Metronidazole Bioindustria Lim

Package leaflet: information for the user

METRONIDAZOLO Bioindustria L.I.M. 500 mg/100 ml infusion solution

Metronidazole
Generic medicine
Please read all of 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 nurse.
• If you experience any side effects, including those not listed in this leaflet, inform your doctor or nurse. See section 4.

Contents of this leaflet:

1. What METRONIDAZOLO Bioindustria L.I.M. is and what it is used for
2. What you need to know before using METRONIDAZOLO Bioindustria L.I.M.
3. How to use METRONIDAZOLO Bioindustria L.I.M.
4. Possible side effects
5. How to store METRONIDAZOLO Bioindustria L.I.M.
6. Contents of the pack and other information

1. What METRONIDAZOLO Bioindustria L.I.M. is and what it is used for

METRONIDAZOLO Bioindustria L.I.M. contains the active substance metronidazole, which belongs to a
group of medicines called antibiotics, used for infections caused by bacteria.
This medicine is indicated for the treatment of severe infections (septicaemia, bacteraemia) in adults and
children caused by the following bacteria: Bacteroides fragilis, Fusobacteria, Eubacteria, Clostridia, and anaerobic Gram-positive cocci.
METRONIDAZOLO Bioindustria L.I.M. is particularly indicated for:

• treatment of infections such as those causing accumulation of infected material (brain and pelvic abscesses), severe lung infections (necrotizing pneumonia), bone and joint infections (osteomyelitis), uterine infections (puerperal fever), peritoneal infections (peritonitis), and wound infections following surgical procedures.
• prevention of infections caused by bacteria (Bacteroides and anaerobic Gram-positive cocci) that may occur following surgical procedures (in pre- and post-operative phases).

2. What you need to know before using METRONIDAZOLE Bioindustria L.I.M.

Do not use METRONIDAZOLE Bioindustria L.I.M.

• if you are allergic to metronidazole or to any of the other ingredients of this medicine (listed in section 6);
• if you suffer from any blood or bone marrow disorder (haematological disorders);
• if you have neurological problems (active central nervous system diseases);
• if you are pregnant or breastfeeding (see section "Pregnancy and breastfeeding").

Warnings and precautions
Talk to your doctor or nurse before you are given METRONIDAZOLE Bioindustria L.I.M.
METRONIDAZOLE Bioindustria L.I.M. will always be administered under strict medical supervision.
METRONIDAZOLE Bioindustria L.I.M. will be administered with great caution and at reduced doses if:

• you have severe kidney problems (impaired renal function);
• you have severe liver problems (severe hepatic disease).

If METRONIDAZOLE Bioindustria L.I.M. is to be administered for longer than 10 days:

• your doctor will assess the risk of developing peripheral nervous system problems (peripheral neuropathy);
• you will undergo regular clinical monitoring.

Cases of liver toxicity (severe hepatotoxicity/acute liver failure), including fatal cases, have been reported with metronidazole-containing medicines in patients affected by Cockayne syndrome.
If you suffer from Cockayne syndrome, your doctor will frequently monitor your liver function both during and after treatment with metronidazole.
Inform your doctor immediately and stop taking metronidazole if you experience:

• stomach pain, anorexia, nausea, vomiting, fever, malaise, fatigue, jaundice, dark urine, pale or grey-green stools, or itching.

Other medicines and METRONIDAZOLE Bioindustria L.I.M.
Inform your doctor or nurse if you are taking, have recently taken, or might take any other medicines.
In particular, inform your doctor if you are taking any of the following medicines:

• oral anticoagulants and coumarins (warfarin and similar medicines), used to reduce blood clotting, as their anticoagulant effect may be increased;
• medicines that interfere with the metabolism of metronidazole, such as phenytoin and phenobarbital, used as antiepileptics.

Do not take METRONIDAZOLE Bioindustria L.I.M. if you have taken disulfiram, a medicine used in the treatment of alcoholism, within the last two weeks.
METRONIDAZOLE Bioindustria L.I.M. and alcohol
Do not drink alcohol while receiving METRONIDAZOLE Bioindustria L.I.M., as you may experience symptoms such as nausea, vomiting, and abdominal cramps.
Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or nurse before being administered this medicine.
Do not use METRONIDAZOLE Bioindustria L.I.M. if you are pregnant or breastfeeding.
Driving and using machines
This medicine does not impair the ability to drive or operate machinery.
METRONIDAZOLE BIOINDUSTRIA L.I.M. contains sodium
This medicine contains 332.6 mg (14.46 mmol) of sodium per 100 ml of solution. This should be taken into consideration in patients with impaired renal function or those on a low-sodium diet.

3. How to use METRONIDAZOLE Bioindustria L.I.M.

Use this medicine exactly as instructed by your doctor or nurse. If you have any doubts, consult your doctor or nurse.
If you use more METRONIDAZOLE Bioindustria L.I.M. than you should
This medicine will be administered by trained healthcare professionals, so it is unlikely that you will receive an excessive dose. However, if you do receive an overdose, contact your doctor, who will advise appropriate treatment for your symptoms.
If you have been given too much of this medicine, contact your doctor or nurse immediately.
If you have any questions about the use of this medicine, consult your doctor or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Frequency not known (frequency cannot be estimated from the available data)

• unpleasant metallic taste sensation, presence of coating on the tongue (furred tongue), loss of appetite (anorexia), nausea, vomiting, stomach and intestinal pain (gastrointestinal disturbances);
• drowsiness, dizziness, headache (cephalaea), loss of muscle coordination (ataxia), fever, development of skin spots and skin irritation (skin rashes), itching, dark-coloured urine, kidney problems (dysuria, cystitis, polyuria, pyuria), decreased libido, Candida infections;
• peripheral nervous system problems (peripheral neuropathies);
• decrease in the number of white blood cells in the blood (leucopenia);
• transient epileptic seizures.

If you experience neurological problems (neuropathies, epileptic seizures), stop treatment.
Side effects in children
The frequency, type and severity of side effects in children are the same as in adults.
Reporting of side effects
If you get any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at www.agenziafarmaco.gov.it/it/responsabili. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store METRONIDAZOLE Bioindustria L.I.M.

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the pack after the words “EXP.”.
The expiry date refers to the last day of that month and to the product in its original, undamaged packaging and
correctly stored.
Store below 25°C. Keep in the original container and outer packaging.
Keep the medicine away from light, as it is light-sensitive.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of
medicines no longer required. This will help protect the environment.

6. Pack contents and other information

What METRONIDAZOLO Bioindustria L.I.M. contains

• The active substance is metronidazole. Each 100 ml vial contains 500 mg of metronidazole.
• The other components are sodium chloride, dibasic sodium phosphate dihydrate, anhydrous citric acid, water for injections.

Description of the appearance of METRONIDAZOLO Bioindustria L.I.M. and pack contents
METRONIDAZOLO Bioindustria L.I.M. is supplied in a pack containing 25 vials of 100 ml each.
Marketing Authorization Holder and Manufacturer
Bioindustria Laboratorio Italiano Medicinali S.p.A. (Bioindustria L.I.M. S.p.A.) - Via De Ambrosiis, 2 -
15067 Novi Ligure (AL)

The following information is intended exclusively for doctors or healthcare professionals

The medicinal product must be used only for slow intravenous infusion.
This type of administration is particularly useful in emergency situations and is indicated in surgical
patients when:

• anaerobic infection is present or suspected preoperatively, such as septicemia, peritonitis, subphrenic or pelvic abscess;
• signs of septic state caused by anaerobic germs appear during surgery;
• there is a risk of contamination by anaerobes originating from the gastrointestinal tract, female genital tract, or oropharynx during surgery.

In patients already receiving intravenous therapy, the medicinal product may be diluted with appropriate volumes of physiological saline, isotonic dextrose solution, 5% dextrose solution, or potassium chloride ( 20 mmol/L and 40 mmol/L ). Avoid adding other medicinal products, apart from metronidazole, to the infusion solution.

Treatment

• Adults and children over 12 years: 100 ml for intravenous infusion (at a rate of 5 ml per minute) every 8 hours. In most patients, 7 days of therapy are sufficient, but in some cases (inaccessible areas for drainage, new contamination, etc.) a longer duration of treatment may be required.
• Children between 8 weeks and 12 years of age: 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 up to 40 mg/kg depending on the severity of the infection. The usual duration of treatment is 7 days.
• Children under 8 weeks of age: 15 mg/kg as a single daily dose or divided into 7.5 mg/kg every 12 hours.
• In neonates with a gestational age below 40 weeks, accumulation of metronidazole may occur during the first week of life; therefore, serum concentrations of metronidazole should preferably be monitored a few days after starting therapy.
• Bacterial vaginosis: Adolescents: 400 mg twice daily for 5–7 days or 2000 mg as a single dose.

Prophylaxis

• Adults and children over 12 years: 100 ml for intravenous infusion immediately before, during, or after surgery, followed by the same dose every 8 hours.
• Children under 12 years: 20–30 mg/kg as a single dose administered 1–2 hours before surgery.
• Neonates with a gestational age below 40 weeks: 10 mg/kg body weight as a single dose before surgery.

Interactions with other medicinal products and other forms of interaction
Metronidazole enhances the activity of warfarin and other oral coumarin anticoagulants, resulting in prolonged prothrombin time; dosage adjustments should therefore be considered in patients concurrently treated with these drugs and metronidazole.
Concomitant administration of drugs that induce hepatic microsomal enzymes (e.g. phenytoin, phenobarbital) may accelerate the elimination of metronidazole, leading to reduced plasma levels of the drug.
Metronidazole should not be administered to patients who have taken disulfiram within the preceding two weeks.

Incompatibilities
Avoid adding other medicinal products to the infusion solution. No additives should be added to the metronidazole solution.

Shelf life
36 months.

Special precautions for storage
Store at temperatures not exceeding 25°C. Keep in the original container and outer packaging. Protect from light.

For further information, consult the Summary of Product Characteristics.