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ERYTHROMYCIN ETHYL SUCCINATE GRANULES 125MG/5ML

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PACKAGE LEAFLET: INFORMATION FOR THE USER
Erythromycin Ethyl Succinate granules for oral Suspension 125mg/5ml, 250mg/5ml and
500mg/5ml
erythromycin
Read all of this leaflet carefully before you start taking this medicine.
• 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 gets serious, or if you notice any side effects not listed in this leaflet,
please tell your doctor or pharmacist.
In this leaflet:
1.
What Erythromycin is and what it is used for
2.
Before you take Erythromycin
3.
How to take Erythromycin
4.
Possible side effects
5.
How to store Erythromycin
6.
Further information.

1.

WHAT ERYTHROMYCIN IS AND WHAT IT IS USED FOR

Erythromycin is an antibiotic, which belongs to a group of medicines called macrolides. It can be used
to treat and prevent a variety of infections, including those that affect the eye, ear, nose, mouth, throat
and respiratory system (chest infections). Erythromycin can also be used to treat infections of the skin,
stomach, gut, prostate, certain urinary tract infections, gonorrhoea, syphilis, diphtheria and scarlet
fever. The antibiotic can also be given before and after surgery to help prevent infection, and may also
be given to prevent infections such as endocarditis and rheumatic fever.

2.

BEFORE YOU TAKE ERYTHROMYCIN

Do not take Erythromycin
• if you are allergic (hypersensitive) to erythromycin or any of the other ingredients of this
medicine (see section 6 for further information)
• if you are taking antihistamines such as terfenadine, mizolastine, astemizole
• if you are taking anti-psychotic drugs (for mental illness) such as pimozide
• if you are taking dihydroergotamine or ergotamine (to treat migraines)
• if you are taking cisapride (for stomach problems)
• if you are taking cilostazol (for cramp-like pains in the legs when walking).
Take special care with Erythromycin
You should tell your doctor before taking this medicine:
• if you suffer from liver disease or are taking medicine that can affect your liver
• if you suffer from a condition called myasthenia gravis, which causes muscle weakness.
Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines,
including medicines obtained without a prescription or any of the following:

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bromocriptine, cabergoline or lisuride (used to treat Parkinson’s disease)
carbamazepine, phenytoin or valproate (used to treat epilepsy)
cimetidine (used to treat ulcers)
clozapine (used to treat mental illness)
digoxin, quinidine or disopyramide (used to treat heart problems)
felodipine (used to treat high blood pressure and angina)
loratadine (used to treat allergic reactions)
methylprednisolone (used to treat some allergic conditions)
lovastatin or simvastatin (used to reduce cholesterol)
midazolam or alfentanil (used for sedation)
reboxetine (an antidepressant)
zopiclone or alprazolam (used to treat anxiety and insomnia)
rifabutin (used to treat tuberculosis)
ritonavir or amprenavir (used to treat HIV infections)
sildenafil (used to treat erectile dysfunction or pulmonary arterial hypertension)
tacrolimus or ciclosporin (used following transplants)
theophylline (used to treat breathing problems)
zafirlukast (used to prevent asthma)
tolterodine (used to treat incontinence)
vinblastine or docetaxel (used to treat cancer)
warfarin or acenocoumarol (medicine to thin the blood)
colchicine (for gout).

If you go 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 think you may be pregnant, you should ask your doctor or pharmacist for advice
before taking this medicine.
It is not recommended to breast-feed your baby while taking erythromycin, as small amounts of this
medicine can pass into breast milk. You should ask your doctor or pharmacist for advice before taking
this medicine.
Driving and using machines
Erythromycin should not affect your ability to drive or use machines. If you are affected, speak to your
doctor or pharmacist.
Important information about some of the ingredients of Erythromycin
This medicine contains sucrose per dose. This should be taken into account in patients with diabetes
mellitus. If you have been told by your doctor that you have an intolerance to some sugars, such as
sucrose, contact your doctor before taking this medicine.

3.

HOW TO TAKE ERYTHROMYCIN

Always take Erythromycin exactly as your doctor has told you. You should check with your doctor or
pharmacist if you are not sure.
Your medicine is in the form of granules for oral suspension. Your pharmacist will make up the
solution and dispense the quantity prescribed by your doctor.


Shake the bottle well before use.
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The usual dose is:
Adults and children over 8 years
For mild to moderate infections:2g daily in divided doses. For severe infections, the dose may be
increased to 4g per day.
Children
Your doctor will decide on the dose depending on the age of the child. For most infections, the usual
dose is as follows:
2 to 8 years: 1g daily in divided doses.
Infants and babies up to 2 years: 500mg daily in divided doses.
For more severe infections the above total daily dosages may be doubled.
Elderly
As adult dose.
In all patients the duration of the prescribed medication will depend upon the severity of the infection
and will be decided by your doctor.
If you take more Erythromycin than you should
Contact your doctor or nearest hospital emergency department immediately. Take the container and
any remaining tablets with you. Symptoms of overdose include nausea, vomiting, hearing loss and
diarrhoea.
If you forget to take Erythromycin
Take the next dose as soon as you remember unless it is almost time for your next dose. Do not take a
double dose to make up for a forgotten dose.
If you stop taking Erythromycin
Do not stop taking Erythromycin without talking to your doctor first. It is important to finish the
course of antibiotic as instructed by your doctor.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4.

POSSIBLE SIDE EFFECTS

Like all medicines, Erythromycin can cause side effects, although not everybody gets them.
If any of the following happens stop taking Erythromycin and tell your doctor immediately or go to
your nearest emergency hospital/ department.



if you develop swelling of the face and/or throat or difficulty in breathing
if you start to suffer from an allergic rash, itching or severe skin reactions with peeling, blistering
or ulcerated skin.
These side effects are rare but serious. You may need medical attention.
If your child is being treated with Erythromycin, and he/she starts vomiting or appears irritable contact
your doctor straight away.
Other possible side effects are:
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abdominal discomfort, feeling or being sick
Diarrhoea. If you suffer from watery diarrhoea, fever and cramps and if these symptoms are severe
or prolonged, contact your doctor immediately
yellowing of the skin and/ or whites of the eyes and loss of appetite (signs of hepatitis or liver
problems)
chest pains, dizziness, palpitations or an abnormal heartbeat. Tell your doctor straight away.
very rarely, inflammation of the pancreas, causing severe pain in the stomach region
discoloured urine, fluid retention or generally feeling unwell
hearing loss ( if you are taking a high dose of Erythromycin, however this side effect should only
be temporary)

If any side effect gets serious, or if you notice any side effects not listed in this leaflet, please tell
your doctor or pharmacist.

5.

HOW TO STORE ERYTHROMYCIN

Keep out of the reach and sight of children.
Do not use Erythromycin after the expiry date, which is stated on the carton. The expiry date refers to
the last day of that month. The reconstituted suspension should not be used after 14 days.
Store the granules below 25°C and the reconstituted suspension below 15°C. Keep the bottle in the
outer carton and protect from direct sunlight.
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 contains
The active substance is erythromycin 125 mg, 250 mg or 500 mg in 5ml of suspension.
The other ingredients are: sodium CMC, sodium citrate, banana flavour E4210 SD, quinoline yellow
14031 E104, sodium saccharin, colloidal silicon dioxide and sucrose.
What Erythromycin looks like and contents of the pack
Erythromycin for oral suspension comes in a glass bottle. The granules are yellow with a banana
flavour. The pharmacist will mix the granules with water to make a suspension.
Marketing Authorisation Holder and Manufacturer
Generics [UK] Ltd, Station Close, Potters Bar, Hertfordshire EN6 1TL, United Kingdom
This leaflet was last approved in {03/2010}.

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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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