Taclonex topical

Follow all directions on your medicine label and package. Tell each of your healthcare providers about all your medical conditions, allergies, and all medicines you use.

You should not use this medicine if you are allergic to betamethasone or calcipotriene.

To make sure this medicine is safe for you, tell your doctor if you have:

• high levels of calcium in your blood (hypercalcemia);

• a history of kidney stones;

• liver or kidney disease;

• severe forms of psoriasis (with pus, skin peeling, severe redness);

• a skin infection; or

• if you are receiving UV light treatments (phototherapy).

It is not known whether this medicine will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

It is not known whether betamethasone and calcipotriene topical passes into breast milk or if it could harm a nursing baby. Do not apply this medicine to your breasts if you are breast-feeding a baby.

Do not use this medicine on a child without a doctor's advice. Children can absorb larger amounts of steroid medicine through the skin and may be more likely to have side effects. Steroid medicine can also affect growth in children. Talk with your doctor if you think your child is not growing at a normal rate while using this medicine.

Betamethasone and calcipotriene topical is not approved for use by anyone younger than 12 years old.

Apply the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next dose. Do not use extra medicine to make up the missed dose.

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Topical steroid medicine can be absorbed through the skin, which may cause steroid side effects throughout the body. Tell your doctor if you have:

• weight gain (especially in your face or your upper back and torso);

• slow wound healing, thinning skin, increased body hair;

• irregular menstrual periods, changes in sexual function; or

• muscle weakness, tired feeling, depression, anxiety, feeling irritable.

Children can absorb larger amounts of this medicine through the skin and may be more likely to have side effects.

Stop using the medicine and call your doctor at once if you have:

• severe burning or irritation where the medicine was applied;

• redness or crusting around your hair follicles;

• pus, swelling, redness, increased itching, or other signs of skin infection;

• high levels of calcium in your blood--constipation, increased thirst or urination, muscle weakness, bone pain, confusion, lack of energy, or tired feeling; or

• signs of low adrenal gland hormones--worsening tiredness or muscle weakness, feeling light-headed, nausea, vomiting, loss of appetite, diarrhea, and weight loss.

Common side effects may include:

• skin dryness, itching, burning, or irritation;

• mild rash; or

• changes in skin color.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

This product contains 2 drugs (betamethasone and calcipotriene) and is used to treat psoriasis of the scalp. Some brands of this medication are also used to treat psoriasis on the body. Betamethasone is a very strong corticosteroid drug that helps decrease the swelling, redness, and itching of the skin that occurs with this condition. Calcipotriene, which is also known as calcipotriol in other countries, is a form of vitamin D. It works by slowing down the growth of skin cells so that they do not build up into thickened, scaly skin patches.

This medication should not be used if you have certain types of psoriasis (skin patches with pus-filled blisters, psoriasis with intense redness/shedding/oozing). Consult your doctor for more information.

This product is not recommended for use in children because they may be at an increased risk for side effects. See also Side Effects and Precautions sections.

How to use Taclonex Suspension, Topical

Read the Patient Information Leaflet provided by your pharmacist before you start using this product and each time you get a refill. If you have any questions, consult your doctor or pharmacist.

This medication is for use on the scalp. Do not apply this product 12 hours before or after any chemical treatments to your hair. Shake the bottle well before use. Part your hair, apply the product only to the affected area(s) of the scalp, and gently rub in, usually once daily or as directed by your doctor. Wash your hands after using, but do not wash your hair right after applying this product. Avoid getting any medication in the eyes or ears. If this occurs, immediately rinse with plenty of water. Do not apply this product to the face, underarms, or groin area.

If your doctor has directed you to use this product on your body, follow your doctor's directions for how much to use and where to use it. Apply to affected areas and gently rub in. Wash your hands after using.

Do not use this medication more often or for longer than directed. Do not use more than 100 grams of this product a week unless directed and closely monitored by your doctor. Do not bandage, wrap, or cover the treated area unless your doctor instructs you to do so. Do not use this product on large areas of damaged skin. Following these instructions helps to reduce your risk of side effects.

Tell your doctor if your condition does not improve or if it worsens. It may take up to 2 weeks to see any improvement.

You should not use Taclonex if you are allergic to betamethasone or calcipotriene.

To make sure this medicine is safe for you, tell your doctor if you have:

• high levels of calcium in your blood (hypercalcemia);

• a history of kidney stones;

• liver or kidney disease;

• severe forms of psoriasis (with pus, skin peeling, severe redness);

• a skin infection; or

• if you are receiving UV light treatments (phototherapy).

It is not known whether Taclonex will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

It is not known whether betamethasone and calcipotriene topical passes into breast milk or if it could harm a nursing baby. Do not apply this medicine to your breasts if you are breast-feeding a baby.

Do not use Taclonex on a child without a doctor's advice. Children can absorb larger amounts of steroid medicine through the skin and may be more likely to have side effects. Steroid medicine can also affect growth in children. Talk with your doctor if you think your child is not growing at a normal rate while using this medicine.

Taclonex is not approved for use by anyone younger than 12 years old.

Use Taclonex exactly as it was prescribed for you. Follow all directions on your prescription label. Do not use this medicine in larger or smaller amounts or for longer than recommended. Do not use Taclonex to treat any condition that has not been checked by your doctor.

Do not take Taclonex by mouth. Topical medicine is for use only on the skin. Do not use in the vagina.

Read all patient information, medication guides, and instruction sheets provided to you. Ask your doctor or pharmacist if you have any questions.

Wash your hands before and after applying this medicine, unless you are using the medicine to treat the skin on your hands.

Shake the Taclonex suspension (liquid) just before using it.

Apply Taclonex once daily to the affected skin and rub it in gently. Do not spread the medicine over a large skin area. Do not apply to areas of thinner skin (face, underarms, groin) unless your doctor tells you to.

Do not cover the treated skin area. Covering skin treated with a topical steroid can increase the amount of medicine your skin absorbs, which may lead to unwanted side effects.

If you use Taclonex liquid:

• Adults should not use more than 100 grams (1 full bottle) of the liquid in 1 week.

• Children age 12 and older should not use more than 60 grams of the liquid in 1 week.

If you use Taclonex ointment: Do not use more than 100 grams (1 large tube) of the ointment in 1 week. Avoid treating an area that is larger than 30% or one-third of your entire body.

Ask your pharmacist if you have questions about how much to apply each time you use the medicine.

Taclonex ointment can be applied daily for up to 4 weeks. The liquid can be used daily for up to 8 weeks. Follow your doctor's instructions about your individual treatment schedule.

Call your doctor if your skin condition does not improve after several days of treatment, or if it gets worse while using this medicine.

If you use Taclonex long-term, you may need frequent medical tests.

Store at room temperature away from moisture and heat. Keep the bottle or tube tightly closed when not in use.

Stop using Taclonex when your skin clears up, unless your doctor tells you otherwise.

Do not use on broken or infected skin. Also avoid using the medicine in open wounds. If this medicine gets in your eyes, nose, mouth, rectum, or vagina, rinse with water.

Do not use more than one topical steroid medicine without your doctor's advice.

Avoid having your hair colored within 12 hours before or after you apply Taclonex to your scalp.

Avoid exposure to sunlight or tanning beds. This medicine can make you sunburn more easily. Wear protective clothing and use sunscreen (SPF 30 or higher) when you are outdoors.