FLAGYL 500MG SUPPOSITORIES

Active substance: METRONIDAZOLE

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Patient Information Leaflet

FLAGYL™
500mg and 1g Suppositories (metronidazole)
Read all of this leaflet carefully before you start using
this medicine.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or your
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 get 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 use Flagyl
3. How to use Flagyl
4. Possible side effects
5. How to store Flagyl
6. Further information
1. WHAT FLAGYL IS AND WHAT IT IS USED FOR
The name of this medicine is Flagyl 500mg or 1g Suppositories
(called Flagyl in this leaflet). Flagyl contains a medicine called
metronidazole. This belongs to a group of medicines called
antibiotics.
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
If you need any further information on your illness, speak to
your doctor.
2. BEFORE YOU USE FLAGYL
Do not use Flagyl if:
• You are allergic (hypersensitive) to metronidazole,
nitroimidazoles (e.g. tinidazole) or any of the other ingredients
of Flagyl Suppositories (see 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 use Flagyl if any of the above apply to you. If you are
not sure, talk to your doctor or pharmacist before using 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 using Flagyl. 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
you buy without a prescription, including herbal medicines. This
is because Flagyl can affect the way some other medicines
work. Also some 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
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• Phenobarbital or phenytoin for epilepsy
• 5 fluorouracil for cancer
• Busulfan for leukaemia (cancer of the blood cells)
• Ciclosporin - to prevent rejection of organs after a transplant
• Disulfiram for alcoholism
If you are not sure, talk to your doctor or pharmacist before
using Flagyl.
Taking Flagyl with food and drink
Do not drink any alcohol while you are using 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
Talk to your doctor before using Flagyl if:
• You are pregnant, might become pregnant or think you
may be pregnant
• 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
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 machines or tools.
Tests
Your doctor may wish to carry out some tests if you have
been using this medicine for more than 10 days.
3. HOW TO USE FLAGYL
How to remove your suppositories from the pack
1.Tear off a
section
containing
one
suppository

2.Pull apart
the plastic
flaps

3. Use the
flaps to peel
the plastic
away from the
suppository

Using your medicine
Always use 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.
• Remember to wash your hands before and after you
insert the suppository
• Flagyl suppositories are used by putting them into your
back passage (rectum)
• 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
The usual dose:
• Suppositories are normally used for 3 days
• As soon as possible after starting treatment with the
suppositories, your doctor will suggest changing to a
medicine taken by mouth
• However, after 3 days, if your doctor wants you or your
child to carry on using the suppositories, you will
probably be told to use the suppositories every 12 hours.
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The usual doses for adults and children using suppositories
are provided below:
To treat infections
Adults and children over 10 years
• Use one 1g suppository, every 8 hours for 3 days. See
above for dosing after 3 days
Children aged 5 - 10 years
• Use one 500mg suppository, every 8 hours for 3 days.
See above for dosing after 3 days
Children aged 1 - 5 years
• Use one half of a 500mg suppository, every 8 hours for
3 days. See above for dosing after 3 days
Infants under 1 year old
• Use one quarter of a 500mg suppository, every 8 hours for
3 days. See above for dosing after 3 days
To prevent infections from happening after surgery
Adults and children over 10 years
• Use one 1g suppository 2 hours before surgery
• Repeat every 8 hours for up to 3 days. See above for
dosing after 3 days
Children aged 5 - 10 years
• Use one 500mg suppository 2 hours before surgery
• Repeat every 8 hours for up to 3 days. See above for
dosing after 3 days
People having kidney dialysis
Your doctor may tell you to stop using Flagyl during your
dialysis and start using it again when your dialysis is finished.
People with liver problems
Your doctor may tell you to use a lower dose or to use the
medicine less often.
If you use more Flagyl than you should
If you have used more suppositories than you should or if
you or a child swallow any suppositories, tell a doctor or go
to a hospital casualty department straight away. Take the
pack and any suppositories left with you. This is so that the
doctors know what you have taken.
If you forget to use Flagyl
If you forget to use a Flagyl suppository, use it as soon as
you remember. However if it is nearly time for the 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 using 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)
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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 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)
If any of the side effects get serious or last longer than a few
days, or if you notice any side effects not listed in the leaflet,
please tell your doctor or pharmacist
5. HOW TO STORE FLAGYL
• Keep your suppositories in a safe place out of the reach
and sight of children.
• Store them below 20°C.
• Store in the original package in order to protect them from
light.
• Do not use this medicine after the expiry date shown on
the pack.
• Ask your pharmacist how to dispose of medicines no longer
required. Do not dispose of medicines by flushing down a
toilet or sink or by throwing out with your normal household
rubbish. This will help to protect the environment.
6. FURTHER INFORMATION
What Flagyl Suppositories contain
Each suppository contains 500mg or 1g of metronidazole as
the active substance.
Other ingredients are: suppository bases E75 and W35,
which are vegetable fats.
What Flagyl Suppositories look like and contents of the pack
Flagyl 500mg and 1g Suppositories are cream coloured,
smooth surfaced and torpedo shaped.
They are available in blister packs of 10 suppositories
The Marketing Authorisation Holder is: Zentiva,
One Onslow Street, Guildford, Surrey, GU1 4YS, UK
The Manufacturer is: Haupt Pharma, Livron, France
This leaflet does not contain all the information about your
medicine. If you have any questions or you are not sure
about anything ask your doctor or pharmacist.
This leaflet was revised in March 2012.
“Flagyl” and “Zentiva” are registered trademarks. ©2012
Zentiva.
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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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