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SUMMARY OF PRODUCT CHARACTERISTICS

1    NAME OF THE MEDICINAL PRODUCT

Erythromycin Tablets 250mg

2.    Qualitative and Quantitative Composition

Erythromycin 250 mg For excipients see 6.1

3.    Pharmaceutical Form

Gastro-resistant tablet Red enteric film coated tablet

4    CLINICAL PARTICULARS

4.1    Therapeutic indications

For the prophylaxis and treatment of infections caused by Erythromycin-sensitive 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 pneumophilia, 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: 1-2g daily in divided doses for mild to moderate infection. This dosage may be increased to 4g 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.

Erythromycin is taken by mouth.

4.3. Contra-indications

Erythromycin is contra-indicated in patients sensitive to Erythromycin. Use of Erythromycin in conjunction with other anti-infection agents except when especially warranted.

Erythromycin is contra-indicated 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 Erythromycin 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.

Erythromycin contains the colour red E124 which may cause allergic-type reactions including asthma. Allergy is more common in those people who are allergic to aspirin.

4.5. Interactions with other Medicaments 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.

Concurrent use of erythromycin and ergotamine or dihydroergotamine has been associated in some patients with acute ergotoxicity with the rapid development of severe peripheral vasospasm and dysesthesia. With the following drugs an increase in serum concentration may occur when they are administered concurrently with erythromycin: digoxin, warfarin, carbamazepine, phenytoin, theophylline, cyclosporin, bromocriptine, disopyramide, alfentanil and triazolam. Monitoring should be undertaken and dosage adjusted accordingly.

Concurrent administration of theophylline with oral erythromycin produces a significant decrease in erythromycin serum concentration which could result in sub-therapeutic concentrations of erythromycin.

4.6. Pregnancy and Lactation

Erythromycin should not be used in pregnancy unless there are compelling reasons to do so.

4.7. Effects on Ability to Drive and Use Machines

Not applicable

Undesirable Effects

Allergic reactions are rare and mild but anaphylaxis has occurred. Skin reactions ranging from mild eruptions to a skin condition known as erythema multiforme, Stevens-Johnson 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 than 4g per day has been reported.

Symptoms of hepatitis, hepatic dysfunction and/or abnormal liver function test results may occur.

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

No relevant information additional to that contained elsewhere in the SPC.

6    PHARMACEUTICAL PARTICULARS

6.1    List of excipients

Core excipients:

Lactose Maize starch Potato starch Sodium starch glycollate Magnesium stearate

Coat excipients:

Cellulose Acetate Phthalate Diethyl phthalate Al Lake (E124)

Macrogol 6000

6.2. Incompatibilities

Not applicable.

Shelf Life

Containers: 36 months Blister packs: 36 months

6.4 Special precautions for storage

Do not store above 25°C.

Containers: Store in the original container and keep the container tightly closed.

Blister packs: Store in the original package. Keep container in the outer carton.

6.5 Nature and contents of container

6.6. Instruction for Use/Handling Not applicable.

Administrative Data

7. Marketing Authorisation Holder

Metwest Pharmaceuticals Limited

15 Runnelfield

Harrow on the Hill

Middlesex

HA1 3NY

United Kingdom

8. Marketing Authorisation Number

PL 17521/0007

9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION 06/01/2009

10 DATE OF REVISION OF THE TEXT

06/09/2013