RIFAXIMIN ALFASIGMA

Main information

  • Trade name:
  • RIFAXIMIN ALFASIGMA
  • Dosage:
  • 550 Milligram
  • Pharmaceutical form:
  • Film Coated Tablet
  • Prescription type:
  • Product subject to prescription which may not be renewed (A)
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • RIFAXIMIN ALFASIGMA
    Ireland
  • Language:
  • English

Therapeutic information

  • Therapeutic area:
  • rifaximin

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization status:
  • Not Marketed
  • Authorization number:
  • PA2206/001/001
  • Authorization date:
  • 18-12-2012
  • Last update:
  • 12-12-2018

Patient Information leaflet: composition, indications, side effects, dosage, interactions, adverse reactions, pregnancy, lactation

Package leaflet: Information for the user

RIFAXIMIN ALFASIGMA 550 mg film-coated tablets

rifaximin

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:

What RIFAXIMIN ALFASIGMA is and what it is used for

What you need to know before you take RIFAXIMIN ALFASIGMA

How to take RIFAXIMIN ALFASIGMA

Possible side effects

How to store RIFAXIMIN ALFASIGMA

Contents of the pack and other information

1.

What RIFAXIMIN ALFASIGMA is and what it is used for

RIFAXIMIN ALFASIGMA 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 ALFASIGMA is used in adults with liver disease to reduce the recurrence of episodes of

overt hepatic encephalopathy.

RIFAXIMIN ALFASIGMA can either be used alone or more commonly together with medicines

containing lactulose (a laxative).

2. What you need to know before you take RIFAXIMIN ALFASIGMA

Do not take RIFAXIMIN ALFASIGMA:

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 ALFASIGMA.

While you are taking RIFAXIMIN ALFASIGMA 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 ALFASIGMA you should stop taking RIFAXIMIN ALFASIGMA and

contact your doctor immediately.

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

Children and adolescents

RIFAXIMIN ALFASIGMA 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 ALFASIGMA

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 ALFASIGMA can harm your unborn baby. RIFAXIMIN

ALFASIGMA 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 ALFASIGMA is

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

Driving and using machines

RIFAXIMIN ALFASIGMA 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 RIFAXIMIN ALFASIGMA

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 ALFASIGMA 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 ALFASIGMA

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 ALFASIGMA

Do not stop taking RIFAXIMIN ALFASIGMA 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 taking RIFAXIMIN ALFASIGMA 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.

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 retention 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 or pharmacist. This includes any possible side effects

not listed in this leaflet. You can also report side effects directly via HPRA Pharmacovigilance

Earlsfort Terrace IRL - Dublin 2; Tel: +353 1 6764971; Fax: +353 1 6762517; Website: www.hpra.ie;

e-mail: medsafety@hpra.ie. By reporting side effects you can help provide more information on the

safety of this medicine.

5.

How to store RIFAXIMIN ALFASIGMA

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 ALFASIGMA 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.

6.

Contents of the pack and other information

What RIFAXIMIN ALFASIGMA contains

The active substance is rifaximin. Each tablet contains 550 mg rifaximin.

The other ingredients are:

Tablet core:

sodium

starch

glycolate

(Type

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 ALFASIGMA looks like and contents of the pack

Pink oval curved film-coated tablets marked with “RX” on one side.

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

Not all pack-sizes may be marketed.

Marketing Authorisation Holder

ALFASIGMA S.p.A.

Via Ragazzi del ’99, n. 5

40133 Bologna (BO)

Italy

Manufacturer

ALFASIGMA S.p.A.

Via E. Fermi 1, 65020 Alanno (PE)

This medicinal product is authorised in the Member States of the EEA under the following

names:

Refero: Austria, Denmark, Finland, Hungary, Luxembourg, Norway, Portugal, Slovakia, United

Kingdom

Tixteller:

Belgium, Germany, Greece, Italy, Netherlands, Poland, Romania, Spain, Sweden

Tixtar: France,

Greece, Italy, Spain

Rifaximin Alfasigma:

Ireland

This leaflet was last revised in