Metronidazole aurovitas

Package leaflet: Information for the user

Metronidazol Aurovitas, 250 mg, coated tablets
Metronidazolum
Read carefully the entire leaflet before taking this medicine, because it contains
important information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm others, even if their symptoms are the same.
• If you experience any adverse reactions, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents of the leaflet:

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

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

Metronidazol Aurovitas is an antimicrobial agent with antiprotozoal and antibacterial activity.
It is used in adults and children for:

• prevention of postoperative anaerobic bacterial infections;
• treatment of infections caused by anaerobic bacteria (peritonitis, brain abscess, osteomyelitis, puerperal fever, pelvic abscess, postoperative wound infections);
• urogenital trichomoniasis in women and men;
• bacterial vaginosis;
• protozoal diseases – amoebiasis and giardiasis;
• acute necrotizing ulcerative gingivitis; acute periodontal infections;
• Helicobacter pylori infection associated with peptic ulcer, in combination with other recommended medicines.

2. Important information before using Metronidazol Aurovitas

When not to use Metronidazol Aurovitas

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

Warnings and precautions
Before starting treatment with Metronidazol Aurovitas, tell your doctor,
pharmacist or nurse if you have:

• severe liver damage,
• blood disorders,
• or a disease affecting the brain, spinal cord, or nerves (nervous system).

In such cases, the doctor will carefully determine whether Metronidazol Aurovitas should be used.
If seizures or other neurological disorders (e.g. numbness of limbs) occur during treatment, therapy will be immediately changed.
If severe diarrhoea develops, which may be caused by a serious bowel condition called "pseudomembranous colitis", treatment must be immediately stopped or changed (see also section 4).
Since prolonged use of metronidazole may affect blood formation (see section "Possible side effects"), blood morphology will be monitored during treatment.
If the patient has received this medicine, urine may become darker.
In patients with Cockayne syndrome, severe hepatic toxicity and/or acute liver failure, including fatal cases, have been reported during treatment with metronidazole-containing medicines.
In patients with Cockayne syndrome, the doctor should frequently monitor liver function during and after treatment with metronidazole.
Immediately inform your doctor and discontinue metronidazole if any of the following occur:

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

Treatment with Metronidazol Aurovitas should generally not continue longer than 10 days; treatment duration may be extended only in exceptional circumstances and if absolutely necessary. Repeated metronidazole therapy will be limited to cases where it is absolutely essential. In such cases, the patient will be closely monitored.

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

Amiodarone (used to treat irregular heartbeat)
Heart function should be monitored after administration of this medicine.
The patient should see a doctor immediately if any cardiac disturbances, dizziness, or fainting occur.

Barbiturates (active substance in sleeping tablets)
Phenobarbital shortens the duration of action of metronidazole; therefore, an increased dose of metronidazole may be necessary.

Oral contraceptives
The contraceptive pill may become ineffective during metronidazole treatment.

Busulfan
Metronidazole should not be administered to patients receiving busulfan, as this increases the risk of toxic effects.

Carbamazepine (used to treat epilepsy)
Concomitant use with carbamazepine requires caution, as metronidazole may prolong the action of carbamazepine.

Cimetidine (used to treat gastrointestinal disorders)
Cimetidine may reduce the elimination of metronidazole in individual cases, leading to increased serum concentrations of metronidazole.

Coumarin derivatives (medicines that inhibit blood clotting)
Metronidazole may enhance the anticoagulant effect of coumarin derivatives.
Therefore, if you are taking a medicine that inhibits blood clotting (e.g. warfarin), you may require a lower dose during metronidazole treatment.

Cyclosporine (used to suppress unwanted immune reactions)
When cyclosporine is administered together with metronidazole, blood levels of cyclosporine may increase; therefore, the doctor will need to adjust the cyclosporine dose accordingly.

Disulfiram (used in the treatment of alcohol dependence)
If the patient is taking disulfiram, metronidazole must not be administered, or disulfiram treatment must be discontinued. Concomitant use of these two medicines may lead to confusion and even severe psychiatric disturbances (psychosis).

Medicines containing alcohol
See "Metronidazol Aurovitas with food, drink and alcohol".

Fluorouracil (anticancer medicine)
When fluorouracil is used together with metronidazole, a reduction in the daily dose of fluorouracil may be necessary, as metronidazole may increase blood levels of fluorouracil.

Lithium (used to treat psychiatric disorders)
Treatment with lithium preparations requires particularly careful monitoring during metronidazole therapy, and the lithium dose may need to be adjusted. Before starting metronidazole, the lithium dose should be gradually reduced or lithium treatment discontinued.

Mycophenolate mofetil (used to prevent organ transplant rejection)
Metronidazole may reduce its effectiveness; therefore, close monitoring of this medicine's effect is recommended.

Phenytoin (used to treat epilepsy)
If the patient is taking phenytoin, the doctor will use metronidazole cautiously, as metronidazole may prolong the action of phenytoin. On the other hand, phenytoin may reduce the effectiveness of metronidazole.

Tacrolimus (used to suppress unwanted immune reactions)
Blood levels of tacrolimus and kidney function should be checked at the beginning and end of metronidazole treatment.

Metronidazol Aurovitas with food, drink and alcohol
Alcohol
Do not drink alcoholic beverages or take medicines containing alcohol during metronidazole treatment and for 48 hours afterwards, as this may cause intolerance reactions such as dizziness and vomiting.

Pregnancy, breastfeeding and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or plans to become pregnant, she should consult her doctor before using this medicine.

Fertility
Animal studies indicate a potential negative effect of metronidazole on the male reproductive system only at very high doses significantly exceeding the maximum recommended human dose.

Contraception in men and women
If the patient is using contraceptive methods, refer to the information under "Metronidazol Aurovitas and other medicines".

Pregnancy
If the patient is pregnant, the doctor will not treat her with metronidazole unless absolutely necessary.

Breastfeeding
Breastfeeding must not be continued during metronidazole treatment and should not be resumed for the next 2 to 3 days, as metronidazole passes into breast milk.

Driving and operating machinery
During treatment with Metronidazol Aurovitas, drowsiness, dizziness, confusion, visual or auditory hallucinations (seeing or hearing things that are not there), seizures, or transient visual disturbances (such as blurred or double vision) may occur. In such cases, do not drive or operate machinery or tools.

Metronidazol Aurovitas contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, meaning the medicine is considered "sodium-free".

3. How to use Metronidazol Aurovitas

This medicine should always be used exactly as directed by your doctor or pharmacist. If you are unsure,
please consult your doctor or pharmacist.
Due to insufficient data on the risk of mutagenicity in humans, your doctor will carefully consider
whether metronidazole can be used for longer than the usually recommended duration.
The usual recommended dosage is as follows:
Prevention of infections caused by anaerobic bacteria (in gynecological or colorectal surgery)
Metronidazole will be administered 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 of age:
Initially, 4 tablets of 250 mg (1000 mg) as a single dose, followed by 1 tablet three times daily before
surgery.
Children under 12 years of age:
20 to 30 mg/kg body weight (b.w.) as a single dose administered 1 to 2 hours before surgery.
Preterm infants born before the 40th week of gestation:
10 mg/kg b.w. as a single dose before surgery.
Anaerobic bacterial infections
Metronidazole may be used therapeutically alone or in combination with other antibacterial agents.
The average treatment duration should not exceed 7 days.
Adults and adolescents over 12 years of age:
1 or 2 tablets of 250 mg three times daily.
Children above 8 weeks to 12 years of age:
The usual daily dose is 20 to 30 mg/kg b.w. as a single dose or divided into doses of 7.5 mg/kg b.w.
every 8 hours. The daily dose may be increased up to 40 mg/kg b.w., depending on the severity of
infection.
Children under 8 weeks of age:
15 mg/kg b.w. per day as a single dose or divided into doses of 7.5 mg/kg b.w. every 12 hours.
In preterm infants born before the 40th week of gestation, accumulation of metronidazole may occur
during the first week of life; therefore, the doctor will monitor serum concentrations of metronidazole
after several days of treatment.
Trichomoniasis
Adults and children over 10 years of age:
8 tablets of 250 mg (2000 mg) as a single dose or 1 tablet three times daily for 7 days, or 2 tablets twice
daily for 5–7 days.
Note: Treatment must be administered simultaneously to sexual partners.
Children under 10 years of age:
40 mg/kg b.w. orally as a single dose or 15 to 30 mg/kg b.w. 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 only).
Adolescents:
8 tablets (2000 mg) as a single dose (once only).
Amoebiasis
Adults:
3 tablets of 250 mg (750 mg) three times daily for 5–10 days.
Adolescents and children over 10 years of age:
2 or 3 tablets of 250 mg (500 mg to 750 mg) three times daily for 5–10 days.
Children aged 7 to 10 years:
250 mg three times daily for 5–10 days.
Alternative dosing regimen for this disease (dose in mg per kg b.w.):
35 to 50 mg/kg b.w. per day in three divided doses for 5 to 10 days, but not exceeding 2400 mg per day.
Giardiasis
Adults:
1 tablet of 250 mg three times daily for 5–7 days or 8 tablets (2000 mg) once daily for 3 days.
Adolescents and children over 10 years of age:
8 tablets (2000 mg) once daily for 3 days or 2 tablets (500 mg) twice daily for 7 to 10 days.
Children aged 7 to 10 years:
4 tablets of 250 mg (1000 mg) once daily for 3 days.
Children aged 3 to 7 years:
3 tablets of 250 mg (750 mg) once daily for 3 days.
Children aged 1 to 3 years:
2 tablets of 250 mg (500 mg) once daily for 3 days.
Alternative dosing regimen for this disease (dose in mg per kg b.w.):
15 to 40 mg/kg b.w. per day, divided into 2 to 3 doses.
Treatment of bacterial infection with Helicobacter pylori (eradication therapy)
Metronidazole should be used for at least 7 days in combination with other medications prescribed
for the treatment of Helicobacter pylori infections.
Adults:
2 tablets of 250 mg (500 mg) 2 to 3 times daily for 7–14 days.
Children and adolescents:
20 mg/kg b.w. per day, but not exceeding 2 tablets (500 mg) twice daily, for 7–14 days.
Before starting treatment, please refer to official guidelines.
Acute necrotizing ulcerative gingivitis
Adults:
1 tablet of 250 mg 2 to 3 times daily for 3 days.
Children:
35 to 50 mg/kg b.w. per day in three divided doses for three days.
Acute periodontal infections
Adults:
1 tablet of 250 mg 2 to 3 times daily for 3–7 days.
Infants and children with body weight less than 10 kg:
Proportionally reduced doses should be administered.
Administration method
Oral administration.
For some of the dosages described above, other metronidazole-containing medicines of different
strengths (e.g., coated tablet, 500 mg) and pharmaceutical forms (e.g., infusion solution, 5 mg/ml) are
also available.
Use in patients with hepatic impairment
In patients with severe liver dysfunction or hepatic encephalopathy, accumulation of the drug may
occur; therefore, the doctor will recommend reducing the daily dose to one-third of the normal dose,
administered once daily.
Use in patients with renal impairment
Dose reduction in these patients is not necessary.
Use in elderly patients
This medicine should be used with caution in elderly patients, especially at high doses.
Use of a higher than recommended dose of Metronidazol Aurovitas
If you take more than the recommended dose, contact your doctor immediately.
Missed dose of Metronidazol Aurovitas
If you miss a dose, take it as soon as possible. However, if it is almost time for your next dose, do not
take the missed dose. Do not take a double dose to make up for a missed dose.
If you have any further questions about the use of this medicine, please consult your doctor or
pharmacist.

4. Possible adverse reactions

Like any medicine, this medicine can cause adverse reactions, although not everyone will experience them.
The frequency, type, and severity of adverse reactions in children are the same as in adults.
If any of the following severe adverse reactions occur, discontinue use of Metronidazole Aurovitas and contact your doctor immediately:
Uncommon (may affect up to 1 in 1,000 people):

• Severe persistent diarrhoea (possibly a sign of a serious intestinal infection called pseudomembranous colitis, see below)
• Severe acute allergic reactions up to anaphylactic shock

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

• Decrease in white blood cell and platelet counts during treatment (granulocytopenia, agranulocytosis, pancytopenia, thrombocytopenia)
• Hepatitis, jaundice, pancreatitis
• Brain disorders, lack of coordination
• Non-bacterial brain fever (aseptic meningitis)
• Severe inflammatory rash affecting mucous membranes and skin with fever, redness and blistering, in very rare cases progressing to extensive skin detachment (Stevens-Johnson syndrome)

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

• Mild to moderate allergic reactions, facial swelling, swelling of lips, throat and (or) tongue (angioedema)
• Sudden attack of forced upward gaze with eye rotation, damage or inflammation of optic nerves
• Decreased white blood cell count (leukopenia), severe anaemia (aplastic anaemia)
• Seizures, neurological disturbances such as numbness, pain, tingling or crawling sensations in hands or feet
• Toxic epidermal necrolysis
• Acute liver failure in patients with Cockayne syndrome (see section 2 "Warnings and precautions")

Other adverse reactions
Common (may affect up to 1 in 10 people):

• Fungal infections (e.g. genital infections)
• Burning/discomfort in the urethra, painful urination, cystitis, polyuria, urinary incontinence

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

• Darkening of urine (due to metronidazole metabolism)
• Nasal mucosal 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, somnolence, fever, visual and movement disturbances, vertigo, speech disorders, seizures
• Visual disturbances, e.g. double vision, myopia
• Liver function disorders (such as increased activity of certain enzymes and serum bilirubin concentration)
• Allergic skin reactions such as itching, urticaria
• Joint and muscle pain

Not known (frequency cannot be estimated from available data):

• Vomiting, nausea, diarrhoea, glossitis or stomatitis, belching and bitter taste, metallic taste, epigastric discomfort, hairy tongue
• Difficulty swallowing
• Anorexia
• Sad (depressed) mood
• Hearing disorders/hearing loss
• Ringing in the ears (tinnitus)
• Somnolence or insomnia, muscle tremors
• Redness and itching of the skin (erythema multiforme)
• Irritation of vein walls (leading to phlebitis and thrombosis) following intravenous administration, weakness, fever
• Clearly defined area of redness and sometimes blistering of the skin caused by drug hypersensitivity (drug eruption)

Treatment of pseudomembranous colitis
If severe persistent diarrhoea occurs, inform your doctor immediately, as this may be due to pseudomembranous colitis, a serious condition requiring immediate treatment. Your doctor will discontinue metronidazole and initiate appropriate therapy.
If any of the adverse reactions worsen or if any adverse symptoms not listed in this leaflet occur, inform your doctor.
Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Reactions of Medicinal Products, 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
Adverse reactions may also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Metronidazol Aurovitas

Keep this medicine out of sight and reach of children.
No special storage conditions are required for this medicine.
Do not use this medicine after the expiry date stated on the cardboard package after:
EXP. The expiry date refers to the last day of the stated 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 Metronidazol Aurovitas contains

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

What Metronidazol Aurovitas looks like and contents of the pack
Coated tablet
White or almost white, round, film-coated tablets, embossed with the letters "M" and "250" on one side and smooth on the other.
Metronidazol Aurovitas coated tablets are available in blisters containing 20, 21 or 40 tablets, packed in a cardboard box.
Not all pack sizes may be marketed.
Marketing Authorisation Holder:
Aurovitas Pharma Polska Sp. z o.o.
Sokratesa 13D, local 27
01-909 Warsaw
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 medicinal product is authorised in the European Economic Area member states 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