Patient Medication Information: uses, side effects, how to take - Synalar (Bausch Health, Canada, 0.025 %)
What is SYNALAR used for?
- SYNALAR is used to treat acute and chronic skin eruptions.
How does SYNALAR work?
SYNALAR (fluocinolone acetonide) is a topical corticosteroid, which reduces inflammation, itching and possesses blood vessel constriction properties.
What are the ingredients in SYNALAR?
Medicinal ingredients:
Ointment 0.025% w/w: Fluocinolone Acetonide.
Non-medicinal ingredients:
Ointment 0.025% w/w:White Petrolium.
SYNALAR comes in the following dosage forms:
Ointment: 0.025% w/w
Do not use SYNALAR if you have:
- untreated bacterial, tubercular and fungal lesions of the skin
- viral lesions of the skin (including herpes simplex, vaccinia and varicella)
- Have, or have ever had, an unusual or allergic reaction to this drug or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container.
To help avoid side effects and ensure proper use, talk to your healthcare professional before you take SYNALAR. Talk about any health conditions or problems you may have, including if you:
- have stasis dermatitis (inflammation, ulcers, and itchy skin on your lower legs)
- Other skin diseases caused by poor blood circulation.
Other warnings you should know about:
Avoid contact of the medicinal product with eyes.
It has not been determined if SYNALAR is safe for use during pregnancy or lactation. If you are pregnant or breastfeeding, talk to your healthcare profession. Your healthcare professional will determine if SYNALAR is right for you.
Do not apply SYNALAR in your eyes. Apply SYNALAR carefully on lesions close to your eyes. If you get any SYNALAR in your eyes, flush out your eyes with lots of water.
Using SYNALAR for a long time may cause thinning of the skin and tissues. Your healthcare professional will tell you exactly how long to use SYNALAR for.
If you have to use SYNALAR for a long time, your healthcare professional may stop your treatment for a short period. Your healthcare professional may also treat only one area of your body at a time. Your healthcare professional will tell you exactly how to use SYNALAR. Your healthcare professional will also tell you how long you should be using SYNALAR for.
If you do not see any improvements in your skin within in a few days to a week after using SYNALAR, talk to your healthcare professional. Your healthcare professional may stop your treatment with SYNALAR.
During the use of SYNALAR, you may develop other skin infections or an allergic reaction. If this happens, stop using SYNALAR and let your healthcare professional know.
Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.
How to take SYNALAR:
Do not use this medication if it looks cloudy or is leaking.
You should not cover the treated skin area with a bandage or other covering unless your healthcare professional tells you to.
Usual dose:
Apply a small amount of SYNALAR ointments 0.025% gently on the affected skin area. Apply SYNALAR 2 or 3 times daily, as needed.
Overdose:
| If you think you, or a person you are caring for, have taken too much SYNALAR, contact a healthcare professional, hospital emergency department, or regional poison control centre immediately, even if there are no symptoms. |
What are possible side effects from using SYNALAR?
The following adverse skin reactions have been reported with the use of topical steroids:
- rebound eczema
- contact dermatitis (red, itchy, skin rash)
- dryness
- burning itching
- local irritation
- striae (stretch marks that are red, pink or purple)
- skin atrophy (thinning of the skin)
- atrophy of subcutaneous tissues (thinning of the skin’s tissues)
- telangiectasia (spider veins)
- hypertrichosis change in pigmentation (excessive hair growth over the body)
- secondary infection
Serious Side effects and what to do about them
| Symptom / effect | Talk with your healthcare professional | Stop taking drug and get immediate medical help | |
| Only if severe | In all cases | ||
| Common | |||
Subcapsular cataracts (clouding of the normally clear lens of your eyes): blurred or decrease vision (difficulties in seeing clearly), increasing difficulty with vision at night, sensitivity to light and glare, need for brighter light for reading and other activities, seeing "halos" around lights | ✓ | ||
| Adrenal suppression (adrenal glands do not produce enough hormones): fatigue, muscle and joint pain, psychiatric symptoms (psychosis, depression, mania, memory impairment, mild to moderate organic brain syndrome), hypoglycemia (low blood sugar), hyponatremia (low levels of sodium), hypotension (low blood pressure), gastrointestinal complaints (nausea vomiting, abdominal pain, diarrhea, constipation) | ✓ | ||
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.
Storage:
Store at room temperature, 15°C - 30°C.
Do not use this medicine after the date shown on the container.
Keep out of the reach and sight of children.
If you want more information about SYNALAR:
- 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); can be found by contacting the sponsor, Bauschhealth, Canada inc. at 1-800-553-5340.
Last Revised: June 25, 2021
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.
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- 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.