KALIXOCIN®
Consumer Medicine Information (CMI) summary
The full CMI on the next page has more details. If you are worried about taking this medicine,
speak to your doctor or pharmacist.
KALIXOCIN contains the active ingredient clarithromycin. KALIXOCIN is used to treat
certain bacterial infections including respiratory tract infections, ear infections,
skin infections and peptic ulcer. KALIXOCIN is also used to prevent a specific bacterial
infection associated with HIV infection. For more information, see Section 1. Why am I taking KALIXOCIN? in the full CMI.
Do not take if you have ever had an allergic reaction to clarithromycin, other antibiotics
from the macrolide family or any of the ingredients listed at the end of the CMI.
Talk to your doctor if you have any other medical conditions, take any other medicines, or are pregnant or plan to become pregnant or are breastfeeding.
For more information, see Section 2. What should I know before I take KALIXOCIN? in the full CMI.
Talk to your doctor if you have any other medical conditions, take any other medicines, or are pregnant or plan to become pregnant or are breastfeeding.
For more information, see Section 2. What should I know before I take KALIXOCIN? in the full CMI.
Some medicines may interfere with KALIXOCIN and affect how it works or may be affected
by KALIXOCIN.
A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI.
A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI.
Your doctor will tell you how much to take and when to take it. Take KALIXOCIN exactly
as directed by your doctor. More instructions can be found in Section 4. How do I take KALIXOCIN? in the full CMI.
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Things you should do
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Remind any doctor, dentist or pharmacist you visit that you are taking KALIXOCIN.
Tell your doctor if you are taking KALIXOCIN for an infection and your symptoms do
not improve within a few days, or they become worse, you become pregnant, you get
severe diarrhoea, you experience heart palpitations, changes in heartbeat, dizziness
or fainting or you are having urine tests.
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Things you should not do
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Do not take KALIXOCIN to treat any other complaints unless your doctor says so.
Do not give this medicine to anyone else, even if their symptoms seem similar to yours.
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Driving or using machines
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Be careful driving or operating machinery until you know how KALIXOCIN affects you.
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Looking after your medicine
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Keep KALIXOCIN tablets in a cool dry place below 25°C and protected from light.
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For more information, see Section 5. What should I know while taking KALIXOCIN? in the full CMI.
Tell your doctor if you experience any of the following: stomach cramps and pains, nausea, vomiting and diarrhoea, oral thrush or vaginal
thrush, change in taste sensation, headache, asthma, shortness of breath, muscle weakness,
pain or spasms, conjunctivitis, chills, fatigue, eructation (belching), stomach distension
or flatulence. Tell your doctor immediately if you notice any of the following as you may need urgent
medical care: yellowing of the eyes or skin, feeling generally unwell and having poor appetite,
hearing disturbances, chest pain, dizziness, confusion, hallucinations, convulsions,
fainting, irregular heartbeat, any type of skin rash, itching, hives, severe diarrhoea,
especially if bloody or severe upper stomach pain, with nausea and vomiting. Stop taking KALIXOCIN and call your doctor straight away, or go straight to the Emergency
Department at your nearest hospital if you notice any of these serious side effects: swelling to the face, lips, mouth, throat or neck which may cause difficulty in swallowing
or breathing or sudden collapse.
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.
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.
KALIXOCIN®
Active ingredient:
clarithromycin
Consumer Medicine Information (CMI)
This leaflet provides important information about using KALIXOCIN. 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 KALIXOCIN.
Where to find information in this leaflet:
KALIXOCIN contains the active ingredient clarithromycin, an antibiotic that belongs to the group of medicines called macrolides. These medicines
work by killing or stopping the growth of bacteria which cause infections. KALIXOCIN
will not work against infections caused by viruses, such as colds or flu.
KALIXOCIN is used to treat certain bacterial infections, including the following:
respiratory tract infections (throat, airways and lungs)
ear infections
skin infections
peptic ulcer
KALIXOCIN is also used to prevent a specific bacterial infection associated with HIV
infection.
Your doctor, however, may have prescribed KALIXOCIN for another purpose. Ask your
doctor if you have any questions about why KALIXOCIN has been prescribed for you.
KALIXOCIN to treat peptic ulcer
Peptic ulcers are associated with an infection in the intestine and stomach by a type
of bacteria called Helicobacter pylori (H. pylori). Nearly all patients with peptic
ulcers are infected with this bacteria.
The H. pylori infection can be treated with a combination of KALIXOCIN (clarithromycin)
and other appropriate antibiotic and stomach acid control treatments. However, the
best combination of tablets to treat H. pylori infection is yet to be determined.
Your doctor will determine the best combination for you.
If your symptoms return, consult your doctor. It is possible that KALIXOCIN may no
longer be effective in killing the H. pylori infection and a different antibiotic
may be needed.
Do not take KALIXOCIN if:
you are allergic to clarithromycin, other antibiotics from the macrolide family, including
erythromycin, roxithromycin or azithromycin or any of the ingredients listed at the
end of this leaflet.
Always check the ingredients to make sure you can take this medicine.
you have severe liver problems and poor kidney function.
you have an irregular heartbeat.
you have ever had a heart condition called long QT syndrome (or QT prolongation).
you have low magnesium or potassium levels.
you are taking any of the following medicines:
astemizole or terfenadine (commonly used to treat allergy symptoms - these medicines
may be available without a prescription)
cisapride (used to relieve certain stomach problems)
colchicine (used to treat gout)
domperidone (used for nausea)
ergotamine or dihydroergotamine (used to treat headaches)
lomitapide (used to treat high cholesterol)
lovastatin or simvastatin (used to treat high cholesterol)
midazolam tablets or syrup (used to treat sleeplessness and anxiety)
pimozide (used to treat schizophrenia)
ticagrelor or ranolazine (used to prevent blood clotting)
Taking KALIXOCIN with any of the above medicines may cause serious side effects.
If you are not sure whether you should start taking this medicine, talk to your doctor.
Do not take KALIXOCIN after the expiry date or if the packaging is torn or shows any
signs of tampering.
If it has expired or is damaged return it to your pharmacist for disposal.
Check with your doctor if you have:
any other medical conditions or take any medicines for any other condition
allergies to any other medicines, foods, dyes or preservatives
heart problems, including slow heart rate
liver problems
poor kidney function
myasthenia gravis, a condition which the muscles become weak and tire easily
intolerance to sugars
any electrolyte imbalances
Your doctor may want to take special care if you have any of these conditions. If
you have not told your doctor or pharmacist about any of the above, tell them before
you start taking or are given KALIXOCIN.
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. Your doctor
will discuss the risks and benefits of taking KALIXOCIN when pregnant.
Talk to your doctor if you are breastfeeding or intend to breastfeed. Your doctor
will discuss the risks and benefits of taking KALIXOCIN when breastfeeding.
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 KALIXOCIN and affect how it works or may be affected
by KALIXOCIN. These include the medicines already listed under "Do not take KALIXOCIN
if" (see above) and the following medicines:
aminoglycosides (used to treat infections)
calcium channel blockers such as verapamil, amlodipine, diltiazem (used to treat high
blood pressure)
carbamazepine, phenytoin, phenobarbital (phenobarbitone), sodium valproate (used to
treat epilepsy)
ciclosporin, tacrolimus (medicines affecting the immune system)
cilostazol (used to treat poor circulation)
digoxin, quinidine, disopyramide (used to treat heart failure)
fluconazole and itraconazole (used to treat fungal infections)
fluoxetine (used to treat depression)
herbal medicines such as St John's Wort
ibrutinib (used in cancer therapy)
insulin (used to treat diabetes)
medicines used to treat HIV infection
methylprednisolone (a corticosteroid)
nateglinide, repaglinide, pioglitazone, rosiglitazone (used to treat diabetes)
omeprazole (used to treat stomach problems)
quetiapine (used in psychotic disorders)
rifabutin, rifapentine, rifampicin (used to treat some infections)
sildenafil, tadalafil, vardenafil (used to treat erectile dysfunction in adult males)
statins such as atorvastatin, rosuvastatin (used to treat high cholesterol)
theophylline (used to treat asthma)
tolterodine (used to treat bladder problems)
triazolam, alprazolam, midazolam (used to treat sleeplessness and anxiety)
vinblastine (used to treat cancer)
warfarin and other anticoagulants such as apixaban, dabigatran and rivaroxaban (used
to prevent blood clotting)
These medicines may be affected by KALIXOCIN or may affect how well KALIXOCIN works.
You may need different amounts of your medicines, or you may need to take different
medicines. Your doctor or pharmacist can tell you what to do if you are taking any
of these medicines. They also have a more complete list of medicines to be careful
with or avoid while taking KALIXOCIN.
Check with your doctor or pharmacist if you are not sure about what medicines, vitamins
or supplements you are taking and if these affect KALIXOCIN.
How much to take
Your doctor will tell you how much to take and when to take it. Take KALIXOCIN exactly
as directed by your doctor. This may differ from the information contained in this
leaflet.
The dose of KALIXOCIN will depend on the infection to be treated.
For respiratory tract infections and skin infections, the usual adult dose is one
KALIXOCIN 250 mg tablet twice a day.
For more severe infections, the dose can be increased to two KALIXOCIN 250 mg tablets
twice a day.
Your doctor will adjust the amount or frequency of your doses according to the infection
being treated and the severity of your condition.
If you do not understand the instructions on the pack, ask your doctor or pharmacist
for help.
When to take KALIXOCIN
KALIXOCIN should be taken at about the same time each day.
This will allow your medicine to have the best effect and help you remember to take
it.
How long to take it
Keep taking KALIXOCIN until you finish the pack or for as long as your doctor tells
you.
If you are being treated for an infection, KALIXOCIN is usually taken for one or two
weeks.
Do not stop taking KALIXOCIN, even if you feel better after a few days, unless advised
by your doctor.
Your infection may not clear completely if you stop taking your medicine too soon.
Check with your doctor if you are not sure how long you should be taking KALIXOCIN.
If you forget to take KALIXOCIN
If it is almost time for your next dose, skip the dose you missed and take your next
dose when you are meant to.
Otherwise, take it as soon as you remember, and then continue taking your medicine
as you would normally.
Do not take a double dose to make up for the dose you missed.
If you miss more than one dose, are not sure what to do, or have any questions, check
with your doctor or pharmacist.
If you take too much KALIXOCIN
If you think that you have taken too much KALIXOCIN, you may need urgent medical attention.
You should immediately:
phone the Poisons Information Centre
(Australia telephone 13 11 26) for advice, or
(Australia telephone 13 11 26) for advice, 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.
If you take too much KALIXOCIN, you may develop severe gastrointestinal symptoms,
liver problems, or allergic reactions.
Things you should do
If you are taking KALIXOCIN for an infection and your symptoms do not improve within
a few days, or if they become worse, tell your doctor.
Tell your doctor if you become pregnant while taking KALIXOCIN.
Call your doctor straight away if you:
get severe diarrhoea. Do this even if it occurs several weeks after stopping KALIXOCIN. Diarrhoea may mean
that you have a serious condition affecting your bowel. You may need urgent medical
care. Do not take any medicine to stop your diarrhoea without first checking with
your doctor.
experience any heart palpitations, changes in heartbeat, dizziness or fainting while
taking KALIXOCIN.
If you are having any urine tests, tell your doctor you are taking KALIXOCIN as it
may affect the results of some laboratory tests.
If you are about to start taking a new medicine, tell your doctor or pharmacist that
you are taking KALIXOCIN.
Remind any doctor, dentist or pharmacist you visit that you are taking KALIXOCIN.
Things you should not do
Do not take KALIXOCIN to treat any other complaints unless your doctor says so.
Do not give this medicine to anyone else, even if their symptoms seem similar to yours.
Driving or using machines
Be careful before you drive or use any machines or tools until you know how KALIXOCIN
affects you.
Looking after your medicine
Keep your tablets in the pack until it is time to take them.
If you take the tablets out of the pack, they will not keep well.
Keep KALIXOCIN tablets in a cool dry place below 25°C and protected from light.
Store it in a cool dry place away from moisture, heat or sunlight. 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. A locked cupboard at least 1.5 metres above the ground is a good place to store medicines.
Getting rid of any unwanted medicine
If you no longer need to take this medicine or it is out of date, take it to any pharmacy
for safe disposal.
Do not take this medicine after the expiry date.
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.
KALIXOCIN treats infections in most people, but it may have unwanted side effects
in some people.
See the information below and, if you need to, ask your doctor or pharmacist if you
have any further questions about side effects. Do not be alarmed by this list of possible
side effects. You may not experience any of them.
Less serious side effects
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Less serious side effects
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What to do
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stomach cramps and pains
nausea, vomiting and diarrhoea
oral thrush (sore white mouth or tongue) or vaginal thrush (vaginal itching or discharge)
change in taste sensation
headache
asthma, shortness of breath
muscle weakness, pain or spasms
conjunctivitis
chills
fatigue
eructation (belching)
stomach distension (bloating)
flatulence
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Speak to your 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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yellowing of the eyes or skin (jaundice)
feeling generally unwell and having poor appetite
hearing disturbances
chest pain
dizziness, confusion, hallucinations, convulsions
fainting, irregular heartbeat
any type of skin rash, itching, hives
severe diarrhoea, especially if bloody
severe upper stomach pain, with nausea and vomiting (pancreatitis)
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Tell your doctor straight away if you notice any of these symptoms as you may need
urgent medical care.
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swelling to the face, lips, mouth, throat or neck which may cause difficulty in swallowing
or breathing or sudden collapse
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Stop taking KALIXOCIN and call your doctor straight away, or go straight to the Emergency
Department at your nearest hospital if you notice any of these serious side effects.
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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.
After you have finished taking KALIXOCIN
Tell your doctor immediately if you notice any of the following side effects, even
if they occur several weeks after stopping treatment with KALIXOCIN:
severe stomach or abdominal cramps
watery and severe diarrhoea, which may also be bloody (this may occur several weeks
after you stop taking KALIXOCIN)
fever, in combination with one or both of the above
These are rare but serious side effects. You may have a serious condition affecting
your bowel and you may need urgent medical care.
Do not take any diarrhoea medicine without first checking with your doctor.
Other side effects not listed above may also occur in some patients. Ask your doctor
or pharmacist for more information about side effects, as they have a more complete
list of side effects. Tell your doctor about these or any other symptoms. If the condition
persists or worsens, seek medical attention.
Tell your doctor if you notice anything that is making you feel unwell while you are
taking, or soon after you have finished taking KALIXOCIN, even if it is not on this
list.
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 KALIXOCIN Tablet contains
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Active ingredient
(main ingredient)
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250 mg clarithromycin
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Other ingredients
(inactive ingredients)
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croscarmellose sodium
povidone
silicon dioxide
microcrystalline cellulose
purified talc
hyprolose
hypromellose
sorbitan mono-oleate
stearic acid
magnesium stearate
propylene glycol
sorbic acid
vanillin
titanium dioxide
quinoline yellow
pregelatinised maize starch
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Potential allergens
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KALIXOCIN tablets contain sorbates
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Do not take this medicine if you are allergic to any of these ingredients.
