Details for: CLINDOXYL
Company: GLAXOSMITHKLINE INC
| DIN | DIN name | Active Ingredient(s) | Strength | Dosage Form | Route of Administration |
|---|---|---|---|---|---|
| 02382822 | CLINDOXYL ADV GEL | BENZOYL PEROXIDE; CLINDAMYCIN (CLINDAMYCIN PHOSPHATE) | 3 % / W/W; 1 % / W/W | GEL | TOPICAL |
| 02243158 | CLINDOXYL 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
CLINDOXYL ADV Gel / CLINDOXYL Gel is used on the skin to treat moderate acne. It should not be used to treat severe (cystic) acne.
CLINDOXYL ADV Gel / CLINDOXYL Gel contains an antibacterial ingredient called clindamycin that treats only bacterial infections. Clindamycin does not treat viral infections.
It is not known if CLINDOXYL ADV Gel / CLINDOXYL Gel are safe and effective in people under the age of 12 years old and over the age of 65 years old.
What it does
CLINDOXYL ADV Gel / CLINDOXYL Gel works by:
- slowing or stopping the growth of acne bacteria.
- killing acne bacteria.
When it should not be used
You are allergic to:
- clindamycin.
- benzoyl peroxide.
- lincomycin, an antibiotic.
- any of the other ingredients in CLINDOXYL ADV Gel / CLINDOXYL Gel. See What are the ingredients in CLINDOXYL ADV Gel / CLINDOXYL 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
Medicinal ingredients in CLINDOXYL ADV Gel / CLINDOXYL Gel: clindamycin phosphate and benzoyl peroxide.
What the non-medicinal ingredients are
Non-medicinal ingredients in CLINDOXYL ADV Gel: carbomer homopolymer,
dimethicone, disodium lauryl sulfosuccinate, edetate disodium, glycerin, poloxamer,
purified water, silicon dioxide and sodium hydroxide.
Non-medicinal ingredients in CLINDOXYL Gel: carbomer homopolymer, dimethicone,
disodium lauryl sulfosuccinate, edetate disodium, glycerin, methylparaben, poloxamer,
purified water, silicon dioxide and sodium hydroxide.
What dosage form it comes in
CLINDOXYL ADV (1% clindamycin phosphate / 3% benzoyl peroxide) Topical Gel.
CLINDOXYL (1% clindamycin phosphate / 5% benzoyl peroxide) Topical Gel.
Warnings and precautions
To help avoid side effects and ensure proper use, talk to your healthcare professional before you take CLINDOXYL ADV Gel / CLINDOXYL 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 CLINDOXYL ADV Gel / CLINDOXYL Gel.
Other warnings you should know about:
- CLINDOXYL ADV Gel / CLINDOXYL Gel is for external use only.
- Keep CLINDOXYL ADV Gel / CLINDOXYL 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, CLINDOXYL ADV Gel / CLINDOXYL 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
- 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
- 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 CLINDOXYL ADV Gel / CLINDOXYL Gel could lead to the growth of bacteria that will not be killed by clindamycin (resistance). This means that CLINDOXYL ADV Gel / CLINDOXYL 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 CLINDOXYL ADV Gel / CLINDOXYL 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 CLINDOXYL ADV Gel / CLINDOXYL 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 to your healthcare professional Only if severe | Talk to your healthcare professional In all cases | Stop taking drug and get immediate Only if 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 CLINDOXYL ADV Gel / CLINDOXYL 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-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: 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
- 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 www.gsk.ca, or by calling 1-800-387-7374.
This leaflet was prepared by GlaxoSmithKline Inc.
Last Revised November 2, 2018
© 2018 GSK group of companies or its licensor
Trademarks are owned by or licensed to the GSK group of companies