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S669 LEAFLET Erythroped A 20131223

PACKAGE LEAFLET: INFORMATION FOR THE USER ERYTHROPED A 500mg TABLETS (erythromycin ethylsuccinate)

Your medicine is known as Erythroped A 500mg Tablets but will be referred to as Erythroped A Tablets throughout the following 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.

In this leaflet:

1.    What Erythroped A Tablets are and what they are used for.

2.    Before you take Erythroped A Tablets.

3.    How to take Erythroped A Tablets.

4.    Possible side effects.

5.    How to store Erythroped A Tablets.

6.    Further information.

1. WHAT ERYTHROPED A TABLETS ARE AND WHAT THEY ARE USED FOR

The name of your medicine is Erythroped A Tablets. Erythroped A Tablets contain the active ingredient erythromycin ethylsuccinate, which belongs to a group of medicines called macrolide antibiotics.

Erythroped A Tablets are 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 ERYTHROPED A TABLETS

Do not take Erythroped A Tablets if you:

•    have been told that you are allergic to erythromycin or any of the other ingredients of Erythroped A Tablets.

•    are currently taking a medicine called

-    astemizole or terfenadine (used to treat allergies such as hay fever)

-    pimozide (used to treat mental problems)

-    ergotamine or dihydroergotamine (used to relieve migraine)

-    cisapride (used to treat acid reflux)

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 called:

•    astemizole, terfenadine or mizolastine (used to treat allergies such as hay fever),

•    pimozide (used to treat mental problems),

• clarithromycin (an antibiotic),

• cisapride (used to treat acid reflux),

•    ergotamine or dihydroergotamine (used to relieve migraine),

•    digoxin or disopyramide 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 (used to treat asthma and other breathing problems),

•    ciclosporin or tacrolimus (used following organ transplants),

•    bromocriptine (used to treat Parkinson's disease),

•    alfentanil, zopiclone or triazolam (used to help you sleep),

•    rifabutin (used to treat tuberculosis (TB)),

•    lovastatin (used to control cholesterol levels).

If you or your child goes for any medical tests, tell your doctor that you are taking Erythroped A Tablets, as this may interfere with some test results.

Pregnancy and breast-feeding

If you are pregnant or think you may be pregnant, or if you are breast-feeding please consult your doctor before taking this medicine.

3. HOW TO TAKE ERYTHROPED A TABLETS

Always take Erythroped A Tablets exactly as your doctor has told you.

You should check with your doctor if you are not sure.

The usual dose for adults and children over 8 years is:

2 g daily in divided doses i.e. two tablets twice a day, 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.

If you take more Erythroped A Tablets 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 Erythroped A Tablets could cause temporary hearing loss, nausea, vomiting and diarrhoea.

If you forget to take Erythroped A Tablets

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.

Take special care with Erythroped A tablets if you:

•    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.

Like all medicines, Erythroped A Tablets can cause side effects, although not everybody gets them.

If you notice any of the following, stop taking Erythroped A Tablets and 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.

If you develop severe or prolonged diarrhoea during or after taking Erythroped A Tablets, tell your doctor immediately.

Other side effects of Erythroped A Tablets include:

•    Feeling sick or being sick

•    Stomach pains

•    Reversible loss of hearing (usually with high doses)

•    Damage to the blood, kidneys or nervous systems.

•    Yellowing of the skin and/or eyes, which are signs of liver problems including jaundice

•    Chest pain

•    Dizziness

•    Abnormal heart rhythm

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.

   KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.

•    Do not store above 25°C.

• Store in the original package to protect from light and moisture.

• Do not use after the expiry date printed on the carton label or blister strip.

•    If your doctor tells you to stop using the medicine, please take it back to the pharmacist for safe disposal. Only keep the medicine if your doctor tells you to.

•    If the medicine becomes discoloured or shows any other signs of deterioration, you should seek the advice of your pharmacist who will tell you what to do.

6. FURTHER INFORMATION

What Erythroped A Tablet contains

•    Each film-coated tablet contains 500mg of erythromycin (as erythromycin ethylsuccinate),

•    Erythroped A Tablets also contain the following inactive ingredients: calcium hydrogen phosphate (E341), sodium starch glycollate, maize starch, povidone (E1201), magnesium stearate (E470B), hypromellose (E464), macrogol 400, macrogol 8000, titanium dioxide (E171) and sorbic acid (E200).

What Erythroped A Tablet looks like and contents of the pack

Erythroped A tablets are oval, white tablet marked with the

company logo on one side and plain on the other.

Erythroped A Tablets are available as blister packs of 28 tablets.

Product Licence holder

Procured from within the EU and repackaged by the Product

Licence holder: S&M Medical Ltd, Chemilines House,

Alperton Lane, Wembley, HA0 1 DX.

Manufacturer

This product is manufactured by either:

•    Amdipharm Limited, Temple Chambers, 3 Burlington Road, Dublin 4, Ireland or

•    Aesica Queenborough Ltd., Queenborough Kent,

ME11 5EL, United Kingdom.

|POM | PL No: 19488/0669 Erythroped A Tablets

Leaflet revision date: 23 December 2013

Erythroped is a registered trade mark of Abbott Laboratories, USA.

S669 LEAFLET Erythroped A 20131223

S669 LEAFLET Erythromycin 20131223

PACKAGE LEAFLET: INFORMATION FOR THE USER ERYTHROMYCIN 500mg TABLETS (erythromycin ethylsuccinate)

Your medicine is known as Erythromycin 500mg Tablets but will be referred to as Erythromycin Tablets throughout the following 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.

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.

1. WHAT ERYTHROMYCIN TABLETS ARE AND WHAT THEY ARE USED FOR

The name of your medicine is Erythromycin Tablets. Erythromycin Tablets contain the active ingredient erythromycin ethylsuccinate, which belongs to a group of medicines called macrolide antibiotics. Erythromycin Tablets are 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 TABLETS

Do not take Erythromycin Tablets if you:

•    have been told that you are allergic to erythromycin or any of the other ingredients of Erythromycin Tablets.

•    are currently taking a medicine called

-    astemizole or terfenadine (used to treat allergies such as hay fever)

-    pimozide (used to treat mental problems)

-    ergotamine or dihydroergotamine (used to relieve migraine)

-    cisapride (used to treat acid reflux)

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 called:

•    astemizole, terfenadine or mizolastine (used to treat allergies such as hay fever),

•    pimozide (used to treat mental problems),

• clarithromycin (an antibiotic),

• cisapride (used to treat acid reflux),

•    ergotamine or dihydroergotamine (used to relieve migraine),

•    digoxin or disopyramide 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 (used to treat asthma and other breathing problems),

•    ciclosporin or tacrolimus (used following organ transplants),

•    bromocriptine (used to treat Parkinson's disease),

•    alfentanil, zopiclone or triazolam (used to help you sleep),

•    rifabutin (used to treat tuberculosis (TB)),

•    lovastatin (used to control cholesterol levels).

If you or your child goes for any medical tests, tell your doctor that you are taking Erythromycin Tablets, as this may interfere with some test results.

Pregnancy and breast-feeding

If you are pregnant or think you may be pregnant, or if you are breast-feeding please consult your doctor before taking this medicine.

3. HOW TO TAKE ERYTHROMYCIN TABLETS

Always take Erythromycin Tablets exactly as your doctor has told you.

You should check with your doctor if you are not sure.

The usual dose for adults and children over 8 years is:

2 g daily in divided doses i.e. two tablets twice a day, 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.

If you take more Erythromycin Tablets 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 Tablets could cause temporary hearing loss, nausea, vomiting and diarrhoea.

If you forget to take Erythromycin Tablets

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.

Take special care with Erythromycin tablets if you:

•    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.

Like all medicines, Erythromycin Tablets can cause side effects, although not everybody gets them.

If you notice any of the following, stop taking Erythromycin Tablets and 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.

If you develop severe or prolonged diarrhoea during or after taking Erythromycin Tablets, tell your doctor immediately.

Other side effects of Erythromycin Tablets include:

•    Feeling sick or being sick

•    Stomach pains

•    Reversible loss of hearing (usually with high doses)

•    Damage to the blood, kidneys or nervous systems.

•    Yellowing of the skin and/or eyes, which are signs of liver problems including jaundice

•    Chest pain

•    Dizziness

•    Abnormal heart rhythm

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.

   KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.

•    Do not store above 25°C.

• Store in the original package to protect from light and moisture.

• Do not use after the expiry date printed on the carton label or blister strip.

•    If your doctor tells you to stop using the medicine, please take it back to the pharmacist for safe disposal. Only keep the medicine if your doctor tells you to.

•    If the medicine becomes discoloured or shows any other signs of deterioration, you should seek the advice of your pharmacist who will tell you what to do.

6. FURTHER INFORMATION

What Erythromycin Tablet contains

•    Each film-coated tablet contains 500mg of erythromycin (as erythromycin ethylsuccinate),

•    Erythromycin Tablets also contain the following inactive ingredients: calcium hydrogen phosphate (E341), sodium starch glycollate, maize starch, povidone (E1201), magnesium stearate (E470B), hypromellose (E464), macrogol 400, macrogol 8000, titanium dioxide (E171) and sorbic acid (E200).

What Erythromycin Tablet looks like and contents of the pack

Erythromycin tablets are oval, white tablet marked with the

company logo on one side and plain on the other.

Erythromycin Tablets are available as blister packs of 28 tablets.

Product Licence holder

Procured from within the EU and repackaged by the Product

Licence holder: S&M Medical Ltd, Chemilines House,

Alperton Lane, Wembley, HA0 1 DX.

Manufacturer

This product is manufactured by either:

•    Amdipharm Limited, Temple Chambers, 3 Burlington Road, Dublin 4, Ireland or

•    Aesica Queenborough Ltd., Queenborough Kent,

ME11 5EL, United Kingdom.

|POM | PL No: 19488/0669 Erythromycin Tablets

Leaflet revision date: 23 December 2013

S669 LEAFLET Erythromycin 20131223