Metronidazol Polpharma

Leaflet attached to the packaging: information for the user

Metronidazole Polpharma, 250 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 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 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 lambliaand Balantidium;
• prevention of postoperative infections caused by anaerobic bacteria, especially species of the genus Bacteroidesand Streptococcus;
• 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 peri-dental infections;
• ulcers of the lower limbs and bedsores (infections with anaerobic bacteria);
• 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:

• if the patient is 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 starting treatment with Metronidazole Polpharma, discuss it with your doctor or
pharmacist.
Special caution should be exercised when taking Metronidazole Polpharma:

• if the patient has active or chronic disease of the central and peripheral nervous system (brain, spinal cord or nerves);
• if the patient has experienced neurological disorders (numbness, tingling of limbs, dizziness, clumsiness or convulsions) during treatment;
• if the patient has severe liver or kidney damage (see section 3);
• if the patient is taking anti-inflammatory medicines called corticosteroids and if the patient is prone to swelling;
• if before starting and after finishing treatment with metronidazole, significant abnormalities were found in the blood picture and differential count. If it is necessary to reapply metronidazole, such a patient should remain under medical supervision. During treatment, the doctor should monitor the blood picture, especially the white blood cell count. If the medicine is used for more than 10 days, such monitoring is absolutely necessary.

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 bacteria that cause trichomoniasis, the infection may still persist.
During treatment with metronidazole and for at least 48 hours after finishing treatment with metronidazole, you should not consume alcoholic beverages, due to the possibility of adverse reactions (see "Metronidazole Polpharma with food, drink and alcohol").
Metronidazole may affect the results of some laboratory tests (ASAT, ALAT, LDH, triglycerides, glucose).
During treatment with metronidazole, blistering skin reactions may occasionally occur, sometimes fatal, such as Stevens-Johnson syndrome or toxic epidermal necrolysis (see section 4). If symptoms such as flu-like symptoms, progressive rash (often with blisters or mucosal lesions) occur, treatment should be discontinued and a doctor consulted.
The medicine may cause darker urine colouring.
In patients with Cockayne syndrome, cases of severe hepatotoxicity (acute liver failure), including fatal cases, have been reported during treatment with metronidazole.
In patients with Cockayne syndrome, the doctor should monitor liver function during and after treatment with metronidazole.
If the patient experiences any of the following symptoms, they should immediately inform their doctor and stop taking metronidazole:

• abdominal pain, loss of appetite, nausea, vomiting, fever, malaise, fatigue, jaundice, dark urine colour, sticky or loose stools or skin itching.

Metronidazole Polpharma and other medicines

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

• oral anticoagulants (e.g. acenocoumarol, warfarin);
• amiodarone (a medicine used to treat heart rhythm disorders);
• lithium salts, haloperidol, pimozide, thioridazine, mezoridazine (medicines used to treat mental illnesses);
• donepezil (a medicine used to treat Alzheimer's disease);
• terfenadine and astemizole (antihistamines);
• disulfiram (a medicine used to treat alcoholism); treatment with metronidazole can be started only after 2 weeks after finishing treatment with disulfiram;
• medicines that increase liver enzyme activity (e.g. phenytoin, phenobarbital);
• medicines that decrease liver enzyme activity (e.g. cimetidine);
• cisapride (a medicine used to treat gastroesophageal reflux);
• certain antibiotics (such as ciprofloxacin, levofloxacin, sparfloxacin, erythromycin, clarithromycin);
• mefloquine (an antimalarial medicine);
• ketoconazole (an antifungal medicine);
• 5-fluorouracil, busulfan, tamoxifen (medicines used to treat cancer);
• 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 with Metronidazole Polpharma may cause adverse reactions, such as: feeling of heat, sweating, headaches, nausea, vomiting, abdominal pain.

Pregnancy, breastfeeding and fertility

If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, consult your doctor before taking this medicine.
Taking Metronidazole Polpharma is contraindicated in the first trimester of pregnancy.
In the second and third trimester of pregnancy, the medicine can be used only when, in the doctor's opinion, the expected benefit to the mother outweighs the risk to the foetus.
Metronidazole passes into breast milk, reaching concentrations close to those in plasma.
During breastfeeding, do not take the medicine. If treatment is necessary, a decision should be made to stop breastfeeding.

Driving and using machines

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

The medicine contains glucose

Each tablet contains 6.60 mg of glucose. If you have previously been diagnosed with intolerance to some sugars, consult your doctor before taking the medicine.

3. How to take Metronidazole Polpharma

Always take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor.
Due to insufficient evidence regarding the risk of mutagenicity in humans, the doctor will assess whether it is necessary to use metronidazole for a longer period than usually recommended.

Usually, the following dosing is recommended:

Prevention of infections caused by anaerobic bacteria
Adults and adolescents over 12 years:

• initially 4 tablets of 250 mg (1000 mg) in a single dose, then 1 tablet 3 times a day, until the preoperative fasting period. Children under 12 years:
• 20-30 mg/kg body weight in a single dose given 1-2 hours before surgery. Newborns born before the 40th week of gestation:
• 10 mg/kg body weight in a single dose before surgery. Infections with anaerobic bacteria Therapeutically, metronidazole can be used as a single medicine or in combination with other antibacterial medicines. The average treatment period 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:
• usually, the daily dose is 20-30 mg/kg body weight as a single dose or divided into doses of 7.5 mg/kg body weight given every 8 hours. The daily dose may be increased to 40 mg/kg body weight, depending on the severity of the infection. Children under 8 weeks of age:
• 15 mg/kg body weight per day as a single dose or divided into doses of 7.5 mg/kg body weight given every 12 hours. In newborns born before the 40th week of gestation, metronidazole may accumulate after a few days of treatment, so it is necessary to monitor the metronidazole concentration in serum. Trichomoniasis Adults and children over 10 years:
• 8 tablets of 250 mg (2000 mg) in a single dose or 1 tablet 3 times a day for 7 days or 2 tablets twice a day for 5-7 days. Note: treatment is carried out simultaneously in both sexual partners. Children under 10 years:
• 40 mg/kg body weight orally in a single dose or 15-30 mg/kg body weight per day divided into 2-3 doses for 7 days. A 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) in a single dose (once). Adolescents:
• 8 tablets (2000 mg) in a single dose (once). Amoebiasis (amebiasis) Adults:
• 3 tablets of 250 mg (750 mg) 3 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) 3 times a day for 5-10 days. Children from 7 to 10 years:
• 250 mg 3 times a day for 5-10 days.

Alternative dosing regimen for this indication (dose expressed in mg/kg body weight):
35-50 mg/kg body weight per day in 3 divided doses for 5-10 days, not exceeding 2400 mg per day.
Giardiasis (lambliasis)
Adults:

• 1 tablet of 250 mg 3 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 7-10 days. Children from 7 to 10 years:
• 4 tablets of 250 mg (1000 mg) once a day for 3 days. Children from 3 to 7 years:
• 3 tablets of 250 mg (750 mg) once a day for 3 days. Children from 1 year to 3 years:
• 2 tablets of 250 mg (500 mg) once a day for 3 days.

Alternative dosing regimen for this indication (dose expressed in mg/kg body weight):
15-40 mg/kg body weight per day divided into 2-3 doses.
Treatment of Helicobacter pyloriinfection (called eradication)
Metronidazole is used for at least 7 days in combination with other medicines recommended for the treatment of Helicobacter pyloriinfections.
Adults:

• 2 tablets of 250 mg (500 mg) 2-3 times a day for 7-14 days. Children and adolescents:
• 20 mg/kg body weight per day, 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 2-3 times a day for 3 days. Children:
• 35-50 mg/kg body weight per day in three divided doses for 3 days.

Acute peri-dental infections
Adults:

• 1 tablet of 250 mg 2-3 times a day for 3-7 days. Infants and children with a body weight of less than 10 kg:
• administer proportionally smaller doses.

Ulcers of the lower limbs and bedsores
Adults:

• 2 tablets of 250 mg (500 mg) twice a day for 7 days.

Method of administration

The medicine is taken orally.

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

The line on the tablet only facilitates its crushing, for easier swallowing, and not for dividing into equal doses.
A solution for injections and infusions is also available.
Do not change the dosage of the medicine yourself.

Use in patients with liver failure

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 failure

Reducing the dose of the medicine in these patients is not necessary.
In patients undergoing haemodialysis, metronidazole and its metabolites are removed during 8 hours of dialysis, so the patient should take another dose of metronidazole immediately after dialysis.
In patients undergoing intermittent or continuous ambulatory peritoneal dialysis, there is no need to change the dosage.

Use in elderly patients

In elderly patients, the medicine should be used with caution, especially when administering large doses.

Using a higher dose of Metronidazole Polpharma than recommended

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

Missing a dose of Metronidazole Polpharma

In case of missing a dose, take it as soon as possible. If it is almost 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 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.

If the patient experiences any of the following serious side effects, they should stop taking Metronidazole Polpharma and contact their doctor immediately:

• rare side effects(occurring in less than 1 in 1,000 people):
• agranulocytosis (lack of granulocytes in the blood), 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, ecchymosis, nosebleeds),
• anaphylaxis.
• side effects with unknown frequency(frequency cannot be estimated from the available data):
• angioedema (swelling of the face, tongue and trachea, causing breathing difficulties),
• urticaria,
• fever,
• acute liver failure in patients with Cockayne syndrome (see section 2 "Warnings and precautions").

Other side effects that may occur after taking metronidazole

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

• psychotic disorders, including confusion and hallucinations;
• encephalopathy (brain disorders, e.g. confusion, fever, headache, hallucinations, paralysis, sensitivity to light, vision and movement disorders, stiffness of the neck) and subacute cerebellar syndrome (e.g. coordination disorders, speech disorders, gait disorders, nystagmus and tremors), which may resolve after discontinuation of the medicine;
• drowsiness, dizziness, convulsions, headaches;
• vision disorders, such as double vision and myopia, usually transient;
• increased liver enzyme activity (ASAT, ALAT, alkaline phosphatase), hepatitis, liver cell damage, jaundice and pancreatitis, resolving after discontinuation of the medicine; in patients treated with metronidazole in combination with other antibiotics, cases of liver failure requiring liver transplantation have been reported;
• rash, pustular eruptions, itching, redness;
• muscle pain, joint pain;
• darkening of urine colour due to the presence of water-soluble dyes formed during metronidazole metabolism. side effects with unknown frequency(frequency cannot be estimated from the available data):
• leukopenia (reduced white blood cell count);
• loss of appetite;
• depressive mood;
• peripheral sensory neuropathy (numbness, tingling, e.g. pinching, burning) or transient seizure-like episodes [reported during intensive and/or prolonged treatment with metronidazole]; in most cases, neuropathy resolved after discontinuation of the medicine or dose reduction;
• aseptic meningitis;
• optic neuropathy or optic neuritis;
• taste disorders, oral mucosa inflammation, hairy tongue, nausea, vomiting, gastrointestinal disorders, such as abdominal pain and diarrhoea;
• erythema multiforme, Stevens-Johnson syndrome (blisters turning into ulcers, on the mucous membranes of the mouth, conjunctiva, genital organs), toxic epidermal necrolysis (rash-blisters in the skin and mucous membranes leading to exfoliation of large skin areas and exposure of large skin areas);

genital and anal pruritus, vaginal and genital candidiasis.

• vaginal and genital candidiasis.

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 Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Jerozolimskie Avenue 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.
Store in the original packaging. Do not store above 25°C.
Do not use this medicine after the expiry date stated on the packaging.
The expiry date refers to the last day of the 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 no longer required. 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 250 mg of metronidazole.
• The other ingredients are: potato starch, gelatine, glucose syrup, magnesium stearate.

What Metronidazole Polpharma looks like and contents of the pack

White tablets with a yellowish tint, turning yellow under the influence of light, round, flat on both sides, with a line on one side.
The line on the tablet only facilitates its crushing, for easier swallowing, and not for dividing into equal doses.
The packaging contains 20 tablets.

Marketing authorisation holder and manufacturer

Marketing authorisation holder

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

Manufacturer

Polpharma S.A. Pharmaceutical Works
Pelplińska 19, 83-200 Starogard Gdański
Polpharma S.A. Medana Branch in Sieradz
Władysława Łokietka 10, 98-200 Sieradz
Date of last revision of the leaflet: