Vilantrin

PATIENT INFORMATION LEAFLET

Leaflet accompanying the packaging: patient information

Vilantrin, 500 mg, vaginal capsules

Metronidazole

Please read the contents of the leaflet carefully before using the medicine, as it contains important information for the patient.

• Please keep this leaflet, so that you can read it again if you need to.
• If you have any doubts, you should 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 inform their doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is Vilantrin and what is it 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 packaging and other information

1. What is Vilantrin and what is it used for

Vilantrin is a medicine containing metronidazole with antibacterial and antiprotozoal properties, in the form of vaginal capsules.
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 is hypersensitive (allergic) to metronidazole, other 5-nitroimidazole derivatives, or to the excipient (listed in section 6).
• If the patient is in the first trimester of pregnancy.

Warnings and precautions

Before starting treatment with Vilantrin, the patient should discuss it with their doctor or pharmacist.
Vilantrin should be used with caution in patients:

• with active central nervous system disease (e.g., epilepsy),
• with severe liver dysfunction or hepatic encephalopathy,
• with abnormal blood counts - leukopenia (reduced white blood cell count) or a history of leukopenia.

Vilantrin may affect the results of some laboratory tests (ASAT, ALAT, LDH, triglycerides, leukocytes, glucose hexokinase).
During treatment with Vilantrin, the risk of vaginal or cervical candidiasis may increase.
During treatment with Vilantrin and for at least two days after completion of treatment, the patient should not consume alcohol, due to the risk of side effects.
During treatment with metronidazole in patients with Cockayne syndrome, cases of severe hepatotoxicity (acute liver failure), including fatal cases, have been reported. 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, clay-colored or loose stools, or skin itching.

Vilantrin and other medicines

The patient should inform their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take. In particular, the patient should inform their doctor about:

• medicines that increase liver enzyme activity, such as antiepileptic drugs (phenobarbital, phenytoin);
• medicines that decrease liver enzyme activity, such as a drug used to treat stomach and duodenal ulcers (cimetidine);
• anticoagulant medicines - coumarin derivatives (e.g., warfarin);
• a medicine used to treat bipolar affective disorders, mania, and recurrent depressive disorders (lithium);
• a medicine used to treat alcoholism (disulfiram). The patient should not take Vilantrin during disulfiram treatment and for 2 weeks after its completion.

Using Vilantrin with alcohol

Metronidazole enhances the toxic effects of alcohol. The patient should avoid consuming alcohol during treatment with Vilantrin and for 48 hours after its completion.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before using this medicine.
This medicine should not be used during the first trimester of pregnancy (if the woman could be pregnant, a pregnancy test should be performed before starting treatment). In the second and third trimesters of pregnancy, the medicine may be used only if, in the doctor's opinion, it is necessary, and other treatment methods are ineffective or contraindicated.
This medicine should not be used during breastfeeding, as metronidazole passes into breast milk. If there is a need to use the medicine, breastfeeding should be discontinued.

Driving and using machines

There is no data on the effect of Vilantrin on the ability to drive and use machines.

3. How to use Vilantrin

This medicine should always be used according to the doctor's recommendations. If there are any doubts, the patient should consult their doctor or pharmacist.

Adults and adolescents (12-18 years old):

The recommended dose is:
One vaginal capsule (500 mg) per night for 10 days.

Note:

Trichomoniasis treatment should be performed 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.

Using a higher dose of Vilantrin than recommended

In case of taking a higher dose of the medicine than recommended, the patient should contact their doctor.

Missing a dose of Vilantrin

In case of missing a dose, the patient should take the missed dose as soon as possible. Then, they should apply the next dose at the usual time. However, if this means taking two doses in a short period, the patient should not take the missed dose. The patient should not take a double dose to make up for the missed dose.

4. Possible side effects

Like all medicines, Vilantrin can cause side effects, although not everybody gets them.
During treatment with Vilantrin, the following side effects may occur:

• genital tract disorders, such as fungal infections ( Candida) in the genital area;
• metallic taste in the mouth, dry mouth, tongue inflammation;
• gastrointestinal disorders: nausea, abdominal pain;
• headache;
• dark urine (due to metronidazole metabolites);
• burning sensation while urinating;
• vulvitis;
• irritation, itching, swelling, hypersensitivity of the vagina.

During systemic administration of metronidazole, changes have occurred that may also occur after vaginal administration (e.g., skin and subcutaneous tissue disorders, such as skin reactions (hives); cerebellar dysfunction; consciousness disorders; seizures). Treatment with this medicine should be discontinued in case of neurological symptoms (nervous system disorders).

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in the leaflet, they should inform their doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, 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. Side effects can also be reported to the marketing authorization holder. By reporting side effects, more information can be gathered on the safety of the medicine.

5. How to store Vilantrin

Store at a temperature below 25°C.
The medicine should be stored in a place inaccessible and invisible to children.
Do not use after the expiry date stated on the packaging. The expiry date refers to the last day of the specified month.

6. Contents of the packaging and other information

What Vilantrin contains

• The active substance of the medicine is metronidazole. One vaginal capsule contains 500 mg of metronidazole.
• The excipient is solid fat.

What Vilantrin looks like and what the packaging contains

The outer packaging is a cardboard box containing 10 cream-white vaginal capsules in PVC/PE blisters and a leaflet.

Marketing authorization 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
To obtain more detailed information about this medicine, please contact the marketing authorization holder: Farmina sp. z o.o., tel.: +48 12 290 90 00

Date of the last update of the leaflet: