Skip to Content

ERYTHROMYCIN ETHYLSUCCINATE 125MG/5ML GRANULES FOR ORAL SUSPENSION

Active substance(s): ERYTHROMYCIN ETHYL SUCCINATE

PDF options:  View Fullscreen   Download PDF

PDF Transcript

ERYTHROMYCIN ETHYL
SUCCINATE
#125 MG/
#5 ML

Overprinting Area
should be kept unvarnished & blank,
without pre-printed text or colour
(for Man., Exp. Date, Batch Number
& 2D datamatrix code when available)

147.0 mm

Drawn by:

Erythromycin
Ethyl Succinate
55.0 mm

ERYTHROMYCIN ETHYL
SUCCINATE
#125 MG/
#5 ML

LAMINATION
WINDOW
LEFT FOR
OVERPRINT

125 mg/5 ml
Granules for
Oral Suspension

For oral administration
100 ml when reconstituted
Clonmel, Ireland.

For oral administration. Each 5 ml of
Erythromycin Suspension contains
125 mg of Erythromycin activity. This
product also includes sucrose and sodium.

Katrina Connolly
Louise Foley
Sarah Condon

TO THE PATIENT

Read the package leaflet before use.
Reconstituted suspension should not
be stored above 15˚C. Do not freeze.
Shake well before use. Keep tightly
closed and use within 14 days.
Keep out of the sight and reach of
children.
Dosage: As directed by physician.

TO THE PHARMACIST

Erythromycin Ethyl Succinate
granules for oral suspension.
Do not store granules above 25˚C.
To reconstitute add 60 ml water
and shake the bottle vigorously. The
resulting 100 ml of suspension contains
125 mg of Erythromycin activity in
each 5 ml. PL 04917/0013 POM
Pinewood Laboratories Ltd.,
23LL05252PW
Clonmel, Ireland.

Proofed by:

Artwork
Code:

23LL05252PW

Font:

Times 7-13pt

Date

12/01/2018

Dimensions:

55 x 147 mm - 8 Pages

Pantones:

Black

299

Braille

***

Keyline

Text Free

Varnish Free

***

Other information: Previous Code - 23LL04815PW

Signature:
Date:

Version:

4

Proofed by:
Signature:
Date:

2D area allocated 51(L) x 35(H) mm - varnish free

LC 117578 PINEWOOD 23LL5252PW TEMPLATE 14/12/2017 PROOF 1 KEYLINE

PATIENT INFORMATION LEAFLET
Erythromycin ethyl succinate 125 mg/5 ml
Granules for Oral Suspension
Erythromycin ethyl succinate
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 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
Erythromycin contains erythromycin ethyl succinate, which is an
antibiotic (macrolide group). It is used to treat or prevent bacterial
infections, including sexually transmitted diseases and dental
infections. It may be used to prevent whooping cough, diphtheria
or to treat certain skin infections (Acne vulgaris).
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE
ERYTHROMYCIN
Do not take Erythromycin:
• if you are allergic to erythromycin or any of the other
ingredients of this medicine (listed in section 6)
• if you are currently taking a medicine called
- ergotamine or dihydroergotamine (used to treat migraines) as
this may cause serious side effects while taking erythromycin
- terfenadine or astemizole or mizolastine (widely taken for
hayfever and allergies), domperidone (for nausea (feeling
sick) and vomiting (being sick)), cisapride (for stomach
disorders) or pimozide or amisulpride (for psychiatric
conditions) while receiving erythromycin, as combining

these drugs can sometimes cause serious disturbance in
heart rhythm. Consult your doctor for advice on alternative
medicine you can take instead
- simvastatin (used to lower cholesterol and triglycerides
(types of fat) in the blood)
- tolterodine (used for treating overactive bladder with
symptoms of urinary frequency, urgency and leakage).
Warnings and precautions
Talk to your doctor or pharmacist before taking Erythromycin:
• if you are taking colchicine (used for treatment of gout and
arthritis) as this may cause serious side effects whilst taking
erythromycin
• if you have any liver problems or have been told that any
drugs you are taking can cause liver problems
• if you have previously experienced diarrhoea following the
use of antibiotics
• if you are pregnant and have been told that you have a
sexually transmitted disease called syphilis. In this case
erythromycin may not be effective for preventing the transfer
of this infection to your baby. Alternatively if you were treated

for early stages of syphilis during your pregnancy, and your
child is under 1 year and is prescribed erythromycin, consult
your doctor before giving erythromycin to your child
• if you are treating a young child with antibiotics and they
are irritable or vomit when fed
• if you suffer from a condition called myasthenia gravis,
which causes muscle weakness
• if you are taking erythromycin with ‘statins’ such as
simvastatin or lovastatin (used to lower cholesterol).
Contact your doctor as soon as possible if you develop
watery and bloody stools during or up to 2 months after
treatment, with or without stomach cramps and fever (to rule
out the possibility of pseudomembranous colitis).
Other medicines and Erythromycin
Tell your doctor or pharmacist if you are taking, have recently
taken or might take any other medicines.
This is especially important if you are taking medicines from
the following families:
• astemizole, terfenadine or mizolastine (used to treat allergies

such as hayfever)
domperidone (used to treat nausea and vomiting)
pimozide (used to treat mental problems)
ergotamine or dihydroergotamine (for migraine)
cisapride (for stomach disorders)
statins (used to help lower cholesterol levels e.g. lovastatin
and simvastatin)
• protease inhibitors (used to treat viral infections e.g.
saquinavir)
• oral contraceptives.
This is also important if you are taking medicines called:
• colchicine (used to treat gout and arthritis)
• cimetidine and omeprazole (used to treat acid reflux and
other related conditions)
• clarithromycin, rifabutin, or rifampicin (medicines used to
treat different types of bacterial infections)
• fluconazole, ketoconazole and itraconazole (medicines used
to treat fungal infections)
• digoxin, quinidine or disopyramide (used to treat heart
problems)






• cilostazol (a medicine used to treat peripheral circulation
problems)
• hexobarbitone, phenobarbital or midazolam (used as
sedatives)
• warfarin and acenocoumarol (used to help thin the blood)
• valproate, carbamazepine or phenytoin (used to control
epilepsy)
• theophylline (used to treat asthma and other breathing
problems)
• ciclosporin or tacrolimus (used following organ transplants)
• bromocriptine (used to treat Parkinson’s disease)
• zopiclone or triazolam/alprazolam (used to help you sleep
or relieve states of anxiety)
• alfentanil (a medicine used to provide pain relief)
• methylprednisolone (used to help suppress the body’s
immune system – this is useful in treating a wide range of
conditions)
• St John’s Wort (a herbal medicine used to treat depression)
• verapamil (used to treat high blood pressure and chest pain)
• vinblastine (used to treat certain types of cancer)
• sildenafil (used to treat erectile dysfunction).

Page 15
measure this dose.
If you forget to take Erythromycin
Take the dose as soon as you remember, unless it is nearly time
for your next dose. Do not take a double dose to make up for
the missed dose.
If you take more Erythromycin than you should
If you accidentally take more medicine in one day than your
doctor has told you to, or if a child has taken some of the
medicine by mistake, contact your doctor or go to your nearest
hospital emergency department immediately. An overdose could
cause temporary hearing loss, nausea, vomiting and diarrhoea.
If you stop taking Erythromycin
Continue to take this medicine until the course is completed or
until your doctor tells you to stop; do not stop taking your
medicine, even if you feel better. If you stop the treatment too
early your problem could come back.
If you have any further questions on the use of this medicine,
ask your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS
Like all medicines, this medicine can cause side effects, although
not everybody gets them.
Contact a doctor immediately if you experience a serious skin
reaction: a red, scaly rash with bumps under the skin and blisters
(exanthematous pustulosis). The frequency of this side effect is
not known (cannot be estimated from the available data).
If you notice any of the following, contact your doctor
immediately: difficulty breathing, fainting, swelling of the face,
lips or throat, skin rashes, severe skin reactions including large
fluid-filled blisters, sores and ulcers, ulcers in the mouth or
throat. These may be signs of an allergic reaction.
Other side effects of Erythromycin include:
• diarrhoea which may be severe or prolonged and may contain
blood or mucus
• feeling or being sick
• increase in a particular type of white blood cells (eosinophilia)
• stomach pains; these may be a symptom of an inflamed
pancreas (pancreatitis)

• ringing in the ears (tinnitus)
• reversible loss of hearing (usually associated with high doses
or in patients with kidney problems)
• various liver or gall-bladder problems, which can cause
yellowing of the skin and/or eyes (jaundice) or pale stools
with dark urine
• chest pain
• abnormal heart rhythms (including palpitations)
• fever
• loss of appetite
• confusion
• fits (seizures)
• vertigo (problems with balance that can result in feelings of
dizziness or sickness – particularly on standing)
• hallucinations (seeing or hearing things that aren’t there)
• feeling generally unwell (malaise)
• inflammation of the kidneys (a condition known as interstitial
nephritis)
• low blood pressure
• serious skin rashes that may involve blistering and can cover
large areas of the torso, face and limbs (conditions known as

Stevens Johnson syndrome, toxic epidermal necrolysis and
erythema multiforme)
• vomiting and irritability in young children between the age
of 1 month and 12 months
• visual impairment/blurred vision (Mitochondrial optic
neuropathy).
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist.
This includes any possible side effects not listed in this leaflet.
You can also report side effects directly via the Yellow Card
Scheme at www.mhra.gov.uk/yellowcard or search for MHRA
Yellow Card in the Google Play or Apple App Store. By
reporting side effects you can help provide more information
on the safety of this medicine.
5. HOW TO STORE ERYTHROMYCIN
Keep this medicine out of the sight and reach of children. Do
not use your medicine after the expiry date which is stated on
the label.
Once the granules are reconstituted by your doctor or

pharmacist, do not store above 15˚C, keep the cap tightly
closed, and use within 14 days. Do not freeze.
Do not throw away any medicines via wastewater or household
waste. Ask your pharmacist how to throw away medicines you
no longer use. These measures will help protect the environment.
6. CONTENTS OF THE PACK AND OTHER
INFORMATION
What Erythromycin contains
• the active substance is erythromycin ethyl succinate; each
5 ml of the oral suspension contains erythromycin 125 mg.
• the other ingredients are sodium carboxymethylcellulose,
sodium citrate, banana flavour (E4210), quinolone yellow
(E104), sodium saccharin, colloidal silicon dioxide and
sucrose (see end of Section 2).
What Erythromycin looks like and contents of the pack
Erythromycin comes as granules for preparation by your
pharmacist. Once reconstituted it is a yellow liquid. It is
available in 100 ml amber glass with pilfer evident caps or
white plastic HDPE bottles with pilfer proof screw caps or

child resistant caps, and is also available in strengths of 250 mg
or 500 mg per 5 ml.
Marketing Authorisation Holder and Manufacturer
Pinewood Laboratories Ltd.,
Ballymacarbry, Clonmel,
Co. Tipperary, Ireland.
PL 04917/0013
This leaflet was last updated in 01/2018.

If you or your child goes for any medical tests, tell your doctor
that you are taking Erythromycin, as this may interfere with
some test results.
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may be pregnant
or are planning to have a baby, ask your doctor or pharmacist for
advice before taking this medicine.
Erythromycin contains sucrose and sodium
If you have been told by your doctor that you have an intolerance
to some sugars, contact your doctor before taking this medicinal
product. This medicine contains 46.53 mg/5 ml of sodium. To be
taken into consideration by patients on a controlled sodium diet.
3. HOW TO TAKE ERYTHROMYCIN
Always take this medicine exactly as your doctor or pharmacist
has told you. Check with your doctor or pharmacist if you are
not sure.
Patients with kidney problems must be given a reduced dose.
Shake Erythromycin well before use.
Taking Erythromycin with food and drink: Take Erythromycin

before meals.
The recommended doses are:
For adults and children over 8 years of age:
2 g per day in divided doses. In severe infections, this can
increase up to 4 g per day in divided doses. Two to four 5 ml
spoonfuls four times a day.
For Acne vulgaris, the dose is two 5 ml spoonfuls 3 times daily
before meals, for 1 to 4 weeks, and then reduced to twice daily
until improvement occurs.
For children aged 2 - 8 years:
30 mg per kg of bodyweight per day in divided doses. In severe
infections, this can increase up to 50 mg per kg of bodyweight
per day in divided doses. Two 5 ml spoonfuls four times a day
or as advised by your doctor.
For infants under 2 years of age:
30 mg per kg of bodyweight per day in divided doses. In severe
infections, this can increase up to 50 mg per kg of bodyweight
per day in divided doses. One 5 ml spoonful four times a day or
as advised by your doctor. An oral syringe may be used to

Page 16
For oral administration. Each 5 ml of
Erythromycin Suspension contains
125 mg of Erythromycin activity. This
product also includes sucrose and sodium.

Erythromycin
ERYTHROMYEthyl Succinate
CIN ETHYL
SUCCINATE
#125 MG/
#5 ML
TO THE PATIENT

125 mg/5 ml
Granules for
Oral Suspension

For oral administration
100 ml when reconstituted
Clonmel, Ireland.

Read the package leaflet before use.
Reconstituted suspension should not
be stored above 15˚C. Do not freeze.
Shake well before use. Keep tightly
closed and use within 14 days.
Keep out of the sight and reach of
children.
Dosage: As directed by physician.

TO THE PHARMACIST

Erythromycin Ethyl Succinate
granules for oral suspension.
Do not store granules above 25˚C.
To reconstitute add 60 ml water
and shake the bottle vigorously. The
resulting 100 ml of suspension contains
125 mg of Erythromycin activity in
each 5 ml. PL 04917/0013 POM
Pinewood Laboratories Ltd.,
23LL05252PW
Clonmel, Ireland.

+ Expand Transcript

Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

Hide