Erythromycin 250mg gastro-resistant tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Erythromycin

Available from:

A A H Pharmaceuticals Ltd

ATC code:

J01FA01

INN (International Name):

Erythromycin

Dosage:

250mg

Pharmaceutical form:

Gastro-resistant tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 05010500; GTIN: 5025903003557

Patient Information leaflet

50 MM
16 MM
13.25 MM
13.25 MM
6 MM
1
122XXXX-V1
PACKAGE LEAFLET: INFORMATION FOR THE USER
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 Erythromycin Tablets are and what they are
used for
2.
What
you
need
to
know
before
you
take
Erythromycin Tablets
3.
How to take Erythromycin Tablets
4.
Possible side effects
5.
How to store Erythromycin Tablets
6.
Contents of the pack and other information
1.
WHAT
ERYTHROMYCIN
TABLETS
ARE
AND WHAT THEY ARE USED FOR
Erythromycin belongs to a group of medicines called
antibiotics which act by preventing the growth and
multiplication of bacteria.
Erythromycin is used for the treatment and prevention
of
infections
caused
by
erythromycin-sensitive
organisms, such as:
•
Upper and lower respiratory tract infections
•
Eye and ear infections
•
Oral infections
•
Skin and soft tissue infections
•
Gastrointestinal infections
•
Prophylaxis pre- and post- operative trauma, burns,
rheumatic fever
•
Other infections: osteomyelitis, urethritis, gonorrhoea,
syphilis, lymphogranuloma venereum, diphtheria,
prostatitis, scarlet fever
2.
WHAT YOU NEED TO KNOW BEFORE YOU
TAKE ERYTHROMYCIN TABLETS
DO NOT TAKE ERYTHROMYCIN TABLETS:
•
if you are allergic (hypersensitive) to erythromycin
or any of the other ingredients in the product (see
Section 6 ‘What Erythromycin Tablets contain’).
WARNINGS AND PRECAUTIONS
Talk
to
your
doctor
or
pharmacist
before
taking
Erythromycin Tablets:
•
If you are taking any of the following medication:
-
dihydroergotamine, ergo

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Erythromycin 250mg Gastro-resistant Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Erythromycin 250mg
For a full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Gastro-resistant tablets;
Reddish orange coloured round biconvex tablets, plain on both sides.
They are
made Gastro-resistant by enteric coating.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
For the prophylaxis and treatment of infections caused by
Erythromycin-sensitive
organisms.
Erythromycin is highly effective in the treatment of a great variety
of clinical
infections such as:
1.
Upper respiratory tract infections: Tonsillitis, peritonsillar
abscess,
pharyngitis, laryngitis, sinusitis, secondary infections in influenza
and
common colds.
2.
Lower respiratory tract infections: Tracheitis, acute and chronic
bronchitis,
pneumonia (lobar pneumonia, bronchopneumonia, primary atypical
pneumonia), bronchiectasis, Legionnaire's disease
3.
Ear infections: Otitis media and otitis externa, mastoiditis.
4.
Eye infections: Blepharitis
5.
Oral infections: Gingivitis, Vincent's angina
6.
Skin and soft tissue infections: Boils and carbuncles, paronychia,
abscesses,
pustular acne, impetigo, cellulitis, erysipelas
7.
Gastro-intestinal infections: cholecystitis, staphylococcal
enterocolitis
8.
Prophylaxis: pre- and post- operative trauma, burns, rheumatic fever
9.
Other infections: osteomyelitis, urethritis, gonorrhoea, syphilis,
lymphogranuloma venereum, diphtheria, prostatitis, scarlet fever
Note:
Erythromycin has also proved to be of value in endocarditis and
septicaemia,
but in these conditions initial administration of erythromycin
lactobionate by the
intravenous route is advisable.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
For oral administration
Adults and children over 8 years: For mild to moderate infections 2g
daily in
divided doses Up to 4g daily in severe infections.
Elderly: No special dosage recommendations.
Note: For younger children, infants and babies, Erythroped,
ery