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PLIAGLIS 70 MG/G + 70 MG/G CREAM

Active substance(s): LIDOCAINE BASE / TETRACAINE BASE

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70 mg/g + 70 mg/g, cream

(lidocaine & tetracaine)

Package leaflet: Information for the user

Pliaglis 70 mg/g + 70 mg/g Cream
Lidocaine and Tetracaine
Read all of this leaflet carefully before you start using this
medicine because it contains important information for you.
- 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 only. Do not pass
it on to others. It may harm them, even if their signs of illness
are the same as yours.
- 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.
What is in this leaflet:
1.
What Pliaglis is and what it is used for
2.
What you need to know before you use Pliaglis
3.
How to use Pliaglis
4.
Possible side effects
5.
How to store Pliaglis
6.
Contents of the pack and other information

1.

What Pliaglis is and what it is used for

Pliaglis is a cream containing local anaesthetics, lidocaine and
tetracaine which are used to numb an area of skin before a
painful procedure such as needle insertion or laser treatments.

2.

What you need to know before you use Pliaglis

Do not use Pliaglis
- if you are allergic to lidocaine or tetracaine, any similar local
anaesthetics or any of the other ingredients of this medicine
(listed in section 6).
- if you know that you are allergic to para-aminobenzoic acid
(sometimes called PABA), a substance that is made when
your body breaks down tetracaine, methyl parahydroxybenzoate (E218) or propyl parahydroxybenzoate (E216)
- on broken or irritated skin
- on mucous surfaces such as your mouth
Warnings and precautions
Talk to your doctor or pharmacist before using Pliaglis
- if you have problems with your liver, kidney or heart
- if you are very ill or physically weak as you may be more
sensitive to Pliaglis
Take care to avoid contact with the eyes. If Pliaglis comes into
contact with your eye, immediately rinse your eye with water
or salt solution and protect it until feeling returns.
Pliaglis should not be applied for a longer time than recommended.
See section 3.
Once Pliaglis has been removed, your skin will feel numb. Take
care not to scratch or rub the numbed area or touch very hot
or cold surfaces until the numbness has stopped as you could
accidently damage the skin.
Children and adolescents
Do not give this medicine to children and adolescents aged up to 18
years because the safety and efficacy have not been established.
Other medicines and Pliaglis
Tell your doctor or pharmacist if you are taking or have recently
taken, or might take any other medicines.
The risk of side effects increases if Pliaglis is used at the same
time as other medicines, e.g.:
- some medicines for treatment of heart conditions such as
quinidine, disopyramide, tocainide, mexiletine and amidarone,
- medicines known to induce methemoglobinemia such as:
fonamides, naphthalene, nitrates and nitrites, nitrofurantoin,
nitroglycerin, nitroprusside, pamaquine, and quinine,
- other medicines containing lidocaine and / or tetracaine.
Pliaglis with food and drink
You can use Pliaglis either before or after eating or drinking
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may be
pregnant or are planning to have a baby, ask your doctor or
pharmacist for advice before taking this medicine.

Product code: P25220-1
Product description: PLIAGLIS CRE
Market: GBR / IRL
Article: Leaflet
Font size: 8 pt
Flat size: 180x315
Pharmacode: 706
Fold size: 180x26,25
Specification n° MT.09.MPS.1470
LAUNCHING DEPARTMENT - Z.I. Galderma
74540 ALBY-SUR-CHERAN - FRANCE

Pregnancy
Ask your doctor or pharmacist for advice before using Pliaglis
during pregnancy.
Breastfeeding
Breastfeeding can continue while using Pliaglis as long as you
do not apply Pliaglis on your breast.
Driving and using machines
Pliaglis has no or negligible influence on your ability to drive
and use machines.
Pliaglis contains methyl parahydroxybenzoate (E218) and
propyl parahydroxybenzoate (E216).
May cause allergic reactions (possibly delayed).

3.

How to use Pliaglis

Always use this medicine exactly as your doctor has told you.
Check with your doctor or pharmacist if you are not sure.
The recommended dose is approximately 1.3 g of cream per
10 cm2.
Pliaglis is for single patient use.
Pliaglis should only be applied to dry, intact skin.
Do NOT apply Pliaglis on your face yourself.
Application of Pliaglis on your face should only be done by
your physician.
Pliaglis has to be spread evenly and thinly (approximately 1 mm
thickness) across the area to be treated (as determined by your
doctor) using a flat-surfaced tool such as a metal spatula or
tongue depressor. Pliaglis should never be applied with fingers.
Do not cover the treated area with an occlusive dressing.
Do not touch the cream with your fingers.
Take care to avoid contact with the eyes. If Pliaglis comes into
contact with your eye, immediately rinse your eye with water
or salt solution and protect it until feeling returns.
The cream should be left to dry for 30 to 60 minutes depending
on the procedure, as determined by your doctor.
After waiting for the required application time the dried cream
will have formed a soft peel on your skin. Pliaglis can be
removed by grasping a free-edge of the peel and pulling it
away from the skin.
The peel should be carefully disposed of immediately after
removal (see Section 5 for more information on how to dispose
the peel).
Wipe with a compress (such as a tissue or cotton wool) any
remaining peel residue from the area.
Hands should be washed immediately after removing and
disposal of the peel.
If you use more Pliaglis than you should
The maximum application area should not exceed 400cm2
(no more than two 30g tubes should be used). If too much Pliaglis
is used you should tell your doctor or pharmacist immediately.
If you think the amount of Pliaglis is too little, tell your
doctor immediately.
If you have any further questions on the use of this medicine,
ask your doctor or pharmacist.

4.

Possible side effects

Like all medicines, this medicine can cause side effects,
although not everybody gets them.
Most side effects happen where the cream has been placed on
the skin. They are generally mild, only last for a short time and
usually go away after the end of treatment.
The two medicines that make up Pliaglis (lidocaine and
tetracaine) may cause allergic (anaphylactoid) reactions
such as skin rash, swelling and breathing difficulties.
If you experience any of these side effects, you must
remove Pliaglis immediately and contact a doctor.
Most of these side effects occurred on the site of application.
Very common: may affect more than 1 in 10 people
• Redness of the skin
• Skin discolouration

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The following information is intended for medical or
healthcare professionals only.

Common: may affect up to 1 in 10 people
• Swelling of the skin
Uncommon side effects: may affect up to 1 in 100 people
• Itchy skin
• Pain or pain of skin

Pliaglis is for single patient use.
For facial procedures, Pliaglis should be applied by healthcare
professionals. For procedures on any other part of the body,
Pliaglis should be applied by healthcare professionals or by patients
adequately instructed in appropriate application technique.

Rare: may affect up to 1 in 1,000 people
• Pallor of the skin
• Skin burning sensation
• Swelling of the face
• Peeling of the skin
• Skin irritation
• Tingling feeling
• Swelling of the eyelid

Patients and healthcare professionals are recommended to
avoid repeated direct contact with the cream or the skin
covered with the cream, in order to prevent contact dermatitis.
Pliaglis should never be applied with fingers.

Not known: frequency cannot be estimated from the available data
• Urticaria
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 (see details below).
By reporting side effects you can help provide more
information on the safety of this medicine.
United Kingdom
Yellow Card Scheme
Website: www.mhra.gov.uk/yellowcard
Ireland
FREEPOST: HPRA Pharmacovigilance, Earlsfort Terrace, IRL Dublin 2; Tel: +353 1 6764971; Fax: +353 1 6762517.
Website: www.hpra.ie; E-mail:medsafety@hpra.ie

5.

How to store Pliaglis

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated
on the tube and carton after “EXP”. The expiry date refers to
the last day of that month
Pliaglis should be stored in a refrigerator (2°C -8°C).
Once removed from the refrigerator, store Pliaglis below 25°C
for a maximum of 3 months. Do not refrigerate again. Do not freeze.
It is recommended that the date of removal from the
refrigerator is noted on the packaging.
Shelf life after first opening: 3 months.
Do not use Pliaglis if you notice the packaging is damaged in
any way.
Dispose of waste peel with care, since the waste peel contains
concentrated quantities of the ingredients. To help protect the
environment, do not flush waste peel down the toilet. Waste
peel should be put in a closed container, such as a plastic bag.
Do not throw away any medicines via wastewater. Ask your
pharmacist how to throw away medicines you no longer use.
These measures will help protect the environment.

6.

Pliaglis should only be applied using a flat-surfaced tool such
as a spatula or a tongue depressor.
Hands should be washed immediately after removing and
disposal of the peel.
For dermatological procedures such as pulse-dye laser
therapy, laser-assisted hair removal, non-ablative laser facial
resurfacing, dermal filler injections and vascular access, apply
approximately 1.3 g of Pliaglis per 10 cm2 onto intact skin at a
thickness of 1 mm for 30 minutes.
For dermatological procedures such as laser-assisted tattoo
removal and laser leg vein ablation, apply approximately 1.3 g
of Pliaglis per 10 cm2 onto intact skin at a thickness of 1 mm
for 60 minutes.
Determine the size of the area to be treated.
The table below can be used as an indication of the quantity
of cream to be applied to obtain a 1mm thickness depending
on the area to be treated.

Surface Area
of Treatment
Site (cm2)

Approximate
weight
of Pliaglis
Dispensed (g)

10

1.3

2 fingertip units

50

6.5

Half content of a 15g tube

100

13

Full content of a 15g tube

200

26

Full content of a 30g tube

400

52

Full content of two 30g tubes

The maximum application area should not exceed 400cm2.
1) Spread Pliaglis evenly and thinly (approximately 1 mm
thickness) across the area to be treated using a flat-surfaced
tool such as a metal spatula or tongue depressor. Take care
to avoid contact with the patient’s eyes and your eyes.

Contents of the pack and other information

What Pliaglis contains
- The active substances are lidocaine and tetracaine; 1 gram of
cream contains: 70 mg lidocaine and 70 mg tetracaine.
- The other ingredients are calcium hydrogen phosphate
anhydrous, purified water, polyvinyl alcohol, paraffin white
soft, sorbitan monopalmitate, methyl parahydroxybenzoate
(E218) and propyl parahydroxybenzoate (E216).
What Pliaglis looks like and contents of the pack
This medicinal product is presented as a white to off
white cream.
It will come in a 15 or 30 g tube with a screw cap packed
in a cardboard carton.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Galderma (UK) Ltd
Meridien House
69-71 Clarendon Road
Watford
Herts WD17 1DS - UK
Product Licence Number: PL 10590/0059 (UK) & PA 590/26/1 (IRE)
Manufacturer:
Laboratoires Galderma
Z.I. – Montdésir
74 540 Alby-sur-Chéran
France

2) Depending on the procedure, the cream should be left to
dry either 30 or 60 min.
3) After waiting for the required application time the cream will
have formed a pliable peel on the skin. Remove Pliaglis by
grasping a free-edge of the peel with your fingers and
pulling it away from the skin

4) Wipe any remaining peel residue from the area and prepare
the patient for the procedure. The duration of skin anaesthesia
can last from 2 to 13 hours after removal of the peel.
5) Immediately after removal, the peel should disposed of in
accordance with local requirements
6) Wash your hands immediately after removing and disposing
of the peel.

This medicinal product is authorised in the Member States
of the EEA under the following names:
AT, BE, FR, DE, EL, FI, IE, IT, LU, NL, PL, PT, ES, UK: PLIAGLIS
DK, NO: PLIAPEL
P25220-1

This leaflet was last approved in 05/2014.

Product code: P25220-1
Product description: PLIAGLIS CRE
Market: GBR / IRL
Article: Leaflet
Font size: 8 pt
Flat size: 180x315
Pharmacode: 706
Fold size: 180x26,25
Specification n° MT.09.MPS.1470
LAUNCHING DEPARTMENT - Z.I. Galderma
74540 ALBY-SUR-CHERAN - FRANCE

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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