FLAGYL 500MG/100ML SOLUTION FOR INFUSION

Active substance: METRONIDAZOLE

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Taking other medicines
Please tell your doctor 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.

PATIENT INFORMATION LEAFLET

FLAGYL™ 500MG/100ML
SOLUTION FOR INFUSION

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 before receiving your
medicine.

Minibag Plus
Metronidazole
Read all of this leaflet carefully before you are given 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.

Having Flagyl with food and drink
Do not drink any alcohol while you are having Flagyl and for 48
hours after finishing your course. Drinking alcohol whilst you are
being treated 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.

In this leaflet:
1. What Flagyl is and what it is used for
2. Before you are given Flagyl
3. How you will be given Flagyl
4. Possible side effects
5. How to store Flagyl
6. Further information

Pregnancy and breast-feeding
Tell your doctor before having 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.

1. WHAT FLAGYL IS AND WHAT IT IS USED FOR
The name of this medicine is Flagyl 500mg/100ml Solution for
Infusion (called Flagyl in this leaflet). Flagyl contains a medicine
called metronidazole. This belongs to a group of medicines called
antibiotics.

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.

It works by killing the bacteria that cause infections in your body.
It can be used to:
• Treat infections of the blood, brain, lung, bones, genital tract,
pelvic area and stomach
• Prevent infections after surgery

Tests
Your doctor may wish to carry out some tests if you have been
having this medicine for more than 10 days.

If you need any further information on your illness, speak to your
doctor.

Important information about some of the ingredients of your
Flagyl Infusion
• Sodium: There is 307mg of sodium per 100ml infusion bag. This
may be harmful to people on a low sodium or low salt diet.

2. BEFORE YOU ARE GIVEN FLAGYL
Do not have Flagyl 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 have Flagyl if any of the above apply to you. If you are
not sure, talk to your doctor or pharmacist before receiving your
medicine.

3. HOW YOU WILL BE GIVEN FLAGYL
How your medicine will be given
Your medicine will be administered to you by a doctor or nurse. The
length of your course of treatment will depend on your needs and
the illness being treated.
• Flagyl is administered into a vein using a drip at a rate of
5ml/minute
• Other antibiotics can be administered using the same minibag as
Flagyl to help treat your infection.
• 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 infection
you have and how bad it is
• As soon as possible after starting your treatment with Flagyl, your
doctor will suggest changing to a medicine taken by mouth

Take special care with Flagyl and check with your doctor before
having 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 before receiving your medicine. Do this even if they have
applied in the past.

CB-30-01-783

3

EUROPEAN LABELLING CENTRE
ARTWORK APPROVAL
DATE 18 Apr 2013

3rd DRAFT
RA
PROOFREAD + APPROVED

MARKETING
APPROVED

Country
Name
Signature
Date

RA Proofreading Checklist
Product Information proofread as
per RA SOP CE-RAPV-009

Product name,strength,composition
(API & excipients)

Compliance with National
Regulations

Consistency check with all figures
cited in the product information

Barcodes, Symbols and Reimbursement Information

Storage Conditions and Shelf-Life

Tell your doctor or nurse if you notice any of the following side
effects:

The usual dose for adults and children is given below:
To treat bacterial infection
Adults
• You will be given 500mg (100ml) Flagyl every 8 hours
Children
• Your doctor will work out how much your child should be
given depending on their weight
• The dose will be repeated 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

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)

To prevent infections from happening after surgery
Adults
• You will be given 500mg (100ml) Flagyl shortly before your
operation
• The dose will be repeated every 8 hours
Children
• Your doctor will work out how much your child should be
given depending on their weight
• Your child will receive the first dose 1-2 hours before their
operation

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 pains, 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)
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, please tell
your doctor or nurse.

People having kidney dialysis
Kidney dialysis removes Flagyl from your blood. If you are having
kidney dialysis you must have this medicine after your dialysis
treatment.
People with liver problems
Your doctor may lower your dose or use the medicine less often.
If you are given more Flagyl than you should
It is unlikely that your doctor or nurse will give you too much
medicine. Your doctor or nurse will monitor your progress and check
how much medicine you are given. Always ask if you are not sure
why you are being given a medicine.

5. HOW TO STORE FLAGYL
• The doctor and hospital pharmacist are usually responsible for
storing, using and disposing of Flagyl correctly.
• Keep this medicine in a safe place out of the reach and sight of
children.
• Do not use this medicine after the expiry date shown on the bag
label.
• Store this medicine below 25° C in a dark place to protect from
light.
• Do not dispose of medicines, which are no longer needed, by
flushing down a toilet or sink or by throwing out with your normal
household rubbish. This will help protect the environment.

If you are not given Flagyl at the right time
If you do not receive your dose at the right time tell your doctor or
nurse as soon as possible to arrange for another injection.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Flagyl can cause side effects, although not
everybody gets them.
Tell a doctor 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.
• You get a high fever, headache, see or hear things that are
not there, feel clumsy or have difficulty in controlling your
movements, are confused, more sensitive to light than usual,
notice a stiff neck, unusual behaviour or eye movements or have
problems with speaking. This could be a serious but very rare
condition called encephalopathy

6. FURTHER INFORMATION
What Flagyl Solution for Infusion contains
Each 100ml of solution contains 500mg metronidazole as the active
substance.
The other ingredients are: Sodium phosphate, citric acid anhydrous,
sodium chloride and water for injections.
What Flagyl Solution for Infusion looks like
Flagyl Solution for Infusion is a bright, pale yellow solution.
Flagyl Solution for Infusion is available in minibags containing 100ml
of solution.

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)

The Marketing Authorisation Holder is:
Zentiva, One Onslow Street, Guildford, Surrey, GU1 4YS, UK
The Manufacturer is:
Baxter Healthcare S.A., Castlebar, Co. Mayo, Republic of Ireland
This leaflet was last updated in April 2013
“Flagyl” and “Zentiva” are registered trademarks.
©2013 Zentiva.
CB-30-01-783

4

EUROPEAN LABELLING CENTRE
ARTWORK APPROVAL
DATE 18 Apr 2013

3rd DRAFT
RA
PROOFREAD + APPROVED

MARKETING
APPROVED

Country
Name
Signature
Date

RA Proofreading Checklist
Product Information proofread as
per RA SOP CE-RAPV-009

Product name,strength,composition
(API & excipients)

Compliance with National
Regulations

Consistency check with all figures
cited in the product information

Barcodes, Symbols and Reimbursement Information

Storage Conditions and Shelf-Life

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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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