SUMMARY CMI
XIFAXAN®
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.
1. Why am I taking XIFAXAN?
XIFAXAN contains the active ingredient rifaximin. XIFAXAN is used to treat travellers' diarrhoea that is caused by bacteria that do not invade the gut wall, in people aged 12 years and older.
For more information, see Section 1. Why am I taking XIFAXAN? in the full CMI.
2. What should I know before I take XIFAXAN?
Do not take if you have ever had an allergic reaction to XIFAXAN 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 XIFAXAN? in the full CMI.
3. What if I am taking other medicines?
Some medicines may interfere with XIFAXAN 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 take XIFAXAN?
The recommended dosage of XIFAXAN tablets is one 200 mg tablet three times a day for three days (a total of 9 doses).
More instructions can be found in Section 4. How do I take XIFAXAN? in the full CMI.
5. What should I know while taking XIFAXAN?
Things you should do |
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Things you should not do |
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Driving or using machines |
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Drinking alcohol |
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Looking after your medicine |
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For more information, see Section 5. What should I know while taking XIFAXAN? in the full CMI.
6. Are there any side effects?
Side effects that are common and less serious include dizziness, headache, wind, abdominal bloating and pain, constipation, diarrhoea, involuntary, painful, or ineffective straining on the toilet, nausea, vomiting and fever.
Serious side effects which need immediate medical attention include thrush, cold sore, swollen throat, inflammation or infection of the nose or throat, loss of appetite, dehydration depressed moos, sleeplessness, nervousness, earache, cough, dry or sore throat, runny nose, shortness of breath, blocked nose, muscle cramps, muscle pain, back or neck pain, chills, cold sweats, perspiration, flu-like symptoms, rash, blotchy skin, hot flushes. If you suffer with cirrhosis (a type of liver disease), you may notice flu-like symptoms and painful rash or blistering affecting the skin, mouth, eyes, and genitals.
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
XIFAXAN®
Active ingredient(s): Rifaximin
Consumer Medicine Information (CMI)
This leaflet provides important information about taking XIFAXAN tablets. 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 XIFAXAN.
Where to find information in this leaflet:
1. Why am I taking XIFAXAN?
2. What should I know before I take XIFAXAN?
3. What if I am taking other medicines?
4. How do I take XIFAXAN?
5. What should I know while taking XIFAXAN?
6. Are there any side effects?
7. Product details
1. Why am I taking XIFAXAN?
XIFAXAN contains the active ingredient rifaximin. Rifaximin is an antibiotic that passes through the gastrointestinal tract and very little is absorbed.
XIFAXAN is used to treat travellers' diarrhoea that is caused by bacteria that do not invade the gut wall, in people aged 12 years and older. XIFAXAN is not effective for diarrhoea caused by bacteria that invade the gut wall.
There is no experience taking XIFAXAN to treat travellers' diarrhoea in children under 12 years of age. XIFAXAN may be prescribed for you before you travel overseas, so you have it with you if you need to treat an episode of diarrhoea.
Before you travel overseas, ask your doctor or pharmacist if you have any questions about why XIFAXAN has been prescribed for you, or how to take it.
Your doctor may have recommended XIFAXAN tablets for another reason.
2. What should I know before I take XIFAXAN?
Warnings
Do not take XIFAXAN if:
- you are allergic to rifaximin or any of the rifamycin antibiotics (rifampicin, rifabutin) or to any other ingredient contained in this medicine, listed at the end of this leaflet. 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, itchiness or hives on the skin.
- You have bowel obstruction (a blocked bowel).
- You also have a fever, or blood in your stools. These are signs that the diarrhoea may be caused by an invasive bacteria that will not be effectively treated by XIFAXAN.
Always check the ingredients to make sure you can take this medicine.
If you are not sure whether you should start taking this medicine, seek medical advice.
Check with your doctor if you:
- have any other medical conditions
- take any medicines for any other condition
If you suffer with cirrhosis (a type of liver disease) you may experience severe skin reactions which may be life-threatening with painful rashes or blistering affecting the skin, mouth, eyes and genitals. If severe skin reactions or other allergic reactions occur, stop taking this medicine and seek urgent medical advice
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 can discuss with you the risks and benefits involved.
Talk to your doctor if you are breastfeeding or intend to breastfeed. It is not known if your baby can absorb rifaximin from breast milk if you are breastfeeding.
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.
There is a possibility that XIFAXAN can interact with other medicines, including ciclosporin, oral contraceptives and warfarin. Your doctor and pharmacist have more information on which medicines to be careful with or avoid while taking this 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 XIFAXAN tablets.
4. How do I take XIFAXAN tablets?
How much to take
The recommended dosage of XIFAXAN tablets is one tablet three times a day for three days (a total of 9 doses). Follow the instructions provided when XIFAXAN was prescribed.
When to take XIFAXAN tablets
XIFAXAN should be taken orally three times a day for three days.
How to take XIFAXAN
Swallow the tablet whole with a glass of water. You can take XIFAXAN tablets with or without food.
If you forget to take XIFAXAN tablets
XIFAXAN should be taken regularly at the same time each day. If you miss your dose at the usual time, take it as soon as you remember, and then go back to taking your medicine as you would normally.
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 take too much XIFAXAN
If you think that you have taken too much XIFAXAN, 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 taking XIFAXAN?
Things you should do
Tell any other doctors, dentists, and pharmacists who treat you that you are taking this medicine.
Call your doctor straight away if you:
- experience fever,
- experience worsening diarrhoea,
- have blood in your stools, or if symptoms have not resolved after 3 days of treatment, then contact a doctor for assessment. Do not take a second course of XIFAXAN.
Remind any doctor, dentist or pharmacist you visit that you are taking XIFAXAN.
Things you should not do
- Do not stop taking this medicine suddenly, your condition may worsen or you may have unwanted side effects. Do not stop taking your medicine or lower the dosage without checking with your doctor.
- Do not take XIFAXAN to treat any other conditions unless your doctor tells you to.
- Do not give your medicine to anyone else, even if they have the same condition as you.
Driving or using machines
Be careful before you drive or use any machines or tools until you know how XIFAXAN affects you.
Drinking alcohol
Tell your doctor if you drink alcohol.
As with all medicines, drinking alcohol while using medicines is not recommended.
Looking after your medicine
- Keep your tablets in the blister packaging until it is time to take them. If you take the tablets out of the packaging they will not keep well.
- Keep your tablets in a cool dry place where the temperature stays below 25°C.
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.
Keep it where young children cannot reach it.
When to discard your medicine
Do not take this medicine after the expiry date.
The expiry date refers to the last day of that month.
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.
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
Less serious side effects | What to do |
| Speak to your doctor if you have any of these less serious side effects and they worry you. |
Serious side effects
Serious side effects | What to do |
If you suffer with cirrhosis (a type of liver disease) you may experience
| 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. |
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 have experienced, 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 XIFAXAN contains
Active ingredient (main ingredient) | Rifaximin |
Other ingredients (inactive ingredients) | Microcrystalline cellulose Glyceryl diisostearate Sodium starch glycolate Type A Colloidal anhydrous silica Purified talc The film coating contains Hypromellose Titanium dioxide Disodium edetate Propylene glycol Iron oxide red |
Do not take this medicine if you are allergic to any of these ingredients.
What XIFAXAN looks like
XIFAXAN tablets are pink, round, biconvex, film-coated tablets. (Aust R 222643).
Who distributes XIFAXAN tablets
Norgine Pty Ltd
Suite 3.01 Building A
20 Rodborough Road
Frenchs Forest NSW 2086
AUSTRALIA
Phone: 1800 766 936
www.norgine.com.au
This leaflet was prepared in April 2023.
Published by MIMS June 2023