Details for: ACZONE
Company: BAUSCH HEALTH, CANADA INC.
| DIN | DIN name | Active Ingredient(s) | Strength | Dosage Form | Route of Administration |
|---|---|---|---|---|---|
| 02281074 | ACZONE | DAPSONE | 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
ACZONE is a topical prescription medicine used to help treat acne in people 12 years of age and older. ACZONE can be used to help treat acne on the face, chest, back, and shoulders.
ACZONE contains an antibacterial ingredient called dapsone, and it should be used exactly as directed by your healthcare professional. Misuse or overuse of ACZONE could lead to the growth of bacteria that will not be killed by dapsone. This means that ACZONE or other medicines that contain dapsone may not work for you in the future. Do not share your medicine.
What it does
It is not known exactly how ACZONE works.
When it should not be used
Do not use ACZONE if you are allergic to dapsone (a drug that contains sulfa) or any of the non-medicinal ingredients in ACZONE. See the section 'What the non-medicinal ingredients are', below.
What the medicinal ingredient is
The active ingredient in ACZONE is dapsone.
What the non-medicinal ingredients are
Carbomer 980, Diethylene Glycol Monoethyl Ether (DGME), Methylparaben, Sodium Hydroxide, and Purified Water.
What dosage form it comes in
ACZONE is a topical gel of 5% dapsone w/w in an aqueous base.
Warnings and precautions
Serious Warnings and Precautions
BEFORE you use ACZONE talk to your doctor or pharmacist if you:
- are pregnant or planning to be pregnant. Your doctor will decide with you whether the benefit justifies the risk to the foetus.
- are breast feeding or planning to breast feed. Dapsone is excreted in human breast milk. Your doctor will decide with you whether you should continue breastfeeding or discontinue ACZONE.
- are less than 12 years of age.
- are using other products including cosmetics or medicines applied to the skin.
- have glucose-6-phosphate dehydrogenese (G6PD) deficiency.
- have history of slate grey or blueish discoloration of skin, mucous membranes, lips and nail beds due to lack of sufficient oxygen in the blood (methemoglobinemia).
It is important to let your doctor know about all the medicines you are taking including prescription and non-prescription medicines, vitamins and herbal supplements.
When using ACZONE avoid contact with, eyes mouth and mucous membranes. If you experience excessive redness or peeling contact your doctor.
Interactions with this medication
Use of benzoyl peroxide together with ACZONE at the same time may cause your skin and facial hair to temporarily turn yellow or orange at the site of application. The use of any other topical medications, including benzoyl peroxide at the same time as ACZONE should be discussed with your doctor or pharmacist.
Proper use of this medication
Usual dose - Adults and children over 12 years of age:
Be sure to follow your doctor’s instructions on how to use ACZONE.
Use ACZONE once in the morning and once in the evening or as your doctor has prescribed.
A pea-sized amount of ACZONE will usually be enough to cover the cheeks, chin, and forehead.
To use ACZONE correctly follow these steps:
- Wash the areas of your skin where you will apply ACZONE with a mild non-medicated soap. Gently pat your skin dry with a clean towel.
- Apply a thin layer of ACZONE to the areas of your skin that have acne.
- Avoid contact with eyes, mouth, and mucous membranes. In case of accidental contact rinse with large amounts of water.
- Rub the medicine in gently and completely.
- Make sure to put the cap back on the tube and close it tightly.
- Wash your hands after applying ACZONE.
- Do not expect to see an immediate improvement in your acne but be patient and continue to use your medication as directed.
- ACZONE has been prescribed by your doctor for you. Do not allow others to use this medication.
Overdose
ACZONE is not for oral use. If oral ingestion occurs, seek medical advice or consult a poison control centre.
Missed Dose
If an application of ACZONE is missed, it should be applied as soon as possible. This will help to keep a constant amount of medication in the skin. However, if it is almost time for the next application, skip the missed application and go back to the regular schedule. Do not double applications.
Side effects and what to do about them
Like all medicines, ACZONE can cause some side effects, including dryness, redness, oiliness, peeling, rash, hives, and swelling of the face including lips and eyes. These side effects are usually mild. Call your doctor if you have any side effects that do not go away or bother you.
The active ingredient of ACZONE (called dapsone) has been associated with blood cell abnormalities, usually when taken orally as a pill. Applying ACZONE on the skin is not expected to put enough dapsone in the blood to cause these abnormalities, and they have not been seen in ACZONE clinical trials. Nonetheless, methemoglobinemia has been reported during use of ACZONE Gel, 5%.
You are advised to be alert for the symptoms suggestive of these conditions (see "Anemia", “Methemoglobinemia “and "Low white blood cell" symptoms below) and follow the instructions indicated if they happen to you.
| Symptom / effect | Talk to your healthcare professional Only if severe | Talk to your healthcare professional In all cases | Stop taking drug and get immediate medical help |
|---|---|---|---|
| Uncommon | |||
| Pancreatitis symptoms (pancreas inflammation) | |||
| persistent low-grade fever | ✔ | ||
| nausea | ✔ | ||
| vomiting | ✔ | ||
| persistent abdominal pain | ✔ | ||
| Anemia symptoms | |||
| rapid heart beat | ✔ | ||
| breathlessness | ✔ | ||
| loss of stamina | ✔ | ||
| red-brown urine | ✔ | ||
| persistent fatigue | ✔ | ||
| acute back pain | ✔ | ||
| jaundice (yellow eyes or skin) | ✔ | ||
| Uncommon | |||
| Methemoglobinemia symptoms (high levels of methemoglobin in the blood) | |||
| headache | ✔ | ||
| fatigue | ✔ | ||
| dizziness | ✔ | ||
| slate grey or blueish coloring of the skin, especially in: buccal mucous membranes, lips and nail beds | ✔ | ||
| breathlessness | ✔ | ||
| Low white blood cell symptoms | |||
| persistent lethargy | ✔ | ||
| weakness | ✔ | ||
| sore throat | ✔ | ||
| persistent fever | ✔ | ||
| other symptoms of infections | ✔ | ||
This is not a complete list of side effects. For any unexpected effects while taking ACZONE, contact your doctor or pharmacist.
How to store
Store at controlled room temperature, 15-30°C. Protect from freezing. Keep out of reach of children and pets.
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 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; by contacting the sponsor: Bausch Health, Canada Inc., 2150 St-Elzéar Blvd. West, Laval, (Quebec) H7L 4A8; or by calling 1-800-361-4261.
This leaflet was prepared by Bausch Health, Canada Inc.
Last revised: June 3, 2020