The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine. It is written for patients and gives information about taking or using a medicine. It is possible that the leaflet in your medicine pack may differ from this version because it may have been updated since your medicine was packaged.
Please click on the link to the left to view the PIL in PDF format.
Text only version for the visually impaired
Below is a text only representation of the Patient Information leaflet. The original may contain images or tables and can be viewed in PDF format using the link to the left. This PIL may be available from the RNIB in large print, Braille or audio CD. For further information please call the RNIB Medicine Leaflet line on 0800 198 5000. The product code(s) for this leaflet is/are: PL20011/0021.
XIFAXANTA 200 mg Film-coated Tablets
PACKAGE LEAFLET: INFORMATION FOR THE USER
XIFAXANTA ® 200 mg film-coated tablets
Read all of this leaflet carefully before you start taking this medicine
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your doctor or pharmacist.
- This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
- If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
In this leaflet:
1. What Xifaxanta 200 mg film-coated tablets are and what they are used for
2. What you need to know before you take Xifaxanta 200 mg film-coated tablets
3. How to take Xifaxanta 200 mg film-coated tablets
4. Possible side effects
5. How to store Xifaxanta 200 mg film-coated tablets
6. Contents of the pack and other information
1. WHAT XIFAXANTA 200 MG FILM-COATED TABLETS ARE AND WHAT THEY ARE USED FOR
Xifaxanta 200 mg film-coated tablets are an intestinal antibiotic and are used to treat
- traveller´s diarrhoea in adults when the diarrhoea is not accompanied by fever or blood in the stools, or 8 or more unformed (soft or liquid) stools in the last 24 hours.
- Xifaxanta 200 mg film-coated tablets are not recommended for use in children (aged less than 18 years).
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE XIFAXANTA 200 MG FILM-COATED TABLETS
Do not take Xifaxanta 200 mg film-coated tablets
- if you are allergic (hypersensitive) to rifaximin, to similar types of antibiotics (such as rifampicin or rifabutin) or to any of the other ingredients (see section 6) of Xifaxanta film coated tablets.
- if you have a fever;
- if you have blood in your stools;
- if you passed 8 or more unformed stools in the last 24 hours.
- If you have constipation, abdominal pain and vomiting caused by blockage of the bowel
Take special care with Xifaxanta 200 mg film-coated tablets
- if, after 3 days of treatment, your symptoms continue or re-appear shortly afterwards do not take a second course of Xifaxanta 200 mg film-coated tablets, see a doctor
- if your symptoms get worse during treatment stop taking Xifaxanta 200 mg film-coated tablets and consult a doctor.
Taking other medicines.
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
- Please tell your doctor if you are taking ciclosporin (immunosuppressor) or warfarin (medicine to prevent blood clotting).
If you are using activated charcoal (for example to treat wind or diarrhoea) please take Xifaxanta 200 mg film-coated tablets at least 2 hours after taking charcoal.
Taking Xifaxanta 200 mg film-coated tablets with food and drink
Xifaxanta 200 mg film-coated tablets can be taken with or without food. Orally with a glass of water.
Taking this medicine may cause a reddish discolouration of your urine
Pregnancy, breast-feeding and fertility
Xifaxanta 200 mg film-coated tablets are not recommended during pregnancy or in fertile women not using contraception.
It is recommended that you take additional contraceptive precautions, in particular if the oestrogen content of oral contraceptives is less than 50μg , as the effectiveness of your oral contraceptive can decease whilst taking this medicine.
Inform your doctor
- if you are pregnant or think you may be pregnant or are thinking of becoming pregnant
- if you are breast-feeding or planning to start breast-feeding.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
Xifaxanta 200 mg film-coated tablets are unlikely to affect your reactions when driving or using machines.
If you feel dizzy or drowsy you should not drive or operate machinery
3. HOW TO TAKE XIFAXANTA 200 MG FILM-COATED TABLETS
Always take Xifaxanta 200 mg film-coated tablets exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.
- Unless otherwise prescribed by the doctor, the usual dose is 1 tablet every 8 hours (600 mg/day). You should continue taking Xifaxanta 200 mg film-coated tablets for three days even if your symptoms have improved.
- Unless otherwise prescribed, the duration of the treatment should not exceed three days. If your symptoms persist for more than three days please see a doctor.
If you take more Xifaxanta 200 mg film-coated tablets than you should
If you take more than the recommended number of tablets, please contact a doctor.
If you forget to take Xifaxanta 200 mg film-coated tablets
- take the missed dose as soon as you remember and take the next scheduled dose at its regular time.
If you stop taking Xifaxanta 200 mg film-coated tablets
If you do not complete the three days of treatment recommended, your symptoms may worsen.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Xifaxanta 200 mg film-coated tablets can cause side effects, although not everybody gets them.
Common (may affect up to 1 in 10 people):
- Dizziness, headache
- wind, abdominal bloating, abdominal pain, constipation, diarrhoea, urgency to evacuate faeces, nausea, involuntary and painful or ineffective straining, vomiting
Uncommon (may affect up to 1 in 100 people):
- Thrush, cold sore, swollen throat, inflammation or infection of the nose and throat
- abnormal blood test results (increased lymphocytes, increased monocytes, reduced neutrophilic granulocytes)
- loss of appetite, loss of body fluid (dehydration)
- abnormal dreams, depressed mood, sleeplessness, nervousness
- numbness, migraine, pins and needles, sinus headache, drowsiness
- double vision
- earache, sensation of the room going round (vertigo)
- heart racing
- increased blood pressure, hot flushes
- cough, dry throat, shortness of breath, blocked nose, sore throat, runny nose
- upper abdominal pain, indigestion, intestinal movement disorder, dry lips, hard stools, blood in the stools, mucus in stools, taste disorders
- blood test results: increased liver enzyme values (aspartate-aminotransferase)
- rashes, purplish discoloration of the skin caused by bleeding into the skin (purpura), blotchy skin, sunburn
- back pain, muscle cramps, muscle weakness, muscle pain, neck pain
- urinalysis results: blood in urine (haematuria), protein in urine (proteinuria), sugar in urine (glycosuria),
- frequent urination, excessive urination (polyuria),
- frequent periods (polymenorrhoea)
- loss of strength, chills, cold sweat, increased perspiration, flu-like illness, swollen arm, pain.
The following side effects have been reported, however their frequency cannot be estimated from the available data:
- bacterial infections (Clostridial infections)
- abnormal blood tests (reduced platelets, liver function tests out of normal range, international normalised ratio abnormalities)
- severe acute reactions to the drug, allergic reactions to the drug
- near fainting
- giant hives
- skin roughness, skin redness, itching, wheals.
Treatment with any antibiotic may cause Clostridium difficile associated diarrhoea (CDAD).
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on the safety of this medicine.
5. HOW TO STORE XIFAXANTA 200 MG FILM-COATED TABLETS
Keep out of the reach and sight of children.
Xifaxanta 200 mg film-coated tablets do not require any special storage conditions.
Do not use Xifaxanta 200 mg film-coated tablets after the expiry date which is stated on the carton and the blister. The expiry date refers to the last day of that month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
6. CONTENTS OF THE PACK AND OTHER INFORMATION
What Xifaxanta 200 mg film-coated tablets contain
- The active substance is: Rifaximin. Each film-coated tablet contains: 200 mg of Rifaximin. The other ingredients are: Tablet core: sodium starch glycolate type A, glycerol distearate, colloidal anhydrous silica, talc, microcrystalline cellulose. Tablet coating: hypromellose, titanium dioxide, disodium edetate, propylene glycol, red iron oxide E172.
What Xifaxanta 200 mg film-coated tablets look like and contents of the pack
- Xifaxanta 200 mg film-coated tablets are pink circular biconvex coated tablets, with “AW” embossed on one side.
- They are provided in a blister pack containing 9 tablets.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Via E. Fermi, 1
65020 Alanno (PE)
This leaflet was last revised in November 2016
Norgine House, Widewater Place, Moorhall Road, Harefield, Middlesex, UB9 6NS
+44 (0)1895 825 865
+44 (0)1895 826 600