TARGAXAN 550 MG FILM-COATED TABLETS, RIFAXIMIN 550 MG FILM-COATED TABLETS - patient leaflet, side effects, dosage

Patient Information Leaflet

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• 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.

Your medicine is called TARGAXAN 550mg film-coated tablets but will be referred to as TARGAXAN throughout the leaflet.

What is in this leaflet:

MB What TARGAXAN is and what it is used for

r2B What you need to know before you take TARGAXAN

[3B How to take TARGAXAN

^4l Possible side effects

How to store TARGAXAN

r6B Contents of the pack and other information

jHWhat 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).

^■What you need to know before you take 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.

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.

^■Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Stop taking TARGAXAN and tell your doctor IMMEDIATELY if you have any of the following side effects:

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):

• 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. Frequency is not known (cannot be estimated from the available data).

Patient Information Leaflet (continued)

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 (see details below). By reporting side effects you can help provide more information on the safety of this medicine.

United Kingdom Yellow Card scheme at: or search for MHRA Yellow Card in the Google Play or Apple App Store.

r^How to store TARGAXAN

• Keep out of the sight and reach of children.

• TARGAXAN does not require any special storage conditions.

• Do not use TARGAXAN 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.

• If your doctor tells you to stop taking this medicine, return any unused tablets to your pharmacist (chemist) for safe disposal. Only keep this medicine if your doctor tells you to.

• * If the tablets become discoloured or show any other signs of deterioration, you should seek the advice of your pharmacist who will tell you what to do. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines that are no longer required. These measures will help to protect the environment.

^■Contents of the pack and other information

What TARGAXAN contains:

Each film-coated tablet contains 550mg 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

Patient Information Leaflet

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• 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.

Your medicine is called RIFAXIMIN 550mg film-coated tablets but will be referred to as RIFAXIMIN throughout the leaflet.

What is in this leaflet:

mB What RIFAXIMIN is and what it is used for

r2H What you need to know before you take RIFAXIMIN

^B How to take RIFAXIMIN

^4l Possible side effects

[5B How to store RIFAXIMIN

f6H Contents of the pack and other information

jBwhat RIFAXIMIN is and what it is used for

RIFAXIMIN contains the active substance RIFAXIMIN. RIFAXIMIN 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).

RIFAXIMIN is used in adults with liver disease to reduce the recurrence of episodes of overt hepatic encephalopathy.

RIFAXIMINcan either be used alone or more commonly together with medicines containing lactulose (a laxative).

^BWhat you need to know before you take RIFAXIMIN

Do not take RIFAXIMIN:

• 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 RIFAXIMIN.

While you are taking RIFAXIMIN 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 RIFAXIMIN you should stop taking RIFAXIMIN and contact your doctor immediately. If your liver problems are severe your doctor will need to observe you carefully.

RIFAXIMIN contains sodium

This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free’.

Children and adolescents

RIFAXIMIN is not recommended for children and adolescents aged under 18 years. This medicine has not been studied in children and adolescents.

Other medicines and RIFAXIMIN

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 RIFAXIMIN can harm your unborn baby. RIFAXIMIN 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.

RIFAXIMIN is therefore not to be used if you are breast-feeding.

Driving and using machines

RIFAXIMIN 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.

^■How to take RIFAXIMIN

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 RIFAXIMIN until your doctor tells you to stop.

If you take more RIFAXIMIN 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 RIFAXIMIN

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 Rifaximin

Do not stop taking RIFAXIMIN 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.

Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Stop taking RIFAXIMIN and tell your doctor IMMEDIATELY if you have any of the following side effects:

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):

• 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. Frequency is not known (cannot be estimated from the available data).

Patient Information Leaflet (continued)

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 (Interna-tional 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 (see details below). By reporting side effects you can help provide more information on the safety of this medicine.

United Kingdom Yellow Card scheme at: or search for MHRA Yellow Card in the Google Play or Apple App Store.

^■hgw to store RIFAXIMIN

• Keep out of the sight and reach of children.

• Rifaximin does not require any special storage conditions.

• Do not use RIFAXIMIN 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.

• If your doctor tells you to stop taking this medicine, return any unused tablets to your pharmacist (chemist) for safe disposal. Only keep this medicine if your doctor tells you to.

• * If the tablets become discoloured or show any other signs of deterioration, you should seek the advice of your pharmacist who will tell you what to do. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines that are no longer required. These measures will help to protect the environment.

J6MContents of the pack and other information

What RIFAXIMIN contains:

Each film-coated tablet contains 550mg 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 RIFAXIMIN looks like and contents of the pack

Pink, oval, biconvex, film-coated tablets embossed with “RX” on one side and plain on the other.

Each pack contains 56 film-coated tablets.

Manufacturer and Licence Holder

Manufactured by Alfasigma S.p.A. Via Enrico Fermi, 1 IT – 65020 Alanno pescara, Italy and is procured from within the EU and repackaged by the Product Licence Holder: Lexon (UK) Limited, Unit 18, Oxleasow Road, East Moons Moat, Redditch, Worcestershire, B98 0RE.

If you have any questions or are not sure about anything, ask your doctor or pharmacist. They will have additional information about this medicine and will be able to advise you.

RIFAXIMIN is a registered trademark of ALFASIGMA S.p.A.

|PQM| PL 15184/2466 RIFAXIMIN 550mg

film-coated tablets

Revision date: 30/11/2021

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Tel: 01527 505414 to obtain the leaflet in a format suitable for you