E-MYCIN® Erythromycin Ethylsuccinate Tablets, Film Coated 400 Mg Granules for Oral Suspension 200 Mg Per 5 Ml and 400 Mg Per 5 Ml

NEW ZEALAND CONSUMER MEDICINE INFORMATION E-MYCIN® Erythromycin ethylsuccinate Tablets, Film Coated 400 mg Granules for Oral Suspension 200 mg per 5 mL and 400 mg per 5 mL

Ask your doctor if you have any Medicines which can cause heart What is in this leaflet questions about why this muscle to take longer than normal medicine has been prescribed for to recharge between beats Please read this leaflet carefully you. (prolongation of the QT interval) before you start taking E-Mycin. Your doctor may have prescribed it such as: This leaflet answers some common for another reason. questions about E-Mycin.  some medicines used to There is no evidence that E-Mycin manage psychosis mainly It does not contain all the available is addictive. in schizophrenia and bipolar information. It does not take the disorder place of talking to your doctor or E-Mycin is available only with a  some tri- and tetracyclic pharmacist. doctor's prescription. antidepressants  some fluroquinolones (a All medicines have risks and type of antibiotic) benefits. Your doctor has weighed Before you take  imidazole antifungal the risks of you taking E-Mycin E-Mycin medicines against the benefits they expect it  some medicines used to will have for you. prevent or treat malaria When you must not take it:  arsenic trioxide, methadone If you have any concerns about Do not take E-Mycin if you have and budipine taking this medicine, ask your an allergy to: doctor or pharmacist. Taking E-Mycin with any of the  medicines containing medicines above may cause Keep this leaflet with the erythromycin or any other serious side effects. medicine. You may need to read it antibiotic from the again. macrolide group Do not take E-Mycin if you have:  any of the ingredients listed at the end of this leaflet.  severe liver disease What E-Mycin is  heart rhythm disorders Some of the symptoms of an from birth or have used for allergic reaction may include: developed it shortness of breath; wheezing or  irregular heartbeat or E-Mycin is used to: difficulty breathing; swelling of the severe chronic heart failure face, lips, tongue or other parts of  deficiency of potassium the body; rash, itching or hives on  treat certain infections and magnesium in blood caused by bacteria the skin.  prevent infections in Do not take E-Mycin if the Do not take E-Mycin if you are patients with a history of packaging shows signs of taking: rheumatic disease, who are tampering. allergic to penicillin antibiotics.  cisapride (a medicine that Do not take E-Mycin if the expiry helps move food through date printed on the label has E-Mycin is an antibiotic that belongs the digestive system) passed. to a group of medicines called  pimozide (a medicine to If you take this medicine after the macrolides. These medicines work treat certain mental and expiry date, it may not work as well. by killing or stopping the growth of emotional conditions) the bacteria which are causing the  ergotamine or ergotamine Do not take any E-Mycin mixture infection. derivatives (medicines used left in the bottle after 10 days. for migraine). E-Mycin will not work against  terfenadine or astemizole If you are not sure whether you infections caused by viruses, such  simvastatin, lovastatin or should start taking this medicine, as colds or flu. atorvastatin talk to your doctor.

Page 1 of 5 Before you start to take  cyclosporin, tacrolimus, carefully. (medicines used to prevent They may differ from the information it: organ transplant rejection or contained in this leaflet. Tell your doctor if you have to treat certain problems allergies to any other medicines, with the immune system) If you do not understand the foods, preservatives or dyes.  bromocriptine (a medicine instructions on the bottle, ask used to treat Parkinson’s your doctor or pharmacist for Tell your doctor if you have or Disease) help. have had any of the following  risperidone and haloperidol medical conditions: (medicines used to treat How much to take some mental disorders  liver problems such as schizophrenia and Your doctor will tell you how much E-Mycin you need to take each day.  heart problems anxiety) It is important that you take E-Mycin  salt imbalances  citalopram (a medicine as directed by your doctor.  myasthenia gravis, a used to treat depression)  methylprednisolone (a Do not take more than the condition where tmulscles recommended dose. become weak and tire medicine used to suppress easily inflammation)  ciprofloxacin (a medicine The usual adult dose is one  eye disorder E-Mycin tablet (400 mg) every six  pneumonia used to treat bacterial infections) hours. This will vary from person to person. Tell your doctor if you are  cilostazol (a medicine used to help with blood pregnant or plan to become Your doctor may advise you to take pregnant or are breast-feeding. circulation)  vinblastine (a medicine a different dose. This depends on Your doctor can discuss with you the infection being treated and how the risks and benefits involved. used in the treatment of Hodgkin's Disease) severe it is.  sildenafil (Viagra) (a If you have not told your doctor For children, their doctor will work medicine used to treat about any of the above, tell out the dose according to their age, erection problems in men) him/her before you start taking body weight and how severe the  HMG-CoA Reductase E-Mycin. infection is. Inhibitors (medicines used Taking other medicines to lower high cholesterol and triglyceride levels in the How to take it Tell your doctor or pharmacist if body such as lovastatin and Tablets: Swallow whole with a glass you are taking any other simvastatin (e.g. Lipex, of water. medicines, including any that you Zocor)) get without a prescription from  colchicine (a medicine used Mixture: Always shake the bottle your pharmacy, supermarket or to treat gout) well before taking E-Mycin. Use a health food shop.  rifabutin (a medicine used metric measure to ensure that you in the treatment of measure the correct dose. tuberculosis). Some medicines and E-Mycin may interfere with each other. These These medicines may be affected When to take it include: by E-Mycin or may affect how well it Space the doses of E-Mycin evenly works. You may need different apart and take them at about the  theophylline (a medicine amounts of your medicines, or you same time(s) each day. This will used to treat asthma) may need to take different allow E-Mycin to have its best effect  medicines used to treat medicines. and also help you remember when heart failure and fast to take it. irregular heartbeats e.g. If you are not sure whether you are digoxin, disopyramide, taking any of these medicines, E-Mycin can be taken with or quinidine, amiodarone check with your doctor or without food. However, taking  medicines used to thin your pharmacist. E-Mycin with food may help reduce blood such as warfarin the chance of a stomach upset  medicines used to treat Your doctor and pharmacist have occurring. sleep problems or as a more information on medicines to sedative (e.g. zopiclone, be careful with or avoid while taking How long to take it triazolam, alfentanil, E-Mycin. hexobarbital) Keep taking E-Mycin until you  some medication used for finish the tablets or mixture, or epilepsy such as How to take E-Mycin for as long as your doctor carbamazepine, phenytoin recommends. or sodium valproate Follow all directions given to you by your doctor or pharmacist

Page 2 of 5 Do not stop taking E-Mycin, even Tell any other doctors, dentists, infections it is prescribed for, if you feel better after a few days, and pharmacists who treat you however it may have unwanted side unless advised by your doctor. that you are taking this medicine. effects in a few people. All medicines can have side effects. If you are being treated for an Tell your doctor if you develop a Sometimes they are serious, most infection, E-Mycin is usually taken skin rash or hives while taking of the time they are not. You may for one to two weeks. Your infection E-Mycin. need medical attention if you get may not clear completely if you stop some of the side effects. taking your medicine too soon. If you are going to have surgery, tell the surgeon or anaesthetist Do not be alarmed by the If you forget to take it that you are taking this medicine. following lists of side effects. It may affect other medicines used You may not experience any of If it is almost time for your next during surgery. them. dose, skip the dose you missed and take your next dose when you are If you become pregnant while Ask your doctor or pharmacist to meant to. Otherwise, take the taking this medicine, tell your answer any questions you may missed dose as soon as you doctor immediately. have. remember, and then go back to taking your medicine as you would If you are about to have any Tell your doctor or pharmacist if normally. blood tests, tell your doctor that you notice any of the following you are taking this medicine. and they worry you: Do not take a double dose to It may interfere with the results of  stomach cramps and pains make up for the dose you some tests. missed.  feeling sick, vomiting, accumulation of gas and This may increase the chance of Keep all of your doctor’s diarrhoea you getting an unwanted side effect. appointments so that your progress can be checked.  oral thrush (white, furry sore If you have any questions or are not Your doctor may do some tests tongue and mouth) sure what to do, ask your doctor or from time to time to make sure the  vaginal thrush (sore and pharmacist. medicine is working and to prevent itchy vagina, vaginal unwanted side effects. discharge). If you take too much  weight loss  fever, headache (overdose) Things you must not do Immediately telephone your Do not take E-Mycin to treat any The above list includes the more doctor or the National Poisons other complaints unless your common side effects of E-Mycin. Information Centre (0800 POISON doctor tells you to. They are usually mild and short- or 0800 764 766) for advice, or go lived. to Accident and Emergency at Do not give your medicine to the nearest hospital, if you think anyone else, even if they have Tell your doctor as soon as that you or anyone else may have the same condition as you. possible if you notice any of the taken too much E-Mycin. Do this following: Do not stop taking your medicine even if there are no signs of  yellowing of the eyes or or lower the dosage without discomfort or poisoning. You may skin (jaundice), feeling checking with your doctor. need urgent medical attention. generally unwell and having poor appetite Take the bottle of E-Mycin with you Things to be careful of  hearing loss / deafness if you can. Be careful driving or operating  ringing or buzzing in the ears Keep telephone numbers for these machinery until you know how  dizziness, drowsiness places handy. E-Mycin affects you. This medicine may cause dizziness  confusion, hallucinations in some people. If you have this  fits While you are using symptom, do not drive, operate  in infants, irritability with machinery or do anything else that feeding or severe vomiting E-Mycin could be dangerous.  muscle pain, weakness and joint swelling  any vision problem Things you must do Side effects If you are about to be started on The above list includes serious side any new medicine, remind your Tell your doctor or pharmacist as effects that may require medical doctor and pharmacist that you soon as possible if you do not attention. Serious side effects are are taking E-Mycin. feel well while you are taking rare. E-Mycin. E-Mycin is effective in treating most

Page 3 of 5 If any of the following happen, Do not take any medicine for The active ingredient in E-Mycin stop taking E-Mycin and tell your diarrhoea without first checking tablets and mixtures is erythromycin doctor immediately or go to with your doctor. (as erythromycin ethylsuccinate). Accident and Emergency at the nearest hospital: After using E-Mycin E-Mycin tablets  signs of an allergic reaction E-Mycin tablets contain 400 mg of such as any type of skin erythromycin. rash, itching, or hives Storage  swelling of the face, lips, Keep your tablets/mixture in the E-Mycin tablets also contain the tongue or other parts of the bottle until it is time to take them. following inactive ingredients: body If you take the tablets/mixture out of  severe blisters and bleeding the bottle they may not keep well.  calcium hydrogen in the lips, eyes, mouth, phosphate anhydrous nose and genitals Keep E-Mycin tablets in a cool  maize starch dry place where the temperature  shortness of breath,  sorbic acid wheezing, troubled stays below 30°C.  povidone breathing Keep E-Mycin mixture in the  purified talc  fast, irregular or pounding refrigerator but not in the freezer.  sodium starch glycollate heart beat Do not use any mixture left in the  magnesium stearate.  chest pain bottle after 10 days.  watery and severe The film coating also contains: diarrhoea, which may also Do not store E-Mycin or any other be bloody. medicine in the bathroom or near a sink. Do not leave it on a window sill  polyvinyl alcohol The above list includes very serious or in the car.  titanium dioxide side effects. You may need urgent Heat and dampness can destroy  lecithin medical attention or hospitalisation. some medicines.  iron oxide red These side effects are very rare.  xanthan gum. Keep E-Mycin where children Tell your doctor or pharmacist if cannot reach it. E-Mycin tablets do not contain you notice anything that is A locked cupboard at least one-and- lactose or gluten. making you feel unwell. a half metres above the ground is a Other side effects not listed above good place to store medicines. E-Mycin mixtures may also occur in some people. Disposal Each 5 mL of E-Mycin 200 mixture Some of these side effects (for contains 200 mg of erythromycin. example, changes in liver function If your doctor tells you to stop tests) can only be found when your taking this medicine or the expiry Each 5 mL of E-Mycin 400 mixture doctor does tests from time to time date has passed, ask your contains 400 mg of erythromycin. to check your progress. pharmacist what to do with any medicine that is left over. The mixtures also contain the After you have finished following inactive ingredients: taking E-Mycin Product description  sorbitol Tell your doctor immediately if  sodium citrate dihydrate you notice any of the following What it looks like  aspartame side effects, particularly if they  propylene glycol alginate occur several weeks after E-Mycin is available as tablets or  silicon dioxide, colloidal stopping treatment with E-Mycin: mixtures.  sodium benzoate E-Mycin tablets are flesh pink in  erythrosine CI45430  severe abdominal cramps colour, oval-shaped, film-coated  cherry flavour (contains or stomach cramps and marked E-N on one side and preservative 320).  watery and severe diarrhoea, which may also "" on the other. be bloody E-Mycin mixtures come in 2 If you want to know  fever, in combination with strengths - E-Mycin 200 and one or both of the above. E-Mycin 400. Both mixtures are more pink, cherry flavoured and sugar- You may have a serious condition free. Should you have any questions affecting your bowel. These are rare regarding this product, please but serious side effects. Therefore, contact your pharmacist or doctor. you may need urgent medical Ingredients attention. Who supplies this medicine

Page 4 of 5 E-Mycin is supplied in New Zealand by:

Viatris Ltd, PO Box 11-183, Ellerslie AUCKLAND www.viatris.co.nz Telephone 0800 168 169

Date of Preparation

5 August 2021 (Based on datasheet dated 5 August 2021)

E-Mycin® is a Viatris company trade mark.

Page 5 of 5