House Dust Mite Allergen Extract sublingual tablets

What is this medication?

HOUSE DUST MITE ALLERGEN EXTRACT (hauz dest mite AL er jen EK strakt) is an allergy medicine. It is used to treat sneezing, runny or itchy nose, nasal congestion, and watery eyes caused by house dust mite allergies.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

COMMON BRAND NAME(S): ODACTRA 12

What should I tell my care team before I take this medication?

They need to know if you have any of these conditions:

• heart disease
• high blood pressure
• history of eosinophilic esophagitis
• history of irregular heartbeat
• lung or breathing disease, like asthma
• previous swelling of the tongue, face, or lips with difficulty breathing, difficulty swallowing, hoarseness, or tightening of the throat
• receiving or have received allergy shots
• sores, wounds, or infection in your mouth
• an unusual or allergic reaction to house dust mite allergen extract, mannitol, gelatin, fish, other medicines, foods, dyes, or preservatives
• pregnant or trying to get pregnant
• breast-feeding

How should I use this medication?

Take this medicine by mouth. Follow the directions on the prescription label. Leave the tablet in the sealed blister pack until you are ready to take it. With dry hands, open the blister and gently remove the tablet. If the tablet breaks or crumbles, throw it away and take a new tablet out of the blister pack. Place the tablet under the tongue and allow it to dissolve for at least 10 seconds. Do not swallow for at least 1 minute. Do not take this medicine with food or drink. Do not eat or drink for at least 5 minutes after taking the medicine. Wash your hands after handling the tablet. Take your medicine at regular intervals. Do not take it more often than directed. Do not stop taking except on your doctor's advice.

A special MedGuide will be given to you by the pharmacist with each prescription and refill. Be sure to read this information carefully each time.

Talk to your pediatrician regarding the use of this medicine in children. Special care may be needed.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses. If you miss more than one dose, contact your doctor before restarting.

What may interact with this medication?

Interactions have not been studied.

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medication?

Tell your doctor or healthcare professional if your symptoms do not start to get better or if they get worse.

Your doctor or healthcare professional should prescribe auto-injectable epinephrine for you to keep at home for treating a severe allergic reaction if needed. Your healthcare professional will tell you how to use the auto-injectable epinephrine. Some medicines may make epinephrine not work as well or worsen side effects. Talk with your health care professional if you take any of these medicines:

• certain medicines for blood pressure, heart disease, irregular heart beat
• certain medicines for depression, anxiety, or psychotic disturbances
• chlorpheniramine
• diphenhydramine
• diuretics
• ergot alkaloids like dihydroergotamine, ergonovine, ergotamine, methylergonovine
• MAOIs like Carbex, Eldepryl, Marplan, Nardil, and Parnate
• thyroid hormone

What side effects may I notice from receiving this medication?

Side effects that you should report to your doctor or health care professional as soon as possible:

• allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue
• breathing problems
• chest pain or chest tightness
• dizziness
• facial flushing
• severe cough
• trouble swallowing
• vomiting

Side effects that usually do not require medical attention (report these to your doctor or health care professional if they continue or are bothersome):

• changes in taste
• mouth pain or tingling
• nausea
• throat irritation
• upset stomach

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medication?

Keep out of the reach of children.

Store at room temperature between 20 and 25 degrees C (68 and 77 degrees F). Keep this medicine in the original package until use to protect from moisture. Throw away any unused medicine after the expiration date.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.