PATIENT INFORMATION LEAFLET

Tiloryth 250mg gastro-resistant capsules (Erythromycin)

Take special care with Tiloryth

Tell your doctor before taking this medicine:

■    If you suffer from liver problems

■    If you have prolonged or repetitive treatment of

erythromycin

■    If you suffer from asthma and are taking theophylline

■    If you suffer from fatigue and exhaustion of muscles

(myasthenia gravis)

■    If you are to have a urine test to determine the level of catecholamines in your body (used to diagnose an adrenal gland tumor), as Tiloryth may affect the results

The use of Tiloryth may cause abnormal liver function test results, so you need to mention you are taking Tiloryth to your doctor when having any laboratory/hospital tests carried out.

Taking other medicines

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

Medicines which should not to be taken with Tiloryth:

■    Astemizole, terfenadine or mizolastine (for allergy relief)

■    Cisapride (for indigestion)

■    Pimozide or sentindole (for psychiatric disorders)

■    Ergotamine or dihydroergotamine (ergot alkaloids) (for treatment of migraine)

■    Amisulpride (for schizophrenia)

■    Simvastatin (for lowering cholesterol statins)

■    Tolterodine (for urinary incontinence)

Certain other medicines may affect the effectiveness of Tiloryth or visa-versa. Such medicines include:

■    Theophylline (for treatment of asthma)

■    Lovastatin and atorvastatin (statins for lowering cholesterol)

■    Acenocoumarol and warfarin (for thinning the blood)

■    Alfentanil (a strong painkiller)

■    Bromocriptine and cabergoline (for treatment of Parkinson's disease)

Please note: Tiloryth should not be used during treatment with the medicines marked with an asterix (*) or for two weeks after using them.

Pregnancy and breast-feeding

Ask your doctor or pharmacist for advice before taking any medicine.

If you are pregnant or breast-feeding do not take Tiloryth before consulting your doctor.

Important information about some of the ingredients of Tiloryth

This medicine contains sucrose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking Tiloryth.

How to take Tiloryth

The doctor will prescribe the individual dosage which is appropriate for you. It is important that you take your medicine precisely in accordance with the doctor's instructions.

Dosage

The usual dose is:

Adults, the elderly and children over 8 years:

■    Normal dose: 1 to 2 capsules every 6 hours.

■    For more serious infections: 2 to 4 capsules every 12 hours.

■    For severe infections: up to 16 capsules daily in divided doses may be recommended by your doctor.

Early syphilis:

■    2 capsules four times daily for 14 days.

Non-gonococcal urethritis:

2 capsules, four times daily for 7 days.

Streptococcal infections:

Active infection:

■    The full therapeutic dose, for at least 10 days.

continued....

Hard to Read? Phone 0800 970 6115 for help

Prevention against re-occurrence in patients with rheumatic fever:

■    1 capsule twice daily.

Prevention of bacterial endocarditis in patients with valvular disease due to undergo dental/surgical treatment:

■    Before surgery - Adults 4 capsules (children 20mg/kg body weight), two hours before surgery

■    Following surgery - Adults 2 capsules (children 10mg/kg body weight), every six hours for 8 doses

Bacterial endocarditis:

■    Before surgery - Adults 4 capsules (children 20mg/kg body weight), two hours before surgery

■    After surgery - Adults 2 capsules, (children 10mg/kg body weight), every six hours, for 8 doses

Amoebic dysentery:

■    Adults - 1 capsule four times daily for 10 to 14 days

■    Children - 30 to 50mg/kg body weight daily in divided doses for 10 to 14 days

Legionnaires’ disease:

■    4 to 16 capsules daily in divided doses

Your doctor may decide it is necessary to extend the duration of your treatment.

Pertussis:

■    30-50mg/kg body weight daily, in divided doses for 5-14 days

Acne:

■    1 capsule twice daily

This may be reduced to one capsule once a day after a month.

Your doctor may decide it is necessary to extend the duration of your treatment.

Children (under 8 years old)

Use for children under 8 years of age is not recommended.

Method of use

■    For oral use

■    Tiloryth must be swallowed whole and not chewed

■    This medicine may be taken just before or with meals

If you have taken more Tiloryth than you should:

If you have taken too much Tiloryth, contact your doctor or hospital as soon as possible.

Symptoms of an over dose may be feeling sick (severe), being sick, diarrhoea or loss of hearing.

If you forget to take Tiloryth

If you forget to take Tiloryth, continue treatment following the normal dosage, recommended by your doctor. Do not take a double dose to make up for the forgotten individual dose.

If you stop taking Tiloryth

It is important that you take your medicine in accordance with the doctor's instructions. Do not suddenly stop taking Tiloryth without discussing it first with your doctor.

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

[4 Possible side effects

Like most medicines, Tiloryth can cause side effects,

although not everybody gets them.

Serious side effects

If you notice any of the following symptoms after taking this

medicine stop taking the capsules and contact your

doctor or nearest hospital immediately:

■    Allergic reaction such as an itchy rash, skin eruption or with shortness of breath, rash and wheezing (anaphylaxis)

■    Swelling of the face or throat

■    Blistering of the skin, mouth, eyes and genitals (Stevens-Johnson Syndrome & toxic epidermal necrolysis)

■    Irregular heart beat (symptom of Torsades de pointes)

■    Severe vomiting (being sick) by infants (infantile hypertrophic pyloric stenosis)

■    Infection of the colon which may be mild and cause diarrhoea, fever and abdominal pain or severe e.g. bloody stools, watery diarrhoea, severe abdominal pain, fever (pseudomembranous colitis)

■    Yellowing of the skin and/or the whites of the eyes (jaundice) or loss of appetite and abdominal discomfort due to inflammation of the liver (hepatitis)

■    Yellowing of the skin and eyes, itching, dark-coloured urine or pale-coloured stools due to liver failure

Rare side effects include:

■    Skin eruptions

■    Redness and swelling of the skin

■    Itching

■    Skin rashes

Severe pain in the abdomen and back, due to inflammation of the pancreas (pancreatitis) Abnormal heartbeat

Very rare side effects include:

■    Hearing loss (reversible), particularly with elderly patients, those with kidney problems or those on higher doses

Other side effects reported:

■    Feeling or being sick

■    Stomach and upper abdominal pain

■    Diarrhoea

■    Loss of appetite

■    Frequent wheezing, breathlessness, abdominal pain, diarrhoea, fever, cough and rashes due to an increase in a certain type of white blood cells (eosinophilia -diagnosed through blood test)

■    Heart problems such as prolonged QT interval (detected through electrocardiogram (ECG) test), feeling your heart beat (palpitations) or faster heart beat

■    Deafness

■    Hearing disturbances (transient) in patients on a dose of 4g daily and usually when given by injection

■    Ringing in the ear (tinnitus)

■    Chest pains

■    Fever

■    General feeling of being unwell

■    Enlarged liver

■    Confusion

■    Fits

■    Feeling of dizziness or "spinning" (vertigo)

■    Seeing or hearing things that are not real (hallucinations)

■    Inflammation of the kidneys (detected through blood test)

■    Low blood pressure

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

How to store Tiloryth

Keep out of reach and sight of children.

Do not store above 25°C.

Protect from light.

Keep in the original container.

Keep bottles tightly closed.

Do not take after the expiry date, which is stated on the carton after EXP The expiry date refers to the last day of that month.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

Further information

What Tiloryth contains

The active substance is Erythromycin base 250mg.

The other ingredients are: neutral microgranules (sucrose 75%, corn starch 25%), hydroxypropyl methylcellulose, triacetin, methacrylic acid and ethyl acrylic copolymer, talc, hard gelatin capsules, opacode S-1-8144 black (printing Ink).

What Tiloryth looks like and the contents of the pack

Colourless, transparent capsules containing white granules. ‘Tiloryth 250' is printed on the capsule body.

Pack sizes: 28, 30 and 100 capsules Not all pack sizes may be marketed

Marketing Authorisation Holder:

Tillomed Laboratories Ltd,

3 Howard Road, Eaton Socon, St Neots, Cambridgeshire,

PE19 8ET.

United Kingdom.

Manufacturer:

Ethypharm Industries,

ZI Saint-Arnoult,

28170 Chateauneuf-en-Thymerais,

France.

Product Licence Number:

Tiloryth 250mg (Erythromycin): PL 11311/0028

Date of last revision: July 2012

Hard to Read? Phone 0800 970 6115 for help

Till-Ver.6.2s