Kalixocin
NOTICE: This Consumer Medicine Information (CMI) is intended for persons living in Australia.
KALIXOCIN
clarithromycin
CONSUMER MEDICINE INFORMATION
What is in this leaflet
This leaflet answers some common questions about Kalixocin.
It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist.
All medicines have benefits and risks. Your doctor has weighed the risks of you taking Kalixocin against the benefits expected for you.
If you have any concerns about taking this medicine, talk to your doctor or pharmacist.
Keep this leaflet with your medicine.
You may need to read it again.
What Kalixocin is used for
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 is 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 available only with a doctor’s prescription.
There is no evidence that Kalixocin is addictive.
Klacid 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 Klacid (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 Klacid may no longer be effective in killing the H. pylori infection and a different antibiotic may be needed.
Before you take Kalixocin
When you must not take it
Do not take Kalixocin if you have ever had an allergic reaction to:
medicines containing clarithromycin
other antibiotics from the macrolide family, including erythromycin, roxithromycin or azithromycin
any of the ingredients listed at the end of this leaflet.
Some symptoms of an allergic reaction include skin rash, itching, shortness of breath or swelling of the face, lips or tongue, which may cause difficulty in swallowing or breathing.
Do not take Kalixocin if you have severe liver problems and poor kidney function.
Do not take Kalixocin if you have an irregular heartbeat.
Do not take Klacid if you have ever had a heart condition called long QT syndrome (or QT prolongation).
Do not take Kalixocin if you have low potassium levels.
Do not take Kalixocin after the expiry date or if the packaging is torn or shows signs of tampering.
If it has expired or is damaged, return it to your pharmacist for disposal.
Do not take Kalixocin if you are taking any of the following medicines:
astemizole or terfenadine (commonly used to treat allergy symptoms – these medicines may be available without prescription)
cisapride (used to relieve certain stomach problems)
domperidone (used for nausea)
pimozide (used to treat schizophrenia)
ergotamine or dihydroergotamine (used to treat headaches)
lovastatin or simvastatin (used to treat high cholesterol)
ticagrelor or ranolazine (used to prevent blood clotting)
colchicine (used to treat gout)
midazolam tablets or syrup (used to treat sleeplessness and anxiety)
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.
Before you start to take it
Tell your doctor if you are allergic to any other medicines, foods, dyes or preservatives.
Tell your doctor if you are pregnant or plan to become pregnant.
Your doctor will discuss the risks and benefits of taking Kalixocin when pregnant.
Tell your doctor if you are breastfeeding or wish to breastfeed.
Your doctor will discuss the risks and benefits of taking Kalixocin when breastfeeding.
Tell your doctor if you have, or have ever had, any other health problems or medical conditions, including:
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
low magnesium or any other 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 Kalixocin or are given Kalixocin.
Taking other medicines
Tell your doctor or pharmacist if you are taking any other medicines, including any that you buy without a prescription from your pharmacy, supermarket or health food store.
Some medicines may affect the way Kalixocin works or may be affected by it. These include the medicines already listed under “When you must not take it” (see above) and the following medicines:
digoxin, quinidine, disopyramide (used to treat heart failure)
warfarin and other anticoagulants (used to prevent blood clotting)
phenytoin, carbamazepine, phenobarbital (phenobarbitone), sodium valproate (used to treat epilepsy)
theophylline (used to treat asthma)
triazolam, alprazolam, midazolam (used to treat sleeplessness and anxiety)
cilostazol (used to treat poor circulation)
statins such as rosuvastatin, atorvastatin (used to treat high cholesterol)
methylprednisolone (a corticosteroid)
vinblastine (used to treat cancer)
sildenafil, tadalafil, vardenafil (used to treat erectile dysfunction in adult males)
ciclosporin, tacrolimus (medicines affecting the immune system)
medicines used to treat HIV infection
rifampicin, rifapentine, rifabutin (used to treat some infections)
repaglinide, nateglinide, pioglitazone, and rosiglitazone (used to treat diabetes)
insulin (used to treat diabetes)
calcium channel blockers such as verapamil, amlodipine, diltiazem (used to treat high blood pressure)
fluoxetine (used to treat depression)
omeprazole (used to treat stomach problems)
aminoglycosides (used to treat infections)
fluconazole and itraconazole (used to treat fungal infections)
tolterodine (used to treat bladder problems)
herbal medicines such as St John’s Wort
quetiapine (used in psychotic disorders)
ibrutinib (used in cancer therapy)
These medicines may be affected by Kalixocin or may affect how well it 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.
How to take Kalixocin
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.
How much to take
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.
How to take it
Swallow the tablets whole with a glass of water.
When to take it
Take your medicine 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 it
If it is almost time for you to take your next dose, skip the dose you missed and take your next dose when you are meant to.
Otherwise, take the missed dose as soon as you remember, and then continue taking your tablets as you would normally.
Do not take a double dose to make up for the dose that you missed.
If you miss more than one dose, or are not sure what to do or have any questions, check with your doctor or pharmacist.
If you take too much (overdose)
Immediately telephone your doctor or the Poisons Information Centre (telephone 13 11 26) for advice, or go to Accident and Emergency at your nearest hospital, if you think that you or anyone else may have taken too much Kalixocin. Do this even if there are no signs of discomfort or poisoning.
You may need urgent medical attention. Keep telephone numbers for these places/services handy
If you take too much Kalixocin, you may develop severe gastrointestinal symptoms, liver problems or allergic reactions.
While you are taking Kalixocin
Things you must 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.
If you get severe diarrhoea, tell your doctor or pharmacist immediately.
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.
Tell your doctor immediately if you experience any heart palpitations, changes in heartbeat, dizziness or fainting while taking Klacid.
If you must have 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.
Tell all the doctors, dentists and pharmacists who are treating you that you are taking Kalixocin.
Things you must not do
Do not use Kalixocin to treat any other conditions unless your doctor tells you to.
Do not give Kalixocin to anyone else, even if their symptoms seem like yours.
Things to be careful of
Be careful driving or operating machinery until you know how Kalixocin affects you.
Side effects
Tell your doctor or pharmacist as soon as possible if you do not feel well while you are taking Kalixocin.
Kalixocin treats infections in most people, but it may have unwanted side effects in some people.
All medicines can have side effects. Sometimes they are serious, most of the time they are not. You may need medical treatment if you get some of the side effects.
Do not be alarmed by this list of possible side effects.
You may not experience any of them.
Ask your doctor or pharmacist to answer any questions you may have.
While you are taking Kalixocin
Tell your doctor if you experience any of the following:
stomach cramps and pains
nausea, vomiting and severe 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
stomach distension
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 (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)
Stop taking Kalixocin and tell your doctor immediately or go to Accident and Emergency at your nearest hospital if any of the following happen:
swelling to the face, lips, mouth, throat or neck which may cause difficulty in swallowing or breathing or sudden collapse
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. Inform your doctor promptly about these or any other symptoms. If the condition persists or worsens, seek medical attention.
Do not be alarmed by this list of possible side effects. You may not experience any of them or only some of them
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.
After taking Kalixocin
Storage
Keep Kalixocin where children cannot reach it.
A locked cupboard at least one-and-a-half metres above the ground is a good place to store medicines.
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 your tablets in a cool dry place, protected from light, where the temperature stays below 25°C.
Do not store Kalixocin or any other medicine in the bathroom or near a sink.
Do not leave Kalixocin in the car or on window sills.
Heat and dampness can destroy some medicines.
Disposal
If your doctor tells you to stop taking Kalixocin, or your tablets have passed their expiry date, ask your pharmacist what to do with any that are left over.
Product description
What it looks like
Kalixocin 250 mg tablets are yellow, oval shaped, film-coated tablets.
Each pack contains 14 tablets.
Ingredients
The active ingredient in Kalixocin is clarithromycin.
Each Kalixocin tablet contains 250 mg of clarithromycin.
The tablets also contain the following inactive ingredients:
microcrystalline cellulose
croscarmellose sodium
hyprolose
hypromellose
magnesium stearate
povidone
propylene glycol
quinoline yellow
silicon dioxide
sorbic acid
sorbitan mono-oleate
pregelatinised maize starch
stearic acid
purified talc
titanium dioxide
vanillin.
Kalixocin tablets contain sorbates. The tablets do not contain lactose or gluten.
Supplier
Kalixocin is supplied by:
Mylan Health Pty Ltd
Level 1, 30 The Bond
30-34 Hickson Road
Millers Point NSW 2000
www.mylan.com.au
Australian registration number:
Kalixocin – AUST R 99707
This leaflet was prepared in October 2019.
Kalixocin_cmi\Oct19/00
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