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Metronidazole BP 400mg Tablet POM x21

Metronidazole BP 400mg Tablet POM x21

Generic

Pharmaceutical Product
  • UK marketing authorisation (Prescription Only Medicine) for metronidazole 400mg tablets.
  • Manufactured and quality Controlled in accordance with Good Manufacturing Practice (GMP) and relevant EU/UK medicinal product regulations.
Antimicrobial / Nitroimidazole antibiotic and antiprotozoal

Description

Metronidazole BP 400mg Tablet POM x21 is a prescription-only oral antimicrobial medicine containing 400mg of metronidazole BP per tablet. It is indicated for the prophylaxis and treatment of infections in which anaerobic bacteria have been identified or are suspected to be the cause, and is also active against certain protozoa. The product is supplied as film-coated tablets in blister packs of 21 tablets and is used in adults and children for a range of anaerobic bacterial and protozoal infections according to current clinical guidance and the licensed Summary of Product Characteristics.

Bnefits

  • Active against a wide range of pathogenic anaerobic bacteria, including Bacteroides, Fusobacteria, Clostridia, Eubacteria and anaerobic cocci.
  • Active against Gardnerella vaginalis and several protozoal pathogens such as Trichomonas vaginalis, Entamoeba histolytica, Giardia lamblia and Balantidium coli.
  • Useful in both prophylaxis and treatment of anaerobic infections associated with surgery or systemic sepsis.
  • Oral tablet formulation facilitates systemic treatment of deep-seated infections (e.g. intra-abdominal, pelvic, CNS) when appropriate.
  • Recognised treatment option for urogenital trichomoniasis, bacterial vaginosis, amoebiasis, giardiasis and certain dental infections.
  • Supports management of anaerobically infected leg ulcers and pressure sores as part of a comprehensive treatment plan.
  • Film-coated tablet aids swallowing and helps mask the bitter taste of metronidazole.

Indications

  • Prophylaxis and treatment of infections in which anaerobic bacteria have been identified or are suspected to be the cause.
  • Prevention of post-operative infections due to anaerobic bacteria, particularly Bacteroides species and anaerobic streptococci.
  • Treatment of septicaemia and bacteraemia caused by susceptible anaerobic organisms.
  • Treatment of peritonitis and intra-abdominal infections involving anaerobic bacteria.
  • Treatment of brain abscess and necrotising pneumonia where susceptible anaerobes are implicated.
  • Treatment of osteomyelitis, puerperal sepsis, pelvic abscess and pelvic cellulitis due to anaerobic pathogens.
  • Treatment of post-operative wound infections from which pathogenic anaerobes have been isolated.
  • Treatment of urogenital trichomoniasis in females (trichomonal vaginitis) and males.
  • Treatment of bacterial vaginosis (non-specific vaginitis, anaerobic/Gardnerella vaginitis).
  • Treatment of all forms of amoebiasis, including intestinal, extra-intestinal disease and asymptomatic cyst passers.
  • Treatment of giardiasis.
  • Treatment of acute ulcerative gingivitis.
  • Treatment of anaerobically infected leg ulcers and pressure sores.
  • Treatment of acute dental infections such as acute pericoronitis and acute apical infections.
  • Use should follow official guidance on the appropriate use of antibacterial agents and local antimicrobial policies.

Composition

  • Active ingredient: Metronidazole BP 400mg per tablet.
  • Tablet core (typical generic composition): includes excipients such as microcrystalline cellulose, hydroxypropylcellulose, colloidal anhydrous silica, crospovidone and stearic acid (exact excipients may vary by manufacturer).
  • Film coating (typical generic composition): film-coating system such as Opadry Yellow containing polymers, pigments and excipients appropriate for oral use (exact composition may vary by manufacturer).
  • Pharmaceutical form: film-coated tablet for oral administration.

Formulation

  • Film-coated tablet containing 400mg metronidazole BP as the active substance.
  • Designed for oral administration with systemic absorption of metronidazole.
  • Tablets are generally white to off-white or light yellow film-coated, caplet or oval shaped, depending on manufacturer.
  • Prescription-only medicine (POM) classified as an antimicrobial nitroimidazole with antibacterial and antiprotozoal activity.
  • Generic BP formulation aligned with British Pharmacopoeia specifications for metronidazole tablets.

Packaging

  • Supplied as Prescription Only Medicine (POM) in packs of 21 tablets.
  • Tablets are typically packed in aluminium/PVC or PVC/PVDC blister strips.
  • Outer carton contains blister packs (e.g. 7, 10, 14, 21, 28, 30, 84 or 100 tablets) with a patient information leaflet enclosed; the WMS listing refers specifically to a 21-tablet pack.
  • Some presentations may also be supplied in HDPE bottles (e.g. 100 or 250 tablets) within an outer carton with leaflet, depending on manufacturer and market.
  • Pack markings include product name, strength (400mg), quantity, batch number, expiry date, legal classification (POM) and manufacturer/marketing authorisation holder details.

Usage

  • For oral use only; tablets should generally be swallowed whole with water, with or after food if recommended in the patient information leaflet.
  • Dose, dosing frequency and duration of treatment must be determined by a prescriber, based on the type and severity of infection, patient age, weight, renal/hepatic function and local guidelines.
  • Use strictly according to the directions given by the prescribing healthcare professional and the approved Summary of Product Characteristics (SmPC) / Patient Information Leaflet (PIL).
  • Do not exceed the prescribed dose or duration of therapy.
  • Patients should complete the full prescribed course even if symptoms improve earlier, unless instructed otherwise by their prescriber.
  • Alcohol should generally be avoided during treatment and for a period after stopping metronidazole due to the risk of a disulfiram-like reaction (nausea, vomiting, flushing, tachycardia).
  • If a dose is missed, patients should follow the guidance in the patient leaflet or from their prescriber (e.g. take as soon as remembered unless close to the next dose; do not double doses).
  • If significant side effects or signs of allergic reaction occur, patients should seek medical advice promptly.
  • Use in children and special populations (e.g. pregnant, breastfeeding, hepatic impairment) must follow specific medical advice and current product labelling.

Contraindications

  • Known hypersensitivity to metronidazole, other nitroimidazole derivatives, or any of the excipients in the formulation.
  • First trimester of pregnancy, unless clearly necessary and the potential benefits outweigh the risks as determined by a physician.
  • History of blood dyscrasias or active severe haematological disorders, where metronidazole should generally be avoided.
  • Caution or avoidance in patients with active or history of severe central nervous system disorders (e.g. epilepsy, peripheral neuropathy) where nitroimidazole therapy may pose additional risk.
  • Concomitant use with disulfiram may be contraindicated due to the risk of psychotic reactions; an interval is usually recommended between the two medicines.
  • Use with caution and under close supervision in patients with severe hepatic impairment, due to reduced clearance and risk of accumulation.
  • Specific contraindications and cautions should always be checked against the current SmPC for the particular product and patient situation.

Adverse Effects

  • Gastrointestinal effects: nausea, vomiting, epigastric discomfort, abdominal pain, diarrhoea, loss of appetite and metallic taste are among the most commonly reported adverse reactions.
  • Neurological effects: headache, dizziness and, less commonly, peripheral neuropathy, seizures or encephalopathy, particularly with prolonged or high-dose therapy.
  • Hypersensitivity reactions: skin rash, pruritus, urticaria and, rarely, angioedema or anaphylactic reactions.
  • Oral and mucosal effects: dry mouth, furry tongue, glossitis and stomatitis; darkening of urine may also occur due to metronidazole metabolites.
  • Hepatic effects: elevated liver enzymes and rarely cholestatic or mixed hepatocellular-cholestatic hepatitis, particularly in predisposed patients.
  • Haematological effects: rare cases of leukopenia, neutropenia or thrombocytopenia have been reported.
  • Other effects: transient taste disturbance, fatigue and, rarely, fever or arthralgia.
  • Patients should consult the patient information leaflet for a full list of potential side effects and seek medical advice if they experience serious, persistent or unusual symptoms.

Storage Conditions

  • This medicinal product does not require any special storage conditions.
  • Store in the original package to protect the tablets from moisture and light.
  • Keep out of the sight and reach of children.
  • Do not use after the expiry date stated on the blister and carton.
  • Do not use if the packaging is damaged or shows signs of tampering.

Duration

Treatment duration varies according to the indication, severity of infection, patient factors and prescriber judgment; typical courses may range from a few days to several weeks as specified in the SmPC and local antimicrobial guidelines.

Onset

Antimicrobial activity begins as systemic therapeutic levels of metronidazole are reached after oral dosing; clinical improvement is usually observed within a few days in responsive infections, although full resolution depends on the site and severity of infection and concurrent measures (e.g. surgery, drainage).

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