Details for: STIEPROX SHAMPOO
Company: GLAXOSMITHKLINE INC
| DIN | DIN name | Active Ingredient(s) | Strength | Dosage Form | Route of Administration |
|---|---|---|---|---|---|
| 02247228 | STIEPROX SHAMPOO | CICLOPIROX OLAMINE | 1.5 % | SHAMPOO | TOPICAL |
Consumer Information
This information was provided by the drug’s manufacturer when this drug product was approved for sale in Canada. It is designed for consumers and care givers. It is a summary of information about the drug and will not tell you everything about the drug. Contact your doctor or pharmacist if you have any questions about the drug.
What the medication is used for
STIEPROX®
is a shampoo used to treat and prevent the
return of dandruff or to treat seborrhoeic dermatitis in adults
18 years of age and older. It is important to read and follow
these instructions for use.
It is not known if STIEPROX® is safe and effective in
children less than 18 years old, or in adults more than 65
years old.
What it does
Dandruff and seborrhoeic dermatitis can be caused by a fungus called Malassezia furfur. STIEPROX® contains the antifungal agent ciclopirox olamine which is a medication that, when applied to the skin of the scalp, will “kill” M. furfur.
When it should not be used
STIEPROX® should not be used if you are hypersensitive to ciclopirox olamine or to any of the ingredients contained in this shampoo. (See What the important nonmedicinal ingredients are).
What the medicinal ingredient is
Ciclopirox olamine.
What the non-medicinal ingredients are
Purified water, sodium lauryl ether sulphate, cocamidopropyl betaine, disodium phosphate dodecahydrate, citric acid monohydrate, coconut diethanolamide, hexylene glycol, oleyl alcohol, polysorbate 80, polyquaternium 10, fragrance (including dipropylene glycol), and sodium hydroxide.
What dosage form it comes in
STIEPROX® is a shampoo with a ciclopirox olamine content of 1.5% w/w. It is available in a 150 mL bottle.
Warnings and precautions
- STIEPROX® is for external use only.
- Like any other shampoo, care should be taken to keep STIEPROX® out of your eyes and off your eyelids. If contact occurs, flush eyes with copious amounts of water. If discomfort persists, consult your doctor.
- If skin irritation occurs and worsens or persists, consult your doctor.
- Consult your doctor prior to the use of STIEPROX® if you are pregnant, planning to become pregnant, nursing or planning to nurse.
- Nursing mothers are advised to ensure that any residual product is fully washed off the breast prior to breast-feeding to avoid possible ingestion by nursing infant.
- Do not use STIEPROX® if you have a reaction to ciclopirox olamine.
- Take special care with STIEPROX® if you have grey, white, or chemically damaged hair (for example, due to hair dye) as STIEPROX® may cause your hair to change colour.
Interactions with this medication
No drug interactions have been reported with ciclopirox olamine.
Proper use of this medication
For use by adults 18 years and older on the scalp and
areas next to the hairline only.
Directions for Use
- Wet the scalp, then apply sufficient shampoo to produce lather.
- The scalp and its edges should be vigorously massaged with the fingertips.
- The shampoo should be left on the scalp for 2-3 minutes.
- The hair should be thoroughly rinsed.
- Apply a second time by repeating Steps 1 to 4.
- Dandruff - Apply 2 or 3 times a week, or as directed by your doctor.
Overdose
Missed Dose
If you forget to shampoo your hair with STIEPROX® on a given day, you should wash your hair with STIEPROX® the next day.
Side effects and what to do about them
Side effects may include:
Effects on your skin
Itching*
(pruritus), skin and scalp irritation*
, skin redness*
(erythema), a skin burning sensation*
, application site rash*
,
flaking of the skin*
, sores on the scalp, eczema.
Effects on your eyes
Stinging, burning, watering, infection.
Other effects
Headache, hair loss*
, hair discolouration, changes to hair
texture and/or colour, nausea.
If any other side effects occur or existing side effects
worsen, contact your doctor.
*
Since these effects are also symptoms of the underlying disease, it is
expected that these side effects would manifest as a worsening of
symptoms.
How to store
Store STIEPROX®
between 4° and 30°C.
Keep out of reach and sight of children.
Reporting 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 three ways:
- Report online at www.healthcanada.gc.ca/medeffect
- Call toll-free at 1-866-234-2345
- Complete a Canada Vigilance Reporting Form and:
- Fax toll-free to 1-866-678-6789, or
- Mail to:
Canada Vigilance Program
Health Canada
Postal Locator 0701E
Ottawa ON K1A 0K9
Postage paid labels, Canada Vigilance Reporting Form and the adverse reaction reporting guidelines are available on the MedEffectTM Canada Web site at www.healthcanada.gc.ca/medeffect.
NOTE: Should you require information related to the management of side effects, contact your health 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 at:
http://www.stiefel.ca or by contacting the sponsor,
GlaxoSmithKline Inc.
7333 Mississauga Road
Mississauga, Ontario
L5N 6L4
1-800-387-7374
This leaflet was prepared by GlaxoSmithKline Inc.
Last revised: September 8, 2014
©
2014 GlaxoSmithKline Inc. All Rights Reserved.
®
STIEPROX is a registered trade-mark, used under license by
GlaxoSmithKline Inc.