Consumer Information for: TARO-MOMETASONE OINTMENT

What the medication is used for

In adults Taro-Mometasone Cream, Ointment and Lotion:

are used for the relief of swelling and itching caused by skin conditions like psoriasis and atopic dermatitis (a type of eczema). The lotion may be applied to scalp lesions.
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

Taro-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 Taro-Mometasone Cream, Ointment or Lotion if you:

are allergic to mometasone furoate, to other corticosteroids or to any of the other ingredients of Taro-Mometasone
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 Taro-Mometasone in the eyes.

What the medicinal ingredient is

Mometasone furoate

What the non-medicinal ingredients are

Cream:

aluminum starch octenylsuccinate
cetereath-20
phosphoric acid
propylene glycol
propylene glycol stearate
purified water
stearyl alcohol
white petrolatum
white wax

Ointment:

hexylene glycol
propylene glycol stearate
white petrolatum
white wax

Lotion:

hydroxypropyl cellulose
isopropyl alcohol
phosphoric acid
propylene glycol
purified water
sodium phosphate monobasic

What dosage form it comes in

Taro-Mometasone Cream 0.1% (w/w) is supplied in 15 g and 50 g aluminum tubes, boxes of one.
Taro-Mometasone Ointment 0.1% (w/w) is supplied in 15 g and 50 g aluminum or laminate tubes, boxes of one.
Taro-Mometasone Lotion 0.1% (w/w) is supplied in 30 mL and 75 mL bottles

Warnings and precautions

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

Always follow your doctor’s instructions.

Taro-Mometasone is NOT recommended for use with airtight bandage.

Taro-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 Taro-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 Taro-Mometasone will appear in breast milk. You should only use Taro-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 Taro-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 Taro-Mometasone or use it less often.

While using Taro-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 Taro-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 Taro-Mometasone near the eyes.

Children absorb larger amounts of topical corticosteroids and therefore, may be more likely to develop side effects. Taro-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 Taro-Mometasone interacts with other medication. Some medicines may affect how Taro-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 Taro-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.

Taro-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:

Taro-Mometasone Cream/Ointment
Apply a thin film to the affected skin areas once a day 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.

Taro-Mometasone Lotion
Apply a few drops to the affected skin areas (which may include scalp sites) once a day, or as directed by your doctor; massage gently and thoroughly until the medication disappears.

Use for a maximum of:

5 days on the scalp, 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 Taro-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 Taro-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

In case of drug overdose, contact a healthcare practitioner, hospital emergency department or regional Poison Control Center immediately, even if there are no symptoms.

Missed Dose

If you forget to use Taro-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 Taro-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

Taro-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 In all cases	Stop taking drug and call your doctor or pharmacist
Un- common
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	✔
Hyperglyce- mia (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	✔
Osteopo- rosis: 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 Taro-Mometasone Cream, Ointment or Lotion contact your doctor or pharmacist.

How to store

Cream: Store between 15°C and 25°C.
Ointment: Store between 15°C and 30°C.
Lotion: Store between 15°C 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 help improve the safe use of health products for Canadians by reporting serious and unexpected side effects to Health Canada. Your report may help to identify new side effects and change the product safety information.

3 ways to report:

Online at MedEffect;
By calling 1-866-234-2345 (toll-free);
By completing a Consumer Side Effect Reporting Form and sending it by:
- Fax to 1-866-678-6789 (toll-free), or
- Mail to: Canada Vigilance Program
  Health Canada
  Postal Locator 0701E
  Ottawa, Ontario
  K1A 0K9

Postage paid labels and the Consumer Side Effect Reporting Form are available at MedEffect.

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 Taro-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 or Taro Pharmaceuticals Inc. website www.taro.ca or by calling Taro Pharmaceuticals Inc. at 1-800-268-1975

This leaflet was prepared by Taro Pharmaceuticals Inc TARO is a registered trademark of Taro Pharmaceuticals Inc.

Last revised: October 09, 2018

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