ZITHROMAX (Azithromycin Dihydrate) Tablet, Film Coated [REMEDYREPACK INC.]

ZITHROMAX ® (Zith-roe-maks)

(azithromycin)

Tablets

ZITHROMAX ®

(azithromycin)

Oral Suspension

Read this Patient Information leaflet before you start taking ZITHROMAX and each time you get a refill. There may be new information. This information does not take the place of talking to your healthcare provider about your medical condition or your treatment.

What is ZITHROMAX?

ZITHROMAX is a macrolide antibiotic prescription medicine used in adults 18 years or older to treat certain infections caused by certain germs called bacteria. These bacterial infections include:

• acute worsening of chronic bronchitis
• acute sinus infection
• community-acquired pneumonia
• infected throat or tonsils
• skin infections
• infections of the urethra or cervix
• genital ulcers in men

ZITHROMAX is also used in children to treat:

• ear infections
• community-acquired pneumonia
• infected throat or tonsils

Azithromycin should not be taken by people who cannot tolerate oral medications because they are very ill or have certain other risk factors including:

• have cystic fibrosis
• have hospital acquired infections
• have known or suspected bacteria in the blood
• need to be in the hospital
• are elderly
• have any medical problems that can lower the ability of the immune system to fight infections

ZITHROMAX is not for viral infections such as the common cold.

It is not known if ZITHROMAX is safe and effective for genital ulcers in women.

It is not known if ZITHROMAX is safe and effective for children with ear infections, sinus infections, and community-acquired pneumonia under 6 months of age.

It is not known if ZITHROMAX is safe and effective for infected throat or tonsils in children under 2 years of age.

Who should not take ZITHROMAX?

Do not take ZITHROMAX if you:

• have had a severe allergic reaction to certain antibiotics known as macrolides or ketolides including azithromycin and erythromycin.
• have a history of cholestatic jaundice or hepatic dysfunction that happened with the use of azithromycin.

What should I tell my healthcare provider before taking ZITHROMAX?

Before you take ZITHROMAX, tell your healthcare provider if you:

• have pneumonia
• have cystic fibrosis
• have known or suspected bacteremia (bacterial infection in the blood)
• have liver or kidney problems
• have an irregular heartbeat, especially a problem called "QT prolongation"
• have a problem that causes muscle weakness (myasthenia gravis)
• have any other medical problems
• are pregnant or plan to become pregnant. It is not known if ZITHROMAX will harm your unborn baby.
• are breastfeeding or plan to breastfeed. ZITHROMAX has been reported to pass into breast milk. Talk to your healthcare provider about the best way to feed your baby while you take ZITHROMAX.

Tell your healthcare provider about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements.

ZITHROMAX and other medicines may affect each other causing side effects. ZITHROMAX may affect the way other medicines work, and other medicines may affect how ZITHROMAX works.

Especially tell your healthcare provider if you take:

• nelfinavir
• a blood thinner (warfarin)
• digoxin
• phenytoin
• an antacid that contains aluminum or magnesium

Know the medicines you take. Keep a list of your medicines and show it to your healthcare provider and pharmacist when you get a new medicine.

How should I take ZITHROMAX?

• Take ZITHROMAX exactly as your healthcare provider tells you to take it.
• ZITHROMAX can be taken with or without food.
• If you take ZITHROMAX Oral Suspension, shake the bottle well just before you take it.
• Do not skip any doses of ZITHROMAX or stop taking it, even if you begin to feel better, until you finish your prescribed treatment unless you have a serious allergic reaction or your healthcare provider tells you to stop taking ZITHROMAX. "See What are the possible side effects of ZITHROMAX?" If you skip doses, or do not complete the total course of ZITHROMAX your treatment may not work as well and your infection may be harder to treat. Taking all of your ZITHROMAX doses will help lower the chance that the bacteria will become resistant to ZITHROMAX.
• If the bacteria becomes resistant to ZITHROMAX, ZITHROMAX and other antibiotic medicines may not work for you in the future.
• If you take too much ZITHROMAX, call your healthcare provider or get medical help right away.

id="sideeffect"> What are the possible side effects of ZITHROMAX?

ZITHROMAX can cause serious side effects, including:

• Serious allergic reactions. Allergic reactions can happen in people taking azithromcyin the active ingredient in ZITHROMAX, even after only 1 dose. Stop taking ZITHROMAX and get emergency medical help right away if you have any of the following symptoms of a severe allergic reaction:
  • trouble breathing or swallowing
  • swelling of the lips, tongue, face
  • throat tightness, hoarseness
  • rapid heartbeat
  • faintness
  • skin rash (hives)
  • new onset of fever and swollen lymph nodes

  Stop taking ZITHROMAX at the first sign of a skin rash and call your healthcare provider. Skin rash may be a sign of a more serious reaction to ZITHROMAX.

• Liver damage (hepatotoxicity). Hepatotoxicity can happen in people who take ZITHROMAX. Call your healthcare provider right away if you have unexplained symptoms such as:

  nausea or vomiting stomach pain fever weakness abdominal pain or tenderness itching unusual tiredness

  loss of appetite change in the color of your bowel movements dark colored urine yellowing of your skin or of the whites of your eyes

  Stop taking ZITHROMAX and tell your healthcare provider right away if you have yellowing of your skin or white part of your eyes, or if you have dark urine. These can be signs of a serious reaction to ZITHROMAX (a liver problem).

• Serious heart rhythm changes (QT prolongation and torsades de pointes).

  Tell your healthcare provider right away if you have a change in your heartbeat (a fast or irregular heartbeat), or if you feel faint and dizzy. ZITHROMAX may cause a rare heart problem known as prolongation of the QT interval. This condition can cause an abnormal heartbeat and can be very dangerous. The chances of this happening are higher in people:

  • who are elderly
  • with a family history of prolonged QT interval
  • with low blood potassium
  • who take certain medicines to control heart rhythm (antiarrhythmics)
• Worsening of myasthenia gravis (a problem that causes muscle weakness). Certain antibiotics like ZITHROMAX may cause worsening of myasthenia gravis symptoms, including muscle weakness and breathing problems. Call your healthcare provider right away if you have any worsening muscle weakness or breathing problems.
• Diarrhea. Tell your healthcare provider right away if you have watery diarrhea, diarrhea that does not go away, or bloody stools. You may experience cramping and a fever. This could happen after you have finished your ZITHROMAX.

  The most common side effects of ZITHROMAX include:

  • nausea
  • stomach pain
  • vomiting

These are not all the possible side effects of ZITHROMAX. Tell your healthcare provider about any side effect that bothers you or that does not go away.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

How should I store ZITHROMAX?

• Store ZITHROMAX Tablets at 59°F to 86°F (15°C to 30°C).
• Store ZITHROMAX Oral Suspension at 41°F to 86°F (5°C to 30°C).
• Keep ZITHROMAX Oral Suspension in a tightly closed container.
• Safely throw away any medicine that is out of date or no longer needed.

Keep ZITHROMAX and all medicines out of the reach of children.

General information about the safe and effective use of ZITHROMAX.

Medicines are sometimes prescribed for purposes other than those listed in the Patient Information leaflet. Do not use ZITHROMAX for a condition for which it was not prescribed.

Do not give ZITHROMAX to other people, even if they have the same symptoms you have.

It may harm them.

This Patient Information leaflet summarizes the most important information about ZITHROMAX. If you would like more information, talk with your healthcare provider. You can ask your pharmacist or healthcare provider for information about ZITHROMAX that is written for health professionals.

For more information, go to www.zithromax.com or call 1-800-438-1986.

What are the ingredients in ZITHROMAX Tablets and Oral Suspension?

ZITHROMAX Tablets and Oral Suspension

Active ingredient: azithromycin dehydrate

ZITHROMAX Tablets:

Inactive ingredients: dibasic calcium phosphate anhydrous, pregelatinized starch, sodium croscarmellose, magnesium stearate, sodium lauryl sulfate, hypromellose, lactose, titanium dioxide, triacetin, and D&C Red #30 aluminum lake.

ZITHROMAX Oral Suspension:

Inactive ingredients: sucrose; sodium phosphate, tribasic, anhydrous; hydroxypropyl cellulose; xanthan gum; FD&C Red #40; and spray dried artificial cherry, creme de vanilla, and banana flavors.

This Patient Information has been approved by the U.S. Food and Drug Administration.

LAB-0372-4.0

Revised May 2015

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ZITHROMAX (Azithromycin Dihydrate) Tablet, Film Coated [REMEDYREPACK INC.]