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METRONIDAZOLE 400MG TABLETS BP

Active substance(s): METRONIDAZOLE / METRONIDAZOLE / METRONIDAZOLE

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Metronidazole 200mg &400mg 06-04-2017.qxp_Metronidazole 0010110317-04........... 175 X 297mm 06/04/2017 15:43 Page 1

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:
x bacterial infections including infection of the abdomen,
brain, blood, lung, bones, pelvic area, intestines and the
genital tract
x certain bacterial and protozoal infection of the genital tract
in women
x ulceration of the gums and other dental infection.
x infected pressure sores and leg ulcers
x 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:

x 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)
x you are in the first 3 months of pregnancy or are
breastfeeding VHHµ3UHJQDQF\DQGEUHDVWIHHGLQJ¶ODWHU
in this leaflet)
‹ Warnings and precautions
Talk to your doctor or pharmacist before taking these
tablets if you:
x are suffering from, or have suffered from, any liver disease
x are suffering from any disease of the nervous system
x are having kidney dialysis
x are in the 4th-9th month of pregnancy
x have epilepsy or have ever had fits
x have porphyria (a genetic disease that can cause skin
blisters, abdominal pain and brain/nervous system
disorders)
x have any disorder of the blood and/or blood cells
x have been exposed to any sexually transmitted disease
Cases of severe liver toxicity/acute liver failure, including
cases with a fatal outcome, in patients with Cockayne
syndrome have been reported with product containing
metronidazole.
If you are affected by Cockayne syndrome, your doctor
should also monitor your liver function frequently while you
are being treated with metronidazole and afterwards.
Tell your doctor immediately and stop taking metronidazole if
you develop:
x Stomach pain, annorexia, nausea, vomiting, fever, malaise,
fatigue, jaundice, dark urine, putty or mastic coloured stools
or itching
‹ 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:
x anticoagulants ( medicines to thin the blood), such as
warfarin
x lithium (for the treatment of mania in bi-polar patients).
If taken at the same time as Metronidazole, your kidneys
may be affected
x medicines used to treat epilepsy, such as phenytoin,
phenobarbitone
x cimetidine (used to treat stomach ulcer)
x 5-flurouracil, busulfan for cancer
x ciclosporin, to prevent the rejection of organs after
transplant
x disulfiram for alcoholism
x 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
x Treatment of bacterial infection
Adults: 800mg initially followed by 400mg every 8 hours,
for 7 days.
x Children up to 12 years of age: Your doctor will advise on
the number of tablets to give your child.
x Bacterial Vaginosis
Adolescents: 400mg twice daily for 5-7 days.
x Treatment of postoperative infections
Children under 12 years: Your doctor will advise on the
number of tablets to give your child.
x 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.
x 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.

Metronidazole 200mg &400mg 06-04-2017.qxp_Metronidazole 0010110317-04........... 175 X 297mm 06/04/2017 15:43 Page 2

x 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.
x 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.
x 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.
x Treatment of infection of gums
Adults and children over 10 years: 200mg 3 times daily for
3-7 days.
x Treatment of infected leg ulcers
Adults and children over 10 years: 400mg 3 times daily for
3-7 days.
x 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:
x 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).
x 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.
x 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
x 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:
x yellowing of the skin and eyes (jaundice).
x unexpected infections, mouth ulcers, bruising, bleeding
gums, or severe tiredness.
x 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):
x fits (convulsions)

x mental problems such as feeling confused and seeing or

hearing things that are not there (hallucinations)

x problems with your eyesight such as blurred or double

vision
skin rash and flushing
headache, drowsiness or dizziness
darkening of the urine
pain in the muscles or joints
Not known (frequency cannot be estimated from the available
data):
x numbness, tingling, pain, or a feeling of weakness, in the
arms or legs
x sore mouth, unpleasant taste in the mouth and furred tongue
x feeling sick (nausea), being sick (vomiting), upset stomach,
or diarrhoea, pain in upper part of abdomen
x loss of appetite, fever, feeling depressed
x pain in your eyes (optic neuritis)
x red skin patches and itching (erythema multiforme)
‹ Reporting of side effects
x
x
x
x

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
x Do not use the tablets after the expiry date stated on the
ODEHODIWHUµ(;3¶7KHH[SLU\GDWHUHIHUVWRWKHODVWGD\RI
that month.
x Do not store aboYHÛC.
x Keep container tightly closed.
x 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:

x The active substance is 200mg of Metronidazole.
x 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:
x The active substance is 400mg of Metronidazole.
x 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
x Metronidazole 200mg tablets are white, biconvex and
HPERVVHGµ0¶RQRQHVLGHDQGµ39¶RQWKHRWKHUVLGH
x Metronidazole 400mg tablets are yellow, biconvex and
HPERVVHGµ0¶RQRQHVLGHDQGµ39¶ on the other side.
x Metronidazole 200mg tablets are available in packs
containing ³14, 21, 100, 250 and 500 tablets´
x Metronidazole 400mg tablets are available in packs
containing ³14, 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: 0010110317/04
The leaflet was last revised in March 2017

Expand Transcript

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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