Package leaflet: Information for the user

Warning!
Keep this leaflet. The 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 this medicine, as it contains
important information for the patient.

Keep this leaflet, as you may need to read it again.
If you have any questions, please consult your doctor, pharmacist, or nurse.
This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm others, even if their symptoms are the same.
If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. 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, without affecting 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 simultaneous presence 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 morphological blood abnormalities, she should inform her doctor before starting treatment.
Do not use the medicine for prolonged periods. When large doses of chlorinated quinoline derivatives (including chlorquinaldol) are used long-term, sensory disturbances, muscle weakness, pain, and visual disturbances (symptoms of so-called subacute myelo-optic neuropathy) may occur.
This medicine is intended for vaginal use only. Do not take it orally.
Avoid using the medicine during menstruation.
Both during infection and treatment, sexual intercourse should be avoided.
When treating a vaginal infection in a patient, it is recommended that her partner also receives appropriate treatment.

Severe hepatotoxicity (acute liver failure), including fatal cases, has been reported in patients with Cockayne syndrome treated with medicines containing metronidazole.
In patients with Cockayne syndrome, liver function should be monitored by the physician during and after treatment with metronidazole.
If any of the following symptoms occur, the patient must immediately inform her doctor and discontinue metronidazole:

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

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

If the patient is taking any of the following medicines, she should inform her doctor, as special precautions may be necessary:
disulfiram (used in alcohol dependence) – when used concomitantly 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 compounds and iodine preparations – may reduce the effectiveness of chlorquinaldol.
If the patient is to undergo blood laboratory tests, she should inform the laboratory about using Gynalgin, as it may affect results of certain tests (determination of AlAT, AspAT, lactic acid, triglycerides, glucose hexokinase).
Alcohol consumption may cause an alcohol intolerance reaction (so-called disulfiram-like reaction).

The likelihood of the above effects occurring during treatment with Gynalgin is low because serum concentrations of metronidazole achieved with vaginal administration are minimal.
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 is advised when using Gynalgin during breastfeeding.
Driving and using machines
Gynalgin has no effect or negligible effect on the ability to drive motor vehicles and operate machinery.

3. How to use Gynalgin

This medicine should always be used according to the doctor's instructions. 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 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 may 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
No cases of overdose have been reported so far.
In case of accidental or mistaken oral ingestion of the medicine, seek medical advice immediately.
Treatment consists of removing the medicine from the body (inducing vomiting, gastric lavage).
Metronidazole can be removed from blood serum by hemodialysis or peritoneal dialysis.
Missed dose of Gynalgin
If you miss a dose at the scheduled time, take it as soon as possible. However, if it is almost time for
the next dose, skip the missed dose. Do not use a double dose to make up for the missed dose.
Stopping treatment with Gynalgin
If treatment with Gynalgin is stopped 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 medicinal product can cause adverse reactions, although not everyone experiences them.
The frequency of the adverse reactions listed below is unknown (cannot be determined from 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, dryness of the mouth.
Dark discolouration of urine.
Itching, irritation and burning in the vagina, discomfort in the pelvic area, 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 your doctor, pharmacist or nurse. 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 the collection of additional 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 package 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 ingredients: citric acid, monohydrate lactose, rice starch, sodium carboxymethyl starch, macrogol 6000, magnesium stearate.

What Gynalgin looks like and contents of the pack
Beige-colored, smooth, elongated tablets with 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 authorisation holder or the parallel importer.

Marketing authorisation holder in Bulgaria, country of export:
Mylan EOOD
“Serdika offices” office building
48, Sitnyakovo Blvd., 7 floor
1505 Sofia
Bulgaria

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

Parallel importer:
Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź
Poland

Repackaged in:
Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź
Poland

Marketing authorisation number in Bulgaria, country of export: 9800185
Parallel import licence number: 58/15