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 using Amoxicillin/Clavulanic Acid Viatris 500/125 or Amoxicillin/Clavulanic
Acid Viatris 875/125?
2. What should I know before I use Amoxicillin/Clavulanic Acid Viatris 500/125 or Amoxicillin/Clavulanic
Acid Viatris 875/125 tablets?
3. What if I am taking other medicines?
Some medicines may interfere with Amoxicillin/Clavulanic Acid Viatris 500/125 or Amoxicillin/Clavulanic
Acid Viatris 875/125 tablets 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.
4. How do I use Amoxicillin/Clavulanic Acid Viatris 500/125 or Amoxicillin/Clavulanic
Acid Viatris 875/125 tablets?
5. What should I know while using Amoxicillin/Clavulanic Acid Viatris 500/125 or Amoxicillin/Clavulanic
Acid Viatris 875/125 tablets?
Things you should do
|
Take Amoxicillin/Clavulanic Acid Viatris 500/125 or Amoxicillin/Clavulanic Acid Viatris
875/125 tablets as exactly as your doctor has prescribed.
Tell your doctor if, for any reason, you have not taken your medicine exactly as directed.
Remind any doctor, dentist or pharmacist you visit that you are using Amoxicillin/Clavulanic
Acid Viatris 500/125 or Amoxicillin/Clavulanic Acid Viatris 875/125 tablets.
Tell your doctor if the symptoms of your infection become worse, or do not improve
within a few days of starting Amoxicillin/Clavulanic Acid Viatris 500/125 or Amoxicillin/Clavulanic
Acid Viatris 875/125 tablets.
|
Things you should not do
|
Do not give this medicine to anyone else, even if their symptoms seem similar to yours.
Do not use to treat any other complaints unless your doctor says to.
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Driving or using machines
|
Be careful before your drive or use any machines or tools until you know how Amoxicillin/Clavulanic
Acid Viatris 500/125 or Amoxicillin/Clavulanic Acid Viatris 875/125 tablets affects
you.
|
Drinking alcohol
|
Alcohol should be avoided during and for several days after treatment with Amoxicillin/Clavulanic
Acid Viatris 500/125 or Amoxicillin/Clavulanic Acid Viatris 875/125 tablets.
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Looking after your medicine
|
Keep your tablets in the original pack until it is time to take them.
Store it in a cool dry place away from moisture, heat or sunlight.
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6. Are there any side effects?
The most common side effects of Amoxicillin/Clavulanic Acid Viatris 500/125 and Amoxicillin/Clavulanic
Acid Viatris 875/125 tablets are diarrhoea, nausea and vomiting.
Active ingredient(s):
amoxicillin (as trihydrate) and clavulanic acid (as potassium clavulanate)
Full Consumer Medicine Information (CMI)
This leaflet provides important information about using Amoxicillin/Clavulanic Acid
Viatris 500/125 or Amoxicillin/Clavulanic Acid Viatris 875/125 tablets. 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 Amoxicillin/Clavulanic Acid Viatris
500/125 or Amoxicillin/Clavulanic Acid Viatris 875/125 tablets.
Where to find information in this leaflet:
1. Why am I using Amoxicillin/Clavulanic Acid Viatris 500/125 or Amoxicillin/Clavulanic
Acid Viatris 875/125 tablets?
Amoxicillin/Clavulanic Acid Viatris 500/125 or Amoxicillin/Clavulanic Acid Viatris
875/125 tablets contains two active ingredients. One of these is a penicillin called
amoxicillin and the other is clavulanic acid. Amoxicillin/Clavulanic Acid Viatris 500/125 or Amoxicillin/Clavulanic Acid Viatris
875/125 tablets belong to the penicillin group of antibiotics. Amoxicillin/Clavulanic
Acid Viatris 500/125 or Amoxicillin/Clavulanic Acid Viatris 875/125 tablets works
by killing the bacteria that cause these infections. It will not work against infections
caused by viruses such as colds or the flu.
Amoxicillin/Clavulanic Acid Viatris 500/125 or Amoxicillin/Clavulanic Acid Viatris
875/125 tablets are used for the short term treatment of a wide range of infections
in the body caused by bacteria. These infections may affect the chest (bronchitis
or pneumonia), bladder (cystitis), sinuses (sinusitis), the ears (otitis media) or
the skin.
Your doctor may prescribe Amoxicillin/Clavulanic Acid Viatris 500/125 or Amoxicillin/Clavulanic
Acid Viatris 875/125 tablets for another use. If you want more information, ask your
doctor.
There is no evidence that Amoxicillin/Clavulanic Acid Viatris 500/125 or Amoxicillin/Clavulanic
Acid Viatris 875/125 tablets are addictive.
2. What should I know before I use Amoxicillin/Clavulanic Acid Viatris 500/125 or Amoxicillin/Clavulanic
Acid Viatris 875/125 tablets?
Warnings
Do not use Amoxicillin/Clavulanic Acid Viatris 500/125 or Amoxicillin/Clavulanic Acid
Viatris 875/125 tablets if:
you are allergic to amoxicillin trihydrate, potassium clavulanate, penicillin or similar
types of antibiotics (such as cephalosporins), or any of the ingredients listed at
the end of this leaflet.
Some of the symptoms of an allergic reaction may include skin rash, itching, difficulty
in breathing and swelling of the face or tongue.
you have previously experienced liver problems after taking Amoxicillin/Clavulanic
Acid Viatris 500/125 or Amoxicillin/Clavulanic Acid Viatris 875/125 tablets or any
other medicines.
the expiry date (EXP) printed on the pack has passed.
the packaging is torn or show signs of tampering.
Do not give this medicine to anyone else; your doctor has prescribed it specifically
for you and your condition.
Check with your doctor if you:
have ever had an allergic reaction (such as a rash) to antibiotics or other substances
in the past.
are allergic to foods, dyes, preservatives or any other medicines.
have glandular fever (mononucleosis) or leukaemia.
have any kidney or liver problems.
The dosage of Amoxicillin/Clavulanic Acid Viatris 500/125 or Amoxicillin/Clavulanic
Acid Viatris 875/125 tablets may need to be changed or you may need to be given an
alternative medicine.
have to test your urine for sugar.
Amoxicillin/Clavulanic Acid Viatris 500/125 or Amoxicillin/Clavulanic Acid Viatris
875/125 tablets may affect the results of these tests.
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 will discuss the risks and benefits of taking Amoxicillin/Clavulanic Acid
Viatris 500/125 or Amoxicillin/Clavulanic Acid Viatris 875/125 tablets during pregnancy
or while you are breastfeeding. Amoxicillin/Clavulanic Acid Viatris 500/125 or Amoxicillin/Clavulanic
Acid Viatris 875/125 tablets can pass to your baby from breast milk.
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.
In particular, tell your doctor or pharmacist if you are taking any of the following:
warfarin or other medicines used to prevent blood clots
mycophenolate
medicines to treat gout (e.g. probenecid or allopurinol)
other antibiotics. These may interfere with the actions of Amoxicillin/Clavulanic
Acid Viatris 500/125 or Amoxicillin/Clavulanic Acid Viatris 875/125 tablets.
methotrexate (a medicine used to treat cancer or rheumatic diseases.
contraceptive pill. As with other antibiotics, you may need to use extra birth control
methods (e.g. condoms) while taking Amoxicillin/Clavulanic Acid Viatris 500/125 or
Amoxicillin/Clavulanic Acid Viatris 875/125 tablets.
Some medicines may interfere with Amoxicillin/Clavulanic Acid Viatris 500/125 and
Amoxicillin/Clavulanic Acid Viatris 875/125 tablets and affect how it works. Check
with your doctor or pharmacist if you are not sure about what medicines, vitamins
or supplements you are taking and if these affect Amoxicillin/Clavulanic Acid Viatris
500/125 or Amoxicillin/Clavulanic Acid Viatris 875/125 tablets.
4. How do I use Amoxicillin/Clavulanic Acid Viatris 500/125 or Amoxicillin/Clavulanic
Acid Viatris 875/125 tablets?
Follow the directions given to you by your doctor and pharmacist. Their directions
may differ from the information contained in this leaflet.
Please read the direction label carefully. If you have any concerns about how to take
this medicine, talk to your doctor or pharmacist.
How much to take
Swallow the Amoxicillin/Clavulanic Acid Viatris 500/125 or Amoxicillin/Clavulanic
Acid Viatris 875/125 tablets with a full glass of water or other liquid. Amoxicillin/Clavulanic
Acid Viatris 875/125 tablets can be broken in half, but should not be chewed.
Amoxicillin/Clavulanic Acid Viatris 500/125 or Amoxicillin/Clavulanic Acid Viatris
875/125 tablets should be taken immediately before or with the first mouthful of food.
Amoxicillin/Clavulanic Acid Viatris 500/125 or Amoxicillin/Clavulanic Acid Viatris
875/125 tablets work best when taken this way. It may also help to prevent stomach
upsets. However, Amoxicillin/Clavulanic Acid Viatris 500/125 or Amoxicillin/Clavulanic
Acid Viatris 875/125 tablets will still work if they are taken without food.
Space the doses as evenly as possible throughout the day. If you are taking Amoxicillin/Clavulanic
Acid Viatris 500/125 or Amoxicillin/Clavulanic Acid Viatris 875/125 tablets twice
a day, take a dose about every twelve hours.
How long to take it for
Keep taking Amoxicillin/Clavulanic Acid Viatris 500/125 or Amoxicillin/Clavulanic
Acid Viatris 875/125 tablets until the course is finished or for as long as your doctor
tells you.
Do not stop taking Amoxicillin/Clavulanic Acid Viatris 500/125 or Amoxicillin/Clavulanic
Acid Viatris 875/125 tablets just because you feel better as the infection can return.
Do not stop taking Amoxicillin/Clavulanic Acid Viatris 500/125 or Amoxicillin/Clavulanic
Acid Viatris 875/125 tablets, or change the dose, without first checking with your
doctor.
If you forget to take Amoxicillin/Clavulanic Acid Viatris 500/125 or Amoxicillin/Clavulanic
Acid Viatris 875/125 tablets
If your next dose is due within six hours, skip the dose you missed and take your
next dose at the normal time. Otherwise, take the missed dose as soon as you remember
and then go back to taking your tablets as directed by your doctor.
Do not take a double dose to make up for the dose you missed. Taking more than the prescribed dose can increase the chance of unwanted side-effects.
If you are not sure what to do, ask your doctor or pharmacist.
If you use too much Amoxicillin/Clavulanic Acid Viatris 500/125 or Amoxicillin/Clavulanic
Acid Viatris 875/125 tablets
If you think that you have used too much Amoxicillin/Clavulanic Acid Viatris 500/125
or Amoxicillin/Clavulanic Acid Viatris 875/125, you may need urgent medical attention.
Symptoms of overdose include mild to severe nausea, vomiting, cramps and diarrhoea.
You should immediately:
phone the Poisons Information Centre
(by calling 13 11 26), or
contact your doctor, or
go to the Emergency Department at your nearest hospital.
You should do this even if there are no signs of discomfort or poisoning.
5. What should I know while using Amoxicillin/Clavulanic Acid Viatris 500/125 or Amoxicillin/Clavulanic
Acid Viatris 875/125?
Things you should do
Take Amoxicillin/Clavulanic Acid Viatris 500/125 or Amoxicillin/Clavulanic Acid Viatris
875/125 tablets exactly as your doctor has prescribed.
Tell your doctor if, for any reason, you have not taken your medicine exactly as directed.
Otherwise your doctor may think that it was not working as it should and change your
treatment unnecessarily.
Tell your doctor if the symptoms of your infection become worse, or do not improve
within a few days of starting Amoxicillin/Clavulanic Acid Viatris 500/125 or Amoxicillin/Clavulanic
Acid Viatris 875/125 tablets.
Remind any doctor, dentist or pharmacist you visit that you are using Amoxicillin/Clavulanic
Acid Viatris 500/125 or Amoxicillin/Clavulanic Acid Viatris 875/125 tablets before
starting any other medicines. Some medicines may affect the way other medicines work.
Things you should not do
Do not give this medicine to anyone else, even if their symptoms seem similar to yours.
Do not take this medicine to treat any other complaint unless your doctor says so.
Things to be careful of
If you develop severe diarrhoea either when taking Amoxicillin/Clavulanic Acid Viatris
500/125 or Amoxicillin/Clavulanic Acid Viatris 875/125 tablets or within several weeks
after treatment, tell your doctor as soon as possible. Do not take any medication
to stop the diarrhoea (eg. Lomotil® or Imodium®).
Driving or using machines
Be careful before you drive or use any machines or tools until you know how Amoxicillin/Clavulanic
Acid Viatris 500/125 or Amoxicillin/Clavulanic Acid Viatris 875/125 tablets affects
you.
Generally, these tablets do not cause any problems with your ability to drive a car
or operate machinery. However, as with many other medicines, it may cause dizziness
or tiredness in some people.
Drinking alcohol
Alcohol should be avoided during and for several days after treatment with Amoxicillin/Clavulanic
Acid Viatris 500/125 or Amoxicillin/Clavulanic Acid Viatris 875/125 tablets. Some people who drink alcohol while taking antibiotics similar to Amoxicillin/Clavulanic
Acid Viatris 500/125 or Amoxicillin/Clavulanic Acid Viatris 875/125 tablets have experienced
adverse effects.
Looking after your medicine
Keep your tablets in the original pack until it is time to take them.
Store it in a cool dry place below 25°C away from moisture, heat or sunlight; for
example, do not store it:
in the bathroom or near a sink, or
in the car or on window sills.
Keep it where young children cannot reach it.
Getting rid of any unwanted medicine
If you no longer need to use this medicine or it is out of date, take it to any pharmacy
for safe disposal.
Do not use this medicine after the expiry date.
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
Remember, you should tell your doctor or pharmacist as soon as possible if any of
these, or any other unusual events or problems, occur during or after treatment with
Amoxicillin/Clavulanic Acid Viatris 500/125 or Amoxicillin/Clavulanic Acid Viatris
875/125 tablets.
This is not a complete list of all possible side-effects. Others may occur in some
people and there may be some side-effects not yet known.
Tell your doctor or pharmacist if you notice anything else that may be making you
feel unwell.
Do not be alarmed by this list 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 Amoxicillin/Clavulanic Acid Viatris 500/125 or Amoxicillin/Clavulanic Acid Viatris
875/125 tablets contains
Active ingredient
(main ingredient)
|
Amoxicillin/Clavulanic Acid Viatris 500/125 tablets:
amoxicillin 500 mg
clavulanic acid 125 mg
Amoxicillin/Clavulanic Acid Viatris 875/125 tablets:
amoxicillin 875 mg
clavulanic acid 125 mg
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Other ingredients
(inactive ingredients)
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magnesium stearate
purified talc
povidone
croscarmellose sodium
microcrystalline cellulose
triethyl citrate
ethylcellulose
sodium lauryl sulfate
cetyl alcohol
hypromellose
titanium dioxide
Amoxicillin/Clavulanic Acid Viatris 875/125 tablets:
silicon dioxide.
|
Amoxicillin/Clavulanic Acid Viatris 500/125 or Amoxicillin/Clavulanic Acid Viatris
875/125 tablets do not contain sucrose, lactose, gluten, tartrazine or any other azo
dyes.
Do not take this medicine if you are allergic to any of these ingredients.
What Amoxicillin/Clavulanic Acid Viatris 500/125 or Amoxicillin/Clavulanic Acid Viatris
875/125 tablets looks like
Amoxicillin/Clavulanic Acid Viatris 500/125 - Off-white, oval, biconvex, film-coated tablet, scored on both sides.
Blister packs of 10 tablets (AUST R 230395).
Amoxicillin/Clavulanic Acid Viatris 875/125 - White to pale yellow, oblong, biconvex, film-coated tablet, scored on both sides.
Blister packs of 10 tablets (AUST R 230396).
Who distributes Amoxicillin/Clavulanic Acid Viatris 500/125 or Amoxicillin/Clavulanic
Acid Viatris 875/125 tablets
Sandoz Pty Ltd
100 Pacific Highway
North Sydney, NSW 2060
Australia
Tel 1800 726 369
This leaflet was revised in June 2024.
® Registered Trade Mark. The trade marks mentioned in this material are the property
of their respective owners.