PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

Warning! Keep the leaflet; information on the immediate packaging is in a foreign language!
Gynalgin
250 mg + 100 mg, vaginal tablets
Metronidazolum + Chlorquinaldolum
Please read the entire leaflet carefully before using the medicine, as it contains
important information for the patient.

Keep this leaflet for future reference.
If you have any questions, consult your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not share it with others. This medicine may harm other people, even if their symptoms are the same.
If you experience any adverse reactions, including those not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents

What Gynalgin is and what it is used for
Important information before using Gynalgin
How to use Gynalgin
Possible side effects
How to store Gynalgin
Contents of the pack and other information

1. What Gynalgin is and what it is used for

Gynalgin is a combination medicine containing two active substances: metronidazole and
chlorquinaldol. Metronidazole belongs to a group of medicines with antibacterial (mainly against
anaerobic bacteria) and antiprotozoal activity, and does not affect the physiological bacterial flora
of the vagina.
Chlorquinaldol, on the other hand, has antibacterial, antifungal, and antiprotozoal properties.
The combination of these two substances results in a medicine with broad-spectrum antibacterial,
antifungal, and antiprotozoal activity.
Gynalgin is used in the treatment of vaginal infections caused by susceptible bacteria and the
protozoan Trichomonas vaginalis.
Gynalgin is effective in treating inflammatory conditions of the vagina caused by a combination of
bacteria, Trichomonas vaginalis, and fungi.

2. Important information before using Gynalgin

When not to use Gynalgin

If the patient is allergic to metronidazole, chlorquinaldol, or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Before starting treatment with Gynalgin, discuss with your doctor or pharmacist:

If the patient has severe liver impairment or current or past blood morphology disorders, she should inform her doctor before starting treatment;
Do not use the medicine long-term; prolonged use of high doses of chlorinated derivatives of quinoline (including chlorquinaldol) may lead to sensory disturbances, muscle weakness, pain, and visual disturbances (symptoms of so-called subacute myelo-optic neuropathy);
This medicine is intended for vaginal use only. Do not take it orally;
Avoid using the medicine during menstruation;
Both during infection and during treatment, sexual intercourse should be avoided;
During treatment of vaginal infection, appropriate treatment of the patient's partner is also recommended.

In patients with Cockayne syndrome, severe hepatotoxicity (acute liver failure), including fatal cases, has been reported during treatment with metronidazole-containing medicines.
In patients with Cockayne syndrome, liver function should be monitored by the physician during and after treatment with metronidazole.
If the patient develops any of the following symptoms, the physician should be informed immediately and metronidazole should be discontinued:

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

Gynalgin with other medicines
Inform your doctor about all medicines currently or recently taken, as well as any medicines the patient plans to use.

If the patient is taking any of the following medicines, she should inform her doctor, as special caution may be required:
disulfiram (used in alcohol dependence) – when used with metronidazole may cause psychotic reactions and confusion;
warfarin (used to treat blood clots);
lithium (used to treat depression);
cyclosporine (used after organ transplantation);
5-fluorouracil (used in cancer treatment);
metallic and iodine compounds – may reduce the effectiveness of chlorquinaldol.
If the patient is to undergo blood laboratory tests, she should inform the doctor about using Gynalgin, as it may affect the results of certain tests (determination of AlAT, AspAT, lactic acid, triglycerides, glucose hexokinase);
Alcohol consumption may cause alcohol intolerance reaction (so-called disulfiram-like reaction).

The likelihood of the above effects occurring during treatment with Gynalgin is low, because when metronidazole is administered vaginally, serum concentrations achieved are low.
Gynalgin and alcohol
Do not drink alcohol during treatment with Gynalgin, as an alcohol intolerance reaction may occur.
Pregnancy, breastfeeding and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult her doctor before using this medicine.
Gynalgin should not be used during pregnancy unless absolutely necessary. Caution should be exercised when using the medicine during breastfeeding.
Driving and operating machinery
Gynalgin has no effect or negligible effect on the ability to drive motor vehicles and operate machinery.

3. How to use Gynalgin

Always use this medicine exactly as recommended by your doctor. If in doubt, consult your doctor.
This medicine is intended for vaginal use only. Do not take it orally.

Recommended dose
Adults
One tablet deeply inserted into the vagina once daily, preferably at bedtime.
Treatment should begin 2 to 4 days after the end of menstruation and continue for 10 days. If necessary, your doctor will recommend repeating the treatment cycle.

Children and adolescents under 18 years of age
Use of the medicine is not recommended.

Elderly patients
No dose adjustment is necessary.

Patients with liver or kidney function disorders
No dose adjustment is necessary.

Use of a higher than recommended dose of Gynalgin
There have been no reports of overdose so far.
In case of accidental or mistaken oral ingestion of the medicine, seek immediate medical advice.
Treatment consists of removing the medicine from the body (inducing vomiting, gastric lavage).
Metronidazole can be removed from blood serum by haemodialysis or peritoneal dialysis.

Missed dose of Gynalgin
If you miss a dose at the scheduled time, use it as soon as possible. However, if the time for the next dose is approaching, skip the missed dose. Do not use a double dose to make up for the missed dose.

Discontinuation of Gynalgin
If treatment with Gynalgin is discontinued prematurely, symptoms of vaginitis may worsen.

If you have any further doubts regarding 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 everyone will experience them.
The frequency of the adverse reactions listed below is unknown (cannot be determined from the available data).

Pain and dizziness, abnormal sensory sensations in the limbs;
Depression, sleep disorders;
Cramping abdominal pain, discomfort in the abdominal cavity, nausea, vomiting, unpleasant taste in the mouth, diarrhoea, constipation, bloating, dry mouth;
Darkening of urine;
Itching, irritation and burning in the vagina, pelvic discomfort, vaginal discharge, swelling of the labia, menstrual disorders, vaginal bleeding, spotting;
Skin itching;
Muscle cramps;
Feeling of excessive fatigue, increased irritability;
Leakage of the preparation from the vagina;
Decreased appetite;
Symptoms of subacute myelooptic neuropathy (sensory disturbances, muscle weakness, pain, visual disturbances).

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform a 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, phone: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl
Reporting adverse reactions allows gathering further information on the safety of using the medicine.

5. How to store Gynalgin

Store below 25°C. Keep in the original packaging.
Keep the medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the stated month.
Medicines must not be disposed of via wastewater or household waste.
Ask your pharmacist how to dispose of medicines no longer in use.
This will help protect the environment.

6. Contents of the pack and other information

What Gynalgin contains

The active substances are metronidazole and chlorquinaldol. Each vaginal tablet contains 250 mg of metronidazole and 100 mg of chlorquinaldol.
Other components are: citric acid, monohydrate lactose, rice starch, sodium carboxymethyl starch (type C), macrogol 6000, magnesium stearate.

What Gynalgin looks like and contents of the pack
Beige-colored, smooth, elongated tablets with a marbled surface and engraved with the letter "G".
The medicine is available in a pack containing 10 tablets (2 blisters made of Al/OPA/Al/PVC foil, each containing 5 tablets, in a cardboard box).
For more detailed information, please contact the marketing authorization holder or the parallel importer.

Marketing authorization holder in Bulgaria, country of export:
Mylan EOOD
Office building “Serdika Offices”
Sitnyakovo Blvd. 48, fl. 7
1505 Sofia,
Bulgaria

Manufacturer:
ICN Polfa Rzeszów S.A.
Przemysłowa Street 2
35-959 Rzeszów
Poland

Parallel importer:
Medezin Sp. z o.o.
Zbąszyńska Street 3
91-342 Łódź

Repackaged in:
Medezin Sp. z o.o.
Zbąszyńska Street 3
91-342 Łódź
CEFEA Sp. z o.o. Sp. komandytowa
Działkowa Street 56
02-234 Warsaw
Pharma Innovations Sp. z o.o.
Jagiellońska Street 76
03-301 Warsaw
SHIRAZ PRODUCTIONS Sp. z o.o.
Tymiankowa Street 24/28
95-054 Ksawerów
CANPOLAND SPÓŁKA AKCYJNA
Beskidzka Street 190
91-610 Łódź

Marketing authorization number in Bulgaria, country of export: 9800185
Parallel import authorization number: 378/22