Metronidazole Tablets USP 200mg Taj Pharma

1. 1. Name of the medicinal product

   Metronidazole Tablets USP 200mg Taj Pharma
   Metronidazole Tablets USP 250mg Taj Pharma
   Metronidazole Tablets USP 500mg Taj Pharma

   2. Qualitative and quantitative composition

a) Metronidazole Tablets USP 200mg Taj Pharma
Each film coated tablet contains:
Metronidazole USP 200mg
Excipients: Q.S.

b) Metronidazole Tablets USP 250mg Taj Pharma
Each film-coated tablet contains:
Metronidazole USP 250mg
Excipients: Q.S.

c) Metronidazole Tablets USP 500mg Taj Pharma
Each film-coated tablet contains:
Metronidazole USP 500mg
Excipients: Q.S.

Excipients with known effect: lactose monohydrate

For the full list of excipients, see section 6.1

3. Pharmaceutical form

Film-coated tablets.

4. Clinical particulars

• Therapeutic indications

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

It is also active against Trichomonas vaginalis, Entamoeba histolytica, Gardia lamblia, Balantidium coli and Helicobacter pylori.

Metronidazole Taj Pharma is indicated in adults and children for the following indications:

• Prevention of post-operative infections due to anaerobic bacteria, particularly species of bacteroidsand anaerobic streptococci.
• The treatment of septicaemia, bacteraemia, peritonitis, brain abscess, necrotising pneumonia, osteomyelitis, puerperal sepsis, pelvic abscess, pelvic cellulitis and post-operative wound infections from which pathogenic anaerobes have been isolated.
• Urogenital trichomoniasis in the female (Trichomonas vaginalis), and in man.
• Bacterial vaginosis (also known as non-specific vaginitis, anaerobic vaginosis or Gardnerella vaginalis).
• All forms of amoebiasis (intestinal and extra-intestinal disease and asymptomatic cyst passers).
• Acute ulcerative gingivitis.
• Acute dental infections (egacute pericoronitis and acute apical infections)
• Anaerobically-infected leg ulcers and pressure sores.

Treatment of Helicobacter pylori infection associated with peptic ulcer as part of triple therapy.

Consideration should be given to official guidance on the appropriate use of antibacterial agents.

• Posology and method of administration

Posology

Metronidazole Taj Pharma 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 information available on modification of dosage.

Hepatic impairment: Caution is advised in patients with hepatic encephalopathy. One third of the daily dose given once a day should be considered (see section 4.4).

1) Anaerobic infections:

Treatment for 7 days should be satisfactory for most patients but, depending upon clinical and bacteriological assessments, the physician may decide to prolong treatment, eg for eradication of infection from sites which cannot be drained or are liable to endogenous recontamination by anaerobic pathogens from the gut, oropharynx or genital tract.

Children > 8 weeks to 12 years of age: The usual daily dose is 20-30mg/kg/day as a single dose or divided into 7.5mg/kg every 8 hours. The daily dose may be increased to 40mg/kg, depending on the severity of the infection. Duration of treatment is usually 7 days.

Children < 8 weeks of age: 15mg/kg as a single dose daily or divided into 7.5mg/kg every 12 hours.

In newborns with a gestation age <40 weeks, accumulation of metronidazole can occur during the first week of life, why the concentrations of metronidazole in serum should preferable be monitored after a few days therapy.

Children under 10 years: A more suitable dosage form should be used for this age group.

Prophylaxis against anaerobic infection – chiefly in the context of abdominal (especially colorectal) and gynaecological surgery.

Adults: 1g stat dose 24 hours pre-operatively, followed by 400mg at 8 hourly intervals during the 24 hours preceding operation followed by post-operative iv or rectal administration until the patient is able to take tablets.

Children < 12 years: 20-30mg/kg as a single dose given 1-2 hours before surgery.

Newborns with a gestation age <40 weeks: 10mg/kg body weight as a single dose before operation.

Children under 10 years: A more suitable dosage form should be used for this age group.

2) Treatment of established infections:

Adults and children over 10 years: 800mg followed by 400mg 8 hourly.

Children under 10 years: A more suitable dosage form should be used for this age group.

3) Urogenital trichomoniasis:

Where reinfection is likely, sexual partners should be treated concomitantly.

Adults and adolescents: 2000mg as a single dose or 200mg 3 times daily for 7 days or 400mg twice daily for 5-7 days.

Children < 10 years: 40mg/kg orally as a single dose or 15 – 30mg/kg/day divided in 2-3 doses for 7 days; not to exceed 2000mg/dose.

Children under 10 years: A more suitable dosage form should be used for this age group.

4) Bacterial vaginosis

Adults: 400mg twice daily for 7 days, or 2g as a single dose for one day only.

Adolescents: 400mg twice daily for 5-7 days or 2000mg as a single dose.

5) Amoebiasis

Adults> 10 years: 400 to 800mg 3 times daily for 5-10 days.

Children 7 to 10 years: 200 to 400mg 3 times daily for 5-10 days.

Children 3 to 7 years: 100 to 200mg 4 times daily for 5-10 days.

Children 1 to 3 years: 100 to 200mg 3 times daily for 5-10 days.

Alternatively, doses may be expressed by body weight:

35 to 50mg/kg daily in 3 divided doses for 5 to 10 days, not to exceed 2400mg/day.

Children under 7 years: A more suitable dosage form should be used for this age group.

6) Giardiasis:

Adults > 10 years: 2000mg once daily for 3 days, or 400mg. three times daily for 5 days, or 500mg twice daily for 7 to 10 days.

Children 7 to 10 years: 1000mg once daily for 3 days.

Children 3 to 7 years: 600 to 800mg once daily for 3 days.

Children 1 to 3 years: 500mg once daily for 3 days.

Alternatively, as expressed inmg per kg of body weight:

15-40mg/kg/day divided in 2-3 doses.

Children under 7 years: A more suitable dosage form should be used for this age group.

7) Acute ulcerative gingivitis (for 3 day duration):

Adults and children over 10 years: 200mg three times daily.

Children under 10 years: A more suitable dosage form should be used for this age.

8) Acute dental infections (for 3-7 day duration):

Adults and children over 10 years: 200mg three times daily.

9) Leg ulcers and pressure sores (for 7 day duration):

Adults and children over 10 years: 400mg three times daily.

10) Treatment of Helicobacter pylori in infected patients

As a part of a combination therapy, 20mg/kg/day not to exceed 500mg twice daily for 7-14 days. Official guidelines should be consulted before initiating therapy.

Method of Administration

For oral administration.

• Contraindications

• Known hypersensitivity to nitroimidazoles, metronidazole or to any of the excipients listed in 6.1.
• Pregnancy – metronidazole should not be used in the first trimester in patients with trichomoniasis or bacterial vaginosis (see section 4.6).
• Breast feeding should be discontinued for 12-24 hours when single high dose (e.g. 2g) therapy is used (see section 4.6).
  • Special warnings and precautions for use
• Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take metronidazole as this product contains lactose.
• 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).
• Caution is advised in patients with porphyria.
• Metronidazole Taj Pharma tablets should not be used in patients with blood dyscrasias or with active non-infectious disease of the central nervous system. High doses of metronidazole may mask the presence of syphilis.
• Caution in patients with epilepsy or those who have had seizures as high doses of Metronidazole Taj Pharma can induce seizures.
• Use with caution in the second and third trimester when used to treat trichomoniais or bacterial vaginosis (see section 4.6.)
• Regular clinical and laboratory surveillance are advised if treatment continues for more than 10 days.
• Consideration of the therapeutic benefit against the risk of peripheral neuropathy is advised with continuous therapy for chronic conditions.
• There is a possibility that after Trichomonas vaginalishas been eliminated a gonococcal infection might persist.
• The elimination half-life of metronidazole remains unchanged in the presence of renal failure. The dosage of metronidazole, therefore, needs no reduction. Such patients, however, retain the metabolites of metronidazole. The clinical significance of this is not known at present.
• In patients undergoing haemodialysis metronidazole and metabolites are efficiently rmoved during an eight-hour period of dialysis. Metronidazole Taj Pharma should, therefore, be readministered immediately after haemodialysis.
• No routine adjustment in the dosage of metronidazole need be made in patients with renal failure undergoing intermittent peritoneal dialysis (IPD) or continuous ambulatory peritoneal dialysis (CAPD).
• Metronidazole Taj Pharma is mainly metabolised by hepatic oxidation. Substantial impairment of metronidazole clearance may occur in the presence of advanced hepatic insufficiency. Signficant cumulation may occur in patients with hepatic encephalopathy and the resulting high plasma concentrations of metronidazole may contribute to symptoms of the encephalopathy. Therefore, metronidazole should be administered with caution to patients with hepatic encephalopathy. The daily dosage should be reduced to one third and may be administered once daily.
• Cases of severe hepatotoxicity/acute hepatic failure, including cases with a fatal outcome with very rapid onset after treatment initiation in patients with Cockayne syndrome have been reported with products containing metronidazole for systemic use. In this population, metronidazole should therefore be used after careful benefit-risk assessment and only if no alternative treatment is available. Liver function tests must be performed just prior to the start of therapy, throughout and after end of treatment until liver function is within normal ranges, or until the baseline values are reached. If the liver function tests become markedly elevated during treatment, the drug should be discontinued. Patients with Cockayne syndrome should be advised to immediately report any symptoms of potential liver injury to their physician and stop taking metronidazole.
• Patients should be warned that metronidazole may darken urine.
• Due to inadequate evidence on the mutagenicity risk in humans (see section 5.3), the use of metronidazole for longer treatment than usually required should be carefully considered.
  • Interaction with other medicinal products and other forms of interaction

Interactions 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 treatment should be tapered or withdrawn before administering metronidazole. Plasma concentration of lithium, creatinine, and electrolytes should be monitored in patients under treatment with lithium while they receive metronidazole.
• Anticoagulants: Some potentiation of anticoagulant therapy has been reported when metronidazole has been used with the warfarin type oral anticoagulants. Dosage of the latter may require reducing. Prothrombin times should be monitored. No interactions have been reported with anticoagulants of the heparin type. However, anticoagulant activity should be routinely monitored with these products.
• Alcohol: Patients should be advised not to take alcohol during metronidazole therapy and for at least 48 hours after because of the possibility of a disulfiram-like reaction.
• Disulfiram:Psychotic reactions have been reported.
• Immunosuppressants: Patients receiving ciclosporin are at risk of elevated ciclosporin serum levels. Serum ciclosporin and serum creatinine should be closely monitored when coadministration is necessary.

Pharmacokinetic interactions:

• Antiepileptics: Patients receiving phenobarbital metabolise metronidazole at a much greater rate than normally, reducing the half-life to approximately 3 hours. Metronidazole Taj Pharma inhibits metabolism of phenytoin (increases plasma-phenytoin concentration). Primidone accelerates the metabolism of Metronidazole Taj Pharma causing reduced plasma concentrations.
• Cytotoxics: Metronidazole Taj Pharma inhibits metabolism of fluorouracil. Therefore, increased toxicity of fluorouracil can result. Plasma levels of busulfan may be increased by metronidazole which may lead to severe busulfan toxicity.
• Ulcer-healing drugs:Cimetidine inhibits the metabolism of metronidazole (increases plasma-metronidazole concentration).
• Oestrogens:broad spectrum antibiotics possibly reduce the contraceptive effect. See local/national guidelines or BNF for specific advice.
• Drug-lab modifications: Aspartate amino transferase assays may give spuriously low values in patients taking metronidazole, depending on the method used.

Fertility, pregnancy and lactation

There is inadequate evidence of the safety of metronidazole in pregnancy but it has been in wide use for many years without apparent ill consequence. 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.

Pregnancy

Metronidazole Taj Pharma is contraindicated in the first trimester (see section 4.3) and should be used with caution in the second and third trimester when used to treat trichomoniais or bacterial vaginosis (see section 4.4).

For all other indications Metronidazole Taj Pharma should only be used if the benefits outweight the risks or no other alternative is available especially in the first trimester.

Breast-feeding

It is advisable to stop breast feeding until 12 – 24 hours after Metronidazole Taj Pharma therapy has been discontinued (see section 4.3).

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 occur.

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 (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000), not known (cannot be estimated from the available data).

Serious adverse reactions occur rarely with standard recommended regimens.

Frequency, type and severity of adverse reactions in children are the same as in adults.

Clinicians who contemplate continuous therapy for the relief of chronic conditions, for periods longer than those recommended, are advised to consider the possible therapeutic benefit against the risk of peripheral neuropathy.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product.

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 epileptiform seizures have been reported following intensive or prolonged therapy. Other adverse effects occurring in these circumstances include peripheral motor neuropathy, blood dyscrasias and liver damage.

The combination of alcohol and metronidazole has been said to cause disulfiram type reactions in about 10% of individuals with sudden onset of excitement, giddiness, flushing, nausea, headache, hypotension and dyspnoea. However the mechanism of this reaction has been questioned.

Treatment:

Unlikely to be required.

Disulfiram type reactions should be treated with intravenous fluids and plasma expanders if necessary. Symptomatic and supportive.

In more serious cases:

Single brief convulsions do not require treatment. If frequent or prolonged control with intravenous diazepam (10-20mg in adults; 0.1-0.3mg/kg body weight) or lorazepam (4mg in an adult and 0.05mg/kg in a child). Give oxygen and correct acid base and metabolic disturbances as required.

Other measures as indicated by the patient’s clinical condition.

5. Pharmacological properties

• Pharmacodynamic properties

Pharmacotherapeutic group: Nitroimidazole derivatives

Mechanism of action

Metronidazole Taj Pharma has antiprotozoan and antibacterial effects. It is effects against Trichomonas vaginalis, Gardnerella vaginalis and other protazoa including Entamoeba histolytica, Gardia lamblia and anaerobic bacteria.

• Pharmacokinetic properties

Absorption

Metronidazole Taj Pharma 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 is not reduced overall, by administration with food.

Distribution

Metronidazole Taj Pharma is widely distributed. It appears in most body tissues and fluids. It also crosses the placenta and rapidly enters foetal circulation. No more than 20% is bound to plasma proteins.

Biotransformation

Metronidazole Taj Pharma is metabolised in the liver by side-chain oxidation and glucuronide formation. The half-life of metronidazole is 6.5 ± 2.9 hours. The half-life of metronidazole is reported to be longer in neonates and in patients with severe liver disease.

Elimination

The majority of a dose of metronidazole is excreted in the urine, mainly as metabolites; a small amount appears in the faeces. Metronidazole Taj Pharma can be used in chronic renal failure; it is rapidly removed from the plasma by dialysis. Metronidazole Taj Pharma is excreted in milk but the intake of a suckling infant of a mother receiving normal dosage would be considerably less than the therapeutic dosage for infants.

• Preclinical safety data

Metronidazole Taj Pharma 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 studies have provided no clear evidence of an increased carcinogenic risk in humans.

Metronidazole Taj Pharma has been shown to be mutagenic in bacteria in vitro. In studies conducted in mammalian cells in vitro as well as in rodent or humans in vivo, there was inadequate evidence of a mutagenic effect of metronidazole, with some studies reporting mutagenic effects, while others studies were negative.

6. Pharmaceutical particulars

• List of excipients

Lactose, maize starch, povidone, magnesium stearate, carmellose sodium, microcrystalline cellulose, purified water, methylhydroxypropylcellulose, macrogol 400, titanium dioxide.

• Incompatibilities

None.

• Shelf life

3 years.

• Special precautions for storage

Store below 25°C. Protect from light.

• Nature and contents of container

Polyethylene container with pilfer-proof polyethylene closure, pack sizes of 50, 100, 250 and 500 tablets.

Amber glass bottles, pack sizes of 50, 100, 250 and 500 tablets.

Blister pack (aluminium (20 µm)/PVC (250 µm)), pack sizes of 14, 21, 30 and 60 tablets.

Not all pack sizes may be marketed

6.6 Special precautions for disposal and other handling

Not applicable.

Manufactured in India by:
TAJ PHARMACEUTICALS LTD.
Mumbai, India
Unit No. 214.Old Bake House,
Maharashtra chambers of  Commerce Lane,
Fort, Mumbai – 400001
at:Gujarat, INDIA.
Customer Service and Product Inquiries:
1-800-TRY-FIRST (1-800-222-434 & 1-800-222-825)
Monday through Saturday 9:00 a.m. to 7:00 p.m. EST
E-mail: tajgroup@tajpharma.com

Metronidazole Taj Pharma Tablets USP 200mg Taj Pharma

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet

1. What Metronidazole Taj Pharma tablets are and what they are used for
2. What you need to know before you take Metronidazole Taj Pharma tablets
3. How to take Metronidazole Taj Pharma tablets
4. Possible side effects
5. How to store Metronidazole Taj Pharma tablets
6. Contents of the pack and other information
7. What Metronidazole Taj Pharma tablets are and what they are used for

Metronidazole Taj Pharma tablets belong to a group of medicines called antiinfective agents. They may be used to treat:

• infections, caused by bacteria of the blood, brain, bone, lung, stomach lining and pelvic area, following childbirth or in a wound following an operation
• urinary or genital infections caused by a parasite, Trichomonas
• genital infection in women caused by bacteria
• the parasitic diseases amoebiasis
• the disease giardiasis
• gum and teeth infections
• infected leg ulcers or pressure sores
• stomach ulcers caused by Helicobacter pylori.
• or prevent infections occurring after operations.

2. What you need to know before you take Metronidazole Taj Pharma tablets

Do not take Metronidazole Taj Pharma tablets:

• if you are allergic to metronidazole, nitroimidazoles (e.g. tinidazole) or any of the other ingredients of this medicine (listed in section 6). Signs of an allergic reaction include: a rash, swallowing or breathing problems, swelling of your lips, face, throat or tongue.
• if you are in the first 3 months of pregnancy or are breastfeeding.

Warnings and precautions

Talk to your doctor, pharmacist or nurse before taking

Metronidazole Taj Pharma tablets:

• if you have kidney disease, particularly if you require dialysis treatments
• if you have ever suffered from any liver disease
• if you are in the 4th-9th month of pregnancy
• if you have epilepsy or have ever had fits
• if you have porphyria (a genetic disease that can cause skin blisters, abdominal pain and brain/nervous system disorders)
• if you have any disorder of the blood and/or blood cells
• if you have any nervous system disorders
• if you have been exposed to any sexually transmitted disease.

Cases of severe liver toxicity/acute liver failure, including cases with a fatal outcome, in patients with Cockayne syndrome have been reported with product containing metronidazole.

If you are affected by Cockayne syndrome, your doctor should also monitor your liver function frequently while you are being treated with metronidazole and afterwards.

Tell your doctor immediately and stop taking metronidazole if you develop:

• Stomach pain, anorexia, nausea, vomiting, fever, malaise, fatigue, jaundice, dark urine, putty or mastic coloured stools or itching.

Other medicines and Metronidazole Taj Pharma tablets

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines including those obtained without a prescription and herbal medicines. This is because Metronidazole Taj Pharma tablets can affect the way some other medicines work. Also, some other medicines can affect the way Metronidazole Taj Pharma tablets work. Especially:

• medicines to stop the blood clotting such as warfarin
• lithium (used to treat depression)
• medicines to treat epilepsy such as phenobarbital, phenytoin, primidone
• disulfiram (to treat alcohol addiction)
• ciclosporin (used following organ transplants)
• fluorouracil (used to treat some forms of cancer)
• busulfan for leukaemia (cancer of the blood cells)
• cimetidine (used to treat stomach ulcers)
• oestrogen contraceptives (‘the pill’).

If you are not sure, talk to your doctor or pharmacist before taking this medicine.

Metronidazole Taj Pharma tablets with food, drink and alcohol

You are advised not to drink alcohol whilst taking this medicine and for 48 hours after finishing the course of tablets, as this might cause unpleasant side-effects, such as feeling or being sick, stomach pain, hot flushes, palpitations and headache.

Pregnancy and breastfeeding

Metronidazole Taj Pharma tablets must not be taken during the first 3 months of pregnancy and should not be taken during the rest of the pregnancy.

If you breastfeed you should stop whilst taking Metronidazole Taj Pharma tablets and for 12-24 hours after the course of tablets has finished before breastfeeding again.

Ask your doctor or pharmacist for advice before taking this medicine.

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines

Metronidazole Taj Pharma tablets may make you feel drowsy, dizzy, confused or affect your vision, cause fits or hallucinations. Make sure you are not affected before you drive, operate machinery or take part in any activities where these may put you or others at risk.

Metronidazole Taj Pharma tablets contain lactose

If you have been told you have an intolerance to some sugars, contact your doctor before taking this medicine, as it contains a sugar called lactose.

Tests

If you are taking this medicine for more than 10 days, your doctor may wish to carry out further tests.

If you need any blood or urine tests, tell your doctor you are taking Metronidazole Taj Pharma tablets before the test.

3. How to take Metronidazole Taj Pharma tablets

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

Swallow the tablets whole, during or after meals, with a glass of water. Do not chew them.

The recommended dose is:

For doses less than 500mg (one tablet) an alternative dosage form should be used.

To treat bacterial infections

• Adults and children over 10 years: 800mg followed by 400mg at eight hourly intervals. Treatment is usually for 7 days but will depend upon your condition.

To treat anaerobic infections

• Children 8 weeks-12 years: 20-30mg/kg/day as a single dose or divided into 7.5mg/kg every 8 hours for 7 days. The daily dose may be increased to 40mg/kg, depending on the severity of the infection.
• Children under 8 weeks: 15mg/kg/day as a single dose or divided into 7.5mg/kg every 12 hours.
• Children under 10 years: A more suitable dosage form should be used for this age group.

To treat infection caused by Trichomonas

• Adults and adolescents: 2g as a single dose, or 200mg three times a day for 7 days, or 400mg twice a day for 5-7 days. Your partner should also be treated.
• Children under 10 years: 40mg/kg as a single dose or 15-30mg/kg/ day two to three times daily for 7 days. Doses should not to exceed 2000mg/dose.
• Children under 10 years: A more suitable dosage form should be used for this age group.

To treat non-specific genital infection in women

• Women: 400mg twice a day for 7 days, or 2g as a single dose for 1 day only.
• Adolescent girls: 400mg twice daily for 5 to 7 days or 2g as a single dose.

To treat amoebiasis

• Adults and children over 10 years: 400mg-800mg three times a day for 5 to 10 days.
• Children 7-10 years: 200mg-400mg three times a day for 5 to 10 days.
• Children 3-7 years: 100mg-200mg four times daily for 5 to 10 days.
• Children 1-3 years: 100mg-200mg three times daily for 5 to 10 days. Or 35-50mg/kg/day in 3 divided doses for 5 to 10 days.
• Children under 7 years: A more suitable dosage form should be used for this age group.

To treat giardiasis

• Adults and children over 10 years: 2g once a day for 3 days, or 400mg three times a day for 5 days or 500mg twice daily for 7 to 10 days.
• Children 7-10 years: 1 g once a day for 3 days.
• Children 3-7 years: 600mg-800mg once daily for 3 days.
• Children 1-3 years: 500mg once daily for 3 days. Or 15-40mg/kg/day divided in two to three doses.
• Children under 7 years: A more suitable dosage form should be used for this age group.

To treat infections of the gums (for 3 days) or teeth (for 3-7days)

• Adults and children over 10 years: 200mg three times a day.

To treat infected leg ulcers or pressure sores (for 7 days)

• Adults and children over 10 years: 400mg three times a day

To treat stomach ulcers caused by Helicobacter pylori

To be taken as directed by your doctor as part of a course with two other medicines.

To prevent infections after surgery

• Adults: 1g as a single dose 24 hours before surgery then, 400mg at 8 hourly intervals during the 24 hours before the operation.
• Children under 12 years: 20-30mg/kg as a single dose 1-2 hours before the operation.
• Newborns with a gestation age less than 40 weeks: 10mg/kg body weight as a single dose before operation.
• Children under 10 years: A more suitable dosage form should be used for this age group.

If you are elderly or have liver disease, it is particularly important to take this medicine exactly as directed by the doctor.

If you take more Metronidazole Taj Pharma tablets than you should

If you (or someone else) swallow a lot of tablets at the same time, or you think a child may have swallowed any contact your nearest hospital casualty department or tell your doctor immediately.

Signs of an overdose include feeling or being sick, loss of appetite, diarrhoea, metallic taste, headache, dizziness, insomnia or drowsiness.

If you forget to take Metronidazole Taj Pharma tablets

Do not take a double dose to make up for a forgotten dose. If you forget to take a dose take it as soon as you remember it and then take the next dose at the right time.

If you stop taking Metronidazole Taj Pharma tablets

If you stop taking the tablets your infection may come back.

Talk to your doctor before you stop taking the tablets and follow their advice.

4. Possible side effects

Like all medicines, this medicine can cause side effects, particularly when you first start taking it, although not everybody gets them.

Stop taking Metronidazole Taj Pharma tablets and contact your doctor at once if you notice any of the following side effects:

• allergic reactions: skin rash, which may be itchy, swelling of the face, lips, tongue or throat, fever or difficulty in breathing.
• symptoms of a severe but rare brain disease (encephalopathy).

Symptoms vary but you might get fever, stiff neck, headache, see or hear things that aren’t there. You might also have problems using your arms and legs, problems with speaking or feel confused.

• you develop skin rashes with blistering, peeling or bleeding of the skin around the lips, eyes, mouth, nose, and genitals. You may also have flu-like symptoms and a high temperature. These could be signs of something called ‘Stevens-Johnson Syndrome’ or ‘toxic epidermal necrolysis’.

Tell your doctor if you notice any of the following side effects or notice any other effects not listed:

Very rare (less than 1 in 10,000 users):

• increased bruising, nosebleeds, sore throats or infections, this medicine may alter the numbers and types of your blood cells. You should tell your doctor who might want you to have a blood test
• mental health problems including confusion, hallucinations (seeing or hearing things that are not there), drowsiness, dizziness, headache, fits, tingling, pain or a feeling of weakness in the arms or legs, numbness
• Cerebellar syndrome (poor co-ordination or muscle control, involuntary shakiness, uncontrolled eye movements, speech disorders, walking abnormally)
• double vision, short sightedness
• liver problems including life-threatening liver failure (hepatocellular liver injury), changes in liver function tests, jaundice (yellowing of the skin or whites of the eyes), inflammation of the pancreas (pancreatitis causing very severe abdominal pain)
• skin rashes, flushing, itching, small pus-containing blisters, muscle and joint pain, darkening of the urine

Not known (cannot be estimated from the available data):

• bone marrow depression disorders such as aplastic anaemia (causing weakness, bruising, making infections more likely)
• urticaria (itchy, pale or red irregular raised patches of skin), fever
• depression, ‘pins and needles’
• pain in your eyes (optic neuritis)
• a group of symptoms together including: fever, nausea, vomiting, headache, stiff neck and extreme sensitivity to bright light. This may be caused by an inflammation of the membranes that cover the brain and spinal cord (meningitis)
• hearing impairment/hearing loss
• ringing in the ears (tinnitus)
• unpleasant taste in the mouth, changes in taste, furred tongue, mouth ulcers, feeling or being sick, loss of appetite, diarrhoea, stomach pain and upset stomach
• erythema multiforme (circular, irregular red patches)

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse.

This includes any possible side effects not listed in this leaflet. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Metronidazole Taj Pharma tablets

Keep this medicine out of the sight and reach of children.

Store below 25°C protect from light.

Do not use Metronidazole Taj Pharma tablets after the expiry date stated on the label/carton/bottle. The expiry date refers to the last day of that month.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. Contents of the pack and other information

What Metronidazole Taj Pharma tablets contain

• The active substance (the ingredient that makes the tablets work) is metronidazole.
• The other ingredients are carmellose sodium, lactose, povidone, magnesium stearate, maize starch, microcrystalline cellulose, methylhydroxypropylcellulose, macrogol 400 and titanium dioxide.

What Metronidazole Taj Pharma tablets look like and contents of the pack

Metronidazole Taj Pharma are white, film-coated tablets.

Polyethylene container with pilfer-proof polyethylene closure, pack sizes of 50, 100, 250 and 500 tablets.

Amber glass bottles, pack sizes of 50, 100, 250 and 500 tablets.

Blister pack (aluminium (20 µm)/PVC (250 µm)), pack sizes of 14, 21, 30 and 60 tablets.

Not all pack size may be marketed

Manufactured in India by:
TAJ PHARMACEUTICALS LTD.
Mumbai, India
Unit No. 214.Old Bake House,
Maharashtra chambers of  Commerce Lane,
Fort, Mumbai – 400001
at:Gujarat, INDIA.
Customer Service and Product Inquiries:
1-800-TRY-FIRST (1-800-222-434 & 1-800-222-825)
Monday through Saturday 9:00 a.m. to 7:00 p.m. EST
E-mail: tajgroup@tajpharma.com