Erythromycin 250 mg gastro-resistant tablets – patient leaflet, side effects, dosage

1. What Erythromycin Gastro-resistant Tablets are and what they are used for

The name of your medicine is Erythromycin 250 mg Gastro-resistant Tablets and it contains erythromycin which belongs to a group of medicines called macrolide antibiotics. This medicine is used to prevent and treat infections such as:

• Chest infections, such as bronchitis and pneumonia
• Eye and ear infections
• Mouth and dental infections
• Throat and sinus infections
• Skin and soft tissue infections such as acne
• Gastrointestinal infections
• Prophylaxis pre- and post- operative trauma, burns, rheumatic fever or dental procedures
• Other infections: osteomyelitis, urethritis, gonorrhoea, syphilis, lymphogranuloma venereum, diphtheria, prostatitis, scarlet fever You must talk to a doctor if you do not feel better or if you feel worse.

2. What you need to know before you take Erythromycin Gastro-resistant Tablets

Do not take Erythromycin Gastro-resistant Tablets if you are:

• Allergic (hypersensitive) to erythromycin or other macrolide antibiotics such as clarithromycin or azithromycin or any of the other ingredients in the product (see Section 6 ‘What Erythromycin Gastro-resistant Tablets contains’)

• are currently taking a medicine called

  • ergotamine or dihydroergotamine (used to treat migraines) while taking erythromycin as this may cause serious side effects.
  • terfenadine or astemizole or mizolastine (widely taken for hayfever or 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 in heart rhythm. Consult your doctor for advice on alternative medicines you can take instead.

  • 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).
  • you have abnormally low levels of potassium or magnesium in your blood (hypomagnesaemia or hypokalaemia)

  • 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”.

  • 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 or pharmacist before taking Erythromycin Gastro-resistant Tablets if you:

• are taking other medicines which are known to cause serious disturbances in heart rhythm
• have heart problems

If you or your child goes for any medical tests, tell your doctor that you are taking this medicine, as this may interfere with some test results. Pregnancy and breast-feeding

Tell your doctor if you are pregnant or planning to become pregnant. Erythromycin has been reported to cross the placental barrier. Erythromycin passes into breast milk. Ask your doctor or pharmacist for advice before taking any medicine.

If you are pregnant and treated with oral Erythromycin Gastro-resistant Tablets for early syphilis, please consult your doctor as erythromycin may not be effective in preventing infection to the baby.

Driving and using machines

Erythromycin Gastro-resistant Tablets are not expected to affect your ability to drive or operate machinery.

3. How to take Erythromycin Gastro-resistant Tablets

• Always take these tablets exactly as advised by your doctor. You should check with your doctor or pharmacist if you are not sure.
• The dosage and duration of treatment will depend on the type and severity of the infection.
• Swallow the tablets whole with a glass of water.

Adults and children over 8 years is:

The usual dosage is 1-2g daily in divided doses i.e. four to eight 250mg tablets daily taken just before or with meals or food. If you have a bad infection you may be told to take up to 4g daily.

It is important that you complete your full course of antibiotics; do not stop taking the tablets early even if you feel better.

If you take more Erythromycin Gastro-resistant Tablets than you should

If you or a child accidentally takes too much medicine, contact your doctor or nearest hospital emergency department immediately even if there are no signs of discomfort. Take this leaflet, the box and any tablets remaining with you, if possible. Symptoms of overdose include nausea, vomiting and diarrhoea and temporary loss of hearing.

If you forget to take Erythromycin Gastro-resistant Tablets

If you miss a dose, take the tablets as soon as you remember and carry on as before. If it is almost time for your next dose, skip the missed dose and continue as usual. DO NOT take a double dose to make up for the forgotten dose.

If you stop taking Erythromycin Gastro-resistant Tablets

Keep taking this medicine until your doctor tells you to stop, DO NOT stop taking it just because you feel better. If you stop taking the medicine, your condition may re-occur or get worse.

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 Gastro-resistant Tablets can cause side effects, although not everyone gets them.

STOP taking this medicine and seek medical help IMMEDIATELY if you experience any of the following reactions:

• 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.

Other side effects which may occur are:

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 or being sick
• increase in a particular type of white blood cells (eosinophilia)

• stomach pains; these may be a symptom of an inflamed pancreas

  (pancreatitis)

• ringing in the ears (tinnitus)
• reversible loss of hearing (usually associated with high doses in patients with kidney problems)
• various liver or gall- bladder problems, which can cause yellowing of the skin and/or eyes (jaundice) or pale stools with dark urine
• chest pains
• 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);
• fever

• anorexia

  LERY01/03 COLOURS

• confusion
• fits (seizures)

• vertigo (problems with balance that can result in feelings of dizziness or

  sickness - particularly on standing)

• hallucinations (seeing or hearing things that aren’t there)
• feeling generally unwell (malaise)
• inflammation of the kidneys (a condition known as interstitial nephritis)
• low blood pressure

• 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

• visual impairment/blurred vision (Mitochondrial optic neuropathy). Additional side effects in children and adolescents

Adverse drug reactions in children are similar to those in adults. 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).

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 national reporting Yellow Card Scheme Website: 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 Gastro-resistant Tablets

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton. The expiry date refers to the last day of that month.

Do not store above 25°C. Store in the original container.

Do not throw away any medicines 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 Erythromycin Gastro-resistant Tablets contain

The active substance is Erythromycin. Each tablet contains 250 mg of Erythromycin.

The other ingredients are: maize starch, croscarmellose sodium, Type A povidone, talc, magnesium stearate (E572), hypromellose (E464), macrogol 6000, erythrosine (E127), methacrylic acid copolymer and polysorbate 80 (E433)

What Erythromycin Gastro-resistant Tablets look like and contents of the pack

The tablets are reddish orange colored, round biconvex tablets, plain on both sides.

They are available in blister packs of 28 tablets.

This leaflet was last revised in February 2025.

Marketing Authorisation Holder and Manufacturer:

NOUMED LIFE SCIENCES LIMITED

Noumed House, Shoppenhangers Road, Maidenhead, Berkshire, SL6 2RB, United Kingdom.

To listen to or request a copy of this leaflet in Braille, large print or audio, please call 020 33 99 8960 (UK only).

Please be ready to give the following information:

Product name Reference number

Erythromycin 250 mg PL 44041/0015

Gastro-resistant Tablets

• are taking colchicine (used for treatment of gout and arthritis) whilst taking erythromycin as this may cause serious side effects.
• have any liver problems or have been told that any drugs you are taking can cause liver problems.
• suffer from a condition called myasthenia gravis, which causes muscle weakness, consult your doctor before receiving erythromycin
• irregular heart rhythm
• a condition called porphyria
• have previously experienced diarrhoea following the use of antibiotics
• are treating a young child with antibiotics and they are irritable or vomit when fed, you should contact your physician immediately.
• 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 body. Consult your doctor before receiving erythromycin. Alternatively, if you were treated for early stages of syphilis during your pregnancy, and child is under 1 year and is prescribed erythromycin, consult your doctor before giving erythromycin to your child.
• are taking erythromycin with 'statins' such as simvastatin or lovastatin (used to lower cholesterol) as serious side effects can occur. If any of these apply to you, or if you are not sure, tell your doctor. Children

If you are treating a young child with antibiotics and they are irritable or vomit when fed, you should contact your physician immediately.

Effect on urine test

If you are having urine test, let the doctor or nurse know that you are taking erythromycin. This is because erythromycin can affect the results of these tests.

Other medicines and Erythromycin Gastro-resistant Tablets

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

This is also important if you are taking medicines called:

• anticoagulants e.g. warfarin, acenocoumarol and rivaroxaban (used to thin

  the blood)

• cisapride (used for stomach disorders)
• pimozide (used in the treatment of psychiatric disorders)

• clarithromycin, rifabutin or rifampicin (used to treat different types of

  bacterial infections)

• ergotamine or dihydroergotamine (for migraine)
• theophylline (used to treat asthma and other breathing problems)
• cilostazol (for blood circulation problems)
• rifabutin (for tuberculosis)
• sildenafil (for erectile dysfunction)
• vinblastine (for cancer)
• antifungals e.g. fluconazole, ketoconazole and itraconazole

• colchicine (for gout and arthritis) whilst taking erythromycin as this may

  cause serious side effects.

• protease inhibitors (used to treat viral infections e.g. saquinavir)

• cimetidine and omeprazole (used to treat acid reflux and other related

  conditions)

• 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)
• Any contraceptive pills

• Other drug interactions include: bromocriptine (used to treat Parkinson’s

  disease), digoxin or disopyramide or quinidine (all heart drugs), hexobarbitone, phenobarbital or midazolam (used as a sedative), ciclosporin or tacrolimus (used following organ transplants), alfentanil (pain relief), zopiclone or triazolam/alprozolam (induces sleep), phenytoin, carbamazipine or valproate (drugs for epilepsy), lovastatin and simvastatin (cholesterol lowering agents).Your doctor should monitor you appropriately and may adjust your dosage of erythromycin as necessary.

• 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.

Do not take simvastatin, tolterodine, mizolatine, amisulpride, terfenadine, domperidone or astemizole (for the treatment of hayfever and other allergies) if you have been prescribed Erythromycin Gastro-resistant Tablets.