Luteina 50

Leaflet attached to the packaging: patient information

Luteina 50

50 mg, sublingual tablets

Progesterone

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

• Please keep this leaflet, so you can read it again if you need to.
• If you have any doubts, please consult your 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 you experience any side effects, including those not listed in this leaflet, please inform your doctor or pharmacist. See section 4.

Table of contents of the leaflet:

• 1. What is Luteina 50 and what is it used for
• 2. Important information before taking Luteina 50
• 3. How to take Luteina 50
• 4. Possible side effects
• 5. How to store Luteina 50
• 6. Package contents and other information

1. What is Luteina 50 and what is it used for

Progesterone contained in Luteina 50 is a synthetically obtained natural hormone of the corpus luteum. The corpus luteum produces progesterone in the second phase of the menstrual cycle in increasing amounts from about 5 mg per day to 55 mg per day on the 20-22nd day of the cycle and decreasing to the 27th day of the cycle. In the female body, progesterone acts through specific receptors located in the mucous membrane of the uterus, breast glands, central nervous system, and pituitary gland. The most important effects of progesterone on the reproductive organ are: enabling ovulation, transforming the mucous membrane of the uterus (endometrium) to allow implantation of the 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 act on the breast gland, stimulating the growth of glands and epithelium of the ducts and allowing breastfeeding. Progesterone is a hormone necessary for maintaining pregnancy throughout its duration: it inhibits the mother's immune reaction to fetal antigens, is a substrate for the production of fetal hormones, initiates labor, and eliminates the spontaneous contractions of the pregnant uterus.

Indications for use of Luteina 50:

• Menstrual disorders caused by a deficiency of endogenous progesterone;
• Secondary amenorrhea;
• Pre-menstrual tension syndrome;
• Functional bleeding from the genital tract;
• Luteal insufficiency;
• Anovulatory cycles;
• Supportive treatment of infertility, e.g., in vitro fertilization and other assisted reproduction techniques;
• Habitual and threatened miscarriages due to endogenous progesterone deficiency;
• Prevention of endometrial hyperplasia in women taking estrogens (e.g., in hormone replacement therapy).

2. Important information before taking Luteina 50

Before starting treatment, the doctor should perform a gynecological examination, breast examination, and evaluate the cytological smear from the cervix to rule out tumors of these organs. If necessary, the doctor may also prescribe other tests. If bleeding from the uterus occurs before or during treatment, please inform your gynecologist. During progesterone treatment, you should be under constant medical supervision, and periodic tests are necessary. Please inform your doctor about any changes in your breasts.

When not to take Luteina 50

If you have:

• hypersensitivity to the active substance or any of the other ingredients of this medicine (listed in section 6),
• undiagnosed genital tract bleeding,
• severe liver dysfunction,
• cholestatic jaundice (related to bile flow disorders),
• Rotor syndrome and Dubin-Johnson syndrome (a mild, genetically determined liver disease with jaundice),
• breast and genital tract tumors,
• a history of or current venous thromboembolic disease (deep vein thrombosis, pulmonary embolism),
• active or recent arterial thromboembolic disorders (angina pectoris, myocardial infarction),
• miscarriages and the presence of residues after miscarriage in the uterine cavity.

Warnings and precautions

Before taking Luteina 50, you should discuss it with your doctor or pharmacist. You should be particularly cautious when taking Luteina 50 in the following cases:

• history of thromboembolic disorders (stroke, deep vein thrombosis),
• depressive states,
• liver disease,
• diabetes or impaired glucose tolerance.

Children and adolescents

This medicine is not used in children.

Luteina 50 and other medicines

Please tell your doctor or pharmacist about all medicines you are taking or have recently taken, as well as any medicines you plan to take. No clinically significant interactions between progesterone and other medicines have been found. The metabolism of progesterone may be accelerated by concomitant administration of substances that induce cytochrome P450 enzymes, such as antiepileptic drugs, antibiotics, and mixtures. In vitro studies have shown that drugs that reduce the activity of cytochrome P450 (e.g., ketoconazole) may slow down the metabolism of progesterone. The clinical significance of this interaction is unknown. The use of progesterone may increase the serum concentration of cyclosporine.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, please consult your doctor before taking this medicine. The use of Luteina 50 during breastfeeding is contraindicated due to the hormone's penetration into breast milk.

Driving and using machines

It is not known whether progesterone treatment affects driving, operating machines, and psychophysical performance. If in doubt, please consult your doctor.

Luteina 50 contains lactose

If you have previously been diagnosed with intolerance to some sugars, please consult your doctor before taking the medicine.

3. How to take Luteina 50

This medicine should always be taken as directed by your doctor. If in doubt, please consult your doctor.

Dosage Adults

The dosage and method of administration of Luteina 50 are always determined individually by the doctor for the given patient, depending on the indications and efficacy of the treatment.

• In menstrual disorders and premenstrual tension syndrome, 50 mg (1 tablet) is taken sublingually 3-4 times a day. In menstrual cycle disorders and premenstrual tension syndrome, treatment is continued for 3-6 consecutive cycles.
• In the prevention of endometrial hyperplasia (in hormone replacement therapy) in combination with estrogens, 50 mg (1 tablet) is usually taken sublingually 3-4 times a day. In the continuous sequential regimen, the medicine is taken for the last 12-14 days of a 28-day cycle. In the continuous combined regimen, the medicine is taken daily without interruption. The dose of Luteina 50 should be dependent on the dose of estrogens to ensure protection of the endometrium from the proliferative effect of estrogens.
• In the progesterone test in secondary amenorrhea, 50 mg (1 tablet) is taken sublingually 3-4 times a day. Bleeding should occur within 7-10 days after stopping treatment.
• In the treatment of functional bleeding from the genital tract, 50 mg (1 tablet) is taken sublingually 3-4 times a day. Treatment should be continued for the next 2-3 months from the 15th to the 25th day of the cycle.
• In habitual and threatened miscarriages, anovulatory cycles, and induced cycles, 100 mg (2 tablets) is taken sublingually 3-4 times a day.
• In the case of habitual miscarriages, the use of Luteina 50 should be started in the cycle in which pregnancy is planned, or even earlier. It should be continued uninterrupted until about the 18-22nd week of pregnancy.
• In in vitro fertilization programs, 100-150 mg (2-3 tablets) is taken sublingually 3-4 times a day.

Treatment should be discontinued 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 50 in children and adolescents.

Use of a higher dose of Luteina 50 than recommended

The most common symptoms of overdose are drowsiness, dizziness, nausea, depression. If these symptoms occur, please discontinue the medicine and consult your doctor.

Missing a dose of Luteina 50

Do not take a double dose to make up for a missed dose. If you have any further doubts about taking this medicine, please consult your doctor or pharmacist.

Possible side effects

Like all medicines, Luteina 50 can cause side effects, although not everybody gets them. Progesterone, as an endogenous hormone, usually does not cause side effects, except for symptoms that occur in case of overdose. During the use of progesterone, which is identical to the endogenous hormone, side effects occur: Uncommon (less than 1 in 100 people): Gastrointestinal disorders: nausea; Nervous system disorders: drowsiness, pain, and dizziness; Psychiatric disorders: concentration and attention disorders, feeling of anxiety, depression. Rare (less than 1 in 1000 people): Gastrointestinal disorders: dry mouth; Hepatobiliary disorders: cholestatic jaundice; Metabolic and nutritional disorders: weight changes; Reproductive system and breast disorders: abnormal genital tract bleeding, spotting, amenorrhea; Skin and subcutaneous tissue disorders: skin redness, acne, allergic reactions; Vascular disorders: gum bleeding, thrombotic disorders.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, please inform your doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, 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. Side effects can also be reported to the representative of the marketing authorization holder. By reporting side effects, you can help gather more information on the safety of the medicine.

5. How to store Luteina 50

There are no special precautions for storage. 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 carton. The expiry date refers to the last day of the specified month. Medicines should not be disposed of via wastewater or household waste. Please ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Package contents and other information

What Luteina 50 contains

• The active substance of the medicine is progesterone. One tablet contains 50 mg of progesterone.
• The other ingredients of the medicine are: lactose monohydrate, potato starch, povidone K-25, magnesium stearate, ethyl cellulose, talc, vanillin.

What Luteina 50 looks like and what the package contains

Uncoated tablets, white, single-sided, and concave. The tablets are packaged in blisters of PA/Aluminum/PVC/Aluminum foil or a polyethylene container, in a cardboard box. 30 tablets in a blister. 30 tablets in a container.

Marketing authorization holder and manufacturer

Adamed Pharma S.A. Pieńków, ul. M. Adamkiewicza 6A 05-152 Czosnów

Date of the last update of the leaflet: