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ELOCOM-CI_E

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El Khal
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0% found this document useful (0 votes)
10 views

ELOCOM-CI_E

Uploaded by

El Khal
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF, TXT or read online on Scribd
You are on page 1/ 3

IMPORTANT: PLEASE READ

PART III: CONSUMER INFORMATION Ointment:


• hexylene glycol
ELOCOM® • phosphoric acid
Mometasone Furoate Cream, BP • propylene glycol monostearate
Mometasone Furoate Ointment, Organon Standard • purified water
Mometasone Furoate Lotion • white soft paraffin
• white wax
This leaflet is part III of a three-part “Product Monograph”
published when ELOCOM® was approved for sale in Canada Lotion:
and is designed specifically for Consumers. This leaflet is a • hydroxypropylcellulose
summary and will not tell you everything about ELOCOM®. • isopropyl alcohol
Contact your doctor or pharmacist if you have any questions • phosphoric acid
about the drug. • propylene glycol
• purified water
ABOUT THIS MEDICATION • sodium phosphate monobasic

What the medication is used for: What dosage forms it comes in:
In adult, ELOCOM® Cream, Ointment and Lotion: • ELOCOM® Cream 0.1% is supplied in 15 g and 50 g tubes
• are used for the relief of swelling and itching caused by skin • ELOCOM® Ointment 0.1% is supplied in 50 g tubes
conditions like psoriasis and atopic dermatitis (a type of • ELOCOM® Lotion 0.1% is supplied in 75 mL plastic bottles
eczema). The lotion may be applied to scalp lesions.
• can be used for a maximum of: WARNINGS AND PRECAUTIONS
o 5 days on the face, scalp, skin-fold areas and groin
o 3 weeks on the body Apply just enough ELOCOM® to cover the areas. ELOCOM® can
get into the blood and cause side effects.
What it does:
ELOCOM®, has anti-inflammatory and vasoconstrictive actions Always follow your doctor’s instructions.
(makes blood vessels constrict) to help relieve swelling and itching.
The exact mechanism of action is not known. ELOCOM® is NOT recommended for use with airtight bandage.
When it should not be used: ELOCOM® is more likely to cause side effects when used:
Do not use ELOCOM® Cream, Ointment or Lotion if you: • over large areas
• are allergic to mometasone furoate, other corticosteroids, or to • on sensitive areas such as the face, scalp, skin fold areas like
any of the other ingredients of ELOCOM® the armpit and groin
• have bacterial, fungal, parasitic, viral skin infection (e.g. herpes • on broken skin
simplex, chickenpox), tuberculous or syphilis skin lesions, or • for a long time
skin reaction following a recent vaccination
• have acne Inform any doctor you consult that you are using or have previously
• have rosacea (a facial skin condition where the nose, cheeks, used corticosteroids.
chin, forehead or entire face are unusually red, with or without
tiny visible blood vessels, bumps (papules) or pus-filled bumps Before using ELOCOM®, talk to your doctor or pharmacist if:
(pustules) • you have any skin disease around a leg ulcer; use of a topical
• have itchy skin which is not inflamed corticosteroid may increase the risk of an allergic reaction or an
infection around the ulcer.
Do not apply ELOCOM® in the eyes. • you are currently treating an infection using an antifungal or
antibacterial agent.
What the medicinal ingredient is: • you have other inflammatory skin diseases in the leg as a result
Mometasone furoate of impaired circulation (such as stasis dermatitis).
• you are pregnant or planning to become pregnant.
What the important nonmedicinal ingredients are:
• you are breastfeeding. It is not known if ELOCOM® will appear
Cream:
in breast milk. You should only use ELOCOM® while
• aluminum starch octenylsuccinate
breastfeeding if you and your doctor decide if the benefits to the
• hexylene glycol mother outweigh the risks to the baby. If you do breastfeed
• hydrogenated soybean lecithin when using ELOCOM®, do not apply it on your breasts to ensure
• phosphoric acid the infant does not accidentally get it in their mouth.
• purified water • you have problems with your kidney and liver. You may need
• titanium dioxide to use a smaller amount of ELOCOM® or use it less often.
• white soft paraffin
• white wax

ELOCOM® (mometasone furoate) Page 30 of 32


IMPORTANT: PLEASE READ
While using ELOCOM®, talk to your doctor or pharmacist if: Use for a maximum of:
• you develop any skin infection • 5 days on the scalp, face, skin-fold areas and groin.
• you have an allergic reaction • 3 weeks on the body. If your condition worsens or no
• you develop significant skin irritation improvement is seen within 2 weeks, contact your doctor.
• you experience skin thinning or softening
• your condition worsens or does not improve Use ELOCOM® only as directed by your health care provider.
Do NOT use more of it, do NOT use it more often and do NOT
Care should be taken when applying ELOCOM® to the face or in use it for a longer period of time than your health care provider
skin-fold areas, such as the groin and the armpit since these areas recommended. Using too much ELOCOM® may increase your
are more prone to skin thinning. chances of unwanted and sometimes dangerous side effects.

Use with caution when applying ELOCOM® near the eyes. This medication has been prescribed specifically for you. Do
NOT give it to anyone else. It may harm them, even if their
Children absorb larger amounts of topical corticosteroids and symptoms seem to be similar to yours.
therefore, may be more likely to develop side effects. ELOCOM®
is not recommended for use in children under 18 years of age. Overdose:

Do NOT cover the affected skin or scalp areas with airtight In case of drug overdose, contact a health care practitioner, hospital
bandages. emergency department or regional Poison Control Centre
immediately, even if there are no symptoms.
INTERACTIONS WITH THIS MEDICATION
Missed dose:
If you forget to use ELOCOM®, apply it as soon as you remember.
It is NOT known whether ELOCOM® interacts with other If it is close to the time scheduled to apply your next dose, wait and
medication. Some medicines may affect how ELOCOM® works apply your next scheduled dose and then continue as before. Do not
and may make it more likely that you will have side effects. Some apply extra ELOCOM® to make up for missed doses.
of these medicines may include:
 Ritonavir (for HIV).
 Itraconazole (for fungal infections). SIDE EFFECTS AND WHAT TO DO ABOUT THEM

Tell your doctor or pharmacist about all your other medications, Side effects may include:
including medicines that you bought without a prescription and • your condition worsens or does not improve
natural health products. • skin sensations such as:
- burning, tingling, or stinging
PROPER USE OF THIS MEDICATION - strong itching sensation
- softening and thinning of the skin
- inflammation of hair follicles
Use the minimum quantity of ELOCOM® for the shortest amount
- acne-like reactions
of time necessary to achieve the desired results. This is especially
important if you are 65 years or older or have liver or kidney
Very rarely the following may occur:
disease.
• aggravation of the disease
• dry skin, abnormal redness, appearance of boils, aggravated
ELOCOM® is for use on the skin and scalp only. It is NOT for
use in the eyes or other mucous membranes. allergy, dermatitis (swelling of the skin), increased lesion size
• nausea
Usual Adult Dose:
ELOCOM® Cream or Ointment Additionally, the following side effects have been found to occur
Apply a thin film to the affected skin areas once a day or as directed with the use of other topical corticosteroids:
by your doctor. • infection or signs of infection, irritation
• unwanted hair, lightening of skin color
Use for a maximum of: • dermatitis (swelling of the skin) near or around the mouth,
• 5 days on the face, skin-fold areas and groin. allergic contact dermatitis
• 3 weeks on the body. If your condition worsens or no • stretch marks
improvement is seen within 2 weeks, contact your doctor. • heat rash

ELOCOM® Lotion ELOCOM® can cause abnormal blood and urine test results. Your
Apply a few drops to the affected skin areas (which may include doctor will decide when to perform tests and will interpret the results.
scalp sites) once a day, or as directed by your doctor. Massage
gently and thoroughly until the medication disappears.

ELOCOM® (mometasone furoate) Page 31 of 32


IMPORTANT: PLEASE READ
SERIOUS SIDE EFFECTS, HOW OFTEN THEY HAPPEN HOW TO STORE IT
AND WHAT TO DO ABOUT THEM
Symptom / effect Talk with your Stop taking Store between 15° and 30°C
doctor or drug and call
pharmacist your doctor or Do NOT use if past expiry date on the label.
pharmacist
Only if In all Keep out of reach of children
severe cases
Allergic Reporting Side Effects
reaction: chills,
fever, muscle
You can help improve the safe use of health products for
aches or pains or Canadians by reporting serious and unexpected side effects to
Uncommon other flu-like  Health Canada. Your report may help to identify new side
symptoms effects and change the product safety information.
occurring with or
before a skin rash
3 ways to report:
Cushing's
• Online at MedEffect;
Syndrome: • By calling 1-866-234-2345 (toll-free);
Rare
weight gain,
 • By completing a Consumer Side Effect Reporting
moon face /
rounding of the
Form and sending it by:
face and obesity - Fax to 1-866-678-6789 (toll-free), or
Steroid - Mail to: Canada Vigilance Program
Withdrawal Health Canada, Postal Locator 0701E
Syndrome: Ottawa, ON
weight loss,  K1A 0K9
fatigue, nausea,
diarrhea and Postage paid labels and the Consumer Side
abdominal pain Effect Reporting Form are available at
Hyperglycemia MedEffect.
(increased blood
sugar): frequent  NOTE: Contact your health professional if you need
urination, thirst
and hunger information about how to manage your side effects. The
Glucosuria Canada Vigilance Program does not provide medical advice.
(sugar in urine):
excessive or 
sweet smelling
urine MORE INFORMATION
Hypertension
(high blood
Unknown If you want more information about ELOCOM®:
pressure):

headaches, vision • Talk to your healthcare professional
disorders, nausea
• Find the full product monograph that is prepared for
and vomiting
healthcare professionals and includes this Consumer
Osteoporosis:
weakening of the Information by visiting the Health Canada website or
bones potentially Organon Canada website www.organon.ca or by calling
leading to an  Organon Canada at 1-844-820-5468.
increased risk of
bone fracture
This leaflet was prepared by Organon Canada Inc.
Glaucoma,
Cataracts, or
central serous Last revised: April 30, 2021
chorioretinopathy
(CSCR): blurred  ®
N.V. Organon. Used under license.
vision, increased
pressure in your © 2021 Organon Canada Inc. All rights reserved.
eyes, eye pain,
distorted vision
This is not a complete list of side effects. For any unexpected effects
while taking ELOCOM® cream, ointment or lotion contact your
doctor or pharmacist.

ELOCOM® (mometasone furoate) Page 32 of 32

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