TEVA UK Ref: 231-30-01027-C LEA LIDOCAINE 5% OINT 15g TUK <DEB	Version: 1	09 July 2015

LIDOCAINE 5 % m/m OINTMENT

PACKAGE LEAFLET: INFORMATION FOR THE USER

Read all of this leaflet carefully before you start using this medicine.

This medicine is available without prescription. However, you still need to use Lidocaine 5 % m/m Ointment carefully to get the best results from it.

•    Keep this leaflet. You may need to read it again.

•    Ask your pharmacist if you need more information or advice.

•    You must contact a doctor if your symptoms worsen or do not improve after 24 hours.

•    If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

IN THIS LEAFLET:

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

2.    Before you use Lidocaine Ointment

3.    How to use Lidocaine Ointment

4.    Possible side effects

5.    How to store Lidocaine Ointment

6.    Further information

WHAT LIDOCAINE OINTMENT IS AND WHAT IT IS USED FOR

Lidocaine is a medicine called a local anaesthetic which is used to produce numbness to a part of your body to relieve pain or discomfort.

Lidocaine Ointment is used: for numbing gums in dentistry for rectal itch or ulcers (pruritus ani or anal fissures)

for relief of female genital itch (pruritus vulvae)

for relief of piles (haemorrhoids)

for relief of shingles (herpes zoster), cold

sores (herpes labialis)

• for the relief of sore nipples in nursing mothers

as a lubricant for rectal or urethral examination (proctoscopy and cystoscopy).

©■ BEFORE YOU USE LIDOCAINE OINTMENT

DO NOT use Lidocaine Ointment and consult your doctor or pharmacist if you:

• are allergic (hypersensitive) to lidocaine or any of the other ingredients of this ointment

• are allergic to other similar amide local anaesthetics.

Taking other medicines

Talk to your doctor or pharmacist if you are

taking any of the following:

• cimetidine for stomach problems • propranolol for high blood pressure, anxiety or heart problems.

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

Pregnancy and breast-feeding

If you are pregnant, planning to become pregnant or are breast-feeding, ask your doctor for advice before taking any medicine.

Driving and using machines

Lidocaine Ointment may cause drowsiness if it enters your blood stream. If affected, DO NOT drive or operate machinery.

HOW TO USE LIDOCAINE OINTMENT

If your doctor has prescribed this medicine, always use Lidocaine Ointment exactly as your doctor has told you. Otherwise, follow the instructions below.

If you are not sure how to use this medicine, talk to your doctor or pharmacist.

•    Apply using gauze or barrier gloves, if not available, wash your hands before and after applying Lidocaine Ointment.

Note: Lidocaine Ointment is not sterile and should not be used with aseptic techniques.

Adults, the elderly and children:

•    Anaesthesia and pain relief

Apply 1 to 2 ml (about 2 to 4 cm when squeezed out of the tube) and gently spread over the affected area (the ointment will soften at body temperature).

Repeat when necessary but use no more than 5 g (one third of a tube) within 24 hours unless instructed otherwise by your doctor.

•    Nursing mothers

Apply to the nipples using a small piece of lint or gauze, wash off immediately before the next feed.

Dentistry

Apply to dry gum and rub gently.

If you are not sure how to use this medicine talk to your doctor or pharmacist.

If you use more Lidocaine Ointment than you should

If you apply too much ointment, wipe off the excess with a paper towel or similar.

If you (or someone else) swallow any of the ointment, or if you think a child has swallowed any of the ointment, contact your nearest hospital casualty department or your doctor immediately. An overdose is likely to cause a low blood pressure and heart problems. Please take this leaflet, any remaining ointment, and the container with you to the hospital or doctor so that they know which ointment has been consumed.

If you forget to use Lidocaine Ointment

If you forget to apply the ointment at the correct time, make the application as soon as possible, and then make your applications at the correct time. If it is 3 hours, or less, to the next application, then ignore the missed dose.

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

POSSIBLE SIDE EFFECTS

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

If the following happens, stop using the ointment and tell your doctor immediately or go to the casualty department at your nearest hospital:

an allergic reaction (swelling of the lips, face or neck leading to severe difficulty in breathing; skin rash or hives).

This is a very serious but rare side effect. You may need urgent medical attention or hospitalisation.

Most patients using topical lidocaine will have no problems when used in the correct amount for the prescribed time.

Using Lidocaine Ointment for a prolonged period (longer than prescribed) can cause an allergic reaction.

If the condition becomes worse during treatment, or you experience any other ill effects, stop using the ointment and tell your doctor as soon as possible.

Blue box represents the Supplier Code to be added prior to production.