• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet . See section 4.

1. What Erythromycin Lactobionate I.V. is and what is it used for
2. What you need to know before you are given Erythromycin Lactobionate I.V.
3. How you will be given Erythromycin Lactobionate I.V.
4. Possible Side Effects
5. How to store Erythromycin Lactobionate I.V.
6. Contents of the pack and other information

• if you are allergic to erythromycin or any of the other ingredients of this medicine (listed in section 6)
• if you are allergic to other macrolide antibiotics such as clarithromycin or azithromycin.
• if you are taking ergotamine or dihydroergotamine (used to treat migraines) while taking erythromycin as this may cause serious side effects.
• if you are taking 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 in heart rhythm. Consult your doctor for advice on alternative medicines you can take instead.
• if you using 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).
• 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.

Talk to your doctor or pharmacist before you are given Erythrocin I.V. Lactobionate:

• if you are taking colchicine (used for treatment of gout and arthritis) whilst taking erythromycin as this may cause serious side effects;
• 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;
• 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 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 erthyromycin, consult your doctor before giving erythromycin to your child;
• if you are treating a young child with antibiotics and they are irritable or vomit when fed, you should contact your doctor immediately;
• if you suffer from a condition called myasthenia gravis, which causes muscle weakness, consult, your doctor before receiving erythromycin;
• if you are taking erythromycin with 'statins' such as simvastatin or lovastatin (used to lower cholesterol) as serious side effects can occur.

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

Tell your doctor if you are using, have recently used or might use any other medicines.

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

• astemizole, terfenadine or mizolastine (used to treat allergies such as hayfever);
• domperidone (used to treat nausea (feeling sick) and vomiting (being sick);
• pimozide or amisulpride (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);
• 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;
• protease inhibitors (used to treat viral infections e.g.saquinavir);
• oral contraceptives.

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 different types of bacterial infection);
• fluconazole, ketoconazole and itraconazole (medicines 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);
• 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);
• 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 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).

Erythromycin should be used by women during pregnancy only if clearly needed.

If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist before taking this medicine.

The active ingredient of Erythromycin Lactobionate I.V 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 Lactobionate I.V use in early pregnancy.

None reported.

• 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);
• various liver or gall-bladder problems, which can cause yellowing of the skin and/or eyes (jaundice) or pale stools with dark urine;
• 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);
• diarrhoea which may be severe or prolonged and may contain blood or mucus.

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 of Erythromycin Lactobionate I.V. include:

Not known: frequency cannot be estimated from the available data

• 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 or in patients with kidney problems);
• chest pains;
• abnormal heart rhythms (including palpitations, a faster heartbeat);
• fever;
• anorexia;
• 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;
• vomiting and irritability in young children between the age of 1 month and 12 months;
• visual impairment/blurred vision (Mitochondrial optic neuropathy).

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 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.

Each vial of Erythromycin Lactobionate I.V. Injection contains 1 g of the active ingredient erythromycin lactobionate. When made up with 20 ml of Water for Injections, each ml of solution contains 50 mg of erythromycin lactobionate.

This solution must be further diluted prior to use.

There are no other ingredients in the product.

Erythromycin Lactobionate I.V. is available as single 1g vials.

Marketing Authorisation Holder:

Manufacturer: