Lutezin

PATIENT INFORMATION LEAFLET

Leaflet accompanying the packaging: patient information

Lutezin, 50 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 doubts, 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 the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet

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

1. What is Lutezin and what is it used for

Lutezin 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 glands, central nervous system, and pituitary gland.
The most important effects of progesterone on the reproductive organs are: enabling ovulation, transforming the endometrium (mucous membrane of the uterus) to enable implantation of a fertilized egg, inhibiting excessive growth of the endometrium caused by estrogens, cyclic changes in the epithelium of the fallopian tubes, cervix, and vagina. Progesterone and estrogens also affect the breast gland, stimulating the growth of glands and epithelium of the ducts, 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 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, and initiates labor.
Indications for the use of Lutezin:

• States of endogenous progesterone deficiency in the form of menstrual cycle disorders, painful menstruation, anovulatory cycles, premenstrual syndrome, and functional uterine bleeding.
• Endometriosis.
• In vitro fertilization.
• Infertility associated with luteal insufficiency.
• Habitual and threatened miscarriages.
• Luteal phase insufficiency in the premenopausal period.
• Hormone replacement therapy in postmenopausal women with an intact uterus, receiving hormone replacement therapy, to protect the endometrium.

2. Important information before taking Lutezin

When not to take Lutezin

• 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 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 blood clots have occurred in the patient's history;
• If the patient has a risk of cerebral hemorrhage;
• If the patient has a rare blood disease called porphyria, which is inherited from generation to generation.
• If a miscarriage has occurred 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, 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 experience menstruation during treatment, you should make sure you are not pregnant. During treatment, the endometrium may start to overgrow (endometrial hyperplasia) or this overgrowth may worsen. If unexpected bleeding or spotting occurs and persists during prolonged treatment, at the end of treatment, or after treatment, you should contact your doctor.

If you are being treated for depression and your mood changes and depressive symptoms worsen, you should contact your doctor as soon as possible.
Your doctor will inform you about the need to report any changes in your breasts.
This medicine should be used with special caution in patients:

• with mild to moderate liver function disorders,
• with diseases whose symptoms may worsen as a result of fluid retention (e.g. epilepsy, migraine, asthma, heart or kidney disorders),
• with diabetes or diagnosed insulin resistance,
• over 35 years of age, smoking, and with risk factors for atherosclerosis.

Children and adolescents

There is a lack of sufficient data on the safety and efficacy of Lutezin in children and adolescents.

Lutezin and other medicines

Tell your doctor or pharmacist about all medicines you are taking or have recently taken, as well as any medicines you plan to take.
Some medicines may affect the action of Lutezin.

• 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, Lutezin 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 Lutezin,
• Lutezin 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, 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 any known harmful effect on fertility.
• Before starting to take this medicine, discuss it with your doctor.

Driving and using machines

Lutezin 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 Lutezin

Take this medicine always as directed by your doctor. In case of doubts, 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

• In menstrual cycle disorders, painful menstruation, premenstrual syndrome, and luteal phase insufficiency in the premenopausal period, administer

vaginally 25 to 50 mg (½ to 1 tablet) 2 times a day in the second phase of the menstrual cycle (natural or induced) for 10-12 days.

• In menstrual cycle disorders, painful menstruation, premenstrual syndrome, treatment is continued for 3-6 consecutive cycles.
• In luteal phase insufficiency in the premenopausal period, treatment should be continued until menopause occurs.
• In hormone replacement therapy, administer 200 mg per day for 12 days a month or 100-200 mg per day in continuous therapy
• In the progesterone test for secondary amenorrhea, administer vaginally in a dose of 50 mg (1 tablet) 2 times a day for 5-7 days. Bleeding should occur within 7-10 days after discontinuation of the medicine.
• In the treatment of functional uterine bleeding, administer 50 mg (1 tablet) vaginally 2 times a day for 5-7 days. Treatment should be continued for the next 2-3 months, administering 25 to 50 mg (½ to 1 tablet) 2 times a day vaginally from the 15th to the 25th day of the cycle.
• In endometriosis, administer 50 to 100 mg (1 to 2 tablets) 2 times a day vaginally in continuous therapy for 6 months.
• In habitual and threatened miscarriages, anovulatory cycles, and induced cycles, administer vaginally 50 to 150 mg (1 to 3 tablets) 2 times a day.
• In habitual miscarriages, progesterone supplementation should be started in the cycle in which pregnancy is planned. Treatment should be continued uninterrupted until the 18th-20th week of pregnancy.
• In in vitro fertilization programs, administer 100 to 200 mg 2-3 times a day vaginally. Treatment should be 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 a lack of sufficient data on the safety and efficacy of Lutezin, vaginal tablets, in children and adolescents.

Instructions for use

The tablet can be divided into equal doses.
Lutezin should be placed in the vagina.
In pregnant women, due to the softened cervix, it is recommended to apply the medicine with the index finger.

Overdose of Lutezin

In case of taking a larger dose than recommended, contact a doctor or pharmacist immediately.
Symptoms of overdose that may occur are: dizziness, feeling of fatigue, depression.
These symptoms usually subsided on their own after reducing the dose of the medicine. Consult a doctor beforehand.

Missed dose of Lutezin

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

Stopping Lutezin

Sudden discontinuation of progesterone may cause increased anxiety, mood changes, and seizures.
In case of any further doubts related to the use of 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 any of the following side effects:

• stroke, blood clots, or internal bleeding in the brain,
• 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 (in 1 in 10 patients):

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

The following side effects are uncommon (in 1 in 100 patients):

• dizziness
• drowsiness
• 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 determined from available data):

• fatigue
• vomiting
• allergic reactions.

Reporting side effects

If you experience any side effects, including any side effects not listed in this leaflet, tell your doctor or pharmacist.
Side effects can be reported directly to the Department of Adverse Reactions 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
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of this medicine.

5. How to store Lutezin

Store in a temperature below 25°C.
Store in a place out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton. The expiry date refers to the last day of the stated month.
Medicines should not be disposed of via wastewater or household waste. 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 Lutezin contains

• The active substance of the medicine is progesterone.
• One tablet contains 50 mg of progesterone.
• Other ingredients are: lactose monohydrate, cornstarch, citric acid monohydrate, magnesium stearate, hypromellose (6 mPa·s).

What Lutezin looks like and contents of the pack

White, uncoated, round, biconvex tablets with a dividing line on one side, 9 mm in diameter.
PVC/PVDC/Aluminum blisters. The blisters are placed in a cardboard box containing 30, 60, or 90 vaginal tablets.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Adamed Pharma S.A.
Pieńków, ul. M. Adamkiewicza 6A
05-152 Czosnów
tel. +48 22 732 77 00

Manufacturer:

Adamed Pharma S.A.
ul. Marszałka Józefa Piłsudskiego 5,
95-200 Pabianice

Date of last revision of the leaflet: June 2023