Tablet, Suspension, IV Infusion

1. What Filmet is and what it is used for?
Filmet is a sterile, pyrogen free, isotonic formulation for intravenous administration in susceptible life threatening infections. Each 100ml solution contains Metronidazole USP 500mg. Metronidazole is a nitroimidazole with antiprotozoal and antibacterial actions. It is highly effective against Trichomonas vaginalis, Entamoeba histolytica and Giardia lamblia. It has a bactericidal action against a wide range of pathogenic anaerobic microorganisms particularly species of Bacteroides, Fusobacteria, Clostridia, Eubacteria, Anaerobic Cocci and Gardnerella vaginalis

2. Before you take Filmet
Do not take this medicine and tell your doctor if:

Known hypersensitivity to metronidazole.

Take special care with Filmet
Check with your doctor before taking this medicine if:

Regular clinical and laboratory monitoring are advised if administration of Filmet for more than 10 days is considered to be necessary. Metronidazole should be administered with caution to patients with hepatic encephalopathy. Caution is advised in patients with active disease of the central nervous system other than brain abscess. The consumption of alcohol during metronidazole therapy should be avoided since there could be a disulfiram-like reaction

Pregnancy and breast-feeding
There is inadequate evidence of the safety of metronidazole in pregnancy. Metronidazole is excreted in milk and no adverse effects in the newborn have been reported. Filmet should therefore be given during pregnancy or during lactation only when the physicians consider it essential.

3. How to take Filmet
Always use Filmet exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

How much to take?
Filmet may be diluted with appropriate volumes of normal saline, dextrose-saline, dextrose 5% w/v or potassium chloride (20 and 40 mmol) infusions.
For prophylaxis and treatment of anaerobic infections:
Adults: 100 ml (500 mg) immediately before, during or after operation,repeated 8 hourly
Children: 1.5 ml (7.5 mg) per kg body weight every 8 hours
Duration: Treatment for 7 days should be satisfactory for most patients but depending on clinical and bacteriological assessments, the physician may decide to prolong the treatment
Infusion rate: Filmet should be infused at an approximate rate of 5 ml/minute

If you take more Filmet than you should
If you have too much of this medicine, talk to your doctor straight away.

If you forget to take Filmet
If you forget to take a dose, take it as soon as you remember it. However, if it is nearly time for the next dose, skip the missed dose. Do not take a double dose to make up for a forgotten dose

If you stop taking Filmet
Do not stop taking this medicine without talking to your doctor. You should not stop taking Filmet just because you feel better. This is because the problem may come back or get worse again.
If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects
Like all medicines, Filmet can cause side effects, although not everybody gets them.

Serious adverse reactions occur very rarely with standard recommended regimens. Unpleasant taste in the mouth, furred tongue, nausea, vomiting or other gastrointestinal disturbances have been reported. Urticaria, skin rash, pruritus, angioedema and rarely anaphylaxis have occurred. Drowsiness, dizziness, headache, ataxia and darkening of the urine (due to metabolites) have been reported rarely. Peripheral neuropathy and/or transient epileptiform seizures have occurred during prolonged or intensive treatment but in most cases neuropathy disappears on cessation of therapy. A moderate, reversible leucopenia has been reported in some patients

Tell your doctor if any of the side effects gets serious or lasts longer than a few days, or if you notice any side effects not listed in this leaflet

5. How to store Filmet?
Store in a cool and dry place, away from light. Keep out of reach of children.

Filmet Prescribing Information

Located in: Anti-infectives