Emla.pdf

IMPORTANT: PLEASE READ

EMLA ® Patch

lidocaine 2.5% and prilocaine 2.5% Patch

• unusually slow heart beat,

• fainting,

• nervousness,

• unusual sweating,

• trembling

• seizures

Get medical help right away, if you experience any of these side

effects.

PART III:

CONSUMER INFORMATION

This leaflet is part III of a three-part "Product Monograph"

published when EMLA ® Patch was approved for sale in

Canada and is designed specifically for Consumers. This

leaflet is a summary and will not tell you everything about

EMLA ® Patch. Contact your doctor or pharmacist if you

have any questions about the drug.

ABOUT THIS MEDICATION

WHAT THE MEDICATION IS USED FOR:

EMLA Patch is used to create a temporary loss of feeling or

numbness of small areas of skin (slightly larger than a two

dollar coin or “toonie”) and can be used:

• prior to getting a needle or having blood taken, and only

on healthy, unbroken skin;

• prior to vaccination with only the following vaccines:

MMR (Measles-Mumps-Rubella), DPTP (Diptheria-

Pertussis-Tetanus-Poliovirus), Haemophilus influenzae b

or Hepatitis B. Since the effect of EMLA on the immune

response to any other vaccine is unknown, it cannot be

recommended for use with any other vaccine.

Keep this leaflet to refer to until you have used up all your

EMLA Patches.

This medicine has been prescribed for you personally and

you should not pass it on to others. It may harm them, even

if their symptoms are the same as yours.

• EMLA Patch should only be used according to the

section WHAT THE MEDICATION IS USED FOR

because maximum safe doses for other uses are not

known.

• If your doctor has not explained how to use EMLA

Patch, make sure you read and understand the

section, PROPER USE OF THIS MEDICATION.

Follow the instructions. Ask your doctor or

pharmacist to explain the proper use of EMLA Patch

if you do not understand these instructions. Serious

and life threatening side effects have occurred when

EMLA Cream was not used properly.

WHAT IT DOES:

EMLA is the brand name for a topical anesthetic that contains

the drugs lidocaine and prilocaine. Topical anesthetics are used

to cause a temporary loss of feeling or numbness of the skin at

the area where it is applied.

WHEN IT SHOULD NOT BE USED:

• if you/your child have methemoglobinemia (a blood

disorder);

• on infants who require methemoglobin-inducing agents

(e.g., sulfonamides), and are 12 months of age or younger;

• if you are allergic to lidocaine, prilocaine, any other “-

caine” type anesthetics, or any of the non-medicinal

ingredients in the product (see WHAT THE

NONMEDICINAL INGREDIENTS ARE section below);

• on infants less than 3 months of age, unless instructed by

your doctor.

• for procedures requiring large amounts of EMLA over a

large body area that are not conducted in a hospital.

WHAT IS THE MOST IMPORTANT

INFORMATION I SHOULD KNOW ABOUT EMLA

EMLA contains 2.5% lidocaine and 2.5% prilocaine.

Be careful to apply no more than the maximum

recommended dose of EMLA Patch. Serious side effects

from applying too much EMLA Patch can include:

• drowsiness,

• numbness of the tongue,

• brownish or greyish skin especially around lips and nails,

• light-headedness,

• confusion,

• headache,

• sight or hearing problems,

• difficulty breathing,

• vomiting, dizziness,

• weakness,

WHAT THE MEDICINAL INGREDIENT IS:

lidocaine 2.5% and prilocaine 2.5%

WHAT THE NONMEDICINAL INGREDIENTS ARE:

EMLA Patch is composed of a tan-coloured adhesive tape with

a round white pad in the centre that contains EMLA. The

adhesive tape is protected with a peel-off backing which is

removed before the patch is applied.

IMPORTANT: PLEASE READ

EMLA Patch also contains carboxypolymethylene,

polyoxyethylene hydrogenated castor oil, and sodium

hydroxide. The patch adhesive is made from acrylate. The

patch does not contain latex.

PROPER USE OF THIS MEDICATION

USUAL DOSE:

Do not apply the EMLA Patch to infants under 3 months of age

unless a doctor tells you to do so. Infants under 3 months of age

are at a higher risk than older children for methemoglobinemia.

This is a condition in which there is not enough oxygen in the

blood, and it can be caused by an overdose of EMLA.

WHAT DOSAGE FORMS IT COMES IN:

EMLA ® Patch: 1 g patches

WARNINGS AND PRECAUTIONS

If your doctor tells you to use EMLA Patch, follow your

doctor's instructions for use. In any other situation, follow the

directions below.

Serious Warnings and Precautions

EMLA Patch is for use on healthy, unbroken skin. Do

not apply to open wounds, nor to burns or rashes or

other skin conditions, including diaper rash.

Do not put EMLA Patch near the eyes, as it may cause some

irritation. If you accidentally get EMLA in the eye, rinse it well

with lukewarm water and protect it until sensation returns.

BEFORE you use EMLA Patch talk to your doctor or

pharmacist if:

• if you/your child have glucose- 6-phosphate

dehydrogenase deficiency;

• if you/your child have ever had a bad, unusual or allergic

reaction to lidocaine or prilocaine, also available under

brand names such as Xylocaine ® (lidocaine) and

Citanest ® (prilocaine);

• if you think you/your child might be sensitive or allergic

to other ingredients of the patch (see WHAT THE

NONMEDICINAL INGREDIENTS ARE);

• if there is an infection, skin rash or cut at, or near, the

area where you want to apply EMLA Patch;

• if you/your child have dermatitis or any other skin

problems or diseases;

• if you/your child have severe kidney or liver disease (see

PROPER USE OF THIS MEDICATION);

• if you are pregnant, trying to become pregnant or are

breastfeeding.

Do not apply EMLA Patch inside the ear. Do not put EMLA

Patch in your mouth or swallow it. Take special care to ensure

that infants and young children do not put the patch in their

mouth. If an EMLA Patch is accidentally swallowed, call your

doctor.

Do not re-use EMLA Patch.

The numbing effect of EMLA starts working about 1 hour after

it is applied. You may still feel pressure and touch in the area

where you apply EMLA. The numbness of the skin may

continue to increase after the patch is removed, and will last for

at least 2 hours following a 1-2 hour application.

Conditions where adjustments in dose may be required:

• elderly patients

• acutely ill patients

• patients with severe liver disease

• patients with severe kidney disease

• patients also treated with other anesthetics or certain

antiarrhythmic drugs (e.g. mexilitine, amiodarone)

INTERACTIONS WITH THIS MEDICATION

Tell your doctor or pharmacist about any other drugs you take,

or have recently taken including the ones you can buy without a

prescription, including:

• antiarrhythmic drugs for heart problems (e.g. mexilitine,

amiodarone);

• other anesthetics;

• other drugs which may trigger methemoglobin formation,

including: sulfonamides, acetanilide, aniline dyes,

benzocaine (or other “-caine” type anesthetics),

chloroquine, dapsone, naphthalene, nitrates or nitrites,

nitrofurantoin, nitroglycerin, nitroprusside, pamaquine,

para-aminosalicylic acid, phenacetin, phenobarbital,

phenytoin, primaquine, quinine and high doses of

acetaminophen.

EMLA should be used with caution in these patients, who may

be more sensitive to the effects of lidocaine and prilocaine.

Adults

Be careful not to apply more EMLA Patch or replace it

more frequently than the doctor recommended.

Serious and life threatening side effects have occurred when

EMLA Cream was not used properly and more than the

recommended amounts were applied.

EMLA Patch must be applied for at least 1 hour before the

procedure. You will not get any added benefit from leaving

EMLA Patch on for longer than 5 hours.

IMPORTANT: PLEASE READ

Pediatrics

Be careful not to apply more EMLA Patch or replace it

more frequently than the doctor recommended.

3. Apply EMLA patch so that the white,

round pad containing EMLA covers the

area to be treated. Press firmly only

around the edges of the patch to ensure

a good adhesion to the skin. Press

gently on the centre of the patch to

ensure that EMLA comes into contact

with the skin. It is important to make

sure that the patch is firmly secured. If

not, it may not be effective, or others

might be accidentally exposed to the

medication.

Children should be closely observed during and after use of

topical anesthetics, as they are at greater risk than adults

for serious side effects, such as methemoglobinemia (a blood

disorder that causes the skin, especially around lips and nails,

to turn brownish or greyish) . See also SERIOUS SIDE

EFFECTS, HOW OFTEN THEY HAPPEN AND WHAT

TO DO ABOUT THEM.

When using EMLA Patch for your child’s pain relief, remember

it is also very important to provide comfort and emotional

support.

4. Mark the time of application directly on

the patch with a ballpoint pen. EMLA

patch must be applied for at least 1 hour

before the start of the procedure. Care

should be taken that the patch does not

become detached during the 1 hour

wait.

5. Remove EMLA patch and clean the

area thoroughly before the procedure. If

you are applying the EMLA patch for a

procedure to be performed by a doctor,

you should leave it on for the doctor to

remove, unless instructed otherwise.

Throw away used EMLA Patch by carefully folding in half so

the adhesive side sticks to itself and dispose in the garbage out

of the reach of children and pets.

Infants Under 3 Months (ONLY IF INSTRUCTED BY A

DOCTOR):

Do not use more than one EMLA Patch at the same time.

Leave the patch on for 1 hour. Do not leave EMLA Patch on

the skin for longer than 1 hour.

The size of the patch makes it less suitable for use on certain

parts of the body in neonates and infants.

Infants Between 3 and 12 Months of Age:

Do not use more than two EMLA Patches at the same time.

Leave the patch on for at least 1 hour. Do not leave EMLA

Patch on the skin for more than 4 hours.

OVERDOSE:

Children Between 1-6 Years:

Apply one or more patches to the skin area selected for 1 hour.

Do not leave on the skin for more than 5 hours. Apply up to 10

patches.

In case of EMLA overdose or if you think you, or anyone

else, are experiencing any of the side effects described

below or methemoglobinemia, contact your doctor,

hospital emergency department or regional Poison Control

Centre immediately. You may require medical attention.

Children Between 7-12 Years:

Apply one or more patches to the skin area selected for at least

1 hour. Do not leave on the skin for more than 5 hours. Apply

up to 20 patches.

SIDE EFFECTS AND WHAT TO DO ABOUT THEM

INSTRUCTIONS FOR APPLICATION OF

EMLA PATCH

Like any medication, EMLA Patch may result in side effects in

some people.

The skin to which EMLA Patch is applied may stay numb for

up to several hours after the cream is removed. For this reason,

you should be careful to avoid accidental injury to the treated

area, such as scratching, rubbing or exposure to extreme hot or

cold temperatures, until complete sensation returns.

1. Make sure your skin is clear and dry.

Take hold of the aluminium flap at the

corner of the patch and bend it back.

2. While holding the aluminium flap, take

hold of the corner of the tan-coloured

patch layer. Pull the two layers apart,

separating the adhesive surface from the

aluminium paper backing. Do not touch

the white, round pad which contains

EMLA.

Mild side effects that are common with use of EMLA are

whitening or redness of the skin, slight puffiness, and initial

burning or itching on the skin where EMLA is applied. These

are normal reactions and will disappear without any treatment.

Allergic reactions to the active ingredients have been seen but

are rare.

IMPORTANT: PLEASE READ

Medicines affect different people in different ways. Just

because side effects have occurred in some patients, does not

mean that you will get them. If any side effects bother you, or if

you experience any unusual effects while you are using EMLA,

stop using it. Talk to your doctor or pharmacist as soon as

possible.

REPORTING SUSPECTED SIDE EFFECTS

You can report any suspected adverse reactions associated

with the use of health products to the Canada Vigilance

Program by one of the following 3 ways:

Report online at www.healthcanada.gc.ca/medeffect

Call toll-free at: 1-866-234-2345

Complete a Canada Vigilance Reporting Form and:

-Fax toll-free to: 1-866-678-6789 or,

-Mail to: Canada Vigilance Program

Health Canada

Postal Locator 0701C

Ottawa ON K1A 0K9

SERIOUS SIDE EFFECTS, HOW OFTEN THEY

HAPPEN AND WHAT TO DO ABOUT THEM

Symptom / effect

Talk with your

doctor or

pharmacist

Stop taking

drug and

seek

immediate

emergency

help

Only if

severe

In all

cases

Postage paid labels, Canada Vigilance Reporting Form and

the adverse reaction reporting guidelines are available on

the MedEffect ™ Canada Web site at

www.healthcanada.gc.ca/medeffect

Rare Methemoglobinemia

[reduced oxygen to

body tissues causing

brownish or greyish

skin especially

around lips and nails]

NOTE: Should you require information related to the

management of side effects, contact your health

professional. The Canada Vigilance Program does not

provide medical advice.

Rare Eye irritation X*

Rare Allergic reaction X

*If EMLA Patch accidentally enters the eye, immediately rinse the eye

in water or sodium chloride solution and protect the eye until sensation

returns. Contact your doctor or pharmacist.

MORE INFORMATION

This is not a complete list of side effects. For any unexpected

effects while taking EMLA Patch, contact your doctor or

pharmacist.

Important Note: This leaflet alerts you to some of the times

you should call your doctor while using EMLA Patch.

Other situations which cannot be predicted may arise.

Nothing about this leaflet should stop you from calling your

doctor with any questions or concerns you have about using

EMLA Patch.

EMLA Patch can cause serious side effects if too much is

applied. These include drowsiness, numbness of the tongue,

discoloured skin, light-headedness, confusion, headache, sight

or hearing problems, difficulty breathing, vomiting, dizziness,

weakness, unusually slow heart beat, fainting, nervousness,

unusual sweating, trembling or seizures. Stop taking the drug

and seek immediate emergency help if you experience any of

these side effects. Irritation may occur when eyes are

accidentally exposed to EMLA.

NOTE: This CONSUMER INFORMATION leaflet provides

you with the most current information at the time of printing.

For the most current information, the Consumer Information

Leaflet plus the full Product Monograph, prepared for health

professionals can be found at: www.astrazeneca.ca under

Patients with Prescriptions, or by contacting the sponsor,

AstraZeneca Canada Inc. at:

Customer Inquiries – 1(800) 668-6000,

Renseignements – 1(800) 461-3787.

If someone using EMLA shows these signs, or any other sign of

being unwell, they should seek immediate medical attention.

Methemoglobinemia

EMLA Patch, in extremely rare cases, can affect the level of

oxygen that the blood carries, resulting in an increase in the

methemoglobin level in your blood. This condition, known as

methemoglobinemia, causes the colour of the skin to become

brownish or greyish, especially around the lips, fingernails and

toenails. If you see this happening, go to the nearest hospital

right away.

This leaflet was prepared by

AstraZeneca Canada Inc. Mississauga, Ontario L4Y 1M4

EMLA ® and the AstraZeneca logo are trade-marks of the

AstraZeneca group of companies.

HOW TO STORE IT

Keep EMLA Patch well out of the reach of children.

Store EMLA Patch at room temperature. Protect from freezing.

Last revised: May 25, 2010

IMPORTANT: PLEASE READ

EMLA ® Cream

lidocaine 2.5% and prilocaine 2.5% Cream

PART III:

CONSUMER INFORMATION

• sight or hearing problems,

• difficulty breathing,

• vomiting, dizziness,

• weakness,

• unusually slow heart beat,

• fainting,

• nervousness,

• unusual sweating,

• trembling

• seizures

Get medical help right away, if you experience any of these side

effects.

This leaflet is part III of a three-part "Product Monograph"

published when EMLA ® Cream was approved for sale in

Canada and is designed specifically for Consumers. This

leaflet is a summary and will not tell you everything about

EMLA ® Cream. Contact your doctor or pharmacist if you

have any questions about the drug.

ABOUT THIS MEDICATION

Keep this leaflet to refer to until you have used up all your

EMLA Cream.

WHAT THE MEDICATION IS USED FOR:

EMLA Cream is used to create a temporary loss of feeling or

numbness of the skin, and can be used:

• on healthy, unbroken skin before minor skin surgery, or

when getting a needle or having blood taken;

• prior to vaccination with only the following vaccines:

MMR (Measles-Mumps-Rubella), DPTP (Diptheria-

Pertussis-Tetanus-Poliovirus), Haemophilus influenzae b

or Hepatitis B;

• on the genital mucosa;

• for the cleansing of leg ulcers.

For best results talk to your doctor before using the cream on

the genital mucosa or for leg ulcers.

This medicine has been prescribed for you personally and you

should not pass it on to others. It may harm them, even if their

symptoms are the same as yours.

• EMLA Cream should only be used according to the

section WHAT THE MEDICATION IS USED FOR

because maximum safe doses for other uses are not

known. Applying EMLA Cream on large areas of

skin can result in a medical emergency.

• If your doctor has not explained how to use EMLA

Cream, make sure you read and understand the

section, PROPER USE OF THIS MEDICATION.

Follow the instructions. Ask your doctor or

pharmacist to explain the proper use of EMLA

Cream if you do not understand these instructions.

Serious and life threatening side effects have

occurred when EMLA Cream was not used properly.

WHAT IT DOES:

EMLA is the brand name for a topical anesthetic that contains

the drugs lidocaine and prilocaine. Topical anesthetics are used

to cause a temporary loss of feeling or numbness of the skin at

the area where it is applied.

WHAT IS THE MOST IMPORTANT

INFORMATION I SHOULD KNOW ABOUT EMLA

WHEN IT SHOULD NOT BE USED:

• if you/your child have methemoglobinemia (a blood

disorder);

• on infants who required methemoglobin-inducing agents

(e.g., sulfonamides) and are 12 months of age or younger;

• if you/your child are allergic to lidocaine, prilocaine, any

other “-caine” type anesthetics, or any of the non-

medicinal ingredients in the product (see WHAT THE

NONMEDICINAL INGREDIENTS ARE section below);

• on infants less than 3 months of age, unless instructed by

your doctor.

• for procedures requiring large amounts of EMLA over a

large body area that are not conducted in a hospital.

EMLA contains 2.5% lidocaine and 2.5% prilocaine.

Be careful to apply no more than the maximum

recommended dose of EMLA Cream. Serious and life

threatening side effects have occurred when EMLA cream

was used on large areas of skin for topical analgesia during

cosmetic procedures. Serious side effects from applying too

much EMLA Cream can include:

• drowsiness,

• numbness of the tongue,

• brownish or greyish skin especially around lips and nails ,

• light-headedness,

• confusion,

• headache,

WHAT THE MEDICINAL INGREDIENT IS:

lidocaine 2.5% and prilocaine 2.5%

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