Flagyl 250 mg film-coated tablets

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Flagyl 250 mg film-coated tablets

metronidazole

Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if these are effects not listed in this leaflet. See section 4.

Leaflet contents

1. What Flagyl is and what it is used for
2. What you need to know before taking Flagyl
3. How to take Flagyl
4. Possible side effects
5. How to store Flagyl
6. Contents of the pack and other information

1. What Flagyl 250 mg tablets are and what they are used for

Flagyl 250 mg tablets is an anti-infective medicine belonging to the group of imidazoles.

Antibiotics are used to treat bacterial infections and are not effective against viral infections such as flu or the common cold.

It is important that you follow your doctor's instructions regarding dose, dosing interval, and duration of treatment.

Do not store or reuse this medicine. If you have any antibiotic left over after completing treatment, return it to the pharmacy for proper disposal. Do not dispose of medicines via wastewater or household waste.

Metronidazole is used in both adults and children.

It is used to treat infections caused by parasites and bacteria to which this medicine is active. Infections treatable with Flagyl 250 mg tablets include: giardiasis; intestinal and hepatic amoebiasis; infections caused by anaerobic bacteria such as Bacteroides fragilis, Clostridium perfringens, and other anaerobic bacteria; and infections caused by Trichomonas, such as urethritis (inflammation of the urethra) and vaginitis (inflammation of the vagina).

You must follow your doctor's instructions for use.

2. What you need to know before taking Flagyl 250 tablets

Do not take Flagyl 250 mg tablets

• If you are allergic (hypersensitive) to metronidazole, to imidazoles, or to any of the other components of Flagyl (listed in section 6).

Warnings and precautions

Talk to your doctor or pharmacist before taking Flagyl 250 mg:

• If you have severe liver (hepatic) disorders.

• If your treatment is prolonged. Your doctor may ask you to have regular blood tests, especially to monitor your white blood cell count. You will also be closely monitored for neurological side effects such as paresthesia (tingling in feet or hands), ataxia (lack of coordination), dizziness, and seizures.

  • If you have serious acute or chronic diseases of the central or peripheral nervous system, due to the possible risk of worsening.

• If you have severe kidney disorders. In this case, your doctor may reduce your dose if you are not undergoing dialysis or if blood levels of this drug are not monitored.

  • May darken the color of your urine.
  • If you experience dizziness (sensation of spinning).

Cases of severe hepatic toxicity/acute liver failure, some with fatal outcome, have been reported in patients with Cockayne syndrome treated with metronidazole-containing medicines.

If you have Cockayne syndrome, your doctor must frequently monitor your liver function during and after treatment with metronidazole.

Inform your doctor immediately and stop taking metronidazole if you experience:

• stomach pain, loss of appetite, nausea, vomiting, fever, malaise, fatigue, jaundice, dark urine, clay-colored stools, or itching.

Serious bullous skin reactions such as Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), or acute generalized exanthematous pustulosis (AGEP) have been reported with metronidazole (see “Possible side effects”). If symptoms or signs of AGEP, SJS, or TEN occur, Flagyl treatment must be discontinued immediately.

If you are going to have a blood test, inform your doctor or nurse beforehand that you are taking Flagyl. Flagyl may alter the results of certain blood tests.

Taking Flagyl 250 mg tablets with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines, including those obtained without a prescription.

Concomitant administration of metronidazole and disulfiram (a medicine used to help treat alcoholism) is not recommended, as cases of mental disturbances have been reported.

Concomitant use of metronidazole and oral anticoagulants (medicines that help prevent blood clots, such as warfarin) may increase the risk of bleeding. If you take metronidazole together with these medicines, you must be closely monitored by your doctor.

There is a risk of increased blood levels of lithium (a medicine for depression) and cyclosporine (a medicine that suppresses the immune system) when these are administered together with metronidazole. Therefore, if used together, they must be under strict medical supervision.

Phenytoin and phenobarbital (antiepileptic medicines) increase the elimination of metronidazole, thereby reducing its blood levels.

Metronidazole increases the toxicity of fluorouracil and busulfan (medicines used in cancer treatment).

Inform your doctor if you are taking any medicine that may affect heart rhythm (prolongation of the QT interval visible on ECG), such as certain antiarrhythmics (medicines for heart rhythm disorders), certain antibiotics, and medicines mainly used to treat psychosis (including delusions, hallucinations, paranoia, or disordered thinking).

Taking Flagyl 250 mg tablets with food, drinks, and alcohol

Alcoholic beverages and medicines containing alcohol should not be consumed during treatment with metronidazole and for at least one day afterwards, due to the possibility of experiencing the so-called Antabuse effect, a reaction characterized by skin flushing, vomiting, and tachycardia.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

Since metronidazole crosses the placental barrier and there are insufficient data to establish its safety during pregnancy, your doctor will carefully assess whether the use of Flagyl during pregnancy is appropriate.

Metronidazole is excreted in breast milk, so its administration should be avoided during breastfeeding.

Driving and using machines

While taking Flagyl, you may feel dizzy or experience vertigo (spinning sensation), confusion, hallucinations (seeing or hearing things that are not real), seizures (fits), or vision problems (such as blurred or double vision). If this happens, do not drive or operate machinery.

Flagyl 250 mg tablets contain gluten

This medicine contains very low levels of gluten (from wheat starch), and it is very unlikely to cause problems if you have coeliac disease.

One tablet contains no more than 8.215 micrograms of gluten.

If you are allergic to wheat (other than coeliac disease), you should not take this medicine.

3. How to take Flagyl 250 mg tablets

Follow exactly the instructions given by your doctor for taking this medicine.

If in doubt, consult your doctor again.

Remember to take your medicine.

Your doctor will determine your daily dose and the duration of your treatment. Do not stop your treatment early. The dose is individual for you and may be adjusted by your doctor depending on your response to treatment.

If you feel that the effect of Flagyl is too strong or too weak, inform your doctor or pharmacist.

Trichomonas infections:

Urogenital trichomoniasis:

• In adults and adolescents: 2,000 mg as a single dose OR 200 mg three times a day for 7 days OR 400 mg twice a day for 5–7 days.
• Children under 10 years of age: 40 mg/kg orally as a single dose OR 15–30 mg/kg/day divided into 2–3 doses for 7 days; the dose should not exceed 2,000 mg.

Bacterial vaginosis:

• In adolescents: 400 mg twice a day for 5–7 days or 2,000 mg as a single dose.

Regardless of whether your partner has symptoms of Trichomonas vaginalis infection or even if laboratory tests are negative, treatment with oral metronidazole is necessary.

Giardiasis (Lambliasis):

• In individuals over 10 years of age: 2,000 mg once daily for 3 days, OR 400 mg three times a day for 5 days, OR 500 mg twice a day for 7–10 days.
• In children aged 7 to 10 years: 1,000 mg once daily for 3 days.
• In children aged 3 to 7 years: 600 to 800 mg once daily for 3 days.
• In children aged 1 to 3 years: 500 mg once daily for 3 days.

Alternatively, expressed in mg per kilogram of body weight:

15–40 mg/kg/day divided into 2–3 doses.

Amebiasis:

• In individuals over 10 years of age: 400 to 800 mg three times a day for 5–10 days.
• In children aged 7 to 10 years: 200 to 400 mg three times a day for 5–10 days.
• In children aged 3 to 7 years: 100 to 200 mg four times a day for 5–10 days.
• In children aged 1 to 3 years: 100 to 200 mg three times a day for 5–10 days.

Alternatively, doses may be expressed by body weight:

35 to 50 mg/kg per day divided into 3 doses for 5–10 days, not exceeding 2,400 mg/day.

Anaerobic infections:

• In adults: 500 mg every 8 hours.

• In children older than 8 weeks up to 12 years of age: The usual daily dose is 20–30 mg/kg/day as a single dose or divided into doses of 7.5 mg/kg every 8 hours. The daily dose may be increased to 40 mg/kg depending on the severity of the infection. The duration of treatment is generally 7 days.

• In children under 8 weeks of age: 15 mg/kg as a single daily dose or divided into 7.5 mg/kg every 12 hours. In newborns with a gestational age less than 40 weeks, accumulation of metronidazole may occur during the first week of life; therefore, plasma concentrations of metronidazole should preferably be monitored after a few days of treatment.

If you take more Flagyl 250 mg tablets than you should:

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service. Telephone: (91) 562 04 20, indicating the medicine and the amount ingested.

Accidental overdose may cause vomiting, incoordination of movements, and mild disorientation.

There is no known specific antidote for metronidazole overdose. In cases where massive ingestion is suspected, treatment will be based on symptoms.

If you forget to take Flagyl 250 mg tablets:

Do not take a double dose to make up for missed doses.

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, the frequency of which is unknown, although not everyone will experience them.

• Blood and lymphatic system disorders: agranulocytosis and/or neutropenia (decrease in a type of white blood cells, granulocytes or neutrophils, respectively), and thrombocytopenia (reduction in the number of platelets).

• Immune system disorders: swelling of feet, hands, throat, lips, and respiratory tract (angioedema).

Severe allergic reactions such as anaphylactic shock.

• Psychiatric disorders: psychotic disorders, including confusion and hallucinations. Depressive behavior.

• Nervous system disorders: loss of sensation in the limbs, headache, seizures, dizziness, vertigo (sensation of spinning). Neurological disorders, for example: confusion, lack of coordination, speech disorders, gait disturbances, involuntary eye movements, and tremors, which may resolve upon discontinuation of treatment.

A certain type of inflammation of the meninges, the membranes surrounding the brain and spinal cord (aseptic meningitis).

Frequency not known (cannot be estimated from available data): Posterior reversible encephalopathy syndrome (PRES), a brain disorder characterized by symptoms such as headache, confusion, visual disturbances, and seizures.

• Eye disorders: transient visual disturbances such as double vision (diplopia), myopia, blurred vision, decreased visual acuity, changes in color vision. Injury or inflammation of the optic nerve that may cause sudden reduction in vision in the affected eye (optic neuropathy / neuritis).

• Ear and labyrinth disorders: frequency not known: altered hearing/hearing loss (including sensorineural), tinnitus (ringing in the ears).

• Cardiac disorders: frequency not known: disturbances in heart rhythm (prolongation of the QT interval which can be seen on ECG), particularly when Flagyl is administered with other medicines that may cause heart rhythm disturbances.

• Gastrointestinal disorders: upper abdominal pain, nausea, vomiting, diarrhea, inflammation of the oral mucosa, disturbances in taste, loss of appetite, and reversible cases of inflammation of the pancreas (pancreatitis), discoloration of the tongue/hairy tongue (e.g., due to fungal overgrowth).

• Hepatobiliary disorders: increased liver enzymes (AST, ALT, alkaline phosphatase), inflammation of the liver with impaired bile flow, hepatocellular damage, sometimes with yellowing of eyes and skin.

Cases of liver failure requiring liver transplantation have been reported in patients treated with metronidazole in combination with other antibiotics.

Acute liver failure in patients with Cockayne Syndrome (see section 2 “Warnings and precautions”).

• Skin and subcutaneous tissue disorders: skin rash, itching, hot flushes, urticaria (skin irritation and itching), and pustular eruptions (pus-filled spots), red and scaly rash with bumps under the skin and blisters (acute generalized exanthematous pustulosis). Drug-induced fixed eruption, Stevens-Johnson syndrome, toxic epidermal necrolysis.

• General disorders and administration site conditions: fever.

The frequency, type, and severity of adverse effects in children are the same as in adults.

Reporting of adverse effects

If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Flagyl 250 mg tablets

Keep this medicine out of the sight and reach of children.

This medicine does not require any special storage temperature.

Store the blister pack in the outer packaging to protect it from light.

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE Point in your pharmacy. If in doubt, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Flagyl

• The active substance is metronidazole.

Each tablet contains 250 mg of metronidazole.

• The other components are: wheat starch (contains gluten), magnesium stearate, povidone K30, hypromellose, macrogol 20,000 and purified water.

Appearance of the product and contents of the pack

Each pack contains 21 tablets.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Laboratorios Fidia Farmacéutica S.L.U.

Parque Empresarial de la Moraleja - Edificio Torona
Avenida de Europa, 24 - Edificio A - 1 B
28108 Alcobendas - Madrid – Spain

Manufacturer

sanofi-aventis, S.A.
Ctra. C-35 (La Batllòria-Hostalric)
km 63.09
17404 Riells i Viabrea (Girona)
(Spain)

Date of the most recent revision of this leaflet: June 2025

Detailed information on this medicine is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS): http://www.aemps.gob.es/