Patient leaflet - Erythroped A tablets
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. What you need to know before you take Erythroped A Tablets
Do not take Erythroped A Tablets:
- if you are allergic to erythromycin or any of the other ingredients of this medicine (listed in section 6).
if you are currently taking a medicine called
- terfenadine or astemizole or mizolastine (widely taken for hayfever and allergies)
- pimozide or amisulpride (for psychiatric conditions)
- domperidone (for nausea (feeling sick) and vomiting (being sick))
- ergotamine or dihydroergotamine (used to relieve migraine)
- cisapride (used to treat acid reflux)
- simvastatin (used to lower cholesterol and triglycerides (types of fat) in the 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.
- if you have abnormally low levels of potassium or magnesium in your blood (hypomagnesaemia or hypokalaemia).
- if you 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 Erythroped A Tablets:
- if you have any liver problems or are taking any medicines which can cause liver 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 not be effective for preventing the transfer of this infection to your baby. 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
- if you are taking other medicines which are known to cause serious disturbances in heart rhythm
- if you have heart problems
- if you suffer from a condition called myasthenia gravis which causes muscle weakness
- if you are taking erythromycin with ‘statins’ such as simvastatin (used to lower cholesterol) as serious side effects can occur.
Children
If you are treating a young child with antibiotics and they are irritable or vomit when fed, you should contact your physician immediately.
Other medicines and Erythroped A Tablets
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
This is especially important if you are taking medicines called:
- astemizole, terfenadine or mizolastine (used to treat allergies such as hay fever),
- domperidone (used to treat nausea (feeling sick) and vomiting (being sick)),
- 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),
- anticoagulants e.g. warfarin, acenocoumarol and rivaroxaban (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)
- 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 you getting side effects that affect your heart
- 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)
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 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 Erythroped A Tablets 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 Erythroped A Tablets use in early pregnancy.
Erythromycin should be used by women during pregnancy or while breast-feeding only if clearly needed.
Driving and using machines
None reported.
Important information on excipient
This medicine contains less than 1mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium- free’.
3. How to take Erythroped A Tablets
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
The recommended dose is:
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.
Use in children (below 8 years)
For younger children, infants and babies, Erythroped, erythromycin ethylsuccinate suspensions, are normally recommended. The recommended dose for children age 2-8 years, for mild to moderate infections, is 1 gram daily in divided doses. The recommended dose for infants and babies, for mild to moderate infections, is 500 mg daily in divided doses.
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. Do not take a double dose to make up for a forgotten dose.
If you have any further questions on the use of this product ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine 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)
- a life-threatening irregular heart beat called torsades de pointes or abnormal ECG heart tracing) or heart stopping (cardiac arrest)
- yellowing of the skin and/or eyes, which are signs of liver problems including jaundice
- 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)
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).
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:
Very rare: may affect up to 1 in 10,000 people
- Abnormal heart rhythm (including palpitations, a faster heartbeat)
Not known: frequency cannot be estimated from the available data
- Feeling sick or being sick
- Stomach pains
- Reversible loss of hearing (usually with high doses)
- Damage to the blood, kidneys or nervous systems.
- Chest pain
- Dizziness
- Vomiting and irritability in young children between the age of 1 month and 12 months;
- Abnormal liver function test
- Visual impairment/blurred vision (Mitochondrial optic neuropathy).
Reporting of side effects
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 the Yellow Card Scheme at: www.mhra.gov.uk./yellowcard 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 ERYTHROPED A 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 this medicine out of the sight and reach of children.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
6. Contents of the pack and other information What Erythroped A Tablets contain
Each Erythroped A tablet contains 500 mg of the active ingredient erythromycin. The other ingredients are: hydroxypropyl methylcellulose, calcium hydrogen phosphate, sodium starch glycollate, maize starch, povidone, magnesium stearate, titanium dioxide, sorbic acid, polyethylene glycol and quinoline yellow (El04).
What Erythroped A Tablets look like and the contents of the pack
Erythroped A tablets are yellow and are available in bottles of 50, 100 or 500 tablets, or blister packs of 4 or 28 tablets.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Amdipharm UK Limited,
Dashwood House,
69 Old Broad Street,
London, EC2M 1QS, United Kingdom
Manufacturer:
Aesica Oueenborough Limited,
Oueenborough,
Kent MEl1 5EL,
UK.
This leaflet applies only to Erythroped A tablets and was prepared in June 2000. This leaflet was last revised in November 2023