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Lidocaine Hydrochloride Bp Laryngojet 4% W/V

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Document: leaflet MAH GENERIC_PL 03265-0040 change

Patient Information Leaflet: Lidocaine Hydrochloride BP laryngojet 4 % w/v Lidocaine hydrochloride

Read all of this leaflet carefully before you are given this medicine If you have any further questions, ask your doctor or nurse

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

In this leaflet, Lidocaine Hydrochloride BP laryngojet will be called Lidocaine

In this leaflet:

1.    What Lidocaine is for

2.    Before you are given Lidocaine

3.    How Lidocaine will be given to you

4.    Possible side effects

5.    How to store Lidocaine

6.    Further information

1. What Lidocaine is for

Lidocaine belongs to a group of medicines called local anaesthetics. Local anaesthetics work by numbing the area of the body that they are injected into which stops pain being felt.

Lidocaine is used to numb parts of the body, such as the mouth, throat and lungs, before some medical procedures which would otherwise be uncomfortable or painful. Examples of the kind of procedures Lidocaine is used for are putting a breathing tube in during an operation, putting a tube into the lungs to examine them (bronchoscopy), or taking a specimen from the mouth, throat or lungs.

2. Before you are given Lidocaine

Do not have Lidocaine if:

•    You    are allergic to Lidocaine or other local anaesthetics

•    You    are allergic to any of the other ingredients of Lidocaine (see section    6)

•    You have acute porphyria (a blood disorder in which excessive blood pigment, porphyrin is excreted in the urine and you are extremely sensitive to light).

If any of the above applies to you talk to your doctor or nurse.

Check with your doctor before you are given Lidocaine if:

•    You have epilepsy

•    You have liver disease

•    You have any heart problems

•    You have severe breathing    difficulties

•    You have myasthenia gravis (a condition where you have weak muscles)

•    You suffer from loss of blood circulation or less oxygen in the tissue

•    You have unusually low or high levels of potassium in the blood

•    The area to be anaesthetised is infected or cut

•    You    are pregnant, likely to become pregnant, or are breast-feeding

•    You    are suffering from shock. This is an emergency condition where    there is not enough oxygen

reaching all parts of the body. This type of shock can cause many organs to stop working properly.

Tell your doctor if you are taking any of the following medicines:

•    Any medicines for a heart condition (e.g. kinidine, disopyramide, amiodarone, bretylium, sotalol,

dofetilide, metoprolol and nadolol)

•    Medicines for high blood pressure (e.g. propanolol)

•    Medicines for a stomach ulcer (e.g. cimetidine)

•    Medicines for epilepsy (e.g. phenytoin), infections (e.g. erythromycin), depression (e.g. fluvoxamine) or glaucoma (e.g. acetazolamide)

•    Oral contraception or oral HRT

•    Suxamethonium or cistracurium used as muscle relaxants during a general anaesthetic

•    Medicines to increase the rate of urination (e.g. loop diuretics or thiazides)

•    You are taking any other medicine, including medicines obtained without a prescription If any of the above applies to you talk to your doctor or nurse.

Pregnancy and breast-feeding

If you are pregnant, in labour or breastfeeding, Lidocaine will only be given to you if your doctor considers that the benefit of treatment outweighs the risk to the developing baby or new-born baby. Lidocaine is excreted in breast milk, so if you are breastfeeding, your doctor or nurse will observe your baby for any side effects.

Driving and using machines

Lidocaine may make you feel dizzy or tired. If this happens to you, do not drive a vehicle, operate machinery or carry out complex tasks.

3. How Lidocaine will be given to you Important:

Lidocaine will be given to you by a doctor, or nurse in hospital. Your doctor will choose the dose that is right for you.

The solution can be sprayed, instilled or applied with a swab to the area to be numbed. It usually works within 5 minutes.

Adults

The lowest dose possible will be given. The usual adult dose is 1 to 5 ml (40 - 200mg).

The elderly

The elderly may need a lower dose.

Children

The usual dose is up to 3mg for every kg they weigh (so if they weigh 10kg, they could have 3 x 10 = 30mg).

If you think you may be given more Lidocaine than you should

As this medicine will be given to you by a doctor or nurse, it is unlikely that you will be given too little or too much. However, tell your doctor or nurse if you have any concerns.

The effects of an overdose may include fits (convulsions) and/or collapse of the heart and circulatory system.

If you have any further questions about the use of this medicine, ask your doctor or nurse.

4. Possible side effects

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

Seek immediate medical help if you have any of the following symptoms:

Allergic reactions causing

-    Swelling of hands, feet, lips, mouth, tongue or throat

-    Difficulties breathing

-    Itchy skin rash

-    Diarrhoea and stomach    pains

-    Collapse

The other side effects are: Effects on the lungs

-    breathing problems or you may stop breathing

Effects on the heart and circulation

-    irregular heart beat

-    a sudden loss of blood flow due to heart or vessel factors and a very slow heart rate which may lead to a heart attack

-    problems with the electrical system of the heart and reduced function of your heart

-    low blood pressure

Effects on the nervous system

-    unconsciousness

-    fits

-    twitching or tremors

-    feeling sick or being sick

-    dizziness or light headedness

-    drowsiness

-    a feeling of apprehension, nervousness or extreme happiness

-    a feeling of confusion or being unable to distinguish between reality and your imagination

-    headache

-    sensations of heat, cold    or numbness

-    pins and needles

Other effects

-    blurred or double vision

-    uncontrolled movement of the eyes

-    ringing in the ears

-    temporary pain or discomfort in the buttocks or legs

-    a blood disorder where excessive haemoglobin in the blood is converted to another chemical that cannot deliver oxygen to tissues

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 this 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 Lidocaine

Keep out of the reach and sight of children. Do not use Lidocaine after the expiry date on the carton and vial label. The expiry date refers to the last day of that month. Do not store above 25°C. Keep vial in the outer carton to protect from light. Your doctor or nurse will make sure your medicine is correctly stored and disposed of.

6. Further information

What Lidocaine contains

The active substance is lidocaine hydrochloride (160 mg in 4 ml). The other ingredients are sodium hydroxide and water for injections.

What Lidocaine looks like

Lidocaine is a sterile solution in a clear glass vial. Each carton contains one vial. The vial is specially designed for use with the IMS Laryngojet injector device.

Marketing Authorisation Holder

International Medication Systems (UK) Limited 21 St Thomas Street, Bristol, BS1 6JS, UK

Manufacturer

UCB Pharma Ltd, 208 Bath Road, Slough, Berkshire, SL1 3WE, UK This leaflet was last updated August 2016.

If this leaflet is difficult to see or read or you would like it in a different format, please contact: International Medication Systems (UK) Limited, 21 St Thomas Street, Bristol, BS1 6JS, UK