Metronidazol Aurovitas

Package Leaflet: Information for the User

Metronidazole Aurovitas, 250 mg, Film-Coated Tablets

Metronidazole

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

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, please tell your doctor or pharmacist. See section 4.

Contents of the Package Leaflet:

• 1. What Metronidazole Aurovitas is and what it is used for
• 2. Important information before taking Metronidazole Aurovitas
• 3. How to take Metronidazole Aurovitas
• 4. Possible side effects
• 5. How to store Metronidazole Aurovitas
• 6. Contents of the pack and other information

1. What Metronidazole Aurovitas is and what it is used for

Metronidazole Aurovitas is an anti-protozoal and antibacterial medicine.
It is used in adults and children for:

• prevention of post-operative anaerobic bacterial infections;
• treatment of infections caused by anaerobes (peritonitis, brain abscess, osteomyelitis, puerperal fever, pelvic abscess, post-operative wound infections);
• trichomoniasis of the urogenital tract in women and men;
• bacterial vaginosis;
• diseases caused by protozoa - amoebiasis and giardiasis;
• acute ulcerative gingivitis; acute periodontal infections;
• Helicobacter pyloriinfection associated with peptic ulcer disease in combination with other recommended medicines.

2. Important information before taking Metronidazole Aurovitas

When not to take Metronidazole Aurovitas

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

Warnings and precautions

Before taking Metronidazole Aurovitas, tell your doctor,
pharmacist or nurse about:

• severe liver damage,
• blood disorders or
• brain, spinal cord or nerve disease (neurological disorders).

Then the doctor will carefully decide whether you should take Metronidazole Aurovitas.
If seizures or other neurological disorders occur during therapy (e.g.
numbness of limbs), treatment will be changed immediately.
If severe diarrhea occurs, which may be caused by a severe disease of the large intestine called
“pseudomembranous colitis”, treatment must be stopped or changed immediately (see also section 4).
Since long-term use of metronidazole may affect blood formation (see section
“Possible side effects”), the patient's blood morphology will be monitored during treatment.
If you have taken this medicine, your urine may be darker.
In patients with Cockayne syndrome, cases of severe toxic liver damage and (or) acute liver failure, including
fatal cases, have been reported during treatment with metronidazole.
In patients with Cockayne syndrome, the doctor should frequently monitor liver function during
treatment with metronidazole and later on.
You should immediately inform your doctor and stop taking metronidazole if you experience:

• Abdominal pain, anorexia, nausea, vomiting, fever, malaise, fatigue, jaundice, dark urine, rare or hard stools or itching.

Treatment with Metronidazole Aurovitas should not be continued for more than 10 days;
treatment duration will only be extended in exceptional circumstances and if absolutely necessary. Repeated
therapy with metronidazole will be limited to cases where it is absolutely necessary. In such cases, the patient will be
monitored particularly closely.

Metronidazole Aurovitas with other medicines

Tell your doctor or pharmacist about all medicines you are taking now or have recently taken, as well as any
medicines you plan to take.

Amiodarone (used to treat irregular heartbeat)

After taking this medicine, heart function should be monitored.
You should see a doctor if you notice any heart rhythm disturbances, dizziness or fainting.

Barbiturates (active substance in sleeping pills)

Phenobarbital shortens the duration of action of metronidazole; therefore, it may be necessary to increase the
dose of metronidazole.

Oral contraceptives

The contraceptive pill may be ineffective while taking metronidazole.

Busulfan

Metronidazole should not be given to patients receiving busulfan, as toxic effects are more likely to occur in such
cases.

Carbamazepine (a medicine used to treat epilepsy)

Concomitant use with carbamazepine also requires caution, as metronidazole may prolong the duration of action
of carbamazepine.

Cimetidine (a medicine used to treat stomach disorders)

Cimetidine may reduce the elimination of metronidazole in individual cases, and subsequently lead to increased
metronidazole serum concentrations.

Coumarin derivatives (blood-thinning medicines)

Metronidazole may enhance the anticoagulant effect of coumarin derivatives.
Therefore, if you are taking a blood-thinning medicine (e.g. warfarin), you may need less of it while taking
metronidazole.

Cyclosporin (a medicine used to suppress unwanted immune reactions)

When cyclosporin is given with metronidazole, cyclosporin blood levels may increase, so your doctor will need to
adjust the dose of cyclosporin accordingly.

Disulfiram (used to treat alcohol withdrawal)

If you are taking disulfiram, you must not take metronidazole or disulfiram treatment must be stopped. Concomitant
use of these two medicines may lead to confusion and serious mental disorders (psychosis).

Medicines containing alcohol

See “Metronidazole Aurovitas with food, drink and alcohol”.

Fluorouracil (an anticancer medicine)

When fluorouracil is given with metronidazole, it may be necessary to reduce the daily dose of fluorouracil, as
metronidazole may lead to increased fluorouracil blood levels.

Lithium (used to treat mental illnesses)

Lithium treatment requires careful monitoring during metronidazole treatment, and the lithium dose may need to
be adjusted. Before taking metronidazole, the lithium dose should be gradually reduced or lithium treatment
should be stopped.

Mycofenolate mofetil (used to prevent transplant rejection)

Metronidazole may reduce its effectiveness, so careful monitoring of its effect is recommended.

Phenytoin (a medicine used to treat epilepsy)

If you are taking phenytoin, your doctor will use metronidazole with caution, as metronidazole may prolong the
duration of action of phenytoin. On the other hand, phenytoin may reduce the effectiveness of metronidazole.

Tacrolimus (used to suppress unwanted immune reactions)

The level of this medicine in the blood and kidney function should be checked at the start and end of metronidazole
treatment.

Metronidazole Aurovitas with food, drink and alcohol

Alcohol
Do not drink alcoholic beverages or take medicines containing alcohol while taking metronidazole and for 48
hours after, as this may cause intolerance reactions such as dizziness and vomiting.

Pregnancy, breastfeeding and fertility

If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor for
advice before taking this medicine.
Fertility
Animal studies indicate only a potential negative effect of metronidazole on the male reproductive system, but
only at doses much higher than the maximum recommended dose for humans.

Contraception in men and women

If you are using contraceptives, see the information in “Metronidazole Aurovitas with other medicines”.
Pregnancy
If you are pregnant, your doctor will not treat you with metronidazole unless it is absolutely necessary.
Breastfeeding
Do not breastfeed while taking metronidazole and do not restart breastfeeding for 2 to 3 days after, as
metronidazole passes into breast milk.

Driving and using machines

While taking Metronidazole Aurovitas, you may experience drowsiness, dizziness, confusion, hallucinations or
seizures, or temporary vision disturbances (such as blurred or double vision). In such cases, do not drive or
operate machinery or tools.

Metronidazole Aurovitas contains sodium

This medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means it is essentially 'sodium-free'.

3. How to take Metronidazole Aurovitas

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, check with your
doctor or pharmacist.
Due to insufficient data on the risk of mutagenicity in humans, the doctor will carefully consider whether it is
possible to use metronidazole for longer than the usually recommended time.

Posology

Prevention of anaerobic bacterial infections (in gynecological or colorectal surgery)
Metronidazole will be given prophylactically 24 hours before surgery until at least 4 hours after wound closure or
longer, depending on the risk of contamination.
Adults and adolescents over 12 years:
initially 4 tablets of 250 mg (1000 mg) as a single dose, and then 1 tablet three times a day before surgery.
Children under 12 years:
20 to 30 mg/kg body weight (bw) as a single dose 1 to 2 hours before surgery.
Premature infants born before 40 weeks of gestation:
10 mg/kg bw as a single dose before surgery.
Anaerobic bacterial infections
Metronidazole can be used therapeutically alone or in combination with other antibacterial medicines. The average
treatment duration should not exceed 7 days.
Adults and adolescents over 12 years:
1 or 2 tablets of 250 mg 3 times a day.
Children over 8 weeks to 12 years:
Usual daily dose is 20 to 30 mg/kg bw as a single dose or in divided doses 7.5 mg/kg bw every 8 hours. The
daily dose may be increased to 40 mg/kg bw, depending on the severity of the infection.
Children under 8 weeks:
15 mg/kg bw per day as a single dose or in divided doses 7.5 mg/kg bw every 12 hours.
In premature infants born before 40 weeks of gestation, metronidazole accumulation may occur in the first week
of life, so the doctor will monitor metronidazole serum levels after a few days of treatment.
Trichomoniasis
Adults and children over 10 years:
8 tablets of 250 mg (2000 mg) as a single dose or 1 tablet three times a day for 7 days or 2 tablets twice a day
for 5-7 days.
Note: treatment is given simultaneously to sexual partners.
Children under 10 years:
40 mg/kg bw orally as a single dose or 15 to 30 mg/kg bw per day divided into 2 to 3 doses for 7 days. The
single dose should not exceed 2000 mg.
Bacterial vaginosis
Adults:
2 tablets of 250 mg (500 mg) in the morning and evening for 7 days or 8 tablets (2000 mg) as a single dose
(once).
Adolescents:
8 tablets (2000 mg) as a single dose (once).
Amoebiasis
Adults:
3 tablets of 250 mg (750 mg) three times a day for 5-10 days.
Adolescents and children over 10 years:
2 or 3 tablets of 250 mg (500 mg to 750 mg) three times a day for 5-10 days.
Children 7 to 10 years:
250 mg three times a day for 5-10 days.
Alternative dosing regimen for this disease (dose in mg/kg bw):
35 to 50 mg/kg bw per day in three divided doses for 5 to 10 days, but not more than 2400 mg per day.
Giardiasis
Adults:
1 tablet of 250 mg three times a day for 5-7 days or 8 tablets (2000 mg) once a day for 3 days.
Adolescents 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 to 10 days.
Children 7 to 10 years:
4 tablets of 250 mg (1000 mg) once a day for 3 days.
Children 3 to 7 years:
3 tablets of 250 mg (750 mg) once a day for 3 days.
Children 1 to 3 years:
2 tablets of 250 mg (500 mg) once a day for 3 days.
Alternative dosing regimen for this disease (dose in mg/kg bw):
15 to 40 mg/kg bw per day divided into 2 to 3 doses.
Treatment of Helicobacter pyloriinfection (eradication)
Metronidazole should be used for at least 7 days in combination with other medicines prescribed for the treatment
of Helicobacter pyloriinfections.
Adults:
2 tablets of 250 mg (500 mg) 2 to 3 times a day for 7-14 days.
Children and adolescents:
20 mg/kg bw per day, but not more than 2 tablets (500 mg) twice a day for 7-14 days.
Before starting treatment, read the official guidelines.
Acute ulcerative gingivitis
Adults:
1 tablet of 250 mg 2 to 3 times a day for 3 days.
Children:
35 to 50 mg/kg bw per day in three divided doses for 3 days.
Acute periodontal infections
Adults:
1 tablet of 250 mg 2 to 3 times a day for 3-7 days.
Infants and children with a body weight of less than 10 kg:
proportionally smaller doses should be given.
Method of administration
Oral use.
For some of the above doses, there are also other metronidazole medicines with different strengths (film-coated
tablet, 500 mg) and pharmaceutical forms (infusion solution, 5 mg/ml).

Use in patients with liver function disorders

In patients with severe liver failure or liver encephalopathy, the medicine may accumulate in the body, so the doctor
will recommend reducing the daily dose to one-third, given once a day.

Use in patients with kidney function disorders

Dose reduction is not necessary in these patients.

Use in elderly patients

The medicine should be used with caution in elderly patients, especially in high doses.

Overdose

In case of overdose, contact your doctor immediately.

Missed dose

If you miss a dose, take it as soon as possible. If it is already time for your next dose, do not take the missed dose. Do
not take a double dose to make up for the missed dose.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The frequency, type and severity of side effects in children are the same as in adults.

If you experience any of the following serious side effects, stop taking Metronidazole Aurovitas and contact your doctor immediately:

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

• Severe persistent diarrhea (possibly a sign of severe intestinal infection called pseudomembranous colitis, see
  below)
• Severe acute hypersensitivity reactions up to anaphylactic shock

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

• Decreased white blood cell and platelet count during treatment (granulocytopenia, agranulocytosis, pancytopenia,
  thrombocytopenia)
• Hepatitis, jaundice, pancreatitis
• Brain disorders, lack of coordination
• Aseptic meningitis (non-bacterial inflammation of the membranes surrounding the brain and spinal cord)
• Severe inflammatory rash on mucous membranes and skin with fever, redness and blistering, in very rare cases
  leading to skin detachment over large areas (Stevens-Johnson syndrome)

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

• Mild to moderate hypersensitivity reactions, facial swelling, mouth, throat and (or) tongue swelling (angioedema)
• Forced upward gaze with rotation of the eyeballs, damage or inflammation of the eye nerves
• Decreased white blood cell count (leukopenia), severe anemia (aplastic anemia)
• Seizures, neurological disorders such as numbness, pain, tingling or burning sensation in the hands or feet
• 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):

• Fungal infections (e.g. genital infections)
• Burning sensation or discomfort in the urethra, painful urination, urinary tract infection, frequent urination,
  urinary incontinence

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

• Darkening of urine (due to metronidazole metabolism)
• 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 confusion, hallucinations
• Headache, dizziness, drowsiness, fever, vision and movement disorders, dizziness, speech disorders, seizures
• Visual disturbances, such as double vision, myopia
• Liver function disorders (such as increased activity of certain enzymes and bilirubin levels in the blood)
• Allergic skin reactions, such as itching, hives
• Joint and muscle pain

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

• Vomiting, nausea, diarrhea, oral thrush or mouth infection, belching and bitter taste, metallic taste, pressure on the
  stomach, hairy tongue
• Difficulty swallowing
• Anorexia
• Sad (depressed) mood
• Hearing disorders / hearing loss
• Ringing in the ears (tinnitus)
• Drowsiness or insomnia, muscle tremors
• Redness and itching of the skin (erythema multiforme)
• Irritation of the vein wall (leading to vein inflammation and thrombophlebitis) after intravenous administration,
  weakness, fever
• A clearly defined area of skin with redness, and sometimes with blisters, caused by hypersensitivity to the medicine
  (drug rash).

Emergency treatment of pseudomembranous colitis
If you experience severe persistent diarrhea, you should immediately inform your doctor, as this may be caused by
pseudomembranous colitis, a serious disease that needs to be treated immediately. The doctor will stop metronidazole
treatment and provide appropriate treatment.
If any side effect gets serious or you notice any side effects not listed in this leaflet, please tell your doctor or
pharmacist.

Reporting of side effects

If you experience any side effects, including any not listed in this leaflet, please tell your doctor or pharmacist. Side
effects can be reported directly to the Department of Drug Safety, 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 Aurovitas

Keep this medicine out of the sight and reach of children.
There are no special storage instructions for this medicine.
Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiry date refers to the
last day of that month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of
medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

What Metronidazole Aurovitas contains

• The active substance is metronidazole. Each film-coated tablet contains 250 mg of metronidazole.
• The other ingredients are: Tablet core:microcrystalline cellulose, maize starch, hydroxypropylcellulose,
  silica colloidal anhydrous, sodium carboxymethylcellulose (type A), stearic acid. Tablet coating:hypromellose
  2910 (5cps), polyethylene glycol.

What Metronidazole Aurovitas looks like and contents of the pack

Film-coated tablet
White or almost white, round film-coated tablets, with “M” and “250” embossed on one side and smooth on the
other.
Metronidazole Aurovitas film-coated tablets are available in blisters containing 20, 21 or 40 tablets, in a carton.
Not all pack sizes may be marketed.

Marketing authorization holder:

Aurovitas Pharma Polska Sp. z o.o.
ul. Sokratesa 13D lokal 27
01-909 Warsaw
e-mail: medicalinformation@aurovitas.pl
Manufacturer/Importer:
APL Swift Services (Malta) Ltd
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 Génériques
26 Avenue Tony Garnier
69007 Lyon
France

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

France:
MÉTRONIDAZOLE ARROW 250 mg, comprimé pelliculé sécable
Spain:
Metronidazol Aurovitas 250 mg comprimidos recubiertos con película EFG
Netherlands:
Metronidazol Auro 250 mg, filmomhulde tabletten
Poland:
Metronidazol Aurovitas
Portugal:
Metronidazol Generis
Italy:
Metronidazolo Aurobindo

Date of last revision of the leaflet: 08/2023