Patient Medication Information: uses, side effects, how to take - Bryhali
What is BRYHALI used for?
BRYHALI is a prescription corticosteroid medicine for adult use. BRYHALI is used on the skin (topical) to relieve the redness, swelling and itching of the skin caused by certain skin conditions and to treat plaque psoriasis.
How does BRYHALI work?
It is not known exactly how BRYHALI works. It is believed that it affects certain proteins in the body to help reduce skin inflammation. Having less inflammation helps to relieve the redness, swelling and itching of the skin.
What are the ingredients in BRYHALI?
Medicinal ingredient: Halobetasol Propionate
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%.
BRYHALI does not include any fragrance, colorant or alcohol.
BRYHALI comes in the following dosage forms:
- Lotion, 0.01 % w/w
Do not use BRYHALI if:
- you are allergic to halobetasol propionate or any of the other ingredients found in BRYHALI.
- you are allergic to other corticosteroids.
- you have an untreated infection involving the skin from a parasite, bacteria, fungus, such as tuberculosis or syphilis.
- you have a viral disease of the skin, such as chicken pox or herpes.
To help avoid side effects and ensure proper use, talk to your healthcare professional before you use BRYHALI. Talk about any health conditions or problems you may have, including if you:
- have hormonal problems.
- have a condition for which you were previously or are currently taking other corticosteroid drugs. Use of more than one corticosteroid at the same time or close in time may increase your chance of developing adrenal gland problems.
- have other inflammatory skin diseases caused by poor circulation such as stasis dermatitis or chronic ulcers in the legs.
- have diabetes. BRYHALI can raise your blood sugar levels.
- have adrenal gland problems. BRYHALI can affect how your adrenal glands work.
- have liver problems. Liver problems may affect how your body breaks down BRYHALI. This may cause too much BRYHALI to build up in your body.
- use skin products that can dry or irritate your skin.
- have eye problems, such as cataracts and glaucoma. Talk to your doctor if you notice any change to your eyes or eyesight. Cataracts and glaucoma have been reported in patients using topical corticosteroids. Do NOT use BRYHALI in or near the eyes. Take care not to get BRYHALI in your eyes. If you get BRYHALI in your eye, flush it with cold water right away.
- have a skin infection. You may need medicine to treat the skin infection before using BRYHALI. If you develop an infection while using BRYHALI, tell your healthcare professional right away. Your doctor may tell you to stop using BRYHALI until the infection is treated.
are pregnant or if you think you might be pregnant. It is not known if BRYHALI will harm your unborn baby. You should not use BRYHALI if you are pregnant. Avoid becoming pregnant while using BRYHALI. If you become pregnant while using BRYHALI, tell your doctor right away.
- are breastfeeding or plan to breastfeed. It is not known if BRYHALI passes into your breast milk. Talk to your healthcare professional about the best way to feed your baby while you are using BRYHALI. You and your doctor should decide if the benefits or breastfeeding outweigh any possible harm to your baby. If you use BRYHALI and breastfeed, do not apply BRYHALI to your nipple or areola (dark part around nipple) to avoid getting BRYHALI into your baby’s mouth.
- are older than 65 years.
Other warnings you should know about:
- Covering the treated area can increase the amount of medicine absorbed through your skin. This may increase your chance of developing adrenal gland problems. You should not cover the treated skin area with a bandage or other covering unless your healthcare professional tells you to. Using BRYHALI for long time, over large areas of skin or on broken skin can also increase the amount of medicine absorbed through your skin.
- Using BRYHALI for a long time may cause thinning of the skin. If you notice your skin thinning, speak to your healthcare professional.
- It is not known if BRYHALI affects your fertility. Talk to your doctor if this is a concern for you.
- Tell your healthcare professional if your skin is not healing or worsens.
- BRYHALI is NOT for use in patients under 18 years of age. Children and adolescents can absorb larger amounts of this medicine through their skin and are more likely to have serious side effects.
Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.
Especially tell your healthcare professional if you have or are currently taking or using any other corticosteroid medicines or containing products.
The following may interact with BRYHALI:
- There are no known interactions with BRYHALI.
How to use BRYHALI:
- Use this medicine exactly as directed by your healthcare professional.
- Check that the pharmacist has provided you BRYHALI as prescribed by your doctor.
- BRYHALI is for external use only.
- Be sure to apply BRYHALI on dry skin.
- If you take a bath or shower, make sure your skin is dry before applying it.
- Do NOT apply it to normal skin areas or broken skin such as ulcers, open sores, wounds.
- Do NOT use or get BRYHALI in or near your eyes, nose, mouth and other mucous membranes. If you get BRYHALI in your eye or any of these areas, flush it with cold water.
- Do NOT use BRYHALI on your face, scalp, groin or underarms (armpits).
- You should NOT apply a bandage or wrap your skin after applying BRYHALI unless your healthcare professional tells you to.
- Wash your hands after using BRYHALI, unless your hands are being treated.
Usual dose:
- Apply a thin layer of the lotion to the affected skin, once a day. Rub in gently. Once your skin is better, stop using BRYHALI. If your skin worsens after you stop BRYHALI, talk with your doctor.
- You should NOT use more than 50 g of BRYHALI in 1 week.
- Talk to your doctor if your skin does not improve after 8 weeks of use.
- You should NOT use BRYHALI for longer than 8 weeks.
Overdose:
| If you think you, or a person you are caring for, have taken too much BRYHALI, contact a healthcare professional, hospital emergency department, or regional poison control centre immediately, even if there are no symptoms. |
|---|
Missed Dose:
If you missed a dose of this medication, you do not need to make up the missed dose. Skip the missed dose and continue with your next scheduled dose. Do not use extra medicine to make up for the missed dose.
What are possible side effects from using BRYHALI?
These are not all the possible side effects you may feel when taking BRYHALI. If you experience any side effects not listed here, contact your healthcare professional.
Side effects may include:
- red, sore, itchy, blisters or oozing
- itching of the skin
- redness, rash, tears or scrapes
- heat rash
- skin rash around the mouth
- application site pain or burning/stinging sensation
- swelling of the hair follicles
- stretch marks
- excessive hair growth over the body
- acne
- change in skin pigmentation
- spider veins
- thick and leathery skin
- skin dryness and flaking
- cough
- joint pain
- softening and breaking down of skin due to moisture
- tingling or prickling skin sensation
BRYHALI can cause abnormal blood and urine test results. Your doctor will decide when to perform blood and urine tests. He/she may monitor how your liver is working and levels of your blood sugar and hormones. He/she will interpret the results.
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 | |||
| Dermatitis: skin rash or sores | X | ||
| Skin atrophy: thinning of the skin | X | ||
| Skin Irritation at the application site: red, sore or peeling skin; burning/stinging sensation; severe itching and/or dryness | X | ||
| COMMON | |||
| Allergic reactions: rash, hives, swelling of the skin | X | ||
| Cushing's syndrome (excess cortisol secretion): rounded “moon” face, weight gain, pink or purple stretch marks (striae) on the skin, fragile skin that bruises easily, slow healing of cuts, severe fatigue, muscle weakness, headache | X | ||
| Glucocorticosteroid insufficiency (low levels of plasma cortisol): Worsening fatigue and muscle weakness, loss of appetite, weight loss, nausea, vomiting, and diarrhea | X | ||
| Glucosura (excretion of glucose into the urine): feel extremely thirsty or dehydrated feel extremely hungry urinate more than usual urinate accidentally, unexplained weight | X | ||
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 | ||
| loss fatigue trouble seeing slow-healing cuts, sores, or other injuries skin darkening in the folds of your neck, armpits, or other areas | |||
| Hyperglycemia (excess of glucose in the bloodstream): frequent urination, increased thirst, blurred vision, fatigue, headache, fruity-smelling breath, nausea and vomiting, shortness of breath, dry mouth, weakness, confusion, coma and abdominal pain | X | ||
| UNCOMMON | |||
| Cataracts (clouding of the lens of the eye): clouded or blurred vision, double vision, difficulty in seeing during the night, sensitivity to light and glare, need for brighter than normal, light to read or see objects, seeing halo around lights, seeing objects in faded or yellow color, eye pain, headache due to changes in vision | X | ||
| Erythema: redness of the skin or mucous membrane | X | ||
| Gastroenteritis (stomach flu): diarrhea, vomiting stomach pain, cramping, fever, nausea, and headaches | X | ||
| Glaucoma (increased pressure in eye): loss of peripheral or side vision, seeing halos around lights, vision loss, redness in the eye, eye that looks hazy, eye pain, narrowed vision | X | ||
| Hypertension (high blood pressure) | X | ||
| Leukoderma: white patches on the skin | X | ||
| Upper Respiratory Infection (acute infection of the upper | X | ||
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 | |
| respiratory tract, including the nose, sinuses, pharynx, or larynx): nasal obstruction, sore throat, tonsillitis, pharyngitis, laryngitis, sinusitis, otitis media, and the common cold | ||
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:
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 to 30°C). Protect from freezing.
- For use up to 8 weeks after opening.
- Keep out of reach and sight of children.
If you want more information about BRYHALI:
- 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); the manufacturer’s website www.bauschhealth.ca; or by calling 1-800-361-4261.
Bausch Health, Canada Inc.
2150 St. Elzéar Blvd. West
Laval (Quebec) H7L 4A8
www.bauschhealth.ca