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ERYTHROCIN 250 MG TABLETS

Active substance(s): ERYTHROMYCIN

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Erythrocin® 250 mg Tablets

2983
14.08.17[2]

(erythromycin stearate)
PATIENT INFORMATION LEAFLET
Read all of this leaflet carefully before you start taking this medicine.
- Please 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 becomes severe, or if you notice any side effects
not listed in this leaflet, please tell your doctor or pharmacist.
Your medicine is available using the above name but will be referred to as
Erythrocin throughout the leaflet.
In this leaflet:
1. What Erythrocin is and what it is used for
2. Before you take Erythrocin
3. How to take Erythrocin
4. Possible side effects
5. How to store Erythrocin
6. Further information
1. WHAT ERYTHROCIN IS AND WHAT IT IS USED FOR
Erythrocin contains the active ingredient erythromycin which belongs to a
group of medicines called macrolide antibiotics.
Erythrocin is used to prevent and treat infections such as:
- Throat and sinus infections
- Chest infections, such as bronchitis and pneumonia
- Ear infections
- Mouth and dental infections
- Eye infections
- Skin and tissue infections, such as acne
- Stomach and intestinal infections
- Prevention of infection following burns, operations or dental procedures
- Other infections, such as sexually transmitted diseases, bone infections or
scarlet fever
2. BEFORE YOU TAKE ERYTHROCIN
You should not receive Erythrocin if you:
- have been told that you are allergic to erythromycin or other macrolide
antibiotics such as clarithromycin or azithromycin or any of the other
ingredients in these tablets;
- are currently taking a medicine called
- are taking ergotamine or dihydroergotamine (used to treat migraines)
while taking erythromycin as this may cause serious side effects;
- are taking terfenadine or astemizole or mizolastine (widely taken for
hayfever and allergies), domperidone (for nausea (feeling sick) and
vomiting (being sick)), cisapride (for stomach disorders) or pimozide or
amisulpride (for psychiatric conditions) while receiving erythromycin, as
combining these drugs can sometimes cause serious disturbances in
heart rhythm. Consult your doctor for advice on alternative medicines
you can take instead;
- simvastatin (used to lower cholesterol and triglycerides (types of fat) in
the blood);
- tolterodine (used for treating overactive bladder with symptoms of
urinary frequency, urgency, and leakage);
- are taking colchicine (used for treatment of gout and arthritis) whilst taking
erythromycin as this may cause serious side effects;
- have any liver problems or have been told that any drugs you are taking
can cause liver problems;
- have previously experienced diarrhoea following the use of antibiotics;
- are pregnant and have been told that you have a sexually transmitted
disease called syphilis. In this case erythromycin may not be effective for
preventing the transfer of this infection to your baby. Consult your doctor
before receiving erythromycin. Alternatively, if you were treated for early
stages of syphilis during your pregnancy, and your child is under 1 year
and is prescribed erythromycin, consult your doctor before giving
erythromycin to your child;
- are treating a young child with antibiotics and they are irritable or vomit
when fed, you should contact your physician immediately;
- suffer from a condition called myasthenia gravis, which causes muscle
weakness, consult your doctor before receiving erythromycin;
- are taking erythromycin with ‘statins’ such as simvastatin or lovastatin
(used to lower cholesterol) as serious side effects can occur.
If any of these apply to you, or if you are not sure, tell your doctor.

Taking other medicines
Please tell your doctor if you are taking, or have recently taken any other
medicines, including any medicines obtained without a prescription.
This is especially important if you are taking medicines from the following
families:
- astemizole, terfenadine or mizolastine (used to treat allergies such as
hayfever);
- domperidone (used to treat nausea (feeling sick) and vomiting (being
sick));
- pimozide (used to treat mental problems);
- ergotamine or dihydroergotamine (used to relieve migraine);
- cisapride (used to treat stomach disorders);
- statins (used to help lower cholesterol levels e.g. lovastatin and
simvastatin);
- protease inhibitors (used to treat viral infections e.g. saquinavir);
- 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 reflux and other related
conditions);
- clarithromycin, rifabutin, or rifampicin (medicines used to treat different
types of bacterial infection);
- fluconazole, ketoconazole and itraconazole (medicines used to treat
fungal infections);
- digoxin, quinidine or disopyramide (used to treat heart problems);
- cilostazol (a medicine used to treat peripheral circulation problems);
- hexobarbitone, phenobarbital or midazolam (used as sedatives);
- warfarin and acenocoumarol (used to help thin the blood);
- valproate, carbamazepine or phenytoin (used to control epilepsy);
- theophylline (used to treat asthma and other breathing problems);
- ciclosporin or tacrolimus (used following organ transplants);
- 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 treat depression);
- verapamil (used to treat high blood pressure and chest pain);
- vinblastine (used to treat certain types of cancer);
- sildenafil (used to treat erectile dysfunction).
If you or your child goes for any medical tests, tell your doctor that you are
taking Erythrocin, as this may interfere with some test results.
Pregnancy and breast-feeding
Erythromycin should be used by women during pregnancy only if clearly
needed.
If you are pregnant or think you may be pregnant, or if you are breastfeeding, please consult your doctor before taking this medicine.
3. HOW TO TAKE ERYTHROCIN
Always take Erythrocin exactly as your doctor has told you. You should
check with your doctor if you are not sure.
The usual dose of Erythrocin for adults and children over 8 years is:
1-2 g daily in divided doses i.e. four to eight 250 mg tablets daily or two to
four 500 mg tablets daily, taken just before or with meals or food. If you
have a bad infection you may be told to take up to 4 g 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.
If you take more Erythrocin than you should
If you accidentally take more medicine in one day than your doctor has told
you to, or if a child has taken some of the medicine by mistake, contact your
doctor or go to your nearest hospital emergency department immediately.
An overdose of Erythrocin could cause temporary hearing loss, nausea,
vomiting and diarrhoea.
If you forget to take Erythrocin
If you forget to take a dose of your medicine, take it as soon as you
remember. Do not take more medicine in one day than your doctor tells you
to.
If you have any further questions on the use of this product ask your doctor
or pharmacist.

4. POSSIBLE SIDE EFFECTS
Like all medicines, Erythrocin can cause side effects, although not
everybody gets them.
If you notice any of the following, contact your doctor immediately:
- difficulty breathing;
- fainting;
- swelling of the face, lips or throat;
- skin rashes;
- severe skin reactions including large fluid-filled blisters, sores and ulcers;
- ulcers in the mouth and throat, as these may be signs of an allergic
reaction.
Other side effects of Erythrocin include:
- 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 (eosinophilia);
- stomach pains; these may be a symptom of an inflamed pancreas
(pancreatitis);
- ringing in the ears (tinnitus);
- reversible loss of hearing (usually associated with high doses or in
patients with kidney problems);
- 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);
- fever;
- anorexia;
- confusion;
- fits (seizures);
- vertigo (problems with balance that can result in feelings of dizziness or
sickness – particularly on standing);
- hallucinations (seeing or hearing things that aren’t there);
- feeling generally unwell (malaise);
- inflammation of the kidneys (a condition known as interstitial nephritis);
- 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).
If any of the side effects becomes severe, or if you notice any side effects
not listed in this leaflet, please tell your doctor or pharmacist.
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 ERYTHROCIN
Keep out of the sight and reach of children
Do not store above 25°C.
Store in the original package in order to protect from light.
If the tablets become discoloured or show any other signs of deterioration,
consult your pharmacist who will tell you what to do.
Do not use these tablets after the expiry date shown on the label. The expiry
date refers to the last day of that month.
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 Erythrocin contains
Each film-coated tablet contains 250 mg erythromycin as erythromycin
stearate.
Other ingredients include: hydroxypropyl methyl cellulose (E646), maize
starch, povidone (E1201), magnesium hydroxide (E528), polyethylene glycol
6000, polyethylene glycol 400, benzalkonium chloride, amberlite IRP 88.
What Erythrocin look like and the contents of the pack
Erythrocin are white, elongated, oval, film-coated tablet with company
symbol on one side and plain on reverse side.
Available in containers of 100 tablets.
Manufacturer and Product Licence holder
Manufactured by Aesica Queenborough Limited., Queenborough, Kent
ME11 5EL. UK and Procured from the EU by Product Licence holder:
Star Pharmaceuticals Ltd., 5 Sandridge Close, Harrow, Middlesex HA1 1XD.
Repackaged by Servipharm Ltd.
POM

PL 20636/2983

Leaflet revision and issue date (Ref.) 14.08.17[2]
Erythrocin is trademark of Amdipharm International Limited.

Blind or partially sighted?
Is this leaflet hard to see or read?
Call 020 8423 2111 to obtain the
leaflet in a format suitable for you.

Erythromycin 250 mg Tablets

2983
14.08.17[2]

(erythromycin stearate)
PATIENT INFORMATION LEAFLET
Read all of this leaflet carefully before you start taking this medicine.
- Please 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 becomes severe, or if you notice any side effects
not listed in this leaflet, please tell your doctor or pharmacist.
Your medicine is available using the above name but will be referred to as
Erythromycin throughout the leaflet.
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 contains the active ingredient erythromycin which belongs to a
group of medicines called macrolide antibiotics.
Erythromycin is used to prevent and treat infections such as:
- Throat and sinus infections
- Chest infections, such as bronchitis and pneumonia
- Ear infections
- Mouth and dental infections
- Eye infections
- Skin and tissue infections, such as acne
- Stomach and intestinal infections
- Prevention of infection following burns, operations or dental procedures
- Other infections, such as sexually transmitted diseases, bone infections or
scarlet fever
2. BEFORE YOU TAKE ERYTHROMYCIN
You should not receive Erythromycin if you:
- have been told that you are allergic to erythromycin or other macrolide
antibiotics such as clarithromycin or azithromycin or any of the other
ingredients in these tablets;
- are currently taking a medicine called
- are taking ergotamine or dihydroergotamine (used to treat migraines)
while taking erythromycin as this may cause serious side effects;
- are taking terfenadine or astemizole or mizolastine (widely taken for
hayfever and allergies), domperidone (for nausea (feeling sick) and
vomiting (being sick)), cisapride (for stomach disorders) or pimozide or
amisulpride (for psychiatric conditions) while receiving erythromycin, as
combining these drugs can sometimes cause serious disturbances in
heart rhythm. Consult your doctor for advice on alternative medicines
you can take instead;
- simvastatin (used to lower cholesterol and triglycerides (types of fat) in
the blood);
- tolterodine (used for treating overactive bladder with symptoms of
urinary frequency, urgency, and leakage);
- are taking colchicine (used for treatment of gout and arthritis) whilst taking
erythromycin as this may cause serious side effects;
- have any liver problems or have been told that any drugs you are taking
can cause liver problems;
- have previously experienced diarrhoea following the use of antibiotics;
- are pregnant and have been told that you have a sexually transmitted
disease called syphilis. In this case erythromycin may not be effective for
preventing the transfer of this infection to your baby. Consult your doctor
before receiving erythromycin. Alternatively, if you were treated for early
stages of syphilis during your pregnancy, and your child is under 1 year
and is prescribed erythromycin, consult your doctor before giving
erythromycin to your child;
- are treating a young child with antibiotics and they are irritable or vomit
when fed, you should contact your physician immediately;
- suffer from a condition called myasthenia gravis, which causes muscle
weakness, consult your doctor before receiving erythromycin;
- are taking erythromycin with ‘statins’ such as simvastatin or lovastatin
(used to lower cholesterol) as serious side effects can occur.
If any of these apply to you, or if you are not sure, tell your doctor.

Taking other medicines
Please tell your doctor if you are taking, or have recently taken any other
medicines, including any medicines obtained without a prescription.
This is especially important if you are taking medicines from the following
families:
- astemizole, terfenadine or mizolastine (used to treat allergies such as
hayfever);
- domperidone (used to treat nausea (feeling sick) and vomiting (being
sick));
- pimozide (used to treat mental problems);
- ergotamine or dihydroergotamine (used to relieve migraine);
- cisapride (used to treat stomach disorders);
- statins (used to help lower cholesterol levels e.g. lovastatin and
simvastatin);
- protease inhibitors (used to treat viral infections e.g. saquinavir);
- 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 reflux and other related
conditions);
- clarithromycin, rifabutin, or rifampicin (medicines used to treat different
types of bacterial infection);
- fluconazole, ketoconazole and itraconazole (medicines used to treat
fungal infections);
- digoxin, quinidine or disopyramide (used to treat heart problems);
- cilostazol (a medicine used to treat peripheral circulation problems);
- hexobarbitone, phenobarbital or midazolam (used as sedatives);
- warfarin and acenocoumarol (used to help thin the blood);
- valproate, carbamazepine or phenytoin (used to control epilepsy);
- theophylline (used to treat asthma and other breathing problems);
- ciclosporin or tacrolimus (used following organ transplants);
- 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 treat depression);
- verapamil (used to treat high blood pressure and chest pain);
- vinblastine (used to treat certain types of cancer);
- sildenafil (used to treat erectile dysfunction).
If you or your child goes for any medical tests, tell your doctor that you are
taking Erythromycin, as this may interfere with some test results.
Pregnancy and breast-feeding
Erythromycin should be used by women during pregnancy only if clearly
needed.
If you are pregnant or think you may be pregnant, or if you are breastfeeding, please consult 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 if you are not sure.
The usual dose of Erythromycin for adults and children over 8 years is:
1-2 g daily in divided doses i.e. four to eight 250 mg tablets daily or two to
four 500 mg tablets daily, taken just before or with meals or food. If you
have a bad infection you may be told to take up to 4 g 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.
If you take more Erythromycin than you should
If you accidentally take more medicine in one day than your doctor has told
you to, or if a child has taken some of the medicine by mistake, contact your
doctor or go to your nearest hospital emergency department immediately.
An overdose of Erythromycin could cause temporary hearing loss, nausea,
vomiting and diarrhoea.
If you forget to take Erythromycin
If you forget to take a dose of your medicine, take it as soon as you
remember. Do not take more medicine in one day than your doctor tells you
to.
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 can cause side effects, although not
everybody gets them.
If you notice any of the following, contact your doctor immediately:
- difficulty breathing;
- fainting;
- swelling of the face, lips or throat;
- skin rashes;
- severe skin reactions including large fluid-filled blisters, sores and ulcers;
- ulcers in the mouth and throat, as these may be signs of an allergic
reaction.
Other side effects of Erythromycin include:
- 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 (eosinophilia);
- stomach pains; these may be a symptom of an inflamed pancreas
(pancreatitis);
- ringing in the ears (tinnitus);
- reversible loss of hearing (usually associated with high doses or in
patients with kidney problems);
- 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);
- fever;
- anorexia;
- confusion;
- fits (seizures);
- vertigo (problems with balance that can result in feelings of dizziness or
sickness – particularly on standing);
- hallucinations (seeing or hearing things that aren’t there);
- feeling generally unwell (malaise);
- inflammation of the kidneys (a condition known as interstitial nephritis);
- 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).
If any of the side effects becomes severe, or if you notice any side effects
not listed in this leaflet, please tell your doctor or pharmacist.
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
Keep out of the sight and reach of children
Do not store above 25°C.
Store in the original package in order to protect from light.
If the tablets become discoloured or show any other signs of deterioration,
consult your pharmacist who will tell you what to do.
Do not use these tablets after the expiry date shown on the label. The expiry
date refers to the last day of that month.
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
Each film-coated tablet contains 250 mg erythromycin as erythromycin
stearate.
Other ingredients include: hydroxypropyl methyl cellulose (E646), maize
starch, povidone (E1201), magnesium hydroxide (E528), polyethylene glycol
6000, polyethylene glycol 400, benzalkonium chloride, amberlite IRP 88.
What Erythromycin look like and the contents of the pack
Erythromycin are white, elongated, oval, film-coated tablet with company
symbol on one side and plain on reverse side.
Available in containers of 100 tablets.
Manufacturer and Product Licence holder
Manufactured by Aesica Queenborough Limited., Queenborough, Kent
ME11 5EL. UK and Procured from the EU by Product Licence holder:
Star Pharmaceuticals Ltd., 5 Sandridge Close, Harrow, Middlesex HA1 1XD.
Repackaged by Servipharm Ltd.
POM

PL 20636/2983

Leaflet revision and issue date (Ref.) 14.08.17[2]

Blind or partially sighted?
Is this leaflet hard to see or read?
Call 020 8423 2111 to obtain the
leaflet in a format suitable for you.

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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