Metronidazol Polpharma

Leaflet attached to the packaging: information for the user

Metronidazole Polpharma, 500 mg, 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 any side effects 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 Polpharma and what is it used for
• 2. Important information before taking Metronidazole Polpharma
• 3. How to take Metronidazole Polpharma
• 4. Possible side effects
• 5. How to store Metronidazole Polpharma
• 6. Contents of the packaging and other information

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

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

• treatment of infections caused by anaerobic bacteria of the genus Bacteroides, Fusobacterium, Clostridium, Eubacterium, anaerobic cocci, and Gardnerella vaginalis, as well as protozoa Trichomonas, Entamoeba histolytica, Giardia lamblia, and Balantidium;
• prevention of postoperative infections caused by anaerobic bacteria, especially species of the genus Bacteroidesand Streptococcus;
• therapeutic treatment of infections caused by anaerobic bacteria (septicaemia, blood infection called bacteraemia, peritonitis, brain abscess, pneumonia, osteomyelitis, puerperal fever, pelvic abscess, parametritis, surgical wound infections);
• trichomoniasis of the urogenital system in both women and men;
• bacterial vaginosis;
• diseases caused by protozoa - amoebiasis (amebiasis) and giardiasis (lambliasis);
• acute ulcerative gingivitis; acute periodontal infections;
• ulcers of the lower limbs and bedsores (anaerobic bacterial infections);
• in combination with other recommended medicines for the treatment of peptic ulcer with concomitant Helicobacter pyloriinfection.

2. Important information before taking Metronidazole Polpharma

When not to take Metronidazole Polpharma:

• during the first trimester of pregnancy.

Warnings and precautions

Before starting treatment with Metronidazole Polpharma, discuss it with your doctor or pharmacist.
Particular caution is advised and you should inform your doctor if you are taking Metronidazole Polpharma:

During treatment with metronidazole, a vaginal, intestinal, or oral yeast infection may occasionally occur. In such cases, you should consult a doctor who will prescribe an appropriate antifungal medicine.
Metronidazole does not have a direct bactericidal effect on aerobic bacteria and facultative anaerobes.
Despite the elimination of the bacteria causing trichomoniasis, the infection may still persist.
During treatment with metronidazole and for at least 48 hours after the end of treatment, you should not consume alcoholic beverages, due to the risk of adverse reactions (see "Metronidazole Polpharma with food, drink, and alcohol").
Metronidazole may interfere with the results of some laboratory tests (aspartate aminotransferase (AST), alanine aminotransferase (ALT), lactate dehydrogenase (LDH), triglyceride and glucose levels in the blood).
During treatment with metronidazole, blistering skin reactions, sometimes fatal, such as Stevens-Johnson syndrome or toxic epidermal necrolysis, may occasionally occur (see section 4). If symptoms such as flu-like symptoms, progressive rash (often with blisters or changes in mucous membranes), occur, treatment should be discontinued and a doctor consulted. The medicine may cause darker urine.

• If you experience symptoms such as fever, jaundice, dark urine, pale stools, or itching, you should immediately inform your doctor and stop taking Metronidazole Polpharma.

Metronidazole Polpharma and other medicines

Tell your doctor about all the medicines you are taking now or have taken recently, and about the medicines you plan to take.
In particular, inform your doctor about the use of:

• oral anticoagulants (e.g. acenocoumarol, warfarin);
• lithium salts (medicines used in psychiatric diseases);
• terfenadine and astemizole (antihistamine medicines);
• disulfiram (a medicine used in the treatment of alcoholism); treatment with metronidazole can be started only after 2 weeks after the end of disulfiram therapy;
• medicines that increase liver enzyme activity (e.g. phenytoin, phenobarbital);
• medicines that decrease liver enzyme activity (e.g. cimetidine);
• 5-fluorouracil or busulfan (medicines used in cancer treatment);
• cyclosporin (a medicine used in patients after transplants).

Metronidazole Polpharma with food, drink, and alcohol

The medicine can be taken regardless of meals.
Metronidazole enhances the toxic effect of alcohol. Consuming alcohol during treatment may cause adverse reactions, such as a feeling of heat, sweating, headaches, nausea, vomiting, abdominal pain, and rapid heartbeat.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor before taking this medicine.

Pregnancy

The medicine is contraindicated in the first trimester of pregnancy. In the second and third trimesters of pregnancy, the medicine may be used only in cases where the expected benefit to the mother outweighs the risk of harmful effects on the fetus.

Breastfeeding

Metronidazole passes into human milk, reaching concentrations close to those in plasma.
During breastfeeding, do not take the medicine. If the doctor decides that treatment with this medicine is necessary, breastfeeding should be discontinued.

Fertility

No data available.

Driving and using machines

Metronidazole Polpharma may cause drowsiness, dizziness, disorientation, hallucinations, seizures, or transient visual disturbances. It is recommended not to drive vehicles or operate machines if such symptoms occur.

Metronidazole Polpharma contains glucose

If you have previously been diagnosed with intolerance to some sugars, you should consult your doctor before taking the medicine.

3. How to take Metronidazole Polpharma

This medicine should always be taken as directed by your doctor. If you have any doubts, consult your doctor.
Due to the risk of toxic effects (mutagenicity) in humans, the doctor will carefully consider whether it is possible to use metronidazole for longer than the usually recommended time.

Usual recommended dosage:

Prevention of infections caused by anaerobic bacteria
Adults and children over 12 years: 1 g as a single dose, then 500 mg every 8 hours for 24 hours before surgery; after surgery, intravenous or rectal metronidazole is given until the patient can take tablets.
Children under 12 years: 20-30 mg/kg body weight (bw) as a single dose given 1-2 hours before surgery.
Premature infants born before the 40th week of gestation: 10 mg/kg bw as a single dose before surgery.
Anaerobic bacterial infections
Metronidazole can be used therapeutically as a single medicine or in combination with other antibacterial medicines. The average treatment period should not exceed 7 days.
Adults and children over 12 years: 250-500 mg 3 times a day.
Children over 8 weeks to 12 years: the usual daily dose is 20-30 mg/kg bw as a single dose or divided into doses of 7.5 mg/kg bw given 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 divided into doses of 7.5 mg/kg bw given every 12 hours.
Premature infants born before the 40th week of gestation may experience accumulation of metronidazole in the body, so the doctor will monitor the plasma metronidazole 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 both sexual partners.
Children under 10 years: 40 mg/kg bw orally as a single dose or 15-30 mg/kg bw per day divided into 2-3 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 (amebiasis)
Adults and children over 10 years: 500 mg to 750 mg 3 times a day for 5-10 days.
Children 7-10 years: 200 mg to 400 mg 3 times a day for 5-10 days.
Children 3-7 years: 100 mg to 200 mg 4 times a day for 5-10 days.
Children 1-3 years: 100 mg to 200 mg 3 times a day for 5-10 days.
Alternative dosing regimen for this indication (dose expressed in mg/kg bw):
Children 1-10 years: 35-50 mg/kg bw per day in 3 divided doses for 5 to 10 days, not exceeding 2400 mg per day.
Giardiasis (lambliasis)
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 7-10 years: 1000 mg once a day for 3 days.
Children 3-7 years: 600 mg to 800 mg once a day for 3 days.
Children 1-3 years: 500 mg once a day for 3 days.
Alternative dosing regimen for this indication (dose expressed in mg/kg bw):
15-40 mg/kg bw per day, divided into 2-3 doses.
Treatment of Helicobacter pyloriinfection (called eradication)
Metronidazole should be used for at least 7 days in combination with other medicines recommended for the treatment of Helicobacter pyloriinfections.
Adults: 500 mg 2-3 times a day for 7-14 days.
Children and adolescents: 20 mg/kg bw per day, not exceeding 500 mg twice a day for 7-14 days.
Acute ulcerative gingivitis
Adults: 250 mg 3 times a day for 3 days.
Children: 35-50 mg/kg bw per day, in 3 divided doses, for 3 days.
Acute periodontal infections
Adults and adolescents over 17 years: 250 mg 3 times a day for 3-7 days.
Children and adolescents 10-17 years: 200-250 mg 3 times a day for 3-7 days.
Children 7-9 years: 100 mg 3 times a day for 3-7 days.
Children 3-6 years: 100 mg 2 times a day for 3-7 days.
Children 1-2 years: 50 mg 3 times a day for 3-7 days.
Ulcers of the lower limbs and bedsores
Adults: 500 mg 3 times a day for 7 days.

Method of administration

Oral administration.

WARNING! Tablets can be crushed to facilitate administration to children.

A medicine in the form of 250 mg tablets and a solution for injection and infusion is also available.
Do not change the dosage of the medicine on your own.

Use in patients with liver function disorders

In patients with severe liver dysfunction 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.
In patients undergoing haemodialysis, metronidazole and its metabolites are removed during 8 hours of dialysis, so metronidazole should be administered again immediately after dialysis.
In patients undergoing intermittent or continuous ambulatory peritoneal dialysis, there is no need to change the dosage.

Use in elderly patients

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

Use of a higher than recommended dose of Metronidazole Polpharma

In case of using a higher dose than recommended, consult a doctor immediately.

Missing a dose of Metronidazole Polpharma

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.
If you have any further doubts about taking this medicine, consult 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 Polpharma and consult your doctor immediately:

• rare side effects(occurring in less than 1 in 1,000 people):
• anaphylaxis (severe allergic reaction; symptoms include itching, swelling, difficulty breathing, heart problems, dizziness);
• very rare side effects(occurring in less than 1 in 10,000 people):
• agranulocytosis (lack of white blood cells called granulocytes), neutropenia (granulocyte deficiency), thrombocytopenia (reduced platelet count), pancytopenia (deficiency of red and white blood cells and platelets). Symptoms of these blood disorders include fever, sore throat, superficial oral mucosa ulcers, flu-like symptoms, fatigue, bleeding (e.g. bruising, petechiae, bleeding from the nose),
• encephalopathy (brain disorders; symptoms include stiffness of the neck, disorientation, fever, headache, hallucinations, paralysis, hypersensitivity to light, vision and movement disorders);
• side effects with unknown frequency(frequency cannot be estimated from available data):
• angioedema (symptoms include swelling of the face, tongue, and larynx, which can cause breathing difficulties),
• urticaria,
• fever
• acute liver failure in patients with Cockayne syndrome (see section 2 "Warnings and precautions").

Other side effects

very rare side effects(occurring in less than 1 in 10,000 people):

• psychotic disorders, including confusion and hallucinations;
• subacute cerebellar syndrome (symptoms include coordination disorders, speech impairment, gait disorders, nystagmus, and tremors);
• drowsiness, dizziness, seizures, headaches;
• visual disturbances, such as double vision and myopia, usually transient;
• increased liver enzyme activity (AST, ALT, alkaline phosphatase), hepatitis, liver cell damage, jaundice, and pancreatitis, which resolve after discontinuation of the medicine;
• rash, pustular eruptions, itching, redness;
• muscle pain, joint pain;
• darkening of urine due to the presence of the medicine.

side effects with unknown frequency(frequency cannot be estimated from available data):

• leukopenia (reduced white blood cell count);
• loss of appetite;
• depression;
• peripheral sensory neuropathy (symptoms include numbness, tingling, e.g. pinching, burning) or transient seizure-like episodes; in most cases, neuropathy resolved after discontinuation of the medicine or dose reduction;
• aseptic meningitis;
• optic neuropathy/optic neuritis (symptoms include eye pain, vision disturbances);
• taste disorders, oral mucosa inflammation, coated tongue, nausea, vomiting, gastrointestinal disorders, such as abdominal pain and diarrhea;
• erythema multiforme, Stevens-Johnson syndrome (symptoms include blisters that turn into ulcers on the mucous membranes of the mouth, eyes, and genitals), toxic epidermal necrolysis (skin and mucous membrane changes leading to shedding of large areas of skin) - see section 2 "Warnings and precautions";
• vaginal pain and yeast infection. Cases of liver failure requiring transplantation have been reported in patients treated with metronidazole in combination with other antibiotics.

Reporting side effects

If you experience any side effects, including any side effects 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 of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +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 authorisation holder.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Metronidazole Polpharma

Keep the medicine out of the sight and reach of children.
Do not store above 25°C.
Store in the original packaging to protect from light.
Do not use this medicine after the expiry date stated on the packaging.
The expiry date stated on the packaging is the last day of the given month.
The inscription on the packaging after the abbreviation EXP means the expiry date, and after the abbreviation Lot/LOT means the batch number.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Metronidazole Polpharma contains

• The active substance of the medicine is metronidazole. Each tablet contains 500 mg of metronidazole.
• Other ingredients are: potato starch, gelatin, liquid glucose, magnesium stearate.

What Metronidazole Polpharma looks like and what the packaging contains

White to yellowish tablets, oblong, biconvex.
Packaging
The packaging contains 14, 20, or 28 tablets in aluminium/PVC blisters, placed in a cardboard box.
Not all pack sizes may be marketed.

Marketing authorisation holder and manufacturer

Polpharma S.A.
Pelplińska 19, 83-200 Starogard Gdański
Phone: +48 22 364 61 01

Date of last revision of the leaflet: