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Metronidazole 200mg Tablet POM x21

Metronidazole 200mg Tablet POM x21

Generic

Pharmaceutical Product
  • UK marketing authorisation as a Prescription Only Medicine (POM) for metronidazole 200mg film Coated tablets.
  • Manufactured and quality Controlled in compliance with Good Manufacturing Practice (GMP) and applicable UK/EU medicines regulations.
Antimicrobial / Nitroimidazole antibiotic and antiprotozoal

Description

Metronidazole 200mg Tablet POM x21 is a prescription-only oral antimicrobial medicine containing 200mg of metronidazole BP per film-coated tablet. It is indicated for the prophylaxis and treatment of infections where anaerobic bacteria have been identified or are suspected to be the cause and is also active against several protozoal pathogens. This generic product is supplied as 21 tablets in aluminium/PVC or PVC/PVDC blister packs within an outer carton and is used in adults and children according to licensed indications, national guidelines and the current Summary of Product Characteristics.

Bnefits

  • Active against a wide spectrum of pathogenic anaerobic bacteria, including Bacteroides, Fusobacteria, Clostridia, Eubacteria, anaerobic cocci and Gardnerella vaginalis.
  • Active against protozoa such as Trichomonas vaginalis, Entamoeba histolytica, Giardia lamblia and Balantidium coli.
  • Used both in the prophylaxis and treatment of anaerobic infections associated with surgery or systemic sepsis.
  • Oral tablet formulation provides systemic therapy for deep-seated or mixed infections involving anaerobic organisms when appropriate.
  • Recognised treatment option for urogenital trichomoniasis, bacterial vaginosis, amoebiasis, giardiasis and acute dental infections.
  • Supports management of anaerobically infected leg ulcers and pressure sores as part of comprehensive care.
  • Film-coated presentation 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 species of Bacteroides and anaerobic streptococci.
  • Treatment of septicaemia and bacteraemia caused by susceptible anaerobic organisms.
  • Treatment of peritonitis and other 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, pelvic cellulitis and post-operative wound infections from which pathogenic anaerobes have been isolated.
  • Treatment of urogenital trichomoniasis in females (trichomonal vaginitis) and in males.
  • Treatment of bacterial vaginosis (non-specific vaginitis, anaerobic vaginosis, Gardnerella vaginitis).
  • Treatment of all forms of amoebiasis, including intestinal and 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 take account of official guidance and local antimicrobial policies on the appropriate use of antibacterial agents.

Composition

  • Active ingredient: Metronidazole 200mg per film-coated tablet.
  • Tablet core: typical generic excipients may include microcrystalline cellulose, maize starch or pregelatinised starch, povidone, colloidal anhydrous silica, magnesium stearate and/or similar pharmaceutically acceptable excipients (exact composition depends on manufacturer).
  • Film coating: film-coating system containing polymers and pigments suitable for oral use (e.g. hypromellose, titanium dioxide, macrogols; exact composition depends on manufacturer).
  • Pharmaceutical form: film-coated tablet for oral administration.

Formulation

  • Film-coated tablets containing 200mg metronidazole BP each.
  • Designed for oral administration with systemic absorption from the gastrointestinal tract.
  • Typically white or off-white, circular film-coated tablets (appearance may vary slightly between manufacturers).
  • Prescription-Only Medicine (POM) belonging to the nitroimidazole class of antimicrobials with antibacterial and antiprotozoal activity.
  • Generic British Pharmacopoeia-standard formulation aligned with UK/European regulatory requirements for metronidazole 200mg tablets.

Packaging

  • Supplied as packs of 21 tablets (commonly 3 blisters of 7 tablets) intended for prescription use.
  • Tablets are packed in aluminium-PVC or PVC/PVDC blister strips to protect against moisture and handling damage.
  • Outer carton contains the blister strips and a patient information leaflet.
  • Other pack sizes (e.g. 7, 10, 14, 28, 30, 84, 100, or HDPE bottles of 100 and 250 tablets) may exist for the same strength depending on manufacturer and market, but the WMS product refers specifically to the 21-tablet POM pack.
  • Carton and blister labelling include product name, strength, legal classification (POM), batch number, expiry date and details of the marketing authorisation holder/manufacturer.

Usage

  • For oral use only; tablets should generally be swallowed whole with water, and may be taken with or after food if recommended in the patient information leaflet.
  • Dose, frequency and duration of treatment are determined by the prescriber based on indication, site and severity of infection, and patient factors such as age, weight and hepatic/renal function.
  • Patients must follow the directions given by their healthcare professional and the instructions in the Patient Information Leaflet (PIL); they should not exceed the prescribed dose or duration.
  • Patients are usually advised to complete the full prescribed course even if symptoms improve earlier, unless their prescriber advises otherwise.
  • Consumption of alcohol is generally discouraged during treatment with metronidazole and for a period after stopping due to the risk of disulfiram-like reactions (e.g. flushing, nausea, vomiting, tachycardia).
  • If a dose is missed, patients should follow the advice in the PIL (e.g. take it as soon as remembered unless it is nearly time for the next dose; do not double the next dose to make up for a missed one).
  • Patients should seek medical advice promptly if they experience significant side effects, neurological symptoms or signs of hypersensitivity.
  • Use in children, pregnant or breastfeeding women, and patients with hepatic or renal impairment must follow specific medical guidance and current product labelling.

Contraindications

  • Hypersensitivity to metronidazole, other nitroimidazole derivatives, or any of the excipients in the formulation.
  • First trimester of pregnancy, unless the potential benefit clearly outweighs the possible risk and a physician deems it necessary.
  • History of or active severe blood dyscrasias where nitroimidazole therapy is considered unsuitable.
  • Caution or avoidance in patients with active or severe central nervous system disease (e.g. epilepsy, history of seizures, peripheral neuropathy), in line with product labelling.
  • Concomitant use with disulfiram is generally contraindicated due to risk of psychotic reactions; an adequate interval between treatments is recommended.
  • Severe hepatic impairment requires special caution, dose adjustment or close monitoring because of reduced clearance and risk of accumulation.
  • Full details and any additional contraindications should be checked in the current SmPC for the specific product dispensed.

Adverse Effects

  • Gastrointestinal: nausea, vomiting, epigastric discomfort, abdominal pain, diarrhoea, loss of appetite and unpleasant or metallic taste are among the most frequently reported effects.
  • Neurological: headache and dizziness are relatively common; less commonly, peripheral neuropathy, paraesthesia, ataxia, seizures or encephalopathy may occur, especially with prolonged or high-dose treatment.
  • Hypersensitivity: rash, pruritus, urticaria and, rarely, angioedema or anaphylactic reactions.
  • Mucosal/oral: dry mouth, furry tongue, glossitis, stomatitis; darkening of urine may occur due to metabolites and is usually benign.
  • Hepatic: elevated liver enzymes and rare cases of hepatitis or cholestatic jaundice, particularly in susceptible individuals or with prolonged use.
  • Haematological: very rare cases of leukopenia, neutropenia or thrombocytopenia.
  • Other: fatigue, fever or arthralgia have been reported.
  • Patients should refer to the Patient Information Leaflet for the complete list of side effects and contact a healthcare professional 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 printed on the pack.
  • Do not use if the blister strips or outer carton are damaged or show signs of tampering.

Duration

Varies according to the indication, severity of infection, patient factors and prescriber judgement; typical courses range from a few days to several weeks, following the licensed Summary of Product Characteristics and local antimicrobial guidelines.

Onset

Antimicrobial activity begins once therapeutic systemic concentrations are reached after oral dosing; clinical improvement in susceptible infections is usually observed within several days, although full resolution depends on infection type, site, and concurrent management (e.g. surgery, drainage).

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