Erythroped PI SF 125mg/5ml granules for oral suspension

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Erythromycin

Available from:

Amdipharm Limited

ATC code:

J01FA; J01FA01

INN (International Name):

Erythromycin

Dosage:

125 mg/5ml

Pharmaceutical form:

Granules for oral suspension

Prescription type:

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

Therapeutic area:

Macrolides; erythromycin

Authorization status:

Not marketed

Authorization date:

1999-02-19

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
ERYTHROPED
_®_ PI SF 125 MG/5 ML GRANULES FOR ORAL SUSPENSION
ERYTHROPED
_®_ SF 250 MG/5 ML GRANULES FOR ORAL SUSPENSION
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 “Erythroped
Granules”, 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 PI SF 125 mg/ 5ml Granules for
Oral Suspension or
Erythroped SF 250 mg/5 ml Granules for Oral Suspension or Erythroped
Forte SF 500 mg/5 ml
Granules for Oral Suspension (all will be referred to Erythroped
Granules throughout this
leaflet).
WHAT IS IN THIS LEAFLET
_ _
1.
What Erythroped Granules are and what they are used for
2.
What you need to know before you take Erythroped Granules
3.
How to take Erythroped Granules
4.
Possible side effects
5.
How to store Erythroped Granules
6.
Contents of the pack and other information
1
WHAT ERYTHROPED GRANULES ARE AND WHAT THEY ARE USED FOR
Erythroped Granules contains the active substance erythromycin as
erythromycin ethylsuccinate.
They belong to a group of drugs called antibiotics and are used in
adults and children to treat
infections caused by bacteria.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE ERYTHROPED GRANULES
Do not take Erythroped Granules:
•
if you are allergic to erythromycin or any of the other ingredients of
this medicine (listed in
section 6).
•
if you

Summary of Product characteristics

Health Products Regulatory Authority
08 May 2023
CRN00DFY3
Page 1 of 9
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Erythroped PI SF 125mg/5ml granules for oral suspension
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Contains erythromycin (as erythromycin ethylsuccinate) 125 mg/5 ml
Excipients with known effect
Sorbitol (1182 mg/5 ml)
Sodium citrate (255 mg/ 5 ml)
Saccharin sodium (3.4 mg/ 5 ml)
Sodium methyl hydroxybenzoate (5 mg/5 ml)
Sodium propyl hydroxybenzoate (1 mg/ 5 ml)
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Granules for oral suspension
White, free flowing granules with a banana flavour.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Erythroped PI SF 125 mg/5 ml Granules for Oral Suspension are
indicated in adults and children for the 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
_ _
Presentations are available for adults and children over 8 years,
children aged 2-8 years, and for children under 2 years.
_Adults and children over 8 years:_
1 to 2 g/day in divided doses. For severe infections up to 4 g/day in
divided doses.
_Hepatic impairment _
Erythromycin should be used with caution in patients with impaired
hepatic function (see sections 4.4 & 5.2).
_Paediatric population_
_Children 2 - 8 years: _
30 mg/kg/day in divided doses. For severe infections up to 50
mg/kg/day in divided doses.
Normal dose: 250 mg four times a day or 500 mg twice daily.
_Children up to 2 years:_
30 mg/kg/day in divided doses. For severe infections up to 50
mg/kg/day in divided doses.
Normal dose: 125 mg four times a day or 250 mg twice daily.
Method of administration
Health Products Regulatory Authority
08 May 2023
CRN00DFY3
Page 2 of 9
For oral administration
Erythroped PI SF 125 mg/5 ml Granules for Oral Suspension may be
administered without regard to meals.
4.3 CONTRAINDICATIONS
Hypersensitivity to