Refaximin Tablets USP 200mg

Refaximin Tablets USP 200mg
Refaximin Tablets USP 400mg
Refaximin Tablets USP 550mg

Package Leaflet: Information for the user

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.

What is in this leaflet:

  1. What Rifaximin is and what it is used for
  2. What you need to know before you take Rifaximin
  3. How to take Rifaximin
  4. Possible side effects
  5. How to store Rifaximin
  6. Contents of the pack and other information

  7. What Refaximin 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.

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

  • What you need to know before you take Refaximin

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 Tand to contact your doctor immediately.

If your liver problems are severe your doctor will need to observe you carefully.

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 heartbeat)
    • 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 Refaximin

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.

Your doctor will assess the need for you to continue treatment after 6 months.

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).

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 the 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 a blood test)

? Changes in blood coagulation (International Normalised Ratio is seen in a 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. By reporting side effects you can help provide more information on the safety of this medicine.

  • How to store Refaximin

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. Rifaximin does not require any special storage conditions.

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.

  • Contents of the pack and other information

What Rifaximin contains

The active substance is rifaximin. Each tablet contains 200mg and 550mg Rifaximin.

The other ingredients are:

  • Tablet core: Sodium Starch Glycolate (Type A), Glycerol Distearate, Colloidal Anhydrous Silica, Talc, Microcrystalline Cellulose.
    • Tablet coat (paddy oy-s-34907): Hypromellose, Titanium dioxide, Disodium Edetate, Propylene Glycol, Red Iron Oxide.

What Rifaximin looks like and contents of the pack

Rifaximin 200mg film-coated tablets

Rifaximin is available in cartons of 14, 28, 42, 56 and 98 tablets.

Not all pack sizes may be marketed.

Manufactured in India by:
Unit No. 214, Old Bake House,
Bake House Lane, Fort,
at: Ahmedabad- Gujarat, INDIA.
Ho.NO.+91 8448 444 095
Toll Free Phone: (1800-222-434 / 1800-222-825)