Nedocromil Sodium Ophthalmic drops, solution

What is this medicine?

NEDOCROMIL (ne doe KROE mil) is used in the eye to treat itching caused by eye allergies.

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

What should I tell my health care provider before I take this medicine?

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

• wear contact lenses

• an unusual or allergic reaction to nedocromil, other medicines, foods, dyes, or preservatives

• pregnant or trying to get pregnant

• breast-feeding

How should I use this medicine?

This medicine is only for use in the eye. Do not take by mouth. Follow the directions on the prescription label. Wash hands before and after use. Tilt your head back slightly and pull your lower eyelid down with your index finger to form a pouch. Try not to touch the tip of the dropper to your eye, fingertips, or any other surface. Squeeze the prescribed number of drops into the pouch. Close the eye for a few moments to spread the drops. If you are using single-use containers, use the drops immediately after opening. Throw away immediately after using. Use your medicine at regular intervals. Do not use it more often than directed.

Talk to your pediatrician regarding the use of this medicine in children. While this drug may be prescribed for children as young as 3 for selected conditions, precautions do apply.

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, use it as soon as you can. If it is almost time for your next dose, use only that dose. Do not use double or extra doses.

What may interact with this medicine?

Interactions are not expected. Do not use any other eye products without asking your doctor or health care professional.

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 medicine?

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

You should avoid wearing contact lenses while you have signs and symptoms of an eye allergy. Ask your doctor or health care professional when you can wear your lenses again.

Even if your allergy symptoms go away, keep using this medicine until pollen season is over or until you are no longer exposed to the allergen that causes your symptoms.

Wear sunglasses if this medicine makes your eyes more sensitive to sunlight.

What side effects may I notice from receiving this medicine?

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

• redness around the eye

• redness in the white part of the eye

• swelling of the area covering the white part of the eye

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

• bad taste in mouth

• headache

• runny or stuffy nose

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 medicine?

Keep out of the reach of children.

Store between 2 and 25 degrees C (36 and 77 degrees F). Do not freeze. Keep bottle tightly closed when not in use. Throw away any unused medicine after the expiration date.

Nedocromil Sodium Pressurized inhalation, suspension

What is this medicine?

NEDOCROMIL (ne doe KROE mil) helps reduce inflammation. This medicine is used to treat the symptoms of asthma. Never use this medicine to treat an acute asthma attack.

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

What should I tell my health care provider before I take this medicine?

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

• heart disease

• irregular heartbeats

• an unusual or allergic reaction to nedocromil, fluorocarbons, other medicines, foods, dyes, or preservatives

• pregnant or trying to get pregnant

• breast-feeding

How should I use this medicine?

Inhale this medicine through the mouth. Follow the directions on your prescription label. Take your medicine at regular intervals. Do not take your medicine more often than directed. Do not stop taking except on your doctor's advice. Make sure that you are using your inhaler correctly. Ask you doctor or health care provider if you have any questions.

Talk to your pediatrician regarding the use of this medicine in children. While this drug may be prescribed for children as young as 6 years of age for selected conditions, precautions do apply.

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, use it as soon as you can. Then space remaining doses evenly throughout the rest of the day. Do not use double or extra doses.

What may interact with this medicine?

Interactions are not expected.

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 medicine?

Visit your doctor or health care professional for regular checks on your progress. Tell your doctor if your symptoms do not improve. If your symptoms get worse or if you need your short-acting inhalers more often, call your doctor right away.

Do not get this medicine in your eyes. It can cause irritation.

If you get a bitter or unpleasant taste in your mouth, gargle or rinse your mouth after you use this medicine.

What side effects may I notice from receiving this medicine?

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 difficulty, wheezing

• fever, infection

• joint pain

• tremor

• unusually weak or tired

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

• bitter taste

• cough

• headache

• nausea, vomiting

• runny nose

• stomach upset, pain

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 medicine?

Keep out of the reach of children.

Store between 2 and 30 degrees C (36 and 86 degrees F). Do not freeze. Do not puncture or overheat the container. Keep track of the number of doses used. Throw away the inhaler after 104 inhalations or after the expiration date, whichever comes first.