Luteina

Package leaflet: Information for the patient

Luteina, 100 mg, vaginal tablets
Progesteronum
Please read this leaflet carefully before using the medicine, as it contains
important information for the patient.

• Keep this leaflet for future reference.
• If you have any questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not share it with others. The medicine may harm another person, even if their symptoms are the same.
• If you experience any adverse reactions, including those not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents of the leaflet

1. What Luteina is and what it is used for
2. Important information before using Luteina
3. How to use Luteina
4. Possible side effects
5. How to store Luteina
6. Contents of the pack and other information

1. What Luteina is and what it is used for

Luteina is a medicine containing progesterone, a naturally occurring female sex hormone produced 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 endometrium (uterine mucosa) 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 glandular and ductal epithelial growth 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 maternal immune response against 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, dysmenorrhea, anovulatory cycles, premenstrual tension syndrome, and functional uterine bleeding.
• Endometriosis.
• In vitro fertilization (IVF).
• Infertility due to luteal phase deficiency.
• Recurrent and threatened miscarriage.
• Luteal phase deficiency in the perimenopausal period.
• Hormone replacement therapy in postmenopausal women with an intact uterus, to protect the endometrium (uterine mucosa) when receiving estrogen replacement therapy.
• Prevention of preterm birth in singleton pregnancies in certain women [with a short cervix (ultrasound measurement showing cervical length ≤ 25 mm at mid-second trimester) and/or history of spontaneous preterm birth].

2. Important information before using Luteina

When not to use 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 cause;
• If the patient has severe liver dysfunction;
• If the patient has a liver tumour;
• If the patient has a breast or genital organ tumour, or suspected tumour;
• If the patient has active venous thrombosis (e.g. deep vein thrombosis in the limbs or pulmonary embolism), or has a history of such blood clots;
• 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 some tissue remains in the uterus, or if pregnancy is developing outside the uterus (ectopic pregnancy).

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 during menopause (and subsequently at regular annual intervals), a breast and pelvic examination should be performed by a doctor. Inform your doctor if:

• The patient has a history of venous thrombosis;
• The patient experiences uterine bleeding. Discontinue taking this medicine if:
• Any visual disturbances occur (e.g. visual field defects, double vision, retinal vascular lesions);
• Blood clots occur (venous thromboembolic disease or thrombosis);
• Severe headaches develop.
  If the patient misses a menstrual period during treatment, pregnancy should be ruled out.
  During treatment, the endometrium (uterine lining) may undergo excessive growth (endometrial hyperplasia), or existing hyperplasia may worsen. If unexpected bleeding or spotting occurs during prolonged 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.

Luteina with other medicines
Inform your doctor about all medicines currently or recently taken, as well as any medicines the patient intends 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 (an anti-inflammatory medicine);
• Spironolactone (a diuretic);
• Certain antifungal medicines (ketoconazole, griseofulvin).
  Similarly, Luteina 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 Luteina. Luteina may enhance the effects of cyclosporine.

Pregnancy and breastfeeding and effect on fertility
Pregnancy

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

Breastfeeding

• Women who are breastfeeding should not use this medicine. Discuss this with your doctor before starting treatment.

Fertility

• This medicine may be used in women who have difficulty becoming pregnant. This medicine has no harmful effect on fertility.

Driving and using machines
Luteina administered vaginally does not affect the ability to drive or operate machinery. However, if adverse effects such as drowsiness, concentration disturbances, 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 the physician. In case of doubt, consult your
doctor or pharmacist.
The dosage of progesterone should always be individually determined depending on the indication
and treatment response. For doses other than 100 mg, vaginal tablets of 50 mg and 200 mg strength are available.
In menstrual cycle disorders, painful menstruation, premenstrual tension syndrome, and luteal phase deficiency in the premenopausal period, 25 to 50 mg of progesterone should be administered vaginally twice daily during the second phase of the menstrual cycle (natural or reconstructed) for 10–12 days.
In menstrual cycle disorders, painful menstruation, and premenstrual tension syndrome, progesterone treatment should be continued for 3–6 consecutive cycles.
In luteal phase deficiency during the premenopausal period, progesterone treatment should be continued until menopause occurs.
In hormone replacement therapy in combination with estrogens, 25 to 50 mg of progesterone should be administered vaginally twice daily in sequential therapy from day 15 to day 25 of the cycle, or in continuous therapy daily.
In the progesterone test for secondary amenorrhea, progesterone should be administered vaginally at a dose of 50 mg twice daily for 5–7 days. Bleeding should occur within 7–10 days after discontinuation of progesterone.
In the treatment of functional uterine bleeding, 50 mg of progesterone should be administered vaginally twice daily for 5–7 days. Treatment should be continued for the next 2–3 months by administering progesterone vaginally at a dose of 25 to 50 mg twice daily from day 15 to day 25 of the cycle.
In endometriosis, 50 to 100 mg of progesterone should be administered vaginally twice daily in continuous therapy for a period of 6 months.
In habitual and threatened miscarriages, 200 to 400 mg of progesterone should be administered vaginally twice daily.
In cases of habitual miscarriages, progesterone supplementation should be initiated in the cycle in which pregnancy is planned. Treatment should be continued uninterrupted until week 18–22 of pregnancy.
In anovulatory and induced cycles, 50 to 150 mg of progesterone should be administered vaginally twice daily.
In in vitro fertilization programs, 200 to 400 mg of progesterone should be administered vaginally twice daily.
Treatment should be continued until day 77 after embryo transfer.
Discontinuation of therapy should be performed by gradually reducing the administered dose of the medicine.
For prevention of preterm birth in women with a singleton pregnancy, a short cervix, and/or a history of spontaneous preterm birth, 200 mg of progesterone should be administered vaginally once daily from approximately week 20 of pregnancy until week 34 of pregnancy.

Instructions for use
Luteina should be inserted into the vagina using the provided applicator. The applicator supplied with Luteina is intended for personal use only and is designated exclusively for one patient.
In pregnant women, due to a softened cervix, it is recommended to insert Luteina with the index finger.

INSTRUCTIONS FOR THE USE OF THE APPLICATOR

1. Unpack the applicator.
2. Place one Luteina tablet into the designated space at the end of the applicator. The tablet should fit snugly against the walls of the applicator and should not fall out.

3. The applicator can be inserted into the vagina in a comfortable position (standing, sitting, or lying on the back with knees bent).
4. Insert the applicator into the vagina until the convex mark, palpable under the finger, aligns with the level of the labia majora.

5. Press the plunger of the applicator to release the tablet.

6. Then withdraw the applicator, rinse it thoroughly under warm running water, and dry it with a soft cloth.
7. Keep the applicator for reuse.

Use of a higher than recommended dose of Luteina
If a higher than recommended dose of this medicine is taken, contact your doctor or pharmacist immediately.
Symptoms of overdose may include drowsiness, dizziness, and depression.
These symptoms usually resolve spontaneously after reducing the dose. Consult your doctor in advance.
Missed dose of Luteina
If a dose is missed, it should be taken as soon as remembered, 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
If you have any further questions about 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 must stop using this medicine immediately if the patient experiences:

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

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

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

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

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

The following adverse reactions have been observed after marketing of vaginal preparations containing progesterone.
Frequency of occurrence is unknown (cannot be estimated based on available data):

• fatigue,
• vomiting,
• hypersensitivity reactions.

Reporting of adverse reactions
If any adverse symptoms occur, including any adverse symptoms not listed in this leaflet, inform a doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring 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 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

Store below 30°C.
Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the specified 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 contains

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

What Luteina looks like and contents of the pack
A round, white or off-white vaginal tablet, marked with "100" on one side and "22" on the other side.
The package contains 30 vaginal tablets or 60 vaginal tablets and one applicator labelled vaginal applicator 100.
Marketing Authorisation Holder and Manufacturer
Adamed Pharma S.A.
Pieńków, ul. M. Adamkiewicza 6A
05-152 Czosnów
tel.: +48 22 732 77 00