Metronidazole aurovitas

Package leaflet: Information for the user

Metronidazol Aurovitas, 500 mg, coated tablets
Metronidazolum
Please read all of this leaflet carefully before taking this medicine because it contains important information for you.

• Keep this leaflet as you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. 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, inform your doctor or pharmacist. See section 4.

Contents of the leaflet:

1. What Metronidazol Aurovitas is and what it is used for
2. What you need to know 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 and antiprotozoal medicine.
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 impairment,
• blood disorders (disturbances in blood cell formation), or
• brain, spinal cord, or nerve disease (nervous system disorders).

In such cases, your doctor will carefully determine whether Metronidazol Aurovitas should be used.
If seizures or other neurological disturbances (e.g. numbness of limbs) occur during treatment, therapy will be immediately changed.
If severe diarrhoea develops, which may be due to 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 cell formation (see section "Possible side effects"), blood morphology will be monitored during treatment.
If the patient takes 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, liver function should be closely monitored by the physician 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 for longer than 10 days; the treatment period may be extended only under exceptional circumstances and if absolutely necessary. Re-treatment with metronidazole will be limited to cases where it is absolutely essential. In such cases, the patient will be monitored particularly closely.

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 taking this medicine.
The patient should consult a doctor if any disturbances in heart function, 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 required.

Oral contraceptives
Oral contraceptives may be ineffective during metronidazole treatment.

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

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

Cimetidine (a medicine 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 blood clotting inhibition caused by 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 (a medicine 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 withdrawal)
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 (an anticancer medicine)
When fluorouracil is used concomitantly with metronidazole, a reduction in the daily dose of fluorouracil may be necessary, as metronidazole may increase fluorouracil blood levels.

Lithium (used in the treatment of 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 action 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 effectiveness of metronidazole.

Tacrolimus (used to suppress unwanted immune reactions)
Blood levels of this medicine and kidney function should be checked at the beginning of metronidazole treatment and after its completion.

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 have a child, she should consult a doctor before using this medicine.

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

Contraception in men and women
If the patient uses 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 be avoided during metronidazole treatment and for the next 2 to 3 days thereafter, as metronidazole passes into breast milk.

Driving and operating machinery
While taking Metronidazol Aurovitas, drowsiness, dizziness, confusion, seeing or hearing things that are not there (hallucinations), 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 have any doubts,
you should contact your doctor or pharmacist.
Due to insufficient data on mutagenic risk 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 starting 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:
1 g as a single dose, followed by 500 mg every 8 hours during the 24 hours before surgery;
postoperatively, metronidazole should be administered intravenously or rectally until the patient is able to take tablets.
Children under 12 years of age:
20 to 30 mg/kg body weight (b.w.) as a single dose given 1 to 2 hours before surgery.
Preterm neonates born before 40 weeks 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 children over 12 years of age:
250 to 500 mg three times daily.
Children aged over 8 weeks to 12 years:
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.
Treatment duration is usually 7 days.
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 neonates born before 40 weeks of gestation, metronidazole accumulation may occur during the first week of life; therefore, the doctor will monitor serum metronidazole concentrations after several days of treatment.

Trichomoniasis
Adults and children over 10 years of age:
2000 mg as a single dose, or 250 mg three times daily for 7 days, or 500 mg twice daily for 5–7 days.
Note: treatment should 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 and children over 10 years of age:
500 mg in the morning and evening for 7 days or 2000 mg as a single dose.

Amebiasis
Adults and children over 10 years of age:
500 mg to 750 mg three times daily for 5–10 days.
Children aged 7 to 10 years:
200 mg to 400 mg three times daily for 5–10 days.
Children aged 3 to 7 years:
100 mg to 200 mg four times daily for 5–10 days.
Children aged 1 to 3 years:
100 mg to 200 mg three times daily for 5–10 days.
Alternative dosing regimen for this disease (dose in mg per kg b.w.):
Children aged 1 to 10 years:
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 and children over 10 years of age:
2000 mg once daily for 3 days or 500 mg twice daily for 7 to 10 days.
Children aged 7 to 10 years:
1000 mg once daily for 3 days.
Children aged 3 to 7 years:
600 mg to 800 mg once daily for 3 days.
Children aged 1 to 3 years:
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 Helicobacter pylori infection (eradication therapy)
Metronidazole should be used for at least 7 days in combination with other medications prescribed for Helicobacter pylori infections.
Adults:
500 mg two to three times daily for 7–14 days.
Children and adolescents:
20 mg/kg b.w. per day – not exceeding 500 mg twice daily for 7–14 days.

Acute necrotizing ulcerative gingivitis
Adults:
250 mg three times daily for 3 days.
Children:
35 to 50 mg/kg b.w. per day in three divided doses for three days.

Acute periodontitis
Adults and adolescents over 17 years of age:
250 mg three times daily for 3–7 days.
Children and adolescents aged 10 to 17 years:
200 to 250 mg three times daily for 3–7 days.
Children aged 7 to 9 years:
100 mg three times daily for 3–7 days.
Children aged 3 to 6 years:
100 mg twice daily for 3–7 days.
Children aged 1 to 2 years:
50 mg three times daily for 3–7 days.

Method of administration
Oral administration.
The tablet may be divided into equal doses.
For some of the dosages described above, other metronidazole-containing medicines with different strengths (e.g., coated tablet, 250 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 in the body may occur; therefore, the doctor will recommend reducing the daily dose to one-third of the usual 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.

Overdose 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. 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, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
The frequency, type and severity of adverse effects in children are the same as in adults.
If any of the following serious adverse effects occur, treatment with Metronidazol Aurovitas must be discontinued and you should contact your doctor immediately:

Rare (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 hypersensitivity reactions up to anaphylactic shock

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

• White blood cell and platelet counts may decrease during treatment (granulocytopenia, agranulocytosis, pancytopenia, thrombocytopenia)
• Hepatitis, jaundice, pancreatitis
• Brain disorders, lack of coordination
• Brain fever not caused by bacteria (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 unknown (frequency cannot be estimated from available data):

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

Other adverse effects
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 bilirubin concentration in serum)
• Allergic skin reactions, such as itching, urticaria
• Joint and muscle pain

Frequency unknown (frequency cannot be estimated from available data):

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

Treatment of pseudomembranous colitis
In case of severe persistent diarrhoea, inform your doctor immediately, as this may be due to pseudomembranous colitis, a serious condition requiring immediate treatment. Your doctor will discontinue metronidazole and provide appropriate therapy.
If any adverse effects worsen or if any adverse effects not listed in this leaflet occur, inform your doctor.

Reporting of adverse effects
If any adverse effects occur, including any adverse effects not listed in this leaflet, inform your doctor or pharmacist. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions, 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 effects can also be reported to the marketing authorisation holder.
Reporting adverse effects helps to provide more information on the safety of this medicine.

5. How to store Metronidazol Aurovitas

Keep this medicine out of the sight and reach of children.
No special storage instructions apply to this medicine.
Do not use this medicine after the expiry date stated on the cardboard packaging 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. Such measures 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 500 mg of metronidazole.
• Other ingredients are: Tablet core: microcrystalline cellulose, pregelatinized maize starch, hydroxypropylcellulose, colloidal anhydrous silica, sodium carboxymethyl starch (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, elongated coated tablets, embossed with the letters "M" and "500" on one side and a division line on the other. The tablet can be divided into equal doses.
Metronidazol Aurovitas coated tablets are available in blisters containing 4, 14, 20, 28 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 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