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AZITH
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.
AZITH contains the active ingredient azithromycin. It is used to treat pneumonia,
a lung infection caused by certain bacteria.
For more information, see Section 1. Why am I being treated with AZITH? in the full CMI.
You should not be given AZITH if you have ever had an allergic reaction to azithromycin
or any other ketolide or macrolide antibiotic (e.g. roxithromycin, erythromycin, clarithromycin,
telithromycin), or citric acid.
Tell your doctor if you 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; are pregnant or plan to become pregnant, or are breastfeeding.
For more information, see Section 2. What should I know before treatment with AZITH? in the full CMI.
Some medicines may interfere with AZITH and affect how it works.
A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI.
AZITH is given as a slow infusion "drip" into a vein by a doctor or trained nurse.
More instructions can be found in Section 4. How is AZITH given? in the full CMI.
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Things you should do
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Talk to your doctor if the symptoms of your infection do not improve within a few
days or they become worse.
Talk to your doctor about the need for additional method of contraception; if you
become pregnant; if you breastfeed or your baby develops irritability with feeding
or starts vomiting.
Tell all doctors, dentists or pharmacists who are treating you that you are being
given AZITH.
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Things you should not do
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Do not breastfeed your baby without discussing the risks with your doctor.
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Driving or using machines
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This medicine is not expected to affect your ability to drive a car or operate machinery.
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Looking after your medicine
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AZITH is stored in the pharmacy or on the hospital ward under the correct conditions.
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For more information, see Section 5. What should I know during treatment of AZITH? in the full CMI.
Less serious side effects include pain at injection site; oral/vaginal thrush; nausea; vomiting; loss of appetite;
altered taste/smell; abnormal hearing; muscle pain; stomach pain; constipation; indigestion;
dizziness; headache; spinning sensation; drowsiness; fatigue; restlessness. Serious side effects include diarrhoea; 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; fever; numbness or weakness; trouble
speaking, understanding or walking; loss of balance; lack of coordination; altered
vision; 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.
AZITH
Active ingredient:
azithromycin (as monohydrate)
Consumer Medicine Information (CMI)
This leaflet provides important information about using AZITH. You should also speak to your doctor or pharmacist if you would like further information
or if you have any concerns or questions about using AZITH.
Where to find information in this leaflet:
AZITH contains the active ingredient azithromycin (as monohydrate).
This medicine is an antibiotic which belongs to a group of medicines called azalides.
The azalides are a sub-class of a group of antibiotics called macrolides.
AZITH is used to treat pneumonia, a lung infection caused by certain bacteria. It works by killing or stopping the growth of bacteria causing your infection.
AZITH will not work against viral infections such as colds or flu.
Your doctor may have prescribed AZITH for another reason.
Ask your doctor if you have any questions about why this medicine has been prescribed
for you.
There is no evidence that AZITH is addictive.
Warnings
AZITH should not be given to you if you have an allergy to:
azithromycin, any other ketolide or macrolide antibiotic (e.g., roxithromycin, erythromycin,
clarithromycin, telithromycin) or citric acid.
any of the ingredients listed at the end of this leaflet.
If you are not sure if you are allergic to any of the above, ask your doctor.
Some of the symptoms of an allergic reaction may include:
skin rash, itching or hives
swelling of the face, lips, tongue or other parts of the body
shortness of breath, wheezing or difficulty breathing.
Tell your doctor if you have allergies to any other medicines, foods, preservatives
or dyes.
Check with your doctor if you have ever had the following medical conditions:
kidney problems
liver problems
heart problems, including abnormalities of the rhythm
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
Talk your doctor if you are pregnant or plan to become pregnant.
Talk your doctor if you are breastfeeding or plan to breastfeed.
Your doctor will discuss with you the risks and benefits involved.
If you have not told your doctor about any of the above, tell them before you are
given AZITH.
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 AZITH and affect how it works. These include:
antacids, a medicine used to treat indigestion
colchicine, a medicine used to treat gout
coumarin-type oral anticoagulants, 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 hayfever
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.
These medicines may be affected by AZITH 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 being given
AZITH.
Your doctor or pharmacist has more information on medicines to be careful with or
avoid while being given AZITH.
How much is given
Your doctor will decide how much AZITH you should receive and the length of time for
which you should receive it.
The usual dose of AZITH is 500 mg for 2 to 5 days.
This treatment may be followed by a course of oral antibiotics.
How is AZITH given
AZITH is given through slow infusion “drip” into a vein by your doctor or nurse over
a period about 60 minutes.
If you are given too much AZITH
As AZITH will most likely be given to you in hospital under the supervision of your
doctor, it is very unlikely that you will receive too much.
However, if you experience any side effects, especially abnormal hearing, tell your
doctor or nurse immediately. If you are not already in hospital, go to Accident and
Emergency at the nearest hospital or immediately contact the Poisons Information Centre
for advice on overdose (Call 13 11 26).
You should do this even if there are no signs of discomfort or poisoning.
Things you should do
Tell any doctor, nurse or pharmacist 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 get severe diarrhoea, even if it happens several weeks after treatment with AZITH
has been stopped.
Diarrhoea may mean that you have a serious condition affecting your bowel. You may
need urgent medical care.
you get a sore, white mouth or tongue while being given, or soon after stopping AZITH
or you get vaginal itching or discharge.
These symptoms may mean you have a yeast infection called thrush. Sometimes the use
of AZITH allows yeast to grow and the above symptoms to occur. AZITH does not work
against yeast.
you become pregnant while being given AZITH
during treatment with AZITH your baby develops irritability with feeding or starts
vomiting.
This may be a sign of a stomach disorder in the infant.
you are about to start any new medicines.
If you are about to start any new medicines, tell your doctor and pharmacist that
you are being given AZITH.
Tell all doctors, dentists and pharmacists who are treating you that you are being
given AZITH.
Things to be careful of
Protect your skin when you are in the sun, especially between 10 am and 3 pm. If outdoors,
wear protective clothing and use a 30+ sunscreen.
AZITH may cause your skin to be much more sensitive to sunlight than it is normally.
Exposure to sunlight may cause a skin rash, itching, redness, or severe sunburn.
If your skin does appear to be burning tell your doctor immediately.
Things you must not do
Do not stop having treatment with AZITH 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.
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 take any other medicines whether they require a prescription or not without
first telling your doctor or consulting with a pharmacist.
Driving or using machines
Be careful driving or operating machinery until you know how AZITH affects you.
Whilst it is unlikely that you will drive or operate machinery when having AZITH,
you need to be aware that AZITH may cause side effects such as dizziness. This may
affect your ability to drive or operate machinery.
Looking after your medicine
AZITH is stored in the pharmacy or on the hospital ward under the correct conditions.
Tell your doctor, nurse or pharmacist as soon as possible if you do not feel well
while you are being treated with AZITH.
AZITH is effective against certain serious infections for most people but it may have
unwanted side effects in some.
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
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Less serious side effects
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What to do
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pain or inflammation at injection site
oral thrush - white, furry, sore tongue and mouth
vaginal thrush - sore and itchy vagina and/or white discharge
nausea (feeling sick)
vomiting, loss of appetite
constipation
stomach pain, indigestion, wind
dizziness, spinning sensation
headache
tiredness, drowsiness, fatigue, restlessness
muscle or joint aches
rash
hearing loss or ringing in the ears
altered taste and smell.
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Speak to your nurse or doctor if you have any of these less serious side effects and
they worry you.
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Serious side effects
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Serious side effects
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What to do
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diarrhoea, usually with blood and mucus, stomach pain and fever
severe upper stomach pain, often with nausea and vomiting
fast or irregular heartbeat, palpitations
chest pain
sudden dizziness or lightheadedness
cold sweat
sudden signs of allergy such as rash, itching or hives on the skin, swelling of the
face, lips, tongue or other parts of the body, shortness of breath, wheezing or trouble
breathing
widespread body rash, fever and swollen lymph nodes
symptoms of sunburn such as redness, itching, swelling or blistering which may occur
more quickly than normal
decreased feeling or sensitivity, especially in the skin
signs of frequent or worrying infections such as fever, severe chills, sore throat
or mouth ulcers
bleeding or bruising more easily than normal, reddish or purplish blotches under the
skin
dark urine or blood in the urine or bowel motions
blisters or ulcers on the skin, in the mouth or airways that may occur after a period
of fever yellowing of the eyes or skin, also called jaundice
pain or discomfort in the jaw, neck, back, arm, leg or shoulder
numbness or weakness in the face, arm, or leg
trouble with speech, or understanding what others are saying
aggressive reaction, nervousness, agitation or anxiety
problems with vision
trouble walking, loss of balance, or lack of coordination
fainting
convulsions (fits).
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Alert your nurse or doctor straight away if you notice any of these serious side effects.
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The above list includes very serious side effects. You may need urgent medical attention
or hospitalisation.
Tell your doctor, nurse 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.
Do not be alarmed at this list of possible side effects.
You may not experience any of them.
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 AZITH:
Severe abdominal or stomach cramps
Watery and severe diarrhoea, which may be bloody
Fever in combination with one or both of the above.
AZITH 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.
Do not take any medicine for this diarrhoea without first checking with your doctor.
Ask your doctor, nurse or pharmacist if you don't understand anything in these lists.
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.
This medicine is only available with a doctor's prescription.
What AZITH 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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citric acid
sodium hydroxide
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Do not take this medicine if you are allergic to any of these ingredients.
What AZITH looks like
AZITH 500 mg powder for injection is a white powder in a glass vial. The powder is
dissolved and then diluted, providing 100 mg/mL solution following reconstitution.
Available in packs of 1 vial. (AUST R 146755).
