Label: Information for the User

Flagyl 125 mg/5 ml Oral Suspension

metronidazole, benzoate

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

• Keep this label, 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 should not be given 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 label.

Flagyl 125 mg/5 ml oral suspension is an anti-infective medication belonging to the imidazole group.

Metronidazole is used in both adults and children.

It is used to treat infections caused by parasites and bacteria against which this medication is active. The infections susceptible to treatment with Flagyl 125 mg/5 ml oral suspension are: lambliasis; intestinal and hepatic amebiasis; infections by anaerobic bacteria, caused byBacteroides fragilis,Clostridium perfringesand other anaerobic bacteria; and conditions caused byTrichomonas, such as urethritis and vaginitis.

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

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 (hepatic) disorders.

-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 neurological conditions such as paresthesia (tingling in the feet or hands), ataxia (loss of coordination), dizziness, and seizures.

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

• Your urine may darken.
• If you experience dizziness (sensation of spinning).
• This medication contains 600 mg/ml of saccharose, which should be taken into account in diabetic patients.

-Due to its ethanol content, this medication may pose a risk in patients with liver disease, alcoholism, epilepsy, and pregnant women and children.

Severe liver toxicity/acute liver insufficiency, some of which have a fatal outcome, have been described in patients with Cockayne syndrome who have taken 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:

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

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

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

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

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

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.

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

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 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 administered concomitantly with metronidazole. Therefore, if they are administered concomitantly, it should be under strict medical control.

Phenobarbital and phenytoin (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).

Pregnancy, breastfeeding, and fertility

Consult your doctor or pharmacist before using any medication.

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

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

Driving and operating machinery

During treatment with Flagyl, you may feel dizzy or experience dizziness (sensation of spinning), 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 125 mg/5 ml oral suspension contains saccharose, ethanol, propyl and methyl parahydroxybenzoate, and sodium:

- This medication contains saccharose. 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 saccharose 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 perceptible effect.

- Allergic reactions (possibly delayed) may occur 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".

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.

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.

-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 presents or not symptoms of vaginal Trichomonas infection, even if laboratory tests are negative, it is necessary that you be treated with metronidazole orally.

Giardiasis (Lambliasis):

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 the dose of 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 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 period less than 40 weeks, a metronidazole accumulation may occur during the first week of life, therefore plasma metronidazole 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 nearest hospital emergency department accompanied by this leaflet.A accidental overdose could produce vomiting, movement coordination disorder, and slight disorientation.

No specific antidote is known for metronidazole overdose. In cases where a 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 Toxicological Information Service. Phone: (91) 562 04 20, indicating the medication and the amount ingested.

If you forgot to take Flagyl 125 mg/5 ml oral suspension

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

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

The following side 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 (decrease in a type of white blood cell, granulocytes), neutropenia (decrease in a type of white blood cell, neutrophils), and thrombocytopenia (reduction in the number of platelets).

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

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

• Nervous system disorders:Loss of sensation in the extremities, headache, convulsions, dizziness. Very rarely, neurological disorders, for example: confusion, movement coordination disorders, speech disorders, gait disorders, involuntary eye movements, and tremors, which may disappear with treatment interruption.

Frequency not known: aseptic meningitis, vertigo (sensation of rotation).

- Eye disorders:Transient visual disturbances such as double vision (diplopia) and myopia, blurred vision, decreased visual acuity, changes in colour vision. Optic nerve damage that may cause sudden vision loss in the affected eye (neuropathy/optic neuritis).

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

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

• Gastrointestinal disorders:Upper abdominal pain, nausea, vomiting, diarrhea, oral mucosa inflammation, taste disturbances, loss of appetite. Very rarely and reversibly, some cases of pancreatitis have been reported, and discoloration of the tongue/tongue papillae (e.g., due to fungal proliferation).

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

Acute 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, flushing, urticaria (skin irritation and itching).

Very rarely, 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.

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 leaflet. You can also report them directly through the Spanish System for the Vigilance of Medicinal Products for Human Use:https://www.notificaram.es.By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

Do not store at a temperature above 25°C.

Expiration date after first opening: 8 days.

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 disposed of through drains or in the trash. Dispose of the containers and medications you no longer need at theSIGREcollection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medications you no longer need. By doing so, you will help protect the environment.

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 benzoate of metronidazole equivalent to 125 mg of metronidazole, in oral suspension, dosed at 4%.

-The other components are: monosodium phosphate, parahydroxybenzoate of propyl (E-216), parahydroxybenzoate of methyl (E-218), magnesium silicoaluminate, anhydrous sodium saccharin, saccharose, 96% ethanol, concentrated lemon essence, de-pectinated orange essence, and demineralized water.

Appearance of the product and content of the packaging

Container containing 120 ml.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization:

Fidia Farmacéutica S.L.U.

Parque Empresarial de la Moraleja - Torona Building

Avenida de Europa, 24 - Building A - 1 B

28108 Alcobendas - Madrid - Spain

Responsible for manufacturing:

Unither Liquid Manufacturing

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

F-31770 France

Last review date of this leaflet: September 2023

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