Package Insert: Information for the User

Flagyl 250 mg Film-Coated Tablets

metronidazole

Read this package insert carefully before starting to take this medication, as it contains important information for you.

• Keep this package insert, as you may need to refer to it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed only for you, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.

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

Metronidazole is used in both adults and children.

It is used for the treatment of infections caused by parasites and bacteria against which this medication is active. The infections susceptible to treatment with Flagyl 250 mg tablets are: lambliasis; intestinal and hepatic amebiasis; infections by anaerobic bacteria, due toBacteroides fragilis, Clostridium perfringensand other anaerobic bacteria; and conditions caused byTrichomonas, such as urethritis (urethritis) and vaginitis (vaginitis).

You should follow your doctor's instructions for its use.

Do not take Flagyl 250 mg tablets

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

Warnings and precautions

Consult your doctor or pharmacist before starting to take Flagyl 250 mg:

-If you have severe liver disorders (hepatic).

-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 the risk of neurological disorders such as paresthesia (tingling in feet or hands), ataxia (loss of coordination of movements), vertigo, and seizures.

• If you have severe acute or chronic disorders 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 when not undergoing dialysis or when your blood levels of this drug are not controlled.

• Your urine may darken.
• If you experience vertigo (sensation of rotation).

Severe liver toxicity/acute liver failure, some of which have been fatal, have been reported in patients with Cockayne syndrome who have taken metronidazole-containing medications.

If you have Cockayne syndrome, your doctor must closely monitor your liver function while you receive treatment with metronidazole and afterwards.

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

• abdominal pain, anorexia, nausea, vomiting, fever, general malaise, fatigue, icteric, or dark urine, clay-colored stools, or itching.

Severe cutaneous bullous reactions, such as Stevens-Johnson syndrome (SSJ), toxic epidermal necrolysis (TEN), or acute generalized pustular psoriasis (AGPP), have been reported with metronidazole. If you experience symptoms or signs of AGPP, SSJ, or TEN, you must stop taking Flagyl immediately.

Inform your doctor or nurse before undergoing blood tests. Flagyl may alter the results of some blood tests.

Taking Flagyl 250 mg tablets with other medications

Inform your doctor or pharmacist if you are taking or have taken recently or may need to take any other medication, including those purchased without a prescription.

The concomitant administration of metronidazole and disulfiram (a medication used to help treat alcoholism) is not recommended, as cases of mental disorders have been reported.

The concomitant administration of metronidazole and oral anticoagulants (medications that help prevent blood clotting, such as warfarin) may increase the risk of bleeding. If you take metronidazole at the same time as these medications, you must be closely monitored by your doctor.

There is a risk of elevated blood levels of lithium (a medication for depression) and cyclosporine (a medication that reduces the body's defenses) when these medications are administered concomitantly with metronidazole. Therefore, if they are administered concomitantly, it must be under strict medical control.

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

Metronidazole increases the toxicity of fluorouracil and busulfan (medications used to treat cancer).

Inform your doctor if you are taking any medication that may cause alterations in heart rhythm (prolongation of the QT interval, which can be seen on an ECG) as occurs with certain antiarrhythmics, certain antibiotics, and medications primarily used to control psychosis (including delusions, hallucinations, paranoia, or disordered thinking).

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

Drinks and medications containing alcohol should not be consumed during treatment with metronidazole until at least one day after, due to the possibility of the so-called Antabus effect, a reaction characterized by flushing of the skin, vomiting, and tachycardia.

Pregnancy, breastfeeding, and fertility

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

As metronidazole crosses the placental barrier and there is insufficient data to establish its safety during pregnancy, your doctor will carefully evaluate the advisability of using Flagyl during pregnancy.

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

Driving and operating machinery

During use of Flagyl, you may feel dizzy or experience vertigo (sensation of rotation), confusion, hallucinations (seeing or hearing things that do not exist), seizures (having attacks), or vision problems (such as blurred vision or double vision). If this occurs, do not drive vehicles or operate machinery.

Flagyl 250 mg tablets contain gluten

This medication contains very low levels of gluten (from wheat starch) and is very unlikely to cause problems if you have celiac disease.

One tablet contains no more than 8.215 micrograms of gluten.

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

Follow exactly the administration instructions of this medication indicated by your doctor.

In case of doubt, consult your doctor again.

Remember to take your medication.

Your doctor will indicate your daily dose and the duration of your treatment. Do not suspend your treatment beforehand. The dose is individual for you and may be modified by your doctor according to your response to treatment.

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

Trichomoniasis:

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 Vaginitis:

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

Even if your partner does not show symptoms of Trichomonas vaginalis infection, even if laboratory tests are negative, it is necessary for you to be treated with metronidazole orally.

Giardiasis (Lambliasis):

-In individuals over 10 years of age: 2,000 mg once a day 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 a day for 3 days.

-In children aged 3 to 7 years: 600-800 mg once a day for 3 days.

-In children aged 1 to 3 years: 500 mg once a day 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 can be expressed by body weight:

35 to 50 mg/kg/day divided into 3 doses for 5-10 days, not exceeding a daily dose of 2,400 mg.

Anaerobic Infections:

• In adults: 500 mg every 8 hours

-In children over 8 weeks to 12 years of age: The usual daily dose is 20-30 mg/kg/day as a single dose or divided into 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, so plasma metronidazole concentrations should be monitored preferably after a few days of treatment.

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

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service. Phone:(91) 562 04 20, indicating the medication and the amount ingested.

Accidental overdose may cause vomiting, movement coordination disorders, and mild disorientation.

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

If you forgot to take Flagyl 250 mg tablets:

Do not take a double dose to compensate for the missed doses.

Like all medications,this medicationmay cause adverse effects of unknown frequency, although not all people will experience them.

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

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

Severe allergic reactions such as anaphylactic shock.

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

• Nervous system disorders: loss of sensation in the extremities, headache, convulsions, dizziness, vertigo (sensation of rotation). Neurological disorders, for example: confusion, movement coordination disorder, speech disorders, gait alteration, involuntary eye movements, and tremors, which may disappear with treatment interruption.

Certain type of inflammation of the meninges, the membranes that surround the brain and spinal cord (aseptic meningitis).

• Eye disorders: transient visual disturbances such as double vision (diplopia), myopia, blurred vision, decreased visual acuity, changes in color vision. Optic nerve damage that can cause sudden vision loss in the affected eye (optic neuropathy/neuritis).

• Ear and labyrinth disorders: unknown frequency: altered hearing/loss of hearing (including neurosensorial), tinnitus (ear ringing).

• Cardiac disorders:unknown frequency: cardiac rhythm alterations (prolongation of the QT interval that can be seen on the ECG), particularly when Flagyl is administered with other medications that can cause cardiac rhythm alterations.

• Gastrointestinal disorders: upper stomach pain, nausea, vomiting, diarrhea, oral mucosa inflammation, taste disturbances, loss of appetite, and reversible cases of pancreatitis, tongue discoloration/lazy tongue (e.g. due to fungal proliferation).

-Hepatobiliary disorders:increase in liver enzymes (AST, ALT, alkaline phosphatase),inflammation of the liver with bile flow difficulty,hepatocellular damage, sometimes withyellow discoloration in the eyes and skin.

Cases of liver failure requiring liver transplant 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, flushing, urticaria (skin irritation and itching) and pus-filled pimples (pustular eruptions), red and scaly rash with bumps under the skin and blisters (acute generalized pustular exanthema). Fixed drug eruption, Stevens-Johnson syndrome, toxic epidermal necrolysis.

• General disorders and administration site conditions:fever.

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

Reporting of adverse reactions

If you experience any of the adverse reactions, consult your doctor or pharmacist, even if they are not listed in this leaflet. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicinal Products for Human Use: https://www.notificaram.es.By reporting adverse reactions, you can contribute to providing more information on the safety of this medication.

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

This medication does not require any special temperature for conservation.

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

Do not use this medication after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Medications should not be thrown down the drains or in the trash.Dispose of the packaging and medications you no longer need at the SIGRE collection pointat the pharmacy. If in doubtask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Flagyl

-The active ingredient 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 packaging

Each package contains 21 tablets.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

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

Responsible for manufacturing

sanofi-aventis, S.A.

Ctra. C-35 (La Batllòria-Hostalric)

km 63.09

17404 Riells i Viabrea (Girona)

(Spain)

Last review date of this leaflet: March 2023

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