Lustork

PATIENT INFORMATION LEAFLET

Leaflet enclosed with the packaging: patient information

Lustork, 50 mg, vaginal tablets

Progesterone

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• In case of any doubts, 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.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is Lustork and what is it used for
• 2. Important information before taking Lustork
• 3. How to take Lustork
• 4. Possible side effects
• 5. How to store Lustork
• 6. Package contents and other information

1. What is Lustork and what is it used for

Lustork is a medicine that contains a synthetically obtained, natural female sex hormone, progesterone.
In the body, progesterone acts through specific receptors located, among others, in the uterus, breast tissue, central nervous system, and pituitary gland.
The most important effects of progesterone on the reproductive organs are: enabling ovulation, transforming the endometrium (mucous membrane of the uterus) to allow implantation of a fertilized egg, inhibiting excessive growth of the endometrium caused by estrogen, cyclic changes in the epithelium of the fallopian tubes, cervix, and vagina. Progesterone and estrogen also act on the breast tissue, stimulating the growth of glands and epithelium of the ducts and enabling lactation.
Progesterone is a hormone necessary for the proper preparation of the endometrium for implantation of the embryo, for the maintenance of pregnancy throughout its duration: it eliminates the spontaneous contractile activity of the pregnant uterus, inhibits the mother's immune response to fetal antigens, is a basic substance for the production of fetal hormones, initiates labor.
Indications for the use of Lustork:

• States of endogenous progesterone deficiency in the form of menstrual cycle disorders, painful menstruation, anovulatory cycles, premenstrual tension syndrome, and functional uterine bleeding.
• Endometriosis.
• In vitro fertilization.
• Infertility associated with luteal insufficiency.
• Habitual and threatened miscarriages.
• Luteal phase insufficiency in the premenopausal period.
• Hormone replacement therapy in postmenopausal women with an intact uterus, who are receiving hormone replacement therapy, to protect the endometrium.

2. Important information before taking Lustork

When not to take Lustork

• If the patient is allergic to progesterone or any of the other ingredients of this medicine (listed in section 6).
• If the patient has vaginal bleeding of unknown origin;
• If the patient has severe liver failure;
• If the patient has a liver tumor;
• If the patient has or is suspected of having breast or genital cancer;
• If the patient has an active venous thrombosis (thrombophlebitis), e.g. in the limbs (deep vein thrombosis) or lungs (pulmonary embolism), and if such blood clots have occurred in the patient's history;
• If the patient is at risk of cerebral hemorrhage;
• If the patient has a rare blood disease called porphyria, which is inherited from generation to generation (hereditary).
• If a miscarriage has occurred and there is a suspicion that some tissue still remains in the uterus or the pregnancy is developing outside the uterus.

Warnings and precautions

Before starting to take this medicine, discuss it with your doctor.
This medicine, when used as recommended, does not have a contraceptive effect.
Before starting hormone replacement therapy during menopause (and later at regular annual intervals), consult a doctor who will perform a breast and pelvic examination. You should tell your doctor if:

• you have a history of blood clots in the veins (venous thrombosis)
• you have uterine bleeding. You should stop taking this medicine in case of:
• any vision disorders (e.g. vision loss, double vision, vascular changes in the retina);
• blood clots (venous thromboembolism);
• severe headaches; If the patient does not experience menstruation during treatment, it should be ensured that the patient is not pregnant. During treatment, the endometrium may start to overgrow (endometrial hyperplasia) or this overgrowth may worsen. If, during prolonged treatment, at the end of treatment, or after treatment, unexpected bleeding or spotting occurs and persists, you should contact your doctor.

Children and adolescents

There is a lack of sufficient data on the safety and efficacy of Lustork in children and adolescents.

Other medicines and Lustork

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or plan to take.
Some medicines may affect the action of Lustork.

• barbiturates used in sleep disorders or anxiety treatment,
• medicines used in epilepsy (carbamazepine, phenytoin),
• certain antibiotics (ampicillins, tetracyclines, rifampicin),
• phenylbutazone (anti-inflammatory medicine),
• spironolactone (diuretic),
• certain antifungal medicines (ketoconazole, griseofulvin),
• similarly, Lustork may affect the action of certain medicines used to treat diabetes,
• herbal products containing St. John's wort (Hypericum perforatum) may weaken the action of Lustork,
• Lustork may enhance the action of cyclosporine.

Pregnancy, breastfeeding, and fertility Pregnancy

• If you are pregnant, think you may be pregnant, or plan to have a child, consult your doctor or pharmacist before taking this medicine.

Breastfeeding

• Women who are breastfeeding should not take this medicine.
• Before starting to take this medicine, discuss it with your doctor.

Fertility

• This medicine may be taken by women who have difficulty getting pregnant. This medicine does not have any known harmful effect on fertility.
• Before starting to take this medicine, discuss it with your doctor.

Driving and using machines

Lustork, administered vaginally, does not affect the ability to drive and use machines. In case of side effects such as drowsiness, concentration and attention disorders, dizziness, it is not recommended to drive and use machines (see section 4).

3. How to take Lustork

Take this medicine always as directed by your doctor. In case of doubts, consult your doctor or pharmacist.
Dosage
For doses other than 25 and 50 mg, vaginal tablets of 100 mg and 200 mg are available.
Adults

• In menstrual cycle disorders, painful menstruation, premenstrual tension syndrome, luteal phase insufficiency in the premenopausal period, administer 25 to 50 mg (1/2 to 1 tablet) vaginally 2 times a day in the second phase of the menstrual cycle (natural or induced) for 10-12 days.
• In menstrual cycle disorders, painful menstruation, premenstrual tension syndrome, treatment is continued for 3-6 consecutive cycles.
• In luteal phase insufficiency in the premenopausal period, treatment should be continued until menopause occurs.
• In hormone replacement therapy in combination with estrogens, administer 50 to 100 mg (1 to 2 tablets) vaginally 2 times a day in sequential therapy from the 15th to the 25th day of the cycle or in continuous therapy every day.
• In the progesterone test in secondary amenorrhea, administer 50 mg (1 tablet) vaginally 2 times a day for 5-7 days. Bleeding should occur within 7-10 days after discontinuation of the medicine.
• In the treatment of functional uterine bleeding, administer 50 mg (1 tablet) vaginally 2 times a day for 5-7 days. Treatment should be continued for the next 2-3 months, administering 25 to 50 mg (1/2 to 1 tablet) vaginally 2 times a day from the 15th to the 25th day of the cycle.
• In endometriosis, administer 50 to 100 mg (1 to 2 tablets) vaginally 2 times a day in continuous therapy for 6 months.
• In habitual and threatened miscarriages, anovulatory cycles, and induced cycles, administer 50 to 150 mg (1 to 3 tablets) vaginally 2 times a day.
• In habitual miscarriages, progesterone supplementation should be started in the cycle in which pregnancy is planned. Treatment should be continued uninterrupted until the 18th-20th week of pregnancy.
• In in vitro fertilization programs, administer 150 to 200 mg (3 to 4 tablets) vaginally 2 times a day. Treatment should be continued until the 77th day after embryo transfer. The end of therapy should be carried out by gradually reducing the administered dose of the medicine.

Use in children and adolescents

There is a lack of sufficient data on the safety and efficacy of Lustork vaginal tablets in children and adolescents.

Instructions for use

The tablet can be divided into equal doses.
Lustork should be placed in the vagina.
In pregnant women, due to the softened cervix, it is recommended to apply the medicine with the index finger.

Overdose of Lustork

In case of taking a higher dose of this medicine than recommended, contact your doctor or pharmacist immediately.
Overdose symptoms that may occur are: dizziness, feeling of fatigue, depression.
These symptoms usually subsided on their own after reducing the dose of the medicine. You should consult your doctor beforehand.

Missing a dose of Lustork

A missed dose of the medicine should be taken as soon as possible after remembering, unless it is close to the time of taking the next dose. Do not take a double dose to make up for a missed dose.

Stopping treatment with Lustork

In case of any further doubts about taking this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Stop taking this medicine immediately if you experience:

• stroke, blood clots, or internal bleeding in the brain,
• blood clots in the veins of the limbs or pelvis,
• sudden severe headaches,
• vision disorders,
• jaundice (yellowing of the skin or whites of the eyes).

The following side effects are common (in 1 in 10 patients):

• headaches
• abdominal bloating
• abdominal pain
• nausea
• uterine cramps

The following side effects are uncommon (in 1 in 100 patients):

• dizziness
• insomnia
• diarrhea
• constipation
• hives (allergic rash)
• rash
• vaginal disorders (e.g. vaginal discomfort, burning, discharge, dryness, and bleeding)
• vaginal yeast infection
• breast disorders (e.g. breast pain, breast swelling, breast tenderness)
• itching in the genital area
• peripheral edema (swelling due to fluid accumulation)

Frequency not known(cannot be determined from available data):

• fatigue
• vomiting
• allergic reactions.

Reporting side effects

If you experience any side effects, including any side effects not listed in this leaflet, tell your doctor or pharmacist.
Side effects can be reported directly to the Department of Adverse Reactions of Medicinal Products, Medical Devices, and Biocidal Products,
Jerozolimskie Avenue 181C
02-222 Warsaw
Phone: +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 its representative.
By reporting side effects, you can help gather more information on the safety of this medicine.

5. How to store Lustork

Store in a temperature below 25°C.
Store in a place out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton. 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. This will help protect the environment.

6. Package contents and other information

What Lustork contains

• The active substance of the medicine is progesterone.
• One tablet contains 50 mg of progesterone.
• The other ingredients are: lactose monohydrate, cornstarch, citric acid monohydrate, magnesium stearate, hypromellose (6 mPa·s).

What Lustork looks like and what the package contains

White, uncoated, round, biconvex tablets with a dividing line on one side, 9 mm in diameter.
The package contains 30 vaginal tablets or 60 vaginal tablets or 90 vaginal tablets.

Marketing authorization holder and manufacturer

Adamed Pharma S.A.
Pieńków, ul. M. Adamkiewicza 6A
05-152 Czosnów
Date of last revision of the leaflet:04.2023