Patient Medication Information: uses, side effects, how to take - Biacna Topical Gel
ABOUT THIS MEDICATION
What the medication is used for:
BIACNA is an antibiotic and a retinoid (related to Vitamin A) combination medicine used for the topical treatment of facial acne in patients 12 years and older.
BIACNA contains an antibacterial ingredient called clindamycin, and it should be used exactly as directed by your healthcare professional. Misuse or overuse of BIACNA could lead to the growth of bacteria that will not be killed by clindamycin. This means that BIACNA or other medicines that contain clindamycin may not work for you in the future. Do not share your medicine.
What it does:
Clindamycin helps prevent bacterial protein synthesis thereby limiting the growth of bacteria associated with acne.
Tretinoin is thought to normalize the growth of skin cells (keratinocytes) and to cause normal shedding of the cells (corneocytes) that clog the follicles in acne lesions, thereby preventing the build-up of sebum and the formation of microcomedones.
When it should not be used:
Do not use BIACNA if:
You have or have had regional enteritis (Crohn’s disease),
ulcerative colitis, or antibiotic-associated colitis
You are allergic to clindamycin, lincomycin, tretinoin or to
any ingredient of this medication (See “What the nonmedicinal ingredients are”)
What the medicinal ingredients are:
Clindamycin Phosphate 1.2% w/w and Tretinoin 0.025% w/w
What the nonmedicinal ingredients are:
Butylated Hydroxy Toluene, Citric Acid, Disodium Edetate, Polysorbate 80, Methylparaben, Propylparaben, Trometamol, Carbomer, Glycerine and Water.
What dosage forms it comes in:
BIACNA is a gel for topical application available in a 2-gram sample tube, and a 60-gram tube.
WARNINGS AND PRECAUTIONS
This product is available only by prescription and should be used only according to your doctor’s instructions
Safety and effectiveness in children below the age of 12 have not been established.
BIACNA should not be applied to other areas of the body or to other growths or lesions, as the safety and effectiveness of this product have not been evaluated in other disorders.
Caution in the sun. Therapy with BIACNA may make your skin more susceptible to sunburn and other adverse effects of the sun, so unprotected exposure to natural or artificial light (such as a sunlamp) should be minimized. When outside, even on hazy days, areas treated with BIACNA should be protected. An effective sunscreen should be used any time you are outside (consult your physician for a recommendation of an SPF level which will provide you with the necessary high level of protection). Use other protective clothing such as a hat when you are in the sun. If your face becomes sunburnt, stop medication until your skin has healed.
Avoid excessive exposure to wind or cold. Extremes of climate tend to dry or burn normal skin. Skin treated with BIACNA may be more vulnerable to these extremes. Your physician can recommend ways to manage your acne treatment under such conditions.
Use other medication only on your physician's advice. You should avoid preparations that may dry or irritate your skin. These preparations may include certain astringents, toiletries containing alcohol, spices or lime, or certain medicated soaps, shampoos, and hair permanent solutions. Do not allow anyone else to use this medication.
Pregnancy
If you are pregnant, think you are pregnant, or of child-bearing age, do not use this medication until you check with your doctor. Birth defects have been reported among babies born to women exposed to topical tretinoin, although no well-controlled and adequate prospective studies of the use of topical tretinoin in pregnant women have been conducted to determine whether there is harm to the fetus or harm to the reproductive capacity of women. Talk to your doctor before using this medication.
Nursing
It is not known whether clindamycin or tretinoin is excreted in human breastmilk. Discuss with your doctor.
BEFORE you use BIACNA talk to your doctor or pharmacist if:
- You are using sunlamps or tanning booths. Product Monograph – BIACNA™ Topical Gel Page 29 of 30
- You have Crohn’s disease, ulcerative colitis.
- You have developed colitis with past antibiotic use.
You are pregnant or planning to become pregnant. It
is not known if BIACNA may harm your unborn baby.
You are breastfeeding. BIACNA may pass through your
milk and may harm your baby.
- You are taking other medicines, including drugs you can buy without a prescription.
You are allergic to clindamycin, lincomycin or
tretinoin, or any ingredients in the formulation or components of the container (See “What the nonmedicinal ingredients are” section).
AND WHILE YOU'RE ON BIACNA THERAPY Use a gentle cleanser. Avoid frequent washings and harsh scrubbing. Acne is not caused by dirt, so no matter how hard you scrub, you can't wash it away. Washing too frequently (more than 2-3 times per day) or scrubbing too roughly may at times actually make your acne worse. Wash your skin gently and pat skin dry with a towel.
Avoid medicated or abrasive soaps and cleansers, soaps and cosmetics that have a strong drying effect, and skin products that contain alcohol, astringents, spices or lime. These products may cause increased skin irritation if used with BIACNA .
Stop treatment and contact your doctor if symptoms persist for more than 12 weeks.
Do not wash your face more than 2-3 times a day. Washing your face too often or scrubbing may make your acne worse. To get the best results with BIACNA therapy, it is necessary to use it properly. AGAIN, FOLLOW INSTRUCTIONS - BE PATIENT - DON'T START AND STOP THERAPY ON YOUR OWN - IF YOU HAVE QUESTIONS, ASK YOUR DOCTOR.
Overdose:
If medication is applied excessively, no more rapid or better results will be obtained and marked redness, peeling, or discomfort may occur. Oral ingestion of the drug may lead to the same side effects as those associated with excessive oral intake of Vitamin A.
Topically applied BIACNA can be absorbed in sufficient amounts to produce systemic effects (see “WARNINGS AND PRECAUTIONS”]
INTERACTIONS WITH THIS MEDICATION
BIACNA should not be used with Erythromycin containing products.
Tell your doctor if you are using any other medications, such as neuromuscular blocking agents and any other topical medicine including those available without a prescription as they may interfere with each other.
PROPER USE OF THIS MEDICATION
Usual dose:
Adults and children 12 years and older: At bedtime, wash your face gently with mild soap and warm water and pat skin dry with a towel. Squeeze a pea-size amount of medication onto the fingertip. Cover the affected area lightly with BIACNA by first dabbing it on your forehead, chin, and both cheeks, then spreading it evenly over your whole face. Smooth gently into the skin.
To help you use the medication correctly, keep these simple instructions in mind. Apply BIACNA once daily before bedtime. Do not use more than a pea-size amount of BIACNA as suggested by your physician or apply the product more frequently than instructed. Too much medication may irritate the skin, waste medication and will not give faster or better results.
Keep the medication away from the corners of the nose, mouth, eyes, and open wounds. Spread it away from these areas when applying. In case of accidental contact with these sensitive areas, rinse with plenty of lukewarm water.
Missed Dose:
If you forget to use BIACNA at bedtime, you should wait for the next dose at the usual time. You should not double the dose to make up the forgotten dose.
SIDE EFFECTS AND WHAT TO DO ABOUT THEM
You may experience common side effects such as headache, sunburn, and upper respiratory tract infections.
You may develop a temporary skin colour change (lighter or darker) due to BIACNA .
Stop use and immediately contact your doctor if:
- You develop skin irritation due to dryness, redness, peeling, burning or stinging from BIACNA and your skin becomes very red, swollen, blistered or crusted.
- You develop serious side effects such as diarrhea, bloody diarrhea, and colitis (inflamed colon), which have been reported with the use of topical clindamycin.
HOW TO STORE IT
- Store at 15–30°C.
- Protect from light.
- Keep the tube tightly closed
- Keep out of reach and sight of children. If you have taken too much BIACNA , particularly by accidental oral ingestion, contact your doctor, hospital emergency department or your regional Poison Control Centre, even if there are no symptoms.
General Information about BIACNA
Do not use BIACNA for a condition for which it was not prescribed. Do not give BIACNA to other people, even if they have the same symptoms you have. It may harm them.
This leaflet summarizes the most important information about BIACNA . If you would like more information, talk with your doctor. You can also ask your pharmacist or doctor for information about BIACNA that is written for healthcare professionals.
MORE INFORMATION
If you want more information about Biacna:
- 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); by contacting the sponsor: Bausch Health, Canada Inc., 2150 St-Elzéar Blvd. West, Laval, (Quebec) H7L 4A8; or by calling 1- 800-361-4261.
Last revised: October 2, 2020
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.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.