Solugel: Uses, Side Effects and Dosage

ABOUT THIS MEDICATION

What the medication is used for:

SOLUGEL^® Gel is used for the treatment of mild to moderate acne.

What it does:

SOLUGEL^® works by fighting the bacteria that can cause acne.

When it should not be used:

SOLUGEL^® should not be used:

• if you are allergic (hypersensitive) to benzoyl

  peroxide or any of the ingredients in SOLUGEL^® (see What the medicinal ingredient is and What the nonmedicinal ingredients are). If you think this applies to you, don’t use SOLUGEL^® until you have checked with your doctor or pharmacist.

What the medicinal ingredient is:

benzoyl peroxide.

What the important nonmedicinal ingredients are:

cetyl alcohol, dimethyl isosorbide, fragrance, promulgen G, simethicone, sodium hydroxide and purified water.

What dosage forms it comes in:

SOLUGEL^® Gel 8%

SOLUGEL^® Gel 4%

WARNINGS AND PRECAUTIONS

Before using SOLUGEL^®, talk to your doctor or pharmacist if:

• you are pregnant or planning to become pregnant.

  If you do become pregnant during treatment with SOLUGEL^® tell your doctor.

• you are breastfeeding. It is not known whether the ingredients of SOLUGEL^® can pass into breast milk. If you are breastfeeding, you must check with your doctor or pharmacist before using SOLUGEL^®. If you do use SOLUGEL^® 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 SOLUGEL^® in children under the age of 12 has not been established.

The safety and effectiveness of SOLUGEL^® 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.

SOLUGEL^® 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 SOLUGEL^® Gel 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 SOLUGEL^®, 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 SOLUGEL^® or use it more often than prescribed, as this will not help your acne clear up more quickly and may cause skin irritation.

SOLUGEL^® 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 SOLUGEL^®.

SOLUGEL^® 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 SOLUGEL^® 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 SOLUGEL^® 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 SOLUGEL^® exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

Use SOLUGEL^® 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 SOLUGEL^®, your doctor may reduce the amount of times you use SOLUGEL^® or may temporarily stop use of SOLUGEL^® 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.

1. 1.

   Wash your hands and the affected area using non-

   medicated soap (contains no benzoyl peroxide) and gently dry, before use.

2. 2.

   Put a thin film of SOLUGEL^® on the entire affected

   skin area, using your fingertips, and smooth in.

3. 3. Wash your hands after using SOLUGEL^®.

Overdose:

If you apply too much SOLUGEL^® your skin might become very irritated. If this happens stop using SOLUGEL^® and contact your doctor.

The ingredients of SOLUGEL^® 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 SOLUGEL^® in your mouth, rinse immediately with plenty of water and contact your doctor or pharmacist for advice.

Missed Dose:

If you forget to use SOLUGEL^® apply the next dose at the usual time.

SIDE EFFECTS AND WHAT TO DO ABOUT THEM

Like all medications, SOLUGEL^® 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 SOLUGEL^® 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.

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.

This is not a complete list of side effects. For any unexpected effects while taking SOLUGEL^®, contact your doctor or pharmacist.

Store between 15º and 30ºC.

Keep out of the reach and sight of children.

Do not use SOLUGEL^® 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: December 8, 2011

^© 2011 GlaxoSmithKline Inc. All Rights Reserved ^® SOLUGEL is a registered trade-mark, used under license by GlaxoSmithKline Inc.

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