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RETCIN

Active substance(s): ERYTHROMYCIN

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SUMMARY OF PRODUCT CHARACTERISTICS

1

NAME OF THE MEDICINAL PRODUCT
RETCIN / Erythromycin 250 mg tablets

2

QUALITATIVE AND QUANTITATIVE COMPOSITION
Erythromycin Ph. Eur. 274.00 mg

3

PHARMACEUTICAL FORM
Enteric-coated tablet

4

CLINICAL PARTICULARS

4.1

Therapeutic indications
For the prophylaxis and treatment of infections caused by Erythromycinsensitive organisms.
1.
Upper and lower respiratory tract infections.
2.
Soft tissue and skin infections.
3.
Bone infections.
4.
Oral and dental infection.
5.
Gastro-intestinal infections.
6.
Eye infections.
7.
Sexually transmitted diseases.
8.
Prophylaxis.
9.
Microbiological indications. Erythromycin is active against
staphylococci, streptococci, haemophilus influenzae, L-forms, mycoplasma
pneumoniae, legionella pneumophila, branhamella catarrhalis, bordetella
pertussis, corynebacterium diphtheriae, neisseria, treponema pallidum,
chlamydia trachomatis, clostridia, ureaplasma urealytica, campylobacter. In
the case of corynebacterium diphtheriae should be used as an adjunct to
antitoxin.

4.2

Posology and method of administration
Adults and children over 8 years: 1-2 g daily in divided doses for mild to
moderate infection. This dosage may be increased to 4 g daily in divided
doses. Tablets should be taken before or with meals.
Elderly: No special dosage recommendations.
Period of dosing with regard to indications:
Upper respiratory tract infections: 5 to 10 days
Lower respiratory tract infections: 7 to 14 days or until the signs and
symptoms indicate that the condition is cured. Legionnaire's Disease requires
prolonged treatment. It is recommended that initially Erythromycin
lactobionate intravenously should be administered.
Skin and soft tissue infections: 5 to 10 days. Acne may require prolonged
treatment.
Sexually transmitted diseases - NGU and syphilis: 10 to 21 days. Some
conditions may require prolonged treatment.
Oral and dental infections: at least 5 days.
Eye infections - Chlamydia inclusion conjunctivitis: 3 weeks.
Gastro-intestinal infections - Campylobacter: a minimum of 5 days.
RETCIN is taken by mouth.

4.3

Contraindications
RETCIN is contraindicated in patients sensitive to Erythromycin. Use of
RETCIN in conjunction with other anti-infection agents except when
especially warranted.
Erythromycin is contraindicated with either Astemizole or Terfenadine and is
also contra-indicated with ergotamine and di-hydroergotamine.

4.4

Special warnings and precautions for use
Caution should be exercised when administering RETCIN to patients with
impaired hepatic function as the drug is principally excreted by the liver.
Super infection caused by non-susceptible bacteria or fungi may occur during
prolonged or repeated therapy and this is more likely when other anti-bacterial
agents are simultaneously employed.
Hepatic dysfunction including increased liver enzymes and/or cholestatic
hepatitis, with or without jaundice, has been infrequently reported with
erythromycin.
Renal impairment. Prolongation of QT interval (ventricular tachycardia
reported). Porphyria.
RETCIN contains lactose and is unsuitable for people with lactase
insufficiency, galactosaemia or glucose/galactose malabsorption syndrome.
The product also contains ponceau 4R (E124) which may cause allergic-type
reactions including asthma. Allergy is more common in those people who are
allergic to aspirin.

4.5

Interaction with other medicinal products and other forms of interaction
Concomitant use of Erythromycin with terfenadine or astemizole is likely to
result in an enhanced risk of cardiotoxicity with these drugs. The concomitant
use of Erythromycin with either astemizole or terfenadine is therefore
contraindicated. There is also an increased risk of ventricular arrhythmias
when erythromycin is given with cisapride, pimozide or sertindole.
Concomitant use should be avoided. Note, there is a similar risk with
amiodarone, amisulpride, moxifloxacin or quinidine when given with
parenteral erythromycin.
Concurrent use of erythromycin with ergotamine or di-hydroergotamine has
been associated in some patients with acute ergotoxicity with the rapid
development of severe peripheral vasospasm and dysethesia.
The anticoagulant effect of coumarins may be increased by erythromycin.
With the following drugs an increase in serum concentration and/or inhibition
of their metabolism may occur when they are administered concurrently with
erythromycin: acenocoumarol, alfentanil, astemizole, bromocriptine,
buspirone, carbamazepine, cabergoline, ciclosporin, corticosteroids, digoxin,
disopyramide, eletriptan, eplerenone, galantamine, immuno-suppressants (e.g.
sirolimus, tacrolimus), methylprednisolone, midazolam, phenytoin, sildenafil,
terfenadine, triazolam, valproate, vardenafil, warfarin, zopiclone and possibly
clozapine, felodipine, rifabutin, tadalafil and loratidine. Also avoid
concomitant use of mizolastine and cilostazol.
Monitoring should be undertaken and dosage adjusted accordingly.

Plasma concentration of erythromycin may be increased by ritonavir and
amprenavir. Cimetidine increases plasma-erythromycin concentration and
increases risk of toxicity including deafness.
Erythromycin increases the toxicity of vinblastine therefore avoid concomitant
use.
Concurrent administration of Theophylline with oral erythromycin produces a
significant decrease in erythromycin serum concentration, which could result
in sub-therapeutic concentrations of erythromycin.
Plasma concentration of rosuvastatin and zafirlukast is reduced by
erythromycin.
Increased risk of myopathy with simvastatin and possibly atorvastatin,
therefore avoid concomitant use.
Avoid concomitant use with lercanidipine, reboxitine and tolterodine.

4.6

Pregnancy and lactation
There is no evidence of risk from erythromycin in human pregnancy. It has
been in wide use for many years without apparent ill consequence. Animal
studies have reported no risk.
Erythromycin is excreted in breast milk, therefore caution should be exercised
when erythromycin is administered to a breast-feeding patient.

4.7

Effects on ability to drive and use machines
Not applicable

4.8

Undesirable effects
Allergic reactions are rare and mild but anaphylaxis has occurred. Skin
reactions ranging from mild eruptions to erythema multiforme, StevensJohnson Syndrome and toxic epidermal necrolysis have rarely been reported.
Occasionally nausea, abdominal discomfort and vomiting which subside after
a few days without having to discontinue treatment.
As with other broad spectrum antibiotics, pseudomembranous colitis has been
reported rarely with erythromycin.
Reversible hearing loss associated with doses of erythromycin usually greater
then 4 g per day has been reported.

Symptoms of hepatitis, hepatic dysfunction and/or abnormal liver function test
results may occur.
Cardiac effects including chest pain and arrhythmias) and myasthenia-like
synndrome have also been reported.

4.9

Overdose
Gastric lavage and supportive measures.

5

PHARMACOLOGICAL PROPERTIES

5.1

Pharmacodynamic properties
The action of Erythromycin is bacteriostatic or bactericidal, depending on the
organism and the concentration achieved. The effects of Erythromycin in
combination with other antibiotics are unpredictable. The synthesis of
penicillinase is variably affected, resulting in synergy where antagonism with
susceptible beta-lactams. The listericidal effects of penicillins, rifampicin and
gentamycin are antagonised. Erythromycin is synergistic with sulphonamides
against H.influenzae.

5.2

Pharmacokinetic properties
Erythromycin binding to plasma is 73% for the base. The drug is distributed
within an apparent volume of 0.75 l./kg. and eliminated with a half-time of 1
to 1.5 hours. Erythromycin is inactivated by N-demethylation in the liver, but
the concentration of active drug in the bile is high and there is evidence of
entero-hepatic circulation.
The drug passes the placental barrier to reach concentrations in foetal plasma
of 5-20% of those in the maternal circulation.
Erythromycin is distributed to most sites, except brain and CSF.
Erythromycin base is concentrated within alvolar macrophages by active
transport to a concentration of 20-30 times that in the plasma. The drug is also
concentrated in polymorphonuclear leucocytes.
Erythromycin is inactivated by N-demethylation in the liver. From 5 to 10%
of the dose is excreted unchanged in the urine.

5.3

Preclinical safety data
Not applicable

6

PHARMACEUTICAL PARTICULARS

6.1

List of excipients
Lactose
Maize starch
Potato starch
Sodium starch glycollate
Magnesium stearate
Cellacephate
Diethylphthalate
Aluminium lake E124,
approx. 20% dye content
Carnauba wax
Beeswax

6.2

Incompatibilities
None known

6.3

Shelf life
36 months

6.4

Special precautions for storage
Keep container tightly closed. Protect from light. Store below 25°C in a dry
place.

6.5

Nature and contents of container
High density polystyrene or polypropylene containers with polythene or
polypropylene lids and polyurethane/polythene inserts
Pack sizes: 28, 30, 50, 56, 60, 84, 100, 250, 500, 1000.

6.6

Special precautions for disposal
Not applicable.

7

MARKETING AUTHORISATION HOLDER
Chelonia Healthcare Limited
11 Boumpoulinas Street,
3rd floor, 1060 Nicosia
Cyprus

8

MARKETING AUTHORISATION NUMBER(S)
PL 33414/0045

9

DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
02/03/2006

10

DATE OF REVISION OF THE TEXT
18/02/2009

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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