Erythromycin Ethyl Succinate Granules For Oral Suspension 125 Mg/5 Ml
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Erythromycin Ethyl Succinate Granules for Oral Suspension 125mg/5ml Erythromycin Ethyl Succinate Granules for Oral Suspension 250mg/5ml Erythromycin Ethyl Succinate Granules for Oral Suspension 500mg/5ml
This medicine will be called Erythromycin Oral Suspension in this leaflet.
Read all of this leaflet carefully and keep it in case you want to read it again. Do not share medicines with other people.
If any of the side effects get serious, or if you have any other questions, speak to your doctor or pharmacist.
In this leaflet:
1. What Erythromycin Oral Suspension is and what it is used for
2. Before you take Erythromycin Oral Suspension
3. How to take Erythromycin Oral Suspension
4. Possible side effects
5. How to store Erythromycin Oral Suspension
6. Further information
1. What Erythromycin Oral Suspension is and what it is used for
This oral suspension is available in three different strengths. Each 5ml of oral suspension contains either 125mg, 250mg or 500mg of the active ingredient, erythromycin ethyl succinate. Erythromycin is one of a group of medicines called macrolide antibiotics. It is used to kill bacteria which cause infections in your body.
Erythromycin Oral Suspension is used to treat bacterial infections of the ear, eye, mouth, throat, chest/lungs, gastro-intestinal tract (stomach and intestines), skin, urinary tract (kidneys and bladder); also it can be used to treat some sexually transmitted diseases such as syphilis and gonorrhoea. It may also be used for other infections determined by your doctor.
2. Before you take Erythromycin Oral Suspension
Some people must not take this medicine.
Do not take this medicine if:
• you know you are allergic to erythromycin or to any of the other ingredients (these are listed in section 6)
• you suffer from porphyria
• you are taking medicines which can change your ECG (heart trace) such as disopyramide, quinidine (for heart problems), terfenadine, astemizole, mizolastine (antihistamine(s) used to treat allergies), amisulpride, quetiapine, sertindole (for schizophrenia), pimozide (for mental health problems), cisapride (for stomach disorders), clarithromycin (to treat infections)
• you are taking simvastatin (for high cholesterol)
• you are taking ergotamine, dihydroergotamine and methysergide (for migraine)
• you are taking tolterodine (for urine problems).
You must be especially careful if:
• you are pregnant or trying to become pregnant
• you are breastfeeding
• you suffer from any kidney or liver problems
• you are taking a medicine/supplement which is known to cause possible liver damage
• you suffer from myasthenia gravis (a muscle disorder)
• you have previously experienced diarrhoea following the use of antibiotics
you are giving this medicine to a young child and they vomit or become irritable when fed. If this occurs contact your doctor immediately.
If any of the conditions above apply to you, please discuss your treatment with your doctor before taking this medicine.
Taking other medicines
Erythromycin Oral Suspension and other medicines you may be taking may affect how each other work. Make sure your doctor knows if you are taking any of the following:
• theophylline (for asthma or breathing problems)
• cimetidine or omeprazole (for stomach ulcers)
• statins e.g. lovastatin (for cholesterol)
• alfentanil (an analgesic/sedative), midazolam or hexobarbital (sedatives)
• bromocriptine, cabergoline (for Parkinson’s disease)
• buspirone (for anxiety) or St John’s Wort (a herbal medicine for depression)
• carbamazepine, valproate, phenytoin or phenobarbitol (for epilepsy)
• ciclosporin, tacrolimus (used in organ transplants, treatment of eczema or psoriasis)
• cilostazol (for blood circulation problems)
• clozapine, amisulpride (for schizophrenia or other mental health problems)
• eletriptan (for migraines)
• felodipine or verapamil (for high blood pressure and chest pain)
• reboxetine (for depression)
• rifabutin (for tuberculosis)
• sildenafil or tadalafil (for erectile dysfunction)
• zopiclone or triazolam (for sleeping problems)
• artemether (for malaria)
• moxifloxacin (for sinus or breathing problems)
• methylprednisolone (for inflammatory or allergic disorders or for replacement therapy)
• warfarin or acenocoumarol (anticoagulants used to thin the blood)
• digoxin (for heart problems)
• any medicines to treat an irregular heart beat
• rifampicin, clindamycin, lincomycin, chloramphenicol, streptomycin, tetracyclines or colistin (to treat bacterial infections)
• medicines to treat fungal infections e.g. fluconazole, ketoconazole, itraconazole
• protease inhibitors e.g. saquinavir (to treat viral infections)
• vinblastine (for cancer)
• colchicine (for gout).
Always tell your doctor or pharmacist about all the medicines you are taking. This means medicines you have bought yourself as well as those you have on prescription from your doctor.
Other special warnings
• This medicine may interfere with the results of some laboratory tests. If you are going to have any tests tell the doctor or nurse you are taking this medicine.
• Each 5 ml contains approximately 13 mg of sodium; this should be taken into consideration by patients on a controlled sodium diet.
• The different strengths of this medicine contain the following amounts of sucrose: 125mg contains 2.815g; 250mg contains 2.589g and 500mg contains 2.043g. This should be taken into account in patients with diabetes mellitus. Also if you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
Pregnancy and breastfeeding
Check with your doctor before taking this medicine if you are pregnant or trying to become pregnant, or if you are breastfeeding.
Driving and using machinery
Erythromycin Oral Suspension should not affect your ability to drive or operate machinery.
3. How to take Erythromycin Oral Suspension
Shake the bottle well before use. Do not further dilute the prepared product.
For treating some infections the dose may be different to the usual dose given below. The dose for children will depend on the child’s weight. The doctor will decide what dose you or your child need to take. Always take the medicine exactly as the doctor has told you. The dose will be on the pharmacist’s label. If you are not sure, ask your doctor or pharmacist. Carry on taking the medicine for as long as you have been told unless you have any problems. In that case, check with your doctor.
The usual doses are as follows:
Adults and children over 8 years: For mild to moderate infections the usual dose is 2g a day, to be taken in divided doses.
In more severe infections this dose may be doubled by your doctor (up to 4g a day).
Children:
2 to 8 years: For mild to moderate infections the usual dose is 1g a day, to be given in divided doses. Infants and babies up to 2 years: For mild to moderate infections the usual dose is 500 mg a day to be given in divided doses. In more severe infections this dose may be doubled by your doctor.
It is important that you take your medicine at the right times of day. Space the doses out as evenly as possible throughout the day. Keep taking this medicine until your doctor tells you to stop. Do not stop taking it just because you feel better. If you stop taking the medicine, your condition may reoccur or get worse.
If you take more medicine than you should
You should contact your doctor or go to your nearest hospital casualty department immediately. Take the bottle with you so that the doctor knows what you have taken. If you take more of this medicine than your doctor has told you to it could cause hearing loss, nausea, vomiting and diarrhoea.
If you forget to take a dose of Erythromycin Oral Suspension
Take it as soon as you remember. Then carry on as before, unless it is nearly time for your next dose. Do not double the dose.
4. Possible side effects
Like all medicines, Erythromycin Oral Suspension can cause side effects, although not everybody gets them.
If you suffer from any of the following at any time while you are taking this medicine, STOP TAKING and seek IMMEDIATE medical help:
• a serious allergic reaction causing difficulty breathing, dizziness or swelling of the face or throat
• allergic skin reactions e.g. hives, rash, itching, redness, swelling, blistering or peeling or a serious illness with blistering of the skin, mouth, eyes and genitals
• abdominal pain, fever, or diarrhoea that sometimes contains blood (may be signs of inflammation of the colon)
• irregular heart beat, palpitations, fainting (these may be symptoms of torsades de pointes).
Tell your doctor straightaway if you notice any of the following effects:
• projectile vomiting in babies.
Other side effects which may occur are:
• effects on the heart such as chest pain, abnormal heart rhythm, or abnormal ECG heart tracing
• hepatitis or other liver problems (signs of this are yellowing of the skin and/or whites of the eyes, abdominal discomfort and loss of appetite)
• pancreatitis (inflammation of the pancreas which causes severe pain in the abdomen and back)
• temporary hearing loss or hearing disturbances (usually only after taking high doses), ringing in the ears
• feeling or being sick, diarrhoea, abdominal discomfort or pain, loss of appetite
• increase in number of eosinophils (white blood cells)
• hallucinations (seeing or hearing things that are not real)
• confusion, fits (seizures), a feeling of dizziness or spinning
• low blood pressure (symptoms include light-headedness, particularly on standing up, fainting and tiredness)
• inflammation of the kidneys which can cause swollen ankles or high blood pressure
• chest pain, fever, generally feeling unwell.
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 Oral Suspension
Keep out of the reach and sight of children.
Keep tightly closed and store in a refrigerator (2-8°C). Use within 14 days of preparation.
Do not use your medicine after the expiry date shown on the label.
If your doctor tells you to stop taking the medicine, please take any unused medicine back to your pharmacist to be destroyed.
6. Further Information Ingredients
Each 5ml of medicine contains either 125 mg, 250 mg or 500 mg of the active ingredient, Erythromycin Ethyl Succinate. The other ingredients are Carboxymethylcellulose Sodium, Sodium Citrate, Banana Flavour, Quinoline Yellow E104, Sodium Saccharin, Colloidal Anhydrous Silica and Sucrose.
What the medicine looks like
The medicine is a yellow coloured suspension. This bottle contains 100ml of medicine.
Product licence holder and manufacturer
The Product Licence Holder is Medreich PLC, Warwick House, Plane Tree Cresent, Feltham, TW13 7HF.
Product Licence Numbers:
PL 21880/0164 PL 21880/0165 PL 21880/0166
Date leaflet prepared: October 2013.
If you would like this leaflet in a different format, please contact the licence holder at the above address.