Package leaflet: Information for the user

Lustork, 50 mg, vaginal tablets
Progesteronum
Please read carefully all the information in this leaflet 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 another person, 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

What is Lustork and what is it used for
Important information before using Lustork
How to use Lustork
Possible side effects
How to store Lustork
Contents of the pack and other information

1. What is Lustork and what is it used for

Lustork is a medicine containing synthetically produced, natural female sex hormone
progesterone.
In the body, progesterone acts via specific receptors located, among others, in the uterus,
mammary glands, central nervous system and pituitary gland.
The most important effects of progesterone on reproductive organs include: enabling ovulation, transformation
of the endometrium enabling implantation of the fertilized egg, inhibition of excessive endometrial proliferation caused by estrogens, cyclic
changes in the epithelium of the fallopian tubes, cervix and vagina. Progesterone and estrogens also act on
the mammary gland, stimulating growth of glands and ductal epithelium and enabling lactation.
Progesterone is a hormone essential for proper preparation of the endometrium for
embryo implantation, and for maintaining pregnancy throughout its duration: it suppresses spontaneous uterine contractility, inhibits the maternal immune response to fetal antigens, serves as a precursor for fetal hormones, and initiates labor.
Indications for use of Lustork:

Conditions associated with endogenous progesterone deficiency such as menstrual cycle disorders, painful menstruation, anovulatory cycles, premenstrual syndrome and functional uterine bleeding.
Endometriosis.
In vitro fertilization.
Infertility associated with luteal phase deficiency.
Recurrent and threatened miscarriage.
Luteal phase deficiency in the premenopausal period.
Hormone replacement therapy in postmenopausal women with intact uterus, receiving hormone replacement therapy, to protect the endometrium.

2. Important information before using Lustork
When not to use 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 cause;
If the patient has severe liver dysfunction;
If the patient has a liver tumor;
If the patient has or is suspected of having a breast or genital organ tumor;
If the patient has active venous thrombosis, e.g. in the limbs (deep vein thrombosis) or lungs (pulmonary embolism), or if such types of blood clots occurred in the patient's medical history;
If the patient is at risk of cerebral hemorrhage;
If the patient has a rare inherited blood disorder called porphyria.
If miscarriage has occurred and there is suspicion that certain tissues remain in the uterus or if pregnancy develops outside the uterus.

Warnings and precautions
Before starting to use this medicine, discuss it with your doctor.
This medicine, when used as recommended, does not have contraceptive effects.
Before starting hormone replacement therapy during menopause (and subsequently at regular annual intervals), consult your doctor, who will perform breast and pelvic organ examinations. Inform your doctor if:

The patient has a history of venous thrombosis (venous thromboembolism)
The patient experiences uterine bleeding. Discontinue use of this medicine if:
Any visual disturbances occur (e.g. visual field defects, double vision, retinal vascular lesions);
Blood clots occur (venous thromboembolic disease or thrombosis);
Severe headaches occur; If menstruation does not occur during treatment, pregnancy should be ruled out. During treatment, the endometrium may undergo excessive proliferation (endometrial hyperplasia) or existing hyperplasia may worsen. If unexpected bleeding or spotting occurs during long-term treatment, at the end of treatment or after treatment discontinuation and persists, contact your doctor.

Children and adolescents
There is insufficient data on the safety and efficacy of Lustork in children and adolescents.
Other medicines and Lustork
Inform your doctor or pharmacist about all medicines currently or 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 treatment,
antiepileptic drugs (carbamazepine, phenytoin),
certain antibiotics (ampicillins, tetracyclines, rifampicin),
phenylbutazone (anti-inflammatory drug),
spironolactone (diuretic),
certain antifungal drugs (ketoconazole, griseofulvin),
similarly, Lustork may affect the action of certain diabetes medications,
herbal products containing St. John's wort ( Hypericum perforatum ) may reduce the effectiveness of Lustork,
Lustork may enhance the action of cyclosporine.

Pregnancy, breastfeeding and effects on fertility
Pregnancy

If the patient is pregnant, suspects she may be pregnant, or plans to become pregnant, she should consult her doctor or pharmacist before using this medicine.

Breastfeeding

Breastfeeding women should not use this medicine.
Discuss this with your doctor before starting to use this medicine.

Fertility

This medicine may be used by women who have difficulty becoming pregnant. This medicine has no known harmful effect on fertility.
Discuss this with your doctor before starting to use this medicine.

Driving and operating machinery
Lustork administered vaginally does not affect the ability to drive or operate machinery. However, if side effects such as drowsiness, concentration disturbances, attention deficits or dizziness occur, driving and operating machinery are not recommended (see section 4).
3. How to use Lustork
This medicine should always be used according to the doctor's instructions. If in doubt, 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

For menstrual cycle disorders, painful menstruation, premenstrual syndrome, and luteal phase deficiency in the premenopausal period, administer 25 to 50 mg (1/2 to 1 tablet) vaginally twice daily during the second phase of the menstrual cycle (natural or induced) for 10-12 days.
For menstrual cycle disorders, painful menstruation, premenstrual syndrome, treatment should continue for 3-6 consecutive cycles.
For luteal phase deficiency in the premenopausal period, treatment should continue until menopause occurs.
For hormone replacement therapy in combination with estrogens, administer 50 to 100 mg (1 to 2 tablets) vaginally twice daily in sequential therapy from day 15 to day 25 of the cycle or continuously every day.
For progesterone challenge test in secondary amenorrhea, administer 50 mg (1 tablet) vaginally twice daily for 5-7 days. Bleeding should occur within 7-10 days after stopping the medication.
For treatment of functional uterine bleeding, administer 50 mg (1 tablet) vaginally twice daily for 5-7 days. Treatment should continue for the next 2-3 months, administering 25 to 50 mg (1/2 to 1 tablet) vaginally twice daily from day 15 to day 25 of the cycle.
For endometriosis, administer 50 to 100 mg (1 to 2 tablets) twice daily vaginally continuously for 6 months.
For recurrent and threatened miscarriage, anovulatory and induced cycles, administer 50 to 150 mg (1 to 3 tablets) vaginally twice daily.
In recurrent miscarriage, progesterone supplementation should begin in the cycle planned for conception. Treatment should continue uninterrupted until week 18-20 of pregnancy.
In in vitro fertilization programs, administer 150 to 200 mg (3 to 4 tablets) twice daily vaginally. Treatment continues until day 77 after embryo transfer. Discontinuation of therapy should be done by gradually reducing the dose.

Use in children and adolescents
There is insufficient data on the safety and efficacy of Lustork vaginal tablets in children and adolescents.
Instructions for use
Tablets may be divided into equal doses.
Lustork should be inserted into the vagina.
In pregnant women, due to a softened cervix, it is recommended to insert Lustork with the index finger.
Use of a higher than recommended dose of Lustork
If a higher than recommended dose of this medicine is taken, contact your doctor or pharmacist immediately.
Symptoms of overdose may include: dizziness, fatigue, depression.
These symptoms usually resolve spontaneously after dose reduction. Consult your doctor beforehand.
Missed dose of Lustork
If a dose is missed, take it as soon as remembered, unless it is almost time for the next dose. Do not take a double dose to make up for a missed dose.
Stopping use of Lustork
If you have any further questions about using this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
You must stop using this medicine immediately if the patient experiences:

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

The following adverse effects occur frequently (in 1 out of 10 patients):

headaches
abdominal bloating
abdominal pain
nausea
uterine contractions

The following adverse effects occur less frequently (in 1 out of 100 patients):

dizziness
insomnia
diarrhoea
constipation
urticaria (allergic rash)
rash
vaginal disorders (e.g. vaginal discomfort, burning, discharge, dryness and bleeding)
vaginal fungal infection
breast disorders (e.g. breast pain, breast swelling, breast tenderness)
itching in the genital area
peripheral oedema (swelling due to fluid accumulation)

Frequency not known (cannot be estimated from the available data):

fatigue
vomiting
allergic reactions

Reporting of adverse effects
If any adverse effects occur, including any adverse effects not listed in this leaflet, inform a doctor or pharmacist.
Adverse effects can be reported directly to the Department 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
Adverse effects can also be reported to the marketing authorisation holder or its representative.
Reporting adverse effects helps to provide more information on the safety of the medicine.

5. How to store Lustork
Store below 25 °C.
Keep 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 stated month.
Medicines must not be disposed of via wastewater or household waste. Ask a pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the package and other information

What Lustork contains

The active substance is progesterone.
Each tablet contains 50 mg of progesterone.
The other ingredients are: lactose monohydrate, maize starch, citric acid monohydrate, magnesium stearate, hypromellose (6 mPa·s).

What Lustork looks like and contents of the pack
White, uncoated, round, biconvex tablets with a division line on one side, 9 mm in diameter.
The pack contains 30 vaginal tablets or 60 vaginal tablets or 90 vaginal tablets.
Marketing Authorisation Holder and Manufacturer
Adamed Pharma S.A.
Pieńków, ul. M. Adamkiewicza 6A
05-152 Czosnów