Patient leaflet - Erythromycin 250 mg / 5 ml oral suspension
1. WHAT ERYTHROMYCIN ORAL SUSPENSION IS AND WHAT IT IS USED FOR
Erythromycin oral suspension contains Erythromycin which belongs to a group of medicines called macrolide antibiotics.
Erythromycin oral suspension is used to treat and prevention of infections such as:
- throat and sinus infections
- chest infections, such as bronchitis or pneumonia
- ear infections
- mouth and dental infections
- eye infections
- skin and tissue infections such as acne
- stomach and intestinal infections
- prevention infections following burns, operation or dental procedures.
- other infections such as sexually transmitted infections, bone infections or scarlet fever
If you are not sure why you have been prescribed this medicine, then please ask your doctor.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE ERYTHROMYCIN ORAL SUSPENSION
Do not take Erythromycin and tell your doctor if you:
- are allergic to Erythromycin or any of the other ingredients of this medicine listed in section 6).
- are allergic to other macrolide antibiotics such as clarithromycin or azithromycin.
are taking a medicine called,
- Ergotamine or Dihydroergotamine (used to treat a migraines) as this may cause serious side effects while taking erythromycin.
- 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 you can take instead.
- Simvastatin (lower your cholesterol and triglycerides (types of fat) in blood);
- Tolterodine (used for treating overactive bladder with symptoms of urinary frequency, urgency, and leakage).
- lomitapide (used to lower increased blood fats such as cholesterol and triglycerides). Taking this medicine at the same time as erythromycin may lead to a rise in enzymes produced by liver cells (transaminases), which indicates that the liver is under stress and may lead to liver problems.
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- have abnormally low level of potassium or magnesium in your blood (hypomagnesaemia or hypokalaemia);
- or someone in your family has a history of heart rhythm disorders (ventricular cardiac arrhythmia or torsades de pointes) or an abnormality of the electrocardiogram (electrical recording of the heart) called “long QT syndrome”.
Warnings and precautions
Talk to your doctor or pharmacist before taking Erythromycin oral suspension:
- if you are taking colchicine (used for treatment of gout and arthritis) as this may cause serious side effects while taking erythromycin;
- if you have any liver problems or have been told that any drugs you are taking can cause liver problems
- if you are taking other medicines which are known to cause serious disturbances in heart rhythm
- have previously experienced diarrhoea following the use of antibiotics.
- if you have heart problems
- if you have previously experienced diarrhoea following the use of antibiotics
- if you are pregnant and have been told that you have a sexually transmitted disease called syphilis. In this case erythromycin may be not effective for preventing the transfer of this infection to your body. 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.
- if you suffer from a condition called have 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 you are not sure if any of the above apply to you, talk to your doctor or pharmacist before taking this medicine.
Other medicines and Erythromycin oral suspension
Tell your doctor or pharmacist if you are taking, have recently taken or might take other medicines, including any medicines obtained without a prescription. This is because Erythromycin can affect the way some other medicines work. Also, some medicines can affect the way Erythromycin works.
In particular, tell your doctor or pharmacist if you are taking any of the following medicines:
- 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.
- Zafirlukast and reboxetine
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 bacterial infections)
- fluconazole, ketoconazole and itraconazole (medicines 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)
- anticoagulants e.g., warfarin, acenocoumarol and rivaroxaban (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 supress the body’s immune system- this is useful in treating a wide range of conditions)
- St John’s Wort (an 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)
- corticosteroids, given by mouth, by injection or inhaled (used to help suppress the body's immune system - this is useful in treating a wide range of conditions).
- hydroxychloroquine or chloroquine (used to treat conditions including rheumatoid arthritis, or to treat or prevent malaria). Taking these medicines at the same time as erythromycin may increase the chance of getting abnormal heart rhythms and other serious side effects that affect your heart.
Your doctor will monitor you appropriately and may adjust your dose of Erythromycin as necessary.
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
The active ingredient of Erythromycin may cross the placenta in pregnant women and is excreted in breast milk. Information from studies regarding the risk of birth defects is inconsistent, but some studies have reported heart defects following Erythromycin use in early pregnancy.
Erythromycin should be used by women during pregnancy or while breast-feeding only if clearly needed.
Driving and using machines
Erythromycin should not affect your ability to drive or operate machinery.
Important information about some of the ingredients of Erythromycin
This medicinal product contains over 3 g of sucrose in each 5 ml and is unsuitable in hereditary fructose intolerance, glucose-galactose malabsorption syndrome, or sucrase-isomaltose deficiency. It should also be used with caution in patients with diabetes mellitus. This product may be harmful to people on a low sodium diet.
3. HOW TO TAKE ERYTHROMYCIN ORAL SUSPENSION
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
DO NOT stop taking it if you feel better.
Shake the bottle well before each dose.
The recommended dose is:
For adults and children over 8 years of age:
2 g per day in divided doses. In severe infections, this can increase up to 4 g per day in divided doses (see table).
Use in children
For children aged 2-8 years:
30 mg per kg of bodyweight per day in divided doses. In severe infections, this can increase up to 50 mg per kg of bodyweight per day in divided doses (see table).
For infants under 2 years of age:
30 mg per kg of bodyweight per day in divided doses. In severe infections, this can increase up to 50 mg per kg of bodyweight per day in divided doses (see table).
Normal Dose
| Which type of suspension do I have? | How many 5 ml teaspoonfuls should be taken? | How many 5 ml teaspoonfuls should be taken? | How many 5 ml teaspoonfuls should be taken? |
|---|---|---|---|
| For patients Under 2 years | For patients Under 2 years | For patients Under 2 years |
Erythromycin SF 125mg/5 ml | 1 teaspoonful four times a day | 2 teaspoonfuls four times a day | 4 teaspoonfuls four times a day |
|---|---|---|---|
Erythromycin SF 250 mg/5 ml | 1 teaspoonful four times a day | 2 teaspoonfuls four times a day | |
Erythromycin SF 500mg/5ml | 1 teaspoonful four times a day |
If you take more Erythromycin oral suspension than you should
If you accidentally take more medicine than recommended, contact your doctor or pharmacist at once for advice or go to the nearest hospital emergency department immediately. An overdose of erythromycin could cause temporary hearing loss, nausea, vomiting and diarrhoea.
If you forget to take Erythromycin oral suspension
If you forget to take a dose of your medicine, take it as soon as you remember.
Do not take a double dose to make up for a forgotten dose.
4. POSSIBLE SIDE EFFECTS
Like all medicines, this medicine can cause side effects, although not everybody gets them.
If you get any of the following side effects, STOP TAKING this medicine and seek urgent medical help:
- difficulty in breathing, fainting, swelling of the face, lips or throat, skin rashes, severe skin reaction including fluid-filled blisters, sores and ulcers, ulcers in the mouth and throat, as these may be signs of an allergic reaction.
- liver failure, various liver or gall-bladder problems, which can cause yellowing of the skin and/or eyes (jaundice) or pale stools with dark urine.
- abnormal heart rhythms (including palpitations, a faster heartbeat, a life-threatening irregular heartbeat called torsades de pointes or abnormal ECG heart tracing) or heart stopping (cardiac arrest).
- 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);
- vomiting and irritability in young children between the age of 1 month and 12 months.
- inflammation of the kidneys (a condition known as interstitial nephritis).
- Contact a doctor immediately if you experience a serious skin reaction: a red, scaly rash with bumps under the skin and blisters (exanthematous pustulosis). The frequency of this side effect is not known (cannot be estimated from the available data)
Other side effects.
Rare (may affect up to 1 in 1,000 people)
- bowel disease with diarrhoea and abdominal pain (pseudomembranous colitis).
Not known (frequency cannot be estimated from the available data)
- diarrhoea which may be severe or prolonged and may contain blood or mucus.
- feeling sick (nausea) or being sick (vomiting)
- increase in a particular type of white blood cells (eosinophilia)
- stomach pains: these may be symptom of an inflamed pancreas (pancreatitis)
- ringing in the ears (tinnitus)
- reversible loss of hearing (usually associated with high does or in patients with kidney problems)
- chest pains
- fever
- loss of appetite (anorexia)
- confusion
- convulsions (seizures)
- vertigo (problems with balance that can result in feelings of dizziness or sickness -particularly on standing)
- Hallucinations (seeing or hearing things that are not there)
- feeling generally unwell (malaise)
- low blood pressure
- visual impairment/blurred vision (Mitochondrial optic neuropathy)
- increase levels of liver enzymes
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via Yellow card scheme at: www.mhra.gov.uk/Yellow card or search for MHRA Yellow Card in the Google Play or Apple App Store.
By reporting side effects you can help provide more information on the safety of this medicine.
5. HOW TO STORE ERYTHROMYCIN ORAL SUSPENSION
Keep this medicine out of the sight and reach of children.
Store your medicine in the original container. Do not store above 25°C prior to reconstitution by a pharmacist. After reconstitution, store suspension at 2°C - 8°C. Do not freeze. Use within 14 days.
Do not use this medicine after the expiry date which is stated on the label. The expiry date refers to the last day of that month.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
6. CONTENTS OF THE PACK AND OTHER INFORMATION
The name of your medicine is Erythromycin Oral Suspension. It is available in granules in 100 ml bottles for preparation by the pharmacist and is available in two strengths.
After the granules have been reconstituted, each 5 ml of mixture contains either 125 mg or 250 mg of erythromycin as erythromycin ethyl succinate.
It also contains carboxymethylcellulose sodium, sodium citrate, banana flavour, quinoline yellow E104, sodium saccharin, colloidal anhydrous silica and sucrose.
The Product Licence holder is:
Chelonia Healthcare Limited,
Boumpoulinas 11, 3rd Floor, Nicosia 1060, Cyprus.
The manufacturer is: Ranbaxy Ireland Limited,
Spafield, Cork Road, Cashel, Co. Tipperary, Ireland.
A reminder
REMEMBER this medicine is only or you. Only a doctor can prescribe it to you.
Never give it to anyone else, even if they have the same symptoms as you have.
This leaflet is a summary of information about your medicine. It does not contain all the information, if you have any questions ask your doctor or pharmacist.
Erythromycin 125 mg /5 ml Oral Suspension PL 33414/0043
Erythromycin 250 mg /5 ml Oral Suspension PL 33414/0044
This leaflet was produced in Feb 2023