Lutinus

Patient Information Leaflet

Warning! Keep this leaflet! The information on the immediate packaging is in a foreign language.
Lutinus, 100 mg, vaginal tablets
Progesterone
Please read this leaflet carefully before using the medicine, as it contains
important information for the patient.

• Keep this leaflet so that you can read it again if necessary.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. 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 adverse reactions, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents:

1. What Lutinus is and what it is 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 Lutinus is and what it is used for

Lutinus is a vaginal tablet containing the natural female sex hormone progesterone.
Lutinus is intended for women who require additional progesterone during treatment in an assisted reproductive technology (ART) programme.
Progesterone acts on the endometrium, facilitating conception and maintenance of pregnancy in women undergoing treatment for infertility.

2. Important information before using Lutinus

Lutinus may only be used in women participating in an assisted reproductive technology (ART) fertility treatment programme. Treatment is initiated on the day of oocyte retrieval. The patient will be informed by the physician of the exact date to start 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 unexplained vaginal bleeding not yet diagnosed by a physician,
• if a miscarriage has occurred and there is suspicion that some tissue remains in the uterus, or if there is an ectopic pregnancy (pregnancy outside the uterus),
• if there are or have been severe liver diseases in the past,
• if there is or has been breast cancer or cancer of the genital organs, or if such cancer is suspected,
• if there have been or currently exist blood clots in the limbs, lungs, eyes or other parts of the body,
• if the patient suffers from porphyria (a group of inherited or acquired disorders affecting certain enzyme metabolism).

Warnings and precautions
Before starting treatment with Lutinus, discuss with your doctor.
Be particularly cautious and inform your doctor immediately if any of the following symptoms occur during treatment or even several days after the last dose:

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

Before starting treatment with Lutinus, inform your doctor if you currently have or have had in the past any of the following conditions:

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

Children
Lutinus is not indicated for use in children.

Lutinus and other medicines
Inform your doctor about all medicines currently used or recently taken, as well as any medicines planned for use.
Some medicines may interact with vaginal tablets containing progesterone. For example, carbamazepine, rifampicin, and herbal products containing St. John's wort (Hypericum perforatum) may reduce effectiveness, whereas products containing ketoconazole and antifungal vaginal creams may alter the action of progesterone.

Pregnancy and breastfeeding
Lutinus may be used during the first trimester of pregnancy in women requiring additional progesterone supplementation as part of an assisted reproductive technology treatment programme.
The risk of congenital malformations (present at birth), including genital abnormalities in male and female infants, associated with exposure to exogenous progesterone during pregnancy has not been fully established.

Lutinus must not be used during breastfeeding.

Driving and using machines
Lutinus has a minor or moderate influence on the ability to drive and operate machinery. The medicine may cause drowsiness and/or dizziness; therefore, caution is advised for drivers and machine operators.

3. How to use Lutinus

This medicine should always be used exactly as prescribed by the physician. In case of doubt, consult your doctor.

The usual dose of 100 mg is administered directly into the vagina three times daily, starting on the day of oocyte retrieval. If pregnancy is confirmed, treatment with Lutinus should be continued for 30 days.

Instructions for use

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

1. Remove one blister from the strip by tearing along the perforation.
2. To remove the sealing foil from the bottom of the blister, start at the corner of the blister marked with a printed arrow.
3. Unpack the applicator.
4. Place one tablet into the designated spot at the end of the applicator. The tablet should be securely positioned and must not fall out.
5. The applicator with the tablet may be inserted into the vagina while standing, sitting, or lying on the back with knees bent. Gently insert the flattened end of the applicator containing the tablet deep into the vagina.
6. Press the plunger to release the tablet from the applicator.

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

Use of more Lutinus than prescribed

If more Lutinus than prescribed has been used, consult your doctor or pharmacist immediately.

Missed dose of Lutinus

If a dose has been missed, take it as soon as you remember, then continue as before. Do not use a double dose to make up for a forgotten dose.

Stopping Lutinus

If you stop or plan to stop using Lutinus, consult your doctor or pharmacist. Abruptly stopping progesterone may cause increased anxiety, mood swings, and increased susceptibility to seizures.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
The most common adverse reactions are headache, vaginal disorders and uterine contractions.
The following common adverse reactions occur in 1 to 10 out of every 100 treated patients:

• headache,
• abdominal distension (bloating),
• abdominal pain,
• nausea,
• uterine contractions.

The following uncommon adverse reactions occur in 1 to 10 out of every 1,000 treated patients:

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

The following adverse reactions have been observed after marketing authorization of the medicine; frequency is unknown (cannot be estimated from available data):

• feeling of fatigue,
• vomiting,
• allergic reactions.

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can also be reported directly to the Department of Monitoring of Adverse Drug Reactions at 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.
Reporting adverse reactions helps provide more information on the safety of the medicine.

5. How to store Lutinus

Keep this medicine out of 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.
Store in the original packaging to protect from light.
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 pack and other information

What Lutinus contains

• The active substance is progesterone. One vaginal tablet contains 100 mg of progesterone.
• The other ingredients are: colloidal anhydrous silica, monohydrate lactose, pregelatinized maize starch, povidone K 29/32, adipic acid, sodium hydrogen carbonate, sodium lauryl sulphate, magnesium stearate.

What Lutinus looks like and contents of the pack
Lutinus is a vaginal tablet. It is a white or off-white, elongated, biconvex tablet, with the imprint "FPI" on one side and "100" on the other.
Pack size: 21 or 90 vaginal tablets in Al/Al blisters and 1 polyethylene applicator in a cardboard box.
For further information, contact the marketing authorisation holder or the parallel importer.
Marketing Authorisation Holder in Romania, country of export:
Ferring GmbH
Wittland 11
D-24109 Kiel, Germany
Manufacturer:
Ferring GmbH
Wittland 11
D-24109 Kiel, Germany
Parallel Importer:
InPharm Sp. z o.o.
ul. Strumykowa 28/11, 03-138 Warsaw
Repackaged in:
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249, 04-458 Warsaw
Marketing Authorisation Number in Romania, country of export: 7218/2014/01
7218/2014/02
Parallel Import Authorisation Number: 384/22
This medicinal product is authorised for sale in the European Economic Area countries under the following names:
Bulgaria, Denmark, Finland, Greece, Spain, the Netherlands, Ireland, Iceland, Germany, Norway, Poland, the Czech Republic, Slovakia, Sweden, Hungary: Lutinus
Portugal: Luferti
Romania: Lutinus 100 mg, comprimate vaginale
Slovenia: Lutinus 100 mg vaginalne tablete
United Kingdom: Lutigest