PACKAGE LEAFLET: INFORMATION FOR THE USER

Lidocaine Hydrochloride 0.2% and Glucose 5% Infusion as Steriflex® No. 26 or freeflex®

Lidocaine Hydrochloride 0.4% and Glucose 5% Infusion as Steriflex® No. 27 or freeflex®

Read all of this leaflet carefully before you start taking 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.

•    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 doctor or pharmacist.

in this leaflet:

1.    What Lidocaine hydrochloride is and what it is used for

2.    Before you receive Lidocaine hydrochloride

3.    How you are given Lidocaine hydrochloride

4.    Possible side effects

5.    How to store Lidocaine hydrochloride

6.    Further information

1.    WHAT LIDOCAINE HYDROCHLORIDE IS AND WHAT IT IS USED FOR

Lidocaine hydrochloride is used to treat disturbances in the heart's rhythm. Lidocaine reduces the heart's irritability and is given as an intravenous infusion (into the vein) to control irregular activity (arrhythmia) of the heart during heart surgery or following a heart attack.

The following medicines are covered by this leaflet:

Lidocaine hydrochloride 0.2% and Glucose 5% Infusion as Steriflex®

No. 26 or freeflex®

Lidocaine hydrochloride 0.4% and Glucose 5% Infusion as Steriflex®

No. 27 or freeflex®

In this leaflet these 2 solutions are collectively referred to as Lidocaine hydrochloride.

2.    BEFORE YOU RECEIVE LIDOCAINE HYDROCHLORIDE

You should not receive Lidocaine hydrochloride if you:

•    are allergic (hypersensitive) to lidocaine hydrochloride or to one or more of the ingredients of lidocaine hydrochloride mentioned in Section 6 (for symptoms of an allergic reaction please refer to section 4).

•    have hypovolemia - a state of decreased blood volume

•    have a heart block- decreased function of the heart

•    have heart conduction defects- problems with the transfer of electrical signals within the heart

•    suffer from bradycardia-your heart rate is slow

•    suffer from cardiac decompensation- failure of the heart to maintain adequate blood circulation

•    suffer from hypertension- high blood pressure

•    suffer from Porphyria (a deficiency in the enzymes responsible for producing haem - a molecule vital for red blood cells to carry oxygen).

Care should be taken when being administered Lidocaine hydrochloride.

Tell your doctor if you suffer from:

•    epilepsy

•    an impaired heart condition

•    breathing problems

•    damaged liver

•    myasthenia gravis- condition where there is no strength in the muscles

•    heart and circulatory failure

•    Renal impairment

Your doctor or nurse will ensure the solution is clear and free from any particles before use.

Taking other medicines

Please tell your doctor or a nurse if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

Inform your doctor if you take or have recently taken any of the following medicines:

•    beta-adrenergic blockers- for heart arrhythmias

•    cimetidine- used for heartburn and peptic ulcers

•    phenytoin - an antiepileptic medicine

•    methohexitone sodium- an anaesthetic

•    amphotericin- antifungal drug

•    sulphadiazine sodium- used in the treatment of toxoplasmosis

•    ampicillin- for bacterial infections

•    5HT 3 antagonists - drugs used to treat nausea and vomiting

e.g. tropisetron and dolasetron.

•    Diuretics - drugs that remove water from the body by increasing the amount of urine the kidney produces, e.g. acetazolamide, vaprisol, thiazides and loop diuretics.

•    Antivirals - such as Amprenavir, Atazanavir, Lopinavir

Pregnancy and breast-feeding

You should tell your doctor if you are pregnant, if you think you are pregnant or you are planning to be pregnant or if you are breastfeeding.

The doctor will then decide whether you should receive Lidocaine hydrochloride.

Driving and using machines

Depending on where and how Lidocaine hydrochloride is used, it may affect your ability to drive or operate machinery. Lidocaine hydrochloride may cause dizziness, blurred vision and sleepiness.

Ask you doctor when it would be safe to drive or operate machines.

LEAF/Lidocaine

V002/TM

3.    HOW YOU ARE GIVEN LIDOCAINE HYDROCHLORIDE

Lidocaine hydrochloride will be given to you in a hospital by healthcare professionals. You will receive your medicine by infusion (IV drip). Dosage

The amount and rate at which the infusion is given depends on your requirements. Your doctor will decide on the correct dose for you.

Adults

Following a loading dose, lidocaine containing infusions will be administered to you at a rate of 1-4 mg of lidocaine per minute for 12-48 hours. Children and Elderly

Doses should generally be reduced in the elderly and children.

The dosage will be calculated by the doctor on the basis of your ECG changes.

If you receive more Lidocaine hydrochloride than you should:

It is very unlikely that you will receive more infusion than you should.

If you suspect an overdosage with Lidocaine hydrochloride you should look for the symptoms/side effects described below in this leaflet. You should immediately inform your doctor describing the symptoms.

If you have any further questions on the use of this product, ask your doctor.

4.    POSSIBLE SIDE EFFECTS

Like all medicines Lidocaine hydrochloride can cause side effects, although not everybody gets them.

The following serious adverse drug reactions are important and will require immediate action if you experience them:

-    sudden stop of heartbeat (cardiac arrest)

-    lowering or decrease of the heart's activity (myocardial depression) As Lidocaine hydrochloride will be given to you by healthcare professionals your symptoms will be monitored and effective treatment will be readily available if you experience any of these serious side effects.

Lidocaine infusions may also cause drowsiness, difficulties in breathing and coma

All medicines can cause allergic reactions although serious allergic reactions are very rare. If you get any of the following symptoms after receiving this medicine , you should contact your doctor immediately:

•    numbness of the tongue and mouth area.

•    skin rash

•    swelling (particularly of the lips, face, eyelids, tongue and throat).

•    Breathlessness

•    Collapse

The following side effects have also been reported:

•    increased size of blood vessels (peripheral vasodilation) resulting in slow heart rate (bradycardia)

•    irregular activity (arrhythmia) of the chambers of the heart

•    high blood pressure (hypertension)

•    fits (convulsions)

•    shaking, usually of the hands (tremor)

•    muscle twitching

•    feeling sick (nausea) and being sick (vomiting)

•    blurred vision

•    involuntary rapid movement of the eye (nystagmus)

•    sensation of ringing, or other noise in the ears (tinnitus)

•    dizziness

•    nervousness

•    excitement

•    restlessness

•    yawning

If any of the side effects get serious or if you notice any side effects not listed in this leaflet, please tell you doctor.

5.    HOW TO STORE LIDOCAINE HYDROCHLORIDE

Keep out of the reach and sight of children.

Your doctor and hospital pharmacist are responsible for the correct storage, use and disposal of Lidocaine hydrochloride solution.

Lidocaine hydrochloride solution should be stored between 2° to 25°C. Lidocaine hydrochloride solution should be free from any particies/crystais.

The solution must not be used after the expiry date shown on the label. The expiry date refers to the last day of that month.

Any solution remaining after treatment should be disposed of using the approved hospital procedures.

6.    FURTHER INFORMATION

What Lidocaine hydrochloride contains:

Each solution contains: Lidocaine hydrochloride, Glucose Monohydrate for Parenteral use BP 5.5% w/v, Equivalent to Anhydrous Glucose BP 5.0% w/v.

The concentration of Lidocaine hydrochloride in each of the solution types can be seen in the name of each product. They are:

Lidocaine hydrochloride 0.2% and Glucose 5% Infusion as Steriflex®

No. 26 orfreeflex®

Lidocaine hydrochloride 0.4% and Glucose 5% Infusion as Steriflex®

No. 27 orfreeflex®

The infusions also contain Water for Injections, hydrochloric acid, and sodium hydroxide.

What Lidocaine hydrochloride looks like and contents of the pack.

Lidocaine hydrochloride is a clear solution contained in a sealed plastic container known as a Steriflex® bag or a freeflex® bag. The solutions are available in 500 ml.

Not all pack sizes may be marketed.

Marketing Authorisation Holder Fresenius Kabi Limited Cestrian Court, Eastgate Way,

Manor Park, Runcorn,

Cheshire, WA7 1 NT. UK.

Manufacturer:

Terumo BCT Limited,

Old Belfast Road, Millbrook,

Larne, Co. Antrim, BT40 2SH. UK.

This leaflet was last revised in February 2013.