TACLONEX (Page 3 of 4)

OVERDOSAGE

Topically applied Taclonex® Ointment can be absorbed in sufficient amounts to produce systemic effects. (See PRECAUTIONS.)

DOSAGE AND ADMINISTRATION

Apply an adequate layer of Taclonex® Ointment to the affected area(s) once daily for up to 4 weeks. Taclonex® Ointment should be rubbed in gently and completely. The maximum weekly dose should not exceed 100 g. Treatment of more than 30% body surface area is not recommended. Taclonex® Ointment should not be applied to the face, axillae or groin.

HOW SUPPLIED

Taclonex® Ointment (calcipotriene 0.005% and betamethasone dipropionate 0.064%) is available in 60 gram collapsible tubes (NDC 0430-3230-15) and 100 gram collapsible tubes (NDC 0430-3230-16).

Store Taclonex® Ointment between 20 — 25° C (68 — 77° F); excursions permitted between 15 — 30° C (59 — 86° F).

Keep out of reach of children.

Patient Information

Taclonex® Ointment

(calcipotriene 0.005% and betamethasone dipropionate 0.064%)

Read the Patient Information that comes with Taclonex® Ointment before you start using it and each time you use the ointment. There may be new information. This leaflet does not take the place of talking with your doctor about your condition or treatment.

What is Taclonex® Ointment and what is it used for?

Taclonex ® Ointment is a prescription medicine called a topical (skin-use only).

Taclonex ® Ointment is used on the skin to treat psoriasis vulgaris in adults.

Taclonex ® Ointment contains

  • calcipotriene hydrate, which is somewhat similar to vitamin D, but not the same as vitamin D, and
  • betamethasone dipropionate, which is a strong (potent) corticosteroid.

It is very important that you use Taclonex ® Ointment only as directed, in order to avoid serious side effects.

Taclonex ® Ointment is not recommended for use in children. Taclonex ® Ointment has not been studied in patients under the age of 18.

Who should not use Taclonex® Ointment?

Do not use Taclonex® Ointment if you:

  • have a calcium metabolism disorder
  • have one of the following types of psoriasis:

    o erythrodermic psoriasis

    o exfoliative psoriasis

    o pustular psoriasis

  • are allergic to anything in Taclonex® Ointment. See the end of this leaflet for a complete list of ingredients.

What should I tell my doctor before using Taclonex® Ointment?

Tell your doctor about all of your health conditions, including if you:

  • have a skin infection. Your skin infection should be treated before starting Taclonex® Ointment
  • have thin-skin (atrophy) at the site to be treated. You should not use
    Taclonex® Ointment
  • are getting phototherapy treatments for your psoriasis
  • are pregnant or planning to become pregnant. It is not known if Taclonex® Ointment can harm your unborn baby. You and your doctor will have to decide if Taclonex® Ointment is right for you while pregnant
  • are breastfeeding. It is not known if Taclonex® Ointment passes into your milk and if it can harm your baby

Tell your doctor about all the medicines you take, including prescription, and nonprescription medicines, vitamins and herbal supplements. Taclonex® Ointment and some other medicines can interact with each other. Especially tell your doctor if you use:

  • other corticosteroid medicines
  • other medicines for your psoriasis

How should I use Taclonex® Ointment?

  • Use Taclonex® Ointment exactly as directed by your doctor. Do not use more than the recommended weekly amount of 100 grams of Taclonex® Ointment.
  • Do not use Taclonex® Ointment on your face, under your arms or on your groin. Do not get any Taclonex® Ointment in your eyes. Wash your face or eyes right away if you get Taclonex® Ointment on them.

Using Taclonex® Ointment:

  • Remove the cap and check that the aluminum seal covers the tube, before the first use. To break the seal, turn the cap over and push through the seal.
  • Apply Taclonex® Ointment once a day to the areas of your skin affected by psoriasis. Gently rub Taclonex® Ointment into your affected skin areas.
  • Do not bandage or tightly cover or wrap the treated skin area. Wear your usual clothes.
  • Only use Taclonex® Ointment as directed by your doctor. Taclonex® Ointment is recommended for up to 4 weeks of treatment. Do not use Taclonex® Ointment for more than 4 weeks unless prescribed by your doctor.
  • If you forget to use your Taclonex® Ointment, use it as soon as you remember. Then go on as before.
  • Wash your hands well after using Taclonex® Ointment.

What are the possible side effects of Taclonex® Ointment?

The most common side effects are:

  • itching
  • rash
  • skin burning

Other less common side effects with Taclonex® Ointment include:

  • redness of the skin
  • inflamed hair pores (folliculitis)
  • psoriasis
  • skin irritation
  • change of skin color (at the site of application)
  • thinning of the skin (atrophy)
  • swollen fine blood vessels (this makes your skin appear red at the site of application)

Taclonex® Ointment may cause serious side effects if you use too much or use it for too long. Taclonex® Ointment can pass through your skin. Serious side effects may include:

  • too much calcium in your blood
  • adrenal gland problems

Your doctor may do special blood and urine tests to check your calcium levels and adrenal gland function while you are using Taclonex® Ointment.

Call your doctor about any side effect that bothers you or that does not go away.

These are not all of the side effects with Taclonex® Ointment. Ask your doctor or pharmacist for more information.

How should I store Taclonex® Ointment?

  • Taclonex® Ointment should be stored between 68 — 77° F (20 — 25° C); excursions permitted between 59 — 86° F (15 — 30° C). Make sure the cap on the tube is tightly closed.
  • Taclonex® Ointment has an expiry date marked on the tube. Do not use the ointment after this date.
  • Keep Taclonex® Ointment out of the reach of children and pets.

General information about Taclonex® Ointment

Medicines are sometimes prescribed for conditions that are not mentioned in patient information leaflets. Do not use Taclonex® Ointment for a condition for which it was not prescribed. Do not give ointment to other people, even if they have the same symptoms you have. It may harm them.

This leaflet summarizes the most important information about Taclonex® Ointment. If you would like more information, talk with your doctor. You can ask your doctor or pharmacist for information about Taclonex® Ointment that is written for health professionals.

Additional consumer information is available at (800) 521-8813.

What are the ingredients in Taclonex® Ointment?

Active ingredients: calcipotriene hydrate, betamethasone dipropionate

Inactive ingredients: mineral oil, PPG-15 stearyl ether, dl-alpha tocopherol, white petrolatum.

Rx only

LEO Laboratories Ltd. logoLEO Laboratories Ltd. Logo

Manufactured by:
LEO Laboratories Ltd. (LEO Pharma)
Dublin, Ireland

Warner Chilcott (US) logo

Marketed by:
Warner Chilcott (US), LLC
Rockaway, NJ 07866 USA
1-800-521-8813

U.S. Patent Nos.: RE39,706 E and 6,753,013.

3230G025
3230G125
022608-05

Revised July 2008

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