Lidocaine 4% W/W Cream
In this leaflet;
1. What LMX4 is and what it is used tor
2. Before you U3e LMX4
3. How to use LMX4
4. Possible side effects
5. How to store LMX4
6. Further information
PACKAGE LEAFLET: INFORMATION FOR THE USER
LMX4, Lidocaine 4%w/w Cream
Read all of this leaflet carefully before you or your child start using this medicine.
• This medicine is available without prescription, however you still need to use it carefully to get the best results.
• Keep this leaflet. You may need to read it again.
* If you have any questions, ask your doctor or pharmacist.
* If any side offoct becomes more serious, or if you notice any aide effect not listed in this leaflet, please tell your doctor or pharmacist.
1. WHAT LMX4 IS AND WHAT IT IS USED FOR
This medicine is called:
LMX4, Lidocaine 4%w/w Cream Each gram of cream contains 40mg of tne
activ© ingrcdiont lidocaino.
LMX4 is a type of medicine called a local anaesthetic, used to numb an area of the body.
LMX4 temporariy numbs the surface of the skin, providing pain lelief when a needle is inserted into a vein (venipuncture or venous cannulation) for medical purposes, such as extracting blood for 'aboratory tests. It may also be used to numo tne skin prior to administration of painful topical treatments on larger surface areas of intact skin.
Pr»UHia»icy and breast-feeding:
Ask your doctor for advice before using any medicine. Lidocaine is passed into breast milk, but in such small quantities that there is generally no risk for the child.
important information about some uf Ihe nnnertienfK-
Propyiene glycol may cause skin irritation
3. HOW TO USE LMX4
2. BEFORE YOU USE LMX4
Do not useLMX4:
Talk to your doctor or pharmacist (chemist) and do not use LMX4 if.
• You are allergic (hypersensitive) to lidocaine or any of the other ingredients.
• You are allergic to any similar local anaesthetics.
Take special care with LMX4:
Talk lo your docior or pharmacist befoie use if:
• You are acutely ill or elderly (you will be more sensitive to lidocaine)
• You have a history of being sensitive to the ingrodionts of any modicinos.
• You have a severe liver (hepatic) disease
Using with other medicines*
Tell your doctor or pharmacist if you have recently used any' other medicines, with or without a prescription, but specifically:
- LMX4 or any other local anaesthetic.
• Any medicine used to prevent or treat an nteguiat neaii ueai, such asiocaimue, mexitetime or amiodarone.
• Tne beta-OJocker propranolol, for the treatment of hypertension.
• Cimetidine, for the treatment of heartburn or stomach ulcers
Always uso LMX4 exactly as instructed. Ask immediately if you have any questions. Ycur doctor, pharmacist or nurso will either apply the cream for you. or show you how much to use.
Precautions when using LADM*
• For external use only. Do not exceed the recommended dose.
• Do not apply to raw or blistered skin, in the ear. inside the nose, in the mouth, to the anus (back passage), where there is a skin rash or eczema, or where there are cuts, grazes or wounds.
• Avoid getting LMX4 cream in your eyes, as it may cause irritation If you accidentally get any in your eye. immediately nnseit well witn lukewarm water or sodium chloride (salt) solution and protect it until sensaticn returns.
• How you use LMX4 changes, depending upon why you are using the product. Make sure you choose and follow the correct dosage section overleaf.
■ Your doctor or nurse will tell you where you should apply the cream If the. cream is In be used over large areas, a doctor or nurse will apply it for you
• LMX4 blocks all sensations in the treated area. Avoid scratching, rubbing and exposure to extreme hot and cold until the anaesthetic effect has worn off.
Continu'd,,,.
Dosage and how to apply LMX4 to provide pain relief when inserting a needle into a vein:
1g of cream is approximately equal to a 5cm length of crearn squeezed from the 5g tube or 3 5cm squeezed from the 30g tube. Adults, including the elderly, and children over 1 year of age:
1 g to 2 5g of cream, to cover an area of skin 2.5cm x 2 5cm (V’x1 ”). Do not leave on the skin for longer than 5 hours.
Infants over 3 months but below 1 year of aae:
No more than 1 g of cream should be applied. Do not leave on the skin for longer than 4 nours.
Infants over 1 month but below 3 months of age: No more than 1g of cream should be applied. Do not leave on the skin for longer than i hour.
Do not use oil infants below one month old.
1 Appy LMX4 at least 30 minutes before the medical procedure starts
2. Using the quantity stated above, apply the cream in a thick layer to the skin
3. Cover the cream with a dressing, to prevent it being accidentally rubbed off the skin.
4. After approximately 30 minutes remove the dressing, immediately remove the croam with a clean tissue cr gauze.
5. Inserting a needle into the vein should be performed shortly after removing the cream.
Dosage and how to apply LMX4tio
provide anaesthesia prior to
administration of painful topical
traobnente cn lorgw ourfocs e«-ooo -I
intact skin
Adults and the elderly aged 18 years and over:
Use 1.5g to 2g on each i0cm’ area of skin to cover a maximum total area of 900cm2 (approximately equal to a back or thigh).
1 Apply LMX4 approximately 30 to 60 minutes before the procedure starts
2 Using the quantities stated above, apply the cream in a thin layer to the skin.
3. Ensure the cream is not accidentally rubbed off the skin.
4. After approximately 30 to 60 mmutes, remove the cream with a tissue or gauze.
5. The procedure should begin shortly after removal of the cream.
The cream should not be reapplied for at least 12 hours after it has been removed.
Do not use on patients below 18 years of aoe.
IT you use more LMX4 Oran you should:
Overdose is unlikely, but talk to your doctor or nurse straight away, even it you do not feel any symptoms. An overdose may include using more than the recommended amount, applying the cream to large areas or using the cream for longer than recommended.
The following overdose symptoms may be experienced: blurred vision, dizziness or drowsiness, difficulty breathing, trembling, chest pain or an irregular heartbeat.
4. POSSIBLE SIDE EFFECTS
Like ail medicines, as well as benefits. LMX4 can cause side effects, although not everybody gets them.
If you experience any side effect listed below, immediately remove the cream, discontinue use and talk to your doctor or pharmacist.
An allergic reaction is rare, affecting fewer than 1 in 1000 patients. Symptoms may include a rash, swelling, very low blocd pressure or anaphylactic shock.
Skin irritation, redness, itching, dryness or rash at the site of application are all known but uncommon side effects affecting fewer than 1 in 100 patients
You may experience eye irritation if the cream is applied to or around tne eye Refer to ‘Precautions when usiig LMX4 in Section 3 for what to do immediately after accidental eye exposure.
Talk to your doctor or pharmacist if:
• Any side effect becomes more serious or persists.
• Any side effect clears up but occurs again within a lew days
• rf you notice any Side effect not listed. Roporting of sido offocts:
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the MHRA’s Yellow Card Scheme, available at: www.mhra gov uk/yellowcard. By reporting sde effects you can help provide more information on the safety of this medicine.
5. HOW TO STORE LMX4
K^pp out of th» reach and sight of children. Do net store above 25°C.
Do net use after the expiry cate which is stated on the tuhp The expiry date refers to the last day of the month.
Return any unused cream to your pharmacist (chemist).
6. FURTHER INFORMATION
WIrat LMA4 contains:
The active substance is lidocaine. 1g of cream contains 40mg of lidocaine.
The other ngredierts are benzyl alconol, carbomers. cholesterol, phospholipon 80H. potysorbate 80. propylene glycol, trolamine. vitamin E acetate and purified water
What LMX4 looks like and contents of the pack:
LMX4 rs an oTT-wnite cream presented in a 5g or 30g tube It may be packed into a carton tnai also contains dressings that can be used to cover and protect the cream after it nas been applied to the skin.
MarfceUfQj Aulhunsaliuu Holder jiiU Manufacturer.
PL20685/0034
Marketing Authorisation I lolder Ferndale Pharmaceuticals Ltd.
Unit 740 Thorp Arch Estate,
Wetherby, West Yorkshire,
LS23 7FX. UK, Tel. 01937 541122.
E-mail: info@femdalepharma.co uk
Manufacturer:
Laleham Health and Beauty Ltd,
Sycamore Park, Mill Lane Alton, t lampshire,
GU34 2PR. UK
This leafier was last approved in August 2014.
P0G34V®-61 (3W-HW-Alig-U
Panlone 528 C Blac*
Die Line (does not pnnu ARTWORK NOTES: Notes
client eoftncT*
Fcmdnlo
17/07/14 6707 amended
4.25’ * 9’ folded
HW
to 2.125" x ,75", 2-sded
In this leaflet:
1. What LMX4 is and what it is used for
2. Before you use LMX4
3. How to use LMX4
4. Possible side effects
5. How to store LMX4
6. Further information
PACKAGE LEAFLET: INFORMATION FOR THE USER
LMX4, Lidocaine 4%w/w Cream
Read all of this leaflet carefully before you or your child start using this medicine.
■ This medicine is available without prescription, however you still need to use it carefully to get the best results.
• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• If any side effect becomes more serious, or if you notice any side effect not listed in this leaflet, please tell your doctor or pharmacist.
1. WHATLMX4 IS AND WHAT IT IS USED FOR
This medicine is called:
LMX4, Lidocaine 4%w/w Cream Each gram of cream contains 40mg of the active ingredient lidocaine.
LMX4 is a type of medicine called a local anaesthetic, used to numb an area of the body.
LMX4 temporarily numbs the surface of the skin, providing pain relief when a needle is inserted into a vein (venipuncture or venous cannulation) for medical purposes, such as extracting blood for laboratory tests. It may also be used to numb the skin prior to administration of painful topical treatments on larger surface areas of intact skin.
Pregnancy and breast-feeding:
Ask your doctor for advice before using any medicine. Lidocaine is passed into breast milk, but in such small quantities that there is generally no risk for the child.
Important information about some of the ingredients:
Propylene glycol may cause skin irritation.
3. HOW TO USE LMX4
Always use LMX4 exactly as instructed. Ask immediately if you have any questions. Your doctor, pharmacist or nurse will either apply the cream for you, or show you how much to use.
Precautions when using LMX4:
2. BEFORE YOU USE LMX4
Do not use LMX4:
Talk to your doctor or pharmacist (chemist) and do not use LMX4 if:
• You are allergic (hypersensitive) to lidocaine or any of the other ingredients.
• You are allergic to any similar local anaesthetics.
Take special care with LMX4:
Talk to your doctor or pharmacist before use if:
• You are acutely ill or elderly (you will be more sensitive to lidocaine).
• You have a history of being sensitive to the ingredients of any medicines.
• You have a severe liver (hepatic) disease.
Using with other medicines:
Tell your doctor or pharmacist if you have recently used any other medicines, with or without a prescription, but specifically:
• LMX4 or any other local anaesthetic.
• Any medicine used to prevent or treat an irregular heart beat, such as tocainide, mexiletime or amiodarone.
• The beta-blocker propranolol, for the treatment of hypertension.
• Cimetidine, for the treatment of heartburn or stomach ulcers.
• For external use only. Do not exceed the recommended dose.
• Do not apply to raw or blistered skin, in the ear, inside the nose, in the mouth, to the anus (back passage), where there is a skin rash or eczema, or where there are cuts, grazes or wounds.
• Avoid getting LMX4 cream in your eyes, as it may cause irritation. If you accidentally get any in your eye, immediately rinse it well with lukewarm water or sodium chloride (salt) solution and protect it until sensation returns.
• How you use LMX4 changes, depending upon why you are using the product. Make sure you choose and follow the correct dosage section overleaf.
• Your doctor or nurse will tell you where you should apply the cream. If the cream is to be used over large areas, a doctor or nurse will apply it for you.
• LMX4 blocks all sensations in the treated area. Avoid scratching, rubbing and exposure to extreme hot and cold until the anaesthetic effect has worn off.
Continued....
Dosage and how to apply LMX4 to provide pain relief when inserting a needle into a vein:
1g of cream is approximately equal to a 5cm length of cream squeezed from the 5g tube or 3.5cm squeezed from the 30g tube. Adults, including the elderly, and children over 1 year of age:
1 g to 2.5g of cream, to cover an area of skin 2.5cm x 2.5cm (1 ” x 1 ”). Do not leave on the skin for longer than 5 hours.
Infants over 3 months but below 1 year of age:
No more than 1g of cream should be applied. Do not leave on the skin for longer than 4 hours.
Infants over 1 month but below 3 months of age: No more than 1 g of cream should be applied. Do not leave on the skin for longer than 1 hour.
Do not use on infants below one month old.
1. Apply LMX4 at least 30 minutes before the medical procedure starts.
2. Using the quantity stated above, apply the cream in a thick layer to the skin.
3. Cover the cream with a dressing, to prevent it being accidentally rubbed off the skin.
4. After approximately 30 minutes remove the dressing. Immediately remove the cream with a clean tissue or gauze.
5. Inserting a needle into the vein should be performed shortly after removing the cream.
Dosage and how to apply LMX4 to provide anaesthesia prior to administration of painful topical treatments on larger surface areas of intact skin
Adults and the elderly aged 18 years and over:
Use 1.5g to 2g on each 10cm2 area of skin, to cover a maximum total area of 900cm2 (approximately equal to a back or thigh).
1. Apply LMX4 approximately 30 to 60 minutes before the procedure starts.
2. Using the quantities stated above, apply the cream in a thin layer to the skin.
3. Ensure the cream is not accidentally rubbed off the skin.
4. After approximately 30 to 60 minutes, remove the cream with a tissue or gauze.
5. The procedure should begin shortly after removal of the cream.
The cream should not be reapplied for at least 12 hours after it has been removed.
Do not use on patients below 18 years of age.
If you use more LMX4 than you should:
Overdose is unlikely, but talk to your doctor or nurse straight away, even if you do not feel any symptoms. An overdose may include using more than the recommended amount, applying the cream to large areas or using the cream for longer than recommended.
The following overdose symptoms may be experienced: blurred vision, dizziness or drowsiness, difficulty breathing, trembling, chest pain or an irregular heartbeat.
4. POSSIBLE SIDE EFFECTS
Like all medicines, as well as benefits, LMX4 can cause side effects, although not everybody gets them.
If you experience any side effect listed below, immediately remove the cream, discontinue use and talk to your doctor or pharmacist.
An allergic reaction is rare, affecting fewer than 1 in 1000 patients. Symptoms may include a rash, swelling, very low blood pressure or anaphylactic shock.
Skin irritation, redness, itching, dryness or rash at the site of application are all known but uncommon side effects affecting fewer than 1 in 100 patients.
You may experience eye irritation if the cream is applied to or around the eye. Refer to 'Precautions when using LMX4‘ in Section 3 for what to do immediately after accidental eye exposure.
Talk to your doctor or pharmacist if:
• Any side effect becomes more serious or persists.
• Any side effect clears up but occurs again within a few days.
• If you notice any side effect not listed. Reporting of side effects:
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the MHRA’s Yellow Card Scheme, available 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 LMX4
Keep out of the reach and sight of children.
Do not store above 25°C.
Do not use after the expiry date which is stated on the tube. The expiry date refers to the last day of the month.
Return any unused cream to your pharmacist (chemist).
6. FURTHER INFORMATION
What LMX4 contains:
The active substance is lidocaine. 1g of cream contains 40mg of lidocaine.
The other ingredients are benzyl alcohol, carbomers, cholesterol, phospholipon 80H, polysorbate 80, propylene glycol, trolamine, vitamin E acetate and purified water.
What LMX4 looks like and contents of the pack:
LMX4 is an off-white cream presented in a 5g or 30g tube. It may be packed into a carton that also contains dressings that can be used to cover and protect the cream after it has been applied to the skin.
Marketing Authorisation Holder and Manufacturer.
PL20685/0034
Marketing Authorisation Holder:
Ferndale Pharmaceuticals Ltd,
Unit 740 Thorp Arch Estate,
Wetherby, West Yorkshire,
LS23 7FX, UK, Tel: 01937 541122.
E-mail: info@ferndalepharma.co.uk
Manufacturer:
QP-Services UK Limited 46 High Street,
Yatton, Somerset,
BS49 4HJ,
United Kingdom
This leaflet was last approved in February 2016.
P0034v10u-IAa5-HW-Feb-16
4.25” x 9” folded to 2.125” x .75" , 2-sided
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