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|Relagard

Relagard

Relagard is used for:

Increasing and maintaining vaginal acidity in combination with other medicines. It may also be used for other conditions as determined by your doctor.

Relagard is a non-irritating vaginal gel. It works by increasing the acidic level in the vagina.

Do NOT use Relagard if:

• you are allergic to any ingredient in Relagard

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

Before using Relagard :

Some medical conditions may interact with Relagard . 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

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

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

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

• Relagard is for vaginal use only. Do not get Relagard in the eyes, nose, or mouth.
• Attach the enclosed applicator to the tube of Relagard by screwing it on clockwise. Squeeze the tube to force the contents into the barrel until the applicator is filled.
• Detach the applicator from the tube and gently insert it into the vagina as far as it will comfortably go.
• Press the plunger and deposit the medication until the barrel of the applicator is emptied.
• Keeping the plunger depressed, remove the applicator from the vagina.
• Take apart the applicator, and wash it with warm, soapy water and rinse it well after each use.
• Wash your hands immediately after using Relagard .
• Do not use tampons while using Relagard . Use a deodorant-free pad or panty shield instead.
• If you miss a dose of Relagard , 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 Relagard .

Important safety information:

• Relagard may be harmful if swallowed. If you may have taken Relagard by mouth, contact your local poison control center or emergency room immediately.
• LAB TESTS, including vaginal pH levels, may be performed to monitor your progress or to check for side effects. Be sure to keep all doctor and lab appointments.
• PREGNANCY and BREAST-FEEDING: If you become pregnant while taking Relagard , discuss with your doctor the benefits and risks of using Relagard during pregnancy. It is unknown if this medicine is excreted in breast milk. If you are or will be breast-feeding while you are using Relagard , check with your doctor or pharmacist to discuss the risks to your baby.

Possible side effects of Relagard :

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:

Burning or stinging at the application site.

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

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. Relagard may be harmful if swallowed.

Store Relagard 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. Keep Relagard out of the reach of children and away from pets.

General information:

• If you have any questions about Relagard , please talk with your doctor, pharmacist, or other health care provider.
• Relagard 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 this medicine. 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.