METRONIDAZOLO 5 mg /Ml Infusion Solution

Зміст інструкції

1. Metronidazolo Noridem 5 mg/mL solution for infusion
   1. What is Metronidazolo Noridem and what is it used for
   2. What you need to know before you are given Metronidazolo Noridem
   3. How Metronidazolo Noridem is administered
   4. Possible side effects
   5. How to store Metronidazolo Noridem
   6. Contents of the pack and other information

Metronidazolo Noridem 5 mg/mL solution for infusion

metronidazole

Read this leaflet carefully before you are given 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, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

The name of your medicine is Metronidazolo Noridem 5 mg/mL solution for infusion
Contents of this leaflet

• 1. What Metronidazolo Noridem is and what it is used for
• 2. What you need to know before Metronidazol Noridem is given to you
• 3. How Metronidazolo Noridem is given
• 4. Possible side effects
• 5. How to store Metronidazolo Noridem
• 6. Contents of the pack and other information

1. What is Metronidazolo Noridem and what is it used for

Metronidazolo+ Noridem belongs to a group of medicines called antibiotics and is used to
treat serious infections caused by bacteria that can be killed by the active ingredient
metronidazole.
Metronidazolo Noridem may be prescribed to you for the treatment of any of the following
diseases:

• Infections of the blood, brain, lung, bones, genital tract, pelvic area, liver, intestine and stomach If necessary, your treatment may be supplemented with other antibiotics. Metronidazolo Noridem may be prescribed as prophylactic treatment before operations associated with a higher risk of infection from so-called anaerobic bacteria, mainly in gynaecology or stomach and intestinal surgery.

2. What you need to know before you are given Metronidazolo Noridem

Do not take Metronidazolo Noridem

• if you are allergic to metronidazole or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Talk to your doctor, pharmacist or nurse before you are given
Metronidazolo Noridem if you have:

• severe liver damage
• a blood-forming disorder or
• a disease of the brain, spinal cord or nerves

Therefore, the doctor will need to carefully determine whether you should be treated with
Metronidazolo Noridem.
If seizures or other nervous disorders (for example
numbness of the limbs) occur during therapy, your treatment must be reviewed immediately.
Treatment must be stopped or reviewed immediately if you experience severe diarrhea which may
be due to a serious intestinal disease called “pseudomembranous colitis” (see also
section 4.) Because prolonged use of metronidazole can impair blood formation (see section “Possible
undesirable effects”), your blood cell count will be monitored during treatment.
If you have received this medicine, your urine may become dark.
Cases of severe liver toxicity/acute hepatic failure, including cases with
fatal outcome in patients with Cockayne syndrome treated with medicines containing metronidazole, have been reported.
If you suffer from Cockayne syndrome, your doctor must also frequently monitor your
liver function while taking metronidazole and afterwards.
Immediately inform your doctor and stop taking metronidazole if you develop:

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

Treatment with Metronidazolo Noridem should generally not be continued for more than 10
days; the treatment period will only be extended in exceptional circumstances and if absolutely
necessary. Repetition of therapy with metronidazole will be limited to cases where this is
absolutely necessary. In such cases, you will be monitored with particular attention.

Other medicines and Metronidazolo Noridem
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines.

Amiodarone (used to treat irregular heartbeats)
When you receive this medicine, your heart function needs to be monitored. You should see
your doctor if you notice any abnormalities in heart function, dizziness or fainting.

Barbiturates (the active ingredient in sleeping pills)
The duration of action of metronidazole is reduced by phenobarbital; for this reason, your dose of metronidazole may need to be increased.

Contraceptive pills
Your contraceptive pill may be less reliable while you are being given
metronidazole.

Busulfan
Metronidazole should not be given to patients who are taking busulfan because it increases
the likelihood of toxic effects.

Carbamazepine (a medicine used to treat epilepsy)
This combination also requires caution because metronidazole can increase the duration of
action of carbamazepine.

Cimetidine (a medicine for the treatment of stomach problems)
In isolated cases, cimetidine can reduce the elimination of metronidazole and therefore lead to an
increase in metronidazole concentrations in the serum.

Coumarin derivatives (medicines that inhibit blood clotting)
Metronidazole can increase the inhibitory effect on coagulation by coumarins.
Therefore, if you are taking a medicine that prevents blood clotting (e.g. warfarin)
you may need to reduce the dose of this medicine during treatment with
metronidazole.

Cyclosporine (a medicine used to suppress unwanted immune responses)
When cyclosporine is given together with metronidazole, levels of cyclosporine in
the blood may increase; your doctor will therefore need to adjust the dose of cyclosporine in
appropriately.

Disulfiram (used in alcohol detoxification therapy)
If you are taking disulfiram, you should not be prescribed metronidazole, or you should
stop taking disulfiram. The combined use of these two medicines can cause
confusional states that can lead to a serious mental disorder (psychosis).

Medicines containing alcohol
See section “Metronidazolo Noridem with food, drinks and alcohol”.

Fluorouracil (an anticancer medicine)
The daily dose of fluorouracil may need to be reduced if given in conjunction
with metronidazole, because metronidazole can lead to an increase in fluorouracil
levels in the blood.

Lithium (used in the treatment of mental illnesses)
Treatment with lithium preparations requires particularly careful monitoring during
treatment with metronidazole and the dose of the lithium preparation may need to be adjusted. Treatment with lithium should be gradually reduced or discontinued before the
administration of metronidazole.

Mycophenolate mofetil (used for the prevention of rejection reactions after organ
transplantation)
Its effect may be weakened by metronidazole; therefore, careful monitoring of the effect of this medicine is recommended.

Phenytoin (a medicine for the treatment of epilepsy)
If you are taking phenytoin, your doctor will administer metronidazole with particular caution,
because metronidazole can increase the duration of action of phenytoin. Conversely, phenytoin
can reduce the effect of metronidazole.

Tacrolimus (used to suppress unwanted immune responses)
Blood levels of this medicine and kidney function need to be checked at the beginning and
end of treatment with metronidazole.

Metronidazolo Noridemwith food, drinks and alcohol
Alcohol
While you are being given metronidazole and up to 48 hours afterwards, you should not drink alcoholic beverages or take medicines containing alcohol, as this can cause intolerance reactions such as dizziness and vomiting.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you are pregnant or are planning to become pregnant, or if you are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.

Fertility
Studies in animals indicate only a potential negative impact of metronidazole on the male reproductive system if high doses above the maximum recommended dose for humans have been administered.

Contraception in men and women
If you are taking the contraceptive pill, see section “Other medicines and
Metronidazolo Noridem.

Pregnancy
If you are pregnant, your doctor will not prescribe metronidazole unless they consider it
absolutely necessary.

Breastfeeding
During treatment with metronidazole, you should not breastfeed and should not resume breastfeeding
for the next 2-3 days as metronidazole passes into breast milk.

Driving and operating machinery
While taking Metronidazolo Noridem you may feel sleepy, dizzy, confused, may
see or hear things that are not real (hallucinations), have seizures or temporary vision problems (such as blurred or double vision). If this happens, do not drive or use tools or
machinery.

Metronidazolo Noridem contains sodium
This medicine contains 310.58 mg of sodium (the main component of table salt) per
100 mL. This is equivalent to 15.5% of the maximum recommended daily intake of sodium
for an adult.

3. How Metronidazolo Noridem is administered

Dosage
The dosage depends on the nature and severity of your illness, your age and body weight, and
your individual response to treatment.
The usual recommended dosages are:

Adults and adolescents
Treatment of amoebiasis
1.50 g per day (500 mg three times a day, intravenous infusions).
Treatment of infections

Adults
You will be given 100 mL of medicine (500 mg of metronidazole) every 8 hours.
In most cases, the treatment will last 7 days. Only in exceptional cases may the treatment
be continued further, although it should normally not exceed a duration of
10 days.
The dose will be the same for patients with kidney disease.
Lower doses may be necessary for patients with liver disease.
If you have undergone haemodialysis treatment, your doctor will schedule the administration after the
completion of dialysis. No adjustment of the usual dose is necessary.
Prevention of infections that may occur after surgery
If used for the prevention of infections in surgical procedures, you may be given
500 mg of medicine before the operation. The dose will be repeated 8 and 16 hours after
the operation.

Elderly
Your doctor will give you this medicine with particular caution.

Use in children
In children, the dosage is based on body weight.
Treatment of amoebiasis
35-50 mg/kg/day intravenously, divided into 3 doses for 5-10 days. A maximum of
2,400 mg/day should not be exceeded.
Treatment of infections:

Normally the treatment will last 7 days.
Prevention of infections that may occur after surgery:

Method of administration and duration of treatment
Metronidazolo Noridem is administered via a venoclysis directly into the vein
(intravenous infusion).
The infusion of one vial usually takes 60 minutes, but it must not be carried out in less than
20 minutes.
The entire treatment period with metronidazole is usually 7 days and must not exceed
10 days, unless this is absolutely necessary (see also "Warnings and
precautions"). If you are taking other antibiotics at the same time, your doctor will administer these
medicines separately.

If you are given more Metronidazolo Noridem than you should:
Undesirable effects, described in the following section, may appear as signs or symptoms
of an overdose. Single oral doses of metronidazole, up to 12 g, have been reported in
suicide attempts and in cases of accidental overdose.
The symptoms were limited to vomiting, ataxia and mild disorientation.
There is no specific antidote or known specific treatment in case of massive overdose,
but metronidazole can be eliminated from the body by dialysis (artificial kidney treatment).

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
Side effects occur mainly at high doses or with prolonged use.

Inform your doctor immediately if you notice any of the following side effects:
Rare(may affect up to 1 in 1,000 people):

• Severe, persistent diarrhea (likely a symptom of a serious intestinal infection called pseudomembranous colitis, see the paragraph "Emergency treatment of pseudomembranous enterocolitis")
• Severe acute hypersensitivity reactions up to and including anaphylactic shock.

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

• The counts of white blood cells and platelets may decrease during treatment (granulocytopenia, agranulocytosis, pancytopenia, thrombocytopenia).
• Hepatitis (inflammation of the liver), jaundice, inflammation of the pancreas
• Cerebral disorders, lack of coordination
• Febrile meningitis not caused by bacteria (aseptic meningitis)
• Severe inflammatory rash on mucous membranes and skin with fever, redness and blistering rash, in extremely rare cases desquamation may occur in extensive areas (Stevens-Johnson syndrome)

Frequency not known(frequency cannot be estimated on the basis of the available data):

• Hypersensitivity reactions from mild to moderate, swelling of the face, mouth, throat and/or tongue (angioedema)
• Spasm of the gaze, damage or inflammation of the optic nerves
• Reduced white blood cell count (leukopenia), severe anemia (aplastic anemia)
• Convulsions, nervous system pathologies such as numbness, pain, tingling or prickling sensation in arms or legs
• Toxic epidermal necrolysis
• Acute liver failure in patients with Cockayne syndrome (see section 2 "Warnings and precautions")

Other side effects include
Common(may affect up to 1 in 10 people):

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

Uncommon(may affect up to 1 in 100 people):

• Dark colored urine (due to a metronidazole metabolite)

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

• Changes in ECG

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

• Psychotic disorders, including confused states and hallucinations
• Headache, dizziness, drowsiness, fever, visual and motor disturbances, lightheadedness, speech defects, convulsions
• Visual disturbances, e.g. double vision, myopia
• Liver function pathologies (such as elevated serum levels of certain enzymes and bilirubin)
• Allergic skin reactions such as itching, hives
• Muscle and joint pain

Frequency not known(frequency cannot be estimated on the basis of the available data):

• Stomach pain, nausea, diarrhea, inflammation of tongue or mouth, belching and bitter taste, metallic taste, feeling of heaviness in the stomach, coated tongue (whitish-yellow coating)
• Difficulty swallowing
• Anorexia
• Depressed mood (sadness)
• Drowsiness or insomnia, muscle spasms
• Redness and itching of the skin (erythema multiforme)
• Irritation of the vein wall (up to inflammation of the veins and thrombosis) after intravenous administration, feeling of weakness, fever

Emergency management of pseudomembranous enterocolitis.
In case of severe, persistent diarrhea, you should immediately inform your doctor as the cause may be pseudomembranous colitis, a serious condition that needs to be treated immediately.
Your doctor will stop metronidazole and prescribe appropriate treatment.
If any of the side effects worsen, or if you notice any side effect

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your doctor, pharmacist or nurse. You can also report side effects directly through the national reporting system
Website:
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 Noridem

• Keep this medicine out of the sight and reach of children.
• Do not use this medicine after the expiry date stated on the package and bottle after Exp. The expiry date refers to the last day of that month.
• This medicine does not require any special storage conditions. The medicine must be used immediately after first opening. For single use only. Do not use this medicine if the container is leaking or if the solution is not clear. Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Metronidazolo Noridem contains

• The active substance is metronidazole. Each bottle of solution for infusion contains 500 mg of metronidazole. Each mL of solution for infusion contains 5 mg of metronidazole.
• The other ingredients are disodium phosphate dodecahydrate, citric acid monohydrate, sodium chloride, water for injections.

Description of the appearance of Metronidazolo Noridem and contents of the pack
This medicine is presented as an almost colorless to light yellow injectable solution
in a 100 mL polypropylene bottle with a blow-fill seal closure, with a shaped plastic closure cap
with a rubber gasket and tear-off opening, or with a plastic closure cap and twin-port.
Metronidazolo Noridem is available in packs containing 10, 20 or 24 bottles.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Noridem Enterprises Ltd.
Evagorou & Makariou,
Mitsi Building 3, Office 115,
Nicosia 1065, Cyprus

Manufacturer
DEMO S.A. PHARMACEUTICAL INDUSTRY
21st Km National Road Athens-Lamia
14568 Greece

This medicinal product is authorised in the Member States of the European Economic Area and in the
United Kingdom (Northern Ireland) under the following denominations:

The following information is intended for healthcare professionals:
Dosage and method of administration
Dosage
The dosage is adjusted according to the individual patient's response to therapy, based on their
age and body weight and according to the nature and severity of the disease.

The following guidelines should be observed for dosage:
Adults and adolescents:
Amoebiasis
1.50 g per day (500 mg three times a day, intravenous infusions).
In amoebic liver abscess, the abscess must be drained concurrently with
treatment with metronidazole. Duration of treatment: 5-10 days

Treatment of anaerobic infections
500 mg (100 mL) every 8 hours. Alternatively, 1000 mg – 1500 mg may be administered
daily as a single dose.
The duration of therapy depends on the effect of treatment. In most cases a
course of treatment of 7 days is sufficient. If clinically indicated, treatment may be
continued further, although a duration of more than 10 days should normally not be exceeded.

Prophylaxis against post-operative infection caused by anaerobic bacteria

500 mg, with administration completed approximately one hour before the surgical intervention. The dose
is repeated after 8 and 16 hours.

Elderly:
Caution is recommended in elderly patients, especially at high doses, although limited information is available on dosage modification.

Paediatric population
Amoebiasis
35-50 mg/kg/day intravenously, divided into 3 doses for 5 to 10 days. A maximum of 2,400 mg/day should not be
exceeded.
In amoebic liver abscess, the abscess must be drained concurrently with
treatment with metronidazole.

Treatment of anaerobic infections
Children >8 weeks to 12 years:
The usual daily dose is 20-30 mg per kg of body weight per day as a single dose or
divided into 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.
Infants and young children <8 weeks of age:
15 mg per kg of body weight per day as a single dose or divided into 7.5 mg per kg of body
weight every 12 hours.
In neonates with a gestational age <40 weeks, accumulation of metronidazole may occur
during the first week of life; therefore metronidazole serum concentrations should
be monitored preferably after a few days of therapy.
The usual duration of treatment is 7 days.

Prophylaxis against post-operative infections caused by anaerobic bacteria:
Children <12 years:< p>

• 20 – 30 mg/kg of body weight as a single dose administered 1 – 2 hours before the surgical intervention Neonates with gestational age <40 weeks: 10 mg kg of body weight as a single dose administered before the surgical intervention< li>

Patients with renal impairment
Limited data are available in this population. These data do not indicate the need for
dose reduction.
In patients undergoing haemodialysis, the conventional dose of metronidazole should be
scheduled after haemodialysis on dialysis days to compensate for the removal of metronidazole
during the procedure.
No routine dose adjustment is necessary in patients with intermittent peritoneal dialysis (intermittent peritoneal dialysis- IDP) or continuous ambulatory peritoneal dialysis (continuous ambulatory peritoneal dialysis- CAPD).

Patients with hepatic impairment
Since the serum half-life is prolonged and plasma clearance is delayed in case of severe
hepatic impairment, patients with severe liver disease will require lower doses.
In patients with hepatic encephalopathy, the daily dosage should be reduced to one-third and may
be administered once a day.
Method of administration
Intravenous use
The contents of one bottle must be infused slowly i.v., i.e. 100 mL at most in no less
than 20 minutes, normally over more than one hour.
Antibiotics prescribed concurrently must be administered separately.