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Erythromycin Stearate Bp 500mg

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PATIENT INFORMATION LEAFLET ON 57367	0\|
102532-33/LF/l	0\|
ERYTHROCIN® TABLETS	AMDIPHARM *5
(Erythromycin)
Read all of this leaflet carefully before you start	you were treated for early stages of syphilis during your
taking this medicine.	pregnancy, and your child is under 1 year and is
- Please keep this leaflet. You may need to read it	prescribed erthyromycin, consult your doctor before
again.	giving erythromycin to your child.
- If you have any further questions, ask your doctor or	* are treating a young child with antibiotics and they are
pharmacist.	irritable or vomit when fed, you should contact your
- This medicine has been prescribed lor you. Do not pass	physician immediately.
it on to others. It may harm them, even if their	* suffer from a condition called myasthenia gravis, which
symptoms are the same as yours.	causes muscle weakness, consult your doctor before
- If any of the side effects becomes severe, or if you notice any side effects not listed in this leaflet, please	receiving erythromycin.
	* are taking erythromycin with 'statins' such as simvastatin
tell your doctor or pharmacist.	or lovastatin (used to lower cholesterol) as serious side
In this leaflet: 1. What Erythrocin® Tablets are and what they are	effects can occur. If any of these apply to you, or if you are not sure, tell your
used for	doctor.
2. Before you take Erythrocin® Tablets 3. How to take Erythrocin® Tablets	Taking other medicines
4. Possible side effects	Please tell your doctor if you are taking, or have recently
5. How to store Erythrocin® Tablets	taken any other medicines, including any medicines obtained
6. Further information	without a prescription.
1. WHAT ERYTHROCIN® TABLETS ARE AND WHAT	This is especially important if you are taking medicines from
THEY ARE USED FOR	the following families:
The name of your medicine is Erythrocin® Tablets.	* astemizole, terfenadine or mizolastine (used to treat
Erythrocin® contains the active ingredient erythromycin	allergies such as hayfever);
which belongs to a group of medicines called macrolide	• pimozide (used to treat mental problems);
antibiotics.	* ergotamine or dihydroergotamine (used to relieve
Erythrocin® Tablets are used to prevent and treat infections	migraine);
such as:	* cisapride (used to treat stomach disorders);
• Throat and sinus infections	* statins (used to help lower cholesterol levels
■ Chest infections, such as bronchitis and pneumonia	e.g. lovastatin and simvastatin);
* Ear infections	* protease inhibitors (used to treat viral infections
• Mouth and dental infections	e.g. saquinavir);
* Eye infections	* oral contraceptives.
• Skin and tissue infections, such as acne * Stomach and intestinal infections	This is also important if you are taking medicines called:
• Prevention of infection following burns, operations or	* colchicine (used to treat gout and arthritis);
dental procedures	• cimetidine and omeprazole (used to treat acid reflux and
• Other infections, such as sexually transmitted diseases,	other related conditions);
bone infections or scarlet fever	• clarithromycin, rifabutin, or rifampicin (medicines used
2. BEFORE YOU TAKE ERYTHROCIN	to treat different types of bacterial infection); * fluconazole, ketoconazole and itraconazole (medicines
You should not receive Erythrocin Tablets if you:	used to treat fungal infections);
• have been told that you are allergic to erythromycin or	* digoxin, quinidine or disopyramide (used to treat heart
other macrolide antibiotics such as clarithromycin or	problems);
azithromycin or any of the other ingredients in these	• cilostazol (a medicine used to treat peripheral circulation
tablets.	problems);
* are currently taking a medicine called	* hexobarbitone, phenobarbital or midazolam (used as
- are taking ergotamine or dihydroergotamine	sedatives);
(used to treat migraines) while taking	* warfarin and acenocoumarol (used to help thin the
erythromycin as this may cause serious side effects.	blood);
- are taking terfenadine or astemizole (widely taken	* valproate, carbamazepine or phenytoin (used to control
for hayfever and allergies), cisapride (for stomach	epilepsy); * theophylline (used to treat asthma and other breathing
disorders) or pimozide (for psychiatric conditions)
while receiving erythromycin, as combining these	problems);
drugs can sometimes cause serious disturbances in	* cidosporin or tacrolimus (used following organ
heart rhythm. Consult your doctor for advice on	transplants);
alternative medicines you can take instead.	* bromocriptine (used to treat Parkinson's disease);
• are taking colchicine (used for treatment of gout and	* zopidone or triazolam/alprazolam (used to help you
arthritis) whilst taking erythromycin as this may cause	sleep or relieve states of anxiety);
serious side effects.	* alfentanil (a medicine used to provide pain relief);
* have any liver problems or have been told that any	* - methylprednisolone (used to help suppress the body's
drugs you are taking can cause liver problems	immune system - this is useful in treating a wide range
• have previously experienced diarrhoea following the	of conditions);
use of antibiotics;	* St John's Wort (a herbal medicine used to treat
* are pregnant and have been told that you have a	depression);
sexually transmitted disease called syphilis. In this case	* verapamil (used to treat high blood pressure and chest
erythromycin may not be effective for preventing the	pain);
transfer of this infection to your baby. Consult your	• vinblastine (used to treat certain types of cancer);
doctor before receiving erythromycin. Alternatively if	* sildenafil (used to treat erectile dysfunction).

	0 AMDIPHARM
PRODUCT NAME:	ERYTHROCIN TAB 250 &
PIP CODE:	500mg 102532-33/LF/1
COMPONENT:	Leaflet
SIZE:	278 x 140 mm
MARKET:	GB
COMMODITY NO.:	TBC
PRODUCT SITE:	TBC
SCALE:	100*
COLOURS:	Black &
DATE:	10/12/2013
FONT SIZE:	9 pt
VERSION NO:	1
AMENDED BY:	AMCo
PROJECT:	CAC

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PAGE 1 OF 2

If you or your child goes lor 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 breast-feeding, please consult your doctor before taking this medicine.

3. HOW TO TAKE ERYTHROCIN® TABLETS

Always take Erythrocin® Tablets exactly as your doctor has told you. You should check with your doctor if you are not sure.

The usual dose of Erythrocin® Tablets 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® Tablets 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;

AMDIPHARM

* 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 multiferme).

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.

5. HOW TO STORE ERYTHROCIN® TABLETS

Do not store above 25°C. Store in the original package.

Do not use these tablets after the expiry date shown on the blister/label. The expiry date refers to the last day of that month.

KEEP OUT OF THE REACH AND SIGHT OF CHILDREN

Medicines should not be disposed of via waste water 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 Eiythrocin® Tablets contain

Each Erythrocin® 250 tablet contains 250 mg of the active ingredient erythromycin.

Each Erythrocin® 500 tablet contains 500 mg of the active ingredient erythromycin.

The other ingredients are: hydroxypropyl methyl cellulose, maize starch, povidone, magnesium hydroxide, sorbic acid, polyethylene glycol and polacrilin potassium.

What Erythrocin® Tablets look like and the contents of the pack

Erythrocin® tablets are white.

The Erythrocin® 250 tablets are available in containers of

50.100 or 1000 tablets, or blister packs of 28 tablets.

The Erythrocin® 500 tablets are available in containers of

50.100 or 1000 tablets, or blister packs of 10,14,15,28 or 56 tablets.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:

Amdipharm UK Limited,

Capital House,

85 King William Street,

London EC4N 7BL, UK

Manufacturer:

Aesica Queenborough Limited,

Queenborough,

Kent ME11 5EL.

This leaflet applies only to Erythrocin® and This leaflet was last revised in December 2013.

Erythrocin® is a Registered Trademark.

	0 AMDIPHARM
PRODUCT NAME:	ERYTHROCIN TAB 250 &
PIP CODE:	500mg 102532-33/LF/1
COMPONENT:	Leaflet
SIZE:	278 x 140 mm
MARKET:	GB
COMMODITY NO.:	TBC
PRODUCT SITE:	TBC
SCALE:	100%
COLOURS:	Black &
DATE:	10/12/2013
FONT SIZE:	9 pt
VERSION NO:	1
AMENDED BY:	AMCo
PROJECT:	CAC