Patient Medication Information: uses, side effects, how to take - Taro-Adapalene/Benzoyl Peroxide
ABOUT THIS MEDICATION
What the medication is used for:
Taro-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:
Taro-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 Taro-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 Taro-Adapalene / Benzoyl Peroxide or any of its ingredients (see “What thenonmedicinal ingredients are”).
What the medicinal ingredient is:
Taro-Adapalene / Benzoyl Peroxide contains two medicinal ingredients:
- adapalene 0.1% w/w
- benzoyl peroxide 2.5% w/w
What the nonmedicinal ingredients are:
Taro-Adapalene / Benzoyl Peroxide also contains C13-14 isoparaffin, docusate sodium, edetate disodium, glycerin, laureth 7, poloxamer 124, polyacrylamide, propylene glycol, and purified water.
What dosage forms it comes in:
Taro-Adapalene / Benzoyl Peroxide topical gel is available in a
70 g bottle with a pump and in 60 g tubes.
WARNINGS AND PRECAUTIONS
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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 Taro-Adapalene / Benzoyl Peroxide.
Do not apply Taro-Adapalene / Benzoyl Peroxide to cuts, abrasions, eczema or sunburned skin.
BEFORE you use Taro-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 Taro-Adapalene / Benzoyl Peroxide. If you are a female of childbearing years, you should only use Taro-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. Taro-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 Taro-Adapalene / Benzoyl Peroxide.
- If you develop a severe allergic reaction while taking Taro-Adapalene / Benzoyl Peroxide , with reactions such as swollen mouth, throat, extremities, difficulty in breathing, rash or itching, stop using Taro-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 Taro-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 Taro-Adapalene / Benzoyl Peroxide.
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INTERACTIONS WITH THIS MEDICATION
Drugs that may interact with Taro-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 adapalene and benzoyl peroxide, 0.1% / 2.5% w/w topical gel
PROPER USE OF THIS MEDICATION
Usual dose:
In patients 9 years of age and older: Use Taro-Adapalene / Benzoyl Peroxide once a day at night before you go to bed.
Before using Taro-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 Taro-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 Taro-Adapalene / Benzoyl Peroxide.
Keep Taro-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. Taro-Adapalene / Benzoyl Peroxide may bleach hair and coloured fabric. Use caution when applying Taro-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 Taro-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 Taro-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 Taro-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 Taro-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.
| 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 |
| Only if severe | In all cases | |
| Uncommon | ||
Skin becomes very dry, itchy, red, swollen, blistered, or sunburned | ||
| √ | ||
This is not a complete list of side effects. For any unexpected effects while taking Taro-Adapalene / Benzoyl Peroxide contact your doctor or pharmacist.
HOW TO STORE IT
Taro-Adapalene / Benzoyl Peroxide should be stored at room temperature (15˚ to 25˚C). The product should be used within a period of 12 months after first opening. Any unused portion should be discarded 12 months after opening or at product expiry date (whichever comes first). Keep tightly closed. Keep out of reach and sight of children.
REPORTING SIDE EFFECTS
You can report any suspected side effects associated with the use of health products to Health Canada by:
NOTE: Contact your health professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice. |
MORE INFORMATION
If you want more information about Taro Adapalene/BPO:
- Talk to your healthcare professional
- Find the full product monograph that is prepared for healthcare professionals and includes this Patient Medication Information by visiting the Health Canada website (https://www.canada.ca/en/health-canada/services/drugs-health-products/drug- products/drug-product-database.html); the manufacturer’s website www.taro.ca or by calling 1-800-268-1975.
Taro Pharmaceuticals Inc.
130 East Drive
Brampton, Ontario L6T 1C1
Last Prepared: September 11, 2020