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NORMICRON 200 MG FILM-COATED TABLETS

Active substance(s): RIFAXIMIN

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• 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 NORMICRON 200 MG FILM-COATED
TABLETS
Keep out of the reach and sight of children.
Normicron 200 mg film-coated tablets do not require any
special storage conditions.
Do not use Normicron 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 Normicron 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 Normicron 200 mg film-coated tablets look like and
contents of the pack
• Normicron 200 mg film-coated tablets are pink circular
biconvex coated tablets, with “AW” printed on both sides.
• They are provided in blister pack containing 9 tablets.
Marketing Authorisation Holder and Manufacturer
Alfa Wassermann S.p.A. Via E. Fermi, 1 – 65020 Alanno (PE),
ITALY
This leaflet was last revised in March 2016

REG. 09/11

PACKAGE LEAFLET: INFORMATION FOR THE USER

Normicron 200 mg film-coated tablets
Rifaximin

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 Normicron 200 mg film-coated tablets are and what
they are used for
2. What you need to know before you take Normicron 200 mg
film-coated tablets
3. How to take Normicron 200 mg film-coated tablets
4. Possible side effects
5. How to store Normicron 200 mg film-coated tablets
6. Contents of the pack and other information

1. WHAT NORMICRON 200 MG FILM-COATED TABLETS
ARE AND WHAT THEY ARE USED FOR
Normicron 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.
• Normicron 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
NORMICRON 200 MG FILM-COATED TABLETS
Do not take Normicron 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 Normicron 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 Normicron 200 mg film-coated tablets
• if, after 3 days of treatment, your symptoms continue or reappear shortly afterwards do not take a second course of
Normicron 200 mg film-coated tablets, see a doctor;
• if your symptoms get worse during treatment stop taking
Normicron 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 Normicron 200 mg filmcoated tablets at least 2 hours after taking charcoal.
Taking Normicron 200 mg film-coated tablets with food
and drink
Normicron 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
Normicron 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 50 µg, as the effectiveness of your oral contraceptive
can decrease 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
Normicron 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 NORMICRON 200 MG FILM-COATED
TABLETS
Always take Normicron 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 Normicron 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 Normicron 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 Normicron 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 Normicron 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, Normicron 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
• fever.
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 (aspartateaminotransferase)
• rashes, purplish discolouration 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

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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