GYNALGIN

Patient 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 this leaflet carefully before using the medicine, as it contains
important information for the patient.

• Keep this leaflet so that you can read it again if necessary.
• If you have any questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm someone else, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents

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 pack 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 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 a history of blood disorders, she should inform her doctor before starting treatment.

• Do not use the medicine long-term. Prolonged use of high doses of chlorinated quinoline derivatives (including chlorquinaldol) may lead to sensory disturbances, muscle weakness, pain, and visual disturbances (symptoms of so-called subacute myelooptic neuropathy).

• 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 vaginal infection, it is recommended that the patient's partner also receives appropriate treatment.

Severe hepatotoxicity (acute liver failure), including fatal cases, have been reported in patients with Cockayne syndrome receiving metronidazole-containing medicines.
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 should immediately inform the doctor and discontinue metronidazole:

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

Gynalgin and other medicines
Tell your doctor about all medicines the patient is currently taking or has recently taken, as well as any medicines she plans to use.

• If the patient is taking any of the following medicines, she should inform her doctor, as special caution may be required:
• disulfiram (used in alcohol dependence) – when used with metronidazole, may cause psychotic reactions and confusion;
• warfarin (used to treat blood clots);
• lithium (used in the treatment of depression);
• cyclosporine (used after organ transplantation);
• 5-fluorouracil (used in cancer treatment);
• metallic and iodine compounds – may reduce the effectiveness of chlorquinaldol;
• If the patient is due to undergo blood laboratory tests, she should inform the doctor about using Gynalgin, as it may affect the 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 following vaginal administration of metronidazole, serum concentrations achieved are low.
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 clearly necessary.
Caution should be exercised when using this medicine during breastfeeding.
Driving and operating machinery
Gynalgin has no effect or negligible effect on the ability to drive motor vehicles and operate machinery.
Gynalgin contains lactose monohydrate
Gynalgin contains lactose monohydrate. If the patient has been previously diagnosed with intolerance to certain sugars, she should consult her doctor before taking this medicine.

3. How to use Gynalgin

Always use this medicine exactly as recommended by your doctor. 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 inserted 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 this medicine is not recommended.
Elderly patients
No dose adjustment is necessary.
Patients with liver or kidney function disorders
No dose adjustment is necessary.
Overdose of Gynalgin
There have been no reported cases of overdose to date.
In case of accidental or mistaken oral ingestion of the medicine, seek immediate medical attention.
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, administer 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 a missed dose.
Discontinuation of Gynalgin
If treatment with Gynalgin is discontinued prematurely, symptoms of vaginal inflammation may worsen.
If you have any further questions regarding the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everybody will experience them.
The frequency of occurrence of the adverse effects listed below is unknown (cannot be estimated from
the available data).

• Headaches 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, diarrhoea, constipation, bloating, dry mouth.
• Darkening 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.
• Itching of the skin.
• Muscle cramps.
• Feeling of excessive fatigue, increased irritability.
• Leakage of the medicine from the vagina.
• Loss of appetite.
• Symptoms of subacute myelooptic neuropathy (sensory disturbances, muscle weakness, pain, visual disturbances).

Reporting of adverse effects
If any adverse effects occur, including any adverse effects not listed in this leaflet, inform your doctor or pharmacist. Adverse effects can be reported directly to the Department of Monitoring of Adverse Drug Reactions 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.
Reporting adverse effects helps to provide more information on the safety of the medicine.

5. How to store Gynalgin

Store below 25°C. Keep in the original packaging.
Keep the medicine out of the 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 should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the package and other information

What Gynalgin contains

• The active substances are metronidazole and chlortalidol. Each vaginal tablet contains 250 mg of metronidazole and 100 mg of chlortalidol.
• Other components are: citric acid, monohydrate lactose, rice starch, sodium carboxymethyl starch (type C), macrogol 6000, magnesium stearate.

What Gynalgin looks like and contents of the pack
The carton box contains Al/OPA/Al/PVC blisters with 10 vaginal tablets.
For more detailed information, please contact the responsible party or parallel importer.
Marketing Authorisation Holder in Bulgaria, country of export:
Mylan EOOD
Office building “Serdika Offices”
48, Sitnyakovo Blvd., 7 floor
1505 Sofia
Bulgaria
Manufacturer:
ICN Polfa Rzeszów S.A.
Przemysłowa 2 Street
35-959 Rzeszów
Poland
Parallel importer:
InPharm Sp. z o.o.
Strumykowa 28/11 Street
03-138 Warsaw
Repackaged in:
InPharm Sp. z o.o. Services sp. k.
Chełmżyńska 249 Street
04-458 Warsaw
Marketing Authorisation Number in Bulgaria, country of export: 9800185
Parallel Import Authorisation Number: 597/15