1%W/V Lidocaine Injection Bp
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576/13600125/1012
PACKAGE LEAFLET: INFORMATION FOR THE USER
B. Braun Melsungen AG • 34209 Melsungen, Germany
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 1% w/v Lidocaine Injection is and what it is used for
2. Before you use 1% w/v Lidocaine Injection
3. How to use 1% w/v Lidocaine Injection
4. Possible side effects
5. How to store 1% w/v Lidocaine Injection
6. Further information
1. WHAT 1% W/V LIDOCAINE INJECTION IS AND WHAT IT IS USED FOR_
Lidocaine is a locally acting anaesthetic.
1% w/v Lidocaine Injection is used for:
• pain relief around the area of a nerve (nerve block anaesthesia)
• pain relief by injection into the target area (infiltration anaesthesia)
• pain relief in the target area by injection into a vein (intravenous regional anaesthesia).
2. BEFORE YOU USE 1% W/V LIDOCAINE INJECTION
DO NOT USE 1% 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
• if a member of your family has experienced a severe increase in body temperature after receiving an anaesthetic
• 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 1% W/V LIDOCAINE INJECTION
Under certain conditions you may receive 1% w/v Lidocaine Injection only under close medical supervision. 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, metopro-lol)
• 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.
3. HOW TO USE 1% W/V LIDOCAINE INJECTION
This medicine is administered to you by a doctor.
You will receive this medicine as an injection into either a vein, the skin, muscle or nerve area.
Your doctor or dentist will decide how much medicine you will receive. The normal maximum dosage is 200 mg or approximately 20 ml of 1% 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.
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Schwarz 210x297 mm 576/13600125/1012 Latus: 545 GroBbritannien Font size 9
576/13600125/1012
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IF YOU RECEIVED MORE 1% 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.
4. POSSIBLE SIDE EFFECTS_
The following side effects have been reported with the use of 1% 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 chord
• 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.
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 baby's heart rate.
Elderly patients may be more prone to some of the effects mentioned above.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in the package leaflet. You can also report side effects directly via the Yellow Card Scheme at www.mhra.gov.uk/yellowcard.
By reporting side effects you can help provide more information on the safety of this medicine.
5. HOW TO STORE 1% W/V LIDOCAINE INJECTION
Keep out of the reach and sight of children.
Do not store above 25 °C.
Do not use 1% 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 1% 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 1% w/v Lidocaine Injection contains
• The active substance is lidocaine hydrochloride.
One ml of the solution for injection contains 10 mg of lidocaine hydrochloride.
One ampoule of 2 ml contains 20 mg of lidocaine hydrochloride.
One ampoule of 5 ml contains 50 mg of lidocaine hydrochloride.
One ampoule of 10 ml contains 100 mg of lidocaine hydrochloride.
One ampoule of 20 ml contains 200 mg of lidocaine hydrochloride.
• The other ingredients are
sodium chloride, sodium hydroxide and water for injections.
What 1% w/v Lidocaine Injection looks like and contents of the pack
1% 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 February 2015.
BBRAUN
B. Braun Melsungen AG
34209 Melsungen Germany
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Schwarz 210x297 mm 576/13600125/1012 Latus: 545 GroRbritannien Font size 9