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METRONIDAZOLE 200MG TABLETS BP

Active substance(s): METRONIDAZOLE

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METRONIDAZOLE PIL:00590514-02........165 X 297 mm

5/24/14

4:56 PM

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Patient Information Leaflet

METRONIDAZOLE 200MG & 400MG TABLETS

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 or nurse. This includes any possible side
effects not listed in this leaflet. See section 4.
In this leaflet:
1. What Metronidazole is and what it is used for
2. What you need to know before you take Metronidazole
3. How to take Metronidazole
4. Possible side effects
5. How to store Metronidazole
6. Contents of the pack and other information

1. What Metronidazole is and what it is used for

Metronidazole belongs to a group of medicines called
antibiotics.
Metronidazole is used for the treatment of:
• bacterial infections including infection of the
abdomen, brain, blood, lung, bones, pelvic area,
intestines and the genital tract
• certain bacterial and protozoal infection of the genital
tract in women
• ulceration of the gums and other dental infection.
• infected pressure sores and leg ulcers
• infections of intestines due to parasitic microorganisms
It is also used for the prevention and treatment of bacterial
infections after a surgical operation.

2. What you need to know before you take
Metronidazole
Do not take Metronidazole Tablets if:

• you are sensitive or allergic to metronidazole,



















nitroimidazoles or any of the ingredients in your
medicine (signs of an allergic reaction include; a
rash, swallowing or breathing problems, swelling of
your lips, face, throat or tongue)
you are in the first 3 months of pregnancy or are
breastfeeding (see ‘Pregnancy and breastfeeding’
later in this leaflet)
Warnings and precautions
Talk to your doctor or pharmacist before taking these
tablets if you:
are suffering from, or have suffered from, any liver
disease
are suffering from any disease of the nervous system
are having kidney dialysis
are in the 4th-9th month of pregnancy
have epilepsy or have ever had fits
have porphyria (a genetic disease that can cause skin
blisters, abdominal pain and brain/nervous system
disorders)
have any disorder of the blood and/or blood cells
have been exposed to any sexually transmitted
disease
Taking other medicines
Tell your doctor or pharmacist if you are taking, have
recently taken or might take any other medicines. This
is because Metronidazole can affect the way some
other medicines work, also some other medicines may
change the way Metronidazole works.
In particular, tell your doctor if you are taking:
anticoagulants ( medicines to thin the blood), such as
warfarin
lithium (for the treatment of mania in bi-polar
patients). If taken at the same time as Metronidazole,
your kidneys may be affected
medicines used to treat epilepsy, such as phenytoin,
phenobarbitone
cimetidine (used to treat stomach ulcer)
5-flurouracil, busulfan for cancer

• ciclosporin, to prevent the rejection of organs after

transplant

• disulfiram for alcoholism
• oestrogen contraceptive

If you are not sure, talk to your doctor or pharmacist
before taking metronidazole.
Taking this medicine with food and drink
You are advised not to drink any alcohol whilst
taking Metronidazole tablets, and for 48 hours after
finishing your course of tablets, as this might cause
unpleasant side effect, such as nausea and vomiting,
abdominal pain, hot flushes, palpitations and headache.
Pregnancy and breast-feeding
Metronidazole tablets must not be taken during the
first 3 months of pregnancy and should not be taken
during the rest of the pregnancy.
If you breastfeed you should stop whilst taking
Metronidazole tablets and for 12-24 hours after
the course of tablets has finished before breastfeeding
again. Ask your doctor or pharmacist for advice before
taking this medicine.
Driving and using machines
While taking Metronidazole you may feel dizzy,
confused, see or hear things that are not there
(hallucinations), have fits (convulsions) or temporary
eyesight problems. If this happens, do not drive or use
any machinery or tools.
Metronidazole tablet contains lactose
If you have been told by your doctor that you have an
intolerance to some sugars, contact your doctor before
taking this medicine as it contains lactose.
Tests
Your doctor may wish to carry out some tests if you
have been using this medicine for more than 10 days.
This medicine may affect the results of some liver
function tests (used to tell if your liver is working
properly).

3. How to take Metronidazole

Always take metronidazole exactly as your doctor has told
you. Check with your doctor if you are not sure. It is
important to finish a full course of treatment. The length
of a course will depend on your needs and the illness
being treated. The tablets should be swallowed whole with
water preferably during or after a meal. Do not chew
them. Infants and young children will be treated with a
liquid form of this medicine.
Dosage
The usual dose for adults and children is given below
• Treatment of bacterial infection
Adults: 800mg initially followed by 400mg every 8
hours, for 7 days.
• Children up to 12 years of age: Your doctor will
advise on the number of tablets to give your child.
• Bacterial Vaginosis
Adolescents: 400mg twice daily for 5-7 days.
• Treatment of postoperative infections
Children under 12 years: Your doctor will advise on
the number of tablets to give your child.
• Treatment of a genital infection in women
Women and girls over 10 years: 400mg twice daily for
7 days or 2g as a single dose.
• Treatment of Trichomoniasis (infection of the
urogenital tract)
Adults and adolescents: 2g as a single dose or 200mg 3
times daily for 7 days or 400mg twice daily for 5-7
days.
Children under 10 years: Your doctor will advise on
the number of tablets to give your child.
• Treatment of Giardiasis (a parasitic infection of the
intestines)
Adults, elderly and children over 10 years: 2g once
daily for 3 days, or 400mg 3 times daily for 5 days,
or 500mg twice daily for 7-10 days.
Children under 10 years: Your doctor will advise on
the number of tablets to give your child.

METRONIDAZOLE PIL:00590514-02........165 X 297 mm

• Treatment of Amoebiasis (a parasitic infection of

the intestines)
Adults and children over 10 years : 400 to 800mg 3
times daily for 5-10 days
Children under 10 years: Your doctor will advise on
the number of tablets to give your child.
• Treatment of Ulcerative Gingivitis (infection of the
gums with ulcers)
Adults and children over 10 years: 200mg 3 times
daily for 3 days.
Children under 10 years: Your doctor will advise on
the number of tablets to give your child.
• Treatment of infection of gums
Adults and children over 10 years: 200mg 3 times
daily for 3-7 days.
• Treatment of infected leg ulcers
Adults and children over 10 years: 400mg 3 times
daily for 3-7 days.
• Treatment of Helicobacter pylori in children
Your doctor will advise on the number of tablets to
give your child. Your child will also be given another
medicine at the same time.
If you are elderly or have liver disease, it is particularly
important to take this medicine exactly as directed by the
doctor.
If you take more tablets than you should
If you or a child accidentally takes too many tablets,
contact your nearest hospital casualty department or
contact your doctor immediately. Bring any remaining
tablets with you to show the doctor.
Signs of an overdose include feeling or being
sick, loss of appetite, diarrhoea, metallic taste,
headache, dizziness, insomnia or drowsiness.
If you forget to take a dose
Do not worry just take your tablets as soon as you
remember, then go on as before. Do not take a double
dose to make up for a forgotten dose.
If you have any further questions on the use of this
medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Metronidazole Tablets can cause side
effects, although not everybody gets them.
Stop taking these tablets and see a doctor or
go to a hospital straight away if you notice the
following serious side effects:
• swelling of the hands, feet, ankles, face, lips or throat
which may cause difficulty in swallowing or breathing.
You could also notice an itchy, lumpy rash (hives) or
nettle rash (urticaria).
• a serious but very rare side effect which is a brain
disease (encephalopathy). Symptoms include fever,
stiff neck, headache, see or hear things that are not
there. You might also have problems using your arms
and legs, problems with speaking or feel confused.
• a condition called subacute cerebellar syndrome.
Symptoms include lack of muscle co-ordination,
problems with speaking or walking, uncontrolled
movement of the eyes and tremor
• bone marrow depression disorders such as aplastic
anaemia (causing weakness, bruising, making
infections more likely)
• a group of symptoms together including fever, nausea,
vomiting, headache, stiff neck and extreme sensitivity
to bright light (meningitis)
Talk to your doctor straight away if you notice the
following side effects:
• yellowing of the skin and eyes (jaundice).
• unexpected infections, mouth ulcers, bruising,
bleeding gums, or severe tiredness.
• severe stomach pain which may reach through to your
back (pancreatitis).
Tell your doctor or pharmacist if you notice
any of the following side effects
Very rare (affects less than 1 in 10 000 people):
• fits (convulsions)
• mental problems such as feeling confused and seeing
or hearing things that are not there (hallucinations)
• problems with your eyesight such as blurred or double
vision
• skin rash and flushing

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• headache, drowsiness or dizziness
• darkening of the urine
• pain in the muscles or joints

Not known (frequency cannot be estimated from the
available data):
• numbness, tingling, pain, or a feeling of weakness, in
the arms or legs
• sore mouth, unpleasant taste in the mouth and furred
tongue
• feeling sick (nausea), being sick (vomiting), upset
stomach, or diarrhoea, pain in upper part of abdomen
• loss of appetite, fever, feeling depressed
• pain in your eyes (optic neuritis)
• red skin patches and itching (erythema multiforme)
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 the Yellow Card Scheme
at: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 Metronidazole

Keep all medicines out of the sight and reach of
children
• Do not use the tablets after the expiry date stated on
the label after ‘EXP’. The expiry date refers to the last
day of that month.
• Do not store above 25˚C.
• Keep container tightly closed.
• Store in original container.
Do not throw away any medicines via wastewater or
household waste. Ask your pharmacist how to throw away
medicines you no longer use. These measures will help
protect the environment.

6. Contents of the pack and other information

What Metronidazole tablets contain
Metronidazole 200mg tablets:
• The active substance is 200mg of Metronidazole.
• The other ingredients are lactose monohydrate,
sodium starch glycollate (Type A), maize starch,
micro-crystalline cellulose, colloidal anhydrous silica,
macrogol 4000, magnesium stearate (E572) and
povidone (E1201).
Metronidazole 400mg tablets:
• The active substance is 400mg of Metronidazole.
• The other ingredients are lactose monohydrate,
sodium starch glycollate (Type A), maize starch,
macrogol 4000, micro-crystalline cellulose, colloidal
anhydrous silica, magnesium stearate (E572),
povidone (E1201) and aluminium lake quinoline
yellow (E104).
See end of section 2 for further information on lactose.
What Metronidazole looks like and contents of the
pack
• Metronidazole 200mg tablets are white, biconvex
and embossed ‘M/200’ on one side and ‘PV’ on the
other side.
• Metronidazole 400mg tablets are yellow, biconvex
and embossed ‘M/400’ on one side and ‘PV’ on the
other side.
• Metronidazole 200mg tablets are available in packs
containing “14, 21, 100, 250 and 500 tablets”
• Metronidazole 400mg tablets are available in packs
containing “14, 21, 100, 250 and 500 tablets”
Not all pack sizes may be marketed.
Marketing Authorization Holder
and Manufacturer:
Pharmvit Ltd, 177 Bilton Road, Perivale,
Greenford, Middlesex UB6 7HQ.
Telephone: 0208 997 5444
Fax:
0208 997 5433
To request a copy of this leaflet in large print or audio
format or additional copies, please contact the licence
holder at the address (or telephone, fax) above.
PL 04556 / 0010 & 04556 / 0011
Reference: 0010110514/03
The leaflet was last revised in May 2014

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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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