Patient Medication Information: uses, side effects, how to take - Arazlo
What is ARAZLO used for?
ARAZLO is used on the skin to treat people 10 years of age and older with acne vulgaris (acne). It is recommended that for children (10 to less than 12 years of age), ARAZLO should be used on the face only.
- Acne vulgaris is a skin condition that begins with the formation of a plug in the hair follicles. The plug is made up of surface skin, oil and bacteria. It is seen as a whitehead or blackhead (comedones). After the formation of the plug, oil in the gland escapes into the surrounding skin and causes inflammation which is seen as papules, pustules, or cysts.
How does ARAZLO work?
- ARAZLO works by helping the normal growth of the skin cells (keratinocytes) and reducing skin inflammation in acne. It is not known exactly how ARAZLO works.
- Your acne should improve as you continue to use ARAZLO.
What are the ingredients in ARAZLO?
Medicinal ingredients: Tazarotene.
Non-medicinal ingredients: Carbomer Copolymer Type B, Carbomer Homopolymer Type A, Diethyl Sebacate, Edetate Disodium Dihydrate, Light Mineral Oil, Methylparaben, Propylparaben, Purified Water, Sodium Hydroxide, Sorbitan Monooleate and Sorbitol Solution 70%.
ARAZLO does not include any fragrance, colorant or alcohol.
ARAZLO comes in the following dosage forms:
- Tazarotene lotion 0.045% w/w.
- It is available in a 45 g tube and 3 g tube samples.
Do not use ARAZLO if:
- you are allergic to other retinoic compounds, or any ingredient found in ARAZLO (see “What are the ingredients in ARAZLO”).
- you are pregnant or if you think you might be pregnant, or plan to become pregnant. ARAZLO may harm your unborn baby. (See “Other warnings you should know about”).
- you have a skin condition known as seborrheic dermatitis.
To help avoid side effects and ensure proper use, talk to your healthcare professional before you take ARAZLO. Talk about any health conditions or problems you may have, including if you:
- have eczema or any other skin problems (such as skin irritation or sunburnt skin).
Other warnings you should know about:
Skin care
- ARAZLO can increase your chances of having sunburns. If you are going to be exposed to sunlight, you should use sunscreen with a minimum SPF of 15 and wear clothes that can protect you from the sun. This includes sunlamps. If you already have a sunburn, wait until it has healed before using ARAZLO. Tell your doctor if you spend a lot of time in the sun, or if you sunburn easily.
- Avoid skin products (such as benzoyl peroxide) or cosmetics, including moisturizers, creams, lotions, or products that can dry out your skin.
Pregnancy and breastfeeding
If you are pregnant or if you think you might be pregnant, or plan to become pregnant, talk to your healthcare professional. ARAZLO may harm your unborn baby.
- If you are a woman who is able to get pregnant, you should use an appropriate birth control method while you are using ARAZLO.
- You should also start using ARAZLO when your period is normal to make sure you are not pregnant.
- Before you start using ARAZLO, you should confirm with your doctor that you are not pregnant. Your doctor may request a pregnancy test in the 2-week period before ARAZLO treatment.
- STOP using ARAZLO and tell your healthcare professional right away if you become pregnant.
- Tell your doctor if you are breastfeeding. You and your doctor should decide if the benefits of breastfeeding outweigh any possible harm to the baby. It is not known if it is safe to use ARAZLO and breastfeed. If you breastfeed, do not apply ARAZLO to your nipples or areola (dark part around the nipple). This will help decrease direct exposure of the baby to ARAZLO.
Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.
The following may interact with ARAZLO:
- Drugs that make your skin more sensitive to the sun such as thiazides (diuretics), antibiotics (tetracyclines, fluoroquinolones, phenothiazines or sulfonamides).
- Drugs that are applied to the skin or cosmetics that have a strong drying effect. This includes products with high amounts of alcohol, astringents, spices, lime peel, medicated soaps or shampoos, and permanent wave solution.
- Products containing benzoyl peroxide.
How to take ARAZLO:
- Use ARAZLO exactly as your doctor tells you to use it.
- ARAZLO is for skin use only. Do not use ARAZLO in your eyes, nose, mouth or other mucous membranes. If you get ARAZLO in your eye, flush it with cold water.
- Do no use ARAZLO on your scalp, armpits, or areas where two parts of your skin touch (skin folds, thighs, and groin). Do not use ARAZLO on normal skin that does not have acne.
- If you use other medicines on your skin such as benzoyl peroxide during treatment with ARAZLO, you should apply one in the morning and one in the evening to separate the application time.
- You may use a moisturizer after applying ARAZLO as needed. Make sure to allow skin to dry after you apply ARAZLO.
Usual dose:
Adults and children over 10 years of age
Apply a thin layer of ARAZLO to cover the affected areas once a day on clean and dry skin. For face application, dot onto the chin, cheeks, nose, and forehead, then gently rub over the entire face. It is recommended that for children (10 to less than 12 years of age), ARAZLO should be used on the face only.
Wash your hands after applying ARAZLO.
Do not use more than you need to cover the treated areas. Using too much ARAZLO may increase the risk of skin irritation.
If you develop skin irritations, your healthcare provider may tell you to:
- use a moisturizer;
- decrease the number of times you apply ARAZLO;
- completely stop treatment with ARAZLO.
Wind or cold weather may be more irritating to your skin during treatment with ARAZLO.
Overdose:
If you think you, or a person you are caring for, have taken too much ARAZLO, contact your healthcare professional, hospital emergency department or regional poison control centre immediately, even if there are no symptoms.
Missed Dose: Apply the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next dose. Do not use extra medicine to make up the missed dose.
What are possible side effects from using ARAZLO?
These are not all the possible side effects you may feel when taking ARAZLO. If you experience any side effects not listed here, contact your healthcare professional.
Side effects which may occur when using ARAZLO are primarily local effects on the skin. Side effects may happen when your skin is adapting to how ARAZLO works.
Side effects may include:
- Application site pain
- Dryness
- Peeling
- Redness
- Itching
- Sensitivity to sunlight
- Risk of sunburn
- Back and joint pain
- Painful menstrual periods (Dysmenorrhea)
Serious side effects and what to do about them
| Symptom / effect | Talk to your healthcare professional | Stop taking drug and get immediate medical help | |
|---|---|---|---|
| Only if severe | In all cases | ||
| VERY COMMON | |||
| Skin Irritation at the application site: red, sore or peeling skin; burning/stinging sensation; severe itching and/or dryness | √ | ||
Infections and infestations: Viral and upper respiratory tract infection (symptoms include headache, cough, sore throat, runny nose, nasal congestion, fever) | √ | ||
| COMMON | |||
| Hypersensitivity (allergic reaction): fever, skin rash, hives, itching, swelling, shortness of breath, wheezing, runny nose, itchy, watery eyes | √ | ||
| UNCOMMON | |||
| Eosinophilia (increased numbers of certain white blood cells): abdominal pain, rash, weight loss, wheezing | √ | ||
| Gastroenteritis (inflammation of the stomach and intestines): abdominal pain, diarrhea, nausea, vomiting | √ | ||
| Bacterial vaginosis (too much bacteria in the vagina): pain, itching, burning in the vagina, vaginal discharge | √ | ||
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.
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.
Storage:
Store at room temperature (15-30°C).
Keep out of reach and sight of children.
If you want more information about ARAZLO:
- 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.
Bausch Health, Canada Inc.
2150 St-Elzear Blvd., West
Laval, QC, H7L 4A8
www.bauschhealth.ca
For more information on how to use ARAZLO, please consult www.arazlo.ca.