VILANTRIN

Package leaflet: Information for the patient

Vilantrin, 500 mg, globules
Metronidazolum
Please read the entire leaflet carefully 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, please 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 is Vilantrin and what it is used for
2. Important information before using Vilantrin
3. How to use Vilantrin
4. Possible side effects
5. How to store Vilantrin
6. Contents of the pack and other information

1. What is Vilantrin and what it is used for

Vilantrin is a medicine containing metronidazole, which has antibacterial and antiprotozoal activity, and is available in the form of vaginal globules.
Vilantrin is indicated for local treatment of:

• Trichomoniasis caused by Trichomonas vaginalis;
• Bacterial vaginosis caused by Gardnerella vaginalis, Bacteroides spp., Mycoplasma hominis.

2. Important information before using Vilantrin

When not to use Vilantrin:

• If the patient has hypersensitivity (allergy) to metronidazole, other 5-nitroimidazole derivatives, or to any excipient (listed in section 6).
• If the patient is in the first trimester of pregnancy.

Warnings and precautions

Before starting treatment with Vilantrin, consult a doctor or pharmacist.
Vilantrin should be used with caution in patients:

• with active central nervous system disorders (e.g. epilepsy),
• with severe liver function impairment or hepatic encephalopathy,
• with blood abnormalities – leukopenia (reduced white blood cell count) or history of leukopenia.

Vilantrin may affect the results of certain laboratory tests (AspAT, AlAT, LDH, triglycerides, leukocytes, glucose hexokinase).
During treatment with Vilantrin, there may be an increased risk of Candida vulvovaginitis or cervicitis.
Alcohol must not be consumed during treatment with Vilantrin and for at least two days after completion of therapy due to the risk of adverse reactions.
Severe hepatotoxicity (including acute liver failure), sometimes fatal, has been reported in patients with Cockayne syndrome receiving metronidazole. Liver function should be monitored during and after treatment with metronidazole in patients with Cockayne syndrome.
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, pale or loose stools, or skin itching.

Vilantrin and other medicines

Inform the doctor or pharmacist about all medicines currently used, recently used, or planned for use. In particular, inform the doctor about concomitant use of:

• drugs that increase liver enzyme activity, e.g. antiepileptic drugs (phenobarbital, phenytoin);
• drugs that decrease liver enzyme activity, e.g. drugs used in peptic ulcer disease (cimetidine);
• anticoagulants – coumarin derivatives (e.g. warfarin);
• drugs used in bipolar affective disorders, manic states, and recurrent depressive disorders (lithium);
• drugs used in alcoholism treatment (disulfiram). Vilantrin must not be used during disulfiram therapy or within 2 weeks after its discontinuation.

Use of Vilantrin with alcohol

Metronidazole intensifies the toxic effects of alcohol. Alcohol consumption must be avoided during treatment with Vilantrin and for 48 hours after its completion.

Pregnancy and breastfeeding

If the patient is pregnant, breastfeeding, suspects she may be pregnant, or is planning pregnancy, she should consult a doctor or pharmacist before using this medicine.
This medicine must not be used during the first trimester of pregnancy (if pregnancy is possible, a pregnancy test should be performed before starting treatment). In the second and third trimesters of pregnancy, the drug may be used only if considered necessary by the physician and when alternative treatments are ineffective or contraindicated.
This medicine should not be used during breastfeeding, as metronidazole passes into breast milk. If treatment is necessary, breastfeeding should be discontinued.

Driving and operating machinery

There are no data available on the effect of Vilantrin on the ability to drive vehicles or operate machinery.

3. How to use Vilantrin

This medicine should always be used exactly as your doctor has instructed. If you are unsure, consult your doctor or pharmacist.
Adults and adolescents (aged 12–18 years):
The recommended dose is:
One vaginal globule (500 mg) at night for 10 days.
Note:
Treatment of trichomoniasis 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 vaginitis, concomitant treatment in men is generally not necessary.
Taking more Vilantrin than recommended
If you take more than the recommended dose, contact your doctor immediately.
If you miss a dose of Vilantrin
If you miss a dose, take it as soon as possible. Then take the next dose at the usual time. However, if this would mean taking two doses in a short interval, do not take the missed dose. Do not take a double dose to make up for a missed dose.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everybody will experience them.
The following adverse reactions may occur during treatment with Vilantrin:

• genital disorders, such as fungal infections ( Candida ) in the genital area;
• metallic taste in the mouth, dry mouth, inflammation of the tongue;
• gastrointestinal disturbances: nausea, abdominal pain;
• headache;
• darkening of urine (due to metabolites of metronidazole);
• burning sensation during urination;
• vulvitis;
• irritation, itching, swelling, increased sensitivity of the vagina.

When metronidazole is administered systemically, the following reactions have been observed, which may also occur after vaginal administration (including: skin and subcutaneous tissue disorders, such as skin reactions (urticaria); cerebellar dysfunction; disturbances of consciousness; seizures). Treatment with this medicine should be discontinued if neurological symptoms (nervous system disorders) occur.

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

5. How to store Vilantrin

Store below 25°C.
Keep the medicine out of the reach and sight of children.
Do not use after the expiry date stated on the packaging. The expiry date refers to the last day of the stated month.

6. Contents of the pack and other information

What Vilantrin contains

• The active substance is metronidazole. Each vaginal globule contains 500 mg of metronidazole.
• The excipient is hard fat.

What Vilantrin looks like and contents of the pack
The outer packaging is a cardboard box containing 10 white-cream vaginal globules in PVC/PE blisters and a package leaflet.
Marketing Authorisation Holder
Farmina sp. z o.o.
ul. Lipska 44
30-721 Kraków
Manufacturer
Farmina sp. z o.o.
ul. Lipska 44
30-721 Kraków
Farmina sp. z o.o.
Myślenice Plant
ul. Cegielskiego 2
32-400 Myślenice

For further information on this medicinal product, please contact the Marketing Authorisation Holder: Farmina sp. z o.o., tel.: +48 12 290 90 00