Patient Medication Information: uses, side effects, how to take - Kwellada-P Crème Rinse
ABOUT THIS MEDICATION
For External Use Only
Keep out of Sight and Reach of Children
What the medication is used for:
Kwellada-P Crème Rinse is indicated for the treatment of head lice (Pediculus Capitis). It kills head lice and their nits (eggs) on contact.
What it does:
What are head lice?
Head lice are tiny insects that live in human hair.
They hatch from small eggs, called nits, which are
attached to the base of individual hairs. The eggs
hatch in about 7 to 10 days, with the new lice
reaching maturity about 14 days later. The female
louse can live for 20 to 30 days, and can lay as many
as six eggs a day. Since lice multiply fast, they
should be treated promptly.
Who suffers from head lice?
Getting head lice is not as bad as you think. It is not a sign of uncleanliness, or poor health habits. Head lice can occur at any age, and to either sex, so it is wise to learn how to recognize a head lice infestation and how to prevent it from coming back.
How does someone get head lice?
Head lice can be transmitted in a number of ways besides direct head to head contact. Borrowing a comb or brush from a person who has head lice will do it. So can bon-owing hats, ribbons, scarves or other head coverings. Sharing towels or pillows can also spread head lice. Even a stray hair that has nits can transmit head lice.
What signs should I look for?
Persistent itching of the back of the head and behind the ears can indicate head lice. You should also look for infected scratch marks or a rash on the scalp.
Most important of all, look for nits attached to individual hairs at scalp level. These can be seen with the naked eye, but you can probably identify them more easily with the aid of a magnifying glass under strong light. Sometimes small white specks in the hair such as dandruff or droplets of hair spray can be confused with nits. Try removing the specks from the hair shaft. Dandruff or hair spray will come off easily- nits are very difficult to remove. Check with a health professional if you are not sure whether head lice are present.
IMPORTANT: PLEASE READ
Should other family members be checked?
Yes. If one member of your family has head lice, all
household members and sexual partners should be
checked and if necessary treated.
How can I prevent head lice in the future?
All family members should avoid borrowing personal
items - combs, bmshes, hats, towels or clothing -
from each other or from friends. It is best for
everyone to use his or her own personal articles, both
at home and while away.
How to treat the environment?
All articles that may harbour lice or nits, such as
clothes (worn 48 hours prior to treatment), towels
and bed linens, should be washed in hot water, or dry
cleaned or put in dryer hot setting 20 min or sealed
in a plastic bag for 2 weeks then washed normally.
For items that cannot be washed or dry cleaned eg.
mattresses, upholstery, back seat of the car etc., use
R&C II Spray insecticide. Combs and brushes should
be disinfected by washing with pyrethrins, being
careful to rinse thoroughly. Alternatively, combs and
brushes can be disinfected by soaking in hot water
(above 130°F or 54°FC) for 5 to 10 minutes. Due to
the contagious nature of head lice, it is advisable for
all family members to be treated at the same time.
When it should not be used:
It is not to be used on individuals with known
sensitivities or reactions to permethrin, any ingredients
of the product, any synthetic pyrethroid or pyrethrin or
to chrysanthemums.
It should not be used if you are pregnant, nursing, or
planning to breastfeed.
Do not use in children under the age of two years.
What the medicinal ingredient is:
Permethrin 1% w/w as the active ingredient.
What the important non-medicinal ingredients are: It also contains isopropyl alcohol, propylene glycol, stearalkonium chloride, lauryl alcohol, polyoxyethylene 4 lauryl ether, trolamine, polyquaternium-10 and Carbomer 980.
What dosage forms it comes in:
Kwellada-P Crème Rinse is available in plastic bottles containing 50 mL and 200 mL crème rinse.
WARNINGS AND PRECAUTIONS
What precautions should you take?
For external use only. Only use this product to treat existing headlice and nits. For best results use as directed- incorrect use may cause treatment failure. Avoid contact with eyes, nose, mouth and other mucous membranes as well as wounds and broken skin. This product may irritate your eyes. If applying routinely, wear gloves to avoid irritation. In case of contact, rinse with plenty of water. If skin irritation occurs, discontinue use and consult your doctor. If swallowed contact your doctor or Poison Control Centre immediately.
Keep out of sight and reach of children.
INTERACTIONS WITH THIS MEDICATION
No information available.
PROPER USE OF THIS MEDICATION
Usual dose:
How should you use Kwellada-P Crème Rinse?
l. Shampoo the hair with your regular
shampoo, rinse with water and towel
dry.
- 2.
Shake Kwellada-P Crème Rinse well
before using.
- 3.
With scissors, snip off the tip of the
enclosed applicator cap
- 4.
Unscrew cap on bottle and replace with
the applicator cap.
- 5.
Apply Kwellada-P Crème Rinse to damp
hair. Apply sufficient amount to
saturate hair and scalp (25-50mL).
- 6. Leave on for 10 minutes.
- 7.
Rinse thoroughly with water and dry
with towel.
- 8.
Remove dead lice and eggs with the
following steps:
Comb wet hair with a regular comb to remove snarls; separate a strand of hair not wider than the nit comb. Using the enclosed nit comb tilted toward the scalp, comb the strand from scalp to end of hair repeat to remove all eggs, comb all strands in this manner.
- 9.
Store unused product by removing the
applicator cap from the bottle and
replacing it with the original cap.
Store the product between l5°C- 30°C.
Rinse the applicator cap and air dry.
- 9.
SIDE EFFECTS AND WHAT TO DO ABOUT THEM
When using Kwellada-P Crème Rinse you may experience: Tingling sensation in the limbs, skin irritation (including eczema, rash, swelling, reddening and itching) and skin discomfort (including smarting, a burning sensation and pain).
If any side effect should occur, discontinue use and contact your doctor.
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 s ymptoms.
Symptoms and signs of overdose may include: Dizziness, loss of appetite, nausea, vomiting, headache, weakness, seizures, loss of consciousness.
HOW TO STORE IT
How should you store Kwellada-P Crème Rinse?
Store the product between l5-30°C
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
w\vw.heal thca nada.gc.ca.medeffect
- Call toll-free at 1-866-234-2345
Complete a Canada Vigilance Reporting Form and:
o Fax toll-free to 1-855-678-6789, or
o Mail to: Canada Vigilance Program
Health Canada
Posta l Locator 0701C
Ottawa, ON KIA OK9
Postage paid labels, Canada Vigilance Reporting
Form and the adverse reaction reporting guidelines are available on the MedEffecfrtvl Canada Web site at
www.healthcanada.gc.ca /medeffect.
NOTE: Should you require information related to the management of side effects, contact your health care professional. 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 by: contacting the sponsor, Medtech Products Inc. at: 1-800-465-8811