Patient Medication Information: uses, side effects, how to take - Nerisone Oily Cream
ABOUT THIS MEDICATION
What the medication is used for:
NERISONE® is used to help relieve the redness, swelling, and itching of certain skin problems for up to 4 weeks.
What it does:
NERISONE® contains diflucortolone valerate 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 NERISONE® if you are allergic to diflucortolone, other corticosteroids, or to any other ingredients in NERISONE®.
Do not apply NERISONE® to the areas of the skin that:
- have bacterial, fungal, parasitic, viral skin infections (e.g. cold sores, chicken pox), tuberculosis or syphilis skin lesions, or a skin reaction following a recent vaccination
- have acne
- have 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 or pus-filled bumps)
- have rashes around the mouth
- have itchy skin which is not inflamed
- have itchy skin around the anus or genitals (penis and vagina)
Do not apply in or near the eye.
Do not use on children under 1 year of age.
If you think any of these apply to you, don’t use NERISONE® until you have checked with your doctor or pharmacist.
What the medicinal ingredient is:
Diflucortolone valerate
What the nonmedicinal ingredients are:
aluminum stearates, beeswax (PCPC), cera alba (EU); dicocoyl pentaerythrityl distearyl citrate, hydrogenated palm glycerides citrate, mineral oil, purified water, sorbitan sesquioleate, tocopherol, white petrolatum and white wax.
What dosage forms it comes in:
oily cream, available in 30 g and 60 g tubes
WARNINGS AND PRECAUTIONS
NERISONE® should not be applied over large areas unless advised by a physician. Apply only enough to cover the affected areas.
Only use NERISONE® for as long as your doctor recommends.
Before using NERISONE®, talk to your doctor or pharmacist if:
you are pregnant or planning to become pregnant.
- you are breastfeeding. If you do use NERISONE® when breastfeeding, do not use on your breast area to ensure that the baby does not accidentally get it in their mouth.
- you have used corticosteroids before
- you have sores in the leg as a result of poor circulation (such as stasis dermatitis).
- you have problems with your kidney or liver. You may need to use a smaller amount of NERISONE® or use it less often.
Other warnings you should know about:
- NERISONE® should be used with caution on the face, or in skin fold areas, such as the groin or the armpit.
- Avoid applying NERISONE® in or near the eye, or other mucous membranes. In case of contact, wash with water. Absorption may cause increased pressure in the eye (glaucoma), or a cloudy lens in the eye (cataracts).
- Do not use airtight dressings such as a bandage, or cover the treated areas tightly.
- If you are over 65 years of age, use NERISONE® with caution. You may need to use a smaller amount of NERISONE® or use it less often
- The skin of children absorbs larger amounts of topical corticosteroids than the skin of adults; and therefore, children may be more likely to develop side effects.
- Topical corticosteroids may increase the risk of an allergic reaction or an infection if applied near ulcers on the legs.
INTERACTIONS WITH THIS MEDICATION
Some medicines may affect how NERISONE® 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.
PROPER USE OF THIS MEDICATION
NERISONE® is for use on the skin only.
Usual dose:
Use NERISONE® once or twice a day for a maximum of 4 weeks. 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. If your condition does not improve within 2-4 weeks of treatment, speak to your doctor or pharmacist.
If you use NERISONE® regularly, make sure you talk to your doctor before you stop using it. It is important to not stop using NERISONE® suddenly or your skin condition could flare up again and you could develop steroid withdrawal symptoms.
How to Apply NERISONE®:
- 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.
- Your doctor may recommend using a moisturizer as maintenance therapy.If you are also using a moisturizer, allow time for NERISONE® to be absorbed after each application before applying the moisturizer.
NERISONE® should be used for the minimum amount of time required to achieve the desired results, but always use NERISONE® exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
Overdose:
| 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. |
Missed Dose:
If you forget to use NERISONE®, 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 NERISONE® to make up for missed doses.
SIDE EFFECTS AND WHAT TO DO ABOUT THEM
Like all medicines NERISONE® can have side effects although not everybody gets them.
The following side effects have been reported in patients using topical corticosteroids.
If any of the side effects listed becomes severe or troublesome, tell your doctor or pharmacist.
Common side effects
- itchy skin
- skin burning or pain
Very rare side effects
Use of a topical corticosteroid for a long period of time, over a large body surface, or use under an airtight dressing, may cause the following symptoms:
- skin: thinning, softening, wrinkling, dryness, changes to the colour, the appearance of blood vessels under the surface of your skin, pimples, raised bumps with pus under the skin, allergic contact dermatitis/dermatitis, irritation or pain at the site of application
- increased body hair, hair loss/lack of hair growth/damaged looking hair
In children also look out for the following symptoms:
- delayed weight gain
- slow growth
| 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 | ||
| Allergic reactions: rash, hives, swelling of the skin, chills, fever, muscle aches or pains or flu-like symptoms occurring with or before a skin rash. | ✓ | ||
| No improvement or worsening of condition | ✓ | ||
| 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 | ||
|---|---|---|---|
| Skin infection | ✓ | ||
| Cushing's syndrome: weight gain, moon face / rounding of the face and obesity. | |||
| Hyperglycemia (increased blood sugar): frequent urination, thirst and hunger. | ✓ | ||
| Glucosuria (sugar in urine): excessive or sweet smelling urine. | ✓ | ||
| Hypertension (high blood pressure): headaches, vision disorders, nausea and vomiting. | ✓ | ||
| Osteoporosis: weakening of the bones, pain, decreased height, bones prone to fracture easily | ✓ | ||
| Glaucoma or cataracts: blurred vision, increased pressure in your eyes, eye pain. | ✓ | ||
| Low cortisol in your blood or steroid withdrawal: dizziness, weakness, fatigue, weight loss, nausea, diarrhea, and abdominal pain | ✓ | ||
This is not a complete list of side effects. For any unexpected effects while taking NERISONE® 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: --------------------------------------------------------------------------
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. |
MORE INFORMATION
This document plus the full product monograph, prepared for health professionals can be found at:
http://www.gsk.ca or by contacting the sponsor,
GlaxoSmithKline Inc.
7333 Mississauga Road
Mississauga, Ontario
L5N 6L4
1-800-387-7374
Last revised: January 26, 2017
© 2017 GSK Inc. All Rights Reserved
NERISONE is a trademark of Bayer Schering Pharma Aktiengesellschaft, used under license by GSK Inc.