Lutezin

Package leaflet: Information for the patient

Lutezin, 200 mg, vaginal tablets
Progesteronum
Please read the entire leaflet before using the medicine, as it contains important information for the patient.

• Keep this leaflet for possible future reference.
• Consult your doctor or pharmacist if you have any further questions.
• This medicine has been prescribed for a specific individual. Do not give it to others.
• This medicine may harm another person, even if their symptoms are the same.
• If any of the adverse reactions worsen, or if any adverse reactions occur which are not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents:

1. What Lutezin is and what it is 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 Lutezin is and what it is used for

Lutezin 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 reproductive organs include: enabling ovulation, transformation of the endometrium allowing 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 the 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 Lutezin:

• In vitro fertilization.
• Hormone replacement therapy in postmenopausal women with an intact uterus, to protect the 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 cause;
• If the patient has severe liver failure;
• If the patient has a liver tumour;
• If the patient has or is suspected of having a breast or genital organ tumour;
• If the patient has active venous thrombosis (e.g. in the limbs – deep vein thrombosis – or in the lungs – pulmonary embolism), or if such blood clots occurred in the past medical history;
• If the patient is at risk of intracranial haemorrhage;
• If the patient has a rare inherited blood disorder called porphyria;
• If a miscarriage has occurred and there is suspicion that certain tissues still remain 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 starting hormone replacement therapy during menopause (and subsequently at regular annual intervals), consult your doctor, who will perform an examination of the breasts and pelvic organs. Inform your doctor if:

• The patient has a history of venous blood clots (venous thrombosis);
• The patient experiences uterine bleeding. The patient should stop taking this medicine in case of:
• Any visual disturbances (e.g. reduced vision, double vision, pathological changes in retinal blood vessels);
• Blood clots (venous thromboembolic disease or thrombosis);
• Severe headaches.

If menstruation does not occur during treatment, it is necessary to confirm whether the patient is not pregnant. During treatment, the endometrium (uterine lining) may begin to overgrow (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. If a patient with depression experiences mood changes and worsening depressive symptoms during treatment, she should contact her doctor as soon as possible.

The doctor will inform the patient about the necessity of reporting any changes in the breasts.
This medicine should be used with particular caution in patients:

• With mild to moderate liver function impairment;
• With conditions whose symptoms may worsen due to fluid retention (e.g. epilepsy, migraine, asthma, heart or kidney dysfunction);
• With diabetes or diagnosed insulin resistance;
• Over 35 years of age, who smoke, and who have risk factors for atherosclerosis.

Children and adolescents
There is insufficient data on the safety and efficacy of Lutezin in children and adolescents.

Lutezin and other medicines
Inform your doctor about all medicines currently used, recently used, or planned for use.
Some medicines may affect the action of Lutezin:

• Barbiturates used for sleep disorders or anxiety;
• Medicines used in epilepsy (carbamazepine, phenytoin);
• Certain antibiotics (ampicillins, tetracyclines, rifampicin);
• Phenylbutazone (an anti-inflammatory medicine);
• Spironolactone (a 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 reduce the effectiveness of Lutezin;
• Lutezin may enhance the effect of cyclosporine.

Pregnancy, breastfeeding and fertility

Pregnancy

• If the patient is pregnant, suspects she may be pregnant, or plans to become pregnant, she should consult a 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 becoming pregnant. This medicine has no harmful effect on fertility.
• Before starting to take this medicine, discuss it with your doctor.

Driving and operating machinery
Lutezin 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 Lutezin

This medicine should always be used as directed by a physician. In case of doubt, consult your
doctor or pharmacist.
Recommended dose
Progesterone dosage should always be individually determined depending on the indication and
therapeutic response. For doses other than 200 mg, vaginal tablets of 50 mg and 100 mg strength are available.
Adults
In in vitro fertilization programs, 100–200 mg of progesterone should be administered vaginally 2–3 times daily. Treatment should continue until day 77 after embryo transfer. Discontinuation of therapy should be done gradually by reducing the dose.
In hormone replacement therapy:
The dose providing adequate endometrial protection 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 Lutezin vaginal tablets in children and adolescents.
Instructions for use
Lutezin should be inserted into the vagina. In pregnant women, due to a softened cervix, it is recommended to insert the Lutezin tablet with the index finger.
Overdose of Lutezin
If more than the 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 upon dose reduction. Consult your doctor beforehand.
Missed dose of Lutezin
If a dose is missed, it should be taken as soon as remembered, unless it is almost time for the next dose. Do not take a double dose to make up for a missed dose.
Discontinuing Lutezin
Sudden discontinuation of progesterone may cause increased anxiety, mood swings, and seizures.
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 will experience them.
You must stop taking this medicine immediately if any of the following adverse reactions occur:

• stroke, blood clots or internal bleeding in the brain,
• blood clots in the veins of the limbs or pelvis,
• sudden severe headaches,
• visual disturbances,
• yellowing of the skin or whites of the eyes (jaundice).

The following adverse reactions occur frequently (in 1 out of 10 patients):

• headache
• abdominal bloating
• abdominal pain
• nausea
• uterine cramps

The following adverse reactions occur uncommonly (in 1 out of 100 patients):

• dizziness
• drowsiness
• diarrhoea
• constipation
• urticaria (allergic rash)
• rash
• vaginal disorders (e.g. vaginal discomfort, burning sensation, discharge, dryness and bleeding)
• vaginal fungal infection
• breast disorders (e.g. breast pain, breast swelling, breast tenderness)
• genital itching
• peripheral oedema (swelling due to fluid accumulation)

Frequency of occurrence is unknown (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, please inform your doctor or pharmacist.
Adverse reactions can be reported directly to the Department of Monitoring of 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 can also be reported to the marketing authorisation holder.
By reporting adverse reactions, additional information on the safety of the medicine can be collected.

5. How to store Lutezin

Store below 30°C.
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 stated 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 Lutezin contains

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

What Lutezin looks like and contents of the pack
Round tablets, 12 mm in diameter, white or off-white in colour.
PVC/PVDC/Aluminium blisters. The blisters are placed in a cardboard box containing 30
vaginal tablets, 60 vaginal tablets or 90 vaginal tablets.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation 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