Consumer Information for: TEVA-MOMETASONE

Consumer Information

Information about the product including what the product is used for, dosage, warnings, proper use and side effects. This summary will not tell you everything about the product. Contact your healthcare professional if you have any questions about the product.


What the medication is used for

In adult, TEVA-MOMETASONE:

  • is used for the relief of swelling and itching caused by skin conditions like psoriasis and atopic dermatitis (a type of eczema).
  • can be used for a maximum of:
    • 5 days on the face, scalp, skin-fold areas and groin
    • 3 weeks on the body

What it does

TEVA-MOMETASONE, has anti-inflammatory and vasoconstrictive actions (makes blood vessels constrict) to help relieve swelling and itching. The exact mechanism of action is not known.

When it should not be used

Do not use TEVA-MOMETASONE Ointment 0.1%

  • are allergic to mometasone furoate, other corticosteroids or to any of the ingredients of TEVA-MOMETASONE. (See section, What the important nonmedicinal ingredients are).
  • have bacterial, fungal, parasitic, viral skin infection (e.g. herpes simplex, chickenpox), tuberculous or syphilis skin lesions, or 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 (papules) or pus-filled bumps (pustules)
  • have itchy skin which is not inflamed

Do not apply TEVA-MOMETASONE in the eyes.

What the medicinal ingredient is

Mometasone furoate

What the non-medicinal ingredients are
  • hexylene glycol
  • propylene glycol monostearate
  • white petrolatum
  • white wax
What dosage form it comes in
  • TEVA-MOMETASONE Ointment 0.1% is supplied in 15 g and 50 g tubes
Warnings and precautions

Apply just enough TEVA-MOMETASONE to cover the areas. TEVA-MOMETASONE can get into the blood and cause side effects.

Always follow your doctor’s instructions.

TEVA-MOMETASONE is NOT recommended for use with airtight bandage.

TEVA-MOMETASONE 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 have previously used corticosteroids.

BEFORE using TEVA-MOMETASONE, talk to your doctor or pharmacist if:

  • 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.
  • you are currently treating an infection using an antifungal or antibacterial agent.
  • you have other inflammatory skin diseases in the leg as a result of impaired circulation (such as stasis dermatitis).
  • you are pregnant or planning to become pregnant.
  • you are breastfeeding. It is not known if TEVA-MOMETASONE will appear in breast milk. You should only use TEVA-MOMETASONE while breastfeeding if you and your doctor decide if the benefits to the mother outweigh the risks to the baby. If you do breastfeed when using TEVA-MOMETASONE, do not apply it on your breasts to ensure the infant does not accidentally get it in their mouth.
  • you have problems with your kidney and liver. You may need to use a smaller amount of TEVA-MOMETASONE or use it less often.

While using TEVA-MOMETASONE, 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

Care should be taken when applying TEVA-MOMETASONE to the face or in skin-fold areas, such as the groin and the armpit since these areas are more prone to skin thinning.

Use with caution when applying TEVA-MOMETASONE near the eyes.

Children absorb larger amounts of topical corticosteroids and therefore, may be more likely to develop side effects. TEVA-MOMETASONE is not recommended for use in children under 18 years of age.

Do NOT cover the affected skin or scalp areas with airtight bandages.

Interactions with this medication

It is NOT known whether TEVA-MOMETASONE interacts with other medication. Some medicines may affect how TEVA-MOMETASONE works and may make it more likely that you will have side effects. Some of these medicines may include:

  • Ritonavir (for HIV).
  • Itraconazole (for fungal infections).

Tell your doctor or pharmacist about all your other medications, including medicines that you bought without a prescription and natural health products.

Proper use of this medication

Use the minimum quantity of TEVA-MOMETASONE 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.

TEVA-MOMETASONE is for use on the skin and scalp only. It is NOT for use in the eyes or other mucous membranes.

Usual Adult dose

TEVA-MOMETASONE Ointment: Apply a thin film to the affected skin areas once daily or as directed by your doctor. Use for a maximum of:

  • 5 days on the face, skin-fold areas and groin.
  • 3 weeks on the body. If your condition worsens or no improvement is seen within 2 weeks, contact your doctor.

Use TEVA-MOMETASONE 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 TEVA-MOMETASONE 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.

Overdose

If you think you have taken too much TEVA-MOMETASONE, contact your 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 TEVA-MOMETASONE, 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 TEVA-MOMETASONE to make up for missed doses.

Side effects and what to do about them

Side effects may include:

  • your condition worsens or does not improve
  • skin sensations such as:
    • burning, tingling, or stinging
    • strong itching sensation
    • softening and thinning of the skin
    • inflammation of hair follicles
    • acne-like reactions

Very rarely the following may occur:

  • aggravation of the disease
  • dry skin, abnormal redness, appearance of boils, aggravated allergy, dermatitis (swelling of the skin), increased lesion size
  • nausea

Additionally, the following side effects have been found to occur with the use of other topical corticosteroids:

  • infection or signs of infection, irritation
  • unwanted hair, lightening of skin color
  • dermatitis (swelling of the skin) near or around the mouth, allergic contact dermatitis
  • stretch marks
  • heat rash

TEVA-MOMETASONE can cause abnormal blood and urine test results. Your doctor will decide when to perform tests and will interpret the results.

Serious side effects, how often they happen and what to do about them
Symptom / effect Talk with your doctor or pharmacist Only if severe Talk with your doctor or pharmacist In all cases Stop taking drug and get immediate medical help
Uncommon
Allergic reaction: chills, fever, muscle aches or pains or other flu-like symptoms occurring with or before a skin rash     ✔
Rare
Cushing's Syndrome: weight gain, moon face / rounding of the face and obesity     ✔
Unknown
Steroid Withdrawal Syndrome: weight loss, fatigue, nausea, diarrhea and abdominal pain   ✔  
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 potentially leading to an increased risk of bone fracture   ✔  
Glaucoma, Cataracts, or central serous chorioretinopathy (CSCR): blurred vision, increased pressure in your eyes, eye pain, distorted vision   ✔  

This is not a complete list of side effects. For any unexpected effects while taking TEVA-MOMETASONE ointment contact your doctor o r pharmacist.
How to store

Store between 15° and 30°C

Do NOT use if past expiry date on the label.

Keep out of reach and sight of children.

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.

More information

If you want more information about TEVA-MOMETASONE:

  • Talk to your healthcare professional
  • Find the full Product Monograph that is prepared for healthcare professionals and includes this Consumer Information by visiting the Health Canada website (health-products.canada.ca/dpd-bdpp/index-eng.jsp); the manufacturer’s website http://www.tevacanada.com; or by calling 1-800- 268-4127 ext. 3; or email druginfo@tevacanada.com.

This leaflet was prepared by:
Teva Canada Limited
30 Novopharm Court
Toronto, Ontario
M1B 2K9
Canada

www.tevacanada.com

Last revised: May 7, 2018

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