Cream, USP 0.1% w/w
Ointment, USP 0.1% w/w
Lotion 0.1% w/w
This leaflet is part III of a three-part “Product Monograph” and is designed specifically for Consumers. This leaflet is a summary and will not tell you everything about CYCLOCORT®. Contact your doctor or pharmacist if you have any questions about the drug.
ABOUT THIS MEDICATION
What the medication is used for:
CYCLOCORT® is used to help relieve the redness and itchiness of certain skin problems.
What it does:
CYCLOCORT® contains amcinonide which belongs to a group of medicines called steroids. Steroids help to reduce redness, swelling and irritation of the skin.
When it should not be used:
Do not use CYCLOCORT® if you are allergic to amcinonide, other corticosteroids, or to any other ingredients in CYCLOCORT® (see What the nonmedicinal ingredients are).
Do not apply CYCLOCORT® on the areas of the skin that have:
- bacterial, fungal, parasitic, viral skin infections (e.g. herpes simplex, chicken pox), tuberculosis or syphilis skin lesions, or a skin reaction following a recent vaccination.
- acne, rosacea (a facial skin condition where the nose, cheeks, chin, forehead or entire face are unusually red, with or without tiny visible blood vessels, bumps (papules) or pus-filled bumps (pustules)), rashes around the mouth, itchy skin which is not inflamed, itchy skin around the anus or genitals.
Do not apply in or near the eye.
If you think any of these apply to you, don’t use CYCLOCORT® until you have checked with your doctor or pharmacist.
What the medicinal ingredient is:
What the nonmedicinal ingredients are:
The nonmedicinal ingredients of CYCLOCORT® Cream are benzyl alcohol, emulsifying wax, glycerin, isopropyl palmitate, lactic acid, purified water, and sorbitol solution.
The nonmedicinal ingredients of CYCLOCORT®Ointment are benzyl alcohol, emulsifying wax, TENOX II (butylated hydroxyanisole, citric acid, propylene glycol, and propyl gallate), and white petrolatum.
The nonmedicinal ingredients of CYCLOCORT® Lotion are benzyl alcohol, emulsifying wax, glycerin, isopropyl palmitate, lactic acid, purified water, and sorbitol solution.
What dosage forms it comes in:
CYCLOCORT® Cream and Ointment are available in 60 g tubes. CYCLOCORT® Lotion is available in 60 mL bottles.
WARNINGS AND PRECAUTIONS
Apply just enough CYCLOCORT® to cover the affected areas. CYCLOCORT® can get into the blood and cause side effects.
Always follow your doctor’s instructions.
Do NOT use CYCLOCORT® with occlusive dressings such as a bandage, or cover the treated areas tightly.
CYCLOCORT® is more likely to cause side effects when used:
- over large areas
- on sensitive areas such as the face, scalp, skin fold areas like the armpit and groin
- on broken skin
- for a long time
Inform any doctor you consult that you are using or you have previously used corticosteroids.
Before using CYCLOCORT®, talk to your doctor or pharmacist if:
- you are pregnant or planning to become pregnant.
- you are breastfeeding. It is not known if CYCLOCORT® will appear in breast milk. You should only use CYCLOCORT® while breastfeeding if you and your doctor decide that the benefits to the mother outweigh the risks to the baby. If you do use CYCLOCORT® when breastfeeding, do not use on your breast area to ensure that the baby does not accidentally get it in their mouth. If CYCLOCORT® is used on large areas of body, you should stop
- you have inflammatory skin diseases in the leg as a result of impaired circulation (such as stasis dermatitis).
- you have problems with your kidney or liver. You may need to use a smaller amount of CYCLOCORT® or use it less often.
- you have any skin disease around a leg ulcer; use of a topical corticosteroid may increase the risk of an allergic reaction or an infection around the ulcer.
While using CYCLOCORT®, talk to your doctor or pharmacist if:
- you develop any skin infection
- you have an allergic reaction
- you develop significant skin irritation
- you experience skin thinning or softening
- your condition worsens or does not improve
- you develop raised bumps with pus under the skin
CYCLOCORT® should be used with caution on the scalp, face or in skin fold areas, such as the groin or the armpit since these areas are more prone to skin thinning.
Avoid applying CYCLOCORT® in or near the eye, or other mucous membranes. In case of contact, wash with water. Absorption in the body may cause increased pressure in the eye (glaucoma), or a cloudy lens in the eye (cataracts).
Children absorb larger amounts of topical corticosteroids and therefore, may be more likely to develop side effects. CYCLOCORT® is not recommended for use in children under 18 years of age.
INTERACTIONS WITH THIS MEDICATION
It is NOT known whether CYCLOCORT® interacts with other medication. Some medicines may affect how CYCLOCORT® works, or make it more likely that you’ll have side effects. Examples of these medicines include:
- Ritonavir (for HIV)
- Itraconazole (for fungal infections)
Tell your doctor or pharmacist about all your other medications, including medicines that you bought without prescription and natural health products.
Treatment with CYCLOCORT® in the genital or anal area with the simultaneous use of latex products (e.g. condoms, diaphragms) can result in reduction in the reliability and therefore impairment of the safety of these products.
PROPER USE OF THIS MEDICATION
Use the minimum quantity of CYCLOCORT® for the shortest amount of time necessary to achieve the desired results. This is especially important if you are 65 years or older or have liver or kidney disease.
Check with your doctor or pharmacist if you are not sure.
CYCLOCORT® is for use on the skin only. It is NOT for use in the eyes or on other mucous membranes.
Apply a thin film to the affected areas once or twice a day. The number of times you use your medicine may be reduced as your skin gets better or your doctor may prescribe a weaker steroid for you to use instead.
Use for a maximum of:
- 5 days on the face, scalp, skin-fold areas like the armpit and groin.
- 2-3 weeks on the body. If your condition worsens or no improvement is seen within 2 weeks, contact your doctor.
It is important to not stop using CYCLOCORT® suddenly or your skin condition could flare up again.
Use CYCLOCORT® only as directed by your health care provider. Do NOT use more of it, do NOT use it more often and do NOT use it for a longer period of time than your health care provider recommended. Using too much CYCLOCORT® may increase your chances of unwanted and sometimes dangerous side effects.
This medication has been prescribed specifically for you. Do NOT give it to anyone else. It may harm them, even if their symptoms seem to be similar to yours.
How to Apply CYCLOCORT®:
- Apply a thin layer and gently rub in, using only enough to cover the entire affected area.
- Wash your hands after use unless treating the hands.
- Excess product should not be returned to the container, since it may cause contamination.
- If you are also using an emollient (moisturising) preparation allow time for CYCLOCORT® to be absorbed after each application before applying the emollient.
- Your doctor may recommend using a moisturizer as maintenance therapy.
- Do not use occlusive dressings such as a bandage, or cover the treated areas tightly.
CYCLOCORT® Lotion should be shaken before use.
In case of drug overdose, contact a health care practitioner, hospital emergency department or regional Poison Control Centre immediately, even if there are no symptoms.
If you forget to use CYCLOCORT®, apply it as soon as you remember. If it is close to the time scheduled to apply your next dose, wait and apply your next scheduled dose and then continue as before. Do not apply extra CYCLOCORT® to make up for missed doses.
SIDE EFFECTS AND WHAT TO DO ABOUT THEM
Like all medicines CYCLOCORT® can have side effects although not everybody gets them. Side effects will affect your skin and may have an effect on other parts of your body if a sufficient quantity of medicine is absorbed through the skin and enters your blood stream.
If your skin condition gets worse or your skin becomes swollen during treatment. You may be allergic to the medicine or need other treatment. Stop using CYCLOCORT® and tell your doctor as soon as possible.
The following side effects have been reported in patients using topical corticosteroids:
Common side effects
- itchy skin
- local skin burning or pain
Very rare side effects
Use of CYCLOCORT® for a long period of time, over a large body surface, or use under an airtight dressing, may cause the following symptoms:
- increased weight
- moon face/rounding of the face, obesity
- skin thinning (this may cause stretch marks), skin wrinkling, skin dryness, the appearance of blood vessels under the surface of your skin (telangiectasia), changes to the colour of your skin, skin infection
- increased body hair, hair loss/lack of hair growth/damaged looking hair
- allergic reaction, irritation, itching or pain at the site of application
- inflammation of hair follicles
- worsening of condition
- redness, rash or hives
- secondary infection
- allergic contact dermatitis/dermatitis (a type of
- upper abdominal pain
- prickly heat rash
- steroid withdrawal syndrome (symptoms may include weight loss, fatigue, nausea, diarrhea and abdominal pain)
If you have psoriasis you may get raised bumps with pus under the skin. This can happen very rarely during or after treatment and is known as pustular psoriasis.
Other symptoms that may only show in blood tests or when your doctor gives you a medical examination are: decreased hormone cortisol levels in your blood, increased sugar levels in your blood or urine, high blood pressure, cloudy lens in the eye (cataract), increased pressure in the eye (glaucoma), as well as weakening of the bones through gradual mineral loss (osteoporosis) and additional tests may be needed after your medical examination to confirm whether you have osteoporosis.
If any of the side effects listed becomes severe or troublesome, tell your doctor or pharmacist.
SERIOUS SIDE EFFECTS, HOW OFTEN THEY HAPPEN AND WHAT TO DO ABOUT THEM
|Symptom / effect
||Talk with your doctor or pharmacist
||Stop taking drug and call your doctor or pharmacist
|Only if severe
||In all cases
rash, hives, swelling of the skin, chills, fever, muscle aches or pains or flu-like symptoms occurring with or before a skin rash.
weight gain, moon face / rounding of the face and obesity.
(increased blood sugar): b
frequent urination, thirst and hunger.
(sugar in urine):
excessive or sweet smelling urine.
(high blood pressure):
headaches, vision disorders, nausea and vomiting.
weakening of the bones potentially leading to an increased risk of bone fracture.
|Glaucoma or cataracts:
blurred vision, increased pressure in your eyes, eye pain.
This is not a complete list of side effects. For any unexpected effects while taking CYCLOCORT®, contact your doctor or pharmacist.
HOW TO STORE IT
Store between 15° and 25°C. Do not freeze.
Keep out of the sight and reach of children.
REPORTING SUSPECTED SIDE EFFECTS
You can report any suspected adverse reactions associated with the use of health products to the Canada Vigilance Program by one of the following 3 ways:
- Report online at www.healthcanada.gc.ca/medeffect
- Call toll-free at 1-866-234-2345
- Complete a Canada Vigilance Reporting Form and:
- Fax toll-free to 1-866-678-6789, or
- Mail to: Canada Vigilance Program
Postal Locator 0701E
Postage paid labels, Canada Vigilance Reporting Form and the adverse reaction reporting guidelines are available on the MedEffect™ Canada Web site at www.healthcanada.gc.ca/medeffect.
NOTE: Should you require information related to the management of side effects, contact your health professional. The Canada Vigilance Program does not provide medical advice.
This document plus the full product monograph, prepared for health professionals can be found at: http://www.stiefel.ca or by contacting the sponsor,