Metronidazole B. Braun

PATIENT INFORMATION LEAFLET

Leaflet attached to the packaging: information for the user

Metronidazole B. Braun, 5 mg/ml, solution for infusion

Metronidazole

Read the leaflet carefully before using the medicine, as it contains important information for the patient.

• Keep this leaflet, so you can read it again if you need to.
• If you have any doubts, consult your doctor.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same as yours.
• If the patient experiences any side effects, including any not listed in this leaflet, they should inform their doctor. See section 4.

Table of contents of the leaflet

• 1. What is Metronidazole B. Braun and what is it used for
• 2. Important information before using Metronidazole B. Braun
• 3. How to use Metronidazole B. Braun
• 4. Possible side effects
• 5. How to store Metronidazole B. Braun
• 6. Contents of the packaging and other information

1. What is Metronidazole B. Braun and what is it used for

Metronidazole B. Braun is an antibiotic used to treat severe bacterial infections caused by bacteria sensitive to the active substance of the medicine, metronidazole. Metronidazole B. Braun is used to treat the following diseases:

• infections of the central nervous system, such as brain abscesses (local infection with pus), meningitis;
• lung and pleural infections, such as pneumonia with tissue damage, aspiration pneumonia resulting from stomach contents entering the lungs, lung abscesses;
• gastrointestinal tract infections, such as peritonitis, liver abscesses, post-surgical infections of the colon or rectum, purulent infections in the abdominal and pelvic cavities;
• genital infections in women, such as endometritis, postpartum or post-caesarean section infections, septic abortion (sepsis), puerperal fever;
• ear, nose, throat, tooth, jaw, and mouth infections, e.g., ulcerative stomatitis;
• endocarditis;
• bone and joint infections, such as osteomyelitis;
• gas gangrene;
• sepsis with septic thrombophlebitis.

In case of need, other appropriate antibiotics can be used. Metronidazole B. Braun can be used prophylactically before high-risk surgical procedures for bacterial infections (mainly gynecological procedures, stomach and intestine surgeries).

2. Important information before using Metronidazole B. Braun

When not to use Metronidazole B. Braun

• if the patient is allergic to metronidazole or other similar substances or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Before starting treatment with Metronidazole B. Braun, discuss it with your doctor. Be particularly cautious when using Metronidazole B. Braun if the patient has:

• severe liver damage;
• blood cell disorders;
• brain, spinal cord, or nerve disease. In such cases, the treating doctor will decide on the possible use of Metronidazole B. Braun.

If seizures or other nervous system reactions occur during treatment, such as numbness of limbs, the doctor will immediately adjust further treatment. As a rule, Metronidazole B. Braun should not be used for more than 10 days. The treatment duration may be longer only in exceptional cases when it is absolutely necessary. Metronidazole treatment can only be repeated when it is absolutely necessary. In such cases, the doctor will recommend close monitoring of the patient's condition. Therapy should be stopped or verified immediately if the patient experiences severe diarrhea, which may be caused by a severe disease of the large intestine called pseudomembranous colitis (see also section 4). During the use of metronidazole in patients with Cockayne syndrome, cases of severe hepatotoxicity (acute liver failure), including fatal cases, have been reported. In patients with Cockayne syndrome, the doctor should monitor liver function during and after metronidazole treatment. If the patient experiences any of the following symptoms, they should immediately inform their doctor and stop taking metronidazole:

• abdominal pain, loss of appetite, nausea, vomiting, fever, malaise, fatigue, jaundice, dark urine, sticky or loose stools, or skin itching.

Prolonged metronidazole treatment may disrupt blood cell production (see "Possible side effects"), so the doctor will recommend monitoring blood cell counts during treatment.

Metronidazole B. Braun and other medicines

Tell your doctor or pharmacist about all medicines you are taking or have recently taken, as well as any medicines you plan to take. Amiodarone (used to treat heart rhythm disorders)During treatment with this medicine, heart function should be monitored. If the patient notices any heart rhythm disturbances, dizziness, or fainting, they should consult their doctor. Barbiturates (active substance of sleeping pills)Phenobarbital reduces the duration of metronidazole action; therefore, it may be necessary to increase the metronidazole dose. Oral contraceptivesDuring metronidazole treatment, the effectiveness of oral contraceptives may be reduced. BusulfanMetronidazole and busulfan should not be used simultaneously, as this may increase the likelihood of toxic effects. Carbamazepine (a medicine used to treat epilepsy)When used together, caution is necessary, as metronidazole may prolong the action of carbamazepine. Cimetidine (a medicine used to treat stomach disorders)In isolated cases, cimetidine may reduce metronidazole excretion and lead to increased metronidazole serum levels. Coumarin derivatives (blood-thinning medicines)If the patient is taking a blood-thinning medicine (e.g., warfarin), the doctor may recommend reducing the dose of such a medicine during simultaneous administration of metronidazole, as metronidazole may enhance the anticoagulant effect of coumarin medicines. Cyclosporine (a medicine used to suppress unwanted immune reactions)During simultaneous treatment with cyclosporine and metronidazole, cyclosporine blood levels may increase; therefore, the doctor will adjust the cyclosporine dose. Disulfiram (used in the treatment of alcoholism)Metronidazole should not be taken with disulfiram or disulfiram treatment should be stopped. Simultaneous administration of these medicines may cause disorientation or severe mental disorders (psychosis). Fluorouracil (an anticancer medicine)It may be necessary to reduce the daily dose of fluorouracil when used with metronidazole, as metronidazole may increase fluorouracil blood levels. Lithium (used to treat mental illnesses)During metronidazole treatment with lithium salts, close monitoring of the patient is necessary, as lithium dose adjustment may be required. Mycofenolate mofetil (used to prevent organ rejection after transplantation)Metronidazole may reduce the effectiveness of this medicine; therefore, mycophenolate mofetil activity should be closely monitored. Phenytoin (a medicine used to treat epilepsy)If the patient is taking phenytoin, the doctor will recommend metronidazole treatment with caution. Metronidazole may prolong phenytoin action, while phenytoin may reduce metronidazole effectiveness. Tacrolimus (used to suppress unwanted immune reactions)When starting or stopping metronidazole treatment, tacrolimus blood levels and kidney function should be monitored.

Metronidazole B. Braun and alcohol

AlcoholDo not drink any alcoholic beverages during metronidazole treatment, as this may cause intolerance reactions, such as vomiting or dizziness.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor before using this medicine. Contraception in men and womenIf the patient is using contraceptives, see the "Metronidazole B. Braun and other medicines" section. PregnancyIf the patient is pregnant, the doctor will recommend metronidazole only if it is absolutely necessary. BreastfeedingDo not breastfeed during metronidazole treatment. Breastfeeding should not be resumed until 2 to 3 days after the end of metronidazole treatment, as metronidazole passes into breast milk. FertilityAnimal studies indicate only a potential negative effect of metronidazole on the male reproductive system if males receive doses significantly higher than the maximum doses for humans.

Driving and using machines

Do not drive or operate machines while taking metronidazole, as it may impair alertness. This is especially important at the beginning of treatment or if the patient consumes alcohol.

Metronidazole B. Braun contains sodium

The medicine contains 322 mg of sodium (the main component of common salt) per 100 ml, which is 0.16% of the maximum recommended daily sodium intake in the diet for adults.

3. How to use Metronidazole B. Braun

DosageThe dose is determined based on the type and severity of the disease, age, body weight, and patient response to treatment. The recommended dosage is usually as follows: Adults and adolescentsInfection treatment: On the first day of therapy, the patient usually receives 300 ml of the medicine (which corresponds to 1500 mg of metronidazole). From the second day of treatment, the patient receives 200 ml of the medicine (which corresponds to 1000 mg of metronidazole) daily. Alternatively, the patient may receive 100 ml of the medicine (which corresponds to 500 mg of metronidazole) every 8 hours. At the beginning of therapy, the doctor may recommend a higher initial dose of metronidazole. In most cases, therapy lasts 7 days and can only be extended in exceptional cases. Patients with impaired kidney function receive the same doses. In patients with liver disease, dose reduction may be necessary. If the patient is undergoing dialysis (artificial kidney), the doctor will adjust the dose on the day of dialysis. Prevention of infections that may occur after surgical procedures: In the case of metronidazole use to prevent infections in surgery, the patient can be given 500 mg of the medicine before surgery. This dose will be repeated 8 and 16 hours after surgery.

Use in children and adolescents

Dosage in children is based on body weight (bw) Infection treatment

Treatment usually lasts 7 days. Prevention of infections that may occur after surgical procedures: Method of administration and duration of useMetronidazole B. Braun is administered by intravenous infusion directly into a vein. Infusion of the solution from one bottle usually lasts 60 minutes and should not be less than 20 minutes. Before infusion, the product can be diluted in an appropriate infusion solution. As a rule, metronidazole treatment does not last longer than 7 days and cannot last longer than 10 days unless it is absolutely necessary (see "Warnings and precautions"). If the patient is receiving other antibiotics simultaneously, the doctor will administer these medicines separately.

Use of a higher than recommended dose of Metronidazole B. Braun

As subjective or objective symptoms of overdose, the following side effects may occur, as described in the next section. In case of significant metronidazole overdose, there is no specific treatment or antidote known, but metronidazole can be effectively removed from the body during dialysis (i.e., using an artificial kidney).

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

The following side effects may have serious consequences and therefore require immediate treatment:

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

• Severe persistent diarrhea (which may be a symptom of a severe intestinal infection called pseudomembranous colitis).

• Severe acute allergic reactions, up to anaphylactic shock.

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

• During treatment, a decrease in white blood cell and platelet count may occur (granulocytopenia, agranulocytosis, pancytopenia, thrombocytopenia). With prolonged use, regular monitoring of blood morphology is necessary.
• Hepatitis, jaundice, pancreatitis (isolated cases).
• Brain function disorders, lack of coordination.
• Severe inflammatory rash on mucous membranes and skin with fever, redness, and blistering (Stevens-Johnson syndrome).

Frequency not known: frequency cannot be estimated from the available data

• Mild or moderate allergic reactions, including facial swelling, mouth, throat, and (or) tongue swelling (angioedema).
• Forced gaze, nerve damage, or inflammation in the eyes.
• Detachment of skin on large areas (toxic epidermal necrolysis).
• Decreased white blood cell count (leukopenia), severe anemia (aplastic anemia).
• Seizures, nerve disorders, such as numbness, pain, feeling of fur or crawling sensation in arms and legs.
• Brain inflammation not caused by bacteria (aseptic meningitis).

Other side effects

Common: may affect up to 1 in 10 people

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

Uncommon: may affect up to 1 in 100 people

• Dark urine color (caused by a metronidazole metabolite).

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

• ECG changes.

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

• Psychotic disorders, including confusion, hallucinations.
• Headache, dizziness, drowsiness, fever, vision and movement disorders, speech disorders, seizures.
• Vision disorders, e.g., double vision, myopia.
• Liver function disorders (such as increased activity of certain enzymes and increased bilirubin levels).
• Allergic skin reactions, e.g., itching, hives.
• Muscle and joint pain.

Frequency not known: frequency cannot be estimated from the available data

• Vomiting, nausea, diarrhea, oral or mouth inflammation, belching, and bitter taste in the mouth, metallic taste, pressure on the stomach, coated tongue.
• Difficulty swallowing.
• Anorexia.
• Sad (depressive) mood.
• Drowsiness or insomnia, sudden muscle contractions.
• Redness and itching of the skin (erythema multiforme).
• Irritation of the vein wall (even to the point of phlebitis and thrombophlebitis) after intravenous administration, weakness, fever.
• Acute liver failure in patients with Cockayne syndrome (see "Warnings and precautions" in section 2).

Emergency procedure in case of pseudomembranous colitisIn case of persistent, severe diarrhea, immediately inform your doctor, as it may be caused by pseudomembranous colitis, a serious disease that requires immediate treatment. The doctor will stop metronidazole treatment and provide appropriate treatment.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, inform your doctor or nurse. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, Tel: +48 22 49 21 301, Fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl. Side effects can also be reported to the marketing authorization holder. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Metronidazole B. Braun

Store the medicine out of sight and reach of children. Do not use this medicine after the expiry date stated on the bottle and carton. The expiry date refers to the last day of the month. Store the container in the outer packaging to protect it from light. The medicine is for single use only. Any unused remainder should be discarded. From a microbiological point of view, the diluted medicine should be used immediately. If the medicine is not used immediately, the storage time and conditions before use are the responsibility of the user and should not exceed 24 hours at 2°C to 8°C, unless the dilution was performed under controlled, validated aseptic conditions. Use only if the solution is clear and free of visible particles, and the bottle and closure are not damaged. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Metronidazole B. Braun contains

• The active substance of the medicine is metronidazole. 1 ml of Metronidazole B. Braun solution for infusion contains 5 mg of metronidazole. One polyethylene bottle with a capacity of 100 ml contains 500 mg of metronidazole.
• The other ingredients are sodium chloride, disodium phosphate dodecahydrate, citric acid, water for injections.

What Metronidazole B. Braun looks like and what the packaging contains

Metronidazole B. Braun is a clear, colorless or slightly yellowish solution. Metronidazole B. Braun is available in polyethylene bottles with a capacity of 100 ml. The solution is available in packs of 10 or 20 bottles.

Marketing authorization holder

B.Braun Melsungen AG, Carl-Braun-Straße 1, 34212 Melsungen, Germany, Address for correspondence:34209 Melsungen, Germany, Tel. +49-5661-71-0, Fax +49-5661-71-4567

Manufacturer

B.Braun Melsungen AG, Carl-Braun-Straße 1, 34212 Melsungen, Germany, B.Braun Medical, S.A., Carretera de Terrassa 121, 08191 Rubí, Barcelona, Spain. For more detailed information, please contact the local representative of the marketing authorization holder: Aesculap Chifa Sp. z o.o., ul. Tysiąclecia 14, 64-300 Nowy Tomyśl, tel. (061) 44 20 100, fax (061) 44 23 936

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Date of last revision of the leaflet: 05/2023