Metronidazole 400mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Metronidazole

Available from:

Waymade Healthcare Plc

ATC code:

P01AB01

INN (International Name):

Metronidazole

Dosage:

400mg

Pharmaceutical form:

Oral tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 05011100

Patient Information leaflet

Sandoz Ltd
December 2016
Metrolyl (Metronidazole) Tablets 200mg and 400mg
PL 04416/0060 & 0061
PIL.0060-61.005.0d
V018: Updated PIL and SPC
in line with PRAC
recommendations
SL
PATIENT INFORMATION LEAFLET
METROLYL
® (METRONIDAZOLE) TABLETS BP 200MG AND 400MG
WHAT YOU SHOULD KNOW ABOUT METROLYL
®
Please read this carefully before you start to take your medicine.
This leaflet provides a summary of the information
available on your medicine. If you have any questions or are not sure
about anything, ask your doctor or
pharmacist.
The name of your medicine is Metrolyl
®
(Metronidazole) Tablets BP 200mg or 400mg.
WHAT IS IN YOUR MEDICINE?
Each tablet contains 200mg or 400mg of the active ingredient
metronidazole BP. They also contain: lactose,
microcrystalline cellulose, magnesium stearate and maize starch. The
200mg tablets also contain gelatin and the
400mg tablets also contain povidone.
The 200mg tablets are supplied in packs of 14, 21 and 250 and the
400mg tablets are supplied in packs of 14, 21
and 100.
The active ingredient, metronidazole, is an antibacterial agent used
to treat infections.
The product licence holder and manufacturer is: Sandoz Ltd, Frimley
Business Park, Frimley, Camberley, Surrey
GU16 7SR, United Kingdom.
USES
Metrolyl
®
(Metronidazole) Tablets are used to treat different types of
infections which are due to particular types of
bacteria and some other infectious organisms, or to prevent infection
during an operation.
BEFORE TAKING YOUR MEDICINE
DO NOT take this medicine before telling your doctor if:

you are, or might be, pregnant or you are breast-feeding

you have experienced sensitivity to metronidazole, or any of the other
ingredients in this medicine

you have liver disease
Cases of severe liver toxicity/acute liver failure, including cases
with a fatal outcome, in patients with Cockayne
syndrome have been reported with product containing metronidazole.
If you are affected by Cockayne syndrome, your doctor should also
monitor your liver function frequently while you
are being

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Metrolyl* (Metronidazole) Tablets BP 400mg
Metronidazole 400mg Tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 400mg tablet contains metronidazole BP 400mg.
3.
PHARMACEUTICAL FORM
Tablet.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Metrolyl* is indicated in adults and children for the following
indications:
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
eg: Fusobacteria, Eubacteria, Clostridia and anaerobic cocci.
Metrolyl* can be used in septicaemia, bacteraemia, brain abscess,
necrotising
pneumonia, osteomyelitis, puerperal sepsis, pelvic abscess,
peritonitis and post-
operative wound infection from which one or more of these anaerobes
have been
isolated.
Prevention of post-operative infections due to anaerobic bacteria.
Use in treatment of acute ulcerative gingivitis and acute dental,
pericoronitis and
apical infections.
Trichomonas infections.
Amoebiasis.
Giardiasis.
Anaerobically infected leg ulcers and pressure sores.
Bacterial vaginosis.
Consideration should be given to official guidance on the appropriate
use of
antibacterial agents.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Seven days’ treatment should be satisfactory for most patients.
Prolonged
treatment can be used if the physician considers it to be necessary.
Recommended doses are given as a guideline based on experience. If
therapy is
to continue for longer than 10 days, clinical and laboratory
monitoring is advised.
Metrolyl* Tablets should be swallowed with water during or after a
meal.
TREATMENT OF ANAEROBIC INFECTIONS
Metronidazole
tablets
may
be
given
alone
or
in
association
with
other
appropriate bactericidal agents.
Adults:
400mg, 3 times daily.
Children:
Children > 8 weeks to 12 years of age: The usual daily dose is 20-30
mg/kg/day as a single dose or divided into 7