Metronidazole 200mg Tablets

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

METRONIDAZOLE

Available from:

Remedica Limited Limassol Industrial Estate, Aharnon Street, 3056 Limassol, Cyprus

ATC code:

J01XD01

INN (International Name):

METRONIDAZOLE 200 mg

Pharmaceutical form:

TABLET

Composition:

METRONIDAZOLE 200 mg

Prescription type:

POM

Therapeutic area:

ANTIBACTERIALS FOR SYSTEMIC USE

Authorization status:

Authorised

Authorization date:

2007-02-15

Patient Information leaflet

______________________________________________________________________________________________________
1
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
METRONIDAZOLE 200 MG TABLETS
Metronidazole
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 or 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 your doctor or pharmacist. This
includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1. What Metronidazole is and what it is used for
2. What you need to know before you take Metronidazole
3. How to take Metronidazole
4. Possible side effects
5. How to store Metronidazole
6. Contents of the pack and other information
1. WHAT METRONIDAZOLE IS AND WHAT IT IS USED FOR
Metronidazole tablets contain a medicine called metronidazole. This
belongs to a group of
medicines called antibiotics.
It works by killing bacteria and parasites that cause infections in
your body.
It can be used to:
•
Treat infections of the blood, brain, lung, bones, genital tract,
pelvic area, stomach and
intestines
•
Treat gum ulcers and other dental infections.
•
Treat infected leg ulcers and pressure sores.
•
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 TAKE METRONIDAZOLE
DO NOT TAKE METRONIDAZOLE AND TELL YOUR DOCTOR IF:
If you are allergic (hypersensitive) to metronidazole, nitroimidazoles
(e.g. tinidazole) or any of the
other ingredients in your medicine (listed in Section 6: Further
information). Signs of an allergic
reaction include: a rash, swallowing or breathing problems, swelling
of your lips, face, throat or
tongue.
___________________________________________

Summary of Product characteristics

mt-spc-metronidazole-200mg-tabs-v04-r00-a1
Page 1 of 11
SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT
Metronidazole 200 mg tablets
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains metronidazole 200 mg.
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Tablet.
White, round, flat, scored tablets.
The tablet can be divided into equal doses.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Metronidazole is indicated in the prophylaxis and treatment of
infections in which anaerobic
bacteria have been identified or are suspected to be the cause.
Metronidazole is active against a wide range of pathogenic
micro-organisms notably species of
_Bacteroides_
,
_Fusobacteria_
,
_Clostridia_
,
_Eubacteria_
, anaerobic cocci and
_Gardnerella vaginalis_
.
It is also active against
_Trichomonas_
,
_Entamoeba histolytica_
,
_Giardia lamblia_
and
_Balantidium _
_coli_
.
Metronidazole is indicated in adults and children for the following
indications:
1. The prevention of post-operative infections due to anaerobic
bacteria, particularly species of
_Bacteroides_
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 (trichomonal vaginitis) and
in the male.
mt-spc-metronidazole-200mg-tabs-v04-r00-a1
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4. Bacterial vaginosis (also known as non-specific vaginitis,
anaerobic vaginosis or
_Gardnerella _
_vaginitis_
).
5. All forms of amoebiasis (intestinal and extra-intestinal disease
and that of symptomless cyst
passers).
6. Giardiasis.
7. Acute ulcerative gingivitis.
8. Anaerobically-infected leg ulcers and pressure sores.
9. Acute dental infections (e.g. acute pericoronitis and acute apical
infections).
Considerations should be given to official guidance on the appropriate
use of antibacterial
agents