Sandoz Azithromycin Page 64 of 70

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1 PART III: CONSUMER INFORMATION Pr SANDOZ AZITHROMYCIN Azithromycin Tablets 250 mg Azithromycin (as Azithromycin Dihydrate) 500 mg Azithromycin (as Azithromycin Mohydrate Hemiethanolate) Manufacturer s Standard This leaflet is part III of a three-part "Product Mograph" published when Sandoz Azithromycin was approved for sale in Canada and is designed specifically for Csumers. This leaflet is a summary and will not tell you everything about Sandoz Azithromycin. Ctact your if you have any questis about the drug. ABOUT THIS MEDICATION What the medicati is used for: Sandoz Azithromycin is an antibiotic medicine to treat the following types of mild to moderate infectis by certain microorganisms in adults such as brchitis, certain types of skin infectis, strep throat (pharyngitis, tsillitis), genitourinary infectis, and pneumia. This medicati is indicated for adult patients. Your doctor will decide whether Sandoz Azithromycin is the most appropriate antibacterial for you. What it does: Sandoz Azithromycin helps stop the growth of the bacteria that cause infecti. It gets into infected tissue where it is released slowly over time. The medicine fights the infecti for several days after the last dose is taken. Antibiotics work ly infectis caused by bacteria. They do not kill viruses. No antibiotic, including Sandoz Azithromycin, can treat viral infectis such as the comm cold and the flu. When it should not be used: If you have a history of cholestatic jaundice/hepatitis (liver problems) associated with prior use of azithromycin. If you are hypersensitive (allergic) to azithromycin, or any macrolide or ketolide antibiotic (including erythromycin) or any other ingredient of Sandoz Azithromycin (see What the nmedicinal ingredients are: ). What the medicinal ingredient is: Azithromycin Dihydrate (250 mg) Azithromycin Mohydrate Hemiethanolate (500 mg) What the nmedicinal ingredients are: Cellulose microcrystalline, colloidal anhydrous silica, hydroxypropyl methylcellulose, lactose mohydrate, magnesium stearate, maize starch, polyethylene glycol, sodium lauryl sulfate, sodium starch glycolate and titanium dioxide. What dosage forms it comes in: Tablets WARNINGS AND PRECAUTIONS BEFORE you use Sandoz Azithromycin talk to your if you: are taking any prescripti medicines or any over the counter medicines you can buy without a prescripti, including natural/herbal remedies or antacids (See INTERACTIONS WITH THIS MEDICATION) you have a known prolged heart cycle (interval) (QT prolgati) you are currently taking medicati known to prolg QT interval (prolg your heart cycle) such as antiarrhythmics (drugs to regulate your heartbeat such as class IA: quinidine, procainamide and class III: dofetilide, amiodare, sotalol); antipsychotic agents; antidepressants; and fluoroquinoles (a class of antibiotics) you have a history of life-threatening irregular heartbeat you have cstantly low levels of potassium or magnesium you have a history for heart problems such as bradycardia (slow heart rate), cardiac arrhythmia ( irregular heartbeat) or cardiac insufficiency (your heart has a hard time pumping blood to your body) are pregnant or think you are pregnant, are breast feeding or planning to breastfeed. Azithromycin has been reported to be excreted in human breast milk. It is not known if Sandoz Azithromycin could affect your baby. Discuss with your doctor. have ever had any liver or kidney problems have a weak immune system have ever had an allergic reacti to any medicines, including antibiotics such as erythromycin have ever had an allergic reacti to azithromycin or any of the ingredients of Sandoz Azithromycin tablets have myasthenia gravis (a chric autoimmune neuromuscular disease which causes muscle weakness) have hereditary problems of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorpti as this product ctains lactose. You should begin to feel better within the first few days, but be sure to take Sandoz Azithromycin for the full number of days your doctor prescribed. Although Sandoz Azithromycin s dosing is short, you should not expect Sandoz Azithromycin to work faster than other antibiotics which are dosed up to 10 days. If you stop taking Sandoz Azithromycin too so, your infecti could come back. The next infecti may be worse and be more difficult to treat. If you are not able to take all the medicine, tell your doctor. Sandoz Azithromycin Page 64 of 70

2 If you develop diarrhea during or after treatment, tell your doctor at ce. Do not use any medicine to treat your diarrhea without first checking with your doctor. INTERACTIONS WITH THIS MEDICATION Drugs that may interact with Sandoz Azithromycin include: Warfarin (or other anticoagulant medicine); Cyclosporin (used in suppressing of the immune system to prevent and treat the rejecti in organs or be marrow transplants); Digoxin (used for treatment of a heart problem); Nelfinavir (used for treatment of HIV infectis); Ergotamine and ergot derivatives (used for migraine treatment). Ergotamine and ergot derivatives should not be used with Sandoz Azithromycin. Some medicines may affect how well Sandoz Azithromycin works. Check with your doctor before starting any new prescripti or over-the-counter medicines, including natural/herbal remedies or antacids, while Sandoz Azithromycin. PROPER USE OF THIS MEDICATION Usual adult dose: Sandoz Azithromycin can be taken with or without food. If your doctor prescribes Sandoz Azithromycin 250 mg for 3 days, for treatment of brchitis: Days 1 through 3: Take two tablets each day. If your doctor prescribes Sandoz Azithromycin 500 mg for 3 days, for treatment of brchitis: Days 1 through 3: Take e tablet each day. If your doctor prescribes Sandoz Azithromycin 250 mg for 5 days, for treatment of respiratory tract infectis or certain types of skin infectis: Day 1: Take 2 tablets ce. Day 2 through 5: Take 1 tablet daily. Always take Sandoz Azithromycin as the doctor has prescribed for you, depending the specific cditi you have. Overdose: In case of drug overdose, ctact a health care professial, hospital emergency department or regial Pois Ctrol Centre immediately, even if there are no symptoms. Missed Dose: If you forget to take a dose, or doctor. Do not double dose. SIDE EFFECTS As with most drugs, Sandoz Azithromycin can cause some side effects. The most comm side effects are diarrhea/loose stools, stomach pain, nausea, and vomiting. If you experience symptoms such as diarrhea (bloody or watery) with or without fever, abdominal pain, or tenderness, you may have Clostridium difficile colitis (bowel inflammati). If this occurs, stop taking Sandoz Azithromycin and ctact your healthcare professial immediately. Allergic reactis to Sandoz Azithromycin are rare, but these reactis can be very serious if not treated right away by a doctor. If you think you might be having an allergic reacti to Sandoz Azithromycin, doctor right away. If you cannot reach your doctor, go to the nearest hospital emergency room. Symptoms of a allergic reacti may include trouble breathing; swelling of the face, mouth, throat, neck; or skin rash or blisters. If you develop symptoms of hepatitis (liver inflammati) such as abdominal pain, nausea, vomiting, yellowing of skin and eyes, dark urine etc., stop taking the medicine immediately and call the nurse. If you develop symptoms of myasthenia gravis or the symptoms of your existing myasthenia gravis worsen, ctact your doctor. These symptoms could include muscle weakness that gets worse with activity and gets better with rest, drooping eyelid, blurred or double visi, difficulty chewing and swallowing, or trouble breathing. Please tell your doctor right away if you feel your heart beating in your chest or if you have an abnormal heartbeat or get dizzy or faint when taking Sandoz Azithromycin. Comm Diarrhea/loose stools Nausea Stomach pain Headache Vomiting Abnormal heart rhythm Sandoz Azithromycin Page 65 of 70

3 Severe allergic reacti such as trouble breathing, swelling of the face, mouth, throat, neck, skin rash or blisters Liver disorder (symptoms include abdominal pain, nausea, vomiting, yellowing of skin and eyes, dark urine) Myasthenia gravis (muscle weakness, drooping eyelid, visi changes, difficulty chewing and swallowing, trouble breathing) This is not a complete list of side effects. For any unexpected effects while taking Sandoz Azithromycin, ctact your. HOW TO STORE IT REPORTING SUSPECTED SIDE EFFECTS You can report any suspected adverse reactis associated with the use of health products to the Canada Vigilance Program by e of the following 3 ways: Report line at Call toll-free at Complete a Canada Vigilance Reporting Form and: - Fax toll-free to , or - Mail to: Canada Vigilance Program Health Canada Postal Locator 0701E Ottawa, Ontario K1A 0K9 Postage paid labels, Canada Vigilance Reporting Form and the adverse reacti reporting guidelines are available the MedEffect Canada Web site at NOTE: Should you require informati related to the management of side effects, ctact your health professial. The Canada Vigilance Program does not provide medical advice. MORE INFORMATION This document plus the full product mograph, prepared for health professials can be found by ctacting the spsor, Sandoz Canada Inc., at: Or by written request at: 145 Jules-Léger Boucherville QC J4B 7K8 Or by at: medinfo@sandoz.com This leaflet was prepared by Sandoz Canada Inc. Last revised: May 19, 2016 Store Sandoz Azithromycin at ctrolled room temperature (between 15 C-30ºC). Keep Sandoz Azithromycin and all medicines out of the reach and sight of children. Sandoz Azithromycin Page 66 of 70

4 PART III: CONSUMER INFORMATION Pr SANDOZ AZITHROMYCIN Azithromycin for Oral Suspensi 100 mg/5 ml and 200 mg/5 ml Azithromycin (as Azithromycin Mohydrate) Manufacturer s Standard This leaflet is part III of a three-part "Product Mograph" published when Sandoz Azithromycin was approved for sale in Canada and is designed specifically for Csumers. This leaflet is a summary and will not tell you everything about Sandoz Azithromycin. Ctact your if you have any questis about the drug. ABOUT THIS MEDICATION What the medicati is used for: Sandoz Azithromycin is an antibiotic medicine to treat the following types of mild to moderate infectis by certain microorganisms in children: ear infectis, pneumia, and throat infectis and in adults who have difficulty swallowing tablets, for various cditis. What it does: Sandoz Azithromycin gets into infected tissue where it is released slowly over time so the medicine keeps fighting bacteria for many days after the last dose is taken. This is why Sandoz Azithromycin may be taken for as short a time as e day. Antibiotics work ly infectis caused by bacteria. They do not kill viruses. No antibiotic, including Sandoz Azithromycin, can treat viral infectis such as the comm cold and the flu. When it should not be used: If you have a history of cholestatic jaundice/hepatitis (liver problems) associated with prior use of azithromycin. If you are hypersensitive (allergic) to azithromycin, or any macrolide or ketolide antibiotic (including erythromycin) or any other ingredient of Sandoz Azithromycin (see What the nmedicinal ingredients are: ). What the medicinal ingredient is: Azithromycin Mohydrate What the nmedicinal ingredients are: Aspartame, colloidal anhydrous silica, cream caramel, hydroxypropylcellulose, sucrose, titanium dioxide, trisodium phosphate anhydrous and xanthan gum. What dosage forms it comes in: Oral suspensi azithromycin 300, 600, 900 or 1500 mg/bottle, or 100 mg/5 ml, 200 mg/5 ml when recstituted (as azithromycin mohydrate). WARNINGS AND PRECAUTIONS BEFORE you use Sandoz Azithromycin talk to your if you or your child: have a known prolged heart cycle (interval) (QT prolgati) are currently taking medicati known to prolg QT interval (prolg your heart cycle) such as antiarrhythmics (drugs to regulate your heartbeat such as class IA: quinidine, procainamide and class III: dofetilide, amiodare, sotalol); antipsychotic agents; antidepressants; and fluoroquinoles (a class of antibiotics) have a history of life-threatening irregular heartbeat have cstantly low levels of potassium or magnesium have a history for heart problems such as bradycardia (slow heart rate), cardiac arrhythmia ( irregular heartbeat) or cardiac insufficiency (your heart has a hard time pumping blood to your body) is taking any prescripti medicines or any over the counter medicines you can buy without a prescripti, including natural/herbal remedies or antacids (See INTERACTIONS WITH THIS MEDICATION) have diabetes or hereditary problems of fructose intolerance, glucose-galactose malabsorpti or saccharase-isomaltase deficiency, as this product ctains sucrose is pregnant or thinks they are pregnant, is breast feeding or planning to breastfeed. Azithromycin has been reported to be excreted in human breast milk. It is not known if Sandoz Azithromycin could affect a baby. Discuss with your doctor. has ever had any liver or kidney problems has a weak immune system has myasthenia gravis (a chric autoimmune neuromuscular disease which causes muscle weakness) is allergic to any medicines including antibiotics such as erythromycin is allergic to azithromycin or any of the ingredients of Sandoz Azithromycin suspensi. (See What the nmedicinal ingredients are: ) If your child develops diarrhea during or after treatment, tell your child s doctor at ce. Do not use any medicine to treat your child s diarrhea without first checking with your child s doctor. Although Sandoz Azithromycin's dosing is short and you may be able to give all the medicine to your child more easily, you should not expect Sandoz Azithromycin to work faster than other antibiotics which are dosed for up to 10 days. Your child's nurse can advise you when your child should begin feeling better. INTERACTIONS WITH THIS MEDICATION Sandoz Azithromycin Page 67 of 70

5 Drugs that may interact with Sandoz Azithromycin include: Warfarin (or other anticoagulant medicine); Cyclosporin (used in suppressing of the immune system to prevent and treat the rejecti in organs or be marrow transplants); Digoxin (used for treatment of cardiac impairment); Nelfinavir (used for treatment of HIV infectis); Ergotamine and ergot derivatives (used for migraine treatment). Ergotamine and ergot derivatives should not be used with Sandoz Azithromycin. Some medicines may affect how well Sandoz Azithromycin works. Check with your doctor before starting any new prescripti or over-the-counter medicines, including natural/herbal remedies or antacids, while Sandoz Azithromycin. PROPER USE OF THIS MEDICATION Your child's doctor will decide the total amount of Sandoz Azithromycin to give to your child, depending your child's weight and the specific infecti your child has. In additi to deciding the total amount of Sandoz Azithromycin to give to your child, the doctor will tell you to give all the medicine to your child in 1 day or to divide it over 3 days or over 5 days. Sandoz Azithromycin should be taken ce-a-day and may be given with or without food. Shake the bottle well just before you give a dose. Use the dosing device that comes with Sandoz Azithromycin to carefully measure the dose. Do not use a household teaspo as it is not accurate enough. For Throat Infectis (Pharyngitis/Tsillitis) For throat infectis, your child's doctor will tell you to give Sandoz Azithromycin to your child in the following way: ce-a day for 5 days. When Sandoz Azithromycin is given for 5 days for throat infectis, you do not need to give a double dose the first day (as you would with ear infectis). If your child vomits within 30 minutes after the 1-day treatment for an ear infecti, it is recommended that you or child s doctor because your child may need to receive the same dose of medicine again. If you have questis about how to give Sandoz Azithromycin to your child, please ask your child's doctor, nurse or. Instructis for Use of the Dosing Devices: Use ly the dosing device provided to measure the correct amount of suspensi. 1. To open, push down the bottle cap while twisting the cap counter clockwise. Remove cap from bottle. 2. Push plastic stopper into bottle top (if has not de so). 3. Pull back syringe handle to prescribed dose. 4. Insert syringe into bottle top. Give Sandoz Azithromycin for the full number of days prescribed by the doctor, even if your child feels better before finishing all the medicine as prescribed. For Ear Infectis For ear infectis, your child's doctor will tell you to give Sandoz Azithromycin to your child in e of the following ways: the total amount as 1 dose 1 day or ce-a-day for 3 days or ce-a-day for 5 days, with a double dose the first day. Whether given all 1 day, or divided over 3 days or over 5 days, the total amount of Sandoz Azithromycin you give to your child should be the same. For Pneumia For pneumia, your child's doctor will tell you to give Sandoz Azithromycin to your child ce-a-day for 5 days, with a double dose the first day. Overdose: 5. Push down syringe handle to allow air into bottle. 6. Turn bottle upside down and pull back syringe handle, drawing prescribed dose of medicine into syringe. 7. Remove syringe from bottle. Give medicine by mouth by slowly pushing syringe handle. Remember to put the cap back the medicine bottle. Sandoz Azithromycin Page 68 of 70

6 In case of drug overdose, ctact a health care professial, hospital emergency department or regial Pois Ctrol Centre immediately, even if there are no symptoms. Missed Dose: If you forget to give your child a dose, or child s doctor. Do not double dose. SIDE EFFECTS As with most drugs, Sandoz Azithromycin can cause some side effects. The most comm side effects are diarrhea/loose stools, stomach pain, nausea, and vomiting. If your child experiences symptoms such as diarrhea (bloody or watery) with or without fever, abdominal pain, or tenderness, your child may have Clostridium difficile colitis (bowel inflammati). If this occurs, your child should stop taking Sandoz Azithromycin and you should ctact your child s healthcare professial immediately. Allergic reactis to Sandoz Azithromycin are rare, but these reactis can be very serious if not treated right away by a doctor. If you think your child might be having an allergic reacti to Sandoz Azithromycin, child s doctor right away. If you cannot reach your child s doctor, go to the nearest hospital emergency room. Symptoms of a allergic reacti may include trouble breathing; swelling of the face, mouth, throat, neck; or skin rash or blisters. If your child develops symptoms of hepatitis (liver inflammati) such as abdominal pain, nausea, vomiting, yellowing of skin and eyes, dark urine etc., stop taking the medicine immediately and child s nurse. If your child develops symptoms of myasthenia gravis or the symptoms of your child s existing myasthenia gravis worsen, ctact your child s doctor. These symptoms could include muscle weakness that gets worse with activity and gets better with rest, drooping eyelid, blurred or double visi, difficulty chewing and swallowing, or trouble breathing. Please tell your child s doctor right away if your child feels their heart beating in their chest or if your child has an abnormal heartbeat or gets dizzy or faints when taking Sandoz Azithromycin. Comm Diarrhea/loose stools Nausea Stomach pain Headache Vomiting Abnormal heart rhythm Severe allergic reacti such as trouble breathing, swelling of the face, mouth, throat and neck, skin rash or blisters Liver disorder (symptoms include abdominal pain, nausea, vomiting, yellowing of skin and eyes, dark urine) Myasthenia gravis (muscle weakness, drooping eyelid, visi changes, difficulty chewing and swallowing, trouble breathing) This is not a complete list of side effects. For any unexpected effects while taking Sandoz Azithromycin, ctact your. HOW TO STORE IT Sandoz Azithromycin dry powder can be stored at ctrolled room temperature (15 C-30 C). Protect from light. Sandoz Azithromycin Page 69 of 70

7 Recstituted suspensi: Store between 5 C and 30 C. Discard unused porti after 10 days. Throw away any medicine that is left over after treatment. Keep Sandoz Azithromycin and all medicines out of the reach and sight of children. REPORTING SUSPECTED SIDE EFFECTS You can report any suspected adverse reactis associated with the use of health products to the Canada Vigilance Program by e of the following 3 ways: Report line at Call toll-free at Complete a Canada Vigilance Reporting Form and: - Fax toll-free to , or - Mail to: Canada Vigilance Program Health Canada Postal Locator 0701E Ottawa, Ontario K1A 0K9 Postage paid labels, Canada Vigilance Reporting Form and the adverse reacti reporting guidelines are available the MedEffect Canada Web site at NOTE: Should you require informati related to the management of side effects, ctact your health professial. The Canada Vigilance Program does not provide medical advice. MORE INFORMATION This document plus the full product mograph, prepared for health professials can be found by ctacting the spsor, Sandoz Canada Inc., at: Or by written request at: 145 Jules-Léger Boucherville QC J4B 7K8 Or by at: medinfo@sandoz.com This leaflet was prepared by Sandoz Canada Inc. Last revised: June 29, 2016 Sandoz Azithromycin Page 70 of 70