Consumer Information for: SANDOZ AZITHROMYCIN
Consumer Information
Information about the product including what the product is used for, dosage, warnings, proper use and side effects. This summary will not tell you everything about the product. Contact your healthcare professional if you have any questions about the product.
What the medication is used for
Sandoz Azithromycin is an antibiotic medicine used to treat the following types of mild to
moderate infections by certain microorganisms in children: ear infections, pneumonia, and
throat infections and in adults who have difficulty swallowing tablets, for various conditions.
Antibacterial drugs like Sandoz Azithromycin treat only bacterial infections. They do not treat
viral infections such as the common cold. Although you may feel better early in treatment,
Sandoz Azithromycin should be taken exactly as directed. Misuse or overuse of Sandoz
Azithromycin could lead to the growth of bacteria that will not be killed by Sandoz Azithromycin
(resistance). This means that Sandoz Azithromycin may not work for you in the future. Do not
share your medicine.
What it does
Sandoz Azithromycin helps stop the growth of the bacteria that cause infection. It 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 one day.
When it should not be used
Do not use Sandoz Azithromycin if you:
- have a history of liver problems when you have used azithromycin.
- are hypersensitive (allergic) to azithromycin, or any macrolide or ketolide antibiotic (including erythromycin) or any other ingredient of Sandoz Azithromycin (see “What are the ingredients in Sandoz Azithromycin?”).
What the medicinal ingredient is
Azithromycin Tablets
Azithromycin Dihydrate (250 mg);
Azithromycin Monohydrate Hemiethanolate (500 mg)
Azithromycin for Oral Suspension
Azithromycin Monohydrate
What the non-medicinal ingredients are
Azithromycin Tablets
Cellulose microcrystalline, colloidal anhydrous silica, hydroxypropyl methylcellulose, lactose monohydrate, magnesium stearate, maize starch, polyethylene glycol, sodium lauryl sulfate, sodium starch glycolate and titanium dioxide.
Azithromycin for Oral Suspension
Aspartame, colloidal anhydrous silica, cream caramel, hydroxypropylcellulose, sucrose, titanium dioxide, trisodium phosphate anhydrous and xanthan gum.
What dosage form it comes in
Azithromycin Tablets
Tablets: 250 mg, 500 mg
Azithromycin for Oral Suspension
Powder for oral suspension – azithromycin 300, 600, 900 or 1500 mg/bottle, or 100 mg/5 ml, 200 mg/5 ml when reconstituted (as azithromycin monohydrate).
Warnings and precautions
Azithromycin Tablets
To help avoid side effects and ensure proper use, talk to your healthcare professional before you take Sandoz Azithromycin. Talk about any health conditions or problems you may have, including if you:
- have a known prolonged heart cycle (interval) (QT prolongation)
- are currently taking medication known to prolong QT interval (prolong your heart cycle) such as antiarrhythmics (drugs to regulate your heartbeat such as class IA: quinidine, procainamide and class III: dofetilide, amiodarone, sotalol); antipsychotic agents; antidepressants; and fluoroquinolones (a class of antibiotics)
- have a history of life-threatening irregular heartbeat
- have constantly low levels of potassium or magnesium in your blood
- have a history for heart problems such as slow heart rate, irregular heart beat 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 is 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 reaction to any medicines, including antibiotics such as erythromycin
- have myasthenia gravis (a chronic autoimmune neuromuscular disease which causes muscle weakness)
- have hereditary problems of galactose intolerance, Lapp lactase deficiency or glucosegalactose malabsorption as this product contains 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 soon, your infection could come back. The next infection may be worse and be more difficult to treat. If you are not able to take all the medicine, tell your doctor.
If you develop diarrhea during or after treatment with Sandoz Azithromycin, tell your doctor at once. Do not use any medicine to treat your diarrhea without first checking with your doctor.
Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.
Azithromycin for Oral Suspension
- have a known prolonged heart cycle (interval) (QT prolongation)
- are currently taking medication known to prolong QT interval (prolong your heart cycle) such as antiarrhythmics (drugs to regulate your heartbeat such as class IA: quinidine, procainamide and class III: dofetilide, amiodarone, sotalol); antipsychotic agents; antidepressants; and fluoroquinolones (a class of antibiotics)
- have a history of life-threatening irregular heartbeat
- have constantly low levels of potassium or magnesium in your blood
- have a history for heart problems such as slow heart rate, irregular heartbeat or cardiac insufficiency (your heart has a hard time pumping blood to your body)
- have diabetes or hereditary problems of fructose intolerance, glucose-galactose malabsorption or saccharase-isomaltase deficiency, as this product contains sucrose
- are pregnant or think you are pregnant,
- are breastfeeding or planning to breastfeed. Azithromycin is excreted in human breast milk. It is not known if Sandoz Azithromycin could affect a baby. Discuss with your doctor.
- have ever had any liver or kidney problems
- have a weak immune system
- have myasthenia gravis (a chronic autoimmune neuromuscular disease which causes muscle weakness)
- are allergic to any medicines including antibiotics such as erythromycin
Other warnings you should know about:
If your child develops diarrhea during or after treatment with Sandoz Azithromycin, tell your
child’s doctor at once. Do not use any medicine to treat your child’s diarrhea without first
checking with your child’s doctor.
Your child should begin to feel better within the first few days, but be sure to give Sandoz
Azithromycin for the full number of days your child’s doctor prescribed. 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. If you stop giving Sandoz Azithromycin to your child too soon, their
infection could come back. The next infection may be worse and be more difficult to treat. If you
are not able to give all the medicine to your child, tell your child’s doctor.
If your baby develops projectile vomiting or irritability during feeding, during or after treatment
with Sandoz Azithromycin, contact your baby’s doctor at once.
Your child's doctor or nurse can advise you when your child should begin feeling better.
Tell your healthcare professional about all the medicines you take, including any drugs,
vitamins, minerals, natural supplements or alternative medicines.
Interactions with this medication
The following may interact with Sandoz Azithromycin:
- Warfarin (or other anticoagulant medicine);
- Cyclosporin (used to suppress the immune system to prevent and treat rejection in organ or bone marrow transplants);
- Digoxin (used for treatment of heart problems);
- Colchicine (used for treatment of gout);
- Nelfinavir (used for treatment of HIV infections);
- Ergotamine and ergot derivatives (used for migraine treatment). Ergotamine and ergot derivatives should not be used with Sandoz Azithromycin.
Proper use of this medication
Azithromycin Tablets
How to take Sandoz Azithromycin?
Always take Sandoz Azithromycin as the doctor has prescribed for you, depending on the
specific condition you have.
Sandoz Azithromycin can be taken with or without food.
Azithromycin for Oral Suspension
How to take Sandoz Azithromycin:
Your child's doctor will decide the total amount of Sandoz Azithromycin to give to your child,
depending on your child's weight and on the specific infection your child has. In addition 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 once-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 teaspoon as it is not accurate enough.
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.
Usual Dose
Azithromycin Tablets
If your doctor prescribes Sandoz Azithromycin 250 mg tablets for 3 days for treatment of bronchitis:
-
Days 1 through 3: Take two tablets each day.
-
Days 1 through 3: Take one tablet each day.
-
Day 1: Take 2 tablets once.
Day 2 through 5: Take 1 tablet daily.
-
Days 1: Take four tablets once.
-
Days 1: Take eight tablets once.
Azithromycin for Oral Suspension
For Ear Infections
For ear infections, your child's doctor will tell you to give Sandoz Azithromycin to your child in
one of the following ways:
- the total amount as 1 dose on 1 day or
- once-a-day for 3 days or
- once-a-day for 5 days, with a double dose on the first day.
For Pneumonia
For pneumonia, your child's doctor will tell you to give Sandoz Azithromycin to your child oncea-day for 5 days, with a double dose on the first day.
For Throat Infections
For throat infections, your child's doctor will tell you to give Sandoz Azithromycin to your child in the following way: once-a day for 5 days. When Sandoz Azithromycin is given for 5 days for throat infections, you do not need to give a double dose on the first day (as you would with ear infections).
If your child vomits within 30 minutes after the 1-day treatment for an ear infection, it is recommended that you call your pharmacist or child’s doctor because your child may need to receive the same dose of medicine again.
If you have questions about how to give Sandoz Azithromycin to your child, please ask your child's doctor, nurse or pharmacist.
Instructions for Use of the Dosing Devices:
Use only the dosing device provided to measure the correct amount of suspension.
Overdose
Missed Dose
Azithromycin Tablets
If you forget to take a dose, call your pharmacist or doctor. Do not double dose.
Azithromycin for Oral Suspension
If you forget to give your child a dose, call your pharmacist or child’s doctor. Do not double dose.
Side effects and what to do about them
These are not all the possible side effects you may feel when taking Sandoz Azithromycin. If you experience any side effects not listed here, contact your healthcare professional. Side effects may include:
- Diarrhea/loose stools
- Stomach pain
- Nausea and vomiting
- Headache
Azithromycin Tablets
| Symptom / effect | Talk with your doctor, nurse, or pharmacist only if severe | Talk with your doctor, nurse, or pharmacist in all cases | Stop taking drug and get immediate medical help |
|---|---|---|---|
| Common | |||
| Clostridium difficile colitis (bowel inflammation): severe diarrhea (bloody or watery) with or without fever, abdominal pain, or tenderness | ✔ | ||
| Uncommon | |||
| Abnormal heart rhythm: feel your heart beating in your chest, abnormal heartbeat, dizziness or feeling faint | ✔ | ||
| Severe allergic reaction: trouble breathing, swelling of the face, mouth, throat, neck, severe skin rash or blisters | ✔ | ||
| Liver disorder: abdominal pain, nausea, vomiting, yellowing of skin and eyes, dark urine | ✔ | ||
| Myasthenia gravis: muscle weakness, drooping eyelid, vision changes, difficulty chewing and swallowing, trouble breathing | ✔ | ||
If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, talk to your healthcare professional.
Azithromycin for Oral Suspension
| Symptom / effect | Talk with your doctor, nurse, or pharmacist only if severe | Talk with your doctor, nurse, or pharmacist in all cases | Stop taking drug and get immediate medical help |
|---|---|---|---|
| Common | |||
| Clostridium difficile colitis (bowel inflammation): severe diarrhea (bloody or watery) with or without fever, abdominal pain, or tenderness | ✔ | ||
| Uncommon | |||
| Abnormal heart rhythm: feel your heart beating in your chest, abnormal heartbeat, dizziness or feeling faint | ✔ | ||
| Severe allergic reaction: trouble breathing, swelling of the face, mouth, throat, neck, severe skin rash or blisters | ✔ | ||
| Intestinal blockage: Projectile vomiting, irritability during feeding | ✔ | ||
| Liver disorder: abdominal pain, nausea, vomiting, yellowing of skin and eyes, dark urine | ✔ | ||
| Myasthenia gravis: muscle weakness, drooping eyelid, vision changes, difficulty chewing and swallowing, trouble breathing | ✔ | ||
If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, talk to your healthcare professional.
How to store
Store Sandoz Azithromycin at controlled room temperature (between 15°C-30ºC).
Keep out of reach and sight of children.
Reporting side effects
You can report any suspected side effects associated with the use of health products to Health Canada by:
- Visiting the Web page on Adverse Reaction Reporting ( https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/adverse-reaction-reporting.html) for information on how to report online, by mail or by fax; or
- Calling 1-866-234-2345 (toll-free);
More information
If you want more information about Sandoz Azithromycin:
- Talk to your healthcare professional
- Find the full product monograph that is prepared for healthcare professionals and includes this Patient Medication Information by visiting the Health Canada website (https://www.canada.ca/en/health-canada.html); the manufacturer’s website www.sandoz.ca or by calling 1-800-361-3062.
Last revised: November 13, 2018
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