Ginoflor

Leaflet attached to the packaging: information for the user

Gynoflor

50 mg + 0.03 mg, vaginal tablets
(Lactobacillus acidophilus + Estriolum)

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 specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, you should tell your doctor or pharmacist. See section 4.

Table of contents of the leaflet

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

1. What is Gynoflor and what is it used for

Gynoflor contains active substances identical to those found normally in the vagina of women. A healthy vagina remains in a state of biological balance and has natural defense mechanisms that protect it from infections. The main element of these defense mechanisms is the presence of live bacteria Lactobacillus acidophilusthat produce lactic acid and other substances with anti-infectious properties. The production of lactic acid leads to the creation of an acidic environment that favors the growth of lactic acid bacteria and inhibits the growth of pathogenic microorganisms.
Disorders or destruction of the vaginal flora containing lactic acid bacteria may occur as a result of treatment with certain medicines (e.g., antibiotics), local infections, severe systemic disease, or improper hygiene (vaginal irrigation and shower). Gynoflor contains live lactic acid bacteria in a large dose, which helps to restore the natural flora in the vagina.
In addition to the natural vaginal flora, the normal vaginal mucosa also plays an important role in the natural protective mechanisms of the vagina. The vaginal mucosa can be damaged due to hormonal fluctuations or hormone deficiencies (especially during the perimenopausal and postmenopausal periods) and vaginal infections.
As a second active substance, Gynoflor contains estriol, which is a natural female sex hormone. Estriol, even in the very small dose contained in Gynoflor, causes regeneration of the vaginal mucosa, ensures good blood supply to the mucosa, its proper thickness, elasticity, and moisture. This is also important for the growth of lactic acid bacteria in the vagina.
Lactobacillus acidophilusand estriol exert their action locally, in the vagina.
Lactose used in the production of vaginal tablets can also undergo rapid fermentation to lactic acid under the influence of lactic acid bacteria. The multiplication of lactic acid bacteria and their re-colonization of the vagina begins already after the first application of the medicine.
Gynoflor belongs to a group of medicines known as Hormone Replacement Therapy (HRT) for vaginal administration.
Gynoflor is used:

• to restore the flora of Lactobacillus acidophilusafter local or systemic treatment with anti-infectious agents or chemotherapeutics.
• to alleviate symptoms of menopause occurring in the vagina, such as dryness or irritation. In medical terminology, this phenomenon is called "atrophic vaginitis". It is caused by a decrease in estrogen levels in the body and naturally occurs after menopause. Gynoflor acts by replacing estrogen, which is produced by the ovaries. The medicine is administered vaginally, and therefore the hormone is released where it is needed. This can alleviate the feeling of discomfort in the vagina.
• in the treatment of vaginal discharge of unknown origin (leucorrhea) and in the treatment of mild and moderate cases of vaginal infections, when there is no absolute need to use anti-infectious chemotherapy.

2. Important information before using Gynoflor

Medical history and regular check-ups

The use of HRT carries risks that should be considered when a patient decides to use hormone replacement therapy or continue its use.
Experience in treating women in premature menopause (due to ovarian failure or surgical procedure) is limited. If a patient is undergoing premature menopause, the risk associated with HRT may differ. You should talk to your doctor.
Before starting (or resuming) HRT, the doctor should take a medical history, including a family history. The doctor may decide to perform an examination, such as a breast examination and/or gynecological examination, if necessary.
If a patient starts supportive therapy with Gynoflor, she should consult a doctor at least once a year. During follow-up visits, she should discuss with her doctor the benefits and risks of continuing to use Gynoflor.
Patients should regularly perform breast screening tests in accordance with the doctor's recommendation.

When to exercise special caution when using Gynoflor

Before starting treatment, you should inform your doctor about any current or past diseases, as they may recur or worsen during supportive therapy with Gynoflor. In such cases, the doctor may find it necessary to perform more frequent check-ups:

• uterine fibroids;
• presence of endometrial tissue outside the uterus (endometriosis) or excessive growth of endometrial tissue (endometrial hyperplasia) in the past;
• increased risk of blood clots (see "Blood clots in veins (venous thrombosis)");
• increased risk of estrogen-dependent tumors (breast cancer in the mother, sister, or grandmother);
• high blood pressure;
• liver disease, such as a benign liver tumor;
• diabetes;
• gallstones;
• migraine or severe headaches;
• systemic immune system disease affecting many organs - systemic lupus erythematosus;
• epilepsy;
• asthma;
• disease affecting the eardrum and hearing (otosclerosis);
• very high levels of fats (triglycerides) in the blood;
• fluid retention due to impaired heart or kidney function.
• hereditary and acquired angioedema.

When not to use Gynoflor

You should not use Gynoflor if you have any of the following diseases.
If you are not sure if any of the following points apply to you, you should
consult a doctorbefore starting to use Gynoflor.

• if breast cancer has been diagnosed, has occurred in the past, or is suspected;
• if an estrogen-dependent tumor has been diagnosed or is suspected, such as endometrial cancer (cancer of the uterine lining);
• if unexplained vaginal bleeding has been detected;
• if there is excessive thickening of the uterine lining (endometrial hyperplasia) that has not been treated;
• if blood clots in the veins (venous thrombosis) have been diagnosed or have occurred in the past;
• if there is a blood clotting disorder (such as protein C, protein S, or antithrombin deficiency);
• if there is or has been a disease caused by blood clots in the arteries, such as a heart attack, stroke, or angina pectoris;
• if there is or has been inflammation of the veins;
• if there have been problems with previous use of estrogen-containing products;
• if liver disease has been diagnosed or has occurred in the past and liver test results have not returned to normal;
• if jaundice has occurred or has occurred during pregnancy;
• if a rare blood disorder - porphyria - has been diagnosed, which is inherited;
• if liver diseases known as Rotor syndrome or Dubin-Johnson syndrome have been diagnosed (both are inherited diseases in which the liver cannot properly remove bilirubin);
• if a cerebrovascular or coronary disease has been diagnosed;
• if a congenital deafness known as otosclerosis has been diagnosed;
• if endometriosis or suspected endometriosis has been diagnosed;
• if the patient has not reached sexual maturity;
• if an allergy (hypersensitivity) to estriol, lactic acid bacteria (Lactobacillusacidophilus), or any of the other ingredients of this medicine (listed in section 6) has been detected.

If any of the above conditions occur for the first time during treatment with Gynoflor, you should stop using it immediately and contact your doctor as soon as possible.

Warnings and precautions

You should discuss the use of Gynoflor with your doctor or pharmacist before using it.
Breast tenderness or increased vaginal discharge may indicate that the estrogen dose is too high.
In elderly patients, the medicine should be used under control, especially if there are concomitant conditions such as heart failure, renal or liver dysfunction, hypertension, epilepsy, migraine, a history of thromboembolic disorders, endometriosis, fibrocystic breast disease, or diabetes.

You should stop using Gynoflor and contact your doctor immediately

if any of the following conditions occur during therapy with Gynoflor:

• any of the diseases listed in the "When not to use Gynoflor" section above;
• yellowing of the skin and eyes (jaundice), which may be symptoms of liver disease;
• swelling of the face, tongue, and/or throat, and/or difficulty swallowing or hives, including difficulty breathing, which suggest angioedema;
• significant increase in blood pressure (symptoms include headache, fatigue, and dizziness);
• migraine headache that has occurred for the first time;
• pregnancy;
• if the patient experiences symptoms of blood clots, such as:
• painful swelling and redness of the legs,
• sudden chest pain,
• difficulty breathing.

Note:Gynoflor is not a contraceptive. If it has been less than 12 months since the last menstrual period or the patient is under 50 years old, it may be necessary to use an additional method of contraception. You should consult your doctor.

HRT and cancer

Excessive thickening of the uterine lining (endometrial hyperplasia) and uterine lining cancer (endometrial cancer).

Long-term use of HRT in the form of tablets containing only estrogen may increase the risk of developing uterine lining cancer (endometrium).
It is not known whether a similar risk exists during repeated or prolonged (longer than one year) use of Gynoflor. However, Gynoflor is absorbed into the bloodstream to a very small extent, and therefore the addition of progestogen is not necessary.
Bleeding or spotting is not usually a cause for concern, but you should consult your doctor. This may be a sign of endometrial hyperplasia.
The described risks apply to HRT medicines that enter the bloodstream. Gynoflor is used locally in the vagina and its absorption into the bloodstream is very small. It is less likely that the mentioned conditions will worsen or recur during treatment with Gynoflor, but if you have any doubts, you should consult your doctor.
Breast cancer
Data indicate that the use of Gynoflor does not increase the risk of breast cancer in women who have never had it before. It is not known whether Gynoflor can be safely used in women who have had breast cancer.

You should regularly examine your breasts. You should contact your doctor if you notice any of the following changes:

• retraction of the skin,
• changes in the nipple,
• presence of lumps that are visible or palpable.

In addition, it is recommended to perform screening mammography tests in accordance with the doctor's recommendations.
Ovarian cancer
Ovarian cancer is rare - much rarer than breast cancer. The use of HRT that includes only estrogen is associated with a slightly increased risk of ovarian cancer.
The risk of ovarian cancer depends on age. For example, in women between 50 and 54 years old who do not use HRT, ovarian cancer will be diagnosed within 5 years in about 2 out of 2000 women. In women who have used HRT for 5 years, it will occur in about 3 out of 2000 users (i.e., about 1 additional case).

Effect of HRT on the heart and circulation

Blood clots in the veins (venous thrombosis)
The risk of blood clots in the veins is 1.3 to 3 times higher in women using HRT compared to those not using it, especially in the first year of use.
The formation of blood clots can have serious consequences, and if they move to the lungs, they can cause chest pain, shortness of breath, loss of consciousness, and even death.
The risk of blood clots in the veins is higher if the patient is older or if any of the following situations apply to the patient. You should inform your doctor if any of the following situations apply to you:

• the patient is unable to walk for a long time due to a serious operation, injury, or illness (see also section 3, "If an operation is planned");
• there is significant obesity (BMI > 30 kg/m2);
• there are thromboembolic disorders that require long-term use of medicines that prevent blood clots;
• the patient or a close relative has had blood clots in the legs or lungs in the past;
• systemic lupus erythematosus has been diagnosed;
• cancer has been diagnosed.

If symptoms of blood clots occur, see "You should stop using Gynoflor and contact your doctor immediately".
Comparison
In women between 50 and 59 years old who do not use HRT, the number of cases of blood clots in the veins within 5 years is estimated to be 4 to 7 per 1000 women.
In women between 50 and 59 years old who use estrogen-only HRT for more than 5 years, the number of cases will be 5 to 8 per 1000 (i.e., 1 additional case).
Heart disease (heart attack)
In women using estrogen-only HRT, there is no increased risk of developing heart disease.
Stroke
The risk of stroke is about 1.5 times higher in women using HRT compared to those not using it. The number of additional stroke cases caused by HRT increases with age.
Comparison
In women between 50 and 59 years old who do not use HRT, the number of stroke cases within 5 years is estimated to be 8 per 1000 women. In women between 50 and 59 years old who use HRT, the number of cases within 5 years will be 11 per 1000 women (i.e., 3 additional cases).
Other conditions
HRT does not prevent memory loss. The risk of possible memory loss may be slightly higher in women who start using HRT after the age of 65. You should consult your doctor.

Gynoflor and other medicines

You should tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, including those that are available without a prescription, herbal medicines, or other natural products.
Concomitant use of anti-infectious agents (e.g., locally or systemically acting antibiotics) may weaken the effect of Gynoflor.
Specific interactions with other medicines
The likelihood of interactions with other medicines is low, as Gynoflor is used locally in the vagina.
Gynoflor may affect other local treatments used in the vagina, but the likelihood of interactions with other medicines is low.
You should not use vaginal irrigations or douches while using Gynoflor.

Gynoflor with food and drink

The effect of food and drink does not apply to the use of Gynoflor.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, you should consult your doctor or pharmacist before using this medicine.
Pregnancy
You should not use Gynoflor if you are pregnant.
If you become pregnant, you should stop using Gynoflor immediately and contact your doctor.
Based on limited experience with the use of Gynoflor components during pregnancy, it can be stated that there is no evidence of adverse effects of the medicine on pregnancy or the fetus/newborn. Both active substances, Lactobacillus acidophilusand estriol, occur naturally in the human body, and after the use of Gynoflor, their concentrations are not higher than those found in healthy women after menopause.
Breastfeeding
You should not use Gynoflor during breastfeeding.

Driving and using machines

The effect of Gynoflor on driving and using machines is not known.

3. How to use Gynoflor

Gynoflor should be used as recommended by your doctor. If you have any doubts, you should consult your doctor.
The doctor will choose the smallest dose used for the shortest time to treat the symptoms.
If you feel that the effect of Gynoflor is too strong or too weak, you should consult your doctor or pharmacist.
To restore the normal vaginal environment and discharge (leucorrhea):
1-2 vaginal tablets per day for 6 to 12 days.
In atrophic vaginitis:
1 vaginal tablet per day for 6 to 12 days, and then 1 tablet 1-2 times a week as a maintenance dose.

Instructions for use

Vaginal tablets should be inserted deep into the vagina in the evening, before going to bed. It is best to do this in a lying position with slightly bent legs.
During menstruation, treatment should be stopped and resumed after the menstrual bleeding has stopped.
Gynoflor contains ingredients that do not dissolve completely. Therefore, remnants of the tablet can sometimes be seen on underwear. This does not affect the efficacy of Gynoflor.
In rare cases of very severe vaginal dryness, it may happen that the vaginal tablet does not dissolve at all and is expelled from the vagina in its original form.
This is not optimal for treatment, but it is not harmful to the vagina. To avoid this situation, before inserting the tablet into a very dry vagina, you can moisten it with a small amount of water.
During treatment with Gynoflor, you should use sanitary pads.

If you have accidentally taken Gynoflor orally

In case of accidental oral ingestion of Gynoflor, no side effects should occur.

If an operation is planned

If an operation is planned, you should tell the surgeon that you are using Gynoflor.
It may be necessary to stop using Gynoflor about 4 to 6 weeks before the operation to reduce the risk of blood clots (see section 2, "Blood clots in the veins").
You should ask your doctor when you can resume using Gynoflor.

If you have used more Gynoflor than recommended

In case of ingestion of too many vaginal tablets, no side effects should occur, but you should tell your doctor.

If you have missed a dose of Gynoflor

You should not take a double dose to make up for a missed dose.
If you have any additional questions about using Gynoflor, you should consult your doctor.

4. Possible side effects

Like all medicines, Gynoflor can cause side effects, although not everybody gets them.
Immediately after applying Gynoflor, a slight burning or stinging sensation may be felt (1% of patients). There is no need to stop treatment in such cases. However, if the discomfort persists, you should consult your doctor as soon as possible.
In rare cases, intolerance reactions, such as redness and itching, have been reported.
In one case, an allergy to the Lactobacilluslyophilizate contained in Gynoflor was detected.
In such cases, you should consult your doctor as soon as possible.
The following diseases are reported more frequently in women taking HRT in the form of medicines that circulate in the blood compared to women not taking HRT. This risk applies to a lesser extent to medicines administered vaginally, such as Gynoflor:

• ovarian cancer,
• blood clots in the veins of the legs or lungs (venous thromboembolism),
• stroke,
• possible memory loss, if HRT is started after the age of 65. To learn more about these side effects, see section 2.

Reporting side effects

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

5. How to store Gynoflor

The medicine should be stored out of sight and reach of children.
Store in a refrigerator at 2°C to 8°C.
Vaginal tablets can be stored at room temperature during the recommended treatment period, for a period of 6 to 12 days.
Do not use this medicine after the expiry date stated on the carton and blister after the abbreviation EXP. The expiry date refers to the last day of the specified 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. Contents of the packaging and other information

What Gynoflor contains

The active substances are: 50 milligrams of lactic acid bacteria lyophilizate (Lactobacillusacidophilus) and 30 micrograms of estriol (Estriolum).
The other ingredients are: lactose monohydrate, microcrystalline cellulose, anhydrous disodium phosphate, magnesium stearate (E470b), sodium carboxymethylcellulose (type A)

What Gynoflor looks like and what the pack contains

Vaginal tablets are white to beige, speckled, and have an oval, biconvex shape.
6 tablets in a blister pack.
1 or 2 blister packs in a cardboard box.

Marketing authorization holder and manufacturer

Marketing authorization holder

GEDEON RICHTER POLSKA Sp. z o.o.
ul. Ks. J. Poniatowskiego 5
05-825 Grodzisk Mazowiecki

Manufacturer

Haupt Pharma Amareg GmbH
Donaustaufer Str. 378
93055 Regensburg
Germany
To obtain more detailed information about the medicine, you should contact:
GEDEON RICHTER POLSKA Sp. z o.o.
Medical Department
ul. Ks. J. Poniatowskiego 5
05-825 Grodzisk Mazowiecki
Tel. +48 (22)755 96 48
[email protected]

Date of last revision of the leaflet: