Contains the active ingredient, roxithromycin
Consumer Medicine Information
NOTICE: This Consumer Medicine Information (CMI) is intended for persons living in Australia. This page contains answers to some common questions about . It does not contain all the information that is known about . It does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits. Your doctor has weighed the risk of you using this medicine against the benefits he/she expects it will have for you. If you have any concerns about using this medicine, ask your doctor or pharmacist. Bookmark or print this page, you may need to read it again.
What roxithromycin is used for
The name of your medicine is Apo-Roxithromycin. It contains the active ingredient, roxithromycin.
It is used to treat infections in different parts of the body caused by bacteria. For example:
acute pharyngitis (sore throat and discomfort when swallowing)
tonsillitis
sinusitis
acute bronchitis (infection of the bronchi causing coughing)
pneumonia (lung infection characterised by fever, malaise, headache)
skin and soft tissue infections
non gonoccocal urethritis
impetigo (bacterial infection causing sores on the skin)
How it works
Ask your doctor if you have any questions about why this medicine has been prescribed for you.
Roxithromycin is an antibiotic that belongs to a group of medicines called macrolides.
These antibiotics work by killing or stopping the growth of the bacteria that are causing your infection.
Roxithromycin, like other antibiotics, does not work against viral infections such as the flu.
Your doctor may have prescribed roxithromycin for another reason.
This medicine is available only with a doctor's prescription.
There is no evidence that this medicine is addictive.
Use in children
Roxithromycin is not recommended for children less than 40 kg in weight.
Use in the Elderly
Roxithromycin can be used in the elderly with no dosage adjustment required.
Before you take roxithromycin
When you must not take it
Do not take roxithromycin if:
1. you have an allergy to:
roxithromycin or any other macrolide antibiotic eg., azithromycin, clarithromycin or erythromycin.
any of the ingredients listed at the end of this leaflet (see Product description)
Some of the 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.
2. you have severe liver problems
3. you are taking certain medicines for migraine headache called ergot alkaloids (for example -not all brands listed- Migral, Cafergot, Ergodryl, Dihydergot).
Ask your doctor if you are not sure if you are taking one of these medicines.
4. the packaging is torn or shows signs of tampering
5. the expiry date on the pack has passed.
If you take this medicine after the expiry date has passed, it may not work as well.
If you are not sure whether you should start taking roxithromycin, talk to your doctor.
Before you start to take it
Tell your doctor if:
1. you are pregnant or intend to become pregnant
Your doctor will discuss the risks and benefits of using roxithromycin during pregnancy.
2. you are breast-feeding or plan to breast-feed
Roxithromycin passes into the breast milk. Your doctor will discuss the risks and benefits of using roxithromycin while breast-feeding.
3. you have or have ever had any other health problems/medical conditions, including:
kidney problems (impaired function)
liver problems (hepatic cirrhosis with jaundice and/or ascites)
4. you have any allergies to any other medicines or any other substances, such as foods, preservatives or dyes.
If you have not told your doctor about any of the above, tell him/her before you take roxithromycin.
If you have not told your doctor about any of the above, tell them before you start taking this medicine.
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 shop.
Some medicines and roxithromycin may interfere with each other. These include:
theophylline (Neulin, Austyn, Theo-dur), a medicine used to treat asthma
some medicines for migraine headache such as ergotamine (Migral, Ergodryl, Cafergot)or dihydroergotamine (Dihydroergot tablets)
disopyramide (Rythmodan), a medicine to treat irregular heart rhythms
terfenadine (Teldane) and astemizole (Hismanal), over the counter medicines used to treat allergies
warfarin (Coumadin, Marevan), a medicine used to prevent blood clots
digoxin (Lanoxin), a medicine used to treat heart failure
midazolam (Hypnovel), used to induce sleep before operations
cyclosporin (Neoral, Sandimmun), a medicine used to prevent organ transplant rejection or to treat certain problems with the immune system
cisapride (Prepulsid), a medicine used to treat gastrointestinal problems
pimozide (Orap), an antipsychotic medicine
These medicines may be affected by roxithromycin, or may affect how well it works. You may need different amounts of your medicine, or you may need to take different medicines.
Your doctor or pharmacist has more information on medicines to be careful with or avoid while taking roxithromycin.
Other interactions not listed above may also occur.
How to take this medicine
Follow all directions given to you by your doctor or pharmacist carefully.
They may be different to the information in this leaflet.
If you do not understand any written instructions, ask your doctor or pharmacist for help.
How much to take
Your doctor or pharmacist will tell you how many tablets you will need to take. This depends on your condition and whether or not you are taking any other medicines.
The recommended adult dosage is 300mg per day which may be taken according to one of the following alternative dosage regimens:
one 300 mg tablet once a day, or
one 150 mg tablet twice a day, or
two 150 mg tablets once a day
However, depending on your condition and how you react to the medicine, your doctor may ask you to take a different dose.
The recommended dosage for children more than 40 kg, is one 150 mg tablet twice daily.
The dosage of roxithromycin given to children is dependent on the child's weight.
Roxithromycin is not recommended for children less than 40 kg in weight.
How to take it
Swallow roxithromycin tablets whole with a glass of water.
When to take it
Take it at about the same time each day.
Taking your medicine at the same time each day will have the best effect. It will also help you remember when to take it.
Roxithromycin should be taken at least 15 minutes before food or on an empty stomach (that is, more than 3 hours after a meal).
Roxithromycin works best if you take it on an empty stomach.
How long to take it for
Continue taking your medicine for as long as your doctor tells you.
Make sure you have enough to last over weekends and holidays.
For treating infections, roxithromycin is usually taken for 5 to 10 days. However, your doctor may prescribe roxithromycin for longer periods.
Check with your doctor if you are not sure how long you should be taking it.
Continue taking roxithromycin until you finish the pack or until your doctor recommends.
If you forget to take it
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 go back to taking your tablets as you would normally.
If you are not sure whether to skip the dose, talk to your doctor or pharmacist.
Do not double a dose to make up for the dose that you missed.
If you take too much (overdose)
Immediately telephone your doctor or the Poisons Information Centre (Tel: 13 11 26 for Australia) for advice, or go to the Accident and Emergency Department at the nearest hospital, if you think that you or anyone else may have taken too much roxithromycin.
Do this even if there are no signs of discomfort or poisoning.
You may need urgent medical attention.
While you are taking roxithromycin
Things you must do
If the symptoms of your infection do not improve within a few days, or if they become worse, tell your doctor.
If you get severe diarrhoea tell your doctor, pharmacist or nurse immediately. Do this even if it occurs several weeks after roxithromycin 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.
If you get a sore, white mouth or tongue while taking or soon after stopping roxithromycin, tell your doctor or pharmacist.
Also tell your doctor or pharmacist if you get vaginal itching or discharge.
This may mean you have a fungal/yeast infection called thrush. Sometimes the use of roxithromycin allows fungi/yeast to grow and the above symptoms to occur. Roxithromycin does not work against fungi/yeast.
If you become pregnant while you are taking roxithromycin, tell your doctor.
If you are about to start taking any new medicine, tell your doctor and pharmacist that you are taking roxithromycin.
Tell all the doctors, dentists and pharmacists who are treating you that you are taking roxithromycin.
Things you must not do
Do not give this medicine to anyone else, even if their symptoms seem similar to yours.
Do not take your medicine to treat any other complaints unless your doctor or pharmacist tells you to.
Do not stop taking your medicine, or change the dosage, without checking with your doctor.
If you do not complete the full course prescribed by your doctor, all of the bacteria causing your infection may not be killed. These bacteria may continue to grow and multiply so that your infection may not clear completely or it may return.
Things to be careful of
Be careful while driving or operating machinery until you know how roxithromycin affects you.
Side effects of roxithromycin
All medicines may have some unwanted side effects. Sometimes they are serious, but most of the time, they are not. Your doctor has weighed the risks of using this medicine against the benefits they expect it will have for you.
Tell your doctor or pharmacist as soon as possible if you do not feel well while you are taking roxithromycin.
Ask your doctor or pharmacist to answer any questions you may have.
Following is a list of possible side effects. Do not be alarmed by this list. You may not experience any of them.
oral thrush - white, furry, sore tongue and mouth
vaginal thrush - sore and itchy vagina and/or discharge
nausea, vomiting, stomach pain, diarrhoea, flatulence
loss of appetite
red and/or itchy skin
headache, dizziness, ringing in the ears
tiredness
altered taste
Tell your doctor immediately or go to casualty at your nearest hospital if you notice any of the following:
swelling of the face, lips, mouth and tongue; difficulty breathing or asthma
an allergic reaction (for example, itchy skin, rash, swelling, asthma)
severe persistent diarrhoea
These may be signs of a serious allergic reaction.
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 roxithromycin:
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
These are rare but serious side effects. You may have a serious condition affecting your bowel.
Therefore, you may need urgent medical attention. However, this side effect is rare.
Do not take any diarrhoea medicine without first checking with your doctor.
Other side effects not listed above may also occur in some patients. Tell your doctor if you notice any other effects.
Tell your doctor or pharmacist if you notice anything that is making you feel unwell.
After taking this medicine
Storage
Keep your tablets in the blister pack until it is time to take them.
If you take the tablets out of the blister pack, they may not keep well.
Keep roxithromycin in a cool dry place where the temperature stays below 25 degrees C.
Do not store it or any other medicine in the bathroom or near a sink. Do not leave it in the car or on window sills.
Heat and dampness can destroy some medicines.
Keep it 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.
Disposal
If your doctor or pharmacist tells you to stop taking this medicine or it has passed its expiry date, ask your pharmacist what to do with any medicine that is left over.
Where to go for further information
Pharmaceutical companies are not in a position to give people an individual diagnosis or medical advice. Your doctor or pharmacist is the best person to give you advice on the treatment of your condition.
Product description
What Apo-Roxithromycin looks like
The 150 mg and 300 mg tablets are white to off-white round convex and film coated. Each blister pack contains either 5 tablets (300 mg strength) or 10 tablets (150 mg strength).
Ingredients
Each tablet contains either 150 mg or 300 mg of the active ingredient roxithromycin.
The tablets also contain the following inactive ingredients:
maize starch,
hydroxypropylcellulose,
silica - colloidal anhydrous,
sodium starch glycollate,
poloxamer,
povidone,
magnesium stearate,
talc - purified,
propylene glycol,
glucose,
titanium dioxide, and
hypromellose.
This medicine is gluten-free, lactose-free, sucrose-free, tartrazine-free and free of other azo dyesdot.
Australian Registration Numbers
Apo-Roxithromycin 150 mg tablets (blister): AUST R 133748
Apo-Roxithromycin 300 mg tablets (blister): AUST R 133749
Manufacturer/Distributor
Apo-Roxithromycin tablets are manufactured for:
Apotex Pty Ltd
ABN 52 096 916 418
66 Waterloo Road
North Ryde, NSW 2113
Australia
Apotex Pty Ltd is the licensee of the registered trade marks AX logo, APO and APOTEX from the registered proprietor, Apotex Inc
This leaflet was prepared in:
January 2008 and updated in May 2009.
