PLIAGLIS

Package leaflet: Information for the user

Pliaglis 70 mg/g + 70 mg/g cream

lidocaine and tetracaine
Please 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 questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if they have the same symptoms as you, because it could be harmful.
• If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of 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 using Pliaglis

Do not use Pliaglis

• if you are allergic to lidocaine or tetracaine, to any other similar local anaesthetic, or to any of the other ingredients of this medicine (listed in section 6);
• if you know you are allergic to para-aminobenzoic acid (also known as PABA), a substance produced by the body when breaking down tetracaine, methyl parahydroxybenzoate (E218), or propyl parahydroxybenzoate (E216);
• on damaged or irritated skin;
• on mucous membranes such as the mouth.

Warnings and precautions
Talk to your doctor or pharmacist before using Pliaglis

• if you have liver, kidney, or heart disease;
• if you have an acute illness or are physically weakened, as you may be more sensitive to Pliaglis.

Take care to avoid contact with the eyes. If Pliaglis comes into contact with the eye, rinse immediately with water or saline solution and protect the eye until sensitivity is restored.
Pliaglis must not be applied for longer than specified. See section 3.
After Pliaglis has been removed, you will feel numbness in your skin. Be careful not to scratch or rub the numbed area or expose it to very hot or cold surfaces until the numbness has gone, as you could accidentally damage the skin.

Children and adolescents
Do not use this medicine in children and adolescents under 18 years of age, as safety and efficacy have not yet been established.

Other medicines and Pliaglis
Inform your doctor or pharmacist if you are using, have recently used, or might use any other medicines.
The risk of side effects increases if Pliaglis is used at the same time as other medicines, for example:

• medicines used to treat heart conditions such as quinidine, disopyramide, tocainide, mexiletine, and amiodarone;
• medicines known to induce methaemoglobinaemia, such as phenamides, naphthalene, nitrates and nitrites, nitrofurantoin, glyceryl trinitrate, sodium nitroprusside, primaquine, and quinine;
• other medicines containing lidocaine and/or tetracaine.

Pliaglis with food and drink
You may use Pliaglis either before or after eating or drinking.

Pregnancy and breastfeeding
If you are pregnant, breastfeeding, suspect you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.
Pregnancy
Ask your doctor or pharmacist for advice before using Pliaglis during pregnancy.
Breastfeeding
Pliaglis may be used during breastfeeding, provided that Pliaglis is not applied to the breast.

Driving and using machines
Pliaglis does not affect or affects negligibly the ability to drive or use machinery.

Pliaglis contains methyl parahydroxybenzoate (E218) and propyl parahydroxybenzoate (E216). These may cause allergic reactions (including delayed-type reactions).

3. How to use Pliaglis

Use this medicine exactly as instructed by your doctor. If you have any doubts, consult your doctor or pharmacist.

The recommended dose is approximately 1.3 g of cream per 10 cm².

Pliaglis is intended for single-patient use only.

Pliaglis should be applied to dry and intact skin.

DO NOT apply Pliaglis to the face by yourself.

Application of Pliaglis to the face must be performed only by a doctor.

Pliaglis should be applied evenly and in a thin layer (approximately 1 mm thick) over the entire treatment area (as defined by the doctor), using a flat-surfaced instrument such as a metal spatula or tongue depressor. Pliaglis must never be applied with the 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 the eye, immediately rinse with water or saline solution and protect the eye until sensation returns.

The cream should be left to dry for 30 to 60 minutes, depending on the type of procedure, as determined by the doctor.

After the required application time has elapsed, the dried cream will form a light peelable film on your skin. Pliaglis can be removed by gently grasping a free edge of the film and peeling it off the skin.

The film should be carefully discarded immediately after removal (see section 5 for more information on how to dispose of the film).

Any residual film remaining on the skin surface should be wiped off using a swab (tissue or cotton wool).

Wash your hands immediately after removing and disposing of the film.

If you use more Pliaglis than you should

The maximum application area must not exceed 400 cm² (no more than two 30 g tubes should be used). If you have used an excessive dose of Pliaglis, consult your doctor or pharmacist immediately.

If you think the dose of Pliaglis is too low, inform your doctor immediately.

If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
Most side effects occur at the site where the cream is in contact with the skin. These are generally of moderate intensity, short duration, and resolve upon completion of treatment.
The two medicines that make up Pliaglis (lidocaine and tetracaine) can cause allergic reactions
(anaphylactoid reactions) such as skin rash, swelling, and breathing difficulties. If any of these
side effects occur, Pliaglis must be removed immediately and a doctor should be contacted.
Most of the side effects occurred at the application site of the cream.
Very common: may affect more than 1 in 10 people.

• skin redness
• changes in skin colour

Common: may affect up to 1 in 10 people.

• skin swelling

Uncommon: may affect up to 1 in 100 people.

• skin itching
• pain or skin pain

Rare: may affect up to 1 in 1,000 people.

• pale skin
• burning sensation of the skin
• facial swelling
• skin peeling
• skin irritation
• tingling sensation
• eyelid swelling

Not known: frequency cannot be estimated from the available data.

• urticaria

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at www.agenziafarmaco.gov.it/.
By reporting side effects, you can help provide more information on the safety of this medicine.

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 carton and tube after "Exp.". The expiry date refers to the last day of that month.
Pliaglis must be stored in a refrigerator (2°C-8°C), even after opening.
Do not freeze.
Once opened, it must be used within 3 months. It is recommended to write the date of opening on the packaging.
Do not use Pliaglis if you notice that the packaging is in any way damaged.
Dispose of the waste patch carefully, as the patch contains components in concentrated amounts.
To help protect the environment, do not throw the waste patch into the toilet.
The waste patch should be placed in a closed container, such as a plastic bag.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Pliaglis contains

• The active substances are lidocaine and tetracaine; 1 gram of cream contains 70 mg of lidocaine and 70 mg of tetracaine.
• The other components are: Calcium hydrogen phosphate anhydrous, Purified water, Polyvinyl alcohol, Soft white paraffin, Sorbitan monopalmitate, Methyl parahydroxybenzoate (E218), Propyl parahydroxybenzoate (E216)

Description of the appearance of Pliaglis and contents of the pack
The medicinal product is a white or almost white cream.
Pliaglis is available in tubes of 15 g or 30 g with a screw cap, packaged in a cardboard carton.
Not all pack sizes may be marketed.

Marketing Authorization Holder
Difa Cooper spa
Via Milano 160 – 21042 Caronno Pertusella (VA)

Manufacturer responsible for batch release:
Laboratoires Galderma
Z.I. – Montdèsir
74540 Alby-sur-Chéran
France

This medicinal product is authorized in the EEA Member States under the following names:
AT, BE, FR, DE, EL, FI, IE, IT, LU, NL, PL, PT, ES, UK: Pliaglis
DK, NO: Pliapel

The following information is intended exclusively for physicians or healthcare professionals.
Pliaglis is intended for use in a single patient only.
For facial procedures, Pliaglis must be applied by healthcare professionals. For procedures on all other body areas, Pliaglis may be applied by healthcare professionals or by the patients themselves, provided they have been adequately instructed in appropriate application techniques.
Patients and healthcare professionals are advised to avoid touching the cream or the skin covered with the cream to prevent contact dermatitis.
Pliaglis must never be applied with fingers.
Pliaglis should only be applied using a flat-surfaced instrument such as a spatula or tongue depressor.
Hands must be washed immediately after removal and disposal of the peel-off mask.

For dermatological procedures such as pulsed-dye laser therapy, laser-assisted hair removal, non-ablative facial laser resurfacing, dermal filler injections, and vascular access, apply approximately 1.3 g of Pliaglis per 10 cm² to intact skin at a thickness of approximately 1 mm for 30 minutes.

For dermatological procedures such as laser-assisted tattoo removal and laser ablation of leg varicose veins, apply approximately 1.3 g of Pliaglis per 10 cm² to intact skin at a thickness of approximately 1 mm for 60 minutes.

Determine the size of the area to be treated.
The table below provides an approximate guide to the amount of cream required to achieve a thickness of 1 mm according to the area to be treated.

The maximum surface area should not exceed 400 cm².

1. Apply Pliaglis evenly and in a thin layer to the area to be treated only using a flat-surfaced instrument such as a spatula or tongue depressor. Take care to avoid contact with your eyes and the patient's eyes.

2. Depending on the procedure, the cream must be allowed to dry for 30 to 60 minutes.
3. After the required application time has elapsed, the dried cream will form a peel-off mask on the skin. Remove Pliaglis by grasping a free edge of the peel-off mask with fingers and peeling it away from the skin.

4. Remove any remaining mask residue from the skin surface and prepare the patient for the procedure. Cutaneous anesthesia may last from 2 to 13 hours after removal of the mask.
5. The mask must be discarded immediately after removal in accordance with applicable local regulations.
6. Wash hands immediately after removal and disposal of the peel-off mask.