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Document: leaflet HAMELN PHARMACEUTICALS_PL 03551-0013 change

• leaflet ANTIGEN PHARMACEUTICALS_PL 03551-0013
• leaflet HAMELN PHARMACEUTICALS_PL 03551-0013
• leaflet MAH GENERIC_PL 03551-0013

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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. 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.

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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.

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.

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% WIN 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 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 baby's heart rate.

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.

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 2% WIN 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

34212 Melsungen,    Postal address

Germany    34209 Melsungen, Germany

Distributor:

hameln pharmaceuticals ltd Gloucester, UK

This leaflet was last revised in February 2015.

577/12621227/0615

12621227_Lidocaine2_GIF-A5_GB.indd 2 26.06.15 12:37