METRONIDAZOLE Film-coated tablet (2018)
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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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