Patient leaflet - Targaxan 550 mg film-coated tablets
1. What Targaxan is and what it is used for
Targaxan contains the active substance rifaximin. Targaxan is an antibiotic that destroys bacteria, which can cause a disease called hepatic encephalopathy (symptoms include agitation, confusion, muscle problems, difficulty in speaking and in some cases coma).
Targaxan is used in adults with liver disease to reduce the recurrence of episodes of overt hepatic encephalopathy.
Targaxan can either be used alone or more commonly together with medicines containing lactulose (a laxative).
2. What you need to know before you use Targaxan
Do not take Targaxan:
if you are allergic to:
- rifaximin
- similar types of antibiotics (such as rifampicin or rifabutin)
- any of the other ingredients of this medicine (listed in section 6).
- if you have a blockage in your intestine
Warnings and precautions
Talk to your doctor or pharmacist before taking Targaxan. If you have ever developed a severe skin rash or skin peeling, blistering and/or mouth sores after taking rifaximin.
Take special care with rifaximin:
Serious skin reactions including Stevens-Johnson-syndrome and toxic epidermal necrolysis, have been reported in association with rifaximin treatment. Stop using rifaximin and seek medical attention immediately of you notice any of the symptoms related to these serious skin reactions described in section 4. While you are taking Targaxan your urine may turn a reddish colour. This is quite normal. Treatment with any antibiotic including rifaximin may cause severe diarrhoea. This can happen several months after you have finished taking the medicine. If you have severe diarrhoea during or after using Targaxan you should stop taking Targaxan and contact your doctor immediately. If your liver problems are severe your doctor will need to observe you carefully.
Targaxan contains sodium
This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free’.
Children and adolescents
Targaxan is not recommended for children and adolescents aged under 18 years. This medicine has not been studied in children and adolescents.
Other medicines and Targaxan
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. Please tell your doctor if you are taking any of the following medicines:
- antibiotics (medicines to treat infections) – warfarin (medicine to prevent blood clotting) – antiepileptics (medicines for the treatment of epilepsy)
- antiarrhythmics (medicines to treat abnormal heart beat)
- ciclosporin (immunosuppressor)
- oral contraceptives
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking any medicine. It is not known if Targaxan can harm your unborn baby. Targaxan is therefore not to be used if you are pregnant. It is not known if rifaximin may be passed to your baby in breast milk. Targaxan is therefore not to be used if you are breast-feeding.
Driving and using machines
Targaxan does not normally affect the ability to drive and use machines, but may cause dizziness in some patients. If you feel dizzy you should not drive or operate machinery.
3. How to take Targaxan
Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure. The recommended dose is 1 tablet twice a day taken with a glass of water. Continue taking Targaxan until your doctor tells you to stop. If you take more Targaxan than you should
If you take more than the recommended number of tablets, even if you do not notice any problems, please contact your doctor.
If you forget to take Targaxan
Take the next dose at its normal time. Do not take a double dose to make up for a forgotten tablet.
If you stop taking Targaxan
Do not stop taking Targaxan without talking to your doctor first because your symptoms may return. If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Stop using Targaxan and seek medical attention immediately if you notice any of the following symptoms:
Uncommon (may affect up to 1 in 100 people): ● If you have bleeding from swollen blood vessels in your throat (oesophageal varices).
- If you have severe diarrhoea during or after using this medicine. This may be due to an infection of the intestine.
Not known (frequency cannot be estimated from the available data):
- reddish non-elevated, target-like or circular patches on the trunk, often with central blisters, skin peeling, ulcers of mouth, throat, nose, genitals and eyes. These skin rashes can be preceded by fever and flu-like symptoms.
If you get an allergic reaction, hypersensitivity or angioedema.
Symptoms include:
- swelling of the face, tongue or throat – swallowing difficulties
- hives and breathing difficulties.
- If you have any unexpected or unusual bleeding or bruising. This may be due to a decrease in the platelets in your blood which increases the risk of bleeding.
Other side effects that may occur
Common (may affect up to 1 in 10 people): ● Depressed mood
- Dizziness
- Headache
Shortness of breath
- Feeling or being sick
- Stomach ache or bloating/swelling
- Diarrhoea
- Accumulation of fluid in the abdominal cavity (ascites) ● Rash or itching
- Muscle cramps
- Joint pain
- Swelling of ankles, feet or fingers
Uncommon (may affect up to 1 in 100 people): ● Yeast infections (such as thrush)
- Urinary infection (such as cystitis)
- Anaemia (reduction in red blood cells which can make the skin pale and cause weakness or breathlessness)
- Loss of appetite
- Hyperkalaemia (high level of potassium in the blood) ● Confusion
- Anxiety
- Feeling sleepy
- Difficulty sleeping
- Feeling unsteady
- Loss of or poor memory
- Loss of concentration
- Reduced sense of touch
- Convulsions (fits)
- Hot flushes
- Fluid around the lungs (pleural effusion) ● Abdominal pain
- Dry mouth
- Muscle pain
- Needing to pass urine more often than usual ● Difficulty or pain passing urine
- Fever
- Oedema (swelling due to too much fluid in the body) ● Falls
Rare (may affect up to 1 in 1,000 people): ● Chest infections including pneumonia
- Cellulitis (inflammation of tissue under skin) ● Upper respiratory tract infections (nose, mouth, throat)
- Rhinitis (inflammation inside the nose)
- Dehydration (body water loss)
- Changes in blood pressure
- Constant breathing problems (such as chronic bronchitis)
- Constipation
- Back pain
- Protein in the urine
- Feeling weak
- Bruising
Pain following surgery
Not known (frequency cannot be estimated from the available data):
- Fainting or feeling faint
- Skin irritation, eczema (itchy, red, dry skin) ● Reduction in platelets (seen in the blood) ● Changes in the way the liver is working (seen in blood test)
- Changes in blood coagulation (International Normalised Ratio seen in blood test)
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects, you can help provide more information on the safety of this medicine.
5. How to store Targaxan
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton and the blister after EXP. The expiry date refers to the last day of that month.
Targaxan does not require any special storage conditions.
If this medicine becomes discoloured or shows any other signs of deterioration, please contact your pharmacist who will advise you on what to do.
Do not throw away any medicine via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.
6. Contents of the pack and other information
What Targaxan contains
The active substance is rifaximin.
Each tablet contains 550 mg rifaximin.
The other ingredients are:
- Tablet core: sodium starch glycolate (Type A), glycerol distearate, colloidal anhydrous silica, talc, microcrystalline cellulose.
Tablet coat (opadry oy-s-34907):
hypromellose, titanium dioxide (E171), disodium edetate, propylene glycol, red iron oxide (E172).
What Targaxan looks like and contents of the pack
Pink oval curved film-coated tablets marked with “RX” on one side.
Targaxan is available in carton of 56 tablets.
Blind or partially sighted? Is this leaflet hard to see or read? Call +45 63 95 27 00 to obtain the leaflet in a format suitable for you.
Product Licence Holder and Manufacturer
Procured from within the EU by the Product Licence holder Orifarm UK Ltd., Ground Floor Suite A2, Breakspear Park, Breakspear Way, Hemel Hempstead, HP2 4TZ, UK
For any information about this medicine, please contact the Product Licence Holder on
www.orifarm.com/uk
Or phone: (+44) 1923 204333
Repacked by Orifarm Supply s.r.o., Palouky 1366, 253 01 Hostivice, Czech Republic
Manufactured by Alfasigma S.p.A., Via Enrico Fermi, 1 - 65020 Alanno (PE), Italy
or
Alfasigma S.p.A., Via Pontina km 30, 400, 00071 - Pomezia (Roma), Italy
Targaxan 550 mg film-coated tablets
PL 45985/1092
POM
Leaflet revision date: 21/05/2026