Erythromycin 250mg gastro-resistant capsules

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Erythromycin

Available from:

Phoenix Healthcare Distribution Ltd

ATC code:

J01FA01

INN (International Name):

Erythromycin

Dosage:

250mg

Pharmaceutical form:

Gastro-resistant capsule

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 05010500

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
ERYTHROMYCIN 250MG GASTRO-RESISTANT HARD CAPSULES
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 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 is and what it is used for
2. What you need to know before you take Erythromycin
3. How to take Erythromycin
4. Possible side effects
5. How to store Erythromycin
6. Contents of the pack and other information
1.
WHAT ERYTHROMYCIN IS AND WHAT IT IS USED FOR
The name of this medicine is erythromycin 250 mg gastro-resistant hard
capsules. The active
ingredient in them is erythromycin, which belongs to a group of
medicines called antibiotics.
Erythromycin is used to treat ear, nose, throat and chest infections.
It can also be used to treat skin
infections.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE ERYTHROMYCIN
DO NOT TAKE ERYTHROMYCIN:
-
if you are ALLERGIC to active substance or any of the other
ingredients of this medicine (listed in
section 6).
-
if you are taking ANTIHISTAMINES (for allergies) called terfenadine or
astemizole.
-
if you are PREGNANT OR BREAST-FEEDING.
-
if you are taking cisapride (for stomach problems).
-
if you are taking dihydroergotamine or ergotamine (for migraines).
-
if you are taking pimozide or sertindole (mental (health problems).
-
if you are taking simvastatin (for blood cholesterol).
-
if you are taking mizolastine (for hayfever or allergies).
-
if you are taking tolterodine (for urinary incontinence).
-
if you are taking amisulpride (for schizophrenia).
-
if you are taking domperidone (for nausea or vomitin

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Erythromycin 250mg Gastro-resistant Hard Capsules
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 250mg of erythromycin.
Excipient(s) with known effect
Erythromycin 250 mg capsules contain 25.6 mg of Lactose per capsule.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Gastro-resistant capsule, hard.
Hard gelatin capsule with opaque orange cap and clear orange body,
imprinted with
“Erymax 250mg”, and containing white enteric coated pellets of
erythromycin base.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Erythromycin is an antibiotic effective in the treatment of bacterial
disease
caused by susceptible organisms.
Examples of its use are in the treatment of upper and lower
respiratory tract
infections of mild to moderate severity; skin and soft tissue
infections
including pustular acne.
Erythromycin is usually active against the following organisms in
vitro and in
clinical infection: Streptococcus pyogenes; Alpha haemolytic
streptococci;
Staphylococcus aureus; Streptococcus pneumoniae; Mycoplasma
pneumoniae;
Treponema pallidum; Corynebacterium diphtheriae; Corynebacterium
minutissimum; Entamoeba histolytica; Listeria monocytogenes; Neisseria
gonorrhoeae; Bordetella pertussis; Legionella pneumophila; Haemophilus
influenzae; Chlamydia trachomatis; Propionibacterium acnes.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Adults and elderly _
250 mg every six hours - before or with meals. 500 mg every twelve
hours may be
given if desired; b.i.d. dosage should not be used if dosage exceeds
one gram.
_Paediatric population _
The usual dose is 30-50 mg/kg/day erythromycin, in divided doses given
twice daily
or every six hours. In severe infections, this dose may be doubled;
elevated doses
should be given every six hours. The drug should be given before or
with meals.
NOTE: Erythromycin Capsules may be given to children of any age who
can swallow
the capsules whole.
The capsules should be swallowed whol