Patient Medication Information: uses, side effects, how to take - Pliaglis
ABOUT THIS MEDICATION
What the medication is used for:
PLIAGLIS is used in adults on healthy, unbroken skin to reduce pain prior to skin-related procedures such as:
Less painful procedures:
- collagen injections
- laser facial resurfacing
- pulsed dye laser therapy
- laser-assisted hair removal
- having an intravenous line started or when having a blood test
More painful procedures:
- laser-assisted tattoo removal
- laser leg vein treatment
What it does:
PLIAGLIS blocks skin nerve reactions. You therefore feel less pain.
When it should not be used:
You should not use PLIAGLIS:
- on an area larger than the area covered by two standard postcards
- for any longer than 60 minutes
- if you have methemoglobinemia (a blood disorder)
if you are allergic to:
- lidocaine
- tetracaine
- local anesthetics of the amide or ester type
- Para-aminobenzoic acid (PABA)
- any other component of the product
What the medicinal ingredients are:
lidocaine and tetracaine
What the nonmedicinal ingredients are:
calcium hydrogen phosphate (anhydrous), methylparaben, paraffin (white, soft), polyvinyl alcohol, propylparaben, purified water, sorbitan monopalmitate
What dosage forms it comes in:
PLIAGLIS is available as a cream (lidocaine 7% and tetracaine 7%) in a 30 g tube.
WARNINGS AND PRECAUTIONS
For external use only. Not for home use by patient. Only for use in clinical settings.
PLIAGLIS should not be applied to open wounds, irritated skin, mucous membranes including; mouth, lips, nose, eyes, ears, genital or anal areas.
BEFORE you use PLIAGLIS talk to your doctor or pharmacist if you:
- are currently using other products that contain local anaesthetic or that numb the skin.
- have an infection, skin rash or cut at, or near, the area where you want to apply PLIAGLIS
- have dermatitis or any other skin problems or disease
- suffer from liver, kidney or heart problems or any other illness or disease
- have glucose-6-phosphate dehydrogenase deficiency
are pregnant or trying to get pregnant
- are breastfeeding. PLIAGLIS should not be applied to the breasts of breastfeeding women
- are less than 18 or over 65 years of age.
INTERACTIONS WITH THIS MEDICATION
As with most medicines, interactions with other drugs are possible. Tell your doctor, nurse, or pharmacist about all the medicines you take, including drugs prescribed by other doctors, vitamins, minerals, natural supplements, or alternative medicines.
The following may interact with PLIAGLIS:
- heart medications such as quinidine, disopyramide, tocainide, mexiletine, amidarone
- drugs known to induce the blood disorder methemoglobinemia such as sulfonamides, acetaminophen, acetanilide, aniline dyes, benzocaine, chloroquine, dapsone, naphthalene, nitrates and nitrites, nitrofurantoin, nitroglycerin, nitroprusside, pamaquine, para-aminosalicylic acid, phenacetin, phenobarbital, phenytoin, primaquine and quinine.
- other local anesthetic drugs
- aminosalicylic acid
- suxamethonium (succinylcholine)
- HIV protease inhibitors, macrolides, azole antifungals, and cimetidine
- antimyasthenics, cyclophosphamide, echothiophate, isoflurophate, and thiopeta.
PROPER USE OF THIS MEDICATION
PLIAGLIS should be used in the treatment location where the procedure will be performed.
Use PLIAGLIS exactly as prescribed.
If PLIAGLIS comes into contact with your eye, immediately rinse your eye with water or salt solution. Protect the eye and avoid rubbing until feeling returns.
Do not reapply to treated area after the procedure. If your procedure has to be repeated, the treated area must have time to fully recover before using PLIAGLIS again.
PLIAGLIS is not to be used before or after vaccinations.
Usual adult dose:
PLIAGLIS should only be applied to dry, healthy, unbroken skin.
PLIAGLIS should be spread evenly and thinly (approximately 1 mm thickness) with a metal spatula or tongue depressor across the area to be treated (as determined by your doctor). Do not touch PLIAGLIS with your fingers or cover the treated area. Do not rub PLIAGLIS into the skin. PLIAGLIS should be applied only once per procedure.
The amount of PLIAGLIS that should be used is determined by the size of the area to be treated and will be determined by your doctor.
| Area to be treated | Amount of PLIAGLIS dispensed by length (cm) | Amount of PLIAGLIS by weight (g) |
| Approximately the size of a two dollar coin (“toonie”). | 3 | 1.3 |
| Approximately the size of a credit card. | 12 | 5 |
| Approximately the size of two credit cards. | 24 | 11 |
| Approximately the size of a standard postcard. | 61 | 26 (one 30 g tube) |
The area treated should be no bigger than 400cm2 or approximately the size of two postcards | 121 | 52 (two 30 g tubes) |
Less painful procedures:
- The cream must be left to dry for no longer than 20-30 minutes prior to the procedure.
More painful procedures:
- The cream must be left to dry for no longer than 60 minutes prior to the procedure.
After waiting for the required application time the dried cream will have formed a soft peel on your skin. Prior to the procedure, PLIAGLIS must be removed by grasping a free-edge of the peel and pulling it away from the skin.
The peel must be carefully disposed of immediately after removal out of reach and site of children and pets. Even dried PLIAGLIS removed after use may contain a large amount of medicine that could cause serious injury to a pet or small child if chewed on or eaten.
Wipe with a compress any remaining peel residue from the area.
Hands should be washed immediately after removing and disposal of the peel.
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.
Overdose:
In case of drug overdose, contact a health care practitioner, hospital emergency department or regional Poison Control Centre immediately, even if there are no symptoms.
SIDE EFFECTS AND WHAT TO DO ABOUT THEM
Side effects may include:
- headache
- vomiting
- dizziness
- fever
- sore throat (pharyngitis)
- sweating
- tingling in the arms and/or legs (parasthesia)
During or immediately after treatment with PLIAGLIS, the skin at the site of treatment may develop:
- redness, discolouration, paleness
- swelling (including the face and eyelid)
- itching, pain, irritation, tingling, burning sensation
- peeling
| SERIOUS SIDE EFFECTS, HOW OFTEN THEY HAPPEN AND WHAT TO DO ABOUT THEM | ||
| Symptom / effect | Remove PLIAGLIS and seek immediate medical help | |
| Very rare | Allergic reaction: skin rash, hives, itching or swelling, difficulty swallowing or breathing | |
This is not a complete list of side effects. For any unexpected effects while taking PLIAGLIS, contact your doctor or pharmacist.
HOW TO STORE IT
Store in a refrigerator, temperature 2-8°C. Protect from freezing.
Keep out of reach and sight of children.
Access to PLIAGLIS by children or pets should be prevented during use, disposal and storage of the product.
REPORTING SIDE EFFECTS
You can report any suspected side effects associated with the use of health products to Health Canada by:
Visiting the Web page on Adverse Reaction Reporting
(https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect- canada/adverse-reaction-reporting.html) for information on how to report online, by mail or by fax; or
- Calling toll-free at 1-866-234-2345.
NOTE: Contact your healthcare professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice.
MORE INFORMATION
This document plus the full product monograph, prepared for health professionals can be found at:
https://health-products.canada.ca/dpd-
bdpp/switchlocale.do?lang=en&url=t.search.recherche or by contacting the sponsor at:1-833-229-0008.
CRESCITA SKIN SCIENCES INC.
Subsidiary of CRESCITA Therapeutics Inc.
Laval, Quebec
H7V 0A3
Pliaglis is a registered trademark of CRESCITA Therapeutics Inc.