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Metronidazole Benzoate: What Flagyl Is and What It Is Used For
Metronidazole Benzoate: What Flagyl Is and What It Is Used For
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
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.
Cases of severe liver toxicity/acute liver failure, including cases with a fatal outcome, in patients with
Cockayne syndrome have been reported with Flagyl.
If you are affected by Cockayne syndrome, your doctor should also monitor your liver function
frequently while you are being treated with Flagyl and afterwards.
Tell your doctor immediately and stop taking Flagyl if you develop:
• Stomach pain, anorexia, nausea, vomiting, fever, malaise, fatigue, jaundice, dark urine,
putty or mastic coloured stools or itching.
Tests
Your doctor may wish to carry out some tests if you have been using this medicine for more than 10 days.
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.
You develop skin rashes with blistering, peeling or bleeding of the skin around the lips, eyes, mouth, nose
and genitals. You may also have flu-like symptoms and a high temperature. These could be signs of
something called ‘Stevens Johnson Syndrome or toxic epidermal necrolysis’.
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)
By reporting side effects you can help provide more information on the safety of this medicine.
6. Further information
What Flagyl S 200mg/5ml Oral Suspension contains
Each 5 ml of suspension contains 200mg metronidazole (as 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
Or
Zentiva, One Onslow Street, 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
Or
“Flagyl” and “Zentiva” are registered trademarks. ©2016 Zentiva.