Erythromycin tablets BP 250 mg – 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 any of the other

ingredients of this medicine (listed in section 6) ! If you are taking antihistamines for allergies such as

astemizole, terfenadine and mizolastine

! If you are taking pimozide or amisulpride - medicines to

treat mental illness

! If you are taking ergotamine or dihydroergotamine for

migraine

! If you are taking tolterodine to treat urinary incontinence ! If you are taking cisapride for stomach disorders ! If you are taking simvastatin to lower your cholesterol ! If you are taking domperidone for nausea (feeling sick)

and vomiting (being sick)

! 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".

! If you 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, pharmacist or nurse before taking Erythromycin Tablets if you:

! Have liver problems

! Have a muscle disorder called myasthenia gravis

! Have previously experienced diarrhoea following the use

of antibiotics

! Have an irregular heart rhythm

! Are breastfeeding (see section Pregnancy and

breastfeeding)

! 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

! Are treating a young child with antibiotics and they are

irritable or vomit when fed, you should contact your physician immediately

! Suffer with porphyria

! Are taking other medicines which are known to cause

serious disturbances in heart rhythm

! Have heart problems.

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.

In particular, tell your doctor if you are taking any of the following:

! Anticoagulants e.g. warfarin, acenocoumarol and

rivaroxaban (used to thin the blood)

! The antibiotic clarithromycin, used to treat certain

bacterial infections

! Zopiclone, a medicine used to help you sleep or relieve

states of anxiety

! Theophylline, a medicine used to treat breathing

disorders such as asthma

! Alfantanil, hexobarbitone used as anaesthetics ! Bromocriptine used in the treatment of parkinsons

disease, neuroleptic malignant syndrome

! Carbamazepine, phenytoin, phenobarbital, valproate used

to treat epilepsy

! Cyclosporin, tacrolimus used after organ transplants ! Digoxin, disopyramide, quinidine, verapamil used to treat

heart disorders

! Midazolam, triazolam, alprazolam used to treat insomnia ! Cilostazol used to treat muscle pain

! Methylprednisolone used to treat arthritis, bronchitis ! Omeprazole used to treat dyspepsia

! Rifabutin used to treat tuberculosis

! Sildenafil used to treat erectile dysfunction ! Vinblastine used to treat certain cancers

! Fluconazole, ketoconazole, itraconazole used to treat

fungal infections

! Rifampicin, penicillin, cephalosporins, clindamycin,

lincomycin, chloramphenicol, streptomycin, tetracyclines, colistin used to treat bacterial infections

! Herbal remedies e.g. St John's wort used to treat

depression

! Contraceptive pill

! Colchicine used to treat gout

! Cimetidine used to treat stomach disorders. ! 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.

! 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.

DO NOT TAKE Erythromycin Tablets if you are also taking astemizole, terfenadine, mizolastine, pimozide, amisulpride, ergotamine,

dihydroergotamine, tolterodine, cisapride, simvastatin or domperidone.

If you or your child goes for any medical tests, tell your doctor that you are taking Erythromycin, 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 the colouring agent Dispersed Red (E 110 and E 124)

Dispersed Red contains the azo colouring agents Sunset Yellow (E 110) and Ponceau 4R, cochineal Red A (E 124) which may cause allergic reactions.

3. HOW TO TAKE ERYTHROMYCIN TABLETS

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

Adults: The usual dose is 250mg (1 tablet) every 4 to 6 hours. This may be increased to 4g (16 x 250mg tablets) per day depending on the severity of the infection.

Use in children and adolescents: Follow your doctors instructions. The age and weight of the child, and the severity of the infection are all important factors when deciding on the correct dose to be given.

The usual dose is 30-50mg/kg a day, given in divided doses. If dosage is required twice daily in adults and children, one half of the total daily dose may be given every 12 hours, one hour before meals.

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, Erythromycin Tablets 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, a faster

heartbeat, a life-threatening irregular heart beat called torsades de pointes or abnormal ECG heart tracing) or heart stopping (cardiac arrest)

! 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 visions (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 below 20°C. Protect from light. 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 contain the active substance erythromycin BP 250mg in each tablet.

The other ingredients are: maize starch, croscarmellose sodium type A, povidone, (Kollidone K90), talc, magnesium stearate, hydroxypropyl methylcellulose, polyethylene glycol 6000, dispersed red 18152 (Sunset Yellow E110 and Ponceau 4R, cochineal Red A E124), methacrylic acid copolymer, polysorbate 80.

What Erythromycin Tablets look like and contents of the pack

Erythromycin Tablets 250mg are reddish orange coloured, opaque film-coated round tablets with no markings on either side.

Erythromycin Tablets 250mg are supplied in pots and bulk pots of 21, 100, 250, 500 and 1000 tablets.

These tablets are also supplied in blister packs of 28, 56, 84 and 100.

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.