Sandoz Adapalene / Benzoyl Peroxide: Uses, Side Effects and Dosage

ABOUT THIS MEDICATION

What the medication is used for:

Sandoz Adapalene/ Benzoyl Peroxide is used for the topical treatment of mild to moderate acne (acne vulgaris) on your face, chest and back, with comedones (clogged hair follicles - blackheads, whiteheads) and inflammatory papules and pustules (e.g. pimples).

What it does:

Sandoz Adapalene / Benzoyl Peroxide works in two ways. The first is by unplugging your blocked oil glands and by preventing these plugs from forming in the first place. The second is a germ killing effect; it kills the P. acnes bacteria present in acne and helps reduce inflammation. Your acne should improve in 4-8 weeks and you should see more improvement as you continue to use Sandoz Adapalene / Benzoyl Peroxide.

When it should not be used:

• If you are pregnant or planning a pregnancy.

• If you have eczema or very irritated skin (such as seborrheic

  dermatitis) on your face, chest or back.

• If you are allergic to the medicinal ingredients in Sandoz

  Adapalene / Benzoyl Peroxide or any of its ingredients (see “What the important nonmedicinal ingredients are”).

What the medicinal ingredient is:

Sandoz Adapalene / Benzoyl Peroxide contains two medicinal ingredients:

• adapalene 0.1% w/w
• benzoyl peroxide 2.5% w/w

What the important nonmedicinal ingredients are:

Sandoz Adapalene / Benzoyl Peroxide also contains acrylamide/sodium acryloyldimethyltaurate copolymer, docusate sodium, edetate disodium, glycerin, isohexadecane, poloxamer 124, polysorbate 80, propylene glycol, sorbitan oleate, and purified water.

What dosage forms it comes in:

Sandoz Adapalene / Benzoyl Peroxide topical gel is available in a 70 g bottle with a pump.

WARNINGS AND PRECAUTIONS

Avoid using other potentially irritating topical products, such as soaps or cosmetics containing drying agents (e.g. alcohol) or other irritants (astringents, spices, etc.).

Avoid exposure to excessive sunlight, including sunlamps, as this may make your skin more sensitive to the product. In case of sunburn, allow the skin to heal before using Sandoz Adapalene / Benzoyl Peroxide.

Do not apply Sandoz Adapalene / Benzoyl Peroxide to cuts, abrasions, eczema or sunburned skin.

BEFORE you use Sandoz Adapalene / Benzoyl Peroxide talk to your doctor or pharmacist if:

• You are pregnant or planning to become pregnant. If you are pregnant you should not use Sandoz Adapalene / Benzoyl Peroxide . If you are a female of childbearing years, you should only use Sandoz Adapalene / Benzoyl Peroxide after consulting your doctor about contraceptive counselling.
• You are breastfeeding or planning to breastfeed. The product should not be applied to the chest, in order to avoid contact with the child.
• You intend go out in the sun. Before you do, you should use a good sunscreen (SPF 15 or higher) that is designed not to clog pores (non-comedogenic) and use protective clothing.

• You are using any other acne medications. Sandoz Adapalene

  / Benzoyl Peroxide should not be used with other acne medications unless your doctor tells you to use them.

• You are allergic to this drug or its ingredients or components of the container. Check with your doctor if you know you are allergic to certain ingredients or package components to ensure that you can use Sandoz Adapalene / Benzoyl Peroxide.

• If you develop a severe allergic reaction while taking Sandoz

  Adapalene / Benzoyl Peroxide, with reactions such as swollen mouth, throat, extremities, difficulty in breathing, rash or itching, stop using Sandoz Adapalene / Benzoyl Peroxide and seek medical attention.

• You receive hair-removal treatments. Do not use “waxing” as a way of removing unwanted hair in the areas where you will be applying Sandoz Adapalene / Benzoyl Peroxide, as this may increase your skin sensitivity.
• You are or have recently undergone skin procedures such as chemical hair treatments, chemical peels, dermabrasion or laser re-surfacing. Allow the skin to heal before using Sandoz Adapalene / Benzoyl Peroxide.

INTERACTIONS WITH THIS MEDICATION

Drugs that may interact with Sandoz Adapalene / Benzoyl Peroxide include:

Other acne products that have a drying effect on the skin, such as products that contain sulphur, resorcinol, or salicylic acid, as they may increase redness, dryness, and flaking. Talk to your physician about stopping your use of other acne products OR about changing the time of day that you use them. No drug interaction studies have been performed with Sandoz Adapalene / Benzoyl Peroxide.

PROPER USE OF THIS MEDICATION

Usual dose:

In patients 9 years of age and older: Use Sandoz Adapalene / Benzoyl Peroxide once a day at night before you go to bed.

Before using Sandoz Adapalene / Benzoyl Peroxide for the first time, pump the dispenser 10 times. You may need to repeat this process a few times before the gel will start to dispense.

You should first wash your face with a gentle cleanser and blot it dry with a soft towel – do not rub your face. Then, apply a thin film of Sandoz Adapalene / Benzoyl Peroxide to the areas where you have acne. Usually, four pea-sized amounts should be enough to cover your whole face (e.g. one on the forehead, chin and each cheek). DO NOT SPOT APPLY – cover the entire affected area.

Wash your hands after using Sandoz Adapalene / Benzoyl Peroxide.

Keep Sandoz Adapalene / Benzoyl Peroxide away from your eyes, lips, and the corners of your nose. If you get any in your eyes, flush your eyes with clean water right away. Sandoz Adapalene / Benzoyl Peroxide may bleach hair and coloured fabric. Use caution when applying Sandoz Adapalene / Benzoyl Peroxide near the hairline.

If skin irritation develops or worsens during treatment, stop use and contact your doctor. Your doctor may advise you to wait until the irritation goes down and then re-start the treatment only once every other day. If you tolerate this treatment after a few days, then resume the once- daily treatment schedule.

Use only the amount your doctor told you to use. Using more Sandoz Adapalene / Benzoyl Peroxide will not make it work better or faster.

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.

In case of accidental oral ingestion, in addition to the boxed warning above, if you are in your childbearing years discuss with your doctor if a pregnancy test should be done.

Missed Dose:

If you miss a dose, it is not necessary to make up the missed dose. Just wait until the next evening and use Sandoz Adapalene / Benzoyl Peroxide as usual. Apply the same amount you usually would. Do not apply extra.

SIDE EFFECTS AND WHAT TO DO ABOUT THEM

Do not be discouraged if Sandoz Adapalene / Benzoyl Peroxide causes some redness, dryness, itching, burning, or peeling when you first start to use it (2-4 weeks). This happens when your skin is adjusting to Sandoz Adapalene / Benzoyl Peroxide’s action of unplugging clogged pores. If these problems continue to happen or if they are getting worse, talk to your doctor. Your doctor may recommend the use of a moisturizer, a change in your dose, or a change to how often you use the medication.

This is not a complete list of side effects. For any unexpected effects while taking Sandoz Adapalene / Benzoyl Peroxide, contact your doctor or pharmacist.

HOW TO STORE IT

Sandoz Adapalene / Benzoyl Peroxide should be stored at room temperature (15˚ to 25˚C). The product should be used within a period of 6 months after first opening. Any unused portion should be discarded 6 months after opening or at product expiry date (whichever comes first). Keep tightly closed. 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 Health Canada by: --------------------------------------------------------------------------

• Visiting the Web page on Adverse Reaction Reporting

  (https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/adverse-reaction-reporting.html) for information on how to report online, by mail or by fax; or

• Calling toll-free at 1-866-234-2345.

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: www.sandoz.ca or by contacting the sponsor, Sandoz Canada Inc., at 1-800-361-3062.

or by e-mail at: medinfo@sandoz.com

Last revised: June 10, 2021