METRONIDAZOLO <500 MG/100 ML Roztwór do infuzji

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1. METRONIDAZOLO S.A.L.F. 500 mg/100 ml solution for infusion
   1. What is METRONIDAZOLO S.A.L.F. and what is it used for?
   2. What you need to know before using METRONIDAZOLO S.A.L.F.
   3. How to use METRONIDAZOLO S.A.L.F.
   4. Possible side effects
   5. How to store METRONIDAZOLO S.A.L.F.
   6. Package contents and other information

METRONIDAZOLO S.A.L.F. 500 mg/100 ml solution for infusion

Metronidazolo

Generic medicine

Read this leaflet carefully before you start using this medicine as 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 get any side effects, even those not listed in this leaflet, tell your doctor or nurse. See section 4. Contents of this leaflet:
• 1. What METRONIDAZOLO S.A.L.F. is and what it is used for
• 2. What you need to know before you use METRONIDAZOLO S.A.L.F.
• 3. How to use METRONIDAZOLO S.A.L.F.
• 4. Possible side effects
• 5. How to store METRONIDAZOLO S.A.L.F.
• 6. Contents of the pack and other information

1. What is METRONIDAZOLO S.A.L.F. and what is it used for?

METRONIDAZOLO S.A.L.F. contains the active ingredient metronidazole, which belongs to a group of
medicines called antibiotics, used for infections caused by microorganisms.
This medicine is indicated for the treatment of severe infections (septicemia, bacteremia) in adults and
children caused by the following bacteria: Bacteroides fragilis, Fusobacteria, Eubacteria, Clostridiaand Gram-positive anaerobic Cocci.
METRONIDAZOLO S.A.L.F. is particularly indicated for:

• the treatment of infections such as infections causing accumulation of infected material (brain and pelvic abscesses), severe lung infections (necrotizing pneumonia), affecting bones and joints (osteomyelitis), the uterus (puerperal fever), the peritoneum (peritonitis) and infections causing sores following surgical operations;
• prevention of infections caused by bacteria (Bacteroidesand Gram-positive anaerobic Cocci) that occur following surgical operations (in pre- and post-operative phases).

2. What you need to know before using METRONIDAZOLO S.A.L.F.

Do not use METRONIDAZOLO S.A.L.F.

• if you are allergic to metronidazole or any of the other ingredients of this medicine (listed in section 6).
• if you suffer from any blood or bone marrow disease (blood dyscrasias);
• if you suffer from problems with the nervous system (active central nervous system diseases);
• if you are pregnant or breastfeeding (see section “Pregnancy and breastfeeding”).

Warnings and precautions
Consult your doctor or nurse before you are given METRONIDAZOLO S.A.L.F.
METRONIDAZOLO S.A.L.F. will always be given to you under strict medical supervision.
Cases of liver toxicity (severe hepatotoxicity/acute hepatic failure), including cases leading to death, have been reported with medicines containing metronidazole, in patients suffering from
Cockayne syndrome.
If you suffer from Cockayne syndrome, your doctor will also frequently monitor your liver function both during and after treatment with metronidazole.
Immediately inform your doctor and stop taking metronidazole if you experience:

• stomach pain, anorexia, nausea, vomiting, fever, malaise, fatigue, jaundice, dark urine, pale and greenish-grey stools, or itching
• seizures and numbness or altered sensation in a limb (paresthesia)
• severe blistering skin reactions (Stevens-Johnson syndrome and toxic epidermal necrolysis or acute generalized exanthematous pustulosis). During treatment, urine may turn reddish-brown due to the presence of soluble pigments of the drug. Prolonged therapy with metronidazole may be associated with bone marrow suppression with consequent impairment of blood cell production (hematopoiesis). Therefore, during prolonged therapy, blood cell counts should be carefully monitored.

METRONIDAZOLO S.A.L.F. will be administered to you with great caution and at reduced doses if:

• you have severe kidney problems (impaired renal function);
• you have severe liver problems (severe liver disease);
• you suffer from severe active or chronic diseases of the peripheral and central nervous system. Metronidazole should only be used if the expected benefits clearly outweigh the potential risks. If METRONIDAZOLO S.A.L.F. is administered to you for a period longer than 10 days:
• the doctor will assess the risk of peripheral nervous system problems (peripheral neuropathy).
• regular checks of your clinical condition will be carried out. Children and infantsThis medicine can be administered with caution in children. Other medicines and METRONIDAZOLO S.A.L.F.Tell your doctor or nurse if you are taking, have recently taken or might take any other medicines. In particular, tell your doctor if you are taking:
• Disulfiram(medicine for the treatment of chronic alcohol dependence) when taken in the previous two weeks: METRONIDAZOLO S.A.L.F. can cause psychotic reactions (e.g. confusion, behavioral changes and hallucinations).
• Warfarin, acenocoumarol, dicoumarol, phenprocoumon(oral anticoagulant drugs): METRONIDAZOLO S.A.L.F. can increase bleeding time, so your doctor may ask you to have frequent prothrombin time (INR) tests and possibly adjust the dose of the anticoagulant drug.
• Lithium: METRONIDAZOLO S.A.L.F. can increase lithium levels in the blood (lithiemia), so lithium therapy should be discontinued if METRONIDAZOLO S.A.L.F. is taken; if it is necessary to take lithium and METRONIDAZOLO S.A.L.F. at the same time, it is important to regularly check the blood levels of lithium, creatinine and electrolytes (sodium, potassium and chlorine).
• Phenytoin, phenobarbital(antiepileptic drugs): by increasing liver activity, they can accelerate the elimination of METRONIDAZOLO S.A.L.F., decreasing its concentration in the blood.
• Cyclosporine(immunosuppressant drug): METRONIDAZOLO S.A.L.F. can reduce the liver’s ability to eliminate cyclosporine, which can accumulate in the blood with the risk of toxicity.
• Cimetidine(drug used for ulcers, reflux esophagitis or gastritis): can slow down the elimination of METRONIDAZOLO S.A.L.F. from the blood, increasing its concentration.
• Tacrolimus(drug used to prevent organ rejection): concomitant use with METRONIDAZOLO S.A.L.F. can increase the risk of heart problems (QT prolongation and arrhythmias). METRONIDAZOLO S.A.L.F. can also reduce the liver’s ability to eliminate tacrolimus, which can accumulate in the blood with the risk of toxicity.
• Drugs that cause heart problems(QT prolongation): concomitant use with METRONIDAZOLO S.A.L.F. can increase the risk of these problems.
• Cholestyramine(drug used to lower blood cholesterol): the effectiveness of METRONIDAZOLO S.A.L.F. may be reduced.
• Carbamazepine(drug used in the treatment of epilepsy and trigeminal neuralgia): METRONIDAZOLO S.A.L.F. can slow down the elimination of carbamazepine, which can accumulate in the blood with the risk of toxicity to the central nervous system.
• Amprenavir(drug used to treat HIV): METRONIDAZOLO S.A.L.F. should not be administered together with amprenavir oral solution due to the potential risk of toxicity of an excipient of amprenavir (propylene glycol).
• Mycophenolate mofetil(drug used to prevent acute rejection after organ transplantation): if METRONIDAZOLO S.A.L.F. is administered simultaneously with norfloxacin (antibiotic) and mycophenolate mofetil, exposure to the latter drug may be reduced. No interactions have been observed if METRONIDAZOLO S.A.L.F. or norfloxacin are administered together with mycophenolate mofetil but separately from each other.
• Herbal preparations based on silymarin(e.g. milk thistle): can reduce the concentration of METRONIDAZOLO S.A.L.F. in the blood and therefore reduce its effectiveness.
• Ergotamine and dihydroergotamine(drugs for the treatment of migraine): METRONIDAZOLO S.A.L.F. can cause an increase in the concentrations of these drugs in the blood with the risk of toxicity.
• Busulfan(drug indicated for the preparative treatment of hematopoietic stem cell transplantation): METRONIDAZOLO S.A.L.F. can cause an increase in the concentrations of busulfan in the blood with the risk of toxicity.
• 5-fluorouracil(anticancer drug): METRONIDAZOLO S.A.L.F. can cause an increase in the concentrations of this drug in the blood with the risk of toxicity. METRONIDAZOLO S.A.L.F. with alcoholDo not drink alcohol if you have been given METRONIDAZOLO S.A.L.F. as you may experience symptoms such as nausea, vomiting and abdominal cramps. Pregnancy and breastfeedingIf you are pregnant, suspect you may be pregnant, are planning a pregnancy, or are breastfeeding, ask your doctor or nurse for advice before this medicine is given to you. Do not use METRONIDAZOLO S.A.L.F. if you are certainly or presumed to be pregnant and if you are breastfeeding. Driving and operating machinery

This medicine does not impair the ability to drive and operate machinery.

METRONIDAZOLO S.A.L.F. contains sodium
This medicine contains 310 mg (13.5 mmol) of sodium (the main component of table salt) per
100 ml of solution. This is equivalent to 15.6% of the recommended maximum daily intake with the
diet of an adult. This should be taken into consideration in people with impaired renal function or who are following
a low-sodium diet.

3. How to use METRONIDAZOLO S.A.L.F.

Use this medicine following exactly the instructions of your doctor or nurse. If you have any doubts
consult your doctor or nurse.
This medicine must be administered to you only by slow intravenous infusion (5 ml/min).
This type of administration is particularly useful in emergency cases and is indicated in surgical patients when:

• in the pre-operative phase, an infection by anaerobes is present or suspected, e.g., septicemia, peritonitis, subphrenic or pelvic abscess;
• during surgery, signs of a septic state caused by anaerobic germs appear;
• during surgery, there is a possibility of contamination by anaerobes from the gastrointestinal tract, female genital tract, or oropharynx. Avoid adding other medicines and additives, in addition to metronidazole, to the solution to be infused. Use in adults and children over 12 years of ageThe recommended dose is 100 ml for intravenous infusion (at a rate of 5 ml/min) every 8 hours. In the majority of patients, 7 days of therapy are sufficient, but in some cases (regions inaccessible to drainage, new contamination, etc.) the treatment needs to be continued for longer. The recommended dose for the prevention of infections is 100 ml for intravenous infusion immediately before, during or after surgery, followed by the same dose every 8 hours. Use in children under 12 years of age and in newbornsThe recommended dose is:
• children aged between 8 weeks and 12 years: 20 - 30 mg/kg per day in 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 usually 7 days.
• children under 8 weeks of age: 15 mg/kg per day in a single dose or divided into 7.5 mg/kg every 12 hours. In premature newborns: the doctor must administer the medicine with caution and monitor the amount of medicine in the blood. The recommended dose for the prevention of infections is:
• children under 12 years: 20-30 mg/kg in a single dose given 1-2 hours before surgery;
• premature newborns: 10mg/kg of body weight in a single dose before surgery. Each bag or vial is for single use only; any remaining contents must not be used again. If you use more METRONIDAZOLO S.A.L.F. than you should

This medicine will be administered by trained personnel, so it is unlikely that you will be
given an excessive dose. However, if you are given an excessive dose, contact
your doctor who will indicate an appropriate therapy for your symptoms.
If you have been given an excessive amount of this medicine, contact immediately
your doctor or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
If you experience neurological problems (neuropathies, seizures) you should stop treatment.

Frequency not known(the frequency of which cannot be estimated based on available data)

• gastro-intestinal disorders (of the digestive system),
• anorexia (loss of appetite),
• nausea,
• white tongue,
• dry mouth,
• metallic taste,
• glossitis (inflammation of the tongue),
• stomatitis (inflammation of the oral mucosa),
• headache,
• skin rashes,
• dizziness,
• ataxia (lack of coordination of movements),
• depression,
• insomnia,
• nasal congestion (stuffy nose).
• urticaria,
• itching,
• angioedema (swelling of the skin of the face and mucous membranes that can cause difficulty swallowing and breathing),
• anaphylaxis (severe allergic reaction with rapid onset),
• dysuria (difficulty in urination),
• cystitis (inflammation of the urinary bladder),
• fever,
• polyuria (emission of an amount of urine higher than normal),
• pyuria (presence of pus in the urine),
• decreased libido (decreased sexual desire),
• psychotic disorders, including confusion, hallucinations,
• encephalopathy (which manifests with confusion, fever, headache, hallucinations, paralysis, mild sensitivity, visual and movement disorders, stiff neck),
• subacute cerebellar syndrome (which manifests with ataxia, dysarthria, gait disturbance, nystagmus and tremor),
• eye disorders, such as diplopia, myopia, optic neuropathy/neuritis,
• cardiac pathologies such as tachycardia, palpitations
• ear disorders, such as hearing impairment, hearing loss (including sensorineural), tinnitus,
• liver and pancreas disorders (increased liver enzymes, cholestatic hepatitis, hepatocellular damage, jaundice and pancreatitis),
• muscle pain,
• joint pain,
• Stevens-Johnsons syndrome and Toxic Epidermal Necrolysis (two serious, potentially fatal skin diseases), acute generalized exanthematous pustulosis (AGEP),
• Candida infections,
• acute hepatic failure in patients with Cockayne syndrome (see section 2 “Warnings and precautions”) In following prolonged or intensive therapies, sporadic cases of transient leukopenia, agranulocytosis, neutropenia, thrombocytopenia, pancytopenia (low number of white blood cells, granulocytes, platelets in the blood) or peripheral neuropathy (damage to peripheral nerve endings) have been reported. During treatment, urine may assume a reddish-brown color due to soluble pigments of the drug. Adverse effects in childrenThe frequency, type and severity of adverse effects in children are the same as in adults. Reporting of side effectsIf you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. You can also report side effects directly through the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store METRONIDAZOLO S.A.L.F.

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the packaging after the words “EXP.”.
The expiry date refers to the last day of that month and the product in intact packaging and
correctly stored.
Store in the original packaging to protect the medicine from light. Do not refrigerate or freeze.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to dispose of
medicines that you no longer use. This will help protect the environment.
Each vial or bag should be used for a single administration; any remaining contents should not be
used again.

6. Package contents and other information

What does METRONIDAZOLO S.A.L.F. contain?

• The active ingredient is metronidazole. Each bag or bottle of 100 ml contains 500 mg of metronidazole.
• The other ingredients are disodium phosphate dihydrate, citric acid monohydrate, sodium chloride, water for injections. Description of the appearance of METRONIDAZOLO S.A.L.F. and contents of the packMETRONIDAZOLO S.A.L.F. is presented in a pack of 20 bags of 100 ml or in a pack of 30 polypropylene bottles of 100 ml. Marketing authorisation holder and manufacturerS.A.L.F. S.p.A. Farmacological Laboratory - via Marconi, 2 - 24069 Cenate Sotto (BG) - Italy

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The following information is intended exclusively for doctors or healthcare professionals
Dosage and method of administration
METRONIDAZOLO S.A.L.F. for injection must only be used for slow intravenous infusion (5 ml/min).
This type of administration is particularly useful in emergency cases and is indicated in surgical patients when:

• pre-operatively, an infection due to anaerobes is present or suspected, e.g. septicaemia, peritonitis, subphrenic or pelvic abscess;
• during surgery, signs of a septic state caused by anaerobic germs appear;
• during surgery, there is a possibility of contamination by anaerobes from the gastrointestinal tract, the female genital tract, or the oropharynx. Avoid adding other drugs, besides metronidazole, to the solution to be infused. Treatment:Adults and children over 12 years: 100 ml for intravenous infusion (at a speed of 5 ml per minute first) every 8 hours. In the majority of patients, 7 days of therapy are sufficient, but in some cases (regions inaccessible to drainage, new contamination, etc.) treatment needs to be continued for longer. Children under 12 years and in newbornsThe recommended dose is:
• children aged between 8 weeks and 12 years: 20 - 30 mg/kg per day in 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 usually 7 days.
• children under 8 weeks of age: 15 mg/kg per day in a single dose or divided into 7.5 mg/kg every 12 hours. In premature newborns: the doctor must administer the medicine with caution and monitor the amount of medicine in the blood. Prevention: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 and in newborns:
• children under 12 years: 20-30 mg/kg in a single dose given 1-2 hours before surgery;
• premature newborns: 10mg/kg of body weight in a single dose before surgery. Each bag or bottle is for single use only; any remaining contents must not be used again. OverdoseAs there are no specific antidotes for overdose, any treatment of symptoms will be symptomatic. IncompatibilitiesMetronidazolo S.A.L.F. 500 mg/100 ml solution for infusion must not be mixed with cefamandole nafate, sodium cefoxitin, 10% glucose, infusion solutions with sodium lactate, potassium penicillin G. Instructions for use and handling

WARNING: do not use the medicine after the expiry date indicated on the packaging.
Do not use if there is dripping or intense discoloration of the solution. The solution must be
clear, colorless or straw yellow and free from visible particles. Before use, the product must be
visually checked for particles and for a change in color. Do not reuse. The
unused solution must be disposed of.