ERYTHROMYCIN ETHYLSUCCINATE 250 MG / 5 ML GRANULES FOR ORAL SUSPENSION - patient leaflet, side effects, dosage

1. WHAT ERYTHROMYCIN IS AND WHAT IT IS USED FOR

Erythromycin contains erythromycin ethyl succinate, which is an antibiotic (macrolide group). It is used to treat or prevent bacterial infections, including sexually transmitted diseases and dental infections. It may be used to prevent whooping cough, diphtheria or to treat certain skin infections (Acne vulgaris).

2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE ERYTHROMYCIN

Do not take Erythromycin:

• 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

– ergotamine or dihydroergotamine (used to treat migraines) as this may cause serious side effects while taking eiythromycin

– 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 eiythromycin, as combining these drugs can sometimes cause serious disturbance in heart rhythm. Consult your doctor for advice on alternative medicine 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 urinaiy 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 history7 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 Eiythromycin:

• if you are taking colchicine (used for treatment of gout and arthritis) as this may cause serious side effects whilst taking erythromycin
• if you have any liver problems or have been told that any drugs you are taking 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 eiythromycin may not be effective for preventing the transfer of this infection to your baby. 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 eiythromycin to your child
• if you are treating a young child with antibiotics and they are irritable or vomit when fed
• if you suffer from a condition called myasthenia gravis, which causes muscle weakness
• if you are taking erythromycin with ‘statins’ such as simvastatin or lovastatin (used to lower cholesterol)
• if you are taking other medicines which are known to cause serious disturbances in heart rhythm
• if you have heart problems.

Contact your doctor as soon as possible if you develop watery and bloody stools during or up to 2 months after treatment, with or without stomach cramps and fever (to rule out the possibility of pseudomembranous colitis).

Other medicines and Erythromycin

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 from the following families:

• astemizole, terfenadine or mizolastine (used to treat allergies such as hayfever)
• domperidone (used to treat nausea and vomiting)
• pimozide (used to treat mental problems)
• ergotamine or dihydroergotamine (for migraine)
• cisapride (for stomach disorders)
• statins (used to help lower cholesterol levels e.g. lovastatin and simvastatin)
• 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 infections)
• 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).

If you or your child goes for any medical tests, tell your doctor that you are taking Eiythromycin, 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.

Erythromycin contains sucrose and sodium

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product. This medicine contains 48.22 mg/5 ml of sodium. To be taken into consideration by patients on a controlled sodium diet.

3. how to take erythromycin

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

Patients with kidney problems must be given a reduced dose. Shake Erythromycin well before use.

Taking Erythromycin with food and drink: Take Eiythromycin before meals.

The recommended doses are:

For adult s and children ove r 8 y ear s of age :

2 g per day in divided doses. In severe infections, this can increase up to 4 g per day in divided doses. One to two 5 ml spoonfuls four times a day.

For Acne vulgaris, the dose is one 5 ml spoonful 3 times daily before meals, for 1 to 4 weeks, and then reduced to twice daily until improvement occurs.

For children aged 2 – 8 years:

30 mg per kg of body weight per day in divided doses. In severe infections, this can increase up to 50 mg per kg of bodyweight per day in divided doses. One 5 ml spoonful four times a day or as advised by your doctor.

For infants under 2 years of age:

30 mg per kg of body weight per day in divided doses. In severe infections, this can increase up to 50 mg per kg of bodyweight per day in divided doses. One 2.5 ml spoonful four times a day or as advised by your doctor. An oral syringe may be used to measure this dose. A lower strength product containing

125 mg/5 ml of erythromycin is easier to use for this age group.

If you forget to take Erythromycin

Take the dose as soon as you remember, unless it is nearly time for your next dose. Do not take a double dose to make up for the missed dose.

If you take more Erythromycin 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 could cause temporary hearing loss, nausea, vomiting and diarrhoea.

If you stop taking Erythromycin

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 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 everybody gets them.

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 notice any of the following, 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 or throat. These may be signs of an allergic reaction.

Other side effects of Erythromycin include:

• diarrhoea which may be severe or prolonged and may contain blood or mucus
• feeling 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)
• various liver or gall-bladder problems, which can cause yellowing of the skin and/or eyes (jaundice) or pale stools with dark urine
• chest pain
• 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
• loss of appetite
• 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 multi forme)
• vomiting and irritability in young children between the age of 1 month and 12 months
• visual impaiiment/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 vvvvvv.mhra.gov­.uk/yellovvcard 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

Keep this medicine out of the sight and reach of children. Do not use your medicine after the expity date which is stated on the label.

Once the granules are reconstituted by your doctor or pharmacist, do not store above 15°C, keep the cap tightly closed, and use within 14 days. Do not freeze.

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

6. contents of the pack and other information

What Erythromycin contains

• the active substance is erythromycin ethyl succinate; each 5 ml of the oral suspension contains erythromycin 250 mg.
• the other ingredients are sodium carboxymethyl­cellulose, sodium citrate, banana flavour (E4210), quinoline yellow (E104), sodium saccharin, colloidal silicon dioxide and sucrose (see end of Section 2).

What Erythromycin looks like and contents of the pack

Eiythromycin comes as granules for preparation by your pharmacist. Once reconstituted it is a yellow liquid. It is available in 100 ml amber glass with pilfer evident caps or white plastic HDPE bottles with pilfer proof screw caps or child resistant caps, and is also available in strengths of 125 mg or 500 mg per 5 ml.

the package leaflet before use.

Kecbristitutbd suspension should not e above 15' J. Do not freeze.

250 mg/5 ml Shake well ' ?f _e i e Keep tightly

closed and use within 14 days. Keep

tout of the sigh am reach of children. Dosage: As directed by physician. Tu THE PWVRMACIST: I Eiythromyc^Ethyl Succinate granules for oral suspension. Do not store toran0e*ibove£5°C. T>reconstitute, first 4i“ke bot‘le to loosen powder, then add 60 mi water and shake | the bottle vigorous^ until granules are fully suspended. The resulting 100 ml of suspension contains 250 mg of Eiythromycin activity in each 5 ml. Pinewood Laboratories Ltd., I pom I

Ireland. PL 04917/0014. ;3LLo^iS