POM: Prescription only medicine
The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine. It is written for patients and gives information about taking or using a medicine. It is possible that the leaflet in your medicine pack may differ from this version because it may have been updated since your medicine was packaged.
Below is a text only representation of the Patient Information Leaflet. The original leaflet can be viewed using the link above.
The text only version may be available in large print, Braille or audio CD. For further information call emc accessibility on 0800 198 5000. The product code(s) for this leaflet is: PL 04425/0744.
Flagyl 500mg & 1g Suppositories
Patient Information Leaflet
500mg and 1g Suppositories (metronidazole)
Read all of this leaflet carefully before you start using this medicine.
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:
If you need any further information on your illness, speak to your doctor.
2. BEFORE YOU USE FLAGYL
Do not use Flagyl if:
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:
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. 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.
Serious skin reactions including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), acute generalised exanthematous pustulosis (AGEP) have been reported with the use of Flagyl.
The highest risk for occurrence of serious skin reactions is within one week, typically, within 48 hours after start of treatment. If you develop a serious rash or another of these skin symptoms, stop taking Flagyl and contact your doctor or seek medical attention immediately.
Tell your doctor immediately and stop taking Flagyl if you develop:
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:
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:
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.
Your doctor may wish to carry out some tests if you have been using this medicines 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.
The usual dose:
The usual doses for adults and children using suppositories are provided below:
To treat infections
Adults and children over 10 years
Children aged 5 - 10 years
Children aged 1 - 5 years
Infants under 1 year old
To prevent infections from happening after surgery
Adults and children over 10 years
Children aged 5 - 10 years
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:
Talk to your doctor straight away if you notice the following side effects:
Tell your doctor or pharmacist if you notice any of the following side effects:
Very rare (affects less than 1 in 10 000 people)
Not known (frequency cannot be estimated from the available data)
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 or search for MHRA Yellow Card in the Google Play or Apple App Store.
By reporting side effects you can help provide more information on the safety of this medicine.
5. HOW TO STORE FLAGYL
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:
The Manufacturer is:
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 July 2019.
Sanofi, 410 Thames Valley Park Drive, Reading, Berkshire, RG6 1PT, UK
+44 (0)845 372 7101
+44 (0)845 023 0441