Consumer Information for: APO-METRONIDAZOLE

Consumer Information

Information about the product including what the product is used for, dosage, warnings, proper use and side effects. This summary will not tell you everything about the product. Contact your healthcare professional if you have any questions about the product.


What the medication is used for

Antibacterial drugs like APO-METRONIDAZOLE treat only bacterial infections. They do not treat viral infections such as the common cold. Although you may feel better early in treatment, APO-METRONIDAZOLE should be used exactly as directed. Misuse or overuse of APO-METRONIDAZOLE could lead to the growth of bacteria that will not be killed by APO-METRONIDAZOLE (resistance). This means that APO-METRONIDAZOLE may not work for you in the future. Do not share your medicine.

APO-METRONIDAZOLE belongs to a group of medicines called antibacterial - antiprotozoal. It can be used to treat:

  • infections of the genital tract (such as trichomoniasis: a sexually transmitted infection, bacterial vaginosis);
  • stomach, liver and intestinal infections (amebiasis, giardiasis);
  • infections (such as intra-abdominal, brain or lung infections), caused by anaerobic bacteria (bacteria that are able to survive in the absence of oxygen).
What it does

APO-METRONIDAZOLE works by killing bacteria and parasites that cause infections in your body.

When it should not be used

Do not take APO-METRONIDAZOLE and tell your doctor if:

  • You are allergic (hypersensitive) to metronidazole, nitroimidazoles (e.g. tinidazole) or any of the ingredients in APO- METRONIDAZOLE (see What the nonmedicinal ingredients are).
  • You have a disease of the nervous system.
  • You have a history of blood disease, hypothyroidism (underactive thyroid gland) or hypoadrenalism (underactive adrenal glands).

Do not take APO-METRONIDAZOLE if any of the above applies to you. If you are not sure, talk to your doctor or pharmacist before taking APO-METRONIDAZOLE.

What the medicinal ingredient is

Each APO-METRONIDAZOLE capsule contains metronidazole.

What the non-medicinal ingredients are

Capsules:
Colloidal silicon dioxide, croscarmellose sodium and stearic acid. The capsule shell contains the following non-medicinal ingredients: D&C red #33, D&C yellow #10, FD&C blue #1, FD&C green #3, gelatin, talc (antistatic agent) and titanium dioxide. The edible ink used to imprint the capsule shells contains the following non-medicinal ingredients: FD&C blue #2, FD&C red #40, iron oxide black, propylene glycol and shellac glaze.

What dosage form it comes in

APO-METRONIDAZOLE is available as:

  • Oral capsules containing 500 mg metronidazole. Each pale green and light grey capsule, printed "500" contains 500 mg of metronidazole. Available in bottles of 100 capsules.
Warnings and precautions

BEFORE you use APO-METRONIDAZOLE talk to your doctor or pharmacist if you:

  • are pregnant, think you are, or plan to get pregnant.
  • are breastfeeding, or planning to breastfeed, as metronidazole is excreted in human breast milk.
  • have liver problems.
  • have any allergies to this drug or its ingredients (see What the nonmedicinal ingredients are) or a known allergy to nitroimidazoles (e.g. tinidazole).
  • have an active or chronic severe disease of the nervous system.
  • have any blood disorder (e.g. leukemia, hemophilia, or other). Your doctor may order periodic blood tests.
  • have a thyroid condition or hypoadrenalism (underactive adrenal glands).

Contact your doctor if the following occurs while taking APO-METRONIDAZOLE:

  • You feel sleepy, dizzy, confused, see or hear things that are not there (hallucinations), have fits (convulsions), have temporary eyesight problems (e.g. blurred or double vision). If this happens do not drive or use machinery or tools
  • You feel tingling, pain, numbness or weakness in the arms or legs ( peripheral neuropathy)

Unnecessary use of APO-METRONIDAZOLE should be avoided and prolonged treatment duration should be carefully weighed by your doctor. Its use should be reserved for the conditions described in the “What the medication is used for” section.

Avoid alcohol during APO-METRONIDAZOLE treatment and for at least one day following treatment to avoid an adverse reaction.

If a sexual partner shows signs of infection, the partner should be examined and treated by the doctor too.

If you have liver problems, your doctor may tell you to use a lower dose or to use the medicine less often.
APO-METRONIDAZOLE may darken your urine and this is not considered a concern.

Cases of severe liver toxicity/acute liver failure, including deaths, in patients with Cockayne syndrome have been reported with products containing metronidazole.

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

  • Tell your doctor immediately and stop taking APO-METRONIDAZOLE if you develop stomach pain, loss of appetite, nausea, vomiting, fever, malaise, fatigue, jaundice (e.g. yellowing of skin and eyes), dark urine putty or mastic colored stools or itching.
Interactions with this medication

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 APO-METRONIDAZOLE can affect the way some other medicines work. Also, some other medicines can affect the way APO-METRONIDAZOLE works.

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

  • Medicines used to thin the blood such as warfarin (Coumadin®);
  • Lithium;
  • Phenobarbital;
  • Phenytoin (Dilantin®);
  • 5-fluorouracil (or 5-FU);
  • Busulfan (Myleran®);
  • Cyclosporin (Neoral®);
  • Disulfiram
  • Vecuronium

If you are not sure, talk to your doctor or pharmacist before taking APO-METRONIDAZOLE.

Do not drink any alcohol while you are taking APO-METRONIDAZOLE and for at least 1 day after finishing your course. Drinking alcohol while using APO-METRONIDAZOLE 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.

Proper use of this medication

Note: The 250 mg metronidazole tablet is not marketed by Apotex Inc.

Usual adult dose

TREATMENT OF TRICHOMONIASIS

Oral Administration:

Single-Dose Treatment
For both women and men, 2 g (4 capsules) administered as a single dose after a meal.

Standard Ten-day Treatment

  • Women: One 250 mg tablet twice a day, morning and night for 10 consecutive days.
  • Men: One 250 mg tablet twice a day for 10 consecutive days.

For both men and women, it may be occasionally necessary to give a second ten-day course after 4 to 6 weeks.

TREATMENT OF AMEBIASIS

Adults:
Intestinal amebiasis – Three 250 mg tablets three times daily for 5 to 7 days.

Amebic abscesses of the liver – Two to three 250 mg tablets three times daily for 5 to 7 days.

Children:
Administer 35 to 50 mg/kg/day in three divided doses for 5 to 7 days.

TREATMENT OF GIARDIASIS

Adults:
One 250 mg tablet twice daily for 5 to 7 days.

Children:
Administer 25 to 35 mg/kg/day in two divided doses for 5 to 7 days.

TREATMENT OF BACTERIAL VAGINOSIS

Adults:
500 mg orally twice a day for 7 days.

Concurrent treatment of sexual partners is not usually indicated.

ANAEROBIC INFECTIONS

Adults:
In the treatment of most serious anaerobic infections, intravenous metronidazole is usually administered initially. This may be followed by oral therapy with APO-METRONIDAZOLE capsules.

Oral Administration:
500 mg every 8 hours. Treatment for seven days should be satisfactory for most patients.

Overdose

If you think you have taken too much APO-METRONIDAZOLE, contact your health care professional, hospital emergency department or regional Poison Control Centre immediately, even if there are no symptoms.

Missed Dose

If you forget to take APO-METRONIDAZOLE, 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.

Side effects and what to do about them

Like all medicines, APO-METRONIDAZOLE can cause side effects, although not everybody gets them.

These side effects may include:

  • Unpleasant taste in the mouth
  • Furred tongue or tongue
  • Feeling sick (nausea), being sick (vomiting), upset stomach, stomach pain or diarrhea
  • Hearing loss
  • Noise such as buzzing, ringing, or whistling heard in the ear
  • Loss of appetite
  • Feeling sleepy or dizzy

This is not a complete list of side effects. For any unexpected side effects while taking APO-METRONIDAZOLE, contact your doctor or pharmacist.

Serious side effects, how often they happen and what to do about them
Symptom / effect Talk with your doctor or pharmacist Only if severe Talk with your doctor or pharmacist In all cases Stop taking drug and call your doctor or pharmacist
Allergic reaction with symptoms such as swelling of the mouth, throat, hands, difficulty in breathing or swallowing, itching, rash, red spots and blisters     ✔
Diarrhea ✔    
Liver problems including cases of liver failure with symptoms such as intense fatigue, yellowing of the skin and eyes, dark urine, abdominal pain.     ✔
Nervous system problems with symptoms such as inability to coordinate voluntary movements, problems using your arms and legs, problems with speaking or feel confused, convulsions, tingling sensation on the skin,; stiff neck associated with headache, extreme sensitivity to bright light     ✔
Fever, unexpected infections, mouth ulcers, bruising, bleeding gums, or extreme tiredness.   ✔  
Pancreatitis (inflammation of the pancreas) with symptoms such as severe abdominal pain which may reach through to your back, especially associated with nausea, vomiting and fatigue.     ✔
Problems with your eyesight such as blurred or double vision   ✔  
Feeling depressed   ✔  
Pain in your eyes   ✔  
Mental problems such as feeling confused and seeing or hearing things that are not there (hallucinations) ✔    
tingling, pain, or a feeling of weakness, in the arms or legs   ✔  
How to store

Keep out of reach and sight of children.

APO-METRONIDAZOLE (Metronidazole Capsules) should be stored between 15°C to 25°C.

Reporting side effects

You can report any suspected side effects associated with the use of health products to Health Canada by:

NOTE: Contact your health professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice.

More information

For more information, please contact your doctor, pharmacist or other healthcare professional.

This leaflet plus the full product monograph, prepared for health professionals, can be obtained by contacting DISpedia, Apotex's Drug Information Service at:

1-800-667-4708

This leaflet can also be found at: http://www.apotex.ca/products.

This leaflet was prepared by Apotex Inc., Toronto, Ontario, M9L 1T9.

Last Revised: April 9, 2018

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