FLAGYL S 200MG/5ML ORAL SUSPENSION

Active substance: METRONIDAZOLE BENZOATE

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PATIENT INFORMATION LEAFLET
FLAGYLTM S 200MG/5ML ORAL SUSPENSION
Metronidazole Benzoate
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 further questions, please ask your doctor or
pharmacist.
• This medicine has been prescribed for you. Do not pass it
on to others. It may harm them, even if their symptoms
are the same as yours.
• If any of the side effects gets serious, or if you notice any
side effects not listed in this leaflet, please tell your doctor
or pharmacist.
In this leaflet:
1. What Flagyl is and what it is used for
2. Before you take Flagyl
3. How to take Flagyl
4. Possible side effects
5. How to store Flagyl
6. Further information

The name of this medicine is Flagyl S 200mg/5ml Oral
Suspension (called Flagyl in this leaflet). Flagyl contains a
medicine called metronidazole benzoate. This belongs to a
group of medicines called antibiotics.
It works by killing bacteria and parasites that cause infections
in your body.
It can be used to:
• Treat infections of the blood, brain, lung, bones, genital
tract, pelvic area, stomach and intestines
• Treat gum ulcers and other dental infections
• Treat infected leg ulcers and pressure sores
• Prevent infections after surgery
If you need any further information on your illness, speak to
your doctor.

2. Before you take Flagyl
Do not take Flagyl and tell your doctor if:
• You are allergic (hypersensitive) to metronidazole ,
nitroimidazoles (e.g. tinidazole) or any of the other
ingredients in your medicine (listed in Section 6: Further
information).
Signs of an allergic reaction include: a rash, swallowing or
breathing problems, swelling of your lips, face, throat or
tongue.
Do not take Flagyl if any of the above apply to you. If you
are not sure, talk to your doctor or pharmacist before taking
Flagyl.
Take special care with Flagyl and check with your doctor
or pharmacist before using your medicine if:
• You have or have ever had a liver problem.
• You are having kidney dialysis (see section 3: ‘People
having kidney dialysis’)
• You have a disease of the nervous system
If you are not sure if any of the above apply to you, talk to
your doctor or pharmacist before taking your medicine. Do
this even if they have applied in the past.

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Taking Flagyl with food and drink
Do not drink any alcohol while you are taking Flagyl and
for 48 hours after finishing your course. Drinking alcohol
while using Flagyl might cause unpleasant side effects, such
as feeling sick (nausea), being sick (vomiting), stomach pain,
hot flushes, very fast or uneven heartbeat (palpitations) and
headache.
Pregnancy and breast-feeding
Tell your doctor before using Flagyl if:
• You are pregnant, might become pregnant or think you
may be pregnant. Flagyl should not be taken during
pregnancy unless considered absolutely necessary.
• You are breast-feeding. It is better not to use Flagyl if you
are breast-feeding. This is because small amounts may pass
into the mother’s milk.
Driving and using machines
While taking Flagyl you may feel sleepy, dizzy, confused,
see or hear things that are not there (hallucinations), have
fits (convulsions) or temporary eyesight problems (such as
blurred or double vision). If this happens, do not drive or use
any machinery or tools.

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1. What Flagyl is and what it is used for

Brand: FLAGYLS LEAFLET 200MG/5ML ORAL SUSPENSION 25.02.2011 UK

the way Flagyl works.
In particular tell your doctor if you are taking any of the
following medicines:
• Medicines used to thin the blood such as warfarin
• Lithium for mental illness
• Phenobarbital or phenytoin for epilepsy
• 5 fluorouracil for cancer
• Busulfan for leukaemia (cancer of the blood cells)
• Ciclosporin – to prevent the rejection of organs after
transplant
• Disulfiram for alcoholism
If you are not sure, talk to your doctor or pharmacist before
taking Flagyl.

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Tests
Your doctor may wish to carry out some tests if you have
been using this medicine for more than 10 days.
Important information about some of the ingredients of
your medicine
• Sucrose: This is a type of sugar. If you have been told by
you doctor that you cannot tolerate some sugars, talk to
your doctor before taking this medicine.
• Methyl hydroxybenzoate (E218) and propyl
hydroxybenzoate (E216): These are preservatives that are
added to Flagyl to make the medicine last longer. These
can cause an allergic reaction in some people.
• Alcohol: Flagyl contains 0.8% alcohol (ethanol) by volume;
this is equivalent to 32mg alcohol per 5ml dose. At high
doses this could be harmful for those suffering from
alcoholism, liver disease or epilepsy.

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3. How to take Flagyl

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Taking your medicine
Always take Flagyl exactly as your doctor has told you. 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.
Check with your doctor or pharmacist if you are not sure.
• Take Flagyl Suspension by mouth
• The dose of Flagyl will depend on your needs and the
illness being treated
• The length of your treatment will depend on the type of
Taking other medicines
illness you have and how bad it is
Please tell your doctor or pharmacist if you are taking or
• Your doctor or pharmacist may dilute your Flagyl
have recently taken any other medicines. This includes
Suspension. In this case the pharmacist’s label on the
medicines obtained without a prescription, including herbal
packaging will tell you how exactly much to take and how
medicines. This is because Flagyl can affect the way some
often.
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• 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 or flushing
• Headache
• Darkening of the urine
To prevent infections from happening after surgery
• Feeling sleepy or dizzy
Children
• Pains in the muscles or joints
• Give your child Flagyl suspension 2-3 hours before their
• Liver problems including life-threatening liver failure
operation
(hepatocellular liver injury)
• Your doctor will work out how much your child should
take depending on their weight
Not known (frequency cannot be estimated from the
available data)
• Numbness, tingling, pain, or a feeling of weakness, in the
Other types of infections
arms or legs
For treatment of other infections caused by parasites and
some bacteria your doctor will decide how much Flagyl you • Unpleasant taste in the mouth
• Furred tongue
need to take. This will depend on your illness and how bad
• Feeling sick (nausea), being sick (vomiting), upset stomach,
it is. The pharmacist’s label on the packaging will tell you
stomach pain or diarrhoea
exactly how much Flagyl Suspension to take and how often.
• Loss of appetite
• Fever
People having kidney dialysis
• Feeling depressed
Kidney dialysis removes Flagyl from your blood. If you are
• Pain in your eyes (optic neuritis)
having kidney dialysis you must take this medicine after your • A group of symptoms together including: fever, nausea,
dialysis treatment.
vomiting, headache, stiff neck and extreme sensitivity
to bright light. This may be caused by an inflammation
People with liver problems
of the membranes that cover the brain and spinal cord
Your doctor may tell you to use a lower dose or to use the
(meningitis)
medicine less often.
If any of the side effects gets serious, lasts longer than a few
days or you notice any side effects not listed in this leaflet,
If you take more Flagyl than you should
please tell your doctor or pharmacist.
If you take more Flagyl than you should, tell your doctor
or go to your nearest hospital casualty department straight
5. How to store Flagyl
away. Take the carton and bottle with you. This is so the
doctor knows what you have taken.
• Keep your medicine in a safe place and out of the reach
and sight of children.
If you forget to take Flagyl
• Store below 25°C.
If you forget to take Flagyl, take it as soon as you remember. • Store your medicine in the original packaging in order to
However, if it is almost time for your next dose, skip the
protect them from light.
• Do not use this medicine after the expiry date shown on
missed dose. Do not use a double dose to make up for a
the bottle label and packaging.
forgotten dose.
• Ask your pharmacist how to dispose of medicines no
longer required. Do not dispose of medicines by flushing
4. Possible side effects
down a toilet or sink or by throwing out with your normal
household rubbish. This will help protect the environment.
Like all medicines, Flagyl can cause side effects, although not
everybody gets them.

6. Further information

Stop taking Flagyl and see a doctor or go to a hospital
straight away if:
• You get 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)
This may mean you are having an allergic reaction to
Flagyl.
• A serious but very rare side effect is a brain disease
(encephalopathy). Symptoms vary but you might get a
fever, stiff neck, headache, see or hear things that aren’t
there. You might also have problems using your arms and
legs, problems with speaking or feel confused.
Talk to your doctor straight away if you notice the
following side effects.
• Yellowing of the skin and eyes. This could be due to a liver
problem (jaundice).
• Unexpected infections, mouth ulcers, bruising, bleeding
gums, or severe tiredness. This could be caused by a blood
problem.

What Flagyl S 200mg/5ml Oral Suspension contains
Each 5 ml of suspension contains 200mg metronidazole
benzoate as the active substance.
Other ingredients are: Sucrose, sodium dihydrogen
phosphate or sodium acid phosphate crystalline, magnesium
aluminium silicate, methyl hydroxybenzoate (E218), propyl
hydroxybenzoate (E216), ethanol, lemon flavouring, orange
flavouring, purified water.
What Flagyl S 200mg/5ml Oral Suspension looks like and
contents of the pack
The suspension is white to cream coloured with a slight
yellow tinge and an odour of oranges and lemons. It is
available in 100ml bottles.
The Marketing Authorisation Holder is: Winthrop
Pharmaceuticals, PO Box 611, Guildford, Surrey, GU1 4YS, UK
The Manufacturer is: Unither Liquid Manufacturing, 1-3
allée de la Neste, Z.I. d’en Sigal, 31770 Colomiers, France
This leaflet was last updated in March 2012
“Flagyl” and “Winthrop” are registered trademarks. ©2012
Winthrop Pharmaceuticals.
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The usual dose for adults and children is given below:
To treat certain bacterial infection
Adults and children over 10 years
• Take 10ml (400mg) of Flagyl Suspension once every 8 hours
Children and infants
• Your doctor will work out how much your child should
take depending on their weight
• Repeat the dose every 8 hours
• If your child is a baby under 8 weeks of age, your doctor
will give them one daily dose or two separate doses 12
hourly

Brand: FLAGYLS LEAFLET 200MG/5ML ORAL SUSPENSION 25.02.2011 UK
Category:
LEAFLET
Argus Code: 000
Spec No:
00000
Supersedes: 00000
Core Spec No: 00000
Ticket No:
Date:
Issue No:
Operator:
Page:

329510
21.03.12
2
KY
2 of 2

FOR SCHAWK
USE ONLY

Unwind:
N/A
Size:
157x210-RL
Win/RFL Ref: N/A
Barcode:
N/A
Mag:
N/A
BWR:
N/A
BWR to be assigned by printer.
Fonts:

Ocean Sans Std

No. colours and varnish: 1
Black

Artwork Approval
Reason for Circulation:

FOR
WINTHROP USE
..................................
. . . . . . . . . . . .ONLY. . . . . . . . . . . .
..........
..................................
..................................

..................................
Winthrop Marketing
Approved: Yes
No
Date:
Signature:

N/A

THESE
SIGNATURES ARE
Winthrop Pharmacist/Medical Affairs
Approved: Yes
No
N/A
Date:
FOR WINTHROP
Signature:
HEAD OFFICE USE
Winthrop Regulatory Affairs
Approved: Yes
No
ONLY
Date:
Signature:

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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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