Lutinus

Package Leaflet: Information for the Patient

Warning! Keep the leaflet. Information on the immediate packaging in a foreign language.

Lutinus, 100 mg, vaginal tablets

Progesteronum

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

• Keep this leaflet, so you can read it again if you need to.
• If you have any doubts, 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 the patient experiences any side effects, including any side effects not listed in this leaflet, they should inform their doctor, pharmacist, or nurse. See section 4.

Table of Contents of the Leaflet:

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

1. What is Lutinus and what is it used for

Lutinus is a vaginal tablet containing the natural female sex hormone progesterone.
Lutinus is intended for women who require additional amounts of progesterone during assisted reproductive technology (ART) treatment.
Progesterone acts on the uterine lining, facilitating pregnancy and maintaining pregnancy in women being treated for infertility.

2. Important information before using Lutinus

Lutinus should only be used in women participating in infertility treatment programs using assisted reproductive technologies. Treatment begins on the day of egg retrieval. The patient is informed by the doctor about the start of treatment.

When not to use Lutinus:

• if the patient is allergic to progesterone or any other component of this medicine (listed in section 6),
• if there is non-physiological vaginal bleeding whose cause has not been explained by the doctor,
• if a miscarriage has occurred and there is a suspicion that some tissue still remains in the uterus or the pregnancy is developing outside the uterus,
• if there are or have been severe liver diseases,
• if there is cancer or suspected cancer of the breast or genital tract,
• if there are or have been blood clots in the limbs, lungs, eyes, or other parts of the body,
• if there is porphyria (a congenital or acquired disorder of enzyme metabolism).

Warnings and precautions

Before starting Lutinus, discuss it with your doctor.
Pay special attention and immediately inform your doctor if any of the following symptoms occur during treatment or even a few days after taking the last dose:

• pain in the calves or chest, sudden shortness of breath or coughing up blood, which may indicate possible blood clots in the legs, heart, or lungs,
• severe headache, vomiting, dizziness, weakness, vision or speech disorders, general weakness, or numbness of the hands or feet, which may indicate possible blood clots in the brain or eyes,
• exacerbation of depression symptoms.

Before starting Lutinus, inform your doctor if you currently have or have had any of the following diseases:

• epilepsy,
• migraine,
• asthma,
• heart or kidney disorders,
• diabetes.

Children

There is no appropriate use of Lutinus in children.

Lutinus 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 interact with progesterone vaginal tablets. For example, carbamazepine, rifampicin, and herbal products containing St. John's Wort may reduce efficacy, while products containing ketoconazole and vaginal antifungal creams may alter the action of progesterone.

Pregnancy and breastfeeding

Lutinus may be used in the first trimester of pregnancy in women who require additional amounts of progesterone during assisted reproductive technology treatment.
The risk of congenital anomalies (present at birth), including genital organ abnormalities in male and female children, resulting from exposure to exogenous progesterone during pregnancy, has not been fully determined.
Lutinus should not be used during breastfeeding.

Driving and using machines

Lutinus has a minor or moderate effect on the ability to drive and use machines. The medicine may cause drowsiness and/or dizziness, so caution is advised for drivers and machine operators.

3. How to use Lutinus

This medicine should always be used as directed by your doctor. If you are unsure, consult your doctor.
Usually, a dose of 100 mg is administered directly into the vagina three times a day, starting on the day of egg retrieval. If pregnancy is confirmed, Lutinus administration should be continued for 30 days.

Instructions for use

Lutinus should be placed directly into the vagina using the enclosed applicator.

• 1. Remove one blister from the strip by tearing it off along the perforation.
• 2. To remove the protective foil from the bottom of the blister, start at the corner of the blister with the printed arrow
• 3. Unpack the applicator.
• 4. Place one tablet in the designated place at the end of the applicator. The tablet should be securely placed and not fall out.
• 5. The applicator with the tablet can be inserted into the vagina in a standing, sitting, or lying position with bent knees. Gently insert the flattened end of the applicator with the tablet deep into the vagina.
• 6. Press the plunger to release the tablet from the applicator.

Withdraw the applicator, rinse it thoroughly with warm running water, dry it with a soft cloth, and keep it for reuse.

Using more than the recommended dose of Lutinus

In case of using more than the recommended dose of Lutinus, consult a doctor or pharmacist.

Missing a dose of Lutinus

A missed dose should be taken as soon as remembered, and then proceed as before. Do not take a double dose to make up for a missed dose.

Stopping Lutinus treatment

In case of stopping or intending to stop Lutinus treatment, consult a doctor or pharmacist. Abrupt cessation of progesterone administration may cause increased anxiety, mood swings, and increased susceptibility to seizures.

4. Possible side effects

Like all medicines, Lutinus can cause side effects, although not everybody gets them.
The most common side effects are headache, vaginal disorders, and uterine cramps.
The following common side effectsaffect 1 to 10 in every 100 treated patients:

• headache,
• abdominal distension (abdominal swelling),
• abdominal pain,
• nausea,
• uterine cramps.

The following uncommon side effectsaffect 1 to 10 in every 1,000 treated patients:

• dizziness,
• insomnia,
• diarrhea,
• constipation,
• hives (allergic rash),
• rash,
• vaginal disorders (e.g., discomfort in the vagina, burning sensation, discharge, dryness, and bleeding),
• vaginal fungal infection,
• breast disorders (e.g., breast pain, breast swelling, and breast tenderness),
• genital itching,
• peripheral edema (edema caused by fluid accumulation).

The following side effectshave been observed after the medicine was placed on the market; the frequency is not known (cannot be determined from available data):

• fatigue,
• vomiting,
• allergic reactions.

Reporting side effects

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

5. How to store Lutinus

Keep the medicine out of sight and reach of children.
Do not use this medicine after the expiration date stated on the packaging. The expiration date refers to the last day of the specified month.
Store in the original packaging to protect from light.
Medicines should not be disposed of via wastewater or household waste containers. Ask your pharmacist how to dispose of unused medicines. This will help protect the environment.

6. Package contents and other information

What Lutinus contains

• The active substance of Lutinus is progesterone. One vaginal tablet contains 100 mg of progesterone.
• Other ingredients are:
• hydrophobic colloidal silica,
• lactose monohydrate,
• corn starch,
• povidone K 29/32,
• adipic acid,
• sodium bicarbonate,
• sodium lauryl sulfate,
• magnesium stearate.

What Lutinus looks like and what the package contains

Lutinus is a vaginal tablet. It is a convex, elongated tablet, white or off-white in color, with the inscription "FPI" on one side and "100" on the other.
Package size: 21 vaginal tablets and one polyethylene tablet applicator.
For further information, contact the marketing authorization holder or parallel importer.

Marketing authorization holder in Romania, the country of export:

Ferring GmbH
Wittland 11
D-24109 Kiel
Germany

Manufacturer:

Ferring GmbH
Wittland 11
D-24109 Kiel
Germany

Parallel importer:

Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź

Repackaged by:

Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź
Authorization number in Romania, the country of export: 7218/2014/01

Parallel import authorization number: 284/23

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Bulgaria, Denmark, Finland, Greece, Spain, Netherlands, Ireland, Iceland, Germany, Norway, Poland, Czech Republic, Slovakia, Sweden, Hungary: Lutinus
Portugal: Luferti
Romania: Lutinus 100 mg, comprimate vaginale
Slovenia: Lutinus 100 mg vaginalne tablete

Date of leaflet approval: 05.12.2023

[Information about the trademark]