Asenapine Transdermal System (ASENAPINE PATCH - TRANSDERMAL)

Instructions

DO NOT take this medicine by mouth.

Remove the patch after 24 hours.

Store at room temperature away from heat, light, and moisture. Do not keep in the bathroom.

This medicine should only be used on the skin.

This patch should not be cut.

Do not remove the patch from its package until you are ready to use it.

Remove old patch before applying new one. Change the location of the new patch.

Do not use if the pouch containing the medicine is torn or damaged.

Do not use the patch if it is broken, cut, or damaged.

Remove the plastic liner that protects the sticky side of the patch before applying to the skin.

Do not use soap, oils, or alcohol on the area of the skin before applying the patch. Use only water and gently pat dry. Do not rub the skin.

Apply the patch to a clean, dry, hairless area. Avoid skin that is red, scraped, or damaged.

Press patch firmly for a few seconds to make sure it sticks. If it does not, talk to your doctor or pharmacist. Do not cover with a bandage or tape unless your doctor or pharmacist says to.

After removing the patch, fold it together and discard it out of reach of children and pets, NOT in the toilet.

Avoid getting the medicine in the eyes, nose, or mouth. Wash your hands after touching patch.

Put the patch on a different area each time. Wait at least one week before using the same location again.

If the patch falls off or you forgot to use the patch on time, apply a new patch immediately to a different location. Replace this new patch at your next usual dosing time.

Do not apply heat on the area with the patch. Avoid heating blankets, suntan beds, or hot tubs.

You may shower while wearing the patch, but do not bathe or swim.

Avoid placing the patch where tight clothing will rub against it.

Check regularly during the day to make sure the patch is firmly stuck to the skin.

To reduce skin irritation, peel the patch off slowly. Gently clean the area with mild soap and water.

Drug interactions can change how medicines work or increase risk for side effects. Tell your health care providers about all medicines taken. Include prescription and over-the-counter medicines, vitamins, and herbal medicines. Speak with your doctor or pharmacist before starting or stopping any medicine.

Tell your doctor if symptoms do not get better or if they get worse.

This medicine may affect your blood sugar levels. If you have diabetes, talk to your doctor before changing the dose of your diabetes medicine.

Keep all appointments for medical exams and tests while on this medicine.

Cautions

Some patients taking this medicine have experienced serious side effects. Please speak with your doctor to understand the risks and benefits associated with this medicine.

Tell your doctor and pharmacist if you ever had an allergic reaction to a medicine.

Do not use the medication any more than instructed.

This medicine may cause dizziness or fainting. Do not stand or sit up quickly.

If possible, avoid using with alcohol, marijuana, or other medicines that can cause dizziness or drowsiness. These include allergy/cold products, muscle relaxers, sleep aids, and pain relievers.

Your ability to stay alert or to react quickly may be impaired by this medicine. Do not drive or operate machinery until you know how this medicine will affect you.

Avoid becoming overheated during exercise or other activities. Try to stay cool in hot weather.

Tell your doctor if you have severe or persistent sweating, diarrhea or vomiting. These can increase your risk of a serious side effect.

It is unknown if this medicine passes into breast milk. Ask your doctor before breastfeeding.

During pregnancy, this medicine should be used only when clearly needed. Talk to your doctor about the risks and benefits.

It is important that you keep taking each dose of this medicine on time even if you are feeling well.

If you forget to take a dose on time, take it as soon as you remember. If it is almost time for the next dose, do not take the missed dose. Return to your normal schedule. Do not take 2 doses at one time.

Do not share this medicine with anyone who has not been prescribed this medicine.

If you have a painful erection or an erection for more than 4 hours, seek medical care right away.

Side Effects

The following is a list of some common side effects from this medicine. Please speak with your doctor about what you should do if you experience these or other side effects.

• dizziness or drowsiness
• lightheadedness
• skin irritation where medicine is applied
• weight gain

Call your doctor or get medical help right away if you notice any of these more serious side effects:

• breast pain or swelling
• breathing interruption during sleep
• confusion
• cough that does not go away
• drooling
• face appearing mask-like
• fainting
• fever or chills
• severe or persistent headache
• fast, irregular, or slow heartbeat
• signs of kidney damage (such as change in urine color or bubbly urine)
• menstruation changes (missed or fewer periods)
• uncontrollable movement of face, tongue, arms or legs
• muscle pain or weakness
• muscle trembling
• nervousness
• seizures
• problems with sexual functions or desire
• shakiness
• difficulty swallowing

A few people may have an allergic reaction to this medicine. Symptoms can include difficulty breathing, skin rash, itching, swelling, or severe dizziness. If you notice any of these symptoms, seek medical help quickly.