LUTEINA 50

Package leaflet: Information for the patient

Luteina 50
50 mg, sublingual tablets
Progesteronum
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, please ask your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm other people, even if their symptoms are the same as yours. If you experience any side effects, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Contents of the leaflet:

1. What Luteina 50 is and what it is 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. Contents of the pack and other information

1. What Luteina 50 is and what it is used for
Progesterone contained in Luteina 50 is a naturally occurring hormone of the corpus luteum of the ovary, synthetically produced. The corpus luteum produces progesterone during the second phase of the menstrual cycle, in amounts increasing from approximately 5 mg per day to 55 mg per day on days 20–22 of the cycle, decreasing again by day 27.
In the female body, progesterone acts via specific receptors located, among others, in the endometrium, mammary glands, central nervous system, and pituitary gland. The most important effects of progesterone on the reproductive organs include: enabling ovulation, transformation of the endometrium enabling 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 act on the mammary gland, stimulating the growth of glands and ductal epithelium and enabling breastfeeding.
Progesterone is a hormone essential for maintaining pregnancy throughout its duration: it suppresses the mother's immune response to fetal antigens, serves as a substrate for fetal hormone production, initiates labor, and suppresses spontaneous contractile activity of the pregnant uterus.

Indications for Luteina 50:

• Menstrual disorders caused by deficiency of endogenous (internally produced) progesterone;
• Secondary amenorrhea;
• Premenstrual syndrome;
• Functional uterine bleeding;
• Luteal phase deficiency;
• Anovulatory cycles;
• As an adjunct in infertility treatment, e.g., in vitro fertilization and other assisted reproductive techniques;
• Recurrent and threatened miscarriage due to deficiency of endogenous progesterone;
• Prevention of endometrial hyperplasia in women receiving 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 a cervical cytology smear to exclude malignancies of these organs. If necessary, the doctor may recommend additional tests.
If uterine bleeding occurs before or during treatment, inform your gynecologist.
During treatment with progesterone, regular medical supervision is required, and periodic examinations are necessary. Inform your doctor of any changes observed in the breasts.

When not to use Luteina 50
Do not use Luteina 50 if you have:

• Hypersensitivity to the active substance or to any of the other ingredients of this medicine (listed in section 6);
• Undiagnosed uterine bleeding;
• Severe impairment of liver function;
• Cholestatic jaundice (related to impaired bile flow);
• Rotor syndrome or Dubin-Johnson syndrome (benign, genetically determined liver disease associated with jaundice);
• Breast or reproductive organ malignancies;
• History of or current episode of venous thromboembolic disease (deep vein thrombosis, pulmonary embolism);
• Active or recent arterial thromboembolic disorders (angina pectoris, myocardial infarction);
• Spontaneous abortion or presence of retained products of conception in the uterine cavity.

Warnings and precautions
Before starting treatment with Luteina 50 sublingual tablets, discuss this with your doctor or pharmacist.
Exercise particular caution when using Luteina 50 in the following conditions:

• History of thromboembolic disorders (e.g., stroke, deep vein thrombosis);
• Depressive states;
• Liver disease;
• Diabetes mellitus or impaired glucose tolerance.

Children and adolescents
Luteina 50 should not be used in children.

Luteina 50 and other medicines
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.
No clinically significant interactions between progesterone and other medicines have been reported.
The metabolism of progesterone may be accelerated by concomitant administration of substances inducing cytochrome P450 enzymes, such as antiepileptic drugs, antituberculosis drugs, and mixtures.
In vitro studies have shown that drugs reducing cytochrome P450 activity (e.g., ketoconazole) may slow down progesterone metabolism. The clinical significance of this interaction is unknown.
Concomitant use of progesterone may increase cyclosporine plasma concentrations.

Pregnancy, breastfeeding, and fertility
If you are pregnant or breastfeeding, suspect you may be pregnant, or are planning to have a baby, consult your doctor before using this medicine.
Use of Luteina 50 during breastfeeding is contraindicated due to passage of the hormone into breast milk.

Driving and operating machinery
It is not known whether progesterone treatment affects the ability to drive or operate machinery and psycho-physical performance.
If in doubt, consult your doctor.

Luteina 50 contains lactose
If you have been previously diagnosed with an intolerance to certain sugars, consult your doctor before taking this medicine.

3. How to use Luteina 50

This medicine should always be used as directed by the physician. In case of doubt, consult your doctor.
Dosage
Adults
The dosage and method of administration of Luteina 50 are always determined individually by the physician for each patient, depending on the indication and treatment efficacy.

• In menstrual disorders and premenstrual tension syndrome, 50 mg (1 tablet) is administered sublingually 3–4 times daily. For menstrual cycle disorders and premenstrual tension syndrome, treatment is continued for 3–6 consecutive cycles.
• For prevention of endometrial hyperplasia (in hormone replacement therapy) in combination with estrogens, 50 mg (1 tablet) is most commonly administered sublingually 3–4 times daily. In the continuous sequential regimen, the medicine is used during 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 adjusted according to the estrogen dose to ensure protection of the endometrium against the proliferative effects of estrogens.
• In the progesterone challenge test for secondary amenorrhea, 50 mg (1 tablet) is administered sublingually 3–4 times daily. Withdrawal bleeding should occur within 7–10 days after discontinuation of treatment.
• In the treatment of functional uterine bleeding, 50 mg (1 tablet) is administered sublingually 3–4 times daily. Treatment should be continued for 2–3 consecutive months, from day 15 to day 25 of the cycle.
• In recurrent and threatened miscarriages, anovulatory cycles, and induced cycles, 100 mg (2 tablets) is administered sublingually 3–4 times daily.
• In cases of recurrent miscarriage, treatment with Luteina 50 should be initiated in the cycle in which pregnancy is planned, or even earlier. It should be continued continuously until approximately 18–22 weeks of pregnancy.
• In in vitro fertilization (IVF) programs, 100 to 150 mg (2 to 3 tablets) is administered sublingually 3–4 times daily.

Termination of therapy should be achieved by gradually reducing the administered dose.
Use in children and adolescents
There is insufficient data on the safety and efficacy of sublingual Luteina 50 tablets in children and adolescents.
Use of a higher than recommended dose of Luteina 50
The most common symptoms of overdose are drowsiness, dizziness, nausea, and depression.
If these symptoms occur, discontinue the medicine and contact your doctor.
Missed dose of Luteina 50
Do not use a double dose to make up for a missed dose.
If you have any further doubts regarding the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects
Like all medicines, this medicine may cause adverse effects, although not everyone experiences them.
Progesterone, as an endogenous hormone (internally produced), generally does not cause adverse effects except for those associated with overdose.
When using progesterone, which is identical to the endogenous hormone, adverse effects may include:
Not common (less than 1 in 100 people):
Gastrointestinal disorders: nausea;
Nervous system disorders: drowsiness, headache, dizziness;
Psychiatric disorders: difficulty concentrating and attention, anxiety, depression.
Rare (less than 1 in 1000 people):
Gastrointestinal disorders: dry mouth;
Hepatic and biliary disorders: cholestatic jaundice;
Metabolism and nutrition disorders: changes in body weight;
Reproductive system and breast disorders: abnormal uterine bleeding, spotting, amenorrhea;
Skin and subcutaneous tissue disorders: skin redness, acne, allergic reactions;
Vascular disorders: gingival bleeding, coagulation disorders.

Reporting of adverse effects
If any adverse effects occur, including those not listed in this leaflet, inform your doctor or pharmacist. Adverse effects can be reported directly to the Department of Monitoring of Adverse Drug Reactions of 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
Adverse effects can also be reported to the representative of the marketing authorization holder.
Reporting adverse effects helps to gather more information on the safety of the medicine.

5. How to store Luteina 50

No special storage instructions are required.
The medicine should be stored in a place 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 must 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. Contents of the package and other information

What Luteina 50 contains

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

What Luteina 50 looks like and contents of the pack
Uncoated tablets, white, concave on one side.
Tablets are packed in blisters made of PA/Aluminium/PVC/Aluminium foil or in a polyethylene container,
inside a cardboard box.
30 tablets in a blister.
30 tablets in a container.
Marketing Authorisation Holder and Manufacturer
Adamed Pharma S.A.
Pieńków, ul. M. Adamkiewicza 6A
05-152 Czosnów