Metronidazole 500mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Metronidazole

Available from:

A A H Pharmaceuticals Ltd

ATC code:

P01AB01

INN (International Name):

Metronidazole

Dosage:

500mg

Pharmaceutical form:

Oral tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 05011100; GTIN: 5025903085737

Patient Information leaflet

296x210 Leaflet Reel Fed Bi Fold Profile (BST)
Dimensions:
Component:
Date Sent:
Technologist: TECHNICALLY APPROVED
Pharmacode:
JDE No.:
Metronidazole Tablets
500mg x 21 (UK)
296x210 (Reel Fed)
50982487
Leaflet for Blisters
4315
T. Hull
11/11/19
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METRONIDAZOLE 500 MG 21 TABLET PIL - UK
Black
BBBA7074
R.Paul
04.12.2019
18.12.2019
R.Paul
296 x 210 reel fed
7pt
Accord Barnstaple
n/a
3
Version 4
20.11.2019
Profile
page 4
page 1
50982487 BBBA7074
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU
START TAKING 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, pharmacist or nurse.
• 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 your doctor,
pharmacist or nurse. This includes any
possible side effects not listed in this leaflet.
See section 4.
WHAT IS IN THIS LEAFLET
1 WHAT METRONIDAZOLE TABLETS ARE AND
WHAT THEY ARE USED FOR
2 WHAT YOU NEED TO KNOW BEFORE YOU
TAKE METRONIDAZOLE TABLETS
3 HOW TO TAKE METRONIDAZOLE TABLETS
4 POSSIBLE SIDE EFFECTS
5 HOW TO STORE METRONIDAZOLE TABLETS
6 CONTENTS OF THE PACK AND OTHER
INFORMATION
1 WHAT METRONIDAZOLE TABLETS ARE AND
WHAT THEY ARE USED FOR
Metronidazole tablets belong to a group of
medicines called anti-infective agents. They may be
used to TREAT:
•
infections, caused by bacteria of the blood,
brain, bone, lung, stomach lining and

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Metronidazole Tablets 500 mg
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains metronidazole EP 500 mg
Excipients with known effect: lactose monohydrate
For the full list of excipients, see section 6.1
3
PHARMACEUTICAL FORM
Tablets
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Metronidazole is active against a wide range of pathogenic
micro-organisms,
notably species of _Bacteroids, Fusobacteria, Clostridia, Eubacteria_,
anaerobic
cocci and _Gardnerella vaginalis_.
It is also active against _Trichomonas vaginalis, Entamoeba
histolytica, Gardia _
_lamblia_, _Balantidium coli _and_ Helicobacter pylori_.
Metronidazole is indicated in adults and children for the following
indications:
1) Prevention of post-operative infections due to anaerobic bacteria,
particularly species of _bacteroids_ and anaerobic streptococci.
2) The treatment of septicaemia, bacteraemia, peritonitis, brain
abscess,
necrotising pneumonia, osteomyelitis, puerperal sepsis, pelvic
abscess, pelvic
cellulitis and post-operative wound infections from which pathogenic
anaerobes have been isolated.
3) Urogenital trichomoniasis in the female (T_richomonas vaginalis_),
and in
man.
4) Bacterial vaginosis (also known as non-specific vaginitis,
anaerobic
vaginosis or _Gardnerella vaginalis_).
5) All forms of amoebiasis (intestinal and extra-intestinal disease
and
asymptomatic cyst passers).
6) Giardiasis.
7) Acute ulcerative gingivitis.
8) Acute dental infections (_eg_ acute pericoronitis and acute apical
infections)
9) Anaerobically-infected leg ulcers and pressure sores.
10) Treatment of_ Helicobacter pylori_ infection associated with
peptic ulcer as
part of triple therapy.
Consideration should be given to official guidance on the appropriate
use of
antibacterial agents.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Metronidazole Tablets should be taken during or after meals, swallowed
with
water and NOT CHEWED.
_ _
_Elderly_: Caution is advised in the elderly, par