Ginalgin

LEAFLET INCLUDED IN THE PACKAGING: INFORMATION FOR THE PATIENT

Warning! Keep the leaflet, the information on the immediate packaging is in a foreign language!

Gynalgin

250 mg + 100 mg, vaginal tablets

Metronidazole + Chlorquinaldol

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

• You should keep this leaflet, so that you can read it again if necessary.
• In case of any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed to a specific person. It should not be given to others. The medicine may harm another person, even if the symptoms of their illness are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is Gynalgin and what is it used for
• 2. Important information before using Gynalgin
• 3. How to use Gynalgin
• 4. Possible side effects
• 5. How to store Gynalgin
• 6. Contents of the packaging and other information

1. What is Gynalgin and what is it used for

Gynalgin is a combination medicine containing two active substances: metronidazole and chlorquinaldol. Metronidazole belongs to a group of medicines that act antibacterially (mainly on anaerobic bacteria) and antiprotozoally, while not affecting the physiological bacterial flora of the vagina.
Chlorquinaldol, on the other hand, is characterized by antibacterial, antifungal, and antiprotozoal activity. Thanks to the combination of these two substances, a medicine with a wide range of antibacterial, antifungal, and antiprotozoal activity is obtained.
Gynalgin is used to treat vaginal infections caused by susceptible bacteria and Trichomonas vaginalis.
Gynalgin is effective in treating inflammatory conditions of the vagina caused by the 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 to use Gynalgin, you should discuss with your doctor or pharmacist:

• If the patient has severe liver failure or changes in the morphological composition of the blood that are currently present or have occurred in the past, they should tell their doctor before starting to use the medicine;
• The medicine should not be used for a long time, as during such use, large doses of chloroquine derivatives (including chlorquinaldol) may cause sensory disturbances, muscle weakness, pain, and vision disturbances (symptoms of so-called subacute myelo-optic neuropathy);
• The medicine is intended for vaginal use. It should not be used orally;
• The medicine should be avoided during menstruation;
• Both during the infection and during treatment, you should refrain from having sexual intercourse;
• During the treatment of vaginal infection in the patient, it is also recommended to perform appropriate treatment of the partner.

When using metronidazole in patients with Cockayne syndrome, cases of severe hepatotoxicity (acute liver failure), including cases resulting in death, have been reported.
The doctor should monitor liver function during treatment with metronidazole and after its completion in patients with Cockayne syndrome.
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, feeling of fatigue, jaundice, dark urine, sticky or loose stools, or skin itching.

Gynalgin and other medicines

You should tell your doctor about all medicines you are currently taking or have recently taken, as well as any medicines you plan to use.

• If you are taking any of the following medicines, you should tell your doctor, as special caution may be necessary:
• Disulfiram (used in alcohol dependence) - when used with metronidazole, it 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 to treat cancer);
• Metal and iodine compounds - they weaken the effect of chlorquinaldol.
• If you are going to have blood tests, you should tell your doctor that you are using Gynalgin, as it may affect the results of some tests (ALT, AST, lactic acid, triglycerides, hexokinase glucose);
• Consuming alcohol may cause an intolerance reaction to alcohol (so-called disulfiram-like reaction).

The likelihood of the above-mentioned effects during the use of Gynalgin is small, as the concentrations of metronidazole in the serum are low during vaginal use.

Gynalgin and alcohol

When using Gynalgin, you should not drink alcohol, as an intolerance reaction to alcohol may occur.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, you should consult your doctor before using this medicine.
Gynalgin should not be used during pregnancy unless it is absolutely necessary. Caution should be exercised when using the medicine during breastfeeding.

Driving and using machines

Gynalgin does not affect or has a negligible effect on the ability to drive vehicles and use machines.

3. How to use Gynalgin

This medicine should always be used according to the doctor's recommendations. In case of doubts, you should consult a doctor.
The medicine is intended for vaginal use. It should not be used orally.
Recommended dose
Adults
Deeply vaginal 1 tablet 1 time a day, preferably at night.
Treatment should be started from 2 to 4 days after the end of menstruation and continued for 10 days. If necessary, the doctor will recommend repeating the treatment cycle.
Children and adolescents under 18 years of age The use of the medicine is not recommended.
Elderly patients There is no need to change the dosage.
Patients with liver and kidney function disorders There is no need to change the dosage.

Using a higher dose of Gynalgin than recommended

No cases of overdose have been reported so far.
In case of accidental or mistaken oral ingestion of the medicine, you should consult a doctor as soon as possible.
Treatment involves removing the medicine from the body (inducing vomiting, rinsing the stomach). Metronidazole can be removed from the blood serum using hemodialysis or peritoneal dialysis.

Missing a dose of Gynalgin

In case of missing a dose of the medicine at the scheduled time, you should take it as soon as possible. However, if it is close to the time of taking the next dose, you should skip the missed dose. You should not take a double dose to make up for the missed dose.

Stopping the use of Gynalgin

In case of stopping the use of Gynalgin, the symptoms of vaginal inflammation may worsen.
In case of any further doubts related to the use of this medicine, you should consult a doctor or pharmacist.

4. Possible side effects

Like all medicines, Gynalgin can cause side effects, although they may not occur in everyone.
The frequency of the following side effects is unknown (cannot be determined based on available data).

• Pain and dizziness, abnormal sensations in the limbs;
• Depression, sleep disorders;
• Cramping abdominal pain, feeling of discomfort in the abdominal cavity, nausea, vomiting, unpleasant taste in the mouth, diarrhea, constipation, bloating, dry mouth;
• Dark urine;
• Itching, irritation, and burning in the vagina, feeling of discomfort in the pelvis, discharge, swelling of the vulva, menstrual disorders, vaginal bleeding, spotting;
• Itching of the skin;
• Muscle cramps;
• Feeling of excessive fatigue, excessive irritability;
• Leakage of the preparation from the vagina;
• Decreased appetite;
• Symptoms of subacute myelo-optic neuropathy (sensory disturbances, muscle weakness, pain, vision disturbances).

Reporting side effects

If you experience any side effects, including any side effects not listed in this leaflet, you should tell your doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the 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
By reporting side effects, you can help gather more information on the safety of the medicine.

5. How to store Gynalgin

Store at a temperature below 25°C. Store in the original packaging.
The medicine should be stored 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 specified month.
Medicines should not be disposed of via wastewater or household waste containers.
You should ask your pharmacist how to dispose of medicines that are no longer used.
This will help protect the environment.

6. Contents of the packaging and other information

What Gynalgin contains

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

What Gynalgin looks like and what the packaging contains

The tablets are beige, smooth, and have an elongated shape with a marbled surface, and are engraved with the letter G.
Gynalgin is available in a packaging containing 10 tablets (2 blisters of Al/OPA/Al/PVC foil containing 5 tablets, in a cardboard box).
To obtain more detailed information, you should contact the marketing authorization holder or the parallel importer.

Marketing authorization holder in Bulgaria, the country of export:

Mylan EOOD
Office building “Serdika Offices”
Sitnyakovo Blvd. 48, fl. 7
1505 Sofia,
Bulgaria

Manufacturer:

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

Parallel importer:

Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź

Repackaged by:

Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
CEFEA Sp. z o.o. Sp. komandytowa
ul. Działkowa 56
02-234 Warsaw
Pharma Innovations Sp. z o.o.
ul. Jagiellońska 76
03-301 Warsaw
SHIRAZ PRODUCTIONS Sp. z o.o.
ul. Tymiankowa 24/28
95-054 Ksawerów
CANPOLAND SPÓŁKA AKCYJNA
ul. Beskidzka 190
91-610 Łódź
Marketing authorization number in Bulgaria, the country of export: 9800185

Parallel import authorization number: 378/22 Date of leaflet approval: 11.10.2022

[Information about the trademark]