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 Φάρμακα Α - Ζ  Συγχορήγηση  Μητρότητα

METRONIDAZOLE Film-coated tablet (2018)

Αναφορές

Βιβλιογραφική αναφορά

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Περιεχόμενα

Name of the medicinal product

Metronidazole 500 mg Film-Coated Tablets.

Qualitative and quantitative composition

Each tablet contains metronidazole 500 mg. Excipients with known effect: Wheat starch 164.30 mg. For the full list of excipients, see section 6.1.

Pharmaceutical form

Film-Coated Tablets.

Therapeutic indications

Metronidazole is active against a wide range of pathogenic microorganisms, notably species of Bacteroids, Fusobacteria, Clostridia, Eubacteria, anaerobic cocci and Gardnerella vaginalis. It is also active ...

Posology and method of administration

Posology Metronidazole Tablets should be taken during or after meals, swallowed with water and not chewed. Elderly: Caution is advised in the elderly, particularly at high doses, although there is limited ...

Contraindications

Known hypersensitivity to metronidazole or any of the ingredients in the tablets. Pregnancy metronidazole should not be used in the first trimester in patients with trichomoniasis or bacterial vaginosis ...

Special warnings and precautions for use

Contains wheat starch. Suitable for people with coeliac disease. Patients with wheat allergy (different from coeliac disease) should not take this medicine. Patients should abstain from alcohol for at ...

Interaction with other medicinal products and other forms of interaction

Combinations to be used with caution Lithium: Lithium retention accompanied by evidence of possible renal damage has been reported in patients treated simultaneously with lithium and metronidazole. Lithium ...

Pregnancy and lactation

As with all medicines, metronidazole should not be given during pregnancy or during lactation unless it is considered essential, and in these circumstances the short, high-dosage regimens are not recommended. ...

Effects on ability to drive and use machines

Patients should be warned about the potential for drowsiness, dizziness, confusion, hallucinations, convulsions or transient visual disorders, and advised not to drive or operate machinery if these symptoms ...

Undesirable effects

Frequency type and severity of adverse reactions in children are the same as in adults. The frequency of adverse events listed below is defined using the following convention: very common (≥1/10); common ...

Overdose

Features Nausea, vomiting, diarrhoea, anorexia, metallic taste, headache, dizziness and occasionally insomnia and drowsiness. Transiently increased liver enzyme activities have been reported rarely. Transient ...

Pharmacodynamic properties

Pharmacotherapeutic group: Nitroimidazole derivatives ATC Code: P01AB01 Mechanism of action Metronidazole has antiprotozoan and antibacterial effects. It is effects against Trichomonas vaginalis, Gardnerella ...

Pharmacokinetic properties

Absorption Metronidazole is readily absorbed following administration by mouth and bioavailability is 90-100%. Peak plasma concentrations of approximately 5µg/ml and 10µg/ml are achieved an average of ...

Preclinical safety data

None.

List of excipients

Tablet core: Wheat starch Povidone (K30) Magnesium stearate Film coating: Hypromellose Macrogol (type 20000)

Incompatibilities

None.

Shelf life

36 months.

Special precautions for storage

Keep blister in the outer carton, protected from light.

Nature and contents of container

Blister pack (aluminium (25 µm)/PVC (250 µm)), pack sizes of 21 tablets. Not all pack sizes may be marketed.

Special precautions for disposal and other handling

Not applicable.

Marketing authorization holder

Creo Pharma Limited, Felsted Business Centre, Felsted, Essex, CM6 3LY

Marketing authorization number(s)

PL 31862/0015

Date of first authorization / renewal of the authorization

11/10/2018

Date of revision of the text

11/10/2018

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