Flagyl 500mg suppositories

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Metronidazole

Available from:

Sanofi

ATC code:

P01AB01

INN (International Name):

Metronidazole

Dosage:

500mg

Pharmaceutical form:

Suppository

Administration route:

Rectal

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 05011100; GTIN: 5000283652359

Patient Information leaflet

54001151
(Metronidazole)
PACKAGE LEAFLET: INFORMATION FOR THE USER
FLAGYL
TM
FLAGYL
TM
500mg and 1g Suppositories
Is this leaflet hard to see or read? Phone [phone]
for help
Read
all
of
this
leaflet
carefully
before
you
start
using
this
medicine
because it contains important information for you
• 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 only. Do not pass it on
to others. It
may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to you doctor or pharmacist.
This includes any
possible side effects not listed in this leaflet. See section 4.
What is in this leaflet:
1. What Flagyl is and what it is used for
2. What you need to know before you use Flagyl
3. How to use Flagyl
4. Possible side effects
5. How to store Flagyl
6. Contents of the pack and other 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. WHAT YOU NEED TO KNOW BEFORE YOU USE FLAGYL
Do not use Flagyl if:
x
You
are
allergic
(hypersensitive)
to
metronidazole,
nitroimidazoles
(e.g.
tinidazole) or any of the other ingredients of this medicine (see
section 6)
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.
Warnings and precautions
Talk to your doctor or pharmacist before usin

Summary of Product characteristics

OBJECT 1
FLAGYL 500MG SUPPOSITORIES
Summary of Product Characteristics Updated 21-Mar-2022 | SANOFI
•
1. Name of the medicinal product
•
2. Qualitative and quantitative composition
•
3. Pharmaceutical form
•
4. Clinical particulars
•
4.1 Therapeutic indications
•
4.2 Posology and method of administration
•
4.3 Contraindications
•
4.4 Special warnings and precautions for use
•
4.5 Interaction with other medicinal products and other forms of
interaction
•
4.6 Fertility, pregnancy and lactation
•
4.7 Effects on ability to drive and use machines
•
4.8 Undesirable effects
•
4.9 Overdose
•
5. Pharmacological properties
•
5.1 Pharmacodynamic properties
•
5.2 Pharmacokinetic properties
•
5.3 Preclinical safety data
•
6. Pharmaceutical particulars
•
6.1 List of excipients
•
6.2 Incompatibilities
•
6.3 Shelf life
•
6.4 Special precautions for storage
•
6.5 Nature and contents of container
•
6.6 Special precautions for disposal and other handling
•
7. Marketing authorisation holder
•
8. Marketing authorisation number(s)
•
9. Date of first authorisation/renewal of the authorisation
•
10. Date of revision of the text
1. Name of the medicinal product
Flagyl 500 mg Suppositories
2. Qualitative and quantitative composition
Each suppository contains 500 mg metronidazole.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Suppository
A cream coloured, smooth, torpedo-shaped suppository.
4. Clinical particulars
4.1 Therapeutic indications
1. Treatment of infections in which anaerobic bacteria have been
identified or are suspected as pathogens,
particularly _Bacteroides fragilis_ and other species of _Bacteroides_
and including other species for which
metronidazole is bactericidal, such as _Fusobacteria_, _Eubacteria_,
_Clostridia_ and anaerobic cocci.
Flagyl has been used successfully in: septicaemia, bacteraemia, brain
abscess, necrotising pneumonia,
osteomyelitis, puerperal sepsis, pelvic abscess, pelvic cellulitis,
peritonitis and post-operative wound