Package leaflet: Information for the patient

Lustork, 200 mg, vaginal tablets
Progesteronum
Please read the entire leaflet before use, as it contains important information for the patient.

Keep this leaflet so that you can read it again if necessary.
Consult your doctor or pharmacist if you have any further questions.
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 any of the side effects worsen or if any side effects occur, including those not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents:

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

1. What Lustork is and what it is used for

Lustork is a medicine containing the naturally occurring female sex hormone progesterone, synthetically produced.
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 allowing implantation of the fertilized egg, inhibition of excessive endometrial proliferation (endometrium) caused by estrogens, and 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 contractile activity of the pregnant uterus, inhibits the mother's immune response to fetal antigens, serves as a basic substance for the production of fetal hormones, and initiates labor.
Indications for use of Lustork:

In vitro fertilization.
Hormone replacement therapy in postmenopausal women with an intact uterus, 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 failure;
If the patient has a liver tumour;
If the patient has or is suspected of having a tumour of the breast or genital organs;
If the patient has active venous thrombosis (e.g. deep vein thrombosis in the limbs or pulmonary embolism), or has a history of such types of blood clots;
If the patient is at risk of intracranial haemorrhage;
If the patient has a rare inherited blood disorder called porphyria;
If a miscarriage has occurred and there is suspicion that certain tissues remain in the uterus or if pregnancy develops outside the uterus (ectopic pregnancy).

Warnings and precautions
Before starting this medicine, discuss it with your doctor.
This medicine, when used as directed, does not have contraceptive effects.
Before starting hormone replacement therapy during menopause (and subsequently at regular annual intervals), you should consult your doctor, who will perform an examination of the breasts and pelvic organs. Inform your doctor if:

The patient has a history of venous thrombosis (venous blood clots);
The patient experiences uterine bleeding. The patient should stop taking this medicine if:
Any visual disturbances occur (e.g. loss of vision, double vision, pathological changes in retinal blood vessels);
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 endometrial lining may begin to overgrow (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 has ended and persists, contact your doctor.

Children and adolescents
There is insufficient data on the safety and efficacy of using Lustork in children and adolescents.

Other medicines and Lustork
Inform your doctor about all medicines currently used, recently taken, or planned for use.
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 reduce the effectiveness of Lustork;
Lustork may enhance the effect 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

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

Fertility

This medicine may be taken by women who have difficulty becoming pregnant. This medicine has no harmful effect on fertility.
Before starting this medicine, discuss it with your doctor.

Driving and operating machinery
Lustork administered vaginally does not affect the ability to drive or operate machinery. However, if adverse effects such as drowsiness, concentration disturbances, attention disorders, or dizziness occur, driving and operating machinery are not recommended (see section 4).

3. How to use Lustork

This medicine should always be used as directed by the physician. In case of doubt, consult a
physician or pharmacist.
Dosage
The dosage of progesterone should always be individually determined according to the indication
and therapeutic response. For doses other than 200 mg, vaginal tablets with strengths of 50 mg and 100 mg are available.
Adults
In in vitro fertilization programs, 200 mg of progesterone should be administered vaginally twice daily.
Treatment should continue until day 77 after embryo transfer. Discontinuation of therapy should be done by gradually reducing the dose.
The dose providing adequate endometrial protection is 200 mg daily for 12 days or 100–200 mg daily in continuous therapy.
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
Lustork should be inserted into the vagina. In pregnant women, due to a softened cervix, it is recommended to insert the Lustork tablet with the index finger.
Overdose of Lustork
In case of ingestion of a higher than recommended dose of this medicine, contact a physician or pharmacist immediately.
Symptoms of overdose may include: dizziness, fatigue, depression.
These symptoms usually resolve spontaneously after dose reduction. Consult a physician beforehand.
Missed dose of Lustork
If a dose is missed, it should be administered as soon as remembered, unless it is almost time for the next dose. Do not administer a double dose to make up for the missed dose.
Discontinuation of Lustork
In case of any further doubts regarding the use of this medicine, consult a physician or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
You must stop taking 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 reactions are common (occur in 1 out of 10 patients):

headache
abdominal bloating
abdominal pain
nausea
uterine cramps

The following adverse reactions are uncommon (occur 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)
genital itching
peripheral oedema (swelling due to fluid accumulation)

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

fatigue
vomiting
allergic reactions

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed
in this leaflet, tell your doctor or pharmacist.
Adverse reactions can be reported directly to the Department for Monitoring of Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorisation holder or its representative.
Reporting adverse reactions helps provide more information on the safety of this medicine.

5. How to store Lustork

Store below 30°C.
Keep the medicine in a place invisible and out of 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 month indicated.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the packaging and other information

What the medicine Lustork contains

The active substance is progesterone.
One tablet contains 200 mg of progesterone.
The other ingredients are: monohydrate lactose, corn starch gelatin, sodium croscarmellose, hypromellose (6 mPa·s), monohydrate citric acid, magnesium stearate, anhydrous colloidal silicon dioxide.

What Lustork looks like and contents of the pack
Round tablets, 12 mm in diameter, white or off-white in colour.
The pack contains 30 vaginal tablets, 60 vaginal tablets or 90 vaginal tablets.

Marketing Authorisation Holder and Manufacturer
Adamed Pharma S.A.
Pieńków, ul. M. Adamkiewicza 6A
05-152 Czosnów