Luteina

PATIENT INFORMATION LEAFLET

Leaflet included in the packaging: patient information

Luteina, 200 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.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, tell your 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. Contents of the pack 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.
In the body, progesterone acts through specific receptors located 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 (the lining of the uterus) to allow 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 ductal epithelium, 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 suppresses 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, and initiates labor.
Indications for the use of Luteina:

• In vitro fertilization.
• Prevention of endometrial hyperplasia in women taking estrogens (e.g., in hormone replacement therapy).
• Prevention of preterm labor in singleton pregnancies in some women [with a short cervix (in ultrasound examination, cervix length in the middle of the second trimester ≤ 25 mm) and (or) with a history of spontaneous preterm labor].
• Treatment of recurrent and threatened miscarriages.

2. Important information before taking Luteina

When not to take 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 origin;
• If you have severe liver failure;
• If you have a liver tumor;
• If you have a breast or genital tumor or suspected tumor;
• If you have an active venous thrombosis (thromboembolism), e.g., in the limbs (deep vein thrombosis) or lungs (pulmonary embolism), and if such blood clots have occurred in the past;
• If you have a risk of intracranial bleeding;
• If you have a rare blood disease called porphyria, which is inherited from generation to generation (a genetic disease);
• If you have had a miscarriage and there is a suspicion that some tissue still remains in the uterus or if the pregnancy is developing outside the uterus.

Warnings and precautions

Before starting to take Luteina, 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), you should consult a doctor who will perform a breast and pelvic examination. You should tell your doctor if:

• you have a history of blood clots in the veins (venous thrombosis);
• you have uterine bleeding. You should stop taking this medicine if:
• you experience any vision disturbances (e.g., visual impairment, double vision, vascular changes in the retina);
• you have blood clots (thromboembolic disease);
• you have severe headaches. If you experience a lack of menstruation during treatment, you should ensure that you are not pregnant. During treatment, the endometrium may start to overgrow (endometrial hyperplasia) or this overgrowth may worsen. If, during prolonged treatment, at the end of treatment, or after treatment, unexpected bleeding or spotting occurs and persists, you should contact your doctor.

Children and adolescents

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

Luteina and other medicines

Tell your doctor 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 in sleep disorders or anxiety treatment,
• medicines used in 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 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 and breastfeeding Pregnancy

• If you are pregnant, think you may be pregnant, or plan to have a child, consult your doctor or pharmacist before taking this medicine.

Breastfeeding

• Women who are breastfeeding should not take this medicine.

Fertility

• This medicine may be taken by women who have difficulty getting pregnant. This medicine does not have a 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 and use machines. In case of side effects such as drowsiness, concentration and attention disorders, dizziness, it is not recommended to drive and use machines (see section 4).

3. How to take Luteina

Always take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.
The dosage of progesterone should be determined individually each time, depending on the indications and efficacy of the action. For doses other than 200 mg, vaginal tablets of 50 mg and 100 mg are available.
In in vitro fertilization programs, 200-400 mg of progesterone are used 2 times a day vaginally.
Treatment is continued until the 77th day after embryo transfer.
Termination of therapy should be done by gradually reducing the administered dose of the medicine.
A dose that provides adequate endometrial protection is 200 mg daily for 12 days or 100-200 mg daily in continuous therapy every day.
In the prevention of preterm labor in singleton pregnancies with a short cervix and (or) a history of spontaneous preterm labor, 200 mg of progesterone are used vaginally once a day from about the 20th week of pregnancy to the 34th week of pregnancy.
In recurrent and threatened miscarriages, 200-400 mg of progesterone are used vaginally 2 times a day.
In the case of recurrent 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 the case of threatened miscarriages, progesterone is used uninterrupted until the 22nd week of pregnancy.

Instructions for use

Luteina should be placed in the vagina using the enclosed applicator. The applicator enclosed with Luteina is for personal use and is intended for use by one patient only.
In pregnant women, due to the softened cervix, it is recommended to apply the medicine with the index finger.
INSTRUCTIONS FOR USING THE APPLICATOR

• 1. Unpack the applicator.
• 2. Place one Luteina tablet in the designated place at the end of the applicator. The tablet should fit tightly against the applicator walls and should not fall out.

• 3. The applicator can be inserted into the vagina in a convenient position (standing, sitting, lying on your back with bent knees).
• 4. Insert the applicator into the vagina until the raised line felt with the finger is at the level of the labia majora.

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

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

Taking a higher dose of Luteina than recommended

If you take more of this medicine than you should, contact your doctor or pharmacist immediately.
Symptoms of overdose that may occur include drowsiness, dizziness, depression.
These symptoms usually resolved on their own after the dose of the medicine was reduced. You should consult your doctor beforehand.

Missing a 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 treatment with Luteina

If you have any further questions about taking this medicine, ask your 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 intracranial bleeding,
• blood clots in the veins of the limbs or pelvis,
• sudden severe headaches,
• vision disturbances,
• jaundice (yellowing of the skin or whites of the eyes).

The following side effects are common (affecting 1 in 10 patients):

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

The following side effects are uncommon (affecting 1 in 100 patients):

• dizziness,
• drowsiness,
• diarrhea,
• constipation,
• hives (allergic rash),
• rash,
• disorders of the vulva and vagina (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 (swelling due to fluid accumulation).

The following side effects have been reported after the marketing of progesterone vaginal medicines.
Frequency not known(cannot be estimated from the available data):

• fatigue,
• vomiting,
• hypersensitivity reactions.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Adverse Reaction Monitoring, 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 marketing authorization holder.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Luteina

Store below 30°C.
Keep this 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 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. Contents of the pack and other information

What Luteina contains

• The active substance is progesterone. One tablet contains 200 mg of progesterone.
• The other ingredients are: lactose monohydrate, cornstarch, sodium carboxymethylcellulose, hypromellose, citric acid monohydrate, magnesium stearate, colloidal silicon dioxide.

What Luteina looks like and contents of the pack

White or off-white round vaginal tablet.
Blister pack containing 10 vaginal tablets.
Box containing 3 blister packs (30 vaginal tablets) or 6 blister packs (60 vaginal tablets) and one applicator marked vaginal applicator 200.

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: