Lutezin

Package leaflet: information for the patient

Lutezin, 100 mg, vaginal tablets
Progesteronum
Please read all of this leaflet carefully before using this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others.
• It may harm someone else, even if their symptoms are the same.
• If any of the adverse effects worsen, or if you experience any adverse effects 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 obtained 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 uterine mucosa (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 duct 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 fetal hormone production, and initiates labor.

Indications for use of Lutezin:

• Endometriosis.
• In vitro fertilization (IVF).
• Infertility associated with luteal phase deficiency.
• Recurrent and threatened miscarriage.
• Hormone replacement therapy in postmenopausal women with an intact uterus, receiving estrogen replacement therapy, to protect the uterine lining (endometrium).

2. 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 dysfunction;
• If the patient has a liver tumour;
• If the patient has or is suspected of having a tumour of the breast or genital organs;
• If the patient has active venous thrombosis (e.g. deep vein thrombosis in the limbs or pulmonary embolism), or if such types of 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 the pregnancy develops outside the uterus.

Warnings and precautions
Before starting this medicine, discuss it with your doctor.
This medicine, when used as directed, does not have contraceptive effects.
Before initiating hormone replacement therapy for menopausal symptoms (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 thrombosis (venous blood clots);
• The patient experiences uterine bleeding. Discontinue taking this medicine if:
  • Any visual disturbances occur (e.g. visual field defects, double vision, pathological changes in retinal blood vessels);
  • Blood clots occur (venous thromboembolic disease or thrombosis);
  • Severe headaches develop.
• If menstruation does not occur during treatment, pregnancy should be ruled out.
• During treatment, the endometrial lining may undergo excessive growth (endometrial hyperplasia), or existing hyperplasia may worsen.
• If unexpected bleeding or spotting occurs during or after prolonged treatment and persists, contact your doctor.
• If mood changes occur or symptoms of depression worsen during treatment in patients with a history of depression, the patient should contact their doctor as soon as possible.
• The doctor will inform the patient about the need to report any changes in the breasts.

This medicine should be used with particular caution in patients:

• With mild to moderate liver function disorders;
• With conditions whose symptoms may be exacerbated by fluid retention (e.g. epilepsy, migraine, asthma, heart or kidney dysfunction);
• With diabetes or diagnosed insulin resistance;
• In women over 35 years of age who smoke and have risk factors for atherosclerosis.

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

Lutezin with other medicines
Inform your doctor about all medicines currently used, recently taken, 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 (anti-inflammatory medicine);
• Spironolactone (diuretic);
• Certain antifungal medicines (ketoconazole, griseofulvin);
• Similarly, Lutezin may affect the action of certain medicines used in diabetes treatment;
• 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 effects on fertility
Pregnancy

• If the patient is pregnant, suspects she may be pregnant, or plans to become pregnant, she should consult her doctor or pharmacist before using this medicine.

Breastfeeding

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

Fertility

• This medicine may be taken by women who have difficulty becoming pregnant.
• This medicine has no harmful effect on fertility.
• Before starting 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 exactly as recommended by your doctor. In case of doubt, consult your doctor or pharmacist.
Dosage
The dosage of progesterone should always be individually determined depending on the indication and therapeutic response. For doses other than 100 mg, vaginal tablets with strengths of 50 mg and 200 mg are available.
Adults

• In hormone replacement therapy: 200 mg once daily for 12 days per month, or 100–200 mg daily in continuous therapy.
• In endometriosis: 50 to 100 mg (1 to 2 tablets) twice daily administered vaginally in continuous therapy for a period of 6 months.
• In habitual or threatened miscarriage, anovulatory cycles, and induced cycles: 50 to 150 mg of progesterone twice daily administered vaginally.
• In cases of recurrent miscarriage, progesterone supplementation should be initiated in the cycle in which pregnancy is planned. Treatment should be continued continuously until week 18–20 of pregnancy.
• In in vitro fertilization programs: 100 to 200 mg of progesterone twice or three times daily administered vaginally. Treatment should be continued until day 77 after embryo transfer. Discontinuation of therapy should be carried out by gradually reducing the dose.

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 the softened cervix, it is recommended to insert Lutezin with the index finger.
Use of more than the recommended dose of Lutezin
If more than the recommended dose of this medicine has been used, contact your doctor or pharmacist immediately.
Symptoms of overdose may include: dizziness, fatigue, depression.
These symptoms usually resolved spontaneously after dose reduction. Consult your doctor beforehand.
Missed dose of Lutezin
If you forget to take a dose, take it as soon as you remember, unless it is almost time for your next dose. Do not take a double dose to make up for a missed dose.
Stopping Lutezin
If you have any further questions about the use of this medicine, consult your 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 must stop using this medicine immediately if any of the following side effects occur:

• stroke, blood clots or internal bleeding in 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 occur frequently (in 1 out of 10 patients):

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

The following side effects occur less frequently (in 1 out of 100 patients):

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

Frequency is unknown (cannot be estimated from available data):

• fatigue
• vomiting
• allergic reactions

Reporting of side effects
If any side effects occur, including any not listed in this leaflet, inform your doctor or pharmacist.
Side effects can be reported directly to the Department of Monitoring Adverse Drug Reactions at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 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 authorisation holder.
Reporting side effects helps provide more information on the safety of this medicine.

5. How to store Lutezin

Store below 30ºC.
Keep the medicine in a place invisible and inaccessible to 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 sewage 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 packaging and other information

What Lutezin contains

• The active substance is progesterone.
• One tablet contains 100 mg of progesterone.
• The other ingredients are: monohydrate lactose, maize gelatinized starch, sodium croscarmellose, hypromellose (6 mPa·s), monohydrate citric acid, magnesium stearate, anhydrous colloidal silicon dioxide.

What Lutezin looks like and contents of the pack
White or almost white, round vaginal tablet, marked with "100" on one side and "22" on the other side.
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