Uses

This medication is a combination product used to treat a certain skin condition (psoriasis). It contains 2 ingredients: halobetasol and tazarotene. Halobetasol is a very strong (super-high potency) corticosteroid. It helps reduce the itching, redness, scaling, and swelling that can occur with this condition. Tazarotene is a retinoid product (related to vitamin A) that works by affecting the growth of skin cells.

How To Use

Read the Patient Information Leaflet if available from your pharmacist before you start using halobetasol/tazarotene and each time you get a refill. If you have any questions, ask your doctor or pharmacist.

Use this medication only on the affected skin. Do not apply to normal skin areas or broken skin (such as ulcers, sores, wounds). Do not use it on the face, groin, or underarms unless your doctor tells you to.

If you shower or bathe before applying this medication, make sure your skin has dried before applying it. Apply a thin film of medication to the affected areas and gently rub in as directed by your doctor, usually once daily. Do not cover, bandage, or wrap the area unless directed to do so by your doctor.

After applying the medication, wash your hands unless you are using this medication to treat the hands. If applying this medication near the eyes, avoid getting it in the eyes as this may worsen or cause glaucoma. Also avoid getting this medication in the nose or mouth.

Use this medication only for the condition it was prescribed for. Do not apply more than directed, or use it more often or for longer than prescribed . Once your condition is better, stop using this medication. If directed by your doctor, you may then use this medication off and on when needed.

Since this drug is absorbed through the skin and may harm an unborn baby, women who are pregnant or who may become pregnant should not handle this medication.

Tell your doctor if your condition does not get better or if it gets worse.

Side Effects

Irritation, burning, stinging, itching, dryness, peeling, redness, or pain at the application site may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly. Your doctor may tell you to temporarily stop using this medication, or to use it less often.

Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if you have any serious side effects, including:

• stretch marks
• skin thinning/discoloration
• acne
• excessive hair growth
• small red bumps on the skin (folliculitis)

Skin infections can become worse when using this medication. Tell your doctor promptly if redness, swelling or irritation does not get better.

Rarely, it is possible this medication will be absorbed from the skin into the bloodstream. This can lead to side effects of too much corticosteroid. These side effects are more likely in children, and in people who use this medication for a long time or over large areas of the skin. Tell your doctor right away if any of the following side effects occur:

• unusual/extreme tiredness
• weight loss
• headache
• swelling ankles/feet
• increased thirst/urination
• vision problems

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including:

• rash
• itching/swelling (especially of the face/tongue/throat)
• severe dizziness
• trouble breathing

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Precautions

Before using this product, tell your doctor or pharmacist if you are allergic to halobetasol or tazarotene; or to other corticosteroids (such as hydrocortisone, prednisone); or to other vitamin A-related drugs (other retinoids such as isotretinoin); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of:

• other skin conditions (such as rosacea, eczema, sunburn, sun sensitivity)

This medication may make you more sensitive to the sun. Limit your time in the sun. Avoid tanning booths and sunlamps. Use sunscreen daily and wear protective clothing when outdoors. Tell your doctor right away if you get sunburned or have skin blisters/redness. Wait until your skin has completely recovered from a sunburn before using this medication. Weather extremes such as wind or cold may also be irritating to the skin.

Avoid electrolysis, waxing, and chemical depilatories for hair removal on the treated areas while using this product.

Do not use if there is an infection or sore present in the area to be treated.

Rarely, using corticosteroid medications for a long time or over large areas of skin can make it more difficult for your body to respond to physical stress. Before having surgery or emergency treatment, or if you get a serious illness/injury, tell your doctor or dentist that you are using this medication or have used this medication within the past few months.

Though it is unlikely, this medication may temporarily slow down a child's growth if used for a long time. See the doctor regularly so your child's height can be checked.

This medication must not be used during pregnancy. It may harm an unborn baby. Discuss the use of reliable forms of birth control (such as condoms, birth control pills) with your doctor. If you become pregnant or think you may be pregnant, tell your doctor right away. Before starting this medication, women who could become pregnant should have a negative pregnancy test result within the last 2 weeks. This medication should be started during a normal menstrual period.

Since this drug is absorbed through the skin and may harm an unborn baby, women who are pregnant or who may become pregnant should not handle this medication.

It is unknown if this drug passes into breast milk. Consult your doctor before breast-feeding.

Drug Interactions

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

Some products that may interact with this drug are:

• other vitamin A products
• hair perming solutions
• other skin products with strong drying effects
• skin products containing alcohol/lime/spice (including shaving lotions, perfume, astringents such as calamine lotion)
• soaps/shampoos/cleansers that are medicated/abrasive

Overdose

This medicine may be harmful if swallowed. If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Alberta residents can call PADIS (Poison and Drug Information Service) 24 hours a day at 1-800-332-1414. Canada residents can call a provincial poison control center.

Notes

Do not share this medication with others.

This medication has been prescribed for your current condition only. Do not use it later for other skin problems unless your doctor tells you to. A different medication may be necessary in those cases.

Lab and/or medical tests (such as adrenal gland function) may be done while you are using this medication, especially if you use this drug for a long time or apply it over large areas of the body. Keep all medical and lab appointments.

Missed Dose

If you miss a dose, use it as soon as you remember. If it is near the time of the next dose, skip the missed dose. Use your next dose at the regular time. Do not double the dose to catch up.

If you have questions about missing a dose or you don't have more medication, contact your healthcare provider or pharmacist.

Storage

Store at room temperature. Protect from freezing. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.