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|Cromolyn Concentrate

Cromolyn Concentrate

Cromolyn Concentrate is used for:

Treating mastocytosis, including improvement of symptoms such as diarrhea, flushing, headaches, vomiting, hives, stomach pain, nausea, and itching in some patients. It may also be used for other conditions as determined by your doctor.

Cromolyn Concentrate is a mast cell stabilizer. It works by preventing the mast cells of the body from releasing substances that cause symptoms of mastocytosis.

Do NOT use Cromolyn Concentrate if:

• you are allergic to any ingredient in Cromolyn Concentrate

Contact your doctor or health care provider right away if any of these apply to you.

Before using Cromolyn Concentrate:

Some medical conditions may interact with Cromolyn Concentrate. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding
• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
• if you have allergies to medicines, foods, or other substances
• if you have liver or kidney problems

Some MEDICINES MAY INTERACT with Cromolyn Concentrate. However, no specific interactions with Cromolyn Concentrate are known at this time.

This may not be a complete list of all interactions that may occur. Ask your health care provider if Cromolyn Concentrate may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Cromolyn Concentrate:

Use Cromolyn Concentrate as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Cromolyn Concentrate comes with an additional patient leaflet. Read it carefully and reread it each time you get Cromolyn Concentrate refilled.
• Take Cromolyn Concentrate 30 minutes before meals and at bedtime unless directed otherwise by your doctor.
• To use Cromolyn Concentrate, break open the number of ampules prescribed by your doctor and squeeze the medicine into a glass of water. Stir and then drink all of the liquid.
• Do not use Cromolyn Concentrate if it contains particles, is cloudy, or becomes discolored.
• Continue to use Cromolyn Concentrate even if you feel well.
• Cromolyn Concentrate works best if it is used at regular intervals throughout the day as directed. Do not miss any doses. If you miss a dose of Cromolyn Concentrate, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Cromolyn Concentrate.

Important safety information:

• Caution is advised when using Cromolyn Concentrate in CHILDREN younger than 2 years of age because they may be more sensitive to its effects.
• PREGNANCY and BREAST-FEEDING: If you become pregnant, discuss with your doctor the benefits and risks of using Cromolyn Concentrate during pregnancy. It is unknown if Cromolyn Concentrate is excreted in breast milk. If you are or will be breast-feeding, check with your doctor to discuss the benefits and risks to your baby.

Possible side effects of Cromolyn Concentrate:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Diarrhea; headache; nausea.

Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); chest pain; fast or irregular heartbeat; hoarseness; mental or mood changes; seizures.

This is not a complete list of all side effects that may occur. If you have questions or need medical advice about side effects, contact your doctor or health care provider. You may report side effects to the FDA at 1-800-FDA-1088 (1-800-332-1088) or at http://www.fda.gov/medwatch.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org/findyour.htm), or emergency room immediately.

Store Cromolyn Concentrate at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Store ampules in pouch until ready to use. Keep Cromolyn Concentrate out of the reach of children and away from pets.

General information:

• If you have any questions about Cromolyn Concentrate, please talk with your doctor, pharmacist, or other health care provider.
• Cromolyn Concentrate is to be used only by the patient for whom it is prescribed. Do not share it with other people.
• If your symptoms do not improve or if they become worse, check with your doctor.

This information is a summary only. It does not contain all information about Cromolyn Concentrate. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.