Lustork

PATIENT INFORMATION LEAFLET

Leaflet attached to the packaging: patient information

Lustork, 100 mg, vaginal tablets
Progesterone

You should read the contents of the leaflet before using the medicine, as it contains important information for the patient.

• You should keep this leaflet, so you can read it again if you need to.
• You should consult a doctor or pharmacist if you have any further doubts.
• 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 any of the side effects get worse or if you notice any not listed in the leaflet, you should tell your 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. Contents of the pack 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 works 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 mucous membrane of the uterus (endometrium) to allow implantation of a fertilized egg, inhibiting
excessive growth of the uterine mucous membrane caused by estrogen, cyclic changes in the epithelium of the fallopian tubes, cervix, and vagina. Progesterone and estrogen also affect the breast tissue, stimulating the growth of glands and epithelium, and enabling lactation.
Progesterone is a hormone necessary for the proper preparation of the endometrium for implantation of the embryo, for maintaining pregnancy throughout its duration: it eliminates spontaneous contractions of the pregnant uterus, inhibits the mother's immune response to fetal antigens, is a basic substance for the production of fetal hormones, and initiates labor.
Indications for the use of Lustork:

• Endometriosis.
• In vitro fertilization.
• Infertility associated with luteal insufficiency.
• Habitual and threatened miscarriages.
• Hormone replacement therapy in postmenopausal women with an intact uterus, who are receiving hormone replacement therapy, to protect the uterine mucous membrane (endometrium).

2. Important information before taking Lustork

When not to take Lustork:

• If you are allergic to progesterone or any of the other ingredients of this medicine (listed in section 6).
• If you have vaginal bleeding of unknown cause;
• If you have severe liver failure;
• If you have a liver tumor;
• If you have or suspect breast or genital cancer;
• If you have an active blood clot in a vein (thrombosis), e.g. in the limbs (deep vein thrombosis) or lungs (pulmonary embolism), and also if you have had such blood clots in the past;
• If you are at risk of internal bleeding into the brain;
• If you have a rare blood disease called porphyria, which is inherited from generation to generation.
• If you have had a miscarriage 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, you should 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), you should 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 if:
• you experience any vision disturbances (e.g. vision loss, double vision, pathological changes in the blood vessels of the retina);
• you have blood clots (thromboembolic disease of the veins or blood clots);
• you have severe headaches; If you do not have your period during treatment, you should make sure you are not pregnant. During treatment, the uterine mucous membrane may start to overgrow (endometrial hyperplasia) or this overgrowth may worsen. If during prolonged treatment, at the end of treatment, or after stopping treatment, unexpected bleeding or spotting occurs and persists, you should consult a doctor.

Children and adolescents

There is not enough data on the safety and efficacy of Lustork in children and adolescents.

Other medicines and Lustork

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.
Some medicines may affect the action of Lustork.

• barbiturates used for sleep disorders or anxiety,
• medicines used for epilepsy (carbamazepine, phenytoin),
• certain antibiotics (ampicillins, tetracyclines, rifampicin),
• phenylbutazone (an anti-inflammatory medicine),
• spironolactone (a 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, you should consult a doctor or pharmacist before taking this medicine.

Breastfeeding

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

Fertility

• This medicine may be taken by women who have problems getting pregnant. This medicine does not have any harmful effect on fertility.
• Before starting to take this medicine, you should 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, and dizziness, it is not recommended to drive and use machines (see section 4).

3. How to take Lustork

This medicine should always be taken as directed by your doctor. If you are unsure, you should consult your doctor or pharmacist.
Dosage
The dosage of progesterone should be determined individually each time, depending on the indications and efficacy of the action. For doses other than 100 mg, vaginal tablets with a strength of 50 mg and 200 mg are available.
Adults

• In hormone replacement therapy in combination with estrogens, 50 to 100 mg (1 to 2 tablets) are administered 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 endometriosis, 50 to 100 mg (1 to 2 tablets) are administered vaginally 2 times a day in continuous therapy for a period of 6 months.
• In habitual and threatened miscarriages, anovulatory cycles, and induced cycles, 50 to 150 mg of progesterone are administered vaginally 2 times a day.
• In the case of habitual miscarriages, progesterone supplementation should be started in the cycle in which pregnancy is planned. Treatment should be continued uninterrupted until the 18th to 20th week of pregnancy.
• In in vitro fertilization programs, 150 to 200 mg of progesterone are administered vaginally 2 times a day. Treatment is 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 not enough data on the safety and efficacy of Lustork, vaginal tablets, in children and adolescents.

Instructions for use

Lustork should be inserted into the vagina.
In pregnant women, due to the softened cervix, it is recommended to apply the medicine with the index finger.

Using a higher dose of Lustork than recommended

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

Missing a dose of Lustork

A missed dose of the medicine should be taken as soon as you remember, unless it is close to the time for the next dose. You should not take a double dose to make up for a missed dose.

Stopping the use of Lustork

If you have any further doubts about the use of this medicine, you should consult a doctor or pharmacist.

4. Possible side effects

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

You should stop taking this medicine immediately if you experience:

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

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

• headaches
• 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 estimated from the available data):

• fatigue
• vomiting
• allergic reactions.

Reporting side effects

If you experience any side effects, including those not listed in the leaflet, you should tell your doctor or pharmacist.
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
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 provide more information on the safety of the medicine.

5. How to store Lustork

Store in a temperature below 30°C.
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 given 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 pack and other information

What Lustork contains

• The active substance of the medicine is progesterone.
• One tablet contains 100 mg of progesterone.
• The other ingredients are: lactose monohydrate, cornstarch, sodium carboxymethylcellulose, hypromellose (6 mPa·s), citric acid monohydrate, magnesium stearate, anhydrous colloidal silica.

What Lustork looks like and contents of the pack

Round vaginal tablet, white or off-white, with the inscription "100" on one side and "22" on the other.
The pack contains 30 vaginal tablets, 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