is and what it is used for 2.Before you use 2% w/v Lidocaine Injection 3.How to use 2% w/v Lidocaine Injection 4.Possible side effects 5.How to store 2% w/v Lidocaine Injection 6.Further information

1. WHAT 2% W/V LIDOCAINE INJECTION IS AND WHAT IT IS USED FOR
Lidocaine is a locally acting anaesthetic. 2% w/v Lidocaine Injection is used for: pain relief around the area of a nerve (nerve block anaesthesia) treatment of a certain type of fast heartbeat (ventricular tachycardia)

2. BEFORE YOU USE 2% W/V LIDOCAINE INJECTION
DO NOT USE 2% W/V LIDOCAINE INJECTION if you have any of the following conditions: allergy (hypersensitivity) to lidocaine or similar substances that are also used as local anaesthetics certain types of heart disease, particularly those associated with irregularities of heartbeat blood disorders affecting clotting of the blood infections in the area around an injection. You should not receive this medicine if a member of your family has experienced a severe increase in body temperature after receiving an anaesthetic. TAKE SPECIAL CARE WITH 2% W/V LIDOCAINE INJECTION Under certain conditions you may receive 2% w/v Lidocaine Injection only under close medical supervision.

3. HOW TO USE 2% W/V LIDOCAINE INJECTION
This medicine is administered to you by a doctor. You will receive this medicine as an injection into the skin, a muscle, a nerve area, the spinal column or a vein. Your doctor or dentist will decide how much medicine you will receive.

B|BRAUN

577/13600133R/R608

The normal maximum dosage is 200 mg or approximately 10 ml of 2% w/v Lidocaine Injection. In certain groups of people the dose of lidocaine given is reduced. This includes pregnant women, babies, young children, the elderly and people with heart failure and liver disease. If you receive this medicine for the treatment of fast heartbeat (tachycardia), it will be given to you by injection into a vein. The doctor will decide, according to your condition and the effect of the treatment, how much of the medicine you should receive and how long you should receive it. During treatment you will be under close medical supervision. IF YOU RECEIVED MORE 2% W/V LIDOCAINE INJECTION THAN YOU SHOULD A small overdose mainly affects the central nervous functions (see section possible side effects below). Respective unwanted effects will disappear in most cases after stopping lidocaine administration. A large overdose will cause convulsions, impairment or even loss of consciousness, shallow breathing or even stopping breathing, shock, heart affections that might become severe. If such severe symptoms appear, your doctor will know how to manage these and give you any necessary treatment. If you have any further questions on the use of this product, ask your doctor or pharmacist.

Elderly patients may be more prone to some of the effects mentioned above. If any of the side effects become serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

5. HOW TO STORE 2% W/V LIDOCAINE INJECTION
Keep out of the reach and sight of children. Do not store above 25 C. Do not use 2% w/v Lidocaine Injection after the expiry date which is stated on the ampoule and the outer carton after EXP. The expiry date refers to the last day of that month. Do not use 2% w/v Lidocaine Injection if you notice: cloudiness or discoloration of the solution particles in the solution leaking of the ampoule. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. FURTHER INFORMATION
What 2% w/v Lidocaine Injection contains The active substance is lidocaine hydrochloride. One ml of the solution for injection contains 20 mg of lidocaine hydrochloride. One ampoule of 2 ml contains 40 mg of lidocaine hydrochloride. One ampoule of 5 ml contains 100 mg of lidocaine hydrochloride. One ampoule of 10 ml contains 200 mg of lidocaine hydrochloride. One ampoule of 20 ml contains 400 mg of lidocaine hydrochloride. The other ingredients are sodium chloride, sodium hydroxide and water for injections. What 2% w/v Lidocaine Injection looks like and contents of the pack 2% w/v Lidocaine Injection is a solution for injection. It is a clear colourless solution of the aforementioned ingredients in water. It comes in polyethylene plastic ampoules holding 2 ml, 5 ml, 10 ml or 20 ml. It is supplied in packs of 20 ampoules of each size. Marketing Authorisation Holder and Manufacturer B. Braun Melsungen AG Carl-Braun-Strasse 1 Postal address 34212 Melsungen, Germany 34209 Melsungen, Germany This leaflet was last revised in October 2008


4. POSSIBLE SIDE EFFECTS
The following side effects have been reported with the use of 2% w/v Lidocaine Injection Uncommon (in 1 to 10 of 1000 patients): Sleepiness, giddiness, dizziness, confusion, blurred vision, slurred speech, difficulty in swallowing, noise in ears, trembling, tingling, flushing, chills, restlessness, irritability, abnormally good mood, hallucinations, mental depression, loss of appetite, feeling sick and sickness. Rare (in 1 to 10 of 10,000 patients, usually if you have received an overdose): Convulsions, impaired consciousness up to unconsciousness, shallow breathing (in extreme cases up to stopping breathing), drop of blood pressure, low pulse rate, abnormal heart rate and shock. After injection of lidocaine into or around the spinal cord pain in legs and lower back. The pain may last up to 5 days and will disappear without further treatment. long lasting disturbances of nerve function like numbness or palsy of legs and loss of sphincter control leading to incontinence of bowels. Allergic reactions ranging from rashes and swelling to severe allergic reactions such as drop of blood pressure and shock. When used during childbirth, lidocaine can lead to a reduction in the babys heart rate.

B|BRAUN

B. Braun Melsungen AG 34209 Melsungen, Germany

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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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