METRONIDAZOLO 250 mg Film-Coated Tablets

Зміст інструкції

1. Metronidazolo Aurobindo 250 mg film-coated tablets
   1. What is Metronidazolo Aurobindo and what is it used for
   2. What you need to know before taking Metronidazolo Aurobindo
   3. How to take Metronidazolo Aurobindo
   4. Possible side effects
   5. How to store Metronidazolo Aurobindo
   6. Contents of the pack and other information

Metronidazolo Aurobindo 250 mg film-coated tablets

Generic medicine
Read this leaflet carefully before taking 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 pharmacist.
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 experience any side effects, including those not listed in this
leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

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

Metronidazolo Aurobindo belongs to the pharmaceutical category of antiprotozoal and
antibacterial agents. It is used in adults and children:
prevention of postoperative anaerobic bacterial infections;
therapeutic infections caused by anaerobes (peritonitis, cerebral abscess, osteomyelitis,
puerperal fever, pelvic abscess, wound infections after surgery);
trichomoniasis inflammation of the urogenital system in both women and men;
bacterial vaginosis;
diseases caused by protozoa - amoebiasis and giardiasis;
acute ulcerative gingivitis; acute, periodontal infections;
Helicobacter pyloriinfection associated with peptic ulcer, in association with other
medicines recommended.

2. What you need to know before taking Metronidazolo Aurobindo

Do not take Metronidazolo Aurobindo:

• if you are allergic to metronidazole or to other derivatives of 5-nitroimidazole or to any of the other components of this medicine (listed in section 6);
• if you are in the first trimester of pregnancy.

Warnings and precautions
Talk to your doctor, pharmacist or nurse before taking Metronidazolo Aurobindo if
you have:

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

Therefore, the doctor will carefully determine whether you should be treated with Metronidazolo
Aurobindo.
If convulsions or other nervous disorders (e.g. numbness of the limbs) occur during therapy, the treatment will be promptly reviewed.
Treatment must be stopped or reviewed immediately in case of 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 side effects"), blood counts will be monitored during treatment.
If you are being treated with this medicine, your urine may darken.
Cases of severe hepatic toxicity / acute hepatic failure, including cases leading to death, have been reported with medicines containing metronidazole, in patients affected
by Cockayne syndrome.
If you suffer from Cockayne syndrome, your doctor will also frequently check 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, grey-green stools or itching.

Treatment with Metronidazolo Aurobindo should usually not be continued for more than 10
days; the treatment period will only be prolonged 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, it will be monitored with particular attention.

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

Amiodarone (used to treat irregular heartbeat)
When taking this medicine, cardiac function needs to be monitored.
Consult your doctor if you notice abnormalities in cardiac function, dizziness or fainting.

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

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

Busulfan
Metronidazole should not be given to patients being treated with busulfan because in
that case toxic effects are more likely to occur.

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 disorders)
Cimetidine can reduce the elimination of metronidazole in isolated cases and subsequently lead
to an increase in serum concentrations of metronidazole.

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

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

Disulfiram (used in alcohol withdrawal therapy)
If you are taking disulfiram, you should not take metronidazole or disulfiram should be
stopped. The combined use of these two medicines can lead to states of confusion up to severe
mental disorder (psychosis).

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

Fluorouracil (an anti-cancer medicine)
The daily dose of fluorouracil may need to be reduced when given
together with metronidazole because metronidazole can lead to an increase in blood levels of
fluorouracil.

Lithium (used to treat mental illness)
Treatment with lithium preparations requires particularly careful monitoring during
treatment with metronidazole and it may be necessary to readjust the dose of
the lithium preparation. Treatment with lithium should be reduced or suspended before the
administration of metronidazole.

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

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

Tacrolimus (used to suppress unwanted immune responses)
Blood levels of this agent and renal function must be monitored when starting and
stopping treatment with metronidazole.

Metronidazolo Aurobindo with food, drinks and alcohol
Alcohol
You should not drink alcoholic beverages or take medicines containing alcohol while taking
metronidazole and for up to 48 hours afterwards, as this can cause intolerance reactions such as dizziness
and vomiting.

Pregnancy, breastfeeding and fertility
Ask your doctor for advice before taking this medicine if you are pregnant, if you suspect or are planning a pregnancy, or if you are breastfeeding with
breast milk.
Fertility
Studies on animals indicate a potential negative influence of metronidazole on the male reproductive system at high doses above the maximum recommended dose for humans.

Contraception in men and women
If you are taking a contraceptive pill, see the section "Other medicines and
Metronidazolo Aurobindo".
Pregnancy
If you are pregnant, your doctor will not prescribe metronidazole unless they consider it absolutely
necessary.
Breastfeeding
You should not breastfeed during treatment with metronidazole and should not resume
breastfeeding for 2-3 days afterwards as metronidazole passes into breast milk.

Driving and operating machinery
While taking Metronidazolo Aurobindo you may experience drowsiness, dizziness, confusion,
seeing or hearing things that are not there (hallucinations), convulsions or temporary visual problems
(such as blurred or double vision). In this case, do not drive or use machines or
tools.
This medicine contains less than 1 mmol of sodium (23 mg) per tablet, i.e. essentially
"sodium-free".

3. How to take Metronidazolo Aurobindo

Take this medicine always exactly as your doctor or pharmacist has told you.
If you have doubts, consult your doctor or pharmacist.
Due to insufficient evidence of mutagenic risk in humans, the doctor will assess whether it is
necessary to use metronidazole for a period longer than usually recommended.

The recommended dose is as follows:
Prevention of infections caused by anaerobic bacteria (in gynecological or colorectal surgery)
Metronidazole will be administered preventively 24 hours before surgery for
a minimum of 4 hours after wound closure, or longer, depending on the risk of
contamination.
Adults and adolescents over 12 years:

• first four 250 mg tablets (1000 mg) per dose, followed by 1 tablet three times a day until the preoperative fast. Children under 12 years:
• 20 to 30 mg / kg as a single dose administered 1 to 2 hours before the procedure. Newborns born before 40 weeks of gestation:
• 10 mg / kg in a single dose before surgery.

Infection from bacteria
Metronidazole can be used therapeutically, as a single drug or in combination with
other antibacterial agents. The average treatment period should not exceed 7 days.
Adults and adolescents over 12 years:

• 1 or 2 250 mg tablets three times a day. Children between 8 weeks and 12 years:
• The usual daily dose is between 20 and 30 mg / kg as a single dose or in divided doses of 7.5 mg / kg administered every 8 hours. The daily dose may be increased to 40 mg / kg, depending on the severity of the ’infection. Children under 8 weeks:
• 15 mg / kg per day as a single dose or in divided doses of 7.5 mg / kg administered every 12 hours. In newborns born before 40 weeks of gestation, accumulation of metronidazole may occur in the first week of life, therefore serum metronidazole concentrations should be monitored after a few days.

Trichomoniasis
Adults and children over 10 years:

• 8 250 mg tablets (2000 mg) as a single dose or one tablet three times a day for seven days or 2 tablets twice a day for 5-7 days. Note: treatment is carried out simultaneously in sexual partners. Children under 10 years:
• 40 mg / kg orally as a single dose or 15 to 30 mg / kg per day divided into 2-3 doses for 7 days. A single dose should not exceed 2000 mg.

Bacterial vaginosis
Adults:

• Two 250 mg tablets (500 mg) in the morning and evening for seven days or eight tablets (2000 mg) as a single dose (once). Young people:
• 8 tablets (2000 mg) as a single dose (once).

Amebiasis
Adults:

• Three 250 mg tablets (750 mg) three times a day for 5-10 days.

Young people and children over 10 years:

• Two or three 250 mg tablets (500 mg to 750 mg) three times a day for 5-10 days. Children from 7 to 10 years:
• 250 mg three times a day for 5-10 days.

An alternative dosage regimen for this condition (the dose in mg per kg) is 35 to 50 mg /
kg per day in three divided doses for 5-10 days, not exceeding 2400 mg per day.
Giardiasis
Adults:

• One 250 mg tablet three times a day for 5-7 days or eight tablets (2000 mg) once a day for 3 days. Young people and children over 10 years:
• 8 tablets (2000 mg) once a day for 3 days or 2 tablets (500 mg) twice a day for 7-10 days. Children from 7 to 10 years:
• 4 250 mg tablets (1000 mg) once a day for 3 days. Children from 3 to 7 years:
• Three 250 mg tablets (750 mg) once a day for 3 days. Children from 1 to 3 years:
• Two 250 mg tablets (500 mg) once a day for 3 days.

An alternative dosage regimen for this condition (the dose in mg per kg) is 15 to 40 mg /
kg per day divided into 2-3 doses.
Treatment of a ’bacterial infection Helicobacter pylori(called eradication)
Metronidazole is used for at least 7 days in combination with other drugs prescribed for the
treatment of Helicobacter pyloriinfections.
Adults:

• Two 250 mg tablets (500 mg) 2-3 times a day for 7-14 days. Children and young people:
• 20 mg / kg per day, not more than 2 tablets (500 mg) twice a day for 7-14 days. Before starting treatment, consult official guidelines.

Acute ulcerative gingivitis
Adults

• 1 250 mg tablet 2-3 times a day for three days. Children:
• 35 to 50 mg / kg per day in three divided doses for three days

Acute periodontal infections
Adults:

• 1 250 mg tablet 2-3 times a day for 3-7 days. Infants and children weighing less than 10 kg:
• administer proportionally smaller doses.

Method of administration
Oral use.
For some of the dosages described above, there are also other medicines containing metronidazole with
a different dosage (film-coated tablet, 500 mg) and in a different pharmaceutical form
(solution for infusion, 5 mg / ml).
Use in patients with hepatic impairment
In patients with severe hepatic impairment or hepatic encephalopathy, it may lead to drug accumulation
in the body, therefore the doctor will prescribe a reduction of the daily dose to one third,
administered once a day.
Use in patients with renal impairment
It is not necessary to reduce the dose in these patients.
Use in elderly patients
In elderly patients, the drug should be used with caution, especially at high doses.
If you take more Metronidazolo Aurobindo than you should
If you take a dose higher than recommended, consult your doctor immediately.
If you forget to take Metronidazolo Aurobindo
If you forget a dose, take it as soon as possible. If it is almost time for the next dose, do not
take the forgotten dose and continue as usual. Do not take a double dose to
make up for the missed dose.
If you have any doubts about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Metronidazolo Aurobindo can cause side effects, although not everyone
will experience them.
The frequency, type and severity of adverse reactions in children are the same as in adults.

If you experience any of the following serious side effects, stop taking
Metronidazolo Aurobindo and contact your doctor immediately:
Rare(may affect up to 1 in 1,000 people):

• Severe, persistent diarrhea (likely symptom of a serious intestinal infection called pseudomembranous colitis, see below)
• Severe hypersensitivity reactions up to anaphylactic shock

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

• The number 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 blisters, in extremely rare cases up to detachment of the skin on extensive areas (Stevens-Johnson Syndrome)

Not known(frequency cannot be estimated on the basis of 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 number of white blood cells (leukopenia), severe anemia (aplastic anemia)
• Convulsions, nervous system disorders such as numbness, pain, tingling sensation in the arms or legs
• Toxic epidermal necrolysis
• Acute liver failure in patients with Cockayne syndrome (see section 2 “Warnings and precautions”)

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

• Yeast infections (e.g. genital infections)
• Burning/discomfort in the urethra, dysuria, cystitis, polyuria, incontinence

Uncommon(may affect up to 1 in 100 people)

• Dark urine (due to a metabolite of metronidazole)
• Nasal congestion (stuffy nose)

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 states of confusion, hallucinations
• Headache, dizziness, drowsiness, fever, visual and movement disorders, vertigo, speech defects, convulsions
• Visual disturbances, e.g. double vision, myopia
• Disorders of liver function (such as elevated serum levels of certain enzymes and bilirubin)
• Allergic skin reactions such as itching, urticaria
• Joint and muscle pain

Not known(frequency cannot be estimated on the basis of available data)

• General feeling of illness, nausea, diarrhea, inflammation of the tongue or mouth, belching and bitter taste, metallic taste, pressure above the stomach, hairy tongue
• Difficulty swallowing
• Anorexia
• Sad mood (depressed)
• Impaired hearing/hearing loss
• Ringing in the ears (tinnitus)
• Drowsiness or insomnia, muscle contractions
• Redness and itching of the skin (erythema multiforme)
• Irritation of the vein wall (inflamed veins and thrombosis) after intravenous administration, states of weakness, fever
• Clearly defined area of skin with redness and sometimes blisters, caused by hypersensitivity to the drug (fixed drug eruption).

Management of pseudomembranous enterocolitis emergencies
In case of severe, persistent diarrhea, you should inform your doctor promptly because this may
be due to pseudomembranous colitis, a serious condition that must be treated
immediately. The doctor will stop metronidazole and provide appropriate treatment.
If any of the side effects become severe or if you notice side effects not listed in
this leaflet, inform your doctor.

Reporting of side effects
If you get any side effects, see your doctor or pharmacist. You can also report side effects directly
through the national reporting system 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 Aurobindo

Keep this medicine out of the sight and reach of children.
This medicine does not require any special storage conditions.
Do not use this medicine after the expiry date that is stated on the packaging after Exp. The
expiry date refers to the last day of that month.
Do not dispose of any medicine in waste water 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 Aurobindo contains

• The active ingredient is metronidazole. Each film-coated tablet contains 250 mg of metronidazole.
• Other ingredients are: Tablet core:microcrystalline cellulose, pregelatinized starch (corn starch), hydroxypropylcellulose, anhydrous colloidal silica, sodium starch glycolate, stearic acid. Tablet coating:hypromellose 2910 (5 cps), polyethylene glycol.

Description of the appearance of Metronidazolo Aurobindo and contents of the pack
Film-coated tablet
Tablets from white to almost white, round, coated, with imprinted “M” and “250” on one side and
smooth on the other side.
Metronidazolo Aurobindo film-coated tablets are available in blister packs of 20, 21
and 40 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Aurobindo Pharma (Italia) S.r.l.
via San Giuseppe, 102

• 21047 – Saronno (VA)

Manufacturer
APL Swift Services (Malta) Limited
HF26, Hal Far Industrial Estate, Hal Far, Birzebbugia, BBG 3000 Malta
Generis Farmacêutica, S.A.
Rua João de Deus, 19, Venda Nova, 2700-487 Amadora, Portugal
Arrow Generiques
26 Avenue Tony Garnier
Lyon, Rhone – 69007
France

This medicinal product is authorised in the Member States of the European Economic Area with the
following denominations:
France: Métronidazole Arrow 250 mg, film-coated tablet
Italy: Metronidazolo Aurobindo
Netherlands: Metronidazol Auro 250 mg, film-coated tablets
Poland: Metronidazol Aurovitas
Portugal: Metronidazol Generis
Spain: Metronidazol Aurovitas 250 mg film-coated tablets EFG