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METRONIDAZOLE 500 MG TABLETS

Active substance(s): METRONIDAZOLE

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Metronidazole 500 mg Tablets
The name of your medicine is Metronidazole 500 mg Tablets, but will be
referred to as Metronidazole throughout this leaflet.
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, pharmacist or nurse
• 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, pharmacist or nurse.
This includes any possible side effects not listed in this leaflet. See
section 4.
What is 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 tablets belong to a group of medicines called anti-infective
agents. They may be used to treat:
• infections, caused by bacteria of the blood, brain, bone, lung, stomach
lining and pelvic area, following childbirth or in a wound following an
operation
• urinary or genital infections caused by a parasite, Trichomonas
• genital infection in women caused by bacteria
• the parasitic diseases amoebiasis
• the disease giardiasis
• gum and teeth infections
• infected leg ulcers or pressure sores
• stomach ulcers caused by Helicobacter pylori.
• or prevent infections occurring after operations.

2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE
METRONIDAZOLE
Do not take Metronidazole:
• if you are allergic to Metronidazole tablets or any of the other
ingredients of this medicine (listed in section 6).
• if you are in the first 3 months of pregnancy or are breastfeeding.
Warnings and precautions
Talk to your doctor, pharmacist or nurse before taking Metronidazole
tablets:
• if you have kidney disease, particularly if you require dialysis
treatments
• if you have ever suffered from any liver disease
• if you are in the 4th-9th month of pregnancy
• if you have epilepsy or have ever had fits
• if you have porphyria (a genetic disease that can cause skin blisters,
abdominal pain and brain/nervous system disorders)
• if you have any disorder of the blood and/or blood cells
• if you have any nervous system disorders
• if you 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:
• Stomach pain, anorexia, nausea, vomiting, fever, malaise, fatigue,
jaundice, dark urine, putty or mastic coloured stools or itching.
Other medicines and Metronidazole
Tell your doctor or pharmacist if you are taking, have recently taken or
might take any other medicines. Especially:
• medicines to stop the blood clotting such as warfarin
• lithium (used to treat depression)






medicines to treat epilepsy such as phenobarbital, phenytoin,
primidone
disulfiram (to treat alcohol addiction)
ciclosporin (used following organ transplants)
fluorouracil (used to treat some forms of cancer)
cimetidine (used to treat stomach ulcers)

Metronidazole tablets with food, drink and alcohol
You are advised not to drink alcohol whilst taking this medicine and
for 48 hours after finishing the course of tablets, as this might cause
unpleasant side-effects, such as feeling or being sick, stomach pain, hot
flushes, palpitations and headache.
Pregnancy and breastfeeding
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.
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 this medicine.
Driving and using machines
Metronidazole tablets may make you feel drowsy, dizzy, confused or affect
your vision, cause fits or hallucinations. Make sure you are not affected
before you drive, operate machinery or take part in any activities where
these may put you or others at risk.
Metronidazole contains lactose
If you have been told you have an intolerance to some sugars, contact your
doctor before taking this medicine, as it contains a sugar called lactose.
Tests
If you are taking this medicine for more than 10 days, your doctor may wish
to carry out further tests.
If you need any blood or urine tests, tell your doctor you are taking
Metronidazole tablets before the test.

3. HOW TO TAKE METRONIDAZOLE
Always take this medicine exactly as your doctor or pharmacist has told
you. Check with your doctor or pharmacist if you are not sure.
Swallow the tablets whole, during or after meals, with a glass of water.
Do not chew them.
The recommended dose is:
For doses less than 500mg (one tablet) an alternative dosage form
should be used.
To treat bacterial infections
• Adults and children over 10 years: 800mg followed by 400mg at eight
hourly intervals. Treatment is usually for 7 days but will depend upon
your condition.
To treat anaerobic infections
• Children 8 weeks-12 years: 20-30mg/kg/day as a single dose or
divided into 7.5mg/kg every 8 hours for 7 days. The daily dose may be
increased to 40mg/kg, depending on the severity of the infection.
• Children under 8 weeks: 15mg/kg/day as a single dose or divided into
7.5mg/kg every 12 hours.
• Children under 10 years: A more suitable dosage form should be used
for this age group.
To treat infection caused by Trichomonas
• Adults and adolescents: 2g as a single dose, or 200mg three times a
day for 7 days, or 400mg twice a day for 5-7 days. Your partner should
also be treated.
• Children under 10 years: 40mg/kg as a single dose or 15-30mg/kg/day
two to three times daily for 7 days. Doses should not to exceed
2000mg/dose.
• Children under 10 years: A more suitable dosage form should be used
for this age group.
To treat non-specific genital infection in women
• Women: 400mg twice a day for 7 days, or 2g as a single dose for 1 day
only.
• Adolescent girls: 400mg twice daily for 5 to 7 days or 2g as a single
dose.

To treat amoebiasis
• Adults and children over 10 years: 400mg-800mg three times a day for
5 to 10 days.
• Children 7-10 years: 200mg-400mg three times a day for 5 to 10 days.
• Children 3-7 years: 100mg-200mg four times daily for 5 to 10 days.
• Children 1-3 years: 100mg-200mg three times daily for 5 to 10 days.
Or 35-50mg/kg/day in 3 divided doses for 5 to 10 days.
• Children under 7 years: A more suitable dosage form should be used
for this age group.



To treat giardiasis
• Adults and children over 10 years: 2g once a day for 3 days, or 400mg
three times a day for 5 days or 500mg twice daily for 7 to 10 days.
• Children 7-10 years: 1 g once a day for 3 days.
• Children 3-7 years: 600mg-800mg once daily for 3 days.
• Children 1-3 years: 500mg once daily for 3 days. Or 15-40mg/kg/day
divided in two to three doses.
• Children under 7 years: A more suitable dosage form should be used
for this age group.

Not known (cannot be estimated from the available data):
• bone marrow depression disorders such as aplastic anaemia (causing
weakness, bruising, making infections more likely)
• urticaria (itchy, pale or red irregular raised patches of skin), fever
• depression, ‘pins and needles’
• unpleasant taste in the mouth, changes in taste, furred tongue, mouth
ulcers, feeling or being sick, loss of appetite, diarrhoea, stomach pain
and upset stomach
• erythema multiforme (circular, irregular red patches)

To treat infections of the gums (for 3 days) or teeth (for 3-7days)
• Adults and children over 10 years: 200mg three times a day.
To treat infected leg ulcers or pressure sores (for 7 days)
• Adults and children over 10 years: 400mg three times a day
To treat stomach ulcers caused by Helicobacter pylori
To be taken as directed by your doctor as part of a course with two other
medicines.
To prevent infections after surgery
• Adults: 1g as a single dose 24 hours before surgery then, 400mg at 8
hourly intervals during the 24 hours before the operation.
• Children under 12 years: 20-30mg/kg as a single dose 1-2 hours
before the operation.
• Newborns with a gestation age less than 40 weeks: 10 mg/kg body
weight as a single dose before operation.
• Children under 10 years: A more suitable dosage form should be used
for this age group.
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 Metronidazole than you should
If you (or someone else) swallow a lot of tablets at the same time, or you
think a child may have swallowed any contact your nearest hospital
casualty department or tell your doctor immediately. 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 Metronidazole
Do not take a double dose to make up for a forgotten dose. If you forget to
take a dose take it as soon as you remember it and then take the next
dose at the right time.





Cerebellar syndrome (poor co-ordination or muscle control, involuntary
shakiness, uncontrolled eye movements, speech disorders, walking
abnormally)
double vision, short sightedness
changes in liver function tests, jaundice (yellowing of the skin or whites
of the eyes), inflammation of the pancreas (pancreatitis causing very
severe abdominal pain), flushing
skin rashes, itching, small pus-containing blisters, muscle and joint
pain, darkening of the urine

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 this medicine out of the sight and reach of children.
Do not store above 25˚C.
Store in a dry place.
Store in the original package.
Do not use Metronidazole after the expiry date stated on the
label/carton/bottle. The expiry date refers to the last day of that month.
If your medicine becomes discoloured or shows any signs of deterioration
consult your pharmacist who will advise you what to do.
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 Metronidazole contains
• Each film-coated tablet contains 500mg metronidazole
• The other ingredients are carmellose sodium, lactose monohydrate,
povidone, magnesium stearate, maize starch, microcrystalline
cellulose, methylhydroxypropylcellulose, macrogol 400 and titanium
dioxide (E171).
What Metronidazole looks like and contents of the pack
White, bi-convex, film-coated tablet marked 'CL' above and 'J' below a
scoreline and plain on the reverse.
Available in blister packs containing 20 or 30 tablets.
Not all pack sizes may be marketed.

If you stop taking Metronidazole
If you stop taking the tablets your infection may come back. Talk to your
doctor before you stop taking the tablets and follow their advice.

4. POSSIBLE SIDE EFFECTS
Like all medicines, this medicine can cause side effects, particularly when
you first start taking it, although not everybody gets them.
Contact your doctor at once if you notice any of the following side
effects:
• Allergic reactions: skin rash, which may be itchy, swelling of the face,
lips, tongue or throat, fever or difficulty in breathing.
Tell your doctor if you notice any of the following side effects or notice
any other effects not listed:
Very rare (less than 1 in 10,000 users):
• increased bruising, nosebleeds, sore throats or infections, this
medicine may alter the numbers and types of you blood cells. You
should tell your doctor who might want you to have a blood test
• mental health problems including hallucinations (seeing or hearing
things that are not there), drowsiness, dizziness, fits, tingling, pain or a
feeling of weakness in the arms or legs, numbness
• Encephalopathy (headaches, light sensitivity, confusion, fever,
paralysis, stiff neck)

Manufactured by Actavis B.V., Baarnsche Dijk 1, 3741 LN Baarn, The
Netherlands or Balkanpharma – Dupnitsa AD, 3, Samokovsko Shosse Str.,
2600 Dupnitsa, Bulgaria or Sandoz BV, Veluwezoom 22, PO Box 10332,
1301 AH Almere, The Netherlands and procured from within the EU and
repackaged in the UK by the Product Licence holder: CD Pharma Ltd, Unit
3, Manor Point, Manor Way, Borehamwood, Herts WD6 1EE.
Metronidazole 500 mg Tablets
PL: 20492/0560
POM

Blind or partially sighted? Is this
leaflet hard to see or read?
Call 020 8236 3190 to obtain a leaflet
in a format suitable for you.
Date of preparation: 08th June 2017

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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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