Metronidazole polpharma

Package leaflet: Information for the patient

Metronidazol Polpharma, 500 mg, vaginal tablets
Metronidazolum
Please read carefully all the information in this leaflet before using the medicine, as it contains
important information for the patient.

• Keep this leaflet so that you can read it again if necessary.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If any adverse reactions occur in the patient, 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 Polpharma is and what it is used for
2. Important information before using Metronidazol Polpharma
3. How to use Metronidazol Polpharma
4. Possible side effects
5. How to store Metronidazol Polpharma
6. Contents of the pack and other information

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

Metronidazol Polpharma is an antimicrobial and antiprotozoal medicine.
It is indicated for local treatment of trichomoniasis caused by Trichomonas vaginalis
and bacterial vaginosis caused by Gardnerella vaginalis, Bacteroides spp.,
Mycoplasma hominis.

2. Important information before using Metronidazol Polpharma

When not to use Metronidazol 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),
• during the first trimester of pregnancy.

Warnings and precautions
Before starting treatment with Metronidazol Polpharma, discuss with your doctor if:

• the patient has severe liver function disorders (in these patients, metronidazole is metabolized slowly, which may lead to accumulation of the drug and its metabolites in the body),
• the patient has epilepsy or other neurological diseases,
• the patient has leukopenia (low white blood cell count) or has ever had it in the past (during use of vaginal tablets, leukopenia may worsen or may be induced, especially during prolonged or repeated treatment).

During treatment with metronidazole, inflammation of the cervix or vagina caused by yeast may occasionally occur, which may require treatment with an appropriate antifungal medicine.
During treatment with metronidazole and for at least one day after completion of treatment, alcoholic beverages should not be consumed due to the possibility of adverse reactions (see "Metronidazol Polpharma with other medicines").
Metronidazole may affect the results of certain laboratory tests (AspAT, AlAT, LDH, triglycerides, glucose hexokinase, leukocytes).
Severe hepatotoxicity (acute liver failure), including fatal cases, have been reported in patients with Cockayne syndrome treated with metronidazole-containing medicines.
In patients with Cockayne syndrome, the doctor should monitor liver function during and after treatment with metronidazole.
If any of the following symptoms occur, the patient should immediately inform the doctor and discontinue metronidazole:

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

Metronidazol Polpharma with other medicines
Tell your doctor about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take, especially:

• anticoagulant drugs of the coumarin type (e.g. acenocoumarol, warfarin),
• lithium (an antidepressant medicine),
• disulfiram (a medicine used in the treatment of alcoholism). Treatment with metronidazole should not begin until at least 2 weeks after discontinuation of disulfiram therapy,
• drugs that increase the activity of liver enzymes (e.g. phenytoin, phenobarbital),
• drugs that decrease the activity of liver enzymes (e.g. cimetidine),
• busulfan (a medicine used in cancer treatment).

Metronidazol Polpharma and alcohol
Metronidazole intensifies the toxic effects of alcohol. Consumption of alcohol during treatment may cause adverse reactions such as flushing, sweating, headache, nausea, vomiting, and epigastric pain.

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should consult a doctor or pharmacist before using this medicine.

Pregnancy
The medicine is contraindicated during the first trimester of pregnancy. In the second and third trimesters of pregnancy, the medicine may be used only if, in the opinion of the doctor, the expected benefit to the mother outweighs the potential risk to the fetus.

Breastfeeding
Metronidazole passes into human milk, reaching concentrations similar to those in plasma. The medicine should not be taken during breastfeeding. If treatment is necessary, a decision should be made to discontinue breastfeeding.

Driving and operating machinery
There is no data available on the effect of metronidazole on the ability to drive vehicles or operate machinery.

3. How to use Metronidazol Polpharma

This medicine should always be used as prescribed by your doctor. If in doubt, consult your doctor or pharmacist.

Adults and adolescents
The recommended dose is: one 500 mg vaginal tablet in the evening for 10 days.

Note:
Trichomoniasis treatment should be carried out simultaneously in both sexual partners, as asymptomatic trichomoniasis in men is a common source of reinfection in women.
In the case of bacterial vaginosis, concomitant treatment in men is generally not necessary.

Method of administration
Vaginal administration.

In rare cases of significant vaginal dryness, the tablet may not dissolve and may be expelled intact from the vagina. As a result, treatment may not be optimal. To avoid this situation, it is recommended to moisten the tablet gently with boiled and cooled water before inserting it into a very dry vagina.

Do not interrupt treatment during menstruation.

Use of a higher than recommended dose of Metronidazol Polpharma
If a higher than recommended dose of the medicine is used, consult your doctor immediately.

Missed dose of Metronidazol Polpharma
If you miss a dose, take it as soon as possible. If it is already time for the next dose, do not take the missed dose. Do not use a double dose to make up for a missed dose.

If you have any further doubts concerning the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everybody will experience them.
If the patient experiences any of the following serious adverse reactions, she should stop using
Metronidazol Polpharma and contact her doctor immediately:

• Adverse reactions occurring rarely (occur in less than 1 out of 1,000 patients):
  • Anaphylaxis (severe allergic reaction; symptoms include, for example, itching, swelling, breathing difficulties, disturbances in heart function, dizziness);
  • Angioedema (symptoms include, for example, swelling of the face, tongue, and trachea, causing breathing difficulties);
  • Erythema multiforme (formation of blisters, skin peeling, or ulceration of the skin or mucous membranes);
  • Urticaria;
• Adverse reactions occurring very rarely (occur in less than 1 out of 10,000 patients):
  • Agranulocytosis (absence in blood of white blood cells called granulocytes), neutropenia (deficiency of a certain type of granulocytes), thrombocytopenia (reduced number of blood platelets), pancytopenia (deficiency of red and white blood cells as well as platelets). Symptoms of these blood disorders include, among others, fever, sore throat, superficial ulcers of the oral mucosa, flu-like symptoms, fatigue, bleeding (e.g. bruising, petechiae, purpura, nosebleeds);
  • Anaphylactic shock (severe allergic reaction associated with a drop in blood pressure);
  • Psychiatric disorders, including disorientation and hallucinations;
• Adverse reactions occurring with unknown frequency (frequency cannot be estimated from available data):
  • Leukopenia (reduced number of white blood cells). Symptoms may include the appearance of aphthous ulcers and oral mucosal ulceration, as well as fatigue, difficulty concentrating, and reduced well-being;
  • Acute liver failure in patients with Cockayne syndrome (see section 2 "Warnings and precautions").

Other adverse reactions
Adverse reactions occurring frequently (occur in less than 1 out of 10 patients):

• Candidal cervicitis or vaginitis (itching in the vagina, pain during sexual intercourse; thick, white, odourless or mildly odorous vaginal discharge).

Adverse reactions occurring not frequently (occur in less than 1 out of 100 patients):

• Headache, neuropathy (numbness, tingling in limbs), dizziness, coordination disturbances, somnolence, taste disturbances;
• Diarrhoea, nausea or vomiting, taste changes, including metallic taste, dry mouth, coated tongue;
• Abdominal cramps;
• Burning pain during urination or increased frequency of urination, dark urine;
• Vulvitis (itching, burning pain or redness in the genital area), irritation of sexual partner's penis;
• Local discomfort at application site, local irritation at application site;
• Fever, feeling of weakness.

Adverse reactions occurring rarely (occur in less than 1 out of 1,000 patients):

• Rash.

Adverse reactions occurring very rarely (occur in less than 1 out of 10,000 patients):

• Liver function disorders (e.g. increased serum aminotransferase and bilirubin levels). Adverse reactions occurring with unknown frequency (frequency cannot be estimated from available data):
• Loss of appetite;
• Depressed mood, nervousness.

Reporting of adverse reactions
If any adverse symptoms occur, including any adverse symptoms not listed in this leaflet, the patient should inform her doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the 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 can 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 Polpharma

Keep the medicine out of the sight and reach of children.
Store in the original packaging.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the specified month.
The label on the blister pack: the abbreviation EXP indicates the expiry date, and the abbreviation Lot/LOT indicates the batch number.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such practices help protect the environment.

6. Contents of the package and other information

What Metronidazol Polpharma contains

• The active substance is metronidazole. Each vaginal tablet contains 500 mg of metronidazole.
• Other ingredients are: microcrystalline cellulose, povidone, crospovidone, colloidal anhydrous silica, stearic acid.

What Metronidazol Polpharma looks like and contents of the pack
White to slightly yellowish tablets in the form of elongated rods with rounded ends.
The pack contains 10 vaginal tablets.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
POLPHARMA S.A. Pharmaceutical Works
ul. Pelplińska 19, 83-200 Starogard Gdański
tel. +48 22 364 61 01

Manufacturer
POLPHARMA S.A. Pharmaceutical Works
ul. Pelplińska 19, 83-200 Starogard Gdański
POLPHARMA S.A. Pharmaceutical Works
Medana Branch in Sieradz
ul. Władysława Łokietka 10, 98-200 Sieradz