This summary contains important information about Sandoz Azithromycin. Drawing A

DAY 1
IMPORTANT: PLEASE READ
PART III: CONSUMER INFORMATION
DAY 1
Sandoz® Azithromycin
(Azithromycin Monohydrate)
Powder for Oral Suspension
This summary contains important information about Sandoz Azithromycin.
It is not meant to take the place of your child’s doctor’s instructions. Read
this information carefully before you give Sandoz Azithromycin to your child.
Keep this leaflet. You may need to read it again. This leaflet does not contain
the complete information about Sandoz Azithromycin. Ask your child’s doctor, nurse or pharmacist if you do not understand any of this information or
if you want to know more about Sandoz Azithromycin.
This medicine has been prescribed for your child personally and you should
not pass it on to others. It may harm them, even if their symptoms are the
same as your child’s.
What is Sandoz Azithromycin (azithromycin monohydrate)?
Sandoz Azithromycin is an antibiotic medicine that is taken only once a day to
treat the following types of infections in children: ear infections, pneumonia, and
throat infections.
Can Antibiotics Cure a Cold or Flu?
No. Antibiotics work only on infections caused by bacteria. They do not kill viruses.
No antibiotic, including Sandoz Azithromycin, can treat viral infections such as the
common cold and the flu.
What to Tell Your Child’s Doctor Before You Start Sandoz Azithromycin
Only your child’s doctor can decide if Sandoz Azithromycin is right for your child.
Before you start S­ andoz Azithromycin, be sure to tell the doctor if your child:
DAY 1
Drawing A
1-Day Treatment for Ear Infections
DAY 1
DAY 2
DAY 3
DAY 2
DAY 3
DAY 1
DAY 1
Drawing B
3-Day Treatment for Ear Infections
DAY 1
DAY 2
DAY 3
DAY 1
DAY 2
DAY 3
DAY 1
DAY 2
DAY 3
DAY 1
DAY 2
DAY 3
DAY 4
DAY 5
Drawing C
5-Day Treatment for Ear Infections or Pneumonia
DAY 4
DAY 5
DAY 4
DAY 5
•is being given any prescription medicines, including those for asthma
•is being given any over-the-counter medicines you can buy without a prescription, including n­ atural/herbal remedies or antacids
•has ever had any liver or kidney problems
•has any other medical problems
•is allergic to any medicines
•is allergic to certain antibiotics such as erythromycin
•is allergic to azithromycin or any of the ingredients of Sandoz Azithromycin
suspension. (See What Does Sandoz Azithromycin Powder for Oral Suspension Contain?)
When Can I Expect My Child to Begin Feeling Better?
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 doctor or nurse can advise you when your child should begin feeling
better.
How and When to Give Sandoz Azithromycin?
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.
If you forget to give your child a dose, call your pharmacist or child’s doctor.
What is the Right Amount of Sandoz Azithromycin to Give to My Child?
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 one day.
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.
DAY 1
DAY 3
Drawing
D DAY 2
5-Day Treatment for Throat Infections
DAY 1
DAY 2
DAY 3
DAY 4
DAY 5
DAY 1
DAY 2
DAY 3
DAY 4
DAY 5
DAY 1
DAY 2
DAY 3
DAY 4
DAY 5
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 (see
Drawing A), or once-a-day for 3 days (see Drawing B) or once-a-day for 5 days,
with a double dose on the first day (see Drawing C). Whether given all on 1 day,
1
2
DAY 3
4
DAY 5
or DAY
divided
over DAY
3 days
or over
5 days, theDAY
total
amount
of Sandoz Azithromycin you
give to your child should be the same.
For Pneumonia
For pneumonia, your child’s doctor will tell you to give Sandoz Azithromycin to your
child
with
on the
day (see Drawing C).
DAYonce-a-day
1
DAYfor
2 5 days,DAY
3 a double
DAYdose
4
DAYfirst
5
For Throat Infections (Pharyngitis/Tonsillitis)
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 (see Drawing D). 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 you have questions about how to give Sandoz Azithromycin to your child,
please ask your child’s doctor, nurse or pharmacist.
What Should I Do if My Child Vomits (Spits Up) the 1-Day Treatment of
Sandoz Azithromycin?
If your child vomits within 30 minutes after the 1-Day treatment (Drawing A) 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.
Sandoz Azithromycin and Other Medicines
Some medicines can affect how well Sandoz Azithromycin works. Check with your
child’s doctor before giving your child any new medicines.
Possible Side Effects
Like all medicines, Sandoz Azithromycin may cause side effects in some children
that are usually mild to moderate and go away after the medicine is stopped.
The most common ones are diarrhea, abdominal (“tummy”) pain, vomiting and
nausea.
As with other antibiotics, if your child develops diarrhea that becomes severe and
watery or does not go away, stop taking the medicine and call the doctor or nurse.
This could be a sign of a serious medical problem.
Allergic reactions to Sandoz Azithromycin are rare, but these can be very serious
if not treated right away by a doctor. If you think your child might be having an allergic reaction to Sandoz Azithromycin, stop the medicine and call the doctor right
away. If you cannot reach the doctor, go to the nearest hospital emergency room.
Symptoms of a severe allergic reaction may include trouble breathing; swelling of
the face, mouth and neck; or severe skin rash or blisters.
Sandoz Azithromycin may cause other less common side effects besides those
listed here. If you have any unexpected side effects while taking Sandoz Azithromycin, contact your doctor, nurse or pharmacist.
REPORTING SUSPECTED SIDE EFFECTS
You can report any suspected adverse reactions associated with the use
of health products to the Canada Vigilance Program by one of the following
3 ways:
• Report online at www.healthcanada.gc.ca/medeffect
• Call toll-free at 1-866-234-2345
• Complete a Canada Vigilance Reporting form and:
- Fax toll-free to 1-866-678-6789, 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 reaction
reporting guidelines are available on the MedEffect™ Canada Web site at
www.healthcanada.gc.ca/medeffect.
Pull back on syringe
handle to prescribed
dose.
Insert syringe into bottle
top.
5
6
Push down on syringe
handle to allow air into
bottle.
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 on
syringe handle.
Remember to put the
cap back on the
medicine bottle.
Rinse the syringe with water after each daily dose. After your child has taken
Sandoz Azithromycin for the correct number of days, throw out the syringe, cap,
and bottle. Do not save any medicine for future use.
What does Sandoz Azithromycin (azithromycin monohydrate) Powder for
Oral Suspension Contain?
The active substance contained in Sandoz Azithromycin is azithromycin monohydrate equivalent to: 300 mg; 600 mg; 900 mg and 1500 mg of azithromycin
per bottle. The nonmedicinal ingredients include: sucrose, xanthan gum, hydroxypropylcellulose, trisodium phosphate anhydrous, colloidal anhydrous silica,
aspartame, cream caramel, and titanium dioxide. After reconstitution, the 300 mg
strength contains 100 mg/5 mL and the 600, 900 mg and 1500 mg each contain
200 mg/5 mL azithromycin.
MORE INFORMATION
This document plus the full product monograph, prepared for health professionals can be obtained by contacting the sponsor, Sandoz Canada Inc., at:
1-800-361-3062
or by written request at:
145 Jules-Léger
Boucherville QC
J4B 7K8
Or by e-mail at: [email protected]
This leaflet was prepared by Sandoz Canada Inc.
NOTE: Should you require information related to the management of side
effects, contact your health professional. The Canada Vigilance Program does
not provide medical advice.
What to Do for an Overdose
In the event of overdosage, contact your doctor, hospital emergency department or
regional Poison Control Centre.
How to Store Sandoz Azithromycin
Keep Sandoz Azithromycin out of the reach of children. Sandoz Azithromycin
can be stored between 5-30°C. Throw away any medicine that is left over after
treatment.
Instructions for Use of the Dosing Devices:
Use only the dosing device provided to measure the correct amount of suspension.
ORAL SYRINGE
If you receive the oral syringe with Sandoz Azithromycin oral suspension shake the
bottle well before using. The syringe may need to be filled many times to get the
full dose needed for the day.
1
2
To open, push down on
the bottle cap while
twisting the cap
counterclockwise.
Remove cap from
bottle.
Push plastic stopper
into bottle top (if
pharmacist has not
done so).
Once inserted, leave
plastic stopper in place.
3
4
Pull back on syringe
handle to prescribed
dose.
Insert syringe into bottle
top.
® Registered trademark used under license by Sandoz Canada Inc.
Sandoz Canada Inc.
Qc, Canada J4B 7K8
[email protected]
? 1-800-361-3062
Last revised: September 2009
46017915Sus vi
5
6
Push down on syringe
handle to allow air into
bottle.
Turn bottle upside down
and pull back syringe
handle, drawing