Metronidazol Polpharma

Package Leaflet: Information for the Patient

Metronidazol Polpharma, 500 mg, Vaginal Tablets

Metronidazole

Read the Leaflet Carefully Before Using the Medication, as it Contains Important Information for the Patient.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you. 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 those not listed in this leaflet, please inform your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet

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

Metronidazol Polpharma is a medicine with anti-protozoal and antibacterial effects.
The medicine 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 you are 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 Metronidazol Polpharma, discuss it with your doctor:

• if you have severe liver dysfunction (in these patients, metronidazole is metabolized slowly, which may lead to accumulation of the medicine and its metabolites in the body)
• if you have epilepsy or other neurological diseases
• if you have leukopenia (reduced white blood cell count) or have had it in the past (during treatment with vaginal tablets, there is a possibility of exacerbating leukopenia or inducing it, especially during longer or repeated treatment).

During treatment with metronidazole, vaginal candidiasis may occasionally occur, which may require the use of an appropriate antifungal medicine.
During treatment with metronidazole and at least one day after the end of treatment, you should not consume alcoholic beverages, due to the possibility of adverse reactions (see "Metronidazol Polpharma and other medicines").
Metronidazole may affect the results of some laboratory tests (ASAT, ALAT, LDH, triglycerides, glucose hexokinase, white blood cells).
In patients with Cockayne syndrome, cases of severe hepatotoxicity (acute liver failure) have been reported during treatment with metronidazole, including cases resulting in death.
In patients with Cockayne syndrome, the doctor should monitor liver function during and after treatment with metronidazole.
If you experience any of the following symptoms, you should immediately inform your doctor and stop taking metronidazole:

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

Metronidazol Polpharma and Other Medicines

Tell your doctor about all medicines you are taking, have recently taken, or plan to take, especially:

• anticoagulant medicines (e.g., acenocoumarol, warfarin)
• lithium (an antidepressant)
• disulfiram (a medicine used to treat 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)
• busulfan (a medicine used to treat cancer).

Metronidazol Polpharma and Alcohol

Metronidazole increases the toxic effects of alcohol. Consuming alcohol during treatment may cause adverse reactions, such as a feeling of heat, sweating, headaches, nausea, vomiting, and abdominal pain.

Pregnancy and Breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, ask your doctor or pharmacist for advice 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 potential risk to the fetus.
Breastfeeding
Metronidazole passes into breast milk, reaching concentrations similar to those in blood plasma.
During breastfeeding, do not take this medicine. If treatment is necessary, a decision should be made to stop breastfeeding.

Driving and Using Machines

There are no data on the effect of metronidazole on the ability to drive and use machines.

3. How to Use Metronidazol Polpharma

Always use this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.

Adults and Adolescents

The recommended dose is: vaginally, 1 tablet of 500 mg in the evening for 10 days.
Note:
Treatment of trichomoniasis is 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, simultaneous treatment in men is not usually necessary.

Method of Administration

Vaginal administration.
In rare cases of significant vaginal dryness, there is a possibility that the tablet may not dissolve and may be expelled from the vagina in an unchanged form. As a result, the treatment may not be optimal. To avoid this situation, it is recommended to gently moisten the tablet with boiled and cooled water before inserting it into a very dry vagina.
Do not interrupt treatment during menstruation.

Using More Than the Recommended Dose of Metronidazol Polpharma

If you have used more than the recommended dose of the medicine, consult your doctor immediately.

Missing a 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 take a double dose to make up for the missed dose.
If you have any further questions about using this medicine, ask your doctor or pharmacist.

4. Possible Side Effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

If You Experience Any of the Following Serious Side Effects, Stop Using Metronidazol Polpharma and Contact Your Doctor Immediately:

• rare side effects (occurring in less than 1 in 1,000 patients):
• anaphylaxis (severe allergic reaction; symptoms include itching, swelling, difficulty breathing, heart problems, dizziness);
• angioedema (symptoms include swelling of the face, tongue, and throat, which can cause breathing difficulties);
• erythema multiforme (formation of blisters, peeling, or ulcers on the skin or mucous membranes);
• urticaria;
• very rare side effects (occurring in less than 1 in 10,000 patients):
• agranulocytosis (lack of white blood cells called granulocytes), neutropenia (deficiency of a certain type of granulocyte), thrombocytopenia (reduced platelet count), pancytopenia (deficiency of red and white blood cells and platelets). Symptoms of these blood disorders include fever, sore throat, superficial ulcers of the mucous membranes, flu-like symptoms, fatigue, bleeding (e.g., bruising, petechiae, nosebleeds);
• anaphylactic shock (severe allergic reaction accompanied by a decrease in blood pressure);
• psychiatric disorders, including disorientation and hallucinations;
• side effects with unknown frequency (frequency cannot be estimated from available data):
• leukopenia (reduced white blood cell count). Symptoms may include the appearance of aphthae and ulcers in the mouth, as well as fatigue, concentration problems, and decreased well-being;
• acute liver failure in patients with Cockayne syndrome (see section 2 "Warnings and Precautions").

Other Side Effects

Common side effects (occurring in less than 1 in 10 patients):

• vaginal candidiasis (vaginal itching, pain during sexual intercourse; thick, white, odorless or mildly smelling discharge).

Uncommon side effects (occurring in less than 1 in 100 patients):

• headache, neuropathy (numbness, tingling in limbs), dizziness, coordination disorders, drowsiness, taste disorders;
• diarrhea, nausea or vomiting, changes in taste, including metallic taste, dry mouth, coated tongue;
• abdominal cramps;
• burning pain when urinating or frequent urination, dark urine;
• vulvitis (itching, burning pain, or redness in the genital area), irritation of the partner's penis;
• discomfort at the application site, irritation at the application site;
• fever, feeling of weakness.

Rare side effects (occurring in less than 1 in 1,000 patients):

• rash.

Very rare side effects (occurring in less than 1 in 10,000 patients):

• liver function disorders (e.g., increased activity of aminotransferases and bilirubin in serum). Side effects with unknown frequency (frequency cannot be estimated from available data):
• loss of appetite;
• depressive mood, nervousness.

Reporting Side Effects

If you experience any side effects, including those not listed in this leaflet, please inform 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
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 authorization holder.
By reporting side effects, you can help provide more information on the safety of this 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 month.
The inscription on the blister 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 Pack and Other Information

What Metronidazol Polpharma Contains

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

What Metronidazol Polpharma Looks Like and Contents of the Pack

White or yellowish-white tablets, shaped like elongated rods with rounded ends.
The pack contains 10 vaginal tablets.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Zakłady Farmaceutyczne POLPHARMA S.A.
ul. Pelplińska 19, 83-200 Starogard Gdański
phone: +48 22 364 61 01

Manufacturer

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

Date of Last Revision of the Leaflet: