Leaflet: information for the user

Metronidazol B. Braun 5 mg/ml infusion solution

metronidazol

Read this leaflet carefully before you start using 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.

• Si experimenta efectos adversos, consulte a su médico, o farmacéutico o enfermero, incluso si se trata de efectos adversos que no aparecen en este prospecto. Ver sección 4.

Metronidazol B. Braun 5 mg/ml belongs to a group of medicines known as antibiotics and is used to treat severe infections caused by bacteria that can be eliminated by the active ingredient metronidazol.

Metronidazol B. Braun 5 mg/ml can be administered to adults and children for the treatment of any of the following diseases:

• Central nervous system infections such as brain abscesses (infections with pus in the brain), inflammation of the meninges (covering of the brain).
• Lung and lung lining infections, such as tissue-destroying pneumonia, stomach content-induced pneumonia, lung abscesses.
• Gastrointestinal tract infections, such as inflammation of the abdominal and pelvic lining, liver abscesses, intestinal or rectal surgery, abdominal and pelvic infections with pus.
• Female reproductive organ infections, such as uterine inflammation after uterine removal, cesarean section, spontaneous abortion with blood poisoning (sepsis), childbirth fever.
• Ears, nose, and throat, and tooth, jaw, and mouth infections, such as Vincent's angina.
• Heart lining inflammation.
• Bone and joint infections, such as bone marrow inflammation.
• Gas gangrene.
• Blood poisoning due to thrombosis and inflamed veins.

Its treatment may be complemented with other antibiotics if necessary.

Metronidazol B. Braun 5 mg/ml can be administered as a preventive measure before operations associated with a higher risk of infection with anaerobic bacteria, mainly in gynecology or stomach and intestine surgery.

No use Metronidazol B. Braun 5 mg/ml

• If you are allergic to metronidazole or to other similar substances or to some of the other components of this medication (listed in section 6).

Advertencias y precauciones

Consult your doctor before receiving Metronidazol B. Braun 5 mg/ml.

Be especially careful with Metronidazol B. Braun 5 mg/ml if you have:

• Severe liver dysfunction.
• Blood formation disorders.
• Brain, spinal cord, or nerve disease.

Your doctor will carefully determine if you should be treated with Metronidazol B. Braun 5 mg/ml.

If seizures or any other nervous system condition (such as numbness in the limbs) occur during treatment, the treatment will be reviewed.

The treatment with Metronidazol B. Braun 5 mg/ml should not exceed 10 days; the treatment period will only be extended in exceptional circumstances and if absolutely necessary. The repetition of treatment with metronidazole will be limited to cases where it is absolutely necessary. In such cases, you will be closely monitored.

Treatment should be interrupted or reviewed immediately if you have severe diarrhea that may be due to a disease called "pseudomembranous colitis" (see also section 4).

Severe liver toxicity/acute liver failure, some of which have been fatal, 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 metronidazole treatment 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.

Since prolonged use of metronidazole may affect blood formation (see section "Possible side effects"), your blood count will be monitored during treatment.

Otros medicamentos y Metronidazol B. Braun 5 mg/ml:

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

• Amiodarone (used to treat heart arrhythmias):

It is recommended to monitor cardiac function if amiodarone is used in combination with metronidazole. If dizziness, palpitations, or loss of consciousness occur, patients are advised to seek medical attention.

• Barbiturates (active principle in sleep medications):

Fenobarbital may reduce the duration of the effect of metronidazole; the metronidazole dose should be increased.

• Busulfan:

Metronidazole should not be administered to patients treated with Busulfan, as it is more likely to cause toxic effects.

• Carbamazepine (medication for epilepsy):

This combination also requires caution, as metronidazole may increase the duration of carbamazepine action.

• Ciclosporina (medication used to reduce unwanted immune reactions):

When ciclosporin is administered with metronidazole, ciclosporin blood levels may increase; therefore, your doctor should adjust the ciclosporin dose as needed.

• Cimetidina (medication for stomach disorders):

Cimetidina may reduce the elimination of metronidazole in isolated cases and subsequently lead to an increase in metronidazole blood concentrations.

• Derivados de la cumarina (medications that inhibit blood coagulation):

Metronidazole may increase the inhibition of blood coagulation caused by coumarins. Therefore, if you are taking a medication that inhibits blood coagulation (e.g., warfarin), you may need to reduce the dose during metronidazole treatment.

• Disulfiram (used in alcohol dependence treatment):

If you are taking disulfiram, you should not be given metronidazole, or you should discontinue disulfiram treatment. The combined use of these two medications may lead to states of confusion up to the development of a severe mental disorder (psychosis).

• Fluorouracilo (anticancer medication):

The daily dose of fluorouracil may need to be reduced when administered with metronidazole, as the latter may lead to an increase in fluorouracil blood levels.

• Litio (used to treat mental disorders):

Treatment with lithium preparations requires particularly careful monitoring during metronidazole treatment and may require adjustment of the lithium preparation dose. Lithium treatment should be reduced or discontinued before metronidazole administration.

• Píldoras anticonceptivas:

Your contraceptive pill may be less reliable while you are receiving metronidazole treatment.

• Micofenolato de mofetilo (used to prevent rejection after organ transplantation):

Its effect may be diminished by metronidazole; careful monitoring of its effect is recommended.

• Fenitoína (medication for epilepsy);

If you are taking phenytoin, your doctor will only treat you with metronidazole with caution, as it may increase the duration of phenytoin effect. On the other hand, phenytoin may reduce the effect of metronidazole.

• Tacrolimus (medication used to reduce unwanted immune reactions):

The blood levels of this medication and your renal function should be monitored when starting and stopping metronidazole treatment.

Uso deMetronidazol B. Braun 5 mg/ml con alcohol

You should not consume any alcoholic beverages while receiving metronidazole treatment, as this may cause intolerance reactions such as dizziness and vomiting.

Embarazo, lactancia y fertilidad

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

Anticoncepción en hombres y mujeres

If you are taking a contraceptive pill, see the section “Other medications and Metronidazol B. Braun 5 mg/ml”.

Embarazo

If you are pregnant, your doctor will not treat you with metronidazole unless it is absolutely necessary.

Lactancia

It is recommended to stop breastfeeding during metronidazole treatment. Once metronidazole treatment is completed, breastfeeding should not be resumed before 2-3 days, as metronidazole passes into breast milk.

Fertilidad

Animal studies only indicate a possible negative influence of metronidazole on male reproductive systems if high doses are administered, which are far above the maximum recommended dose for humans.

Conducción y uso de máquinas

You should not drive or operate machinery while receiving metronidazole treatment, as metronidazole may affect your alertness. This is especially true at the beginning of treatment or when you have consumed alcohol.

Metronidazol B. Braun 5 mg/ml contiene sodio:

This medication contains 322 mg of sodium (main component of table salt/for cooking) in each 100 ml. This is equivalent to 16% of the recommended daily maximum sodium intake for an adult.

Follow exactly the administration instructions of this medication as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

The dose depends on the nature and severity of the disease, age, and body weight, and individual response to treatment.

The recommended dose in adults and adolescents (over 12 years) is:

Treatment of infections

500 mg (100 ml) every 8 hours.

Alternatively, a single dose of 1500 mg (300 ml) may be administered on the first day of treatment, followed by single doses of 1000 mg (200 ml) on subsequent days. Initially, your doctor may give you a higher initial dose of metronidazole.

Typically, a treatment duration of 7-10 days is sufficient. If clinically indicated, treatment may continue beyond this duration.The duration of metronidazole therapy should not exceed 10 days. The maximum daily dose will not exceed 1500 mg/day.

The dose will be the same for patients with renal diseases.

For patients with liver diseases, lower doses may be necessary.

If you were treated with a renal machine (dialysis), your doctor will adjust the dose on the days of your treatment.

Prevention of infections that may occur after surgery

When used for the prevention of infection in surgery, 500 mg will be administered before surgery. The dose will be repeated after 8 and 16 hours of the operation.

Use in children:

The dosage in children is based on body weight.

Treatment of infections:

• Children > 8 weeks and up to 12 years:20-30 mg per kg of body weight per day as a single dose or 7.5 mg per kg of body weight every 8 hours. The daily dose may be increased to 40 mg per kg of body weight, depending on the severity of the infection.

• Children <8>15 mg per kg of body weight as a single dose or 7.5 mg per kg of body weight every 12 hours.

• Newborns with a gestational age <40Since metronidazole can accumulate during the first week of life, blood metronidazole concentrations should preferably be monitored after a few days of treatment.

Treatment duration is usually 7-10 days.

Prevention of infections that may occur after surgery:

• Children <1220-30 mg per kg of body weight as a single dose administered 1-2 hours before surgery.

• Newborns with a gestational age <4010 mg per kg of body weight as a single dose before surgery.

Administration form

Metronidazole B. Braun 5 mg/ml is administered intravenously.The infusion of a vial usually lasts 60 minutes, but should not be done in less than 20 minutes.

This medication may be diluted in an appropriate vehicle solution for perfusion.

If you are receiving other antibiotics simultaneously, your doctor will give you those medications separately.

If you use more Metronidazole B. Braun 5 mg/ml than you should:

As signs and symptoms of overdose may appear, the undesirable effects described in section 4 “Possible adverse effects”.

No specific antidote or symptomatic treatment for massive overdose is known, but metronidazole can be eliminated from the body by dialysis (i.e., treatment with a renal machine).

In case of overdose or accidental ingestion, consult the Toxicological Information Service. Phone915 620 420 indicating the product and the amount administered.

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

The adverse reactions are mainly related to the dose and duration of treatment, so they usually disappear when the dose is reduced or the therapy is interrupted.

The following side effects may be serious and require immediate treatment:

Rare (may affect up to 1 in 1,000 people)

• Persistent and severe diarrhea (possibly a symptom of a severe intestinal infection called pseudomembranous colitis).
• Severe acute hypersensitivity reactions up to anaphylactic shock.

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

• Decrease in white blood cell and platelet counts during treatment (granulocytopenia, agranulocytosis, pancitopenia, thrombocytopenia).
• Hepatitis (liver inflammation), jaundice, pancreatitis.
• Cerebral disorders, lack of coordination.

• Severe inflammatory reaction in mucous membranes and skin with fever, redness, and blisters, in extremely rare cases up to widespread skin detachment (Stevens-Johnson syndrome, toxic epidermal necrolysis).

Frequency not known (cannot be estimated from available data)

• Reduction in white blood cell count (leucopenia), severe anemia (aplastic anemia).
• Mild to moderate hypersensitivity reactions, facial, oral, pharyngeal, and/or tongue swelling (angioedema).
• Strabismus, nerve damage or inflammation of the eye nerves.
• Seizures, nervous disorders such as numbness, pain, sensation of hair or tingling in the arms or legs.
• Non-bacterial fever (aseptic meningitis).
• Acute liver failure in patients with Cockayne syndrome (see section 2 "Warnings and precautions").

Other side effects

Frequent (may affect up to 1 in 100 people)

• Fungal infections (e.g., genital infections).

Uncommon (may affect up to 1 in 1,000 people)

• Dark urine (caused by metronidazole metabolites).

Rare (may affect up to 1 in 1,000 people)

• Changes in the electrocardiogram (ECG).

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

• Psychotic disorders, including confusion, hallucinations.

• Headache, dizziness, somnolence, fever, visual disturbances, and movement disorders, drowsiness, speech defects, seizures.
• Visual disturbances, e.g., double vision, myopia.
• Liver function disorders (e.g., elevated levels of certain enzymes and bilirubin in the blood).
• Musculoskeletal pain.

Frequency not known (cannot be estimated from available data)

• Anorexia.
• Depression.
• Somnolence or insomnia, muscle spasms.
• Nausea, feeling of discomfort, diarrhea, inflammation of the tongue or mouth, belching, and bitter taste, metallic taste, upper abdominal pressure, hairy tongue, difficulty swallowing.
• Redness and itching of the skin (erythema multiforme).
• Irritation of the venous wall (up to inflammation of the veins and thrombosis) after intravenous administration, weakness, fever.

Emergency treatment of pseudomembranous colitis

In case of persistent and severe diarrhea, you should immediately inform your doctor because this may be due to pseudomembranous colitis, a serious disease that must be treated immediately. Your doctor will interrupt the metronidazole treatment and provide you with appropriate treatment. If you consider that any of the side effects you are experiencing is seriousor if you observe any side effect not mentioned in this leaflet, please inform your doctor

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist or nurse, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use: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 use this medication after the expiration date that appears on the packaging and on the box. The expiration date is the last day of the month indicated.

Keep in its outer packaging to protect it from light.

This medication is intended for single use. Dispose of unused portions.

From a microbiological standpoint, dilutions must be used immediately. If not used immediately, storage times in use and pre-use conditions are the responsibility of the user and are normally not greater than 24 hours at a temperature of 2 to 8°C, unless the dilution has been prepared in controlled and validated aseptic conditions.

This medication should only be used if the solution is clear and free of visible particles and if the container and its closure show no visible signs of damage.

Medications should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the packaging and medications that you no longer need. In this way, you will help protect the environment.

Composition ofMetronidazol B. Braun 5 mg/ml

- The active ingredient is metronidazol.

1 ml of Metronidazol B. Braun 5 mg/ml infusion solution contains 5 mg of metronidazol.

A polyethylene bottle of 100 ml contains 500 mg of metronidazol. A polyethylene bottle of 300 ml contains 1500 mg of metronidazol.

- The other components are sodium chloride, disodium phosphate dodecahydrate, citric acid monohydrate, and water for injection.for injection.

Appearance of the product and contents of the package

Metronidazol B. Braun 5 mg/ml is a clear, colorless, or slightly yellowish aqueous solution.

Metronidazol B. Braun 5 mg/ml is presented in polyethylene bottles (Ecoflac Plus®) containing 100 and 300 ml, in a single unit package and a clinical package of 20 units.

Only some package sizes may be marketed.

Marketing authorization holder and responsible manufacturer

B. Braun Medical, S.A.

Ctra. Terrassa, 121 Rubí

08191 Barcelona (Spain)

Last review date of this leaflet:12/2022

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

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This information is intended solely for healthcare professionals:

Intravenous use.

The contents of a vial should be infused slowly intravenously, i.e., 100 ml at most, over no less than 20 minutes, but usually more than an hour.

Metronidazol B. Braun 5 mg/ml can also be diluted before administration, by adding the medication to an intravenous vehicle solution such as sodium chloride 0.9% or a 5% glucose infusion solution.

For single use only. Dispose of the package and any unused contents after use.

It should only be used if the solution is clear and colorless or slightly yellowish and if the container and its closure show no visible signs of damage.

In patients with severe liver damage or hematopoietic disorders (such as granulocytopenia), metronidazol should only be administered if the expected benefits clearly outweigh the possible risks.

Due to the risk of exacerbation, metronidazol should be used in patients with severe, active, or chronic peripheral and central nervous system diseases only if the expected benefits clearly outweigh the possible risks.

Seizures, myoclonia, and peripheral neuropathy, the latter characterized mainly by numbness or paresthesia of a limb, have been reported in patients treated with metronidazol. The appearance of abnormal neurological signs requires prompt evaluation of the benefit-risk ratio of continuing treatment.

In case of severe hypersensitivity reactions (such as anaphylactic shock), treatment with Metronidazol B. Braun 5 mg/ml should be stopped immediately and emergency treatment established by healthcare professionals.