METRONIDAZOLE Film-coated tablet (2024)

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Περιεχόμενα

Name of the medicinal product

Metronidazole 500 mg film-coated tablets.

Qualitative and quantitative composition

Each film-coated tablet contains 500 mg metronidazole. Excipient(s) with known effect: Each tablet contains 1.981mg of sodium. For the full list of excipients, see Section 6.1.

Pharmaceutical form

Film-coated tablets. White to off white, oblong shaped, coated tablets, debossed with M and '500on one face and a break line on the other face. The size is 16.6 mm x 7.3 mm.

Therapeutic indications

Metronidazole is active against a wide range of pathogenic micro-organisms, notably species of Bacteroids, Fusobacteria, Clostridia, Eubacteria, anaerobic cocci and ...

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

Hypersensitivity to the active substance metronidazole or other nitroimidazole derivatives or to any of the excipients listed in section 6.1. Pregnancy metronidazole should not be used in the first trimester ...

Special warnings and precautions for use

Patients should abstain from alcohol for at least 48 hours following discontinuation of therapy with metronidazole. A disulfiram-like reaction with hypotension and flushing has occurred (see section 4.5). ...

Interaction with other medicinal products and other forms of interaction

Lithium Lithium retention accompanied by evidence of possible renal damage has been reported in patients treated simultaneously with lithium and metronidazole. Lithium treatment should be tapered or withdrawn ...

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, vertigo, confusion, hallucinations, convulsions or transient visual disorders, and advised not to drive or operate machinery if ...

Undesirable effects

The frequency of adverse events listed below is defined using the following convention: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very ...

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 actions and it is effective against Trichomonas ...

Pharmacokinetic properties

Absorption Metronidazole is readily absorbed following administration by mouth and bioavailability is 90-100%. Peak plasma concentrations occur after 20 minutes to 3 hours. Absorption may be delayed, but ...

Preclinical safety data

None.Metronidazole has been shown to be carcinogenic in the mouse and in the rat following chronic oral administration however similar studies in the hamster have given negative results. Epidemiological ...

List of excipients

Tablet core: Cellulose microcrystalline Starch pregelatinised (maize starch) Hydroxypropylcellulose Silica colloidal anhydrous Sodium starch glycolate Stearic acid Tablet coat: Hypromellose ...

Incompatibilities

Not applicable.

Shelf life

3 years.

Special precautions for storage

The medicinal product does not require any special storage conditions.

Nature and contents of container

Metronidazole film-coated tablets are available in clear PVC/Aluminium foil containing 21 film-coated tablets. Not all pack sizes may be marketed.

Special precautions for disposal and other handling

Any unused medicinal product or waste material should be disposed off in accordance with local requirements.

Marketing authorization holder

Milpharm Limited, Ares Block, Odyssey Business Park, West End Road, Ruislip, HA46QD, United Kingdom

Marketing authorization number(s)

PL 16363/0574

Date of first authorization / renewal of the authorization

22/11/2019

Date of revision of the text

17/09/2024

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