Lutezin

PATIENT INFORMATION LEAFLET

Leaflet included in the packaging: patient information

Lutezin, 100 mg, vaginal tablets
Progesterone

You should read the leaflet before taking the medicine, as it contains important information for the patient.

• You should keep this leaflet so that you can read it again if you need to.
• You should consult a doctor or pharmacist if you have any further doubts.
• 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, you should tell your 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 mucous membrane of the uterus (endometrium) to allow implantation of a fertilized egg, inhibiting
excessive growth of the mucous membrane of the uterus caused by estrogen, cyclic changes in the epithelium of the fallopian tubes, cervix, and vagina. Progesterone and estrogen also act on
the breast gland, stimulating the growth of glands and epithelium of the ducts and allowing lactation.
Progesterone is a hormone necessary for the proper preparation of the endometrium for
implantation of the embryo, to maintain pregnancy throughout its duration: it eliminates spontaneous contractions of the pregnant uterus, inhibits the mother's immune response to fetal antigens, is
a basic substance for the production of fetal hormones, initiates labor.
Indications for use of Lutezin:

• Endometriosis.
• In vitro fertilization.
• Infertility associated with luteal insufficiency.
• Habitual and threatened miscarriages.
• Hormone replacement therapy in postmenopausal women with an intact uterus, receiving hormone replacement therapy, to protect the uterine mucosa (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 also if the patient has a history of such blood clots;
• If the patient is at risk of internal bleeding into the brain;
• If the patient has a rare blood disease called porphyria, which is inherited from generation to generation (hereditary).
• 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, you should 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), you should 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);
• you have severe headaches; If you do not have your period during treatment, you should make sure you are not pregnant. During treatment, the uterine mucosa may start to overgrow (endometrial hyperplasia) or this overgrowth may worsen. If during prolonged treatment, at the end of treatment, or after treatment, you experience unexpected bleeding or spotting that persists, you should contact your doctor. If you are being treated for depression and you experience mood changes or worsening of depressive symptoms, you should contact your doctor as soon as possible. Your doctor will inform you about the need to report any changes in the breast area. This medicine should be used with particular caution in patients:
• with mild to moderate liver function disorders,
• with diseases whose symptoms may worsen due to fluid retention (e.g. epilepsy, migraine, asthma, heart or kidney disorders),
• with diabetes or diagnosed insulin resistance.
• over 35 years old, 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

You should 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 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, you should consult a doctor or pharmacist before taking this medicine.

Breastfeeding

• Women who are breastfeeding should not take this medicine.
• Before starting to take this medicine, you should discuss it with your doctor.

Fertility

• This medicine may be taken by women who have problems getting pregnant. This medicine does not have any harmful effect on fertility.
• Before starting to take this medicine, you should discuss it with your doctor.

Driving and using machines

Lutezin, when administered vaginally, does not affect the ability to drive vehicles and operate machines. If you experience side effects such as drowsiness, concentration and attention disorders, dizziness, you should not drive vehicles or operate machines (see section 4).

3. How to take Lutezin

This medicine should always be taken as recommended by your doctor. If you have any doubts, you should consult a 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 100 mg, vaginal tablets of 50 mg and 200 mg are available.
Adults

• In hormone replacement therapy, 200 mg per day is used for 12 days a month or 100-200 mg per day in continuous therapy.
• In endometriosis, 50 to 100 mg (1 to 2 tablets) is used 2 times a day vaginally 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 is used 2 times a day vaginally.
• In the case of 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, 100 to 200 mg of progesterone is used 2-3 times 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 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

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 of this medicine than recommended, you should immediately consult a doctor or pharmacist.
Overdose symptoms that may occur are: dizziness, feeling of fatigue, depression.
These symptoms usually subsided on their own after reducing the dose of the medicine. You should 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. You should not take a double dose to make up for a missed dose.

Stopping Lutezin treatment

If you have any further doubts about taking this medicine, you should consult a doctor or pharmacist.
Sudden discontinuation of progesterone may cause increased anxiety, mood swings, and seizures.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

You should stop taking this medicine immediately if you experience any of the following side effects:

• stroke, blood clots, or internal bleeding into 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 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 (edema due to fluid accumulation)

The frequency of occurrence is unknown (cannot be determined from available data):

• fatigue
• vomiting
• allergic reactions.

Reporting side effects

If you experience any side effects, including those not listed in the leaflet, you should tell your doctor or pharmacist.
Side effects can be reported directly to the Department of Post-Marketing Surveillance of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Jerozolimskie Avenue 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.
By reporting side effects, you can help gather more information on the safety of the medicine.

5. How to store Lutezin

Store in a temperature below 30°C.
The medicine should be stored 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 given month.
Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines that are no longer used. 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 100 mg of progesterone.
• The other ingredients are: lactose monohydrate, cornstarch, sodium carboxymethylcellulose, hypromellose (6 mPa·s), citric acid monohydrate, magnesium stearate, colloidal silica anhydrous.

What Lutezin looks like and what the pack contains

Round vaginal tablet, white or off-white, with the inscription "100" on one side and "22" on the other.
PVC/PVDC/Aluminum blisters. The blisters are placed in a cardboard box containing 30 vaginal tablets, 60 vaginal tablets, 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