Ginalgin

Leaflet attached to the packaging: information for the user

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 you need to.
• If you have any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed to a specific person. Do not pass it on 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. Package contents 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, without affecting the physiological bacterial flora of the vagina. Chlorquinaldol, on the other hand, has antibacterial, antifungal, and antiprotozoal effects. Thanks to the combination of these two substances, a medicine with a broad spectrum of antibacterial, antifungal, and antiprotozoal effects 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 optic neuropathy).

sensory disturbances, muscle weakness, pain, and vision disturbances (symptoms of so-called subacute optic neuropathy).

• The medicine is intended for vaginal use. It should not be taken orally.
• It is recommended to avoid using the medicine 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.

In patients with Cockayne syndrome, cases of severe hepatotoxicity (acute liver failure), including cases resulting in death, have been reported during treatment with metronidazole.
The doctor should monitor liver function during and after treatment with metronidazole 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, 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 take.

• 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) - may cause psychotic reactions and confusion when used with metronidazole;
• 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 - may reduce the effect of chlorquinaldol;
• If you are going to have blood tests, you should tell your doctor that you are taking Gynalgin, as it may affect the results of some tests (ALT, AST, lactic acid, triglycerides, hexokinase glucose).
• Consuming alcohol may cause an alcohol intolerance reaction (so-called disulfiram reaction).

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

Gynalgin and alcohol

You should not drink alcohol while using Gynalgin, as an alcohol intolerance reaction 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 as directed by your doctor. If you are unsure, you should consult your doctor.
The medicine is intended for vaginal use. It should not be taken orally.
Recommended dose
Adults
Deeply insert 1 tablet 1 time a day, preferably at night.
Treatment should be started 2 to 4 days after the end of menstruation and continued for 10 days.
If necessary, your doctor may recommend repeating the treatment cycle.
Children and adolescents under 18 years of age
The use of this medicine is not recommended.
Elderly patients
No dose adjustment is necessary.
Patients with liver and kidney function disorders
No dose adjustment is necessary.

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 your doctor as soon as possible.
Treatment involves removing the medicine from the body (inducing vomiting, stomach lavage).
Metronidazole can be removed from the blood serum using hemodialysis or peritoneal dialysis.

Missing a dose of Gynalgin

If you miss a dose of the medicine at the scheduled time, you should take it as soon as possible. However, if it is almost time for the next dose, you should skip the missed dose. Do not take a double dose to make up for the missed dose.

Stopping treatment with Gynalgin

If you stop using Gynalgin, your symptoms may worsen.
If you have any further doubts about using this medicine, you should consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, Gynalgin can cause side effects, although not everybody gets them.
The frequency of the following side effects is unknown (cannot be determined from available data).

• Headache, dizziness, abnormal sensations in the limbs.
• Depression, sleep disturbances.
• Abdominal cramps, 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, 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 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, 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.
Reporting side effects will help gather more information on the safety of the medicine.

5. How to store Gynalgin

Store in 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 month.
Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Package contents and other information

What Gynalgin contains

• The active substances of the medicine 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 package contains

The tablets are beige, smooth, and have an elongated shape with a marbled surface, and are engraved with the letter G.
The medicine is available in a package containing 10 tablets (2 blisters of PVC/Al/OPA/Aluminum foil containing 5 tablets, in a cardboard box).

Marketing authorization holder

Bausch Health Ireland Limited
3013 Lake Drive
Citywest Business Campus
Dublin 24, D24PPT3
Ireland

Manufacturer

ICN Polfa Rzeszów S.A.
ul. Przemysłowa 2
35-105 Rzeszów
Date of last update of the leaflet:May 2025