ERYTHROMYCIN 250MG GASTRO-RESISTANT HARD CAPSULES
Active substance(s): ERYTHROMYCIN
If you forget a dose, take the next one as soon as you
remember unless it is time for your next dose.
Do not take a double dose.
4. Possible side effects
Like all medicines, erythromycin can cause side
effects, although not everybody gets them.
If you notice any of the following, contact your doctor
• difÀculty breathing;
• swelling of the face, lips or throat;
• skin rashes;
• severe skin reactions including large Áuid-Àlled
blisters, sores and ulcers;
• ulcers in the mouth and throat, as these may be
signs of an allergic reaction.
Other side effects inculde:
• 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
• stomach pains; these may be a symptom of an
inÁamed pancreas (pancreatitis);
• ringing in the ears (tinnitus);
• reversible loss of hearing (usually associated with
high doses or in patients with
• 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);
vertigo (problems with balance that can result in
feelings of dizziness or sickness- particularly on
• hallucinations (seeing or hearing things that aren’t
• feeling generally unwell (malaise);
• inÁammation of the kidneys (a condition known as
• 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).
Reporting of side effects
If you get any side effects, talk to your doctor,
pharmacist or nurse. This includes any possible side
effects not listed in this leaÁet. You can also report
side effects directly via the Yellow Card Scheme at:
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
Do not store above 25°C.
Store in the original packaging and protect from light
Do not use this medicine after the expiry date that is
stated on the carton after EXP. The expiry date refers
to the last day of that month.
Do not throw away any medicine via wastewater or
household waste. Ask your pharmacist how to throw
away medicines no longer use. These measures will
help to protect the environment.
Package leaÁet: Information for the patient
6. FURTHER INFORMATION
Read all of this leaÁet carefully before you start
using this medicine because it contains important
information for you.
• Keep this leaÁet. You may need to read it again.
• If you have any further questions, ask your doctor
• 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
• If you get any side effects, talk to your doctor or
pharmacist. This includes any possible side effects
not listed in this leaÁet. See section 4.
What is in this leaÁet:
1. What erythromycin is and what it is used for
2. What you need to know before you take
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
What erythromycin contains
Erythromycin contains 250 mg of active ingredient,
erythromycin. It also contains cellulose acetate
phthalate, lactose, potassium phosphate monobasic,
povidone, diethyls phthalate, puriÀed water, titanium
dioxide, sunset yellow (E110), erythrosine (E127),
quinoline yellow (E104), black iron oxide (E172),
shellac, potassium hydroxide and propylene glycol as
the inactive ingredients.
What erythromycin looks like and the contents of
Erythromycin is supplied as orange and clear gelatine
capsules containing white coated pellets, with
ERYMAX 250 mg printed on each half.
Packs of 28 or 112 capsules are available.
Marketing Authorisation Holder
Cephalon UK Limited,
Ridings Point, Whistler Drive, Castleford,
West Yorkshire, WF10 5HX, UK.
Almac Pharma Services Ltd.,
Seagoe Industrial Estate, Craigavon, Armagh,
BT63 5UA, UK.
This leaÁet was last revised in November 2016.
Gastro-resistant Hard Capsules
The name of this medicine is erythromycin
250 mg gastro-resistant hard capsules. The active
ingredient in them is erythromycin, which belongs to a
group of medicines called antibiotics.
Erythromycin is used to treat ear, nose, throat and chest
infections. It can also be used to treat skin infections.
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Erythromycin 250mg Gas-Res Hard Caps
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2. What you need to know before you take
Do not take erythromycin if you:
• Are allergic to active substance or any of the other
ingredients of this medicine (listed in section 6)
• Are taking antihistamines (for allergies) called
terfenadine or astemizole
• Are pregnant or breast-feeding
• Are taking cisapride (for stomach problems).
• Are taking dihydroergotamine or ergotamine
• Are taking pimozide or sertindole (mental (health
• Are taking simvastatin (for blood cholesterol)
• Are taking mizolastine (for hayfever or allergies)
• Are taking tolterodine (for urinary incontinence)
• Are taking amisulpride (for schizophrenia)
• Are taking domperidone (for nausea or vomiting).
Talk to your doctor before taking this product if any of
the above apply to you.
Warnings and precautions
Talk to your doctor or pharmacist before taking
• If you have liver disease or have been told that any
drugs you are taking can cause
• If you have previously experienced diarrhoea
following the use of antibiotics
• If you suffer with a muscle disorder called
• If you are taking medicine for high blood
cholesterol (a “statin”, such as atorvastatin)
• If a young child is treated with antibiotics and they
are irritable or vomit when fed., you should contact
your physician immediately.
Other medicines and erythromycin
Please tell your doctor or pharmacist if you are
taking, have recently taken or might take any other
medicines. It is especially important if you are taking
medicines from following families:
• astemizole, terfenadine or mizolastine
(used to treat allergies such as hay fever);
• domperidone (used to treat nausea
(feeling sick) and vomiting (being sick));
• pimozide (used to treat mental problems);
• ergotamine or dihydroergotamine (used to treat
• cisapride (used to treat stomach disorders);
• statins (used to help lower cholesterol e.g.
lovastatins and simvastatin);
• protease inhibitors (used to treat viral infections
• 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
reÁux and other related conditions);
• clarithromycin, rifabutin, or rifampicin (medicines
used to treat different types of bacterial infection);
• Áuconazole, ketoconazole and itraconazole
(medicines used to treat fungal infections);
• digoxin, quinidine or disopyramide (used to treat
• cilostazol (a medicine used to treat peripheral
• hexobarbitone, phenobarbital or midazolam
(used as sedatives);
• warfarin and acenocoumarol (used to help thin
• valporate, carbamazepine or phenytoin (used to
• theophylline (used to treat asthma and other
• ciclosporin or tacrolimus (used following
• 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
• verapamil (used to treat high blood pressure and
• vinblastine (used to treat certain types of cancer);
• sildenaÀl (used to treat erectile dysfunction).
Whilst you are taking erythromycin your doctor may
occasionally check your liver function.
If you are asked to provide a urine test, tell your
doctor that you are taking erythromycin as it may
interfere with certain tests.
Pregnancy, breast-feeding and fertility
If you are pregnant, think you might be pregnant,
or are breast-feeding, you should ask your doctor or
pharmacist for advice before taking erythromycin.
Erythromycin capsules contain lactose, potassium
and sunset yellow
These capsules contain lactose. If you have been told
you have an intolerance to some sugars contact you
doctor before taking this medicine.
Always take your medicine exactly as your doctor
has told you. You should check with your doctor or
pharmacist if you are not sure.
The usual dose for adults is 2 capsules (500mg)
twice daily or 1 capsule 250mg four times a day.
However, the doctor may prescribe a different dose
for you depending on what you are being treated for.
The dose for children will depend upon their weight
and will be calculated by the doctor.
Capsules should be taken either before or with meals
and swallowed whole with a glass of water. Do not
chew the capsules or remove the contents as this will
affect the medicine.
Your doctor will tell you how long to keep taking the
medicine for. You should make sure you complete
the course of treatment prescribed even if you start
feeling better before Ànishing.
If you take more erythromycin than you should
If you take too many capsules contact you nearest
hospital casualty department or tell your doctor or
pharmacist immediately. Take this leaÁet and any
remaining capsules with you.
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These capsules contain potassium which can be
harmful to people on a low potassium diet, causing
stomach upset and diarrhoea.
These capsules contain the colouring agent sunset
yellow E110, which is known to cause allergic
reactions in some people. If you think you might have
an intolerance to this you should contact your doctor
before taking this medicine.
3. How to take Erythromycin
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THIS IS A REPRESENTATION OF AN ELECTRONIC RECORD THAT WAS SIGNED ELECTRONICALLY AND THIS
PAGE IS THE MANIFESTATION OF THE ELECTRONIC SIGNATURE
Teva Pharmaceuticals Europe B.V
Meaning of Signature
Regulatory Affairs Approval
07-Dec-2016 03:22:36 PM
Page 3 of 3
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.