ERYTHROMYCIN SUSPENSION 125MG/5ML SF

Active substance: ERYTHROMYCIN ETHYLSUCCINATE

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PRODUCT NAME: Erythromycin

The usual doses are:

PATIENT INFORMATION LEAFLET ON
GBR 726-6174-APIL

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 (see table).

ERYTHROMYCIN ETHYLSUCCINATE SUGAR FREE (SF) SUSPENSIONS

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 (see table).

(Erythromycin ethylsuccinate)
This leaflet contains information about Erythromycin
Ethylsuccinate SF Suspension 125 mg/5 ml,
Erythromycin Ethylsuccinate SF Suspension 250 mg/5ml and
Erythromycin Ethylsuccinate SF Suspension 500 mg/5 ml.
Read all of this leaflet carefully before you start taking this medicine.
- Please 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. Do not pass it on to others.
It may harm them, even if their symptoms are the same as yours.
- If any of the side effects become severe, or if you notice any side effects not
listed in this leaflet, please tell your doctor or pharmacist.
In this leaflet:
1. What Erythromycin Ethylsuccinate SF Suspensions are and
what they are used for
2. Before you take Erythromycin Ethylsuccinate SF Suspensions
3. How to take Erythromycin Ethylsuccinate SF Suspensions
4. Possible side effects
5. How to store Erythromycin Ethylsuccinate SF Suspensions
6. Further information
1.

WHAT ERYTHROMYCIN ETHYLSUCCINATE SF SUSPENSIONS
ARE AND WHAT THEY ARE USED FOR
The name of your medicine is Erythromycin Ethylsuccinate SF Suspension.
Erythromycin Ethylsuccinate SF Suspension contains the active ingredient
erythromycinwhich belongs to a group of medicines called macrolide antibiotics.
Erythromycin Ethylsuccinate SF Suspensions are used to prevent and treat
infections such as:
• Throat and sinus infections.
• Chest infections, such as bronchitis and pneumonia.
• Ear infections.
• Mouth and dental infections.
• Eye infections.
• Skin and tissue infections, such as acne.
• Stomach and intestinal infections.
• Prevention of infection following burns, operations or dental procedures.
• Other infections, such as sexually transmitted diseases, bone infections
or scarlet fever.
2.

BEFORE YOU TAKE ERYTHROMYCIN ETHYLSUCCINATE SF
SUSPENSIONS
Do not take Erythromycin Ethylsuccinate SF Suspensions if you:
• have been told you that you are allergic to erythromycin or other macrolide
antibiotics such as clarithromycin or azithromycin or any of the other
ingredients of Erythromycin Ethylsuccinate SF Suspensions.
• 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 (widely taken for hayfever and allergies),
cisapride (for stomach disorders) or pimozide (for psychiatric conditions)
while receiving erythromycin, as combining these drugs can sometimes
cause serious disturbances in heart rhythm. Consult your doctor for advice
on alternative medicines you can take instead.
Take special care with Erythromycin Ethylsuccinate SF Suspensions
if you:
• are taking colchicine (used for treatment of gout and arthritis) as this may
cause serious side effects while taking erythromycin;
• have any liver problems or have been told that any drugs you are taking can
cause liver problems;
• have previously experienced diarrhoea following the use of antibiotics;
• 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. Consult your doctor before receiving
erythromycin. Alternatively if you were treated for early stages of syphilis
during your pregnancy, and your child is under 1 year and is prescribed

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 (see table).





erthyromycin, consult your doctor before giving erythromycin to your child;
are treating a young child with antibiotics and they are irritable or vomit when
fed, you should contact your physician immediately;
suffer from a condition called myasthenia gravis, which causes muscle weakness,
consult your doctor before receiving erythromycin;
are taking erythromycin with ‘statins’ such as simvastatin or lovastatin (used to
lower cholesterol) as serious side effects can occur.

If any of these apply to you, or if you are not sure, tell your doctor.
Taking other medicines
Please tell your doctor if you are taking or have recently taken any other medicines,
including any medicines obtained without a prescription.
This is especially important if you are taking medicines from the following families:
• astemizole, terfenadine or mizolastine (used to treat allergies such as
hayfever);
• pimozide (used to treat mental problems);
• ergotamine or dihydroergotamine (used to relieve migraine);
• cisapride (used to treat 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 infection);
• 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).
If you or your child goes for any medical tests, tell your doctor that you are
taking Erythromycin Ethylsuccinate SF Suspensions, as this may interfere with
some test results.
Pregnancy and breast-feeding
If you are pregnant or think you may be pregnant, or if you are
breast-feeding please consult your doctor before taking this medicine.
Important information about some of the ingredients of
Erythromycin Ethylsuccinate SF Suspensions
Each 5 ml teaspoon of this product contains approximately 1.2 g of sorbitol. Hence this
product may be unsuitable if you or your child have been told you have hereditary
fructose intolerance (a carbohydrate metabolism disorder), and therefore you should
contact your doctor.
Sorbitol can cause stomach upset or diarrhoea.
3. HOW TO TAKE ERYTHROMYCIN ETHYLSUCCINATE SF SUSPENSIONS
Always take Erythromycin Ethylsuccinate SF suspensions exactly as your doctor has
told you. You should check with your doctor or pharmacist if you are not sure.

Normal Doses
Which type of suspension
do I have?

How many 5 ml teaspoonfuls should be taken?
For patients
Under 2 years

For patients
between 2 - 8 years

For patients
Over 8 years










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).

If any of the side effects becomes severe, or if you notice any side effects not listed
in this leaflet, please tell your doctor or pharmacist.
5. HOW TO STORE ERYTHROMYCIN ETHYLSUCCINATE SF SUSPENSIONS
Storage conditions
Your medicine will be stored by the pharmacist and reconstituted to a suspension
before giving it to you. It should be used within 7 days of reconstitution.

PIP CODE:
COMPONENT:
SIZE:
MARKET:
COMMODITY NO.:
PRODUCT SITE:
SCALE:
COLOURS:
DATE:
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AMENDED BY:
PROJECT:

Ethylsuccinate (SF)
Susp
GB726-66174LF-AM01

Leaflet
267 x 165 mm
GB
TBC
TBC
100%
Black, Cutter

08/08/2013
8 pt
1
AMCo
CNC

REGULATORY AUTHORITY
APPROVAL CONFIRMATION
Confirmation that this artwork has been approved by
the appropriate market authority (if applicable, e.g.
MHRA, IMB, etc and that Amdipharm have license
approval to distribute this component for sale in the
relevent market.
Accept Artwork ................................................................

Erythromycin Ethylsuccinate 1 teaspoonful
2 teaspoonfuls
SF Suspension 125 mg/5 ml four times a day four times a day

4 teaspoonfuls
four times a day

Do not use these suspensions after the expiry date shown on the bottle.

Reject Artwork .................................................................

Erythromycin Ethylsuccinate
SF Suspension 250 mg/5 ml

2 teaspoonfuls
four times a day

KEEP OUT OF THE REACH AND SIGHT OF CHILDREN

Signature ..........................................................................

Erythromycin Ethylsuccinate
SF Suspension 500 mg/5ml

1 teaspoonful
four times a day

1 teaspoonful
four times a day

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 take more Erythromycin Ethylsuccinate SF Suspensions 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 of Erythromycin Ethylsuccinate SF Suspension could cause temporary
hearing loss, nausea, vomiting and diarrhoea.
If you forget to take Erythromycin Ethylsuccinate SF Suspensions
If you forget to take a dose of your medicine, take it as soon as you remember.
Do not take more medicine in one day than your doctor tells you to.
If you have any further questions on the use of this product ask your doctor
or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Erythromycin Ethylsuccinate SF Suspension can cause side
effects, although not everybody gets them.
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 and throat,
as these may be signs of an allergic reaction.
Other side effects of Erythromycin Ethylsuccinate SF Suspensions include:
• diarrhoea which may be severe or prolonged and may contain blood or mucus;
• feeling sick 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 pains;
• abnormal heart rhythms (including palpitations);
• fever;
• anorexia;

Medicines should not be disposed of via wastewater or household waste. Ask your
pharmacist how to dispose of medicines no longer required. These measures will
help to protect the environment.
6. FURTHER INFORMATION.
What Erythromycin Ethylsuccinate SF Suspensions contain
There are three different strengths of Erythromycin Ethylsuccinate SF
Suspension available. They all contain the active ingredient erythromycin.
• Erythromycin Ethylsuccinate SF Suspension 125 mg/5 ml contains
125 mg of erythromycin as erythromycin ethylsuccinate in every 5 ml.
• Erythromycin Ethylsuccinate SF Suspension 250 mg/5 ml contains
250 mg of erythromycin as erythromycin ethylsuccinate in every 5 ml.
• Erythromycin Ethylsuccinate SF Suspension 500 mg/5 ml contains
500 mg of erythromycin as erythromycin ethylsuccinate in every 5 ml.
The other ingredients are: sodium citrate, saccharin sodium, xanthan gum,
poloxamer, sodium methylhydroxybenzoate, sodium propylhydroxybenzoate,
purified water, colloidal silica, imitation banana No. 2 flavour and imitation
cream flavour, sorbitol and acesulfame (K).
What Erythromycin Ethylsuccinate SF Suspensions looks like and
the contents of the pack
Erythromycin Ethylsuccinate SF are granules which are made up to a white,
opaque suspension by the pharmacist.
Erythromycin Ethylsuccinate SF Suspensions are available in bottles of
100 ml or 140 ml.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Amdipharm UK Limited,
Regency House,
Miles Gray Road,
Basildon,
Essex SS14 3AF.
UK
Manufacturer:
Aesica Queenborough Limited,
Queenborough,
Kent ME11 5EL.
UK

This leaflet was prepared in August 1998. Revised in August 2013.

Name ................................................................................
Date ...................................................................................

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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.

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