Lustork

Package leaflet: Information for the patient

Lustork, 100 mg, vaginal tablets
Progesterone
Please read the entire leaflet carefully before using the medicine, as it contains important information for the patient.

• Keep this leaflet for future reference.
• 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.
• This medicine may harm another person, even if their symptoms are the same.
• If any of the side effects worsens or if any side effects occur, including those not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents:

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

1. What Lustork is and what it is used for

Lustork is a medicine containing progesterone, a naturally occurring female sex hormone produced synthetically.
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 the reproductive organs include enabling ovulation, transformation of the uterine mucosa (endometrium) to allow implantation of the fertilized egg, inhibition of excessive endometrial proliferation 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:

• Endometriosis.
• In vitro fertilization.
• Infertility associated with luteal phase deficiency.
• Recurrent and threatened miscarriage.
• Hormone replacement therapy in postmenopausal women with an intact uterus, to protect the uterine lining (endometrium).

2. Important information before using Lustork

When not to use Lustork:

• If the patient is allergic to progesterone or to 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 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. in the limbs – deep vein thrombosis – or in the lungs – pulmonary embolism), or if such types of blood clots occurred in the past medical history;
• If the patient is at risk of intracranial haemorrhage;
• If the patient suffers from a rare inherited blood disorder called porphyria;
• If a miscarriage has occurred and there is suspicion that some tissue remains in the uterus, or if pregnancy is developing outside the uterus (ectopic pregnancy).

Warnings and precautions
Before starting to take this medicine, discuss it with your doctor.
This medicine, when used as directed, does not have contraceptive effects.
Before initiating hormone replacement therapy (HRT) for menopause (and subsequently at regular annual intervals), a medical examination of the breasts and pelvic organs should be performed by a doctor. Inform your doctor if:

• The patient has a history of venous blood clots (venous thrombosis);
• The patient experiences uterine bleeding. Discontinue taking this medicine if any of the following occur:
  • Any visual disturbances (e.g. visual field defects, double vision, pathological changes in retinal blood vessels);
  • Blood clots (venous thromboembolic disease or thrombosis);
  • Severe headaches.

If menstruation does not occur during treatment, pregnancy should be ruled out. During treatment, the endometrial lining may undergo excessive growth (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 Lustork in children and adolescents.

Other medicines and Lustork
Inform your doctor about all medicines currently used, recently used, or which the patient plans to use.
Some medicines may affect the action of Lustork:

• Barbiturates used for sleep disorders or anxiety;
• Medicines used in epilepsy (carbamazepine, phenytoin);
• Certain antibiotics (ampicillins, tetracyclines, rifampicin);
• Phenylbutazone (an anti-inflammatory drug);
• Spironolactone (a diuretic);
• Certain antifungal medicines (ketoconazole, griseofulvin);
• Similarly, Lustork may affect the action of certain medicines used in diabetes treatment;
• 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 fertility

Pregnancy

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

Breastfeeding

• Women who are breastfeeding should not use this medicine.
• Discuss this with your doctor before starting to take this medicine.

Fertility

• This medicine may be taken by women who have difficulty becoming pregnant. This medicine has no harmful effect on fertility.
• Discuss this with your doctor before starting treatment.

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 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 as directed by the physician. In case of doubt, consult your
doctor or pharmacist.
Dosage
The dosage of progesterone should always be individually determined depending on the indication and therapeutic response. For doses other than 100 mg, vaginal tablets 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) administered vaginally twice daily in sequential regimens from day 15 to day 25 of the cycle, or daily in continuous regimens.
• In endometriosis: 50 to 100 mg (1 to 2 tablets) administered vaginally twice daily 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 administered vaginally twice daily.
• In cases of recurrent miscarriage, progesterone supplementation should be initiated in the cycle in which pregnancy is planned. Treatment should be continued uninterrupted until week 18–20 of pregnancy.
• In in vitro fertilization programs: 150 to 200 mg of progesterone administered vaginally twice daily. Treatment should continue until day 77 after embryo transfer. Discontinuation of therapy should be achieved 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
Lustork should be inserted into the vagina.
In pregnant women, due to the softened cervix, it is recommended to insert the Lustork tablet 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, it should be taken as soon as remembered, unless it is almost time for the next dose. Do not administer a double dose to make up for a missed one.
Stopping treatment with Lustork
If you have any further questions about the use of this medicine, consult your doctor 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 veins of the limbs or pelvis,
• sudden severe headaches,
• vision disturbances,
• yellowing of the skin or whites of the eyes (jaundice).

The following adverse reactions are common (occurring in 1 out of 10 patients):

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

The following adverse reactions are uncommon (occurring 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
• nipple disorders (e.g. breast pain, breast swelling, breast tenderness)
• itching in the genital area
• peripheral oedema (swelling due to fluid accumulation)

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

• fatigue
• vomiting
• allergic reactions.

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

5. How to store the medicine Lustork

Store below 30ºC.
Keep the medicine out of the 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 specified month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the pack and other information

What Lustork contains

• The active substance is progesterone.
• Each tablet contains 100 mg of progesterone.
• The other ingredients are: monohydrate lactose, maize starch, sodium croscarmellose, hypromellose (6 mPa·s), monohydrate citric acid, magnesium stearate, colloidal anhydrous silica.

What Lustork looks like and contents of the pack
White or off-white, round vaginal tablet, marked with "100" on one side and "22" on the other side.
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