Ginalgin

Leaflet attached to the packaging: information for the user

Warning!

The leaflet should be kept. Information on the immediate packaging 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.

• The leaflet should be kept so that it can be read 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, pharmacist, or nurse. 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 against bacteria (mainly anaerobic bacteria) and protozoa, without affecting the physiological bacterial flora of the vagina. Chlorquinaldol, on the other hand, has antibacterial, antifungal, and antiprotozoal properties. Thanks to the combination of these two substances, a medicine with a broad spectrum 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. During such use, high doses of chloroquine derivatives (including chlorquinaldol) may cause

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

• The medicine is intended for vaginal use. It should not be taken orally.
• Using the medicine during menstruation should be avoided.
• 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 the use of metronidazole.

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, 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 take.

• If the patient is taking any of the following medicines, they should tell their 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 effectiveness of chlorquinaldol.
• If the patient is to undergo blood tests, they should tell their doctor about using 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-like reaction).

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

Gynalgin and alcohol

During the use of Gynalgin, you should not drink alcohol, as an alcohol intolerance reaction may occur.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor before using this medicine.

Gynalgin should not be used during pregnancy unless it is absolutely necessary.

Cautious use of the medicine is recommended 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 the doctor. In case of doubts, you should consult a doctor.

The medicine is intended for vaginal use. It should not be taken orally.

Recommended dose

Adults

Deeply vaginal, 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, 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

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 a 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

In case of missing a dose of the medicine at the scheduled time, it should be taken as soon as possible. However, if it is close to the time of the next dose, the missed dose should be skipped. A double dose should not be taken 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, 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 (disorders of sensation, muscle weakness, pain, vision disorders).

Reporting side effects

If any side effects occur, including any side effects not listed in this leaflet, you should tell your doctor, pharmacist, or nurse. 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.

5. How to store Gynalgin

Store at a temperature below 25°C. Store in the original packaging.

The medicine should be stored in a place that is out of sight and reach of children.

Do not use this medicine after the expiration date stated on the packaging. The expiration date is the last day of the specified month.

Medicines should not be disposed of in the sewage system or household waste containers. You should ask your pharmacist how to dispose of unused medicines. 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, 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 marked with the letter G.

The medicine is available in a package containing 10 tablets (2 blisters of Al/OPA/Al/PVC foil containing 5 tablets, in a cardboard box).