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Flagyl ER Extended-Release Tablets is used for:

Treating certain bacterial infections of the vagina (bacterial vaginosis). It may also be used for other conditions as determined by your doctor.

Flagyl ER Extended-Release Tablets is an oral antiprotozoal and antibacterial. It is thought to work by entering the bacterial cell, acting on some components of the cell and destroying the bacteria.

Do NOT use Flagyl ER Extended-Release Tablets if:

• you are allergic to any ingredient in Flagyl ER Extended-Release Tablets or to other nitroimidazoles (eg, tinidazole)
• you are in the first 3 months of pregnancy
• you are taking busulfan, an ergot alkaloid (eg, ergotamine), or you have taken disulfiram within the past 2 weeks
• you are taking an HIV protease inhibitor that contains alcohol (eg, amprenavir solution); check with your pharmacist if you are unsure if the medicine contains alcohol
• you drink alcohol

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

Before using Flagyl ER Extended-Release Tablets:

Some medical conditions may interact with Flagyl ER Extended-Release Tablets. 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 nerve, brain, or blood problems; Crohn disease; or a history of liver problems

Some MEDICINES MAY INTERACT with Flagyl ER Extended-Release Tablets. Tell your health care provider if you are taking any other medicines, especially any of the following:

• Barbiturates (eg, phenobarbital) or phenytoin because they may decrease Flagyl ER Extended-Release Tablets's effectiveness
• Anticoagulants (eg, warfarin), busulfan, ergot alkaloids (eg, ergotamine), HIV protease inhibitors containing alcohol (eg, amprenavir solution), lithium, or macrolide immunosuppressants (eg, tacrolimus) because the risk of their side effects may be increased by Flagyl ER Extended-Release Tablets
• Disulfiram because side effects, such as mental or mood changes, may occur
• Oral contraceptives (eg, birth control pills) because their effectiveness may be decreased by Flagyl ER Extended-Release Tablets

This may not be a complete list of all interactions that may occur. Ask your health care provider if Flagyl ER Extended-Release Tablets 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 Flagyl ER Extended-Release Tablets:

Use Flagyl ER Extended-Release Tablets as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Take Flagyl ER Extended-Release Tablets by mouth on an empty stomach at least 1 hour before or 2 hours after eating.
• Swallow Flagyl ER Extended-Release Tablets whole. Do not break, crush, or chew before swallowing.
• To clear up your infection completely, take Flagyl ER Extended-Release Tablets for the full course of treatment. Keep taking it even if you feel better in a few days.
• If you miss a dose of Flagyl ER Extended-Release Tablets, 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 Flagyl ER Extended-Release Tablets.

Important safety information:

• Flagyl ER Extended-Release Tablets may cause dizziness. These effects may be worse if you take it with alcohol or certain medicines. Use Flagyl ER Extended-Release Tablets with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
• Do not drink alcohol while you are taking Flagyl ER Extended-Release Tablets and for at least 3 days after the last dose.
• Contact your doctor right away if stomach pain or cramps, severe diarrhea, or bloody stools occur. Do not treat diarrhea without first checking with your doctor.
• Flagyl ER Extended-Release Tablets only works against bacteria; it does not treat viral infections (eg, the common cold).
• Be sure to use Flagyl ER Extended-Release Tablets for the full course of treatment. If you do not, the medicine may not clear up your infection completely. The bacteria could also become less sensitive to this or other medicines. This could make the infection harder to treat in the future.
• Long-term or repeated use of Flagyl ER Extended-Release Tablets may cause a second infection. Tell your doctor if signs of a second infection occur. Your medicine may need to be changed to treat this.
• Hormonal birth control (eg, birth control pills) may not work as well while you are using Flagyl ER Extended-Release Tablets. To prevent pregnancy, use an extra form of birth control (eg, condoms).
• Flagyl ER Extended-Release Tablets may interfere with certain lab tests. Be sure your doctor and lab personnel know you are taking Flagyl ER Extended-Release Tablets.
• Lab tests, including liver function and white blood cell counts, may be performed while you use Flagyl ER Extended-Release Tablets. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
• Use Flagyl ER Extended-Release Tablets with caution in the ELDERLY; they may be more sensitive to its effects.
• Flagyl ER Extended-Release Tablets should be used with extreme caution in CHILDREN; safety and effectiveness in children have not been confirmed.
• PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Flagyl ER Extended-Release Tablets while you are pregnant. Do not use Flagyl ER Extended-Release Tablets in the first 3 months of pregnancy. Flagyl ER Extended-Release Tablets is found in breast milk. Do not breast-feed while taking Flagyl ER Extended-Release Tablets.

Possible side effects of Flagyl ER Extended-Release Tablets:

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:

Appetite loss; constipation; diarrhea; dizziness; headache; metallic taste; nausea; stomach upset; vomiting.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); bloody stools; increased or decreased urination; numbness, tingling, or burning of your arms, hands, legs, or feet; seizures; severe diarrhea; sore throat, chills, or fever; stomach pain or cramps; vaginal itching, odor, or discharge; white patches in the mouth.

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. Symptoms may include nausea; seizures; vomiting.

Store Flagyl ER Extended-Release Tablets at 77 degrees F (25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Flagyl ER Extended-Release Tablets out of the reach of children and away from pets.

General information:

• If you have any questions about Flagyl ER Extended-Release Tablets, please talk with your doctor, pharmacist, or other health care provider.
• Flagyl ER Extended-Release Tablets 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 Flagyl ER Extended-Release Tablets. 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.