azithromycin
Consumer Medicine Information (CMI) summary
The
full CMI on the next page has more details. If you are worried about using this medicine,
speak to your doctor or pharmacist.
1. Why am I taking Zithromax?
Zithromax contains an active ingredient azithromycin. Zithromax is used to treat infections
in different parts of the body caused by bacteria. For more information, see Section
1. Why am I taking Zithromax? in the full CMI.
2. What should I know before I take Zithromax?
Do not take Zithromax if you (or your child) have ever had an allergic reaction to
azithromycin or other antibiotics that are the same type, or any of the ingredients
listed at the end of the CMI. Your doctor will know which antibiotics are the same
type as Zithromax. Zithromax tablets contain lactose, the oral suspension contains
milk products and high level of sugars.
Talk to your doctor if you (or your child) have kidney, liver or heart problems including
abnormalities of the rhythm; muscle weakness; low levels of potassium or magnesium
in your blood; take any other medicines; if you are pregnant, or plan to become pregnant
or are breastfeeding. For more information, see Section
2. What should I know before I take Zithromax? in the full CMI.
3. What if I am taking other medicines?
4. How do I take Zithromax?
Your doctor will decide how much Zithromax you or your child should take, it will
depend on the type of infection, or child's bodyweight. More instructions can be found
in Section
4. How do I take Zithromax? in the full CMI.
5. What should I know while taking Zithromax?
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Things you should do
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Tell your doctor if the symptoms of the infection do not improve within a few days
or they become worse; you have chest pain; shortness of breath; dizziness; severe
diarrhoea; sore white mouth or tongue; you have vaginal itching or discharge; you
become pregnant or are breastfeeding.
Talk to your doctor about the need for additional method of contraception.
Tell your doctor immediately if during treatment with Zithromax your baby develops
irritability with feeding or starts vomiting.
Tell any other doctor or dentist you visit that you (or your child) are taking Zithromax.
For more information on "Things you should do" can be found in Section 5 in the full
CMI.
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Things you should not do
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Do not stop taking this medicine or lower the dosage without checking with your doctor.
Do not take Zithromax to treat any other medical complaints unless your doctor tells
you to.
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Driving or using machines
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Be careful driving or using any machines or tools until you know how Zithromax affects
you. Zithromax may cause dizziness in some people.
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Looking after your medicine
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Store in original carton at below 30°C until ready for use.
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6. Are there any side effects?
Side effects of this medicine may include oral/vaginal thrush; nausea; vomiting; loss
of appetite; fever; diarrhoea; stomach pain; constipation; indigestion; dizziness;
headache; spinning sensation; drowsiness; fatigue; restlessness; aggression; nervousness;
agitation; anxiety; chest pain; palpitations; sweat; shortness of breath; wheezing;
convulsions; fainting; rash, itching or hives; swelling of face, lips, tongue or body;
sunburn; decreased sensitivity especially skin; blisters or ulcers on skin, mouth
or airways; muscle pain; numbness or weakness; trouble speaking, understanding or
walking; loss of balance; lack of coordination; abnormal hearing; altered vision,
taste/smell; dark urine or blood in urine or bowel motions; jaundice. For more information,
including what to do if you have any side effects, see Section
6. Are there any side effects? in the full CMI.
azithromycin
Full Consumer Medicine Information (CMI)
This leaflet provides important information about using Zithromax. You should also speak to your doctor or pharmacist if you would like further information
or if you have any concerns or questions about taking Zithromax.
Where to find information in this leaflet:
1. Why am I taking Zithromax?
Zithromax contains the active ingredient azithromycin
which is an antibiotic. It belongs to a group of medicines called azalides. The azalides are a sub-class
of a group of antibiotics called macrolides.
Zithromax is used to treat infections in different parts of the body caused by bacteria.
It is commonly used to treat Chlamydia.
Zithromax works by killing or stopping the growth of bacteria causing your infection.
Zithromax will not work against viral infections such as colds or flu.
Your doctor may have prescribed it for another reason. Ask your doctor if you have any questions about why Zithromax has been prescribed
for you.
2. What should I know before I take Zithromax?
Warnings
Do not take Zithromax if you are allergic to:
azithromycin
any of the ingredients listed at the end of this leaflet
any other macrolide or ketolide antibiotics (e.g., clarithromycin, erythromycin, roxithromycin,
telithromycin). Your doctor will know which antibiotics are the same type as Zithromax
lactose (tablets)
have restrictions concerning sugars or milk products (oral suspension).
Symptoms of an allergic reaction may include shortness of breath, wheezing or difficulty
breathing; swelling of the face, lips, tongue or other parts of the body; rash, itching
or hives on the skin.
Do not take Zithromax if:
the packaging is torn or shows signs of tampering
the expiry date printed on the pack has passed.
Check with your doctor if you have ever had:
liver problems
kidney problems
heart problems, including abnormalities of the rhythm
diabetes
hereditary fructose intolerance, glucose-galactose malabsorption or saccharise-isomaltase
deficiency
cystic fibrosis
muscle weakness
low levels of potassium or magnesium in your blood.
During treatment, you may be at risk of developing certain side effects. It is important
you understand these risks and how to monitor for them. See additional information
under Section
6. Are there any side effects?
Pregnancy and breastfeeding
Check with your doctor if you are pregnant or intend to become pregnant. Talk to your
doctor if you are breastfeeding or intend to breastfeed. Your doctor can discuss with
you the risks and benefits involved.
This medicine is available only with a doctor's prescription.
Zithromax is not addictive.
Use in children
Zithromax oral suspension is for use in children.
3. What if I am taking other medicines?
Tell your doctor or pharmacist if you are taking any other medicines, including any
medicines, vitamins or supplements that you buy without a prescription from your pharmacy,
supermarket or health food shop.
Some medicines may interfere with Zithromax or increase the risk of side effects.
These include:
antacids (medicines used to treat indigestion)
colchicine (a medicine used to treat gout)
coumarin-type oral anti-coagulants (a medicine used to prevent blood clots)
ciclosporin (a medicine used to prevent organ transplant rejection or to treat certain
problems with the immune system)
atorvastatin (a medicine used to lower cholesterol)
digoxin (a medicine used to treat abnormal heart rhythm or heart failure)
ergot derivatives (such as ergotamine, which is used to treat migraines)
terfenadine or astemizole (medicines used to treat allergies and hay fever)
zidovudine, a medicine used to treat patients with AIDS
some medicines used to treat heart rhythm problems (heart arrhythmia) such as amiodarone,
disopyramide, ibutilide and sotalol
antipsychotic medicines used to treat schizophrenia or bipolar mania such as haloperidol,
quetiapine and risperidone
medicines used to treat depression (antidepressants) such as fluoxetine, sertraline
and venlafaxine
fluoroquinolone antibiotics such as ciprofloxacin, lomefloxacin, moxifloxacin and
norfloxacin
oral contraceptives (birth control pills). Some side effects from Zithromax may interfere
with effectiveness of birth control pills.
These medicines may be affected by Zithromax or may affect how well it works. You
may need different amounts of your medicines, or you may need to take different medicines.
Talk to your doctor about the need for additional contraception while taking Zithromax.
Check with your doctor or pharmacist if you are not sure about what medicines, vitamins
or supplements you are taking and if these affect Zithromax.
Your doctor or pharmacist has more information on medicines to be careful with or
to avoid while taking Zithromax.
4. How do I take Zithromax?
How much to take
The doctor will decide what dose of Zithromax is needed depending on certain factors
such as the type of infection and bodyweight of your child.
The usual dose to treat Chlamydia is two 500 mg tablets taken as a single dose.
For other infections Zithromax is usually taken once a day. Sometimes the dose is
taken once a week. Your doctor will decide the right dose for you.
Zithromax oral suspension is for use by children. The dose for your child will depend
on his or her body weight.
Your pharmacist will explain how to use it if you are not sure.
Follow all directions given to you by your doctor or pharmacist carefully.
They may differ from the information contained in this leaflet.
If you do not understand the instructions on the pack, ask your doctor or pharmacist
for help.
How long to take
Continue taking Zithromax until you finish the pack or bottle or until your doctor
recommends.
Do not stop taking it because you are feeling better.
If you do not complete the full course prescribed by your doctor, the infection may
not clear completely or your symptoms may return.
If you are not sure how long you should be taking Zithromax, check with your doctor.
When to take Zithromax
Zithromax may be taken with or without food.
If you are taking an antacid, take it at least one hour before or two hours after
your Zithromax dose.
This will avoid any possible effect of the antacid on the absorption of Zithromax.
How to take Zithromax
Tablets:
Swallow the tablets whole with liquid.
Oral Suspension:
Shake the bottle well before use and use the measuring syringe supplied.
If you forget to take Zithromax
If you are taking Zithromax for three days or longer and you miss a dose, take it
as soon as you remember (within a 24- hour period), then continue as normal.
Do not try to make up for missed doses by taking more than one dose at a time.
If you are not sure what to do, check with your doctor or pharmacist.
If you have trouble remembering to take your Zithromax, ask your pharmacist for some
hints.
If you take too much Zithromax
Immediately telephone your doctor or Poisons Information Centre (13 11 26) for advice
if you think that you or anyone else may have taken too much Zithromax.
Do this even if there are no signs of discomfort or poisoning. You may need urgent
medical attention.
If you take too many tablets or too much oral suspension, you may get an upset stomach,
diarrhoea or skin rashes.
5. What should I know while taking Zithromax?
Things you should do
Call your doctor straight away if:
the symptoms of your infection do not improve within a few days, or if they become
worse
you have chest pain, shortness of breath, sudden dizziness, light-headedness or numbness
in the face, arm, or leg
you have severe diarrhoea. Do this even if it occurs several weeks after Zithromax
has been stopped.
Diarrhoea may mean that you have a serious condition affecting your bowel. You may
need urgent medical care. Do not take any diarrhoea medicine without first checking
with your doctor.
you have a sore, white mouth or tongue while taking, or soon after stopping Zithromax
you have vaginal itching or discharge.
This may mean you have a yeast infection called thrush. Sometimes the use of Zithromax
allows yeast to grow and the above symptoms to occur. Zithromax does not work against
yeast.
your baby develops irritability with feeding or starts vomiting.
This may be a sign of a stomach disorder in the infant.
If you become pregnant while taking Zithromax.
If you are about to start any new medicines, tell your doctor and pharmacist that
you are taking Zithromax.
Tell any other doctor or dentist you visit that you are taking Zithromax.
Things you should not do
Do not stop taking Zithromax or lower the dosage without checking with your doctor.
If you do not complete the full course prescribed by your doctor, all the organisms
causing your infection may not be killed. These organisms may continue to grow and
multiply so that your infection may not clear completely or may return.
Do not give Zithromax to anyone else, even if they have the same condition as you
Do not use Zithromax to treat any other medical complaints unless your doctor tells
you to
Do not take any other medicines whether they require a prescription or not without
first telling your doctor or consulting with a pharmacist.
Things to be careful of
Protect your skin when you are in the sun, especially between 10am and 3pm.
Some macrolide antibiotics may cause your skin to be more sensitive to sunlight than
it is normally. Exposure to sunlight may cause a skin rash, itching, redness or severe
sunburn.
If outdoors, wear protective clothing and use a 30+ sunscreen. If your skin does appear
to be burning tell your doctor immediately.
Driving or using machines
Be careful driving or using any machines or tools until you know how Zithromax affects
you. Zithromax may cause dizziness in some people.
Drinking alcohol
No information available.
Looking after your medicine
Keep Zithromax in its original packaging until it is time to use it. If you take Zithromax
out of its packaging, it may not keep as well.
Keep your Zithromax in a cool, dry place where the temperature stays below 30°C.
Do not store Zithromax or any other medicine in the bathroom or near a sink. Do not
leave it in the car or on a window sill. Heat and dampness can destroy some medicines.
Do not use this medicine after the expiry date.
Keep it where young children cannot reach it.
A locked cupboard at least one-and-a-half meters above the ground is a good place
to store medicines.
When to discard your medicine
If your doctor tells you to stop taking this medicine, or it has passed its expiry
date, take it to any pharmacy for safe disposal.
Discard any oral suspension left over after 10 days.
6. Are there any side effects?
All medicines can have side effects. If you do experience any side effects, most of
them are minor and temporary. However, some side effects may need medical attention.
See the information below and, if you need to, ask your doctor or pharmacist if you
have any further questions about side effects.
Less serious side effects
Serious side effects
These are serious side effects. You may need urgent medical attention or hospitalisation.
These side effects are rare.
Tell your doctor or pharmacist if you notice anything else that may be making you
feel unwell.
Other side effects not listed here may occur in some people.
Some of these side effects (for example certain liver conditions, and blood abnormalities)
can only be found when your doctor does tests from time to time to check your progress.
After finishing it
Tell your doctor immediately if you notice any of the following side effects, particularly
if they occur several weeks after stopping treatment with Zithromax.
Severe abdominal cramps or stomach cramps
Watery and severe diarrhoea, which may also be bloody
Fever in combination with one or both of the above.
Zithromax can cause some bacteria, which are normally present in the bowel and normally
harmless, to multiply and therefore cause the above symptoms. You may need urgent
medical attention. However, this side effect is rare.
Do not take any medicine for this diarrhoea without first checking with your doctor.
Ask your doctor or pharmacist if you don't understand anything in these lists.
Do not be alarmed by the lists of possible side effects. You may not experience any
of them.
Reporting side effects
After you have received medical advice for any side effects you experience, you can
report side effects to the Therapeutic Goods Administration online at
www.tga.gov.au/reporting-problems . By reporting side effects, you can help provide more information on the safety of
this medicine.
Always make sure you speak to your doctor or pharmacist before you decide to stop
taking any of your medicines.
7. Product details
This medicine is only available with a doctor's prescription.
What Zithromax Tablet contains
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Active ingredient
(main ingredient)
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azithromycin
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Other ingredients
(inactive ingredients)
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pregelatinsed-maize starch
calcium hydrogen phosphate
croscarmellose sodium
magnesium stearate
sodium lauryl sulfate
lactose
hypromellose
titanium dioxide
glycerol triacetin
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What Zithromax Powder for Oral Suspension contains
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Active ingredient
(main ingredient)
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azithromycin
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Other ingredients
(inactive ingredients)
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sucrose
sodium phosphate
hyprolose
xanthan gum
cherry flavour
banana flavour
vanilla flavour (contains milk products)
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Do not take this medicine if you are allergic to any of these ingredients.
What Zithromax looks like
Zithromax 500 mg (AUST R 58797) - white to off white, unscored, modified capsule-shaped film coated
tablets, engraved with 'ZTM 500' on one side and 'Pfizer' on the other. Blister packs
of 2 and 3.
Zithromax 600 mg ( AUST R 60057) - white to off white, scored, modified oval film coated tablets,
engraved with 'ZTM 600' on one side and 'PFIZER' on the other. Blister pack of 8.
Zithromax Powder for Oral Suspension (AUST R 60049) - a white to off-white powder in a 15 mL bottle, and it is an off-white
to orange to brown liquid when made up with water.
Who distributes Zithromax
Pfizer Australia Pty Ltd
Sydney NSW
Toll Free Number: 1800 675 229
This leaflet was prepared in December 2024.
® Registered trademark