Erythromycin 250mg and 500mg Tablets PACKAGE LEAFLET: INFORMATION FOR THE USER – patient leaflet, side effects, dosage

1. WHAT ERYTHROMYCIN TABLETS ARE AND WHAT THEY ARE USED FOR

Erythromycin Tablets are from the group of medicines called antibiotics and are useful in the treatment of and prevention of bacterial infections including:

! Infections of the upper respiratory tract i.e. tonsillitis,

pharyngitis, laryngitis, sinusitis and secondary infections in colds and flu

! Infections of the lower respiratory tract i.e. tracheitis,

bronchitis and pneumonia

! Mouth infections i.e. gingivitis (inflamed gums) ! Eye infections i.e. blepharitis (inflammation of the eyelids) ! Ear infections i.e. otitis media, otitis externa and

mastoiditis

! Skin and soft tissue infections

! Genito-urinary infections i.e. urethritis, gonorrhoea,

prostatitis

! Prophylaxis pre- and post-operative trauma, burns,

rheumatic fever

! Other infections such as scarlet fever, diphtheria and

infections of the bones (osteomyelitis).

2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE ERYTHROMYCIN TABLETS

Do not take Erythromycin Tablets if you:

! Are allergic to erythromycin or other macrolide antibiotics

such as clarithromycin or azithromycin or any of the other excipients of this medicine (listed in section 6) ! Are taking antihistamines for allergies such as astemizole,

terfenadine and mizolastine

! Are taking pimozide or amisulpride - medicines to treat

mental illness

! Are taking ergotamine or dihydroergotamine for migraine ! Are taking tolterodine to treat urinary

incontinence

! Are taking cisapride for stomach disorders ! Are taking simvastatin to lower your cholesterol ! Are taking domperidone for nausea (feeling sick) and

vomiting (being sick).

! Are taking 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.

Warnings and Precautions

Talk to your doctor before taking these tablets if you: ! Have any liver problems or have been told that any drugs

you are taking can cause liver problems

! 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 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 doctor immediately

! Suffer from a condition called myasthenia gravis, which

causes muscle weakness, consult your doctor before receiving erythromycin

! Have previously experienced diarrhoea following the use

of antibiotics

! Suffer with porphyria

Other medicines and Erythromycin Tablets

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including those obtained without a prescription.

This is especially important if you are taking medicines from the following families:

! Astemizole, terfenadine or mizolastine (used to treat

allergies such as hayfever)

! Pimozide or amisulpride (used to treat mental problems) ! Ergotamine or dihydroergotamine (used to relieve

migraine)

! Cisapride (used to treat stomach disorders) ! Statins (used to lower cholesterol levels e.g. simvastatin

and lovastatin)

! Protease inhibitors (used to treat viral infections e.g.

saquinavir)

! Oral contraceptives

! Domperidone (used to treat nausea (feeling sick) and

vomiting (being sick)).

! 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.

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

related conditions)

! Clarithromycin, rifabutin, or rifampicin (medicnes used to

treat different types of bacterial infection)

! Fluconazole, ketoconazole and itraconazole (medicnes

used 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)

! Warfarin and acenocoumarol (used to help thin the blood) ! Valporate, 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 Parkinsons disease) ! Zopiclone or triazolam/alprazolam (used to help you sleep

or relieve states of anxiety)

! Alfentanil (used for pain relief)

! Methylprednisolone (used to help suppress the body's

immune system, this is useful in treating a wide range of conditions)

! St John's Wort (a 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); interaction with Lomitapide.

If you or your child goes for any medical tests, tell your doctor that you are taking Erythromycin 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 for advice before taking this medicine.

If you are pregnant and treated with Erythromycin Tablets for early syphilis, you should talk to your doctor as erythromycin may not be effective in preventing the infection affecting the baby.

The active ingredient of Erythromycin 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 Erythromycin 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

Do not drive or use machinery if you think you may be affected by these tablets.

Erythromycin Tablets contain tartrazine (E102)

This may cause allergic reactions. If you have been told by your doctor that you have an intolerance to or are allergic to tartrazine you should talk to your doctor before taking this medicine.

3. HOW TO TAKE ERYTHROMYCIN TABLETS

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

Adults : The usual dosage is 1000mg (4 x 250mg or 2 x 500mg tablets) to 2000mg (8 x 250mg tablets or 4 x 500mg tablets) per day. This is divided into 6, 8 or 12 hourly doses. The dose may be increased to up to 4000mg (16 x 250mg tablets or 8 x 500mg tablets) per day for severe infections. Tablets should be taken before or with meals.

Use in children and adolescents: Follow your doctor's instructions. Children are normally given Erythromycin Suspension. However if tablets are prescribed 30mg daily is given per kg of the child's weight in divided doses. In severe infections the dose may be raised to 50mg daily per kg of the child's weight in divided doses.

If you take more Erythromycin Tablets than you should

This medicine is to be taken at regular intervals, as determined by the physician. If you take too many tablets by mistake contact your nearest hospital casualty department or tell your doctor immediately. Take your tablet pack with you. An overdose of Erythromycin could cause temporary hearing loss, nausea, vomiting and diarrhoea.

If you stop taking Erythromycin Tablets

You may feel better after a few days, but you should keep taking your tablets until the prescribed course is finished. Your symptoms may come back if you stop your treatment too soon.

If you forget to take Erythromycin Tablets

If you have forgotten to take a dose, take the missed dose as soon as you remember, unless it is almost time for your next dose, and carry on as before. Do not take a double dose to make up for a forgotten dose.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS

Like all medicines, this medicine can cause side effects, although not everyone gets them.

If any of the following occur, STOP taking the medicine and contact a doctor immediately:

! Allergic reactions may occur with symptoms such as

rash, itching, swelling of the face, wheeziness, shortness of breath, tightness in the chest, fever, low blood pressure and feeling dizzy when standing up

! Severe skin reactions such as erythema multiforme (a red

rash caused by hypersensitivity to a drug, disease or allergen), Steven's Johnson syndrome (a severe inflammatory eruption of the skin and mucous membranes) and Toxic Epidermal Necrolysis (large areas of the skin become intensely red and begin to peel) ! Liver problems, a yellow discolouration of the eyes and

skin (jaundice) and abnormal liver function tests. These will be picked up by the doctor

! Diarrhoea which may be severe or prolonged and may

contain blood or mucus

! Severe abdominal pain (pancreatitis)

! Abnormal heart rhythms including palpitations (torsade de

pointes)

! 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 reported reactions include:

! Changes in the blood (eosinophilia).

Symptoms include rashes, itching

! Changes in your heart beat and rhythm, chest pains, dizziness, palpitations, low blood pressure

! Hearing disorders including deafness and a ringing in the ears (tinnitus)

! Reversible loss of hearing (usually associated with high doses or in patients with kidney problems) ! Feeling sick, being sick, abdominal pain, loss of appetite

(anorexia)

! Fever, feeling tired (malaise)

! Confusion, seizures and vertigo (feeling that everything around you is spinning)

! Seeing or hearing things that are not there

(hallucinations)

! Kidney disorders such as interstitial nephritis (a disorder where spaces between the kidney tubules become swollen or inflamed)

! Vomiting and irritability in young children between the age of 1 month and 12 months

! Visual impairment/blurred vision (Mitochondrial optic neuropathy).

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 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 TABLETS

Keep out of the sight and reach of children.

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.

Store in a cool dry place.

Do not use this medicine if you notice any visible signs of deterioration.

Do not throw away any medicines via waste water or household waste. Ask your pharmacist how to throw away any medicines you no longer use. These measures help to protect the environment.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What Erythromycin Tablets contain:

Erythromycin Tablets 250mg and 500mg contain the active substance erythromycin stearate equivalent to erythromycin BP 250mg and 500mg in each tablet respectively.

The other ingredients are: povidone, magnesium stearate, maize starch, talc, microcrystalline cellulose, cellulose acetate phthalate, polyethylene glycol 6000, castor oil, triacetin, tartrazine (E102) (see section 2) and red/erythrosine (E127). The 500mg tablets also contain amberlite and sodium citrate.

What Erythromycin Tablets look like and contents of the pack

Erythromycin Tablets 250mg are pink tablets supplied in bulk pots of 500 tablets.

Erythromycin Tablets 500mg are pink tablets supplied in bulk pots of 100 tablets.

However, the amount dispensed will be changed according to your prescription.

Marketing Authorisation Holder

Ennogen IP Ltd

Unit G4, Riverside Industrial Estate,

Riverside Way, Dartford, DA1 5BS, UK

The manufacturer and batch release site

Regent-gm Laboratories Limited

Cunard Road, North Acton, London

NW10 6PN, United Kingdom

This leaflet was last revised in May 2026.