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METRONIDAZOLE SANOFI-AVENTIS 200MG/5ML ORAL SUSPENSION

Active substance(s): METRONIDAZOLE

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Flagyl® S 200mg/5ml Oral Suspension
Metronidazole sanofi-aventis 200mg/5ml Oral Suspension
(metronidazole benzoate)
Your medicine is available using one of the above names, but will be
referred to as Flagyl throughout this:
Patient Information Leaflet
 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

1) What Flagyl is and what it is used for
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.
Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently
taken any other medicines. This includes medicines obtained without a
prescription, including herbal medicines. This is because Flagyl can affect
the way some other medicines work. Also, some other medicines can affect
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.
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 breastfeeding. 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.
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.

3) How to take Flagyl
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 illness you have
and how bad it is
 Your doctor or pharmacist may dilute your Flagyl Suspension. In this
case the pharmacist’s label on the packaging will tell you how exactly
much to take and how often.
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
To prevent infections from happening after surgery Children
 Give your child Flagyl suspension 2-3 hours before their operation
 Your doctor will work out how much your child should take depending
on their weight
Other types of infections
For treatment of other infections caused by parasites and some bacteria
your doctor will decide how much Flagyl you need to take. This will depend
on your illness and how bad it is. The pharmacist’s label on the packaging
will tell you exactly how much Flagyl Suspension to take and how often.
People having kidney dialysis
Kidney dialysis removes Flagyl from your blood. If you are having kidney
dialysis you must take this medicine after your dialysis treatment.
People with liver problems
Your doctor may tell you to use a lower dose or to use the medicine less
often.
If you take more Flagyl than you should
If you take more Flagyl than you should, tell your doctor or go to your
nearest hospital casualty department straight away. Take the carton and
bottle with you. This is so the doctor knows what you have taken.
If you forget to take Flagyl
If you forget to take Flagyl, take it as soon as you remember.
However, if it is almost time for your next dose, skip the missed dose. Do
not use a double dose to make up for a forgotten dose.

4) Possible side effects
Like all medicines, Flagyl can cause side effects, although not everybody
gets them.
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.
 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
 Feeling sleepy or dizzy
 Pains in the muscles or joints



Liver problems including life-threatening liver failure (hepatocellular liver
injury)

Not known (frequency cannot be estimated from the available data)
 Numbness, tingling, pain, or a feeling of weakness, in the arms or legs
 Unpleasant taste in the mouth
 Furred tongue
 Feeling sick (nausea), being sick (vomiting), upset stomach, stomach
pain or diarrhoea
 Loss of appetite
 Fever
 Feeling depressed
 Pain in your eyes (optic neuritis)
 A group of symptoms together including: fever, nausea, vomiting,
headache, stiff neck and extreme sensitivity to bright light. This may be
caused by an inflammation of the membranes that cover the brain and
spinal cord (meningitis)
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 Flagyl







Keep your medicine in a safe place and out of the sight and reach of
children.
Do not store above 25°C.
Store original package in order to protect from light.
Do not use this medicine after the expiry date shown on the bottle label
and packaging.
Medicines should not be disposed of via wastewater of household
waste. Ask your pharmacist how to dispose of medicine no longer
required. These measures will help to protect the environment.
If your medicine becomes discoloured, or shows any other signs of
deterioration, consult your pharmacist who will tell you what to do.

6) Further information
What Flagyl S 200mg/5ml Oral Suspension contains
Each 5ml of suspension contains the equivalent of 200mg metronidazole.
Other ingredients are: sucrose, sodium dihydrogen phosphate dihydrate
(E339), aluminium magnesium silicate, methyl hydroxybenzoate (E218),
propyl hydroxybenzoate (E216), alcohol 96%, lemon flavour, orange flavour
and purified water.
What Flagyl looks like and contents of the pack
Flagyl is a white to cream coloured oral suspension with a slight yellow
tinge and an odour of orange and lemon.
Flagyl is available in 100ml bottles.
PL 10383/2043

POM

Who makes and repackages your medicine?
Your medicine is manufactured by Unither Liquid Manufacturing, F-31770
Colomiers, France. Procured from within the EU and repackaged by the
Product Licence holder: Primecrown Ltd., 4/5 Northolt Trading Estate,
Belvue Road, Northolt, Middlesex UB5 5QS.
Leaflet date: 06.04.2016
Flagyl® is a registered trademark of AVENTIS PHARMA S.A., France.

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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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