FLAGYL 125mg/5 ml ORAL SUSPENSION

Introduction

Package Leaflet: Information for the User

Flagyl 125 mg/5 ml Oral Suspension

metronidazole, benzoate

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

• Keep this package leaflet, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medication has been prescribed to you only, 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 side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet.

Contents of the Package Leaflet

1. What Flagyl 125 mg/5 ml Oral Suspension is and what it is used for
2. What you need to know before taking Flagyl 125 mg/5 ml Oral Suspension
3. How to take Flagyl 125 mg/5 ml Oral Suspension
4. Possible side effects
5. Storage of Flagyl 125 mg/5 ml Oral Suspension
6. Package contents and additional information

1. What Flagyl 125 mg/5 ml Oral Suspension is and what it is used for

Flagyl 125 mg/5 ml Oral Suspension is an anti-infectious medication belonging to the imidazole group.

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

It is essential that you follow the instructions regarding dosage, administration interval, and treatment duration indicated by your doctor.

Do not store or reuse this medication. If you have any leftover antibiotic after completing treatment, return it to the pharmacy for proper disposal. Do not throw medications down the drain or in the trash.

Metronidazole is used in both adults and children.

It is used to treat infections caused by parasites and bacteria that are susceptible to this medication. The infections that can be treated with Flagyl 125 mg/5 ml Oral Suspension include: lambliasis; intestinal and hepatic amebiasis; infections caused by anaerobic bacteria, such as Bacteroides fragilis, Clostridium perfringens, and other anaerobic bacteria; and Trichomonasinfections, such as urethritis (inflammation of the urethra) and vaginitis (inflammation of the vagina).

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

2. What you need to know before taking Flagyl 125 mg/5 ml Oral Suspension

Do not take Flagyl 125 mg/5 ml Oral Suspension

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

Warnings and Precautions

Consult your doctor before starting to take Flagyl 125 mg/5 ml Oral Suspension:

• If you have severe liver disorders (hepatic).
• If your treatment is prolonged. Your doctor may request that you undergo regular blood tests, especially to monitor your white blood cell count. You will also be closely monitored for the risk of nervous system disorders such as paresthesia (tingling in feet or hands), ataxia (lack of coordination), dizziness, and convulsions.

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

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

• It may darken the color of your urine.
• If you experience dizziness (feeling of spinning).
• This medication contains 600 mg/ml of sucrose, which should be taken into account in diabetic patients.

• Since it contains ethanol as an excipient, it may be a risk factor in patients with liver disease, alcoholism, epilepsy, and in pregnant women and children.

There have been reports of severe hepatic toxicity/hepatic failure in patients with Cockayne syndrome taking metronidazole-containing medications.

If you have Cockayne syndrome, your doctor should closely monitor your liver function while you are receiving treatment with metronidazole and afterwards.

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

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

There have been reports of severe bullous skin reactions, such as Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), or acute generalized exanthematous pustulosis (AGEP) with metronidazole (see "Possible side effects"). If symptoms or signs of AGEP, SJS, or TEN appear, treatment with Flagyl should be discontinued immediately.

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

Using Flagyl 125 mg/5 ml Oral Suspension with other medications

Inform your doctor or pharmacist if you are taking or have recently taken or may need to take any other medication.

It is not recommended to take metronidazole and disulfiram (a medication used to help treat alcoholism) together, as there have been reports of mental disorders.

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

Taking metronidazole and oral anticoagulant medications (medications that help prevent blood clots, such as warfarin) together may increase the risk of bleeding. If you take metronidazole at the same time as these medications, you should 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 taken together with metronidazole. Therefore, if they are taken together, it should be under close medical supervision.

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 changes in heart rhythm (prolongation of the QT interval that can be seen on an ECG), such as certain antiarrhythmics (medications for heart rhythm disorders), certain antibiotics, and medications primarily used to control psychosis (including delusions, hallucinations, paranoia, or disordered thinking).

Pregnancy, breastfeeding, and fertility

Consult your doctor or pharmacist before using any medication.

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

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

Driving and using machines

While using Flagyl, you may feel dizzy or experience dizziness (feeling of spinning), confusion, hallucinations (seeing or hearing things that do not exist), convulsions (having seizures), or vision problems (such as blurred vision or double vision). If this occurs, do not drive vehicles or use machines.

Flagyl 125 mg/5 ml Oral Suspension contains sucrose, ethanol, propyl parahydroxybenzoate, and methyl parahydroxybenzoate, and sodium:

• This medication contains sucrose. If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication.

Patients with diabetes mellitus should note that this medication contains 3 g of sucrose per 5 ml of metronidazole.

• This medication contains 6.28 mg of alcohol (ethanol) per ml of oral suspension, which is equivalent to 0.6% (p/v). The amount in one ml of oral suspension of this medication is equivalent to less than 0.15 ml of beer or 0.06 ml of wine.

The small amount of ethanol in this medication does not produce any noticeable effect.

• Reactions may occur (possibly delayed) because it contains propyl parahydroxybenzoate (E-216) and methyl parahydroxybenzoate (E-218).

• This medication contains less than 23 mg of sodium (1 mmol) per ml of oral suspension; it is essentially "sodium-free".

3. How to take Flagyl 125 mg/5 ml Oral Suspension

Follow your doctor's instructions for administering this medication exactly. If you are unsure, consult your doctor again. Remember to take your medication.

Your doctor will indicate your daily dose and treatment duration. Do not stop treatment before completing it. The dose is individualized for you and may be modified by your doctor based on your response to treatment.

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

A small spoonful is equivalent to 5 ml. Each 5 ml contains 125 mg of metronidazole.

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.
• In children under 10 years: 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.

Whether your partner has symptoms of Trichomonasvaginal infection or not, even if laboratory tests are negative, it is necessary for them to be treated with oral metronidazole.

Lambliasis (Giardiasis):

A small spoonful is equivalent to 5 ml. Each 5 ml contains 125 mg of metronidazole.

• In individuals over 10 years: 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 from 7 to 10 years: 1,000 mg once a day for 3 days.
• In children from 3 to 7 years: 600-800 mg once a day for 3 days.
• In children from 1 to 3 years: 500 mg once a day for 3 days.

Or, expressed in mg per kilogram of body weight:

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

Amebiasis:

In individuals over 10 years: 400-800 mg three times a day for 5-10 days.

• In children from 7 to 10 years: 200-400 mg three times a day for 5-10 days.
• In children from 3 to 7 years: 100-200 mg four times a day for 5-10 days.
• In children from 1 to 3 years: 100-200 mg three times a day for 5-10 days.

Or, the doses could be expressed by body weight:

35-50 mg/kg/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 over 8 weeks to 12 years: 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 treatment duration is usually 7 days.

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

If you take more Flagyl 125 mg/5 ml Oral Suspension than you should

Consult your doctor immediately or go to the emergency department of the nearest hospital, accompanied by this package leaflet. Accidental overdose may cause vomiting, lack of coordination, and mild disorientation.

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

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

If you forget to take Flagyl 125 mg/5 ml Oral Suspension

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

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone will experience them.

The following side effects have been reported according to the frequencies listed below:

Very common: may affect more than 1 in 10 people

Common: may affect up to 1 in 10 people

Uncommon: may affect up to 1 in 100 people

Rare: may affect up to 1 in 1,000 people

Very rare: may affect up to 1 in 10,000 people

Frequency not known: cannot be estimated from available data

• Blood and lymphatic system disorders:Very rare: agranulocytosis (decrease in a type of white blood cell, granulocytes), neutropenia (decrease in a type of white blood cell, neutrophils), and thrombocytopenia (reduction in platelet count).

• Immune system disorders:Angioedema (inflammation of feet, hands, face, lips, tongue, and/or throat) that can cause breathing difficulties. Very rare cases of anaphylactic shock.

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

• Nervous system disorders:loss of sensation in extremities, headache, convulsions, dizziness. Very rare cases of neurological disorders, such as confusion, lack of coordination, speech disorders, gait disturbances, involuntary eye movements, and tremors, which may disappear with treatment discontinuation.

Frequency not known: aseptic meningitis, dizziness (feeling of spinning).

Frequency not known (cannot be estimated from available data): posterior reversible encephalopathy syndrome (PRES), a brain disorder characterized by symptoms such as headache, confusion, vision problems, and convulsions.

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

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

• Cardiac disorders:Frequency not known: changes in heart rhythm (prolongation of the QT interval that can be seen on an ECG), particularly when Flagyl is administered with other medications that can cause changes in heart rhythm.

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

• Hepatobiliary disorders:Frequency not known: changes in liver function tests (increased liver enzymes AST, ALT, alkaline phosphatase), liver inflammation with difficulty in bile flow, hepatocellular damage, sometimes with yellowing of the eyes and skin.

Liver failure in patients treated with metronidazole along 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 (irritation and itching of the skin).

Very rare cases of pustular eruptions (pustular exanthematous generalized eruption), erythema multiforme (red and scaly rash with blisters under the skin and blisters), and Stevens-Johnson syndrome, toxic epidermal necrolysis.

Fixed drug eruption.

• General disorders and administration site conditions:Fever.

Reporting of side effects

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

5. Storage of Flagyl 125 mg/5 ml Oral Suspension

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

Do not store above 25°C.

Shelf life after first opening: 8 days.

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

Medications should not be disposed of via wastewater or household waste. Deposit the packaging and any unused medications in the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medications. This will help protect the environment.

6. Container Content and Additional Information

Composition of Flagyl 125 mg/5 ml Oral Suspension

• The active ingredient is metronidazole. Each 5 ml (1 small teaspoon) of suspension contains 200 mg of metronidazole benzoate equivalent to 125 mg of metronidazole, in oral suspension, dosed at 4%.
• The other components are: monosodium phosphate, propyl parahydroxybenzoate (E-216), methyl parahydroxybenzoate (E-218), magnesium silicoaluminate, anhydrous sodium saccharin, sucrose, 96% ethanol, concentrated lemon essence, deteperpenated orange essence, and demineralized water.

Product Appearance and Container Content

Container containing 120 ml.

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:

Unither Liquid Manufacturing

1-3 Allee de la Neste; Z.I. en Sigal (Colomiers)

F-31770 France

Date of the Last Revision of this Prospectus: June 2025

Detailed information about this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/.