Biaxin Filmtab

Biaxin Filmtab is used for:

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Treating infections caused by certain bacteria.

Biaxin Filmtab is a macrolide antibiotic. It works by stopping the growth of or killing sensitive bacteria by reducing the production of important proteins needed by the bacteria to survive.

Do NOT use Biaxin Filmtab if:

• you are allergic to any ingredient in Biaxin Filmtab or to any other macrolide (eg, erythromycin)
• you are taking cisapride, cyclosporine, dofetilide, eletriptan, an ergot alkaloid (eg, dihydroergotamine, ergotamine), an H₁ antagonist (eg, astemizole, terfenadine), pimozide, a QT-prolonging agent (eg, quinidine, sotalol, thioridazine), a quinolone (eg, ciprofloxacin), or sumatriptan

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

Before using Biaxin Filmtab :

Some medical conditions may interact with Biaxin Filmtab . 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 diarrhea, a stomach infection, a blood disorder, severe kidney problems, or liver problems

Some MEDICINES MAY INTERACT with Biaxin Filmtab . Tell your health care provider if you are taking any other medicines, especially any of the following:

• Aldosterone blockers (eg, spironolactone), anticoagulants (eg, warfarin), benzodiazepines (eg, alprazolam), buspirone, carbamazepine, cilostazol, cisapride, colchicine, corticosteroids (eg, hydrocortisone), cyclosporine, digoxin, disopyramide, eletriptan, ergot alkaloids (eg, ergotamine, dihydroergotamine), H₁ antagonists (eg, astemizole, terfenadine), HMG-CoA reductase inhibitors (eg, simvastatin), imatinib, macrolide immunosuppressants (eg, tacrolimus), macrolides and ketolides (eg, azithromycin, erythromycin), phosphodiesterase type 5 inhibitors (eg, sildenafil), rifampin, sumatriptan, theophyllines, or verapamil because their actions and the risk of their side effects may be increased by Biaxin Filmtab
• Dofetilide, macrolides and ketolides (eg, azithromycin, erythromycin), pimozide, QT-prolonging agents (eg, quinidine, sotalol, thioridazine), quinolones (eg, ciprofloxacin), or streptogramins (eg, mikamycin) because serious, possibly life-threatening side effects on the heart or irregular heartbeat may occur
• Rifampin because it may decrease Biaxin Filmtab 's effectiveness

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

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

• Take Biaxin Filmtab by mouth with or without food.
• Biaxin Filmtab works best if it is taken at the same time each day.
• Continue to take Biaxin Filmtab even if you feel well. Do not miss any doses.
• Do not miss any doses. If you miss a dose of Biaxin Filmtab , 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 Biaxin Filmtab .

Important safety information:

• Biaxin Filmtab only works against bacteria; it does not treat viral infections (eg, the common cold).
• This product may contain tartrazine dye (FD & C Yellow No. 5). This may cause an allergic reaction in some patients. If you have ever had an allergic reaction to tartrazine, ask your pharmacist if your product has tartrazine in it.
• Long-term or repeated use of Biaxin Filmtab 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.
• Be sure to use Biaxin Filmtab 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.
• Mild diarrhea is common with antibiotic use. However, a more serious form of diarrhea (pseudomembranous colitis) may rarely occur. This may develop while you use the antibiotic or within several months after you stop using it. 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.
• Lab tests, including complete blood cell counts, may be performed while you use this medicine. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
• Biaxin Filmtab should not be used in CHILDREN younger than 6 months old; safety and effectiveness in these children have not been confirmed.
• PREGNANCY and BREAST-FEEDING: Biaxin Filmtab has been shown to cause harm to the fetus. Biaxin Filmtab is not recommended for use during pregnancy except when no other antibiotics can be used. If you think you may be pregnant, contact your doctor. You will need to discuss the benefits and risks of using Biaxin Filmtab while you are pregnant. It is not known if Biaxin Filmtab is found in breast milk. If you are or will be breast-feeding while you use Biaxin Filmtab , check with your doctor. Discuss any possible risks to your baby.

Possible side effects of Biaxin Filmtab :

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:

Abnormal taste; diarrhea; headache; indigestion; nausea; stomach discomfort; vomiting.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); bloody stools; confusion; decreased urination; depression; emotional or mood changes; hallucinations; nightmares; severe diarrhea; severe stomach pain/cramps; trouble sleeping.

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 / dnn / Resources / FindLocalPoisonCenters / tabid / 130 / Default.aspx), or emergency room immediately. Symptoms may include diarrhea; nausea; stomach pain; vomiting.

Store Biaxin Filmtab at room temperature, between 68 and 77 degrees F (20 and 25 degrees C), in a tightly closed container. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Biaxin Filmtab out of the reach of children and away from pets.

General information:

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