Patient Medication Information: uses, side effects, how to take - Stieprox Shampoo
ABOUT THIS MEDICATION
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 important nonmedicinal 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 forms 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
- 1. Wet the scalp, then apply sufficient shampoo to produce lather.
- 2. The scalp and its edges should be vigorously massaged with the fingertips.
- 3. The shampoo should be left on the scalp for 2-3 minutes.
- 4. The hair should be thoroughly rinsed.
- 5. Apply a second time by repeating Steps 1 to 4.
- 6. Dandruff - Apply 2 or 3 times a week, or as directed by your doctor.
Seborrhoeic dermatitis - Apply 3 times a week, or as directed by 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 symptoms. |
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 IT
Store STIEPROX® between 4° and 30°C.
Keep out of reach and sight of children.
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:
Postage paid labels, Canada Vigilance Reporting Form and the adverse reaction reporting guidelines are available on the MedEffect™ 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
Last revised: September 8, 2014
© 2014 GlaxoSmithKline Inc. All Rights Reserved.
® STIEPROX is a registered trade-mark, used under license by GlaxoSmithKline Inc.