Details for: TARO-CLINDAMYCIN/BENZOYL PEROXIDE GEL
Company: TARO PHARMACEUTICALS INC
| DIN | DIN name | Active Ingredient(s) | Strength | Dosage Form | Route of Administration |
|---|---|---|---|---|---|
| 02440180 | TARO-CLINDAMYCIN/BENZOYL PEROXIDE GEL | BENZOYL PEROXIDE; CLINDAMYCIN (CLINDAMYCIN PHOSPHATE) | 5 % / W/W; 1 % / 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
Taro-Clindamycin / Benzoyl Peroxide Gel is used on the skin to treat moderate acne. It
should not be used to treat severe (cystic) acne
Taro-Clindamycin / Benzoyl Peroxide Gel contains an antibacterial ingredient called
clindamycin that treats only bacterial infections. Clindamycin does not treat viral
infections.
It is not known if Taro-Clindamycin / Benzoyl Peroxide Gel is safe and effective in
people under the age of 12 years old and over the age of 65 years old.
What it does
Taro-Clindamycin / Benzoyl Peroxide Gel works by:
- slowing or stopping the growth of acne bacteria
- killing acne bacteria
When it should not be used
Do not use Taro-Clindamycin / Benzoyl Peroxide Gel if:
You are allergic to:
- clindamycin
- benzoyl peroxide
- lincomycin, an antibiotic.
- any of the other ingredients in Taro-Clindamycin / Benzoyl Peroxide Gel. See What are the ingredients in Taro-Clindamycin / Benzoyl Peroxide Gel?
You have or have had the following:
- inflammatory bowel disease, such as Crohn’s disease or ulcerative colitis
- bloody, severe, or long-lasting diarrhea after using antibiotics.
What the medicinal ingredient is
Clindamycin phosphate and Benzoyl peroxide
What the non-medicinal ingredients are
Carbomer homopolymer, dimethicone, disodium lauryl sulfosuccinate, edetate disodium, glycerin, methylparaben, poloxamer, purified water, silicon dioxide and sodium hydroxide.
What dosage form it comes in
Topical gel.
Warnings and precautions
To help avoid side effects and ensure proper use, talk to your healthcare professional before you take Taro-Clindamycin / Benzoyl Peroxide Gel. Talk about any health conditions or problems you may have, including if you are:
- pregnant or planning to become pregnant
- breast-feeding or planning to breast-feed.
If you do breast-feed:
- Do not apply to the chest or breast area to prevent the infant from ingesting Taro-Clindamycin / Benzoyl Peroxide Gel.
Other warnings you should know about:
- Taro-Clindamycin / Benzoyl Peroxide Gel is for external use only.
- Keep Taro-Clindamycin / Benzoyl Peroxide Gel away from:
- your eyes.
- inside your nose.
- your mouth and lips.
- other mucous membranes, like inside your vagina.
- areas of broken or irritated skin.
- sunburned skin, until it has healed
- If contact occurs with any of the above areas, flush with water for at least 5 minutes. If discomfort continues, talk to your healthcare professional.
- Do not apply too much. Applying too much may cause skin irritation. If this happens, use the gel less often.
- Limit your time in the sun. If you have to be in the sun, wear protective clothing and sunscreen. Do not use sunlamps or tanning beds.
- Do not use other acne medications applied to the skin unless your healthcare professional tells you to do so.
- If you have recently used other medicines with clindamycin or erythromycin, Taro-Clindamycin / Benzoyl Peroxide Gel may not work as well as it should. Tell your healthcare professional if you have recently used these other medicines.
Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.
Interactions with this medication
The following may interact with Taro-Clindamycin / Benzoyl Peroxide Gel:
- Medicines used to relax muscles during surgery.
- Erythromycin, an antibiotic.
- Medicines applied to the skin that contain tretinoin, isotretinoin or tazarotene.
- Medicines called sulphonamides that are applied to the skin such as dapsone or sulfacetamide.
- Other acne medications applied to the skin.
Proper use of this medication
How to take Taro-Clindamycin / Benzoyl Peroxide Gel:
- Before you apply:
- wash your skin with a mild cleanser that doesn’t irritate your skin.
- rinse with warm water.
- gently pat dry.
- Apply only to your skin.
- After you apply:
- wash your hands with soap and water.
- Although you may feel better early in treatment, use only as directed by your healthcare professional.
- Misuse or overuse of Taro-Clindamycin / Benzoyl Peroxide Gel could lead to the growth of bacteria that will not be killed by clindamycin (resistance). This means that Taro-Clindamycin / Benzoyl Peroxide Gel may not work for you in the future.
- Do not share your medicine.
Usual dose:
- Apply a thin layer to the affected area, once a day.
- For the face, apply a pea-sized amount for each affected area of your face, for example, to:
- your chin.
- each cheek.
- your forehead.
Overdose
If you accidently swallow Taro-Clindamycin / Benzoyl Peroxide Gel seek medical advice
Missed dose:
If you missed a dose of this medication, apply it as soon as you remember. Do not apply two doses at the same time.
Side effects and what to do about them
These are not all the possible side effects you may feel when taking Taro-Clindamycin / Benzoyl Peroxide Gel. If you experience any side effects not listed here, contact your healthcare professional.
Side effects may include:
- skin rash that is red or bumpy.
- dry or itchy skin.
- numbness or tingling of the skin.
- burning or stinging of the skin.
- peeling skin.
- a change in colour of the skin where the medicine was applied.
- sensitivity to the sun.
- worsening of acne.
| Symptom / effect | Talk with your doctor or pharmacist Only if severe | Talk with your doctor or pharmacist In all cases | Stop taking Stop taking drug and get immediate medical help |
|---|---|---|---|
| RARE | |||
Colitis (inflammation of the intestines):
|
✔ | ||
Folliculitis (an infection of your hair follicles):
|
✔ | ||
Severe allergic reaction:
|
✔ | ||
If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, talk to your healthcare professional.
How to store
Store at room temperature (15° - 25°C). Do not freeze. Keep tube tightly closed. Keep out
of reach and sight of children
If there is any Taro-Clindamycin / Benzoyl Peroxide Gel left 60 days after you receive it, you should throw it out and talk to your healthcare professional.
Reporting side effects
You can report any suspected side effects 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-healthproducts/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: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-Clindamycin / Benzoyl Peroxide Gel:
- 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 (http://hc-sc.gc.ca/index-eng.php); the manufacturer’s website http://www.taro.ca, or by calling 1-800-268-1975.
This leaflet was prepared by:
Taro Pharmaceuticals Inc.
130 East Drive
Brampton, Ontario L6T 1C1
Last Revised March 4, 2019
TARO is a registered trademark of
Taro Pharmaceuticals Inc.