Patient Medication Information: uses, side effects, how to take - Panoxyl Aquagel 5%
ABOUT THIS MEDICATION
What the medication is used for:
PANOXYL™ is used for the treatment of mild to moderate acne.
What it does:
PANOXYL™ works by fighting the bacteria that can cause acne.
When it should not be used:
PANOXYL™ should not be used:
if you are allergic (hypersensitive) to benzoyl
peroxide or any of the ingredients in PANOXYL™ (see What the medicinal ingredient is and What the nonmedicinal ingredients are). If you think this applies to you, don’t use PANOXYL™ until you have checked with your doctor or pharmacist.
What the medicinal ingredient is:
benzoyl peroxide.
What the nonmedicinal ingredients are:
PANOXYL™ 10 Gel and PANOXYL™ 20 Gel: citric acid anhydrous, ethoxylated lauryl alcohol, ethyl alcohol, hydroxypropyl methylcellulose, magnesium aluminum silicate and purified water.
PANOXYL™ Aquagel 5%: carbopol 940, ethoxylated lauryl alcohol, imidazolidinyl urea, purified water and sodium hydroxide.
PANOXYL™ Wash 5%: citric acid anhydrous, ethoxylated lauryl alcohol, hydroxypropyl methylcellulose, imidazolidinyl urea, magnesium aluminium silicate, purified water, sodium alkyl aryl polyethylene sulfate, sodium dialkyl octyl sulfate succinate and sodium lauryl sulfoacetate.
PANOXYL™ Aquagel 5% and PANOXYL™ Wash 5% contain imidurea (imidazolidinyl urea) as a preservative. Your body can break down imidurea into formaldehyde that may cause redness and itchiness.
PANOXYL™ 5 Bar: cab-o-sil, purified water and tensianol base ks-1.
PANOXYL™ 10 Bar: cab-o-sil, purified water and tensianol soap base ks-1.
What dosage forms it comes in:
PANOXYL™ 10 Gel and PANOXYL 20 Gel PANOXYL™ Aquagel 5%
PANOXYL™ Wash 5%
PANOXYL™ 5 Bar
PANOXYL™ 10 Bar
WARNINGS AND PRECAUTIONS
Before using PANOXYL™, talk to your doctor or pharmacist if:
you are pregnant or planning to become pregnant.
If you do become pregnant during treatment with PANOXYL™ tell your doctor.
- you are breastfeeding. It is not known whether the ingredients of PANOXYL™ can pass into breast milk. If you are breastfeeding, you must check with your doctor or pharmacist before using PANOXYL™. If you do use PANOXYL™ when breastfeeding, do not use on your breast area to ensure that the baby does not accidentally get it in their mouth.
The safety and effectiveness of PANOXYL™ in children under the age of 12 has not been established.
The safety and effectiveness of PANOXYL™ in patients 65 years and above has not been established.
Tell your doctor or pharmacist if you’re using or have recently used any other medicines for acne. This includes medicines bought without a prescription.
PANOXYL™ is for external use only. Avoid contact with the eyes, eyelids, mouth, lips, other mucous membranes such as inside the nose and broken skin such as cuts or scrapes. If contact with these areas occurs, rinse with water immediately.
Take care when applying PANOXYL™ Gel or Aquagel to the neck and other sensitive areas, since skin irritation is more likely to occur.
If you notice some peeling and reddening of the skin during the first weeks of using PANOXYL™, stop using the product for one to two days.
If you experience severe skin irritation (redness, dryness, itching, stinging/burning feeling), discontinue use and consult your doctor.
Do not use too much PANOXYL™ or use it more often than prescribed, as this will not help your acne clear up more quickly and may cause skin irritation.
PANOXYL™ can make your skin more sensitive to the harmful effects of the sun. Avoid the use of sunbeds and sunlamps and minimise the time you spend in the sun. You should use a sunscreen and wear protective clothing while using PANOXYL™.
PANOXYL™ may bleach hair and coloured or dyed fabrics. Avoid contact with hair, fabrics, furniture or carpeting.
INTERACTIONS WITH THIS MEDICATION
Some medicines can affect how PANOXYL™ works, or make it more likely that you’ll have side effects such as redness, peeling and skin irritation.
These include:
acne medicines that are applied to the skin which
contain tretinoin, isotretinoin or tazarotene
- some other acne medicines that are applied to the skin.
Applying PANOXYL™ at the same time as sulphonamide-containing medicines such as dapsone and sulfacetamide can cause a temporary discoloration of skin or facial hair (yellow/orange colour).
Tell your doctor or pharmacist if you are taking any of these medications.
PROPER USE OF THIS MEDICATION
Always use PANOXYL™ exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
Use PANOXYL™ for as long as your doctor or pharmacist recommends. It is important to continue to use this medicine until the acne has gone. If you stop too soon, your acne may return.
If you experience skin irritation (dryness or peeling) while using PANXOYL™, your doctor may reduce the amount of times you use PANOXYL™ or may temporarily stop use of PANOXYL™ for a short time and then start again.
Usual dose (adults and children 12 years of age and older):
Use once or twice daily, or as directed by your doctor. Because drying of the skin may occur, begin with one application daily, and then gradually increase to two applications daily, if needed.
Gel and Aquagel:
- 1. Wash your hands and the affected area using a non-medicated soap (contains no benzoyl peroxide) and gently dry, before use.
- 2. Put a thin film of PANOXYL™ on the entire affected skin area, using your fingertips, and smooth in.
- 3. Wash your hands after using PANOXYL™.
Wash:
- 1. Shake the wash well before using.
- 2. Wet the areas of the skin to be treated with warm water.
- 3. Apply PANOXYL™ Wash and gently massage for one or two minutes.
- 4. Rinse the skin well with warm water and gently dry.
- 5. Wash your hands after using PANOXYL™.
Soap Bar:
- 1. Wet the areas of the skin to be treated with warm water.
- 2. Apply PANOXYL™ and gently massage for one or two minutes.
- 3. Rinse the skin well with warm water and gently dry.
- 4. Wash your hands after using PANOXYL™.
Overdose:
If you apply too much PANOXYL™ your skin might become very irritated. If this happens stop using PANOXYL™ and contact your doctor.
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.
The ingredients of PANOXYL™ are not expected to be
harmful if swallowed in the small amounts normally applied
to the face. However, if you do accidentally get a larger
amount of PANOXYL™ in your mouth, rinse immediately
with plenty of water and contact your doctor or pharmacist
for advice.
Missed Dose:
If you forget to use PANOXYL™ apply the next dose at the
usual time.
SIDE EFFECTS AND WHAT TO DO ABOUT THEM
Like all medications, PANOXYL™ can cause side effects, but not everybody gets them.
Very Common (these may affect more than 1 in 10 people):
Redness and peeling of the skin at the site of
application.
Common (these may affect up to 1 in 10 people):
Dryness, itching or sensitivity of the skin at the site
of application.
Uncommon (these may affect up to 1 in 100 people):
- Burning sensation at the site of application
Rare (these may affect up to 1 in 1,000 people):
At the site of application the following may occur:
discoloration of the skin, skin rash, skin allergy, other skin reactions such as irritation and pain.
Dry lips, lip swelling, and lip inflammation have
been reported when PANOXYL™ was applied close to the mouth (see Warnings and Precautions).
Photosensitivity (a skin reaction, such as a rash,
that occurs after exposure to the sun or any UV light source, including a sunlamp).
Tell your doctor or pharmacist if any of the side effects listed become severe or troublesome, or if you notice any side effects not listed in this leaflet.
| SERIOUS SIDE EFFECTS, HOW OFTEN THEY HAPPEN AND WHAT TO DO ABOUT THEM | ||||
| Symptom / effect | Talk with your doctor or pharmacist | Stop taking drug and call your doctor or pharmacist immediately | ||
| Only if severe | In all cases | |||
| Rare | Severe allergic reaction. Signs may include raised and itchy rash (hives), swelling of the face or mouth (angioedema), causing difficulty in breathing, collapse | ✓ | ✓ | |
This is not a complete list of side effects. For any unexpected effects while taking PANOXYL™, contact your doctor or pharmacist.
HOW TO STORE IT
Store between 15º and 30ºC.
Keep out of the reach and sight of children.
Do not use PANOXYL™ after the expiry date shown on the pack.
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 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, Ontario
K1A 0K9
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 prescribing information, prepared for health professionals can be found at: or by contacting the sponsor,
GlaxoSmithKline Inc.
7333 Mississauga Road
Mississauga, Ontario
L5N 6L4
1-800-387-7374
Last revised: July 5, 2012
© 2012 GlaxoSmithKline Inc. All Rights Reserved ™ PANOXYL is a trademark of Stiefel Laboratories, Inc., used under license by GlaxoSmithKline Inc.