Consumer Information for: M-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 M-METRONIDAZOLE treat only bacterial infections. They do not treat viral infections such as the common cold. Although you may feel better early in treatment, MMETRONIDAZOLE should be used exactly as directed. Misuse or overuse of MMETRONIDAZOLE could lead to the growth of bacteria that will not be killed by MMETRONIDAZOLE (resistance). This means that M-METRONIDAZOLE may not work for you in the future. Do not share your medicine.
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
M-METRONIDAZOLE works by killing bacteria and parasites that cause infections in your body.
When it should not be used
Do not take M-METRONIDAZOLE and tell your doctor if:
- You are allergic (hypersensitive) to metronidazole, nitroimidazoles (e.g.tinidazole) or any of the ingredients in M-METRONIDAZOLE (see What the nonmedicinal ingredients are).
- You have a disease of the nervoussystem.
- You have a history of blood disease, hypothyroidism (underactive thyroid gland)or hypoadrenalism (underactive adrenalglands).
Do not take M-METRONIDAZOLE if any of the above applies to you. If you are not sure, talk to your doctor or pharmacist before taking MMETRONIDAZOLE.
What the medicinal ingredient is
M-METRONIDAZOLE contains a medicine called metronidazole.
What the non-medicinal ingredients are
Oral Capsules:
Silicon dioxide, D&C Red No. 33, D&C Yellow No.10, FD&C Blue No. 1, FD&C Green No. 3, gelatin, lactose monohydrate, magnesium stearate, sodium lauryl sulfate, titanium dioxide and black ink.
What dosage form it comes in
M-METRONIDAZOLE is available as:
- Oral capsules containing 500 mgmetronidazole.
Warnings and precautions
BEFORE you use M-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 itsingredients (see What the nonmedicinal ingredients are) or a known allergy to nitroimidazoles (e.g. tinidazole)
- have an active or chronic severe disease ofthe nervoussystem
- 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 M-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 M-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 M-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. M-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 metronidazole and afterwards.
- Tell your doctor immediately and stop taking 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 MMETRONIDAZOLE can affect the way some other medicines work. Also, some other medicines can affect the way M-METRONIDAZOLE works.
In particular tell your doctor if you are taking any of the following medicines:
- Medicines used to thin the blood such aswarfarin (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 M-METRONIDAZOLE.
Do not drink any alcohol while you are taking MMETRONIDAZOLE and for at least 1 day after finishing your course. Drinking alcohol while using M-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
PROPER USE OF THIS MEDICATION
The 250 mg strength is not marketed by Mantra Pharma 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 consecutivedays.
- Men: One 250 mg tablet twice a dayfor 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 divideddoses 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 M-METRONIDAZOLE capsules.
Oral Administration:
500 mg every 8 hours. Treatment for seven days should be satisfactory for most patients.
Overdose:
Missed Dose
If you forget to take M-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, M-METRONIDAZOLE can cause side effects, although not everybody gets them.
These side effects may include:
- Unpleasant taste in themouth
- Furred tongue ortongue
- 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 MMETRONIDAZOLE, contact your doctor or pharmacist.
| Symptom / effect | Talk to your healthcare professional Only if severe | Talk to your healthcare professional In all cases | Stop taking drug and get immediate medical help |
|---|---|---|---|
| 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 | ✔ | ||
| Feeling depressed | ✔ | ||
| Mental problems such as feeling confused and seeing or hearing things that are not there (hallucinations) | ✔ | ||
| Numbness, tingling, pain, or a feeling of weakness, in the arms or legs | ✔ |
How to store
Keep M-METRONIDAZOLE in a safe place where children cannot reach or see it.
M-METRONIDAZOLE (metronidazole) oral capsules should be stored between 15 and 30° C.
Reporting side effects
You can report any suspected side effects associated with the use of health products to Health Canada by:
- Visiting the Web page on Adverse Reaction Reporting (https://www.canada.ca/en/healthcanada/services/drugs-health-products/medeffectcanada/adverse-reaction-reporting.html)
- Calling toll-free at 1-866-234-2345
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
MORE INFORMATION
This document plus the full product monograph, prepared for health professionals can be found by visiting Health Canada website (https://healthproducts.canada.ca/dpd-bdpp/index-eng.jsp) or by contacting the sponsor, Mantra Pharma Inc. at: medinfo@mantrapharma.ca or 1-833-248-7326.
This leaflet was prepared Mantra Pharma Inc.,
9150 Leduc boulevard, suite 201
Brossard, Quebec, Canada
J4Y 0E3
Flagyl® is a registered trade-mark of Aventis Pharma S.A., France
Coumadin® is a registered trade-mark of Bristol-Myers Squibb Pharma Company
Neoral® is a registered trade-mark of Novartis AG Dilantin® is a registered trade-mark of Warner-Lambert Company LLC Myleran® is a registered trade-mark of Aspen Global Incorporated.
Last Revised: August 25, 2021
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