Lutinus

PATIENT INFORMATION LEAFLET

Leaflet attached to the packaging: information for the patient

Lutinus, 100 mg, vaginal tablets

progesterone

Read the leaflet carefully before using 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 for you only. Do not pass it on to others. It 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 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. Contents of the pack 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 lining of the uterus, facilitating pregnancy and maintaining pregnancy in women treated for infertility.

2. Important information before using Lutinus

Lutinus should only be used in women who are participating in an infertility treatment program using assisted reproductive technology. 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 of the other ingredients of this medicine (listed in section 6),
if there is non-physiological vaginal bleeding, the cause of which has not been determined by the doctor,
if there has been a miscarriage 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 organs,
if there are or have been blood clots in the limbs, lungs, eyes, or other parts of the body,
if the patient has porphyria (a congenital or acquired disorder of metabolism of certain enzymes).

Warnings and precautions

Before starting treatment with Lutinus, discuss it with your doctor.
Pay special attention and inform your doctor immediately 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, or general weakness or numbness of the hands or feet, which may indicate possible blood clots in the brain or eyes,
worsening of depression symptoms.
Before starting treatment with 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

Always use this medicine exactly as your doctor has told you. If you are not sure, ask 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 in 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. Open 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

Take the missed dose as soon as you remember, and then continue as before. Do not take a double dose to make up for the missed dose.

Stopping treatment with Lutinus

If you stop or intend to stop treatment with Lutinus, consult your doctor or pharmacist. Abrupt discontinuation of progesterone may cause increased anxiety, mood swings, and increased susceptibility to seizures.

4. Possible side effects

Like all medicines, this medicine 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 patients:

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

The following uncommon side effectsaffect 1 to 10 in every 1,000 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),
• itching in the genital area,
• peripheral edema (edema caused by fluid accumulation).

The following side effectshave been reported during post-marketing experience; frequency is not known (cannot be estimated from the available data):

• fatigue
• vomiting
• allergic reactions

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, tell your doctor. 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: Aleje Jerozolimskie 181C, 02-222 Warsaw, Tel: +48 22 49 21 301, Fax: +48 22 49 21 309, e-mail: ndl@urpl.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of this medicine.

5. How to store Lutinus

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the packaging after EXP.
The expiry date refers to the last day of that month.
Store in the original packaging to protect from light.
There are no special storage instructions for this medicine.
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 Lutinus contains

• The active substance is progesterone. One vaginal tablet contains 100 mg of progesterone.
• The other ingredients are: hydrophobic colloidal silica, lactose monohydrate, maize starch, povidone K29/32, adipic acid, sodium bicarbonate, sodium lauryl sulfate, magnesium stearate.

What Lutinus looks like and contents of the pack

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 side.
Pack size: 21 or 90 vaginal tablets and one polyethylene applicator.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Ferring GmbH
Wittland 11
D-24109 Kiel
Germany

Manufacturer:

Ferring GmbH
Wittland 11
D-24109 Kiel
Germany

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
United Kingdom: Lutigest
Date of last revision of the leaflet:09/2018
For more detailed information, please contact the representative of the marketing authorization holder:
Ferring Pharmaceuticals Poland Sp. z o.o.
Szamocka 8, 01-748 Warsaw
Tel.: + 48 22 246 06 80, Fax: + 48 22 246 06 81