Details for: FLAGYL
Company: ODAN LABORATORIES LTD
| DIN | DIN name | Active Ingredient(s) | Strength | Dosage Form | Route of Administration |
|---|---|---|---|---|---|
| 01926853 | FLAGYL | METRONIDAZOLE | 500 MG | CAPSULE | ORAL |
Consumer Information
This information was provided by the drug’s manufacturer when this drug product was approved for sale in Canada. It is designed for consumers and care givers. It is a summary of information about the drug and will not tell you everything about the drug. Contact your doctor or pharmacist if you have any questions about the drug.
What the medication is used for
Antibacterial drugs like FLAGYL treat only bacterial infections. They do not treat viral infections such as the common cold. Although you may feel better early in treatment, FLAGYL should be used exactly as directed. Misuse or overuse of FLAGYL could lead to the growth of bacteria that will not be killed by FLAGYL (resistance). This means that FLAGYL may not work for you in the future. Do not share your medicine.
FLAGYL belongs to a group of medicines called antibacterial - antiprotozoal. It can be used to treat:
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
FLAGYL works by killing bacteria and parasites that cause infections in your body.
When it should not be used
Do not take FLAGYL and tell your doctor if:
- You are allergic (hypersensitive) to metronidazole, nitroimidazoles (e.g. tinidazole) or any of the ingredients in FLAGYL (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 FLAGYL if any of the above applies to you. If you are not sure, talk to your doctor or pharmacist before taking FLAGYL.
What the medicinal ingredient is
FLAGYL contains a medicine called metronidazole.
What the non-medicinal ingredients are
Oral Capsules:
Silicon dioxide, D&C Red No. 33 (Acid Fuchsin D),
D&C Yellow No.10 (Quinoline Yellow WS), FD&C
Blue No. 1 (Brillant Blue FCF sodium salt), FD&C
Green No. 3 (Fast Green FCF), gelatin, lactose
monohydrate, magnesium stearate, polacrilin
potassium, sodium lauryl sulfate, titanium dioxide
and black ink. Sodium: <1 mmol (5.47 mg).
What dosage form it comes in
FLAGYL is available as:
- Oral capsules containing 500 mg metronidazole.
Warnings and precautions
BEFORE you use FLAGYL 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 FLAGYL:
- 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 FLAGYL 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 FLAGYL 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.
FLAGYL 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 FLAGYL can affect the way some other medicines work. Also, some other medicines can affect the way FLAGYL 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 FLAGYL.
Do not drink any alcohol while you are taking FLAGYL and for at least 1 day after finishing your course. Drinking alcohol while using FLAGYL 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
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.
Vaginal Treatment:
Cream – One applicator full of FLAGYL Cream (500
mg) once or twice a day into the vagina for 10 or
20 consecutive days even during menstruation.
The applicator should not be used after the 7th month
of pregnancy.
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
FLAGYL 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 FLAGYL, 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, FLAGYL can cause side effects, although not everybody gets them.
These side effects may include:
- Unpleasant taste in the mouth
- Furred tongue or tongue discoloration
- 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 FLAGYL, contact your doctor or pharmacist.
| 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) | ✔ | ||
| Numbness, tingling, pain, or a feeling of weakness, in the arms or legs | ✔ |
How to store
Keep FLAGYL in a safe place where children cannot reach it.
FLAGYL (metronidazole) oral capsules and vaginal cream 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 the Canada Vigilance Program by one of the following:
- Visiting the Web page on Adverse Reaction Reporting (www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/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
This document plus the full product monograph, prepared for health professionals can be found by visiting the Health Canada website (hc-sc.gc.ca/index-eng.php); the manufacturer’s website http://www.odanlab.com , or by calling
1-800-387-9342
This leaflet was prepared by Odan Laboratories Ltd.
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.
Date of Revision: January 29, 2018