Erythrocin 250 mg Tablets

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:

250 milligram(s)

Pharmaceutical form:

Film-coated tablet

Prescription type:

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

Therapeutic area:

Macrolides; erythromycin

Authorization status:

Marketed

Authorization date:

1977-04-01

Patient Information leaflet

1
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
ERYTHROCIN
_®_ 250 MG AND 500 MG TABLETS
Erythromycin stearate
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 Erythrocin 250 mg Tablets or Erythrocin
500 mg Tablets (will be
referred to Erythrocin Tablets throughout this leaflet). Erythrocin
Tablets are available as either 250
mg or 500 mg film-coated tablets.
WHAT IS IN THIS LEAFLET
1.
What Erythrocin Tablets are and what they are used for
2.
What you need to know before you take Erythrocin Tablets
3.
How to take Erythrocin Tablets
4.
Possible side effects
5.
How to store Erythrocin Tablets
6.
Contents of the pack and other information
1.
WHAT ERYTHROCIN TABLETS ARE AND WHAT THEY ARE USED FOR
Erythrocin Tablets contains the active substance erythromycin
stearate. They belong to a group of
drugs called antibiotics and are used in adults and children aged over
8 years to treat infections
which are caused by bacteria.
2
WHAT YOU NEED TO KNOW BEFORE YOU TAKE ERYTHROCIN TABLETS
DO NOT TAKE ERYTHROCIN TABLETS:
•
if you are allergic to erythromycin 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 o

Summary of Product characteristics

Health Products Regulatory Authority
07 March 2023
CRN00DG0C
Page 1 of 8
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Erythrocin 250 mg Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 250 mg erythromycin as erythromycin stearate.
For the full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Film-coated tablets.
White, elongated tablets with the ‘Abbott’ monogram on one face.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Erythrocin 250mg Tablets are indicated in adults and children aged
over 8 years 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
_ _
Adults and children over 8 years.
For mild to moderate infections 1 to 2 g daily in divided doses. Up to
4g 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_
Erythrocin 250 mg 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
Optimal serum levels of erythromycin are reached when erythromycin
stearate is taken in the fasting state or immediately
before meals.
4.3 CONTRAINDICATIONS
Hypersensitivity to the active substanceor 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).
Health Products Regulatory Authority
07 March 2023
CRN00DG0C
Page 2 of 8
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