Lutezin

PATIENT INFORMATION LEAFLET

Leaflet accompanying the packaging: patient information

Lutezin, 200 mg, vaginal tablets
Progesterone

You should read the contents of the leaflet before using 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 side effects 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 using Lutezin
• 3. How to use 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 acts 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 to allow the implantation of a fertilized egg, inhibiting excessive
growth of the uterine mucosa (endometrium) 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 enabling lactation.
Progesterone is a hormone necessary for the proper preparation of the endometrium for the implantation of the embryo, for the maintenance of pregnancy throughout its duration: it eliminates the spontaneous contractile activity of the pregnant uterus, inhibits the mother's immune response to fetal antigens, is a basic substance for the production of fetal hormones, and initiates labor.
Indications for the use of Lutezin:

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

2. Important information before using Lutezin

When not to use 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 blood clot in a vein (thrombophlebitis), e.g. in the limbs (deep vein thrombosis) or lungs (pulmonary embolism), and also if such types of blood clots have occurred in the past;
• If the patient has a 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 it is suspected 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 examination 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. visual impairment, 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 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, unexpected bleeding or spotting occurs and persists, you should contact your doctor. If, during treatment, you experience mood changes and symptoms of depression worsen, you should contact your doctor as soon as possible.

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 function 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

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),
• likewise, 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 your doctor or pharmacist before using this medicine.

Breastfeeding

• Women who are breastfeeding should not use this medicine.

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, you should 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, dizziness, it is not recommended to drive and use machines (see section 4).

3. How to use Lutezin

This medicine should always be used as recommended by your doctor. If you are unsure, you should consult your doctor or pharmacist.
Recommended dose
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, 100-200 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 administered dose of the medicine.
In hormone replacement therapy:
A dose that ensures adequate protection of the endometrium is 200 mg per day for 12 days or 100-200 mg per day in continuous therapy.

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.

Using a higher dose of Lutezin than recommended

In case of taking a higher dose of this medicine than recommended, you should immediately consult a doctor or pharmacist.
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. You should consult a doctor beforehand.

Missing a dose of Lutezin

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

Stopping the use of Lutezin

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

4. Possible side effects

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

You should stop using 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
• abdominal 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 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 Adverse Reaction Monitoring of Medicinal Products, Medical Devices, and Biocidal Products, ul. 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.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Lutezin

Store at a temperature below 30°C.
The medicine should be stored in a place that is 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 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 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 200 mg of progesterone.
• The other ingredients are: lactose monohydrate, maize starch, sodium croscarmellose, hypromellose (6 mPa·s), citric acid monohydrate, magnesium stearate, silica colloidal anhydrous.

What Lutezin looks like and contents of the pack

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