Zmax®
(azithromycin extended release) for Oral Suspension (ZEE-macks)

Read this patient information leaflet carefully before taking Zmax®. It does not replace talking with your doctor. Only your doctor can decide if Zmax is right for you. If you have any questions, ask your doctor or pharmacist.

What is Zmax?

Zmax is an antibiotic that kills bacteria. Zmax is dosed differently from other antibiotics. You take just one dose, one time.

• Day 1: Take Zmax in one dose. Zmax starts working.¹
• Days 2 – 3: As with most antibiotics, you may not feel better right away.
• After day 3: Zmax continues to work over time.^{1, 2} If your symptoms have not improved, call your doctor.

Zmax works in adults against bacteria to treat:

• Sinus infections
• Certain kinds of pneumonia (lung infections)

Zmax only works against bacteria. It does not work against viruses, like cold or flu.

You should not take Zmax if…

• You are allergic to antibiotics like erythromycin or telithromycin (Ketek®).
• You are allergic to anything in Zmax. See a list of ingredients at the end of this leaflet. Talk with your doctor or pharmacist if you have questions about your medicine allergies.

Before you start Zmax…

Tell your doctor about all your medical problems. Be sure to tell your doctor if you:

• Are pregnant, or might be pregnant. It is not known if Zmax could harm your baby.
• Are breast-feeding. Do not take if breast-feeding. Zmax may pass through breast milk into your baby.
• Have liver problems.
• Have kidney problems.

Tell your doctor about any medications you may be taking, including vitamins, herbal products, and over-the-counter drugs. Tell your doctor if you are taking:

• Warfarin (Coumadin®), digoxin, or cyclosporine
• Drugs for migraine headache, seizures, or AIDS (HIV)

Know all the medicines you take. Keep a list of them to show your doctor or pharmacist.

Do I need to prepare Zmax™?

• If you get Zmax in liquid form, it is ready to take.
• If you get Zmax as dry powder, you must add water to the bottle before you take it. To prepare Zmax:

1. Open the pouch and take out the bottle with the dry powder.
2. To open the bottle, press down on the cap and twist.
3. Use a measuring cup to add 60 mL (1/4 cup) water to the Zmax bottle.
4. Tightly close the bottle and shake to mix it.

How do I take Zmax?

• Keep Zmax at room temperature (59 – 86ºF or 15 – 30ºC).
• Shake the bottle well before using.
• Use it within 12 hours after water was added.
• Take all the medicine in the bottle.
• It is recommended that you take Zmax on an empty stomach (at least 1 hour before eating or 2 hours after eating).
• You can take antacids with Zmax.

How will I know Zmax is working?

Zmax needs time to work, so you may not feel better right away. If your symptoms do not improve in a few days, call your doctor.

What are possible side effects?

Zmax may cause serious side effects. These happened in a small number of patients.

• Allergic reactions: Get emergency help right away if you:
  • have hives, trouble swallowing, or your face or throat swells
  • have wheezing or trouble breathing These symptoms could go away and then come back.
• Diarrhea: Diarrhea is a common problem caused by antibiotics which usually ends when the antibiotic is discontinued. Sometimes, however, patients can develop watery and bloody stools (with or without stomach cramps and fever) even as late as two or more months after taking their last dose of the antibiotic. If this occurs, you should contact your physician as soon as possible.

The most common side effects in adults are:

• Diarrhea/loose stools
• Nausea
• Stomach pain

Other side effects are:

• Headache
• Vomiting

Patients who vomit within the first hour should contact their doctor.

There are other, less common side effects. For a list of all reported side effects, ask your doctor or pharmacist.

General advice about Zmax

Doctors can prescribe medicines for conditions that are not in the patient leaflets. Do not use Zmax for anything other than what your doctor prescribed. Do not give it to other people, even if they have the same symptoms you have. It may harm them. If this happens, call your doctor or local poison control center, or go to the emergency room. This leaflet is a summary of the most important information about Zmax. For more information, talk with your doctor or pharmacist, or visit our website at www.zmaxinfo.com.

What is in Zmax?

Active ingredient: azithromycin dihydrate

Inactive ingredients: glyceryl behenate, poloxamer 407, sucrose, sodium phosphate tribasic anhydrous, magnesium hydroxide, hydroxypropyl cellulose, xanthan gum, colloidal silicon dioxide, titanium dioxide, artificial cherry flavor, and artificial banana flavor

Brand names are registered trademarks of their respective owners. Coumadin® is a registered trademark of Bristol-Myers Squibb, Inc. Ketek® is a registered trademark of Aventis Pharmaceuticals Inc.

References

1. Pfizer Inc. Final Study Report A0661112.

2. Pfizer Inc. Final Study Report A066087.

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