METRONIDAZOL 500 mg Tablets

Contents of the leaflet

1. Leaflet accompanying the packaging: information for the user
2. Metronidazole Aurovitas, 500 mg, coated tablets
   1. Read the leaflet carefully before taking the medicine, as it contains important information for the patient.
   2. Table of contents of the leaflet:
3. What is Metronidazole Aurovitas and what is it used for
4. Important information before taking Metronidazole Aurovitas
   1. When not to take Metronidazole Aurovitas
   2. Warnings and precautions
   3. Metronidazole Aurovitas and other medicines
   4. Amiodarone (used to treat irregular heartbeat)
   5. Barbiturates (active substance in sleeping pills)
   6. Contraceptive pills
   7. Busulfan
   8. Carbamazepine (a medicine used to treat epilepsy)
   9. Cimetidine (a medicine used to treat stomach disorders)
   10. Coumarin derivatives (blood-thinning medicines)
   11. Cyclosporin (a medicine used to suppress unwanted immune reactions)
   12. Disulfiram (used to treat alcohol withdrawal)
   13. Medicines containing alcohol
   14. Fluorouracil (an anticancer medicine)
   15. Lithium (used to treat mental illnesses)
   16. Mycofenolate mofetil (used to prevent transplant rejection)
   17. Phenytoin (a medicine used to treat epilepsy)
   18. Tacrolimus (used to suppress unwanted immune reactions)
   19. Metronidazole Aurovitas with food, drink, and alcohol
   20. Pregnancy, breastfeeding, and fertility
   21. Contraception in men and women
   22. Driving and using machines
   23. Metronidazole Aurovitas contains sodium
5. How to take Metronidazole Aurovitas
   1. The usual recommended dosage is as follows:
   2. Use in patients with liver function disorders
   3. Use in patients with kidney function disorders
   4. Use in elderly patients
   5. Overdose of Metronidazole Aurovitas
   6. Missed dose of Metronidazole Aurovitas
6. Possible side effects
   1. Other side effects
   2. Reporting side effects
7. How to store Metronidazole Aurovitas
8. Contents of the packaging and other information
   1. What Metronidazole Aurovitas contains
   2. What Metronidazole Aurovitas looks like and contents of the pack
   3. Marketing authorization holder:
   4. Manufacturer/Importer:
   5. This medicine is authorized in the Member States of the European Economic Area under the following names:
   6. Date of last revision of the leaflet: 08/2023

Leaflet accompanying the packaging: information for the user

Metronidazole Aurovitas, 500 mg, coated tablets

Metronidazole

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

• Keep this leaflet, so you can read it again if you need to.
• If you have any doubts, consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including those not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet:

• 1. What is Metronidazole Aurovitas and what is it 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 packaging and other information

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

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

• preventing post-operative anaerobic bacterial infections;
• treating infections caused by anaerobes (peritonitis, brain abscess, osteomyelitis, puerperal fever, pelvic abscess, post-operative wound infections);
• trichomoniasis of the urogenital system 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 in combination with other recommended medicines.

2. Important information before taking Metronidazole Aurovitas

When not to take Metronidazole Aurovitas

• during the first trimester of pregnancy.

Warnings and precautions

Before starting to take Metronidazole Aurovitas, tell your doctor,
pharmacist, or nurse about:

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

Then the doctor will carefully determine whether Metronidazole Aurovitas should be taken.
If seizures or other nervous system disorders (e.g., numbness of limbs) occur during therapy, 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).
Because long-term use of metronidazole can disrupt blood formation (see "Possible side effects"), the patient's blood morphology will be monitored during treatment.
If the patient has taken this medicine, the urine may be darker.
In patients with Cockayne syndrome, cases of severe toxic liver effects and (or) acute liver failure, including cases resulting in death, have been reported during treatment with metronidazole.
In patients with Cockayne syndrome, the doctor should frequently monitor liver function during metronidazole treatment and later.
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;
the treatment period will only be extended in exceptional circumstances and if absolutely necessary. Repeated metronidazole therapy will be limited to cases where it is absolutely necessary. In such cases, the patient will be closely monitored.

Metronidazole Aurovitas and other medicines

Tell your doctor or pharmacist about all medicines you are taking,
or have recently taken, and about medicines you plan to take.

Amiodarone (used to treat irregular heartbeat)

After taking this medicine, heart function should be monitored.
The patient should see a doctor if they notice any heart function disorders, dizziness, or fainting.

Barbiturates (active substance in sleeping pills)

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

Contraceptive pills

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 action of carbamazepine.

Cimetidine (a medicine used to treat stomach disorders)

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

Coumarin derivatives (blood-thinning medicines)

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

Cyclosporin (a medicine used to suppress unwanted immune reactions)

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

Disulfiram (used to treat alcohol withdrawal)

If the patient is taking disulfiram, they should not receive metronidazole, or disulfiram treatment should be discontinued. Concomitant use of these two medicines can lead to confusion and severe mental disorders (psychosis).

Medicines containing alcohol

See "Metronidazole Aurovitas with food, drink, and alcohol".

Fluorouracil (an anticancer medicine)

When fluorouracil is used with metronidazole, it may be necessary to reduce the daily dose of fluorouracil, as metronidazole may increase the fluorouracil blood concentration.

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 discontinued.

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 the patient is taking phenytoin, the doctor will use metronidazole with caution, as metronidazole may prolong the action of phenytoin. On the other hand, phenytoin may reduce the effect of metronidazole.

Tacrolimus (used to suppress unwanted immune reactions)

The doctor should check the blood concentration of this medicine and kidney function 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 the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult a doctor before taking this medicine.
Fertility
Animal studies indicate only a potential negative effect of metronidazole on the male reproductive system, but only with high doses significantly exceeding the maximum recommended dose for humans.

Contraception in men and women

If the patient is using contraceptive measures, they should read the information "Metronidazole Aurovitas and other medicines".
Pregnancy
If the patient is pregnant, the doctor will not treat the patient with metronidazole unless it is absolutely necessary.
Breastfeeding
Do not breastfeed while taking metronidazole and do not resume breastfeeding for 2 to 3 days after, as metronidazole passes into breast milk.

Driving and using machines

While taking Metronidazole Aurovitas, drowsiness, dizziness, confusion, seeing or hearing things that are not there (hallucinations), seizures, or transient vision disturbances (such as blurred or double vision) may occur. In such cases, do not drive vehicles or operate machines or tools.

Metronidazole Aurovitas contains sodium

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

3. How to take Metronidazole Aurovitas

Take this medicine always as directed by your doctor or pharmacist. If you are unsure, consult 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.

The usual recommended dosage is as follows:

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:
1 g as a single dose, followed by 500 mg every 8 hours for 24 hours before surgery;
post-operatively, metronidazole will be given intravenously or rectally until the patient can take tablets.
Children under 12 years:
20 to 30 mg/kg body weight (bw) as a single dose 1 to 2 hours before surgery.
Preterm infants born before 40 weeks of gestation:
10 mg/kg bw as a single dose before surgery.
Anaerobic bacterial infection
Metronidazole can be used therapeutically alone or in combination with other antibacterial medicines. The average treatment period should not exceed 7 days.
Adults and children over 12 years:
250 to 500 mg 3 times a day.
Children over 8 weeks to 12 years:
The usual daily dose is 20 to 30 mg/kg bw as a single dose or in divided doses of 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. The duration of treatment is usually 7 days.
Children under 8 weeks:
15 mg/kg bw per day as a single dose or in divided doses of 7.5 mg/kg bw every 12 hours.
Preterm infants born before 40 weeks of gestation may experience metronidazole accumulation in the first week of life, so the doctor will monitor the metronidazole serum concentration after a few days of treatment.
Trichomoniasis
Adults and children over 10 years:
2000 mg as a single dose or 250 mg 3 times a day for 7 days or 500 mg twice a day for 5-7 days.
Note: Treatment is carried out simultaneously in sexual partners.
Children under 10 years:
40 mg/kg bw orally as a single dose or 15 to 30 mg/kg bw per day in 2 to 3 divided doses for 7 days. The single dose should not exceed 2000 mg.
Bacterial vaginosis
Adults and children over 10 years:
500 mg in the morning and evening for 7 days or 2000 mg as a single dose.
Amoebiasis
Adults and children over 10 years:
500 to 750 mg 3 times a day for 5-10 days.
Children 7 to 10 years:
200 to 400 mg 3 times a day for 5-10 days.
Children 3 to 7 years:
100 to 200 mg 4 times a day for 5-10 days.
Children 1 to 3 years:
100 to 200 mg 3 times a day for 5-10 days.
Alternative dosing regimen for this disease (dose in mg/kg bw):
Children 1 to 10 years:
35 to 50 mg/kg bw per day in 3 divided doses for 5 to 10 days, but not more than 2400 mg per day.
Giardiasis
Adults and children over 10 years:
2000 mg once a day for 3 days or 500 mg twice a day for 7 to 10 days.
Children 7 to 10 years:
1000 mg once a day for 3 days.
Children 3 to 7 years:
600 to 800 mg once a day for 3 days.
Children 1 to 3 years:
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 pyloribacterial infection (eradication)
Metronidazole should be used for at least 7 days in combination with other medicines prescribed for Helicobacter pyloriinfections.
Adults:
500 mg 2 to 3 times a day for 7-14 days.
Children and adolescents:
20 mg/kg bw per day - not more than 500 mg twice a day for 7-14 days.
Acute ulcerative gingivitis
Adults:
250 mg 3 times a day for 3 days.
Children:
35 to 50 mg/kg bw per day in 3 divided doses for 3 days.
Acute periodontal infection
Adults and adolescents over 17 years:
250 mg 3 times a day for 3-7 days.
Children and adolescents 10 to 17 years:
200 to 250 mg 3 times a day for 3-7 days.
Children 7 to 9 years:
100 mg 3 times a day for 3-7 days.
Children 3 to 6 years:
100 mg twice a day for 3-7 days.
Children 1 to 2 years:
50 mg 3 times a day for 3-7 days.
Method of administration
Oral administration.
The tablet can be divided into equal doses.
For some of the doses described above, there are also other metronidazole medicines with different strengths (coated tablet, 250 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 of Metronidazole Aurovitas

In case of overdose, contact a doctor immediately.

Missed dose of Metronidazole Aurovitas

If a dose is missed, take it as soon as possible. If it is already time for the next dose, do not take the missed dose. Do not take a double dose to make up for the missed dose.
In case of further doubts about the use of this medicine, consult a 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.
In case of any of the following serious side effects, stop taking Metronidazole Aurovitas and contact a doctor immediately:
Rare(may affect up to 1 in 1,000 people):

• Severe persistent diarrhea (likely 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
• Non-bacterial meningitis (aseptic meningitis)
• 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 eye rotation, eye nerve damage or inflammation
• Decreased white blood cell count (leukopenia), severe anemia (aplastic anemia)
• Seizures, nervous system disorders, such as numbness, pain, tingling, or burning sensation in 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 or discomfort in the urethra, painful urination, cystitis, frequent urination, 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):

• ECG changes

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

• Psychotic disorders, including confusion, hallucinations
• Headache, dizziness, drowsiness, fever, movement and vision disorders, dizziness, speech disorders, seizures
• Vision disorders, such as double vision, myopia
• Liver function disorders (such as increased activity of certain enzymes and bilirubin concentration in serum)
• 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 or mouth inflammation, belching, and bitter taste, metallic taste, pressure over the stomach, hairy tongue
• Difficulty swallowing
• Anorexia
• Sad (depressed) mood
• Hearing or hearing loss disorders
• Ringing in the ears (tinnitus)
• Drowsiness or insomnia, muscle tremors
• Redness and itching of the skin (erythema multiforme)
• Irritation of the vein wall (up to inflammation of the veins 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 severe persistent diarrhea occurs, 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 Aurovitas and provide appropriate treatment.
If any side effect worsens or if you experience any side effects not listed in this leaflet, tell your doctor.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, Urząd Rejestracji Produktów Leczniczych, Wyrobów Medycznych i Produktów Biobójczych, Al. Jerozolimskie 181C, 02-222 Warszawa, 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 the medicine out of sight and reach of children.
There are no special precautions for storing the medicine.
Do not use this medicine after the expiry date stated on the carton after EXP. The expiry date refers to the last day of the month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the packaging and other information

What Metronidazole Aurovitas contains

• The active substance is metronidazole. Each coated tablet contains 500 mg of metronidazole.
• Other ingredients are: Tablet core:microcrystalline cellulose, maize starch, hydroxypropylcellulose, colloidal anhydrous silica, sodium carboxymethylcellulose (type A), stearic acid. Coating:hypromellose 2910 (5cps), polyethylene glycol.

What Metronidazole Aurovitas looks like and contents of the pack

Coated tablet
White or almost white, oblong coated tablets, with "M" and "500" embossed on one side and a score line on the other. The tablet can be divided into equal doses.
Metronidazole Aurovitas coated tablets are available in blisters containing 4, 14, 20, 28, 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 Warszawa
e-mail: [email protected]

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 500 mg, comprimé pelliculé sécable
Netherlands:
Metronidazol Auro 500 mg, filmomhulde tabletten
Poland:
Metronidazol Aurovitas
Portugal:
Metronidazol Generis

Date of last revision of the leaflet: 08/2023