Erythroped Adult 500mg Film-coated Tablets

País: Irlanda

Idioma: anglès

Font: HPRA (Health Products Regulatory Authority)

ingredients actius:

Erythromycin

Disponible des:

Amdipharm Limited

Codi ATC:

J01FA; J01FA01

Designació comuna internacional (DCI):

Erythromycin

Dosis:

500 milligram(s)

formulario farmacéutico:

Film-coated tablet

tipo de receta:

Product subject to prescription which may not be renewed (A)

Área terapéutica:

Macrolides; erythromycin

Estat d'Autorització:

Not marketed

Data d'autorització:

1986-01-27

Informació per a l'usuari

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
ERYTHROPED
® ADULT 500 MG FILM-COATED TABLETS
ERYTHROMYCIN ETHYLSUCCINATE
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.
Throughout the leaflet the medicine is referred to as “your”
medicine, but it may have been
given to you to give to your child. In that case, remember that the
information will apply to
your child, and not to you.
The name of your medicine is Erythroped Adult 500 mg Film-coated
Tablets (will be referred
Erythroped Tablets throughout this leaflet).
WHAT IS IN THIS LEAFLET
1.
What Erythroped Tablets are and what they are used for
2.
What you need to know before you take Erythroped Tablets
3.
How to take Erythroped Tablets
4.
Possible side effects
5.
How to store Erythroped Tablets
6.
Contents of the pack and other information
1.
WHAT ERYTHROPED TABLETS ARE AND WHAT THEY ARE USED FOR
Erythroped Tablets contains the active substance erythromycin as
erythromycin
ethylsuccinate. They belong to a group of drugs called antibiotics and
are used in adults and
children aged over 8 years to prevent and treat infections caused by
bacteria.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE ERYTHROPED TABLETS
DO NOT TAKE ERYTHROPED TABLETS:
•
if you are allergic to erythromycin or or any of the other ingredients
of this medicine
(listed in section 6).
•
if you are allergic to other macrolide antibiotics such as
clarithromycin or azithromycin.
•
if you are currently taking a medicine called:
−
ergotamine or dihydroergotamine (used to treat migraines) while

Fitxa tècnica

Health Products Regulatory Authority
08 March 2023
CRN00DG07
Page 1 of 8
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Erythroped Adult 500mg Film-coated Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 500 mg of the active ingredient erythromycin as
erythromycin ethylsuccinate
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film - coated tablet
An oval yellow tablet with the Abbott logo impressed on side.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Erythroped Adult 500 mg Film-coated Tablets are indicated in adults
and children aged over 8 years for the prophylaxis and
treatment of infections caused by erythromycin sensitive organisms.
Consideration should be given to official guidance on the
appropriate use of antibacterial agents.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_ _
_Adults and children over 8 years_.
For mild to moderate infections 1 to 2 g daily in divided doses. Up to
4 g daily in severe infections.
_Elderly:_
No special dosage recommendations.
_ _
_Hepatic impairment_
Erythromycin should be used with caution in patients with impaired
hepatic function (see sections 4.4 & 5.2).
_Paediatric population_
Erythroped Adult 500 mg Film-coated Tablets are not recommended for
use in children aged under 8 years. For younger
children, infants and babies, Erythroped(erythromycin ethylsuccinate)
suspensions are normally recommended.
Method of administration
For oral administration.
Erythroped Adult 500 mg Film-coated Tablets may be administered
without regard to meals.
4.3 CONTRAINDICATIONS
Hypersensitivity to the active substance or to any of the excipients
listed in section 6.1.
Erythromycin is contraindicated in patients taking astemizole,
terfenadine, domperidone, cisapride or pimozide.
Erythromycin should not be given to patients with a history of QT
prolongation (congenital or documented acquired QT
prolongation) or ventricular cardiac arrhythmia, including torsades de
pointes (see section 4.4 and 4.5).
Erythromycin shoul