Prescription drugs info

How to use Aphthasol:

* Apply this medicine to the canker sore as soon as you notice it.
* Squeeze a small amount of the paste (about 1/4 inch) onto your fingertip. Using gentle pressure, dab the paste onto each sore in your mouth.
* Wash your hands immediately after using Aphthasol paste.
* Keep using the medicine until the sore is healed. However, if it is not healed after 10 days, check with your doctor.
* Do not get any of the paste in your eyes. If any gets in your eyes, wash them out with water right away.

Aphthasol Dosing
The dose of Aphthasol paste may be different for different patients. Follow your doctor’s orders or the directions on the label . The following information includes only the average doses of Aphthasol. If your dose is different, do not change it unless your doctor tells you to do so.

* For mucosal-local dosage form (oral paste):
o For treatment of canker sores:
+ Adults—Apply to each canker sore in the mouth four times a day, after you brush your teeth after breakfast, lunch, dinner, and at bedtime.
+ Children—Use and dose must be determined by your doctor.

Aphthasol Missed dose
If you miss a dose of Aphthasol, apply it as soon as possible. However, if it is almost time for the next dose, skip the missed dose and go back to your regular dosing schedule.

Aphthasol Storage
To store Aphthasol:

* Keep out of the reach of children.
* Store away from heat and direct light.
* Do not store in the bathroom, near the kitchen sink, or in other damp places. Heat or moisture may cause the medicine to break down.
* Do not keep outdated medicine or medicine no longer needed. Be sure that any discarded medicine is out of the reach of children.

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In deciding to use a medicine, the risks of using the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For Aphthasol, the following should be considered:

Aphthasol and Allergies
Tell your doctor if you have ever had any unusual or allergic reaction to Aphthasol. Also tell your health care professional if you are allergic to any other substances, such as preservatives or dyes.

Aphthasol and Pregnancy
Aphthasol has not been studied in humans. However, studies in animals have not found that it causes any birth defects or other problems.

Aphthasol and Breast-feeding
It is not known whether Aphthasol passes into breast milk in humans. However, it does pass into the milk in lactating animals. Although most medicines pass into human breast milk in small amounts, many of them may be used safely while breast-feeding. Mothers who are taking this medicine and who wish to breast-feed should discuss this with their doctor.

Aphthasol and Children
There is no specific information comparing use of Aphthasol in children with use in other age groups.

Aphthasol and Older adults
Many medicines have not been studied specifically in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults. There is no specific information comparing use of Aphthasol in the elderly with use in other age groups.

Aphthasol and Other medicines
Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your health care professional if you are using any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Aphthasol and Other medical problems
The presence of other medical problems may affect the use of Aphthasol. Make sure you tell your doctor if you have any other medical problems, especially:

* Immune system problems—It is not known if Aphthasol will work properly in patients with these problems

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Local
Local side effects have included transient stinging, pain or burning at the site of application in 1% to 2% of patients.

Gastrointestinal
Gastrointestinal side effects have included contact mucositis, nausea, and diarrhea in less than 1% of patients.

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* If you have any questions about Aphthasol , please talk with your doctor, pharmacist, or other health care provider.
* Aphthasol 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 Aphthasol . 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.

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

Proper storage of Aphthasol :
Store Aphthasol at room temperature, between 59 and 86 degrees F (15 and 30 degrees C) in a tightly closed container. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Aphthasol out of the reach of children and away from pets.

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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:

Short-term pain, stinging, or burning at the application site.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); inflammation of the lining of the mouth.

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

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* Avoid getting Aphthasol in your eyes. Wash eyes promptly if paste gets into eyes.
* Use Aphthasol with extreme caution in CHILDREN. Safety and effectiveness have not been confirmed.
* PREGNANCY and BREAST-FEEDING: If you become pregnant while taking Aphthasol , discuss with your doctor the benefits and risks of using Aphthasol during pregnancy. It is unknown if Aphthasol is excreted in breast milk. If you are or will be breast feeding while you are using Aphthasol , check with your doctor or pharmacist to discuss the risks to your baby.

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

* Apply Aphthasol after oral hygiene after breakfast, lunch, dinner, and at bedtime unless otherwise directed by your doctor.
* Apply the paste as soon as possible after noticing the symptoms of canker sores.
* Dry the ulcers by gently patting with a soft, clean cloth.
* Wash your hands before and immediately after applying Aphthasol .
* Moisten the tip of your index finger. Squeeze a dab of paste approximately one-fourth of an inch onto your fingertip. Dab paste onto each ulcer in the mouth using gentle pressure.
* Use the paste until the ulcer heals. If significant healing or pain reduction has not occurred within 10 days, consult your dentist or doctor.
* If you miss a dose of Aphthasol , use 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 use 2 doses at once.

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

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Some medical conditions may interact with Aphthasol . 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 a weakened immune system

Some MEDICINES MAY INTERACT with Aphthasol . Because little, if any, of Aphthasol is absorbed into the blood, the risk of it interacting with another medicine is low.

This may not be a complete list of all interactions that may occur. Ask your health care provider if Aphthasol 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.

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* you are allergic to any ingredient in Aphthasol

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

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