Details for: TACTUPUMP
Company: GALDERMA CANADA INC
| DIN | DIN name | Active Ingredient(s) | Strength | Dosage Form | Route of Administration |
|---|---|---|---|---|---|
| 02365871 | TACTUPUMP | ADAPALENE; BENZOYL PEROXIDE | 0.1 % / W/W; 2.5 % / W/W | GEL | TOPICAL |
Consumer Information
This information was provided by the drug’s manufacturer when this drug product was approved for sale in Canada. It is designed for consumers and care givers. It is a summary of information about the drug and will not tell you everything about the drug. Contact your doctor or pharmacist if you have any questions about the drug.
What the medication is used for
TACTUPUMP 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
TACTUPUMP 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 TACTUPUMP.
When it should not be used
- If you are pregnant.
- 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 TACTUPUMP or any of its ingredients (see “What the important nonmedicinal ingredients are”).
What the medicinal ingredient is
TACTUPUMP contains two medicinal ingredients:
- adapalene 0.1% w/w
- benzoyl peroxide 2.5% w/w
What the non-medicinal ingredients are
TACTUPUMP 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 form it comes in
TACTUPUMP topical gel is available in a 70 g bottle with a pump. Physician samples are available in a 15 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 as this may make your skin more sensitive to the product. In case of sunburn, allow the skin to heal before using TACTUPUMP.
Do not apply TACTUPUMP to cuts, abrasions, eczema or sunburned skin
BEFORE you use TACTUPUMP talk to your doctor or pharmacist if:
- You are pregnant or planning to become pregnant. If you are pregnant you should not use TACTUPUMP. If you are a female of childbearing years, you should only use TACTUPUMP after consulting your doctor about contraceptive counselling.
- You are breastfeeding or planning to breastfeed.
- 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. TACTUPUMP 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 TACTUPUMP.
- If you develop a severe allergic reaction while taking TACTUPUMP, with reactions such as swollen mouth, throat, extremities, difficulty in breathing, rash or itching, stop using TACTUPUMP 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 TACTUPUMP, 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 TACTUPUMP.
Interactions with this medication
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 TACTUPUMP.
Proper use of this medication
Usual Dose
In patients 9 years of age and older: Use TACTUPUMP once a day at night before you go to bed.
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 TACTUPUMP 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 TACTUPUMP
Keep TACTUPUMP 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. TACTUPUMP may bleach hair and coloured fabric. Use caution when applying TACTUPUMP 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 TACTUPUMP will not make it work better or faster.
Overdose
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 TACTUPUMP 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 TACTUPUMP 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 TACTUPUMP’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.
| Symptom / effect | Talk with your doctor, nurse, or pharmacist only if severe | Talk with your doctor, nurse, or pharmacist in all cases | Stop taking drug and talk with your doctor or pharmacist |
|---|---|---|---|
| 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 TACTUPUMP, contact your doctor or pharmacist.
How to store
TACTUPUMP 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 adverse reactions associated with the use of health products to the Canada Vigilance Program by one of the following three 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 0701D
Ottawa ON K1A 0K9
Postage paid labels, Canada Vigilance Reporting Form and the adverse reaction reporting guidelines are available on the MedEffectTM 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: www.galderma.ca or by contacting the sponsor, Galderma Canada Inc.
Questions or concerns:1-800-467-2081.
This leaflet was prepared by Galderma Canada Inc. Last revised: May 17, 2019