1.NAME OF THE MEDICINAL PRODUCT
Metronidazole benzoate Oral Suspension USP 200mg/5ml Taj Pharma.

2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 5ml contains

Metronidazole benzoate USP 320mg
equivalent to 200mg metronidazole.

3. PHARMACEUTICAL FORM
Oral Suspension

4. CLINICAL PARTICULARS

4.1 Therapeutic indications
Metronidazole Oral Suspension is indicated in the prophylaxis and treatment of infections in which anaerobic bacteria have been identified or are suspected as the pathogen.

Metronidazole Oral Suspension is active against a wide range of pathogenic micro-organisms, notably Trichomonas vaginalisEntamoeba histolyticaGiardia lambliaBalantidium coli and other species of bacteroides, fusobacteria, eubacteria, clostridia, gardnerella vaginalis and anaerobic cocci.

It is indicated in

Adults, Children and Newborns with a gestation age of over 40 weeks for:

  • The treatment of septicaemia, bacteraemia, brain abscess, necrotising pneumonia, osteomyelitis, puerperal sepsis, pelvic abscess, pelvic cellulitis, peritonitis and post-operative wound infections from which one or more pathogenic anaerobes have been isolated.
  • The prevention of post-operative infections caused by anaerobic bacteria particularly species of bacteroides and anaerobic streptococci.

Adults and Children over 10 years only for:

  • Bacterial vaginosis (also known as non-specific vaginitis, anaerobic vaginitis or Gardnerellavaginitis).
  • Acute dental infections (e.g. acute pericoronitis and acute apical infections).
  • Anaerobically infected leg ulcers and pressure sores.

Adults and Children for:

  • The treatment of urogenital trichomoniasis in the female (trichomonal vaginitis) and in the male.
  • All forms of amoebiasis (intestinal and extra-intestinal disease and that of symptomless cyst passers)
  • Giardiasis
  • Acute ulcerative gingivitis.

Children for

  • Eradication of Helicobacter pylori

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

4.2  Posology and method of administration
Posology
A: Prophylaxis: against anaerobic infection- chiefly in the context of abdominal (especially colorectal) and gynaecological surgery.

Dosage: 400mg at 8 hourly intervals during the 24 hours preceding the operation followed by postoperative intravenous or rectal administration until the patient is able to take Metronidazole Oral Suspension by mouth.

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.

Elderly: Caution is advised in the elderly, particularly at high doses, although there is limited information available on modification of drug.

Anaerobic infections: The duration of a course of Metronidazole treatment is about 7 days but it will depend upon the seriousness of the patient’s condition as assessed clinically and bacteriologically.

B: Treatment of established anaerobic infection:
800mg followed by 400mg at 8 hourly intervals.

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, which is why the concentrations of metronidazole in serum should preferably be monitored after a few days therapy.

C: Treatment of Protozoal and Other Infections:
(See Table).

Duration of dosage in days Adults and children over 10 years** Children*
7-10 years 3-7 years 1-3 years
Urogenital Trichomoniasis

Where re-infection is likely, in adults the consort should receive a similar course of treatment concurrently

7

or

200mg three times daily 40mg/kg orally as a single dose or 15 – 30mg/kg/day divided in 2 – 3 doses not to exceed 2000mg/dose
5 – 7

or

400mg twice daily
1 2000mg as a single dose
Bacterial Vaginosis 5 – 7

or

400mg twice daily
1 2000mg as a single dose
Amoebiasis

(a) Invasive intestinal disease in susceptible subjects

5 800 mg three times daily 400 mg three times daily 200 mg four times daily 200 mg three times daily
(b) Intestinal disease in less susceptible subjects and chronic amoebic hepatitis 5-10 400 mg three times daily 200 mg three times daily 100 mg four times daily 100 mg three times daily
(c) Amoebic liver abscess also other forms of extra-intestinal amoebiasis 5 400 mg three times daily 200 mg three times daily 100 mg four times daily 100 mg three times daily
(d) Symptomless cyst passers 5-10 400-800 mg three times daily 200-400 mg three times daily 100-200 mg four times daily 100-200 mg three times daily
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

Giardiasis 3

or

2000mg once daily 1000mg once daily 600-800mg once daily 500mg once daily
5

or

400mg three times daily
7 – 10 500mg twice daily
Alternatively, as expressed in mg per kg of body weight:

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

Acute Ulcerative Gingivitis 3 200mg three times daily 100mg three times daily 100mg twice daily 50mg three times
Acute Dental Infections 3-7 200mg three times daily
Leg Ulcers and Pressure Sores 7 400mg three times daily

Dosage is given in terms of metronidazole or metronidazole equivalent.

* Children and babies weighing less than 10Kg should receive proportionally smaller doses.

** Metronidazole is well tolerated by the elderly, but a pharmacokinetic study suggests cautious use of high dosage regimen in this age group.

Eradication of Helicobacter pylori in paediatric patients:
As a part of 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 only.

4.3 Contraindications
Known hypersensitivity to Metronidazole, nitroimidazoles and/or hydroxybenzoates or any of the excipients.

4.4 Special Warnings and precautions for use
Regular clinical and laboratory monitoring (especially leucocyte count) are advised if administration of Metronidazole for more than 10 days is considered to be necessary and patients should be monitored for adverse reactions such as peripheral or central neuropathy (such as paraesthesia, ataxia, dizziness, convulsive seizures).

There is the possibility that after Trichomonas vaginalis has 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 removed during an eight-hour period of dialysis. Metronidazole should therefore, be re-administered 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 is mainly metabolised by hepatic oxidation. Substantial impairment of metronidazole clearance may occur in the presence of advanced hepatic insufficiency.

Significant cumulation may occur in patients with hepatic encephalopathy and the resulting high plasma concentrations of metronidazole may contribute to the symptoms of encephalopathy.

Metronidazole should be administered with caution to patients with hepatic encephalopathy. The daily dosage may be reduced to one third and may be administered once daily.

Metronidazole should be used with caution in patients with active or chronic severe peripheral and central nervous system disease due to the risk of neurological aggravation.

Metronidazole Oral Suspension contains glucose, sucrose and sorbitol. Each 5ml contains 1.1g glucose, 0.6g sucrose and 0.6g sorbitol. Patients with hereditary fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine. The glucose and sucrose content should be taken into account in patients with diabetes mellitus. It may also be harmful to teeth.

Methyl, ethyl and propyl hydroxybenzoates are contained in this product which may cause allergic reactions (possibly delayed).

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.

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.

4.5 Interaction with other medicinal products and other forms of interaction
Patients should be advised not to take alcohol during metronidazole therapy and for at least 48 hours afterwards because of the possibility of a disulfiram-like (antabuse effect) reaction.

Psychotic reactions have been reported in patients who were using metronidazole and disulfiram concurrently.

Some potentiation of anticoagulant therapy has been reported when metronidazole has been used with the warfarin type oral anti-coagulants. Dosage of the anticoagulant may require reducing. Prothrombin time should be monitored. No interactions have been reported of the heparin type.

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.

Patients receiving phenobarbital or phenytoin metabolise metronidazole at a much greater rate than normally, reducing the half life to approximately three hours.

Increased serum carbamazepine levels and toxicity have been seen in patients given concomitant metronidazole.

Aspartate amino transferase assays may give spuriously low values in patients taking metronidazole, depending on the method used.

Clinicians who contemplate continuous therapy for the relief of chronic conditions, for periods no longer than those recommended, are advised to consider the possible therapeutic benefit against the risk of peripheral neuropathy.

Metronidazole reduces the clearance of 5-fluorouracil and can therefore result in increased toxicity of 5-fluorouracil.

Patients receiving ciclosporin or tacrolimus with metronidazole are at risk of elevated ciclosporin / tacrolimus serum levels. Serum ciclosporin / tacrolimus and serum creatinine should be closely monitored when coadministration is necessary.

Plasma levels of busulfan may be increased by metronidazole which may lead to severe busulfan toxicity.

4.6 Fertility, Pregnancy and lactation
There is inadequate evidence of the safety of metronidazole in pregnancy. Metronidazole should not therefore be given during pregnancy or during lactation unless the physician considers it essential, in these circumstances short, high dosage regimes are not recommended.

A significant amount of metronidazole is found in breast milk and breast feeding should be avoided after a large dose. This could give a bitter taste to the milk.

4.7 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.

4.8 Undesirable Effects
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).

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

Serious adverse reactions occur very rarely with standard recommended regimens. However, 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.

Blood and lymphatic system disorders:
Very rare: agranulocytosis, neutropenia, thrombocytopenia and pancytopenia, often reversible on drug withdrawal, although fatalities have occurred.
Not known: A moderate leucopenia has been reported in some patients but the white cell count has always returned to normal before or after treatment has been completed.
Immune system disorders:
Rare: Anaphylaxis
Not known: urticaria, angioedema and fever
Metabolism and nutrition disorders:
Not known: anorexia
Psychiatric disorders:
Very rare: psychotic disorders, including confusion and hallucinations
Not known: depressed mood
Nervous system disorders:

Very rare:

• Encephalopathy (eg. confusion, fever, headache, hallucinations, paralysis, light sensitivity, disturbances in sight and movement, stiff neck) and subacute cerebellar syndrome (eg. ataxia, dysathria, gait impairment, nystagmus and tremor) have been reported very rarely which may resolve on discontinuation of the drug

• Drowsiness, dizziness, convulsions, headache, ataxia, inco-ordination of movement

Not known:

• During intensive and/or prolonged metronidazole therapy a few instances of peripheral neuropathy or transient epileptiform seizures have been reported. In most cases neuropathy disappeared after treatment was stopped or when dosage was reduced.

• Aseptic meningitis has been reported

Eye disorders:

Very rare: transient visual disorders such as diplopia and myopia have been reported
Not known: Optic neuropathy/neuritis has been reported
Ear and labyrinth disorders:
Not known: hearing impaired/hearing loss (including sensorineural), tinnitus
Gastrointestinal disorders:
Not known: Unpleasant taste in the mouth, oral mucositis, furred tongue, nausea, vomiting, gastro-intestinal disturbances such as epigastric pain and diarrhoea.
Hepatobiliary disorders:

Very rare:

• Abnormal liver function tests, increase in liver enzymes (AST, ALT, alkaline phosphatase), cholestatic or mixed hepatitis, and hepatocellular liver injury, jaundice and pancreatitis, reversible on drug withdrawal have been reported.

• Cases of liver failure requiring liver transplant have been reported in patients treated with metronidazole in combination with other antibiotic drugs.

Skin and subcutaneous tissue disorders:

Very rare: skin rashes, pustular eruptions, pruritus, flushing
Not known: Erythema multiforme may occur, which may be reversed on drug withdrawal. Stevens-Johnson syndrome or toxic epidermal necrolysis, fixed drug eruption.
Musculoskeletal, connective tissue and bone disorders:
Very rare: myalgia, arthralgia
Renal and urinary disorders:
Very rare: darkening of the urine (due to metronidazole metabolite)

Metronidazole Oral Suspension contains glycerol, which can cause headache, gastro-intestinal disturbance and diarrhoea.

The parahydroxybenzoates used in Metronidazole Oral Suspension may cause immediate or delayed hypersensitivity reactions.

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.

4.9 Overdose
Single oral doses of metronidazole, up to 12g have been reported in suicide attempts and accidental overdoses. Symptoms were limited to vomiting, ataxia and slight disorientation. There is no specific antidote for metronidazole overdosage. In cases of suspected massive overdose, symptomatic and supportive treatment should be instituted.

5. PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties
The selective action of this compound against anaerobes and anoxic and hypoxic cells is due to the mode of action. The nitro group of metronidazole acts as electron acceptor and is thus reduced to a chemically reactive drug form. This produces biochemical lesions in the cells, thus causing death. The major site of action is believed to be DNA, where it causes loss of the helical structure and inhibits synthesis.

5.2 Pharmacokinetic properties
It is readily absorbed from the gastro-intestinal tract and widely distributed in body tissues. Half life in plasma is about 8-10 hours. About 10% is bound to plasma proteins.

It penetrates well into body tissues and fluids, including vaginal secretions, seminal fluid, saliva and breast milk. Therapeutic concentrations are also achieved in cerebrospinal fluid.

Unchanged metronidazole and several metabolites are excreted in the urine, the liver is the main site of metabolism and the major metabolites are as a result of side chain oxidation, forming glucuronides.

5.3 Preclinical safety data
Metronidazole 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 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

6.1 List of excipients
Dispersible cellulose, colloidal silicon dioxide, sucrose, glucose, sorbitol solution, glycerine, polysorbate 80, methyl hydroxybenzoate, ethyl hydroxybenzoate, propyl hydroxybenzoate, propylene glycol, lemon flavour, orange flavour and purified water.

6.2 Incompatibilities
None known.

6.3  Shelf life
24 months

6.4 Special precautions for storage
Store below 25°C and protect from light.

6.5 Nature and contents of container

Bottle: Amber (Type III) glass
Closures: HDPE, EPE wadded, tamper evident, child resistant.
Pack Sizes: 100ml.

 

6.6 Special precautions for disposal and other handling
Keep out of the reach of children.
Shake the bottle well before use.
If a dose of under 5ml is required, the suspension should be administered using an oral dosing device.

7. 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 benzoate Oral Suspension USP 200mg/5ml Taj Pharma

Package leaflet: Information for the patient

Metronidazole benzoate Oral Suspension USP 200mg/5ml 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 or pharmacist.
– 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 any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor.

What is in this leaflet
1. What  Metronidazole is and what it is used for
2. Before you are given Metronidazole
3. How you will be given  Metronidazole
4. Possible side effects
5. How Metronidazole is stored
6. Further Information

1. What Metronidazole is and what it is used for
The name of your medicine is Metronidazole 200mg/5ml Oral Suspension (called Metronidazole in this leaflet). It contains metronidazole benzoate. This belongs to a group of medicines called antibacterials.

Metronidazole can be used for:

Adults and children over 1 year

  • preventing infections after you have an operation
  • treating infections, including infections of your blood, brain, lungs, bones, lining of your abdomen, pelvis and infections following childbirth or around the area where you had an operation
  • treating trichomoniasis. This is a sexually transmitted infection, in both males and females
  • treating amoebiasis – an infection of your intestine or liver caused by a parasite
  • treating giardiasis – an infection that causes swelling of your intestines.

Adults and children over 10 years only

  • treating vaginosis – an infection and swelling of your vagina
  • treating swollen gums and ulcers in your mouth (gingivitis) and other dental infections
  • treating ulcers and pressure sores on your leg.

Children
It can also be used in children to treat a bacterial infection in the stomach (Helicobacter pylori).

Newborns (full term)
It can be used in full term newborns for treating bacteria infections and preventing infections after an operation.

2. Before you are given Metronidazole
Do not take Metronidazole and tell your doctor 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, itching or shortness of breath
  • you are pregnant, think you are pregnant or breast feeding.

Do not take this medicine if any of the above apply to you. If you are not sure, talk to your doctor before taking Metronidazole.

Warnings and precautions
Talk to your doctor before taking Metronidazole if:

  • you have liver problems
  • you have a disease of the nervous system
  • you are having haemodialysis.

If you are on this medicine for more than 10 days, your doctor may give you some tests.

If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before taking Metronidazole.

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
Tell your doctor or pharmacist if you are taking or have recently taken any other medicines. This includes medicines you buy without a prescription, including herbal medicines. This is because Metronidazole can affect the way some other medicines work. Also, some medicines can affect the way Metronidazole works.

In particular, tell your doctor if you are taking any of the following:

  • warfarin – used to thin your blood
  • lithium – used to treat depression
  • phenobarbital, phenytoin or carbamazepine – used to treat epilepsy
  • 5-fluorouracil – used to treat cancer
  • busulfan – used to treat leukaemia
  • ciclosporin or tacrolimus – used after organ transplants
  • disulfiram – used to treat alcoholism.

Metronidazole with food and drink
Do not drink alcohol whilst taking Metronidazole and for 48 hours after finishing the treatment. Drinking alcohol may cause unpleasant side effects such as nausea, vomiting, pain in and around your stomach area (the abdomen), hot flushes, palpitations and headaches.

Pregnancy and breast-feeding
Talk to your doctor before taking this medicine. You should not take Metronidazole if you are pregnant, planning to become pregnant or are breast-feeding.

Driving and using machines
Metronidazole may make you feel drowsy, dizzy or confused. It may cause you to see and hear things that are not there (hallucinations), have fits or give you blurred or double vision. If you are affected, do not drive or operate machines.

Metronidazole Rosemont contains, methyl, ethyl and propyl parahydroxybenzoates, glucose, sucrose and sorbitol

  • methyl, ethyl and propyl parahydroxybenzoates. These may cause an allergic reaction. This allergy may not happen straight away
  • glucose, sucrose and sorbitol. If you have been told by your doctor that you have an intolerance to some sugars, you must contact you doctor before taking this medicine. It may also be harmful to teeth.

3. How you will be given Metronidazole
Take this medicine as your doctor or pharmacist has told you. Look on the label and ask the doctor or pharmacist if you are not sure. The different routines you might follow are shown below.

Taking this medicine

  • This medicine contains 200mg of metronidazole in each 5ml
  • Take this medicine by mouth
  • Always shake the bottle before use
  • Complete the full course of this medicine.

How much to take
The usual doses for adults and children are:

Prevention of infections after surgery
Number of days you will take the medicine for: 1

How much to take – Adult and children over 12 years of age: 10ml (400mg) three times during the day before the operation

How much to take – Children under 12 years of age: Your doctor will work out the right dose on your child’s weight

Bacterial infections
Number of days you will take medicine for: –

How much to take – Adults and children over 12 years of age: A 20ml (800mg) dose followed by 400mg (10ml) three times a day

How much to take – Children under 12 years of age: Your doctor will work out the right dose based on your child’s weight

Other infections
Adults and children over 10years of age

Trichomoniasis
Number of days you will take the medicine for: 1

How much to take: 50ml (2000mg) once a day

Number of days you will take the medicine for: 5 to 7

How much to take: 10ml (400mg) twice a day

Number of days you will take the medicine for: 7

How much to take: 5ml (200mg) three times a day

Vaginosis
Number of days you will take the medicine for: 1

How much to take: 50ml (2000mg) once a day

Number of days you will take the medicine for: 5 to 7

How much to take: 10ml (400mg) twice a day

Amoebiasis
Number of days you will take the medicine for: 5 to 10

How much to take: 10ml (400mg) to 20ml (800mg) three times a day

Giardiasis
Number of days you will take the medicine for: 3

How much to take: 50ml (2000mg) once a day

Number of days you will take the medicine for: 5

How much to take: 10ml (400mg) three times a day

Number of days you will take the medicine for: 7 to 10

How much to take: 12.5ml (500mg) twice a day

Gingivitis
Number of days you will take the medicine for: 3

How much to take: 5ml (200mg) three times a day

Dental infections
Number of days you will take the medicine for: 3 to 7

How much to take: 5ml (200mg) three times a day

Leg ulcers and pressure sores
Number of days you will take the medicine for: 7

How much to take: 10ml (400mg) three times a day

Children under 10 years of age

Trichomoniasis
Number of days you will take the medicine for: 7

How much to take – Children aged 7-10 years: Your doctor will work out the right dose based on your child’s weight. This should not exceed 2000mg a day.

How much to take – Children aged 3-7 years: Your doctor will work out the right dose based on your child’s weight. This should not exceed 2000mg a day.

How much to take – Children aged 1-3 years: Your doctor will work out the right dose based on your child’s weight. This should not exceed 2000mg a day.

Amoebiasis
Number of days you will take the medicine for: 5 to 10

How much to take – Children aged 7-10 years: 5ml (200mg) to 10ml (400mg) three times a day

How much to take – Children aged 3-7 years: 2.5ml (100mg) to 5ml (200mg) four times a day

How much to take – Children aged 1-3 years: 2.5ml (100mg) to 5ml (200mg) three times a day

Your doctor will work out the right dose based on your child’s weight. This should not exceed 2400mg a day

Giardiasis
Number of days you will take the medicine for: 3

How much to take – Children aged 7-10 years: 25ml (1000mg) once a day

How much to take – Children aged 3-7 years: 15ml (600mg) to 20ml (800mg) once a day

How much to take – Children aged 1-3 years: 12.5ml (500mg) once a day

Your doctor will work out the dose based on your child’s weight.

Gingivitis
Number of days you will take the medicine for: 3

How much to take – Children aged 7-10 years: 2.5ml (100mg) three times a day

How much to take – Children aged 3-7 years: 2.5ml (100mg) twice a day

How much to take – Children aged 1-3 years: 1.25ml (50mg) three times a day

Children – treatment for a bacterial infection in the stomach (Helicobacter pylori)
Your child will be given Metronidazole with other medicines. Your doctor will work out the right dose based on your child’s weight.

This should not exceed 500mg twice a day.

Older People and those with liver problems
Your doctor may prescribe a lower dose than that given to adults. This is because you may be more sensitive to the medicine.

If you take more Metronidazole than you should
Talk to a doctor or go to a hospital straight away. Take the medicine pack with you so the doctor knows what you have taken.

If you forget to take Metronidazole
Do not take a double dose (two doses at the same time) to make up for a forgotten dose. Take your next dose as soon as you remember, then go on as before. However, if it is nearly time for the next dose, skip the missed dose.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

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

Stop taking Metronidazole and see a doctor or go to a hospital straight away if:

  • you get a brain disease (encephalopathy) which is a serious but very rare side effect. Symptoms vary but you might get a 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 feeling confused
  • you get 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)
  • you get swelling of the hands, feet, ankles, face, lips or throat which may cause difficulty in swallowing or breathing. You could also notice an itchy, lumpy rash or nettle rash. This may mean you are having an allergic reaction to Metronidazole
  • blistering or bleeding of the skin around the lips, eyes, mouth, nose and genitals. Also flu-like symptoms and fever. This may be something called `Steven Johnson Syndrome’ which is a severe blistering rash where layers of the skin may peel off to leave large areas of raw exposed skin over the body. Also a feeling of being generally unwell, fever, chills and aching muscles. Sometimes called Toxic epidermal necrolysis.

Talk to your doctor straight away if you notice the following side effects:

  • yellowing of your skin and the whites of your eyes (jaundice)
  • blood problems. You may notice signs such as high temperature or chills, unexpected infections, bruising, sore throat, ulcers in your mouth or throat, bleeding gums and unusual tiredness
  • severe stomach pain which may reach through to your back (pancreatitis).

Tell your doctor or pharmacist if you notice any of the following side effects: Very Rare: may affect up to 1 in 10,000 people

  • fits (convulsions)
  • feeling confused
  • seeing or hearing things that are not there (hallucinations)
  • temporary affects on your eyesight, such as difficulty in focusing
  • drowsiness and dizziness
  • clumsiness or poor co-ordination
  • pain and swelling of your skin, skin rashes or flushing
  • headache
  • itching
  • darkening of your urine
  • pains in your joints or muscles
  • liver problems including life-threatening liver failure (hepatocellular liver injury).

Frequency not known

  • numbness, tingling, pain or feeling weak in your arms and legs
  • unpleasant taste in your mouth or a furry tongue
  • feeling or being sick, upset stomach or diarrhoea
  • loss of appetite
  • fever
  • feeling depressed
  • pain in your eyes (optic neuritis)
  • hearing impairment/ hearing loss
  • ringing in the ears (tinnitus)
  • you get a rash or skin discolouration with or without raised areas which often reoccurs at the same location each time the drug is taken.

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. 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 Metronidazole is stored
Keep this medicine out of the sight and reach of children.
Do not store above 25°C.
Do not use this medicine after the expiry date which is stated on the label and carton (Exp: month, year).
The expiry date refers to the last day of that month.
Do not use Metronidazole Rosemont if you notice a change in the appearance or smell of the medicine. Talk to your pharmacist.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.

6. Further information

What Metronidazole contains
The active substance is metronidazole benzoate.
Each 5ml contains
Metronidazole benzoate USP      320mg
equivalent to 200mg metronidazole.
The other ingredients are methyl hydroxybenzoate (E218), ethyl hydroxybenzoate (E214), propyl hydroxybenzoate (E216), propylene glycol (E1520), dispersible cellulose (E460), colloidal silicon dioxide, sucrose, glucose, sorbitol solution (E420), glycerol (E422), polysorbate 80, lemon flavour, orange flavour and purified water.

What Metronidazole looks like and contents of the pack
A creamy white suspension with an odour of citrus.
It comes in a brown glass bottle holding 100ml of suspension.

7. 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