Ginalgin

Leaflet attached to the packaging: information for the user

Warning! Keep the leaflet! 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.

• 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 specifically for this 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 wide range of antibacterial, antifungal, and antiprotozoal activities 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, the patient should discuss with their 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 inform their doctor before starting to use the medicine.
• The medicine should not be used for a long time, as prolonged use of high doses of chloroquine derivatives (including chlorquinaldol) may cause sensory disturbances, muscle weakness, pain, and vision disturbances (symptoms of so-called subacute optic neuropathy).

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

• The patient should avoid using the medicine during menstruation.
• Both during the infection and during treatment, the patient 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 fatal cases, 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, diarrhea or constipation, or skin itching.

Gynalgin and other medicines

The patient should tell their doctor about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.

• If the patient is taking any of the following medicines, they should inform 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 effect of chlorquinaldol;
• If the patient is to undergo laboratory blood tests, they should inform their doctor about the use of 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 such reactions during the use of Gynalgin is low, as the concentrations of metronidazole in the serum are low during vaginal use.

Gynalgin and alcohol

The patient should not drink alcohol while using Gynalgin, as an intolerance reaction to alcohol may occur.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, or 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 absolutely necessary. Caution should be exercised when using the medicine during breastfeeding.

Driving and using machines

Gynalgin has no or negligible influence on the ability to drive and use machines.

3. How to use Gynalgin

This medicine should always be used as directed by the doctor. In case of doubts, the patient should consult their doctor.

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

Recommended dose:

Adults:

Deeply insert 1 tablet vaginally, 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 may 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 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, the patient should consult their doctor as soon as possible.

Treatment involves removing the medicine from the body (inducing vomiting, gastric lavage). Metronidazole can be removed from the blood serum using hemodialysis or peritoneal dialysis.

Missing a dose of Gynalgin

If the patient misses a dose of the medicine at the scheduled time, they should take it as soon as possible. However, if it is close to the time for the next dose, the missed dose should be skipped. The patient should not take a double dose to make up for the missed dose.

Stopping the use of Gynalgin

If the patient stops using Gynalgin, the symptoms of vaginal inflammation may worsen.

In case of any further doubts about the use of this medicine, the patient should consult their 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 estimated from the available data).

• Pain and dizziness, abnormal sensations in the limbs.
• Depression, sleep disturbances.
• 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 pelvic area, discharge, swelling of the vulva, menstrual disturbances, 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 the patient experiences any side effects, including any side effects not listed in this leaflet, they should inform their doctor, pharmacist, or nurse.

Side effects can be reported directly to the Department for 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.

Side effects can also be reported to the marketing authorization holder or parallel importer.

Reporting side effects can 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 specified month.

Medicines should not be disposed of via wastewater or household waste. The patient should ask their 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 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 package 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 package containing 10 tablets (2 blisters of Al/OPA/Al/PVC containing 5 tablets each, in a cardboard box).

For more detailed information, the patient should contact the marketing authorization holder or 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:

Allpharm Sp. z o.o. sp.k.

ul. M. Zdziechowskiego 11/4

02-659 Warsaw

Repackaged by:

CEFEA Sp. z o.o. Sp.

komandytowa

ul. Działkowa 56

02-234 Warsaw

Synoptis Industrial Sp. z o.o.

ul. Forteczna 35-37

87-100 Toruń

Shiraz Productions Sp. z o.o.

ul. Tymiankowa 24/28

95-054 Ksawerów

Marketing authorization number in Bulgaria, the country of export:9800185

Parallel import authorization number: 87/25

Date of leaflet approval: 05.03.2025

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