ERMYCIN Film-coated tablet (2020)
Βιβλιογραφική αναφορά
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Περιεχόμενα
1. Name of the medicinal product
Ermycin 250 mg film-coated tablets. Ermycin 500 mg film-coated tablets.
2. Qualitative and quantitative composition
Ermycin 250 mg film-coated tablets: Each tablet contains erythromycin stearate equivalent to 250 mg erythromycin. Ermycin 500 mg film-coated tablets: Each tablet contains erythromycin stearate equivalent ...
3. Pharmaceutical form
Film-coated tablet. Ermycin 250 mg film-coated tablets are pink, round, scored, film-coated tablets with Remedicas logo on one side. Ermycin 500 mg film-coated tablets are white, modified capsule shaped, ...
4.1. Therapeutic indications
Ermycin film-coated tablets are indicated in adults and children aged over 8 years for the treatment of infections caused by erythromycin-sensitive organisms. Consideration should be given to official ...
4.2. Posology and method of administration
Posology Adults and children over 8 years For mild to moderate infections 1-2 g daily in divided doses. Up to 4g daily in severe infections. Elderly No special dosage recommendations. Paediatric population ...
4.3. Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Erythromycin is contraindicated in patients taking astemizole, terfenadine, domperidone, cisapride or pimozide. ...
4.4. 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 ...
4.5. Interaction with other medicinal products and other forms of interaction
Erythromycin is a moderate inhibitor of CYP3A4 mediated metabolism and P-glycoprotein. Increases in serum concentrations of the following drugs metabolised by the cytochrome P450 system may occur when ...
4.6. Pregnancy and lactation
Pregnancy 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 ...
4.7. Effects on ability to drive and use machines
None known.
4.8. Undesirable effects
System organ class Adverse reactions <b>Blood and lymphatic system disorders</b> Eosinophilia. <b>Immune system disorders</b> Hypersensitivity, anaphylactic reaction. <b>Psychiatric disorders</b> ...
4.9. Overdose
Symptoms Diarrhoea, severe nausea, vomiting and hearing loss. Treatment Gastric lavage, general supportive measures.
5.1. Pharmacodynamic properties
<b>Pharmacotherapeutic Group:</b> Antibacterials for systemic use; Macrolides, Lincosamides and Streptogramins <b>ATC Code:</b> J01FA01 Mechanism of action Erythromycin exerts its antimicrobial action ...
5.2. Pharmacokinetic properties
Absorption Orally administered erythromycin stearate is readily and reliably absorbed. Distribution Optimal serum levels of erythromycin are reached when the drug is taken in the fasting state or immediately ...
5.3. Preclinical safety data
Carcinogenesis, Mutagenesis and Impairment of Fertility Long-term (2 years) oral studies conducted in rats up to about 400 mg/kg/day and in mice up to about 500 mg/kg/day with erythromycin stearate did ...
6.1. List of excipients
Ermycin 250 mg film-coated tablets <u>Core:</u> Povidone Microcrystalline cellulose Croscarmellose sodium Sodium lauryl sulfate Talc <u>Coating:</u> Hypromellose Polyethylene glycol 400 Titanium Dioxide ...
6.2. Incompatibilities
Not applicable.
6.3. Shelf life
5 years.
6.4. Special precautions for storage
Store below 25°C, protected from light and moisture.
6.5. Nature and contents of container
<u>Ermycin 250 mg film-coated tablets:</u> PVC/Aluminium blisters. Pack sizes of 20, 100 and 1000 film-coated tablets. PP containers with PE closure. Pack size of 1000 film-coated tablets. <u>Ermycin 500 ...
6.6. Special precautions for disposal and other handling
No special requirements.
7. Marketing authorization holder
Remedica Ltd, Aharnon Str., Limassol Industrial Estate, 3056 Limassol, Cyprus
8. Marketing authorization number(s)
Ermycin 250 mg film-coated tablets: 9340 Ermycin 500 mg film-coated tablets: 16033
9. Date of first authorization / renewal of the authorization
<u>Ermycin 250 mg film-coated tablets:</u> Date of first authorization: 26 May 1984 Date of latest renewal: 22 December 2011 <u>Ermycin 500 mg film-coated tablets:</u> Date of first authorization: 03 February ...
10. Date of revision of the text
17/02/2020
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