Consumer Information for: DOVOBET OINTMENT

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

DOVOBET should be used topically for up to 4 weeks to treat psoriasis plaques on your body.

DOVOBET should not be used on the face.

What it does

DOVOBET ointment contains two medicines in one product; calcipotriol (a vitamin D-like substance) and betamethasone dipropionate (a corticosteroid) that work together to control psoriasis.

Psoriasis lesions are areas of inflamed skin where the production of skin cells is too rapid. This creates red, scaly, thick patches (plaques) of skin. Treatment is targeted at reducing signs of redness and scaling and symptoms such as itching.

Calcipotriol helps to bring the rate of skin cell growth back to normal. Betamethasone dipropionate works to reduce inflammation (redness, swelling and itching).

When it should not be used

Do not use DOVOBET ointment:

  • if you are allergic to any of the ingredients in DOVOBET ointment, or to components of the tube
  • if you have problems with high calcium levels in your body
  • if you have skin infections caused by viruses (e.g. cold sores, chicken pox), a fungus (e.g. athlete’s foot, ringworm), bacteria, parasites (e.g. scabies), tuberculosis or syphilis
  • on skin areas with perioral dermatitis (red mouth rash), ichthyosis (dry, scaly skin), acne (pimples), rosacea (flushed facial skin)
  • on skin areas that have ulcers, open sores, thin skin, easily damaged veins, stretch marks
  • to treat other types of psoriasis in the eyes
What the medicinal ingredient is

Calcipotriol and betamethasone dipropionate

What the non-medicinal ingredients are

α-tocopherol, butylhydroxytoluene, white soft paraffin, liquid paraffin, polyoxypropylene-11-stearyl ether.

What dosage form it comes in

DOVOBET is available as a topical ointment containing 50 mcg/g calcipotriol (as monohydrate) and 0.5 mg/g betamethasone (as dipropionate). Available in 30 g, 60 g, and 120 g lacquered aluminium tubes (equipped with an aluminium membrane) with re-closable polyethylene screw cap.

Warnings and precautions

BEFORE you use DOVOBET ointment talk to your doctor or pharmacist if you:

  • have diabetes
  • have skin infections
  • use other medicines that contain corticosteroids or calcipotriol (Vitamin D).
  • are pregnant or planning to get pregnant
  • are breast feeding

DOVOBET ointment is not recommended in children and adolescents under 18 years of age.

Calcipotriol in DOVOBET ointment may increase the risk of developing skin cancer caused by ultraviolet radiation (UVR).

While using DOVOBET ointment , you should avoid excessive exposure to natural or artificial sunlight (UVR) such as phototherapy, tanning beds, sunlamps, etc.

Do not use DOVOBET ointment on your face, skin folds (e.g. groin, armpit, under the breast or in the creases of the buttocks), genitals or on open sores on the skin. Do not use DOVOBET ointment in or near the eyes. DOVOBET ointment may cause eye irritation and irritation of facial skin.

Do not bandage, apply a dressing or wrap the treated skin area after applying DOVOBET ointment on your body.

If required, your doctor may recommend a blood test to check your calcium level or the functioning of your adrenal gland.

Interactions with this medication

Before using DOVOBET ointment tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including those you can buy without a prescription, especially medicines that contain a corticosteroid and/or calcipotriol.

Proper use of this medication

Usual Dose

DOVOBET should be gently rubbed onto affected skin areas once a day for up to 4 weeks. The maximum daily dose is 15 g per day or 100 g per week of DOVOBET and/or any other products containing calcipotriol. The total body surface area treated should not exceed 30%.

Using the ointment

  • Remove the cap. Check that the aluminium seal has not been broken before you use it for the first time. To break the seal, use the other end of the cap to pierce the seal.
  • Gently rub the ointment on the areas of your skin affected by psoriasis. Wash your hands after using DOVOBET to prevent getting any on your face. No special dressing or cover is needed.
  • If you accidentally spread DOVOBET onto surrounding healthy skin, wash it off right away.
  • DOVOBET is not recommended for use on your face. If you accidentally get some on your face, wash it off right away.
  • Do not apply DOVOBET on large areas of damaged skin, in skin folds or under an air tight bandage/dressing. This could increase your risk of side effects.
  • If DOVOBET ointment is used together with DOVONEX® cream, ointment or scalp solution, then the combined total for all products together should not be greater than 15 g per day or 100 g per week.

For example, if you use 60 g of DOVOBET ointment in a week, you should not use more than 40 mL of DOVONEX scalp solution during the same week.

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 DOVOBET at the right time, use it as soon as you remember. Then go on as before.

Side effects and what to do about them

The most common side effect from the use of DOVOBET is itching which is usually mild.

Other side effects of using DOVOBET may include:

  • local irritation
  • burning and stinging sensation
  • dryness
  • various types of skin rashesdermatitis
  • photosensitivity and hypersensitivity reactions
  • red and swollen hair follicles
  • lightening of skin colour
  • facial rash and swelling
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 talk with your doctor or pharmacist
Uncommon
worsening of psoriasis (red, scaly, thick patches of skin)     ✔
Rare: pustular psoriasis (headache, fever, chills, arthralgia, malaise, anorexia, nausea)     ✔
Rare
adrenal effects (weakness, increased urination/thirst, fatigue, weight loss)   ✔  
skin thinning (visible veins, stretch marks) ✔    
Very rare
allergic reaction (rash, itching, swelling, trouble breathing, dizziness)     ✔
high blood calcium levels (fatigue, depression mental confusion, anorexia, nausea, vomiting, constipation, increased urination and in some patients, cardiac arrhythmias)     ✔

This is not a complete list of side effects. For any unexpected effects while taking DOVOBET, contact your doctor or pharmacist.

How to store

Store at 5 to 25°C. Use within 12 months of first opening the tube.

  • For easy spreading and to prevent pulling of delicate skin do not refrigerate the ointment.
  • Keep DOVOBET in a safe place where children cannot reach it.
  • Keep DOVOBET away from your pets. The medicine (calcipotriol) can be fatal to dogs if eaten. If your dog eats DOVOBET contact a veterinarian immediately.
  • Do not use DOVOBET past the expiry date marked on the bottom of the tube.
Reporting 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 three 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
      Health Canada
      Postal Locator 0701C
      Ottawa ON K1A 0K9

Postage paid labels, Canada Vigilance Reporting Form and the adverse reaction reporting guidelines are available on the MedEffectTM 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: www.leo-pharma.caor by contacting the sponsor, LEO Pharma Inc., at: 1-800-668-7234.

® LEO Pharma A/S used under license by LEO Pharma Inc., Thornhill, L3T 7W8

This leaflet was prepared by LEO Pharma Inc.
Last revised: April 4, 2016

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