Biaxsig ® Tablets
  • Download PDF Standard Print
  • Download PDF Large Print
 
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.
 

Why am I using Biaxsig?

Biaxsig contains the active ingredient roxithromycin. Biaxsig is used to treat infections in different parts of the body caused by bacteria. For more information, see Section 1. Why am I using Biaxsig? in the full CMI.

What should I know before I use Biaxsig?

Do not use if you have ever had an allergic reaction to roxithromycin 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 use Biaxsig? in the full CMI.

What if I am taking other medicines?

Some medicines may interfere with Biaxsig 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.

How do I use Biaxsig?

The recommended adult dosage is 300 mg per day
The recommended dosage for children more than 40 kg is one 150 mg tablet twice daily.
More instructions can be found in Section 4. How do I use Biaxsig? in the full CMI.

What should I know while using Biaxsig?

Things you should do
Remind any doctor or dentist you visit that you are using Biaxsig.
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 Biaxsig has been stopped.
If you get a sore, white mouth or tongue while taking, or soon after stopping Biaxsig, tell your doctor or pharmacist.
Tell your doctor or pharmacist if you get vaginal itching or discharge.
If you are about to start taking any new medicine, tell your doctor and pharmacist that you are taking Biaxsig
Things you should not do
Do not take more than the recommended dose unless your doctor or pharmacist tells you to.
Do not give this medicine to anyone else, even if they have the same condition as you.
Do not use this medicine to treat any other complaints unless your doctor tells you to.
Do not stop taking your tablets because you are feeling better, unless advised by your doctor or pharmacist.
Driving or using machines
Make sure you know how Biaxsig affects you before driving or operating machinery
Drinking alcohol
Tell your doctor if you drink alcohol
Looking after your medicine
Keep the medicine in a cool dry place where the temperature stays below 25°C.
Keep the tablets in the blister until its time to take them
For more information, see Section 5. What should I know while using Biaxsig? in the full CMI.

Are there any side effects?

Common side effects include: rash; loss of appetite. Refer to the CMI for all side effects. 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.
Biaxsig ® Tablets (bi-ax-sig)
  • Download PDF Standard Print
  • Download PDF Large Print
Active ingredient: Roxithromycin (rocks-e-throw-my-sin)
Consumer Medicine Information (CMI)
This leaflet provides important information about using Biaxsig. 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 Biaxsig.
Where to find information in this leaflet:

Why am I using Biaxsig?

Biaxsig contains the active ingredient roxithromycin. Biaxsig 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.
Biaxsig, like other antibiotics, does not work against viral infections such as the flu.
Biaxsig 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)
exacerbation of chronic bronchitis
pneumonia (lung infection characterised by fever, malaise, headache)
skin and soft tissue infections
non gonococcal urethritis
impetigo (bacterial infection causing sores on the skin)

What should I know before I use Biaxsig?

Warnings

Do not use Biaxsig if:

1. you are allergic to roxithromycin, or any other macrolide antibiotic e.g. azithromycin, clarithromycin or erythromycin, any of the ingredients listed at the end of this leaflet. Symptoms of an allergic reaction may include skin rash, itching, shortness of breath or swelling of the face, lips or tongue which cause difficulty in swallowing or breathing.

Always check the ingredients to make sure you can use this medicine.

2. you have severe liver problems

3. if you are taking certain medicines migraine headache called ergot alkaloids e.g. Cafergot, Dihydergot; (not all brands listed)

4. the product has expired or the packaging appears tampered with.

Check with your doctor if you:

have allergies to any other substances, such as foods, preservatives or dyes
are pregnant or intend to become pregnant
are breastfeeding or plan to breastfeed
have or have had the following medical conditions:
kidney problems (impaired function)
liver problems (hepatic cirrhosis with jaundice and /or ascites)
have any other medical conditions
take any medicines for any other condition
plan to have surgery
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

Tell your doctor or pharmacist if you are pregnant or intend to become pregnant. Like most medicines of this kind, Biaxsig is not recommended for use during pregnancy. Your doctor or pharmacist will discuss the risks and benefits of taking it if you are pregnant
Tell your doctor or pharmacist if you are breastfeeding or plan to breastfeed. Biaxsig passes into breast milk. Your doctor or pharmacist will discuss the risks and benefits of taking it if you are breastfeeding or planning to breastfeed.

Use in the Elderly

Biaxsig can be used in the elderly with no dosage adjustment required

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.
Some medicines may be affected by Biaxsig, or may affect how well Biaxsig works. These include:
theophylline (Neulin), a medicine used to treat asthma
some medicines for migraine headache such as ergotamine (Cafergot)or dihydroergotamine (Dihydergot tablets)
terfenadine and astemizole, over the counter medicines used to treat allergies
warfarin (Coumadin, Marevan), a medicine used to prevent blood clots
digoxin (Lanoxin, Sigmaxin), a medicine used to treat heart failure
midazolam (Hypnovel, Midazolam Sandoz), used to induce sleep before operations
ciclosporin (Neoral, Cicoral, Cysporin, Sandimmun), a medicine used to prevent organ transplant rejection or to treat certain problems with the immune system
cisapride, a medicine used to treat gastrointestinal problems
pimozide (Orap), an antipsychotic medicine
Check with your doctor or pharmacist if you are not sure about what medicines, vitamins or supplements you are taking and if these affect Biaxsig.

How do I use Biaxsig?

How much to take

The recommended adult dosage is 300 mg 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 Biaxsig given to children is dependent on the child's weight.
Your doctor will tell you exactly how much to take.
Follow the instructions provided and use Biaxsig until your doctor tells you to stop.

When to take Biaxsig

Biaxsig should be taken at least 15 minutes before food or on an empty stomach (i.e. more than 3 hours after a meal).
Biaxsig works best if you take it on an empty stomach

How to take it

Swallow the tablets whole with a glass of water.

How long to take it

For treating infections, Biaxsig is usually taken for 5 to 10 days. However, your doctor may prescribe Biaxsig for longer periods
Continue taking the tablets until you finish the pack or until your doctor or pharmacist tells you to stop

If you forget to use Biaxsig

Biaxsig should be used regularly at the same time each day.
If it is almost time for your next dose, skip the dose you missed and take your next dose when you are meant to.
Do not take a double dose to make up for the dose you missed.

If you use too much Biaxsig

If you think that you have used too much Biaxsig, you may need urgent medical attention.
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.

What should I know while using Biaxsig?

Things you should 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 Biaxsig 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 Biaxsig, 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 Biaxsig allows fungi/yeast to grow and the above symptoms to occur. Biaxsig does not work against fungi/yeast.
Tell all the doctors, dentists and pharmacists who are treating you that you are taking Biaxsig.
If you are about to start taking any new medicine, tell your doctor and pharmacist that you are taking Biaxsig
If you plan to have surgery that needs a general anaesthetic tell your doctor or dentist that you are taking this medicine.

Call your doctor straight away if you:

If you become pregnant while you are taking Biaxsig, tell your doctor or pharmacist immediately

Things you should not do

Do not take more than the recommended dose unless your doctor or pharmacist tells you to.
Do not give this medicine to anyone else, even if they have the same condition as you.
Do not use this medicine to treat any other complaints unless your doctor tells you to.
Do not stop taking your tablets because you are feeling better, unless advised by your doctor or pharmacist.
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.

Driving or using machines

Be careful before you drive or use any machines or tools until you know how Biaxsig affects you.

Drinking alcohol

Tell your doctor if you drink alcohol.

Looking after your medicine

Keep the medicine in a cool dry place where the temperature stays below 25°C
Keep your tablets in the blister pack until it is time to take them
Follow the instructions in the carton on how to take care of your medicine properly.
Store it in a cool dry place 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.
Do not use this medicine after the expiry date.
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.

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

Less serious side effects
What to do
oral thrush - white, furry, sore tongue and mouth
vaginal thrush - sore and itchy vagina and/or discharge
nausea, vomiting, stomach pain, indigestion, diarrhoea, flatulence
loss of appetite
red and/or itchy skin
headache, dizziness, ringing in the ears
hallucinations
confusion
tiredness
altered taste
rash
blurred vision and/or visual impairment
Speak to your doctor if you have any of these less serious side effects and they worry you.
These side effects are usually mild and short-lived

Serious side effects

Serious side effects
What to do
severe abdominal cramps or stomach cramps
watery and severe diarrhoea, which may sometimes be bloody
fever, in combination with one or both of the above
Tell your doctor or pharmacist immediately if you notice any of the following, particularly if they occur several weeks after stopping treatment with Biaxsig.
These are rare but serious side effects. You may have a serious condition affecting your bowel. Therefore, you may need urgent medical attention
Do not take any diarrhoea medicine without first checking with your doctor
frequent infections such as fever, severe chills, sore throat or mouth ulcers
severe persistent diarrhoea
swelling of the face, lips, mouth and tongue
difficulty in swallowing or breathing
an allergic reaction (for example, itchy skin, rash, swelling, asthma)
severe blisters and bleeding in the lips, eyes, mouth, nose and genitals
severe skin rash
Stop taking this medicine 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.
These are very serious side effects. If you have them, you may have had a serious allergic reaction to Biaxsig. You may need urgent medical attention or hospitalisation
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.

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.

Product details

This medicine is only available with a doctor's prescription.

What Biaxsig contains

Active ingredient
(main ingredient)
Each tablet contains either 150 mg or 300 mg of roxithromycin
Other ingredients
(inactive ingredients)
hyprolose
poloxamer
povidone
colloidal anhydrous silica
magnesium stearate (470)
purified talc (553)
maize starch
hypromellose
glucose
titanium dioxide (171)
propylene glycol (1520)
Do not take this medicine if you are allergic to any of these ingredients.
Biaxsig does not contain gluten, lactose, sucrose, tartrazine or any other azo dyes

What Biaxsig looks like

Biaxsig 150 mg tablets are round white film coated tablets. Each blister pack contains 10 tablets (Aust R 49134).
Biaxsig 300 mg tablets are round white film coated tablets. Each blister pack contains 5 tablets (Aust R 49135).

Who distributes Biaxsig

Biaxsig tablets are manufactured for:
sanofi aventis australia pty ltd
12-24 Talavera Road
Macquarie Park NSW 2113
This leaflet was prepared in September 2020.
biaxsig-ccdsv7-cmiv8-23sep20

  • Download PDF Standard Print
  • Download PDF Large Print