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ERYTHROMYCIN 500 MG/5ML SUGAR FREE GRANULES FOR ORAL SUSPENSION

Active substance(s): ERYTHROMYCIN ETHYL SUCCINATE ESTER / ERYTHROMYCIN ETHYL SUCCINATE ESTER / ERYTHROMYCIN ETHYL SUCCINATE ESTER

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TEVA UK Ref:

Version:

83941-X LBL ERYTHROMYCIN 500mg/5ml SF SUSP TUK XPIN

7

01 March 2016

SOLID VARNISH AREA

CHECKERBOARD VARNISH AREA

LEAFLET POSITION TOLERANCE

LEAFLET POSITION GUIDE

Erythromycin
BARCODE NUMBER MUST FACE OUTWARDS

500 mg/5 ml
Sugar Free Granules
for Oral Suspension
Erythromycin
Ethyl Succinate

500 mg
per 5 ml
Sugar Free

When

100 ml reconstituted

PATIENT INFORMATION LEAFLET
Erythromycin 500 mg/5 ml Sugar Free Granules for Oral
Suspension
Erythromycin ethyl succinate
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.
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

Infants and babies up to 2 years:
One 1.25ml spoonful every 6 hours or as advised by your
doctor.
An oral syringe may be used to measure this dose. A
lower strength product containing 125mg or 250mg / 5ml
of erythromycin is easier to use for this age group.
Your doctor may advise you to take your medicine
differently, so always follow your doctor’s advice and
check with them if you are not sure. Prolonged use of this
antibiotic may result in you becoming resistant to its
action.
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 take too much Erythromycin, go immediately to
your nearest hospital casualty department, taking your
medicine bottle with you to show what you have taken.

5. How to store Erythromycin
6. Further 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. BEFORE YOU TAKE ERYTHROMYCIN
Do not take Erythromycin if you:
• are allergic to erythromycin or any of the other
ingredients of this medicine (see Section 6 and end of
Section 2)
• have ever reacted to any erythromycin-type antibiotic.
• have an intolerance to some sugars.
Before taking Erythromycin, consult your doctor if you:
• are pregnant, intending to become pregnant, or are

If you stop taking Erythromycin
Remember to keep taking this medicine until your doctor
tells you to stop. Do not stop just because you feel better.
If you stop too early, your infection may return, or get
worse.
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.
STOP taking Erythromycin and contact your doctor
immediately if you experience a rare allergic reaction,
as you may need emergency treatment. Symptoms
include:
• swelling of the face/and throat
• difficulty breathing
• a rash
• itching or skin reactions with blisters or peeling
skin

breast-feeding. New born babies treated with
erythromycin may develop a condition associated with
severe vomiting or irritability with feeding (infantile
hypertrophic pyloric stenosis, IHPS). If this occurs
contact your doctor.
• have a history of or currently have liver disease.
• have kidney problems.
• have myasthenia gravis (a disease of the nerves causing
muscle weakness).
• are taking a urine test based on colour measurement, as
the results may be affected.
• develop unusual aches or pains in your muscles, which
go on for longer than expected.
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).
Taking other medicines
DO NOT take Erythromycin if you are already taking the

Serious side effects: STOP taking Erythromycin and
contact your doctor immediately if you experience any of
the following:
• irregular heartbeat
• chest pain
• liver effects (yellowing of skin and/or whites of your
eyes, abdominal discomfort and loss of appetite)
Common side effects include:
• mild skin rash with no peeling or blistering
• mild allergic skin reactions e.g. hives
• skin rashes with fever (skin red, itchy and patchy in
appearance)
• feeling or being sick
• loss of appetite
• diarrhoea, upset stomach and abdominal discomfort
• pseudomembranous colitis (bloody diarrhoea)
• fever
• general feeling of being unwell
• severe vomiting or irritability with feeding in new born
babies (see section “before taking Erythromycin”)

Erythromycin
#500 MG/#5 ML
SUGAR FREE

For oral administration.
Each 5 ml of Erythromycin Suspension contains
500mg of Erythromycin activity. This product
also includes sorbitol (E420).
TO THE PATIENT
Read the package leaflet before use.
Reconstituted suspension should be stored at
2˚C-8˚C (in a refrigerator).
Do not freeze. Shake well before use.
Keep tightly closed and use within 14 days.
KEEP ALL MEDICINES 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 500 mg of Erythromycin
activity in each 5 ml.
23LL04823PW
PL 04917/0050
Pinewood Laboratories Ltd.,
Clonmel, Ireland
83941-X POM

medicines:
• astemizole (for hives, rash, itching from an allergy, or
fever)
• terfenadine (for hayfever)
• cisapride (for heartburn)
• pimozide (for Tourette’s Syndrome)
• ergotamine or dihydroergotamine (for migraine)
Please tell your doctor if you are taking or have recently
taken any other medicines, including those obtained
without a prescription. Erythromycin may interfere with
other medicines you may be taking. Especially, tell your
doctor if you are taking any of the following:
• Sleeping pills (e.g. triazolam, zopiclone,
hexobarbitone)
• Medicines used to treat anxiety (e.g. diazepam,
midazolam or buspirone)
• Medicines used to prevent organ transplant rejection
(e.g. ciclosporin, tacrolimus)
• Heart drugs (e.g. quinidine, digoxin, disopyramide)
• Cholesterol-lowering drugs (especially lovastatin as

Very rarely, the following effects have been reported:
• irregular heartbeat or palpitations
• reversible deafness
• reinfection following prolonged or repeated doses
• transient confusion, fits and vertigo
• hallucinations
• low blood pressure
• inflammation of the kidneys which may result in
kidney failure
• pancreatitis - inflammation of the pancreas causing
abdominal pain, feeling or being sick.
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. By reporting side effects
you can help provide more information on the safety of
this medicine.

ERYTHROMYCIN #500 MG/#5 ML
SUGAR FREE

your muscles may be affected)
• Medicines used to treat epileptic seizures (e.g. sodium
valproate, carbamazepine, phenytoin)
• Medicines used to reduce pain (e.g. alfentanil)
• Medicines that prevent blood clotting (e.g. warfarin or
acenocoumarol)
• Medicines used to control dopamine levels in the
brain (e.g. bromocriptine)
• Theophylline (medicine that helps you breathe easier)
• Medicines used to treat migraine (e.g. ergotamine)
• Antihistamines (e.g. cetirizine)
• Cardiac glycosides (e.g. digitoxin for heart failure or
abnormal heartbeat)
• Methylprednisolone (to treat sickle cell anaemia, a
rare blood disorder where red blood cells are affected)
• Cimetidine or Omeprazole (to treat stomach ulcers)
• Rifabutin (to treat tuberculosis)
• Sildenafil (used to treat erection problems in men or
pulmonary arterial hypertension)
• Vinblastine (used to treat certain kinds of cancer)

5. HOW TO STORE ERYTHROMYCIN
Keep 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, store medicine at 2˚C-8˚C (in a refrigerator),
keep the cap tightly closed, and use within 14 days. Do not
freeze.
Take unused medicines to your pharmacist for safe
disposal.
6. FURTHER INFORMATION
Erythromycin contains:
• the active substance: erythromycin ethyl succinate;
each 5ml of the oral suspension contains erythromycin
500mg.
• the other ingredients: carmellose sodium, colloidal
anhydrous silica, riboflavin-5-sodium phosphate,
orange flavour (containing traces of propylene glycol),
glyceryl monostearate, anhydrous disodium hydrogen










Antifungals e.g. fluconazole, itraconazole
St. John’s wort (used to treat mild depression)
Contraceptive pill
Other antibiotics
Ritonavir (used to treat HIV)
Verapamil (used to treat high blood pressure)
Cilostazol (used to treat pain in leg when walking)
Medications causing specific changes to your ECG
(heart trace) (prolongation of the QT interval)
• Colchicine (used to treat gout)
Pregnancy and breast-feeding
As with all medicines, ask your doctor for advice before
taking Erythromycin if you are pregnant or if you are
breast-feeding.
Important information about some ingredients of
Erythromycin
Erythromycin contains sorbitol (E420). Tell your doctor
before taking this medicine if you have an intolerance to
some sugars.

phosphate and sorbitol (E420) (see end of Section 2:
‘Important information’).
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 or white plastic bottles, and
is also available in strengths of 125mg or 250mg per 5ml.
Marketing Authorisation Holder and Manufacturer
Pinewood Laboratories Ltd., Ballymacarbry, Clonmel,
Co. Tipperary, Ireland.
PL04917/0050
This leaflet was last updated in 02/2016.

3. HOW TO TAKE ERYTHROMYCIN
The usual dose depends on the severity and nature of the
infection; your doctor will tell you what dose to take.
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 usual dose is:
Adults, the elderly and children (over 8 years):
One 2.5ml spoonful to one 5ml spoonful every 6 hours.
Maximum daily dose: up to 4g, your doctor will work out
the maximum daily dose based on the patient’s body weight.
For Acne vulgaris, the dose is one 2.5ml spoonful 3 times
daily before meals, for 1 to 4 weeks, and then reduced to
twice daily until improvement occurs.
Children aged 2 - 8 years:
One 2.5ml spoonful every 6 hours or as advised by your
doctor.

Erythromycin

For oral administration.
Each 5 ml of Erythromycin Suspension contains
500mg of Erythromycin activity. This product
also includes sorbitol (E420).
TO THE PATIENT
Read the package leaflet before use.
Reconstituted suspension should be stored at
2˚C-8˚C (in a refrigerator).
Do not freeze. Shake well before use.
Keep tightly closed and use within 14 days.
KEEP ALL MEDICINES 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 500 mg of Erythromycin
activity in each 5 ml.
23LL04823PW
PL 04917/0050
Pinewood Laboratories Ltd.,
Clonmel, Ireland
83941-X POM

ERYTHROMYCIN
#500 MG/
#5 ML
SUGAR FREE

500 mg/5 ml
Sugar Free Granules
for Oral Suspension
Erythromycin
Ethyl Succinate

500 mg
per 5 ml

Sugar Free

When

100 ml reconstituted

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.

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