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SPC, UK: ERYTHROCIN Film coated tablets (2018)

Αναφορές

Βιβλιογραφική αναφορά

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Περιεχόμενα

Name of the medicinal product

Erythrocin 250. Erythromycin Stearate BP 250mg.

Qualitative and quantitative composition

Active: Erythromycin as erythromycin stearate 250 mg/tablet.

Pharmaceutical form

Film coated tablet.

Therapeutic indications

For the prophylaxis and treatment of infections caused by erythromycin-sensitive organisms. Erythromycin is highly effective in the treatment of a great variety of clinical infections such as: Upper Respiratory ...

Posology and method of administration

For oral administration. Adults and children over 8 years For mild to moderate infections 2g daily in divided doses. Up to 4g daily in severe infections. Elderly No special dosage recommendations. Note: ...

Contraindications

Known hypersensitivity to erythromycin. Erythromycin is contraindicated in patients taking simvastatin, tolterodine, mizolastine, amisulpride, astemizole, terfenadine, domperidone, cisapride or pimozide. ...

Special warnings and precautions for use

Erythromycin is excreted principally by the liver, so caution should be exercised in administering the antibiotic to patients with impaired hepatic function or concomitantly receiving potentially hepatotoxic ...

Interaction with other medicinal products and other forms of interaction

Increases in serum concentrations of the following drugs metabolised by the cytochrome P450 system may occur: when administered concurrently with erythromycin: acenocoumarol, alfentanil, astemizole, bromocriptine, ...

Pregnancy and lactation

There are no adequate and well-controlled studies in pregnant women. However, observational studies in humans have reported cardiovascular malformations after exposure to medicinal products containing ...

Effects on ability to drive and use machines

None reported.

Undesirable effects

Blood and lymphatic system disorders: Eosinophilia. Cardiac disorders: QTc interval prolongation, torsades de pointes, palpitations, and cardiac rhythm disorders including ventricular tachyarrhythmias. ...

Overdose

Symptoms: hearing loss, severe nausea, vomiting and diarrhoea. Treatment: gastric lavage, general supportive measures.

Pharmacodynamic properties

ATC code: J01FA01 Erythromycin exerts its antimicrobial action by binding to the 50S ribosomal sub-unit of susceptible microorganisms and suppresses protein synthesis. Erythromycin is usually active against ...

Pharmacokinetic properties

Peak blood levels normally occur within one hour of dosing of erythromycin ethylsuccinate granules. The elimination half life is approximately two hours. Doses may be administered two, three or four times ...

Preclinical safety data

There are no pre-clinical data of relevance to the prescriber which are additional to that already included in other sections of the SPC.

List of excipients

Povidone Maize starch Magnesium hydroxide Polacrilin potassium Polyethylene glycol 8000 Polyethylene glycol 400 Hydroxypropyl methyl cellulose Sorbic acid

Incompatibilities

None stated.

Shelf life

Shelf life: 60 months.

Special precautions for storage

None stated.

Nature and contents of container

High density Polyethylene bottle with urea cap with 100 tablets, securitainer or snap-secure container with 50, 100 or 1000 tablets. Blister packs containing 10, 14, 15, 28 or 56 tablets: PVC, heat sealed ...

Special precautions for disposal and other handling

Not applicable.

Marketing authorization holder

Amdipharm UK Limited, Capital House, 85 King William Street, London EC4N 7BL, UK

Marketing authorization number(s)

PL 20072/0036

Date of first authorization / renewal of the authorization

16/01/2006

Date of revision of the text

09/02/2018

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