Lustork

PATIENT INFORMATION LEAFLET

Leaflet accompanying the packaging: patient information

Lustork, 200 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 further questions, 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 any of the side effects get worse or if you notice any not listed in the leaflet, 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 containing a synthetically obtained, natural female sex hormone
progesterone.
In the body, progesterone acts through specific receptors located 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 to allow implantation of the fertilized egg, inhibiting excessive growth of the endometrium (endometrium) caused by estrogens, cyclic changes in the epithelium of the fallopian tubes, cervix, and vagina. Progesterone and estrogens also act on
the breast tissue, stimulating the growth of glands and ductal 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 suppresses the spontaneous contractile activity of the pregnant uterus, inhibits the immune response of the mother to fetal antigens, is
a basic substance for the production of fetal hormones, initiates labor.
Indications for the use of Lustork:

• In vitro fertilization.
• Hormone replacement therapy in postmenopausal women with an intact uterus, to protect the endometrium.

2. Important information before taking Lustork

When not to take Lustork:

• If the patient is allergic to progesterone or any other component 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 (thromboembolism), e.g., in the limbs (deep vein thrombosis) or lungs (pulmonary embolism), and if such thromboses have occurred in the past;
• If the patient is at risk of cerebral hemorrhage;
• If the patient has a rare blood disorder called porphyria, which is inherited from generation to generation.
• If there has been 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, 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 if:
• you experience any vision disturbances (e.g., vision loss, double vision, vascular changes in the retina);
• you have blood clots (thromboembolic disease of the veins or arteries);
• you have severe headaches. If you do not experience menstrual bleeding during treatment, you should ensure that you are not pregnant. During treatment, the endometrium may begin 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 insufficient data on the safety and efficacy of Lustork in children and adolescents.

Other medicines and Lustork

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 treatment,
• medicines used for 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 baby, 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 a 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 or use machines. If side effects such as drowsiness, concentration and attention disorders, or dizziness occur, do not drive or use machines (see section 4).

3. How to take Lustork

Take this medicine always exactly as your doctor has told you. If you are not sure, ask 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 200 mg, vaginal tablets of 50 mg and 100 mg are available.
Adults
In in vitro fertilization programs, 200 mg of progesterone is used twice a day vaginally.
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.
A dose that provides adequate protection of the endometrium 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 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 a doctor or pharmacist immediately.
Overdose symptoms that may occur are: dizziness, fatigue, depression.
These symptoms usually subsided on their own after reducing the dose of the medicine. Consult a doctor beforehand.

Missed dose of Lustork

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

Stopping Lustork treatment

In case of any further doubts about taking this medicine, consult a 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 cerebral hemorrhage,
• blood clots in the veins of the limbs or pelvis,
• sudden severe headaches,
• vision disturbances,
• jaundice (yellowing of the skin or whites of the eyes).

The following side effects are common (affecting up to 1 in 10 people):

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

The following side effects are uncommon (affecting up to 1 in 100 people):

• 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)
• genital itching
• 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, tell your doctor or pharmacist.
Side effects can be reported directly to the Department of Drug Safety Monitoring 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.
Reporting side effects will help gather more information on the safety of this medicine.

5. How to store Lustork

Store below 30°C.
Keep this 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 that 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. Contents of the pack and other information

What Lustork contains

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

What Lustork looks like and contents of the pack

Round tablets with a diameter of 12 mm, white or off-white in color.
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