ERYTHROMYCIN 250MG TABLETS
Active substance(s): ERYTHROMYCIN
ERYTHROMYCIN 250mg TABLETS
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 Tablets are and what they are used for
2. Before you take Erythromycin Tablets
3. How to take Erythromycin Tablets
4. Possible side effects
5. How to store Erythromycin Tablets
6. Further information
WHAT ERYTHROMYCIN TABLETS ARE AND WHAT THEY ARE
Erythromycin is an antibiotic for the treatment and prevention of infections
caused by erythromycin-sensitive organisms, such as:
• Upper and lower respiratory tract infections
• Eye, ear infections
• Oral infections
• Skin and soft tissue infections
• Gastrointestinal infections
• Prophylaxis pre- and post-operative trauma, burns, rheumatic fever
• Other infections: osteomyelitis, urethritis, gonorrhoea, syphilis,
lymphogranuloma venereum, diphtheria, prostatitis, scarlet fever
BEFORE YOU TAKE ERYTHROMYCIN TABLETS
DO NOT take Erythromycin Tablets if you are:
• Allergic (hypersensitive) to erythromycin or any of the other ingredients
in the product (see section 6 ‘What Erythromycin Tablets contain’)
Take special care with Erythromycin Tablets
Speak to your doctor if you have:
• Kidney problems
• Liver disease
• Myasthenia gravis (a muscle disorder)
• Irregular heart rhythm
• A condition called porphyria
Taking other medicines
Please inform your doctor if you are taking or have recently taken any
other medicines, including those obtained without a prescription,
• Warfarin (thins the blood)
• Cisapride (used for stomach disorders)
• Pimozide (used in the treatment of psychiatric disorders)
• Clarithromycin (antibiotic used to treat certain infections)
• Ergotamine or dihydroergotamine (for migraine)
• Zopiclone (induces sleep)
• Theophylline (helps breathing)
• Lovastatin (blood cholesterol lowering drug)
Other drug interactions include: alfentanil, bromocriptine, carbamazepine,
ciclosporin, digoxin, disopyramide, hexobarbitone, midazolam, phenytoin,
quinidine, tacrolimus, triazolam, valproate. Your doctor should monitor you
appropriately and may adjust your dosage of erythromycin as necessary.
DO NOT take simvastatin, tolterodine, mizolastine, amisulpride,
terfenadine or astemizole if you have been prescribed erythromycin.
If you are asked to provide a urine test, tell your doctor that you are taking
Erythromycin as it may interfere with some tests.
Pregnancy and breast-feeding
Tell your doctor if you are pregnant or planning to become pregnant.
Erythromycin has been reported to cross the placental barrier.
Erythromycin passes into breast milk. Ask your doctor or pharmacist for
advice before taking any medicine.
If you are pregnant and treated with an oral erythromycin tablet for early
syphilis, please consult with your doctor as erythromycin may not be
effective in preventing infection to the baby.
Driving and using machines
Erythromycin Tablets are not expected to affect your ability to drive or
HOW TO TAKE ERYTHROMYCIN TABLETS
Always take Erythromycin Tablets exactly as your doctor has told you.
The pharmacist’s label should tell you how much to take and how often.
For oral use only.
Adults: The usual dose is one 250mg tablet every four to six hours.
Increased to 4g per day, if infection is very severe.
Children: The usual regimen is 30mg/kg/day in divided doses. For more
severe infections, this dosage should be 50mg/kg/day.
If administration on a twice daily schedule is desirable in adults or
children, one half of the total daily dose may be given every 12 hours, one
hour before meals.
Is it important you complete your full course of antibiotics; do not stop
taking the tablets early even if you feel better.
If you take more Erythromycin Tablets than you should
If you or a child accidentally takes too much medicine, contact your doctor
or nearest hospital emergency department immediately. Take this leaflet,
the tablet pack and any tablets remaining with you, if possible.
Symptoms of overdose include:
• loss of hearing
If you forget to take Erythromycin Tablets
If you miss a dose, take the tablet as soon as you remember and carry on
as before. If it is almost time for your next dose, skip the missed dose and
continue as usual (do not take a double dose to make up for the forgotten
If you have any further questions on the use of this product, ask your
doctor or pharmacist.
POSSIBLE SIDE EFFECTS
The following have also been reported:
• Nausea, vomiting and diarrhoea
• Hearing loss
• Liver problems, accompanied with or without jaundice (yellowing of the
skin and whites of the eyes)
• Abdominal discomfort
• Anaphylaxis (sudden, severe allergic reaction)
• Erythema multiforme, (a red rash caused by hypersensitivity to a drug
or disease or other allergen)
• Stevens-Johnson syndrome (a severe inflammatory eruption of the skin
and mucus membranes)
• Damage to the blood, kidneys or central nervous system
• Cardiac arrhythmia (an abnormal rate of muscle contractions in the
• Toxic epidermal necrolysis (large portion of the skin becomes intensely
red and peels off)
• Chest pains, dizziness and palpitation (irregular, hard, or rapid
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.
Reporting of side effects
Also you can help to make sure that medicines remain as safe as
possible by reporting any unwanted side effects via the internet at
www.mhra.gov.uk/yellowcard. Alternatively you can call Freephone
0808 100 3352 (available from 10 a.m. to 2 p.m. Mondays to Fridays) or
fill in a paper form available from your local pharmacy.
HOW TO STORE ERYTHROMYCIN TABLETS
KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.
Do not store above 25 C. Store in the original container. Keep the
container tightly closed. Do not use the tablets after the expiry date stated
on the pack.
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.
What Erythromycin Tablets contain
The active substance is erythromycin. Each tablet contains 250mg
The other ingredients are maize starch, croscarmellose sodium Type A,
povidone, talc, magnesium stearate (E572), hypromellose (E464),
macrogol 6000, erythrosine (E127), methacrylic acid ethylacrylate
copolymer (1:1) and polysorbate 80 (E433).
What Erythromycin Tablets look like and contents of the pack
The tablets are reddish orange coloured, biconvex, enteric film-coated
and round in shape.
They are available in containers of 21, 100, 250, 500 and 1,000 tablets
and blister packs of 28, 56, 84 and 100 tablets. In addition bags of 5,000
and 10,000 tablets are also available. Not all pack sizes or pack types
may be marketed.
Marketing Authorisation Holder
Athlone Pharmaceuticals Limited, Ballymurray, Co. Roscommon, Ireland.
APL Swift Services (Malta) Limited
HF26 Hal Far Industrial Estate , Hal Far, Birzebbugia , BBG 3000 , Malta
Ares block, Odyssey Business Park , West End Road , Ruislip, HA4
6QD , UK
Like all medicines, Erythromycin Tablets can cause side effects, although
not everyone gets them.
If you develop an allergic reaction, this may result in swelling of
certain parts of your body, including the face and neck,
accompanied by difficulty in breathing. If this happens to you, stop
taking the tablets and seek urgent medical help.
This leaflet was last revised in July 2014
Originated by: Kent Pharm
Product: Erythromycin 250mg Tablets
Dimensions: 210mm x 297mm
Item Code: CP.ERY.250T.V3P2
Proof No and Date: 2 22/05/13
ARTWORK FOR SUBMISSION