Flagyl 125 mg/5 ml oral suspension

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Flagyl 125 mg/5 ml oral suspension

metronidazol, benzoate

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

• Keep this leaflet. 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 must not be given to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse reactions, consult your doctor or pharmacist, even if they are adverse reactions not listed in this leaflet.

Leaflet contents

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 adverse effects
5. How to store Flagyl 125 mg/5 ml oral suspension
6. Contents of the pack and other 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-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 after completing the 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 that are susceptible to this medicine. The infections treatable with Flagyl 125 mg/5 ml oral suspension include: giardiasis; intestinal and hepatic amoebiasis; infections caused by anaerobic bacteria such as Bacteroides fragilis, Clostridium perfringens, and other anaerobic bacteria; and conditions caused by Trichomonas, 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, to imidazoles, or to any of the other components of this medicine (listed in section 6).

Warnings and precautions

Talk to your doctor before starting to take Flagyl 125 mg/5 ml oral suspension:

• 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 due to the risk of nervous system disorders 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 when you are not undergoing dialysis or when your blood levels of this drug are not being monitored.

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

• Due to the presence of ethanol as an excipient, it may pose a risk in patients with liver disease, alcoholism, epilepsy, and in pregnant women and children.

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

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, general 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 scheduled for a blood test, inform your doctor or nurse beforehand that you are taking Flagyl. Flagyl may alter the results of certain blood tests.

Use of Flagyl 125 mg/5 ml oral suspension with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

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

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

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 at the same time as 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 body's immune defenses) when these are administered together with metronidazole. Therefore, if they are used together, it 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 cause disturbances in heart rhythm (prolongation of the QT interval, which can be seen on an ECG), such as certain antiarrhythmics (medicines for heart rhythm disorders), certain antibiotics, and medicines mainly used to control psychosis (including delusions, hallucinations, paranoia, or disordered thinking).

Pregnancy, breastfeeding, and fertility

Consult your doctor or pharmacist before using any medicine.

Since metronidazole crosses the placental barrier and sufficient data are not available to establish its safety during pregnancy, your doctor will carefully assess the need for using Flagyl during pregnancy.

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

Driving and use of machines

While taking Flagyl, you may feel dizzy or experience vertigo (sensation of spinning), 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 125 mg/5 ml oral suspension contains sucrose, ethanol, propyl parahydroxybenzoate and methyl parahydroxybenzoate, and sodium:

• This medicine contains sucrose. If your doctor has informed you that you have an intolerance to certain sugars, consult with him before taking this medicine.

Patients with diabetes mellitus should be aware that this medicine contains 3 g of sucrose per 5 ml of metronidazole.

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

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

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

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

3. How to take Flagyl 125 mg/5 ml oral suspension

Follow exactly the instructions for use of this medicine given by your doctor. If you are unsure, 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 prematurely. The dose is individual to 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.

A small teaspoon equals 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.
• 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.

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

Giardiasis (Lambliasis):

A small teaspoon equals 5 ml. Each 5 ml contains 125 mg of metronidazole.

• In individuals over 10 years: 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: 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: 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: 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, 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 125 mg/5 ml oral suspension than you should

Contact your doctor immediately or go to the nearest hospital emergency department, taking this leaflet with you. Accidental overdose may cause vomiting, incoordination, 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.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number: (91) 562 04 20, indicating the medicine 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 missed doses.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

The following adverse effects have been reported according to the frequencies detailed 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 (reduction in a type of white blood cells, granulocytes), neutropenia (reduction in a type of white blood cells, neutrophils), and thrombocytopenia (reduction in platelet count).

• Immune system disorders: Inflammation of the feet, hands, face, lips, tongue, and/or throat (angioedema) which may cause breathing difficulties. Anaphylactic shock very rarely.

• Psychiatric disorders: Psychotic disorders, including confusion and hallucinations. Depressive behaviour.

• Nervous system disorders: Loss of sensation in the limbs, headache, seizures, dizziness. Very rare cases of neurological disorders, for example: confusion, lack of coordination, speech disorders, gait disturbances, involuntary eye movements, and tremors, which may resolve upon discontinuation of treatment.

Frequency not known: Aseptic meningitis, vertigo (sensation of spinning).

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

• Eye disorders: Transient visual disturbances such as double vision (diplopia) and myopia, blurred vision, decreased visual acuity, changes in vision (neuritis). 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, diarrhoea, inflammation of the oral mucosa, disturbances in taste sensation, loss of appetite. Very rare and reversible cases of pancreatitis (inflammation of the pancreas) have been reported, as well as discoloration of the tongue/hairy tongue (e.g. due to fungal overgrowth).

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

Liver failure 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).

Very rarely, pustular eruptions (pus-filled spots), red 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.

Reporting of adverse effects

If you experience any adverse effects, consult your doctor or pharmacist, even if they are 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 125 mg/5 ml oral suspension

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

Do not store above 25°C.

Expiry date after first opening: 8 days.

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

Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at a SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of containers and unused medicines. This will help protect the environment.

6. Contents of the container and additional information

Composition of Flagyl 125 mg/5 ml oral suspension

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

Appearance of the product and contents of the container

Container containing 120 ml.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Laboratorios Fidia Farmacéutica S.L.U.

Parque Empresarial de la Moraleja - Torona Building

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 most recent revision of this leaflet: June 2025

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