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ERYTHROMYCIN ETHYLSUCCINATE 500 MG FILM-COATED TABLETS

Active substance(s): ERYTHROMYCIN ETHYLSUCCINATE

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Erythromycin Ethylsuccinate 500mg
film-coated tablets
Erythromycin Ethylsuccinate
Read all of this leaflet carefully before you start taking this medicine
because it contains important information for you.
- 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 only. Do not pass it on to
others. It may harm them, even if their signs of illness are the same as
yours.
- If you get any side effects or if you notice any side effects not listed in this
leaflet, please talk to your doctor or pharmacist.
In this leaflet:
1. What Erythromycin Ethylsuccinate tablets are and what they are used for
2. What you need to know before you take Erythromycin Ethylsuccinate
tablets
3. How to take Erythromycin Ethylsuccinate tablets
4. Possible side effects
5. How to store Erythromycin Ethylsuccinate tablets
6. Contents of the pack and other information
1. WHAT ERYTHROMYCIN ETHYLSUCCINATE TABLETS ARE AND
WHAT THEY ARE USED FOR
The name of your medicine is Erythromycin Ethylsuccinate film-coated
tablets. Erythromycin Ethylsuccinate tablets contain a medicine called
Erythromycin Ethylsuccinate. This medicine belongs to a group of
medicines called antibiotics. Erythromycin Ethylsuccinate is a macrolide
antibiotic. Erythromycin Ethylsuccinate works by impeding the growth of
bacteria in your body.
Erythromycin Ethylsuccinate tablets are used to prevent and treat infections
such as:
- Throat and sinus infections.
- Chest infections. such as bronchitis and pneumonia.
- Ear infections.
- Mouth infections.
- Eye infections.
- Skin and tissue infections, such as acne.
- Stomach and intestinal infections.
- Prevention of infection following burns or operations other infections,
such as sexually transmitted diseases, bone infections or scarlet fever.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE ERYTHROMYCIN
ETHYLSUCCINATE TABLETS

without a prescription. This is because Erythromycin Ethylsuccinate tablets
can affect the way some other medicines work.
In particular, tell your doctor if you are taking any of the following
medicines. This is because it can increase the chances of you getting
side effects, when taken with Erythromycin Ethylsuccinate tablets:
- Astemizole, terfenadine or mizolastine (used to treat allergies such as
hay fever),
- Pimozide (used to treat mental problems),
- Cisapride (used to treat acid reflux),
- Ergotamine or dihydroergotamine (used to relieve migraine),
- Digoxin or disopyramide or quinidine (used to treat heart problems),
- Hexobarbitone or midazolam (used as sedatives),
- Warfarin or acenocoumarol (used to thin the blood),
- Valproate, carbamazepine or phenytoin (used to control epilepsy),
- Theophylline or aminophylline (used to treat asthma and other breathing
problems).
- Cyclosporine or tacrolimus (used following organ transplants),
- Bromocriptine (used to treat Parkinson's disease),
- Alfentanil (used for pain relief),
- Zopiclone or triazolam (used to help you sleep),
- Rifabutin or rifampicin (used to treat tuberculosis (TB).
- Lovastatin or simvastatin (used to control cholesterol levels).
- Citalopram or escitalopram (used to treat mental problems)
- Ritonavir or indinavir (used to treat HIV)
- Sildenafil (used to treat erectile dysfunction)
- Cilostazol (used to prevent platelet aggregation)
- Methylprednisolone (used to treat inflammation and allergies)
- Omeprazole or cimetidine (used to treat heartburn)
- Vinblastine (used for treatment of certain types of cancer)
- Ketoconazole, itraconazole, voriconazole, posaconazole or fluconazole
(used to treat fungal infections)
- Colchicine (used to treat or prevent gout)
- Verapamil (used to treat high blood pressure)
- Phenobarbital (used to control seizures)
- St. John’s Wort (used to treat depression)
If your doctor has prescribed a medical test, tell your doctor that you are
taking Erythromycin Ethylsuccinate tablets, as this may interfere with some
test results.
Pregnancy and breast-feeding and fertility
If you are pregnant or breast-feeding, think you may be pregnant or
planning to have a baby, ask your doctor or pharmacist for advice before
taking this medicine.
Driving and using machines
You may get side effects after taking this medicine, including feeling dizzy.
Some of these side effects can affect you being able to concentrate and
your reaction speed. If this happens, do not drive or carry out any work that
requires a high level of attention.
3. HOW TO TAKE ERYTHROMYCIN ETHYLSUCCINATE TABLETS?

Do not take Erythromycin Ethylsuccinate tablets if you:
- Are allergic to erythromycin ethylsuccinate, any other macrolide antibiotic
or any of the other ingredients of this medicine (listed in section 6). Signs
of an allergic reaction include: a rash, swallowing or breathing problem,
swelling of your lips, face, throat or tongue.
- Are currently taking a medicine called astemizole or terfenadine (used to
treat allergies such as hay fever)
- Are currently taking a medicine called pimozide (used to treat mental
problems)
- Are currently taking a medicine called ergotamine or dihydroergotamine
(used to relieve migraine)
- Are currently taking a medicine called cisapride (used to treat acid reflux)
Take Special Care with Erythromycin Ethylsuccinate tablets if you:
- Ever have any liver problems or are taking any medicines which can
cause liver problems
- Suffer from a condition called myasthenia gravis which causes muscle
weakness.
- have been diagnosed with an ECG abnormality called long QT syndrome
or have an abnormal heartbeat or are taking medicines for treatment of
heart conditions
- have low blood levels of potassium or magnesium.
- take drugs that lower cholesterol levels (also called “statins”)
- take colchicine (for the treatment of gout)
If any of these apply to you, or if you are not sure if any of the above
applies to you, talk to your doctor or pharmacist before taking Erythromycin
Ethylsuccinate tablets.
Taking other medicines
Please tell your doctor or pharmacist if you are taking, or have recently
taken or might take any other medicines, including any medicines obtained

Always take this medicine exactly as described in this leaflet or as your
doctor has told you. Check with your doctor or pharmacist if you are not
sure.
Taking this medicine
- Take this medicine by mouth
- Swallow the tablets whole with a drink of water
- The tablets may be taken just before or with meals or food
How much to take
- Your doctor will decide on how many Erythromycin Ethylsuccinate tablets
you should take
- The dose will depend on the type of infection you have and where the
infection is in your body.
- The length of your treatment will depend on how serious your infection is.
- If you feel the effect of your medicine is too weak or strong, do not
change the dose yourself, but ask your doctor.
Adults and the elderly
The usual dose for adults, adolescents and children over 8 years is:
2 g daily in divided doses taken just before or with meals or food.
If you have a bad infection you may be told to take up to 4 g (8 tablets)
daily.
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.
Children and adolescents
This medicine must not be given to children 8 years of age and below.

If you take more Erythromycin Ethylsuccinate tablets than you should
If you accidentally take more tablets than you should, or if a child has taken
some of the medicine by mistake, tell a doctor or get other medical advice
straight away. Take the medicine pack with you. This is so the doctor
knows what you have taken. The following effects may happen: temporary
hearing loss, nausea, vomiting and diarrhoea.
If you forget to take Erythromycin Ethylsuccinate tablets
If you forgot to take a dose, take it as soon as you remember unless it is
nearly time for your next dose.
Do not double-up the next dose to make up for the missed dose.
If you stop taking Erythromycin Ethylsuccinate tablets
Do not stop taking Erythromycin Ethylsuccinate tablets just because you
feel better. It is important that you complete the course of tablets that your
doctor has prescribed for you. If you stop taking the tablets too soon, the
infection may return, your condition may get worse or the bacteria may
become resistant to the medicine.
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 tablets can cause side
effects, although not everybody gets them.
Stop taking Erythromycin Ethylsuccinate tablets and see a doctor or
go to a hospital straight away if you notice the following side effects:
- Difficulty breathing
- Fainting
- Swelling of the face, lips or throat
- Skin rashes
As these may be signs of an allergic reaction.
- Severe skin reactions which may include blisters and bleeding in the lips,
eyes, mouth, nose and genitals or skin reactions with peeling of the skin,
accompanied by fever and chills, aching muscles and generally feeling
unwell (Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema
multiforme)
If you develop severe or prolonged diarrhoea, or diarrhoea containing
blood or mucus during or after taking Erythromycin ethylsuccinate tablets,
tell your doctor immediately.
Tell your doctor if any of the following side effects gets serious or
lasts longer than a few days:
Common
- Feeling sick or being sick (vomiting, diarrhoea, anorexia)
- Stomach pains
- Loss of appetite
- Increase in the level of some liver enzymes in your blood
- Heartburn
Uncommon
- Inflammation of the kidneys
- Abnormal counts of some blood cells (eosinophilia)
- Dizziness, vertigo and confusion
- Abnormal heart rhythm
- Allergic reactions of various severity
- Chest pain and palpitations
Rare
- Pancreatitis
- Unusual fatigue
- Dark urine
- Inflammation of the liver (hepatitis), enlarged liver, liver failure
- Yellowing of the skin and/or eyes (jaundice), which are signs of liver
problems
- Chest pain
- Muscle weakness
- Impaired hearing
- tinnitus
- Malaise and fever
Very rare
- Reversible loss of hearing (usually with high doses)
- Convulsions and hallucinations
- Infantile hypertrophic pyloric stenosis (a severe stomach condition
affecting newborn babies)

The following side effects occur with unknown frequency:
- Hives, rash, itching
- Low blood pressure
- Swelling of the face, lips, mouth , tongue or throat which may cause
difficulty in swallowing or breathing (angioedema)
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 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.
5. HOW TO STORE ERYTHROMYCIN ETHYLSUCCINATE TABLETS
Keep this medicine out of the sight and reach of children
This medicine does not require any special storage conditions but it is best
to keep Erythromycin Ethylsuccinate tablets in the original blisters and box
in a dry place.
Do not use this medicine after the expiry date which is stated on the carton
and foil after EXP. The expiry date refers to the last day of the month.
Do not throw away any medicines via wastewater or household waste. Ask
your pharmacist how to throw away medicines you no longer use. These
measures will help protect the environment.
If your tablets become discoloured or show any other signs of deterioration,
consult your pharmacist who will tell you what to do.
6. CONTENTS OF THE PACK AND OTHER INFORMATION
What Erythromycin Ethylsuccinate tablets contain
The active ingredient is Erythromycin Ethylsuccinate
Each 500mg film-coated tablet contains 500mg of erythromycin equivalent
to approximately 587.3 mg Erythromycin Ethylsuccinate
The other ingredients are:
For the tablet core: Pregelatinised starch, Anhydrous calcium hydrogen
phosphate, Sodium starch glycolate Type A, Povidone K 30, Magnesium
stearate
For the tablet coating: Opadry Yellow 03G520008 (Hypromellose, Titanium
dioxide, Macrogol, Quinoline Yellow Aluminium Lake, Iron Oxide Yellow)
What Erythromycin Ethylsuccinate tablets look like and the contents
of the pack
Erythromycin Ethylsuccinate tablets are presented as yellow coloured oval
shaped film-coated tablets, debossed “K” on one side and plain on other
side.
Erythromycin Ethylsuccinate film-coated tablets are available in blister
packs of 10, 12, 14, 24, 28, 30, 56 and 84 tablets.
Not all pack sizes may be marketed
Marketing Authorization Holder
DAWA LIMITED
5, Sandridge Close,
Harrow, Middlesex
HA1 1XD
United Kingdom
Manufacturer
DRUGSRUS LIMITED
5, Sandridge Close,
Harrow, Middlesex
HA1 1XD
United Kingdom
This leaflet was last revised in 09/2014

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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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