Luteina

PATIENT INFORMATION LEAFLET

Leaflet enclosed with the packaging: patient information

Luteina, 50 mg, vaginal tablets

Progesterone

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• In case of any doubts, consult a doctor or pharmacist.
• 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 the patient experiences any side effects, including any side effects not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is Luteina and what is it used for
• 2. Important information before taking Luteina
• 3. How to take Luteina
• 4. Possible side effects
• 5. How to store Luteina
• 6. Package contents and other information

1. What is Luteina and what is it used for

Luteina is a medicine that contains a synthetically obtained, natural female sex hormone, progesterone.
Progesterone acts in the body through specific receptors located, among others, in the uterus, breast tissue, central nervous system, and pituitary gland.
The most important effects of progesterone on the reproductive organs are: enabling ovulation, transforming the endometrium (mucous membrane of the uterus) to enable implantation of a fertilized egg, inhibiting excessive growth of the endometrium caused by estrogen, cyclic changes in the epithelium of the fallopian tubes, cervix, and vagina. Progesterone and estrogen also act on the breast tissue, 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 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, initiates labor.
Indications for the use of Luteina

• States of endogenous progesterone deficiency in the form of menstrual cycle disorders, painful menstruation, anovulatory cycles, premenstrual tension syndrome, and functional uterine bleeding,
• Endometriosis,
• In vitro fertilization,
• Infertility associated with luteal insufficiency,
• Habitual and threatened miscarriages,
• Luteal phase insufficiency in the premenopausal period,
• Hormone replacement therapy, in postmenopausal women with an intact uterus, receiving hormone replacement therapy, to protect the endometrium.

2. Important information before taking Luteina

When not to take Luteina

• 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 (thrombophlebitis), e.g. in the limbs (deep vein thrombosis) or lungs (pulmonary embolism), and if the patient has had such thrombi in the past;
• If the patient is at risk of cerebral hemorrhage;
• If the patient has a rare blood disease called porphyria, which is inherited from generation to generation.
• 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, 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), consult a doctor who will examine the breasts and pelvic organs. You should tell your doctor if:

• you have had blood clots in the veins (venous thrombosis) in the past
• 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 of the veins or arteries);
• you have severe headaches;

Children and adolescents

There is a lack of sufficient data on the safety and efficacy of Luteina in children and adolescents.

Other medicines and Luteina:

Tell your doctor or pharmacist about all medicines you are taking or have recently taken, as well as any medicines you plan to take.
Some medicines may affect the action of Luteina.

• barbiturates used in sleep disorders or anxiety treatment,
• medicines used in 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 weaken the action of Luteina,
• Luteina 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, 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, discuss it with your doctor.

Fertility

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

Driving and using machines

Luteina administered vaginally does not affect the ability to drive vehicles and use machines. In case of side effects such as drowsiness, concentration and attention disorders, dizziness, it is not recommended to drive vehicles and use machines (see section 4).

3. How to take Luteina

Take this medicine always as recommended by your doctor. In case of doubts, consult a doctor or pharmacist.
Dosage
For doses other than 25 and 50 mg, vaginal tablets of 100 mg and 200 mg are available.
Adults

• In menstrual cycle disorders, painful menstruation, premenstrual tension syndrome, luteal phase insufficiency in the premenopausal period, administer 25 to 50 mg (½ to 1 tablet) vaginally 2 times a day in the second phase of the menstrual cycle (natural or induced) for 10-12 days.
• In menstrual cycle disorders, painful menstruation, premenstrual tension syndrome, treatment is continued for 3-6 consecutive cycles.
• In luteal phase insufficiency in the premenopausal period, treatment should be continued until menopause occurs.
• In hormone replacement therapy in combination with estrogens, administer 50 to 100 mg (1 to 2 tablets) vaginally 2 times a day in sequential therapy from the 15th to the 25th day of the cycle or in continuous therapy every day.
• In the progesterone test in secondary amenorrhea, administer 50 mg (1 tablet) vaginally 2 times a day for 5-7 days. Bleeding should occur within 7-10 days after discontinuation of the medicine.
• In the treatment of functional uterine bleeding, administer 50 mg (1 tablet) vaginally 2 times a day for 5-7 days. Treatment should be continued for the next 2-3 months, administering 25 to 50 mg (½ to 1 tablet) vaginally 2 times a day from the 15th to the 25th day of the cycle.
• In endometriosis, administer 50 to 100 mg (1 to 2 tablets) vaginally 2 times a day in continuous therapy for 6 months.
• In habitual and threatened miscarriages, administer 200 to 400 mg (4 to 8 tablets) vaginally 2 times a day.
• In habitual miscarriages, progesterone supplementation should be started in the cycle in which pregnancy is planned. Treatment should be continued uninterrupted until the 18th-22nd week of pregnancy.
• In anovulatory and induced cycles, administer 50 to 150 mg (1 to 3 tablets) vaginally 2 times a day.
• In in vitro fertilization programs, administer 200 to 400 mg (4 to 8 tablets) vaginally 2 times a day. Treatment should be 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.

Use in children and adolescents

There is a lack of sufficient data on the safety and efficacy of Luteina vaginal tablets in children and adolescents.

Instructions for use

The tablet can be divided into equal doses.
Luteina should be placed in the vagina.
The Luteina product, vaginal tablets, should be placed directly in the vagina.

Overdose of Luteina

In case of taking a higher dose of this medicine than recommended, contact a doctor or pharmacist immediately.
Symptoms of overdose that may occur are: dizziness, fatigue, depression.
These symptoms usually subsided on their own after reducing the dose of the medicine. Consult a doctor beforehand.

Missed dose of Luteina

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

Discontinuation of Luteina

In case of any further doubts about taking this medicine, consult a doctor or pharmacist.

4. Possible side effects

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

Stop taking this medicine immediately if you experience:

• 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 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,
• insomnia,
• 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).

Frequency not known(cannot be estimated from the available data):

• fatigue,
• vomiting,
• allergic reactions.

Reporting side effects

If you experience any side effects, including any side effects not listed in this leaflet, tell your doctor or pharmacist.
Side effects can be reported directly to the Department of Adverse Reactions 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 Luteina

There are no special recommendations for storage.
Keep this medicine out of the 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 month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Luteina contains

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

What Luteina looks like and what the pack contains

White, uncoated, round, biconvex tablets with a dividing line on one side, 9 mm in diameter.
The pack contains 30 vaginal tablets

Marketing authorization holder and manufacturer

Adamed Pharma S.A.
Pieńków, ul. M. Adamkiewicza 6A
05-152 Czosnów
tel.: +48 22 732 77 00

Date of last revision of the leaflet: