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

1.Name of the medicinal product

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

2.Qualitative and quantitative composition

a) Metronidazole Tablets USP 200mg Tablets
Each tablet contains
Metronidazole USP                   200mg
Excipients                                  q.s.

b) Metronidazole Tablets USP 250mg Tablets
Each tablet contains
Metronidazole USP                   250mg
Excipients                                  q.s.

c) Metronidazole Tablets USP 500mg Tablets
Each tablet contains
Metronidazole USP                     500mg
Excipients                                    q.s.

For a full list of excipients, see section 6.1

3.Pharmaceutical form

Film-coated tablets

White to off-white, circular biconvex, tablets.

4.Clinical particulars

4.1 Therapeutic indications

Metronidazole Tablets is indicated in the prophylaxis and treatment of infections in which anaerobic bacteria have been identified or are suspected to be the cause.

Metronidazole Tablets is active against a wide range of pathogenic micro-organisms notably species of BacteroidesFusobacteriaClostridiaEubacteria, anaerobic cocci and Gardnerella vaginalis.

It is also active against TrichomonasEntamoeba histolyticaGiardia lamblia and Balantidium coli.

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

  1. The prevention of post-operative infections due to anaerobic bacteria, particularly species of Bacteroides and anaerobic streptococci.
  2. 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.
  3. Urogenital trichomoniasis in the female (trichomonal vaginitis) and in the male.
  4. Bacterial vaginosis (also known as non-specific vaginitis, anaerobic vaginosis or Gardnerella vaginitis).
  5. All forms of amoebiasis (intestinal and extra-intestinal disease and that of symptomless cyst passers).
  6. Giardiasis.
  7. Acute ulcerative gingivitis.
  8. Anaerobically-infected leg ulcers and pressure sores.
  9. Acute dental infections (e.g. acute pericoronitis and acute apical infections). Considerations should be given to official guidance on the appropriate use of antibacterial agents.

4.2 Posology and method of administration

Oral route of administration.

Metronidazole Tablets tablets should be swallowed with water (not chewed). It is recommended that the tablets be taken during or after a meal.

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

Adults

400 mg 8 hourly during 24 hours immediately preceding operation followed by postoperative intravenous or rectal administration until the patient is able to take tablets.

Children

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

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

Treatment of established anaerobic infection:

Adults

800 mg followed by 400 mg 8 hourly.

Children

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, therefore the concentrations of metronidazole in serum should preferable be monitored after a few days therapy. Protozoal and other infections:

Dosage is given in terms of metronidazole or metronidazole equivalent
Duration of dosage in days Adults and children over 10 years Children
7 to 10 years 3 to 7 years 1 to 3 years
Urogenital trichomoniasis

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

7

or

2000mg as a single dose or 200 mg three times daily

or

40mg/kg orally as a single dose or 15-30 mg/kg/day divided in 2-3 doses; not to exceed 2000mg/dose
5-7 400mg twice daily
Bacterial vaginosis 5-7

or

400 mg 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 2000mg once daily

or

1000mg once daily 600-800 mg once daily 500 mg once daily
5 400mg three times daily

or

7-10 500mg twice daily
Alternatively, as expressed in mg per kg of body weight:

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

Dosage is given in terms of metronidazole or metronidazole equivalent
Duration of dosage in days Adults and children over 10 years Children
7 to 10 years 3 to 7 years 1 to 3 years
Acute ulcerative gingivitis 3 200 mg three times daily 100 mg three times daily 100 mg twice daily 50 mg three times daily
Acute dental infections 3-7 200 mg three times daily
Leg ulcers and pressure sores 7 400 mg three times daily
Children and infants weighing less than 10 kg should receive proportionally smaller dosages.

Elderly: Metronidazole Tablets is well tolerated by the elderly but a pharmacokinetic study suggests cautious use of high dosage regimens in this age group.

Eradication of Helicobacter pylori in paediatric 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.

4.3 Contraindications

Known hypersensitivity to nitroimidazoles, metronidazole 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 Tablets 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).

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.

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.

Cases of severe bullous skin reactions such as Stevens Johnson syndrome (SJS), toxic epidermal necrolysis (TEN) or acute generalised exanthematous pustulosis (AGEP) have been reported with metronidazole. If symptoms or signs of SJS, TEN or AGEP are present, Metronidazole Tablets treatment must be immediately discontinued.

There is a 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 Tablets need be made in patients with renal failure undergoing intermittent peritoneal dialysis (IDP) 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 the encephalopathy. Metronidazole Tablets should therefore, be administered with caution to patients with hepatic encephalopathy. The daily dosage should be reduced to one third and may be administered once daily.

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 flagyl for longer treatment than usually required should be carefully considered.

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 anticoagulants. Dosage of the latter may require reducing. Prothrombin times should be monitored. There is no interaction with heparin.

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 concentrations 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 3 hours.

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

Patients receiving ciclosporin are at risk of elevated ciclosporin serum levels. Serum ciclosporin 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 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. Nevertheless Metronidazole Tablets, like other medicines, should not be given during pregnancy or during lactation unless the physician considers it essential; in these circumstances the short, high-dosage regimens are not recommended.

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).

Serious adverse reactions occur rarely with standard recommended regimens. 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, pancytopenia

Not known: leucopenia.

Immune system disorders:

Rare: anaphylaxis

Not known: angiodema, urticaria, 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) which may resolve on discontinuation of the drug.
  • drowsiness, dizziness, convulsions, headaches

Not known:

  • during intensive and/or prolonged metronidazole therapy, peripheral sensory neuropathy or transient epileptiform seizures have been reported. In most cases neuropathy disappeared after treatment was stopped or when dosage was reduced.
  • aseptic meningitis

Eye disorders:

Very rare: vision disorders such as diplopia and myopia, which, in most cases, is transient.

Not Known: optic neuropathy/neuritis

Ear and labyrinth disorders

Not known: hearing impaired/hearing loss (including sensorineural), tinnitus

Gastrointestinal disorders:

Not known: taste disorders, oral mucositis, furred tongue, nausea, vomiting, gastro-intestinal disturbances such as epigastric pain and diarrhoea.

Hepatobiliary disorders:

Very rare:

  • increase in liver enzymes (AST, ALT, alkaline phosphatase), cholestatic or mixed hepatitis and hepatocellular liver injury, jaundice and pancreatitis which is reversible on drug withdrawal.
  • 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, acute generalised exanthematous pustulosis, pruritis, flushing

Not known: erythema multiforme, 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 urine (due to metronidazole metabolite).

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. Healthcare professionals are asked to report any suspected adverse reactions.

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

Pharmacotherapeutic group: Antibacterials for systemic use, ATC code: J01X D01

Metronidazole has antiprotozoal and antibacterial actions and is effective against Trichomonas vaginalis and other protozoa including Entamoeba histolytica and Giardia lamblia and against anaerobic bacteria.

5.2 Pharmacokinetic properties

Metronidazole is rapidly and almost completely absorbed on administration of Metronidazole Tablets tablets; peak plasma concentrations occur after 20 min to 3 hours.

The half-life of metronidazole is 8.5 ± 2.9 hours. Metronidazole can be used in chronic renal failure; it is rapidly removed from the plasma by dialysis. Metronidazole 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.

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 other studies were negative.

6.Pharmaceutical particulars

6.1 List of excipients

Calcium hydrogen phosphate, Starch maize, Povidone K30, Magnesium stearate,

Tablet coat: Pharma coat 615, Macrogol 400

6.2 Incompatibilities

Not applicable

6.3 Shelf life

3 years

6.4 Special precautions for storage

Store below 30°C in the original packaging (protect from light).

6.5 Nature and contents of container

Metronidazole Tablets tablets are available in aluminium/plastic blisters of 14 tablets and HDPE bottles of 100 tablets.

200mg, 250mg and 500mg Tablets are white to off-white biconvex tablets.

Metronidazole tablets 200mg Tablets are available in aluminium/plastic blister packs of 21 tablets and HDPE bottles of 100 and 250 tablets.
Metronidazole tablets 250mg Tablets are available in aluminium/plastic blister packs of 21 tablets and HDPE bottles of 100 and 250 tablets
Metronidazole tablets 500mg Tablets are available in aluminium/plastic blister packs of 14 tablets and HDPE bottles of 100 tablets.

Not all pack sizes may be marketed

6.6 Special precautions for disposal and other handling

No special requirements

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 Tablets USP 250mg/500mg Tablets Taj Pharma

(Metronidazole)

Read all of this leaflet carefully before you start taking this medicine.

  • Keep this leaflet. You may need to read it again.
  • If you have further questions, please ask your doctor or pharmacist.
  • This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms 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 or pharmacist.

In this leaflet:

  1. WHAT METRONIDAZOLE TABLETS IS AND WHAT IT IS USED FOR
  2. BEFORE YOU TAKE METRONIDAZOLE TABLETS
  3. HOW TO TAKE METRONIDAZOLE TABLETS
  4. POSSIBLE SIDE EFFECTS
  5. HOW TO STORE METRONIDAZOLE TABLETS
  6. FURTHER INFORMATION

    1.WHAT METRONIDAZOLE TABLETS IS AND WHAT IT IS USED FOR

The name of this medicine is metronidazole tablets 200mg, 250mg or 500mg Tablets (called metronidazole tablets in this leaflet). metronidazole tablets contains a medicine called metronidazole. This belongs to a group of medicines called antibiotics.

It works by killing bacteria and parasites that cause infections in your body.

It can be used to:

  • Treat infections of the blood, brain, lung, bones, genital tract, pelvic area, stomach and intestines
  • Treat gum ulcers and other dental infections
  • Treat infected leg ulcers and pressure sores.
  • Prevent infections after surgery

If you need any further information on your illness, speak to your doctor.

  1. BEFORE YOU TAKE METRONIDAZOLE TABLETS
    Do not take metronidazole tablets and tell your doctor if:
  • You are allergic (hypersensitive) to metronidazole, nitroimidazoles (e.g. tinidazole) or any of the other ingredients in your medicine (listed in Section 6: Further information). Signs of an allergic reaction include: a rash, swallowing or breathing problems, swelling of your lips, face, throat or tongue.

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

Take special care with metronidazole tablets and check with your doctor or pharmacist before using your medicine if:

  • You have or have ever had a liver problem
  • You are having kidney dialysis (see section 3: ‘People having kidney dialysis’)
  • You have a disease of the nervous system

If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before taking your medicine. Do this even if they have applied in the past.

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

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

Serious skin reactions including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), acute generalised exanthematous pustulosis (AGEP) have been reported with the use of metronidazole tablets.

  • SJS/TEN can appear initially as reddish target-like spots or circular patches often with central blisters on the trunk. Also, ulcers of the mouth, throat, nose, genitals and eyes (red and swollen eyes) can occur. These serious skin rashes are often preceded by fever and/or flu-like symptoms. The rashes may progress to widespread peeling of the skin and life-threatening complications or be fatal.
  • AGEP appears at the initiation of treatment as a red, scaly widespread rash with bumps under the skin and blisters accompanied by fever. The most common location: mainly localised on the skin folds, trunk, and upper extremities.

The highest risk for occurrence of serious skin reactions is within one week, typically, within 48 hours after start of treatment. If you develop a serious rash or another of these skin symptoms, stop taking metronidazole tablets and contact your doctor or seek medical attention immediately.

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

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

Taking other medicines

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

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

  • Medicines used to thin the blood such as warfarin
  • Lithium for mental illness
  • Phenobarbital or phenytoin for epilepsy
  • 5 fluorouracil for cancer
  • Busulfan for leukaemia (cancer of the blood cells)
  • Ciclosporin – to prevent the rejection of organs after transplant
  • Disulfiram for alcoholism

If you are not sure, talk to your doctor or pharmacist before taking metronidazole tablets.

Taking metronidazole tablets with food and drink

Do not drink any alcohol while you are taking metronidazole tablets and for   48 hours after finishing your course. Drinking alcohol while using metronidazole tablets might cause unpleasant side effects, such as feeling sick (nausea), being sick (vomiting), stomach pain, hot flushes, very fast or uneven heartbeat (palpitations) and headache.

Pregnancy and breast-feeding

Tell your doctor before using metronidazole tablets if:

  • You are pregnant, might become pregnant or think you may be pregnant. metronidazole tablets should not be taken during pregnancy unless considered absolutely necessary.
  • You are breast-feeding. It is better not to use metronidazole tablets if you are breast-feeding. This is because small amounts may pass into the mother’s milk.

Driving and using machines

While taking metronidazole tablets you may feel sleepy, dizzy, confused, see or hear things that are not there (hallucinations), have fits (convulsions) or temporary eyesight problems (such as blurred or double vision). If this happens, do not drive or use any machinery or tools.

Tests

Your doctor may wish to carry out some tests if you have been using this medicine for more than 10 days.

  1. HOW TO TAKE METRONIDAZOLE TABLETS

Taking your medicine

Always take metronidazole tablets exactly as your doctor has told you. It is important to finish a full course of treatment. The length of a course will depend on your needs and the illness being treated. Check with your doctor or pharmacist if you are not sure.

  • Swallow the tablets whole with a drink of water
  • Do not crush or chew the tablets
  • Take these tablets during or just after a meal
  • The dose of metronidazole tablets will depend on your needs and the illness being treated
  • The length of your treatment will depend on the type of illness you have and how bad it is

The usual dose for adults and children is given below:

To treat bacterial infection Adults

  • The initial dose is 800mg
  • After 8 hours take another dose of 400mg and repeat this dose every 8 hours

Children

  • Your doctor will work out how much your child should take depending on their weight
  • Repeat the dose every 8 hours
  • If your child is a baby under 8 weeks of age, your doctor will give them one daily dose or two separate doses 12 hourly

To prevent infections from happening after surgery Adults

Start Taking metronidazole tablets Tablets 24 hours before your operation

Take 400 mg of metronidazole tablets every 8 hours

After the operation you may be given metronidazole tablets either through a drip into a vein or rectally as a suppository until you are able to take tablets again

Children

Give your child metronidazole tablets Tablets 1-2 hours before their operation

Your doctor will work out how much your child should take depending on their weight

After the operation your child may be given metronidazole tablets either through a drip into a vein or rectally as a suppository until they are able to take tablets again

Other types of infections

For treatment of other infections caused by parasites and some bacteria your doctor will decide how much metronidazole tablets you need to take and how often. This will depend on your illness and how bad it is. The pharmacist’s label on the packaging will tell you how many tablets to take and how often to take them.

People having kidney dialysis

Kidney dialysis removes metronidazole tablets from your blood. If you are having kidney dialysis you must take this medicine after your dialysis treatment.

People with liver problems

Your doctor may tell you to use a lower dose or to use the medicine less often.

If you take more metronidazole tablets than you should

If you take more metronidazole tablets than you should, tell your doctor or go to your nearest hospital casualty department straight away. Take the pack and any tablets left with you. This is so the doctor knows what you have taken.

If you forget to take metronidazole tablets

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

  1. POSSIBLE SIDE EFFECTS

Like all medicines, metronidazole tablets can cause side effects, although not everybody gets them.

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

  • 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 (hives) or nettle rash (urticaria)
  • This may mean you are having an allergic reaction to metronidazole tablets.
  • A serious but very rare side effect is a brain disease (encephalopathy).
  • 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 feel confused.
  • You develop skin rashes including Stevens-Johnson syndrome or toxic epidermal necrolysis. These  can appear as reddish target-like spots or circular patches often with central blisters on the  trunk,  skin  peeling, ulcers of the mouth, throat, nose, genitals and eyes and can be preceded by fever and flu-like symptoms. Stop using metronidazole tablets if you develop these symptoms and contact your doctor or seek medical attention immediately. See also section 2.

You develop a red, scaly widespread rash with bumps under the skin and blisters accompanied by fever at the initiation of treatment (acute generalised exanthematous pustulosis). Stop using metronidazole tablets if you develop these symptoms and contact your doctor or seek medical attention immediately. See also section 2.

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

  • Yellowing of the skin and eyes. This could be due to a liver problem (jaundice).
  • Unexpected infections, mouth ulcers, bruising, bleeding gums, or severe tiredness. This could be caused by a blood problem.
  • 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 (affects less than 1 in 10 000 people)

  • Fits (convulsions)
  • Mental problems such as feeling confused and seeing or hearing things that are not there (hallucinations)
  • Problems with your eyesight such as blurred or double vision
  • Skin rash or flushing
  • Headache
  • Darkening of the urine
  • Feeling sleepy or dizzy
  • Pains in the muscles or joints
  • Liver problems including life-threatening liver failure (hepatocellular liver injury)

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

  • Numbness, tingling, pain, or a feeling of weakness, in the arms or legs
  • Unpleasant taste in the mouth
  • Furred tongue
  • Feeling sick (nausea), being sick (vomiting), upset stomach, stomach pain or diarrhoea
  • Loss of appetite
  • Fever
  • Feeling depressed
  • 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).
  • 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

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. You can also report side effects directly.

By reporting side effects you can help provide more information on the safety of this medicine.

  1. HOW TO STORE METRONIDAZOLE TABLETS
  • Keep your medicine in a safe place and out of the reach and sight of children.
  • Store below 30º C in the original packaging (protect from light).
  • Do not use this medici ne after the expiry date shown on the pack.
  • Ask your pharmacist how to dispose of medicines no longer required. Do not dispose of medicines by flushing down a toilet or sink or by throwing out with your normal household rubbish. This will help protect the environment.
  1. FURTHER INFORMATION

What metronidazole tablets contain

Each tablet contains 250mg or 500mg of metronidazole as the active substance.

Other ingredients are: calcium hydrogen phosphate, starch maize, povidone K30 and magnesium stearate. The coating of the tablets contains: Pharmacoat 615  and Macrogol 400.

What metronidazole tablets look like and contents of the pack

Metronidazole Tablets tablets are available in aluminium/plastic blisters of 14 tablets and HDPE bottles of 100 tablets.

200mg, 250mg and 500mg Tablets are white to off-white biconvex tablets.

Metronidazole tablets 200mg Tablets are available in aluminium/plastic blister packs of 21 tablets and HDPE bottles of 100 and 250 tablets.
Metronidazole tablets 250mg Tablets are available in aluminium/plastic blister packs of 21 tablets and HDPE bottles of 100 and 250 tablets
Metronidazole tablets 500mg Tablets are available in aluminium/plastic blister packs of 14 tablets and HDPE bottles of 100 tablets.

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