SUMMARY CMI

Biaxsig^® Tablets

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 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.

2. 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.

3. 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.

4. 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.

5. What should I know while using Biaxsig?

For more information, see Section 5. What should I know while using Biaxsig? in the full CMI.

6. 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.

FULL CMI

Biaxsig^® Tablets (bi-ax-sig)

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:

1. Why am I using Biaxsig?
2. What should I know before I use Biaxsig?
3. What if I am taking other medicines?
4. How do I use Biaxsig?
5. What should I know while using Biaxsig?
6. Are there any side effects?
7. Product details

1. 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)

2. 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

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.

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
• hydroxychloroquine or chloroquine, used to treat conditions including rheumatoid arthritis, or to treat or prevent malaria. Taking these medicines at the same time as Rulide D may increase the chance of you getting side effects that affect your heart.

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.

4. 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.

5. 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.

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

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.

7. Product details

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

What Biaxsig contains

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

Distributed in Australia by:

sanofi aventis australia pty ltd
12-24 Talavera Road
Macquarie Park NSW 2113
Freecall: 1800 818 806
Email: [email protected]

Distributed in New Zealand by:

Pharmacy Retailing (NZ) Ltd t/a Healthcare Logistics
58 Richard Pearse Drive
Airport Oaks
Mangere 2022
Auckland
Freecall: 0800 283 684
Email: [email protected]

This leaflet was prepared in October 2022.

biaxsig-ccdsv8-cmiv9-21oct22

Published by MIMS December 2022

1 Name of Medicine

Roxithromycin.

2 Qualitative and Quantitative Composition

300 mg and 150 mg tablets contain 300 mg and 150 mg of roxithromycin per tablet respectively.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Biaxsig 300 mg tablets.

Biaxsig 150 mg tablets.

4 Clinical Particulars

4.1 Therapeutic Indications

Adults.

Children.

4.2 Dose and Method of Administration

Adults.

Children.

4.3 Contraindications

Known hypersensitivity to macrolides, including erythromycin.
Severely impaired hepatic function (see Section 4.4 Special Warnings and Precautions for Use).
Concomitant therapy with vasoconstrictive ergot alkaloids (see Section 4.5 Interactions with Other Medicines and Other Forms of Interactions).

4.4 Special Warnings and Precautions for Use

Prolonged or repeated use of antibiotics including Biaxsig may result in superinfection by resistant organisms. In the event of superinfection, Biaxsig should be discontinued and appropriate therapy instituted.
When indicated, incision, drainage or other appropriate surgical procedures should be performed in conjunction with antibiotic therapy.
Antibiotic associated pseudomembranous colitis has been reported with many antibiotics. A toxin produced by Clostridium difficile appears to be the primary cause. The severity of the colitis may range from mild to life threatening. It is important to consider this diagnosis in patients who develop diarrhoea or colitis in association with antibiotic use (this may occur up to several weeks after cessation of antibiotic therapy). Mild cases usually respond to drug discontinuation alone. However, in moderate to severe cases, appropriate therapy with a suitable oral antibacterial agent effective against Clostridium difficile should be considered. Fluids, electrolytes and protein replacement therapy should be provided when indicated.
Drugs which delay peristalsis, e.g. opiates and diphenoxylate with atropine (Lomotil), may prolong and/or worsen the condition and should not be used.
Roxithromycin, like erythromycin, has been shown in vitro to elicit a concentration dependent lengthening in cardiac action potential duration. Such an effect is manifested only at supratherapeutic concentrations. Accordingly, the recommended doses should not be exceeded.
In certain conditions macrolides, including roxithromycin, have the potential to prolong the QT interval. Therefore roxithromycin should be used with caution in patients with congenital prolongation of the QT interval, with ongoing proarrhythmic conditions (i.e. uncorrected hypokalemia or hypomagnesaemia, clinically significant bradycardia), and in patients receiving class IA and III antiarrhythmic agents and drugs such as astemizole, cisapride or pimozide, and hydroxychloroquine or chloroquine (see Section 4.5 Interactions with Other Medicines and Other Forms of Interactions).
As with other macrolides, roxithromycin may have the potential to aggravate myasthenia gravis.
Clostridium difficile associated disease: diarrhoea, particularly if severe, persistent and/or bloody, during or after treatment with Biaxsig, may be symptomatic of pseudomembranous colitis (see Section 4.8 Adverse Effects (Undesirable Effects)). If pseudomembranous colitis is suspected, Biaxsig must be stopped immediately.
Cases of severe bullous skin reactions such as Stevens-Johnson syndrome or Toxic Epidermal Necrosis have been reported with Biaxsig (see Section 4.8 Adverse Effects (Undesirable Effects)). If symptoms or signs of SJS or TEN (e.g. progressive skin rash often with blisters or mucosal lesions) are present, Biaxsig treatment should be discontinued.
Severe vasoconstriction (ergotism) with possibly necrosis of the extremities has been reported when macrolides antibiotics have been associated with vasoconstrictive ergot alkaloids. Absence of treatment by these alkaloids must always be checked before prescribing Biaxsig.
Carefully consider the balance of benefits and risks before prescribing roxithromycin or other macrolides for any patients taking hydroxychloroquine or chloroquine, because of the potential for an increased risk of cardiovascular events and cardiovascular mortality (see Section 4.5 Interactions with Other Medicines and Other Forms of Interactions).

Use in hepatic impairment.

Use in renal impairment.

Use in the elderly.

Paediatric use.

Effects on laboratory tests.

4.5 Interactions with Other Medicines and Other Forms of Interactions

Roxithromycin has a much lower affinity for cytochrome P450 than erythromycin and consequently has fewer interactions.
Biaxsig does not appear to interact with oral contraceptives containing oestrogens and progestogens, prednisolone, carbamazepine, ranitidine or antacids.

Theophylline.

Ergot alkaloids.

Terfenadine.

Cisapride and pimozide.

Vitamin K antagonists.

Hydroxychloroquine or chloroquine.

Digoxin and other cardiac glycosides.

Midazolam.

Theophylline and ciclosporin.

CYP3A.

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

4.7 Effects on Ability to Drive and Use Machines

Attention should be drawn to the possibility of dizziness, visual impairment and blurred vision.

4.8 Adverse Effects (Undesirable Effects)

Biaxsig is generally well tolerated. In clinical trials, treatment discontinuation due to adverse effects occurred in only 1.2% of adult patients and 1% of children. The following side effects or serious adverse events possibly associated with roxithromycin have been reported.

Gastrointestinal.

Hypersensitivity.

Liver.

Others.

Reporting suspected adverse effects.

4.9 Overdose

Symptomatic treatment should be provided as required. There is no specific antidote.
For information on the management of overdose, contact the Poison Information Centre on 131126 (Australia).

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Mechanism of action.

Susceptibility tests.

Note.

Clinical trials.

5.2 Pharmacokinetic Properties

Absorption.

Distribution.

Elimination.

Metabolism.

Excretion.

5.3 Preclinical Safety Data

Mutagenesis.

Genotoxicity.

Carcinogenicity.

6 Pharmaceutical Particulars

6.1 List of Excipients

Excipients present in Biaxsig tablets are colloidal anhydrous silica, glucose, hyprolose, hypromellose, magnesium stearate, maize starch, poloxamer, povidone, propylene glycol, purified talc and titanium dioxide.

6.2 Incompatibilities

Incompatibilities were either not assessed or not identified as part of the registration of this medicine.

6.3 Shelf Life

In Australia, information on the shelf life can be found on the public summary of the Australian Register of Therapeutic Goods (ARTG). The expiry date can be found on the packaging.

6.4 Special Precautions for Storage

Biaxsig 300 mg tablets.

Biaxsig 150 mg tablets.

6.5 Nature and Contents of Container

Biaxsig 300 mg tablets.

Biaxsig 150 mg tablets.

6.6 Special Precautions for Disposal

In Australia, any unused medicine or waste material should be disposed of by taking to your local pharmacy.

6.7 Physicochemical Properties

Roxithromycin is an acid stable semisynthetic macrolide antibiotic. It is a white crystalline powder. Roxithromycin is very slightly soluble in water, freely soluble in acetone, in alcohol and in methylene chloride. It is slightly soluble in dilute hydrochloric acid.

Chemical structure.

CAS number.

7 Medicine Schedule (Poisons Standard)

Prescription Only Medicine (S4).

Summary Table of Changes