Pharmacotherapeutic group
Flagyl is an antibacterial and antiparasitic antibiotic belonging to the 5-nitroimidazole group of medicines.
Therapeutic indications
It is used to treat certain infections caused by bacteria or parasites that are sensitive to Flagyl.

Contraindications
Do not take Flagyl 250 mg:
- if you are allergic to metronidazole, to any medicine in the imidazole group (the group of antibiotics that includes metronidazole) or to any other ingredient of this medicine listed in Section 6,
- if you are allergic (hypersensitive) to wheat, as this medicine contains wheat starch (gluten),
- if the patient is a child under 6 years of age (see “Warnings and precautions”).
Appropriate precautions for use; special warnings
Warnings and precautions
Before taking Flagyl 250 mg, tell your doctor if:
- you have severe, chronic or progressive
nervous disorders,
- you have psychiatric disorders,
- you have blood disorders,
- you have ever had meningitis under metronidazole
treatment.
Tell your doctor immediately if any of the following problems occur during treatment with Flagyl 250 mg:
From the first dose, there is a risk of severe and sudden allergic reaction (anaphylactic shock, angioedema) possibly causing the following symptoms: tight chest, dizziness, nausea or fainting, or dizziness when standing up (see “Possible side effects”). If these symptoms occur, stop taking this medicine because your life might be in danger and immediately contact a doctor.
If, at the start of treatment, you experience redness all over the body and pustules, accompanied by fever, a serious reaction known as acute generalized exanthematous pustulosis should be suspected (see “Possible side effects”); inform your doctor immediately as treatment must be stopped. Any further administration of metronidazole alone or in combination with another active substance in the same medicine is contraindicated if such a reaction occurs.
If you find it difficult to coordinate voluntary movements or if you feel dizzy or confused, you should stop taking the medicine and see a doctor.
From the very first doses of treatment, your behavior may alter and put you at risk, especially if you have had psychiatric problems in the past (see “Possible side effects”). If this happens, you should stop taking the medicine and see a doctor.
During long-term treatment, you should watch out for any signs of nervous disorders such as tingling, difficulty coordinating movements, dizziness or seizures. If these occur, it is important to inform your doctor.

If you have had blood disorders in the past, or received high-dose and/or long-term treatment, your doctor may prescribe regular blood tests to check your complete blood count.
Inform the doctor or analysis laboratory that you are taking this medicine if you have to have a medical laboratory test: taking metronidazole may interfere with some laboratory test results (test for treponema), by triggering a false positive result for a test (Nelson test).
Children
The administration of tablets is contraindicated in children under 6 years of age due to the risk of choking. More suitable dosage forms and strengths of this antibiotic exist for young children.
Talk to your doctor or pharmacist before taking Flagyl 250 mg.
Other medicines and Flagyl 250 mg
Tell your doctor or pharmacist if you are taking, have recently taken or may take any other medicines.
Tell your doctor if you are taking:
- medicines containing alcohol because of the risk of side effects such as redness of the face, feeling hot, vomiting and increased heart rate,
- busulfan (recommended for the treatment of certain types of blood disorders and for the preparation of a bone marrow transplant),
- disulfiram (used to prevent relapse in alcohol-dependent patients).
Flagyl 250 mg with alcohol
Drinking alcoholic beverages should be avoided during treatment because of the risk of side effects such as redness of the face, feeling hot, vomiting and increased heart rate.
Pregnancy and breast-feeding
If necessary, this medicine may be taken during pregnancy. However, you must always ask your doctor or pharmacist for advice before taking it.
You should avoid breast-feeding while taking this medicine.
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Driving and using machines
You should be aware, particularly if you drive or use machines, that there is a risk of dizziness, confusion, hallucinations, seizures and vision disorders associated with this medicine.
Important information about some of the ingredients of Flagyl 250 mg
You may take this medicine if you have celiac disease. Wheat starch can contain gluten, but only traces, and is therefore considered safe for patients with celiac disease.

Dosage
This medicine is for adults and children from 6 years of age only. More suitable dosage forms exist for children under 6 years of age.
The dosage depends on your age and the illness being treated.
As an indication, the usual dose is:
- Adults: 0.50 g/day to 1.5 g/day,
- Children: 375 mg/day to 20-40 mg/kg/day.
In some cases, it is essential that your partner be treated, whether or not he/she has any clinical signs.
IN ALL CASES, FOLLOW YOUR DOCTOR’S PRESCRIPTION.
How Flagyl should be taken
Oral use.
Swallow the tablets with a glass of water.
How often Flagyl should be taken
2 to 3 times a day depending on why you are taking this medicine.
How long Flagyl should be used for
In order to be effective, this antibiotic must be used regularly at the prescribed doses and for as long as your doctor advises.
If your fever or any other symptom disappears, it does not mean that you are cured.
If you feel tired, this is not due to the antibiotic treatment but to the infection itself. Reducing or suspending treatment would have no effect on this feeling and would only delay your recovery.
Particular cases: treatment of giardiasis (infection caused by a parasite) should last 5 days, treatment of amebiasis (infection caused by a parasite) and some types of vaginosis (infection of the vagina), 7 days and treatment of trichomoniasis (infection caused by a parasite), consists of a single dose.
If you take more Flagyl 250 mg than you should
If you are vomiting, have difficulty coordinating your movements or are disorientated, consult your doctor. Your doctor may decide to prescribe medication.

Like all medicines, Flagyl 250 mg can cause side effects, although not everybody gets them.
Digestive disturbances:
- digestive disorders that are not serious, such as stomach pains, nausea, vomiting, diarrhea,
- inflammation of the tongue and dry mouth, inflammation of the mouth, taste disorders, loss of appetite,
- pancreatitis (inflammation of the pancreas), which is reversible after stopping treatment.
Effects on the skin and mucous membranes:
- hot flushes with redness of the face, itching, skin rashes sometimes accompanied by fever,
- hives (skin rash similar to nettle rash), sudden allergic swelling of the face and neck (angio-edema), allergic shock which could be life-threatening (see “What you need to know before you take Flagyl 250 mg”),
- very rare cases of redness spreading to the whole body with pustules, accompanied by fever (acute generalized exanthematous pustulosis) (see “What you need to know before you take Flagyl 250 mg”).

Nervous system disorders:
- headache,
- nerve impairment in the limbs,
- seizures, dizziness,
- confusion,
- neurological disorders which can include consciousness disorders, behavioral disorders, difficulty coordinating movements, pronunciation disorders, gait disorders, involuntary eye movements, shakiness. These disorders are generally reversible on treatment discontinuation.
- non-bacterial meningitis.
Mental disorders:
- hallucinations,
- personality disorders (paranoia, delusion) possibly with suicidal ideas or attempts (see “What you need to know before you take Flagyl 250 mg”),
- depressive tendencies.
Vision disorders:
- temporary vision disorders such as blurred vision, double vision, short-sightedness, decreased vision, changes in color vision,
- optic nerve damage/inflammation.
Blood disorders:
- abnormally low platelet counts, abnormally low or major drop in the number of certain white blood cells (neutrophils).
Liver effects:
- abnormal liver function test results which are reversible, hepatitis (liver disease) possibly caused by biliary tract obstruction (sometimes with jaundice).
Other effects:
- reddish-brown colored urine caused by the medicine.
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.

KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.
Do not use Flagyl 250 mg after the expiry date which is stated on the outer packaging.
Store below 30 °C, protected from light.
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 protect the environment.