Package leaflet: information for the patient

Luteina, 50 mg, vaginal tablets
Progesteronum
Please read carefully the entire leaflet before using the medicine, as it contains
important information for the patient.

Keep this leaflet, so that you can read it again if necessary.
If you have any questions, please consult your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents of the leaflet

What Luteina is and what it is used for
Important information before using Luteina
How to use Luteina
Possible side effects
How to store Luteina
Contents of the pack and other information

1. What Luteina is and what it is used for

Luteina is a medicine containing synthetically produced, natural female sex hormone
progesterone.
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, cyclic
changes in the epithelium of the fallopian tubes, cervix and vagina. Progesterone and estrogens also act on
the mammary gland, stimulating 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 precursor for fetal hormone production, and initiates labor.
Indications for use of Luteina

Conditions associated with endogenous progesterone deficiency, such as menstrual cycle disorders, painful menstruation, anovulatory cycles, premenstrual tension syndrome and functional uterine bleeding,
Endometriosis,
In vitro fertilization,
Infertility associated with luteal phase deficiency,
Recurrent and threatened miscarriages,
Luteal phase deficiency in the premenopausal period,
Hormone replacement therapy in postmenopausal women with an intact uterus, to protect the uterine mucosa (endometrium).

2. Important information before using Luteina
When not to use Luteina

If you are allergic to progesterone or any of the other ingredients of this medicine (listed in section 6).
If you have vaginal bleeding of unknown cause;
If you have severe liver failure;
If you have a liver tumor;
If you have or are suspected of having a breast or genital organ tumor;
If you have active venous thrombosis (e.g. deep vein thrombosis in the limbs or pulmonary embolism), or if you have had such blood clots in the past;
If you are at risk of cerebral hemorrhage;
If you have a rare inherited blood disorder called porphyria.
If a miscarriage has occurred and there is suspicion that certain tissues remain in the uterus or if the pregnancy is ectopic.

Warnings and precautions
Before starting to use this medicine, discuss it with your doctor.
This medicine, when used as directed, does not have contraceptive effects.
Before initiating hormone replacement therapy during menopause (and subsequently at regular annual intervals), you should consult your doctor, who will perform an examination of the breasts and pelvic organs. Inform your doctor if:

you have previously experienced venous thrombosis (venous thrombosis)
you have uterine bleeding. You should stop taking this medicine if:
you experience any visual disturbances (e.g. visual field defects, double vision, pathological changes in retinal blood vessels);
you develop blood clots (venous thromboembolic disease or thrombosis);
you experience severe headaches. If you do not have a menstrual period during treatment, you should confirm whether you are pregnant. During treatment, the uterine mucosa 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.

Children and adolescents
There is insufficient data on the safety and efficacy of Luteina in children and adolescents.
Other medicines and Luteina:
Inform your doctor or pharmacist 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 Luteina.

barbiturates used for sleep disorders or anxiety,
medicines used for epilepsy (carbamazepine, phenytoin),
certain antibiotics (ampicillins, tetracyclines, rifampicin),
phenylbutazone (anti-inflammatory medicine),
spironolactone (diuretic),
certain antifungal medicines (ketoconazole, griseofulvin),
similarly, Luteina 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 Luteina,
Luteina may enhance the action of cyclosporine.

Pregnancy, breastfeeding and effects on fertility
Pregnancy

If you are pregnant, suspect you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

Breastfeeding

Breastfeeding women should not use this medicine.
Before starting to take this medicine, discuss it with your doctor.

Fertility

This medicine may be taken by women who have difficulty becoming pregnant. This medicine has no known harmful effect on fertility.
Before starting to take this medicine, discuss it with your doctor.

Driving and operating machinery
Luteina administered vaginally does not affect the ability to drive and operate
machinery. However, if adverse reactions such as drowsiness, concentration disturbances,
attention deficits or dizziness occur, driving and operating machinery are not recommended (see section 4).
3. How to use Luteina
This medicine should always be used as directed by your doctor. If in doubt, 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

For menstrual cycle disorders, painful menstruation, premenstrual tension syndrome, luteal phase deficiency in the premenopausal period: administer 25 to 50 mg (½ to 1 tablet) vaginally twice daily during the second phase of the menstrual cycle (natural or induced) for 10-12 days.
For menstrual cycle disorders, painful menstruation, premenstrual tension syndrome: continue treatment for 3-6 consecutive cycles.
For luteal phase deficiency in the premenopausal period: continue treatment until menopause occurs.
In hormone replacement therapy in combination with estrogens: administer 50 to 100 mg (1 to 2 tablets) vaginally twice daily in sequential therapy from day 15 to day 25 of the cycle or continuously every day.
In a progesterone challenge test for secondary amenorrhea: administer 50 mg (1 tablet) vaginally twice daily for 5-7 days. Bleeding should occur within 7-10 days after stopping the medicine.
In the treatment of functional genital tract bleeding: administer 50 mg (1 tablet) vaginally twice daily for 5-7 days. Continue treatment for the next 2-3 months by administering 25 to 50 mg (½ to 1 tablet) vaginally twice daily from day 15 to day 25 of the cycle.
In endometriosis: administer 50 to 100 mg (1 to 2 tablets) twice daily vaginally continuously for 6 months.
In recurrent and threatened miscarriages: administer 200 to 400 mg (4 to 8 tablets) vaginally twice daily.
In recurrent miscarriages, progesterone supplementation should be initiated in the cycle in which pregnancy is planned. Treatment should be continued continuously until week 18-22 of pregnancy.
In anovulatory and induced cycles: administer 50 to 150 mg (1 to 3 tablets) vaginally twice daily.
In in vitro fertilization programs: administer 200 to 400 mg (4 to 8 tablets) vaginally twice daily. Continue treatment until day 77 after embryo transfer. Discontinuation of therapy should be done by gradually reducing the dose.

Use in children and adolescents
There is insufficient data on the safety and efficacy of Luteina vaginal tablets in children and adolescents.
Instructions for use
The tablet may be divided into equal doses.
Luteina should be placed in the vagina.
Luteina vaginal tablets should be placed directly into the vagina.
Taking more than the recommended dose of Luteina
If you take more than the recommended dose of this medicine, contact your
doctor or pharmacist immediately.
Symptoms of overdose may include: dizziness, fatigue, depression.
These symptoms usually resolve spontaneously after reducing the dose. Consult your doctor beforehand.
Missed dose of Luteina
Take the missed dose as soon as you remember, unless it is almost time for the next dose. Do not take a double dose to make up for a missed dose.
Stopping Luteina treatment
If you have any further doubts regarding 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 experiences them.
You should stop using this medicine immediately if the patient experiences:

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

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

headache,
abdominal bloating,
abdominal pain,
nausea,
uterine cramps.

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

dizziness,
insomnia,
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 reactions occur, including any not listed in this leaflet, inform your doctor or pharmacist.
Adverse reactions can be reported directly to the Department of Pharmacovigilance of 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.
Reporting adverse reactions helps to provide more information on the safety of this medicine.

5. How to store Luteina
No special storage conditions required.
Keep the medicine 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 no longer required. These measures will help protect the environment.

6. Contents of the packaging and other information

What Luteina contains

The active substance is progesterone.
Each tablet contains 50 mg of progesterone.
The other ingredients are: monohydrate lactose, corn starch, monohydrate citric acid, magnesium stearate, hypromellose.

What Luteina looks like and contents of the pack
White, uncoated, round, biconvex tablets with a division line on one side, 9 mm in diameter.
The pack contains 30 vaginal tablets.
Marketing Authorisation Holder and Manufacturer
Adamed Pharma S.A.
Pieńków, ul. M. Adamkiewicza 6A
05-152 Czosnów
tel.: +48 22 732 77 00