PACKAGE LEAFLET: INFORMATION FOR THE USER

Warning! Keep the leaflet; the information on the immediate packaging is in a foreign language!
Utrogestan,
200 mg, soft vaginal capsules
Progesteronum
Please read the entire leaflet carefully before using the medicine, as it contains
important information for the patient.

Keep this leaflet, so you can read it again if necessary.
If you have any questions, consult your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not share it with others. The medicine may harm someone else, even if their symptoms are identical.
If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents of the leaflet

What Utrogestan is and what it is used for
Important information before using Utrogestan
How to use Utrogestan
Possible side effects
How to store Utrogestan
Contents of the pack and other information

1. What Utrogestan is and what it is used for

The name of this medicine is Utrogestan. Utrogestan contains a hormone called progesterone.
What Utrogestan is used for
Maintenance of pregnancy during infertility treatment
Utrogestan is intended for women who require additional progesterone to maintain pregnancy during treatment as part of an assisted reproductive technology (ART) program.
Prevention of preterm birth in women with singleton pregnancies
Utrogestan is intended for women who have previously delivered a baby prematurely and/or who have a short cervix.

2. Important information before using Utrogestan

When not to use Utrogestan:
If the patient has hypersensitivity (allergy) to soy or peanuts;

If the patient is allergic to progesterone or any of the other ingredients of this medicine (listed in section 6);
If the patient has liver function disorders;
If the patient has yellowing of the skin or eyes (jaundice);
If the patient has vaginal bleeding of unknown cause;
If the patient has cancer of the breast or genital organs;
If the patient has thrombophlebitis;
If the patient currently has or has previously had venous thrombosis (blood clots in the veins), for example in the legs (deep vein thrombosis) or lungs (pulmonary embolism);
If the patient has previously experienced a cerebral haemorrhage;
If the patient has a rare inherited blood disorder called "porphyria";
If the patient is pregnant but the fetus has died (missed miscarriage);
If the patient's "waters have broken".

Do not use Utrogestan if any of the above situations apply to the patient.
If in doubt, discuss this with a doctor or pharmacist before using Utrogestan.

Warnings and precautions

Utrogestan is not a contraceptive.
If the patient suspects that a miscarriage may have occurred, she should consult a doctor, as use of Utrogestan must then be discontinued.
If the patient experiences vaginal bleeding, she should consult a doctor.

If the patient is using this medicine to support pregnancy during infertility treatment
Utrogestan should be used only during the first 3 months of pregnancy.

If the patient is using this medicine to prevent preterm birth in a singleton pregnancy
The doctor will discuss with the patient the risks and benefits of the available treatment options. The doctor and the patient will jointly decide on the most appropriate treatment.
If the patient is at risk of preterm birth, she may use Utrogestan from approximately week 20 to week 34 of pregnancy. If the patient's waters break while using this medicine, she must contact her doctor as soon as possible. This situation may pose an immediate risk to the patient and her baby.
Rarely, use during the second and third trimesters of pregnancy may lead to liver problems. If the patient develops itching, which may be a symptom of liver problems, she should contact her doctor.

Children
Utrogestan is not intended for use in children.

Diagnostic and monitoring tests
Before starting treatment and regularly during treatment, the doctor will perform a full medical examination.

Utrogestan with other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines she plans to take. This includes medicines available without a prescription, including herbal medicines. This is because Utrogestan may affect the action of certain other medicines. Likewise, certain other medicines may affect the action of Utrogestan.
In particular, inform the doctor or pharmacist if any of the following medicines are being used:

Bromocriptine, used to treat disorders related to the pituitary gland or Parkinson's disease;
Cyclosporine (used to suppress the immune system);
Rifamycin derivatives, such as rifampicin (used to treat infections);
Ketoconazole (used to treat fungal infections).

Utrogestan with food and drink
Utrogestan should be administered vaginally. Food and drink do not affect treatment.

Pregnancy, breastfeeding and fertility

Utrogestan is used to support pregnancy during infertility treatment or if the doctor has determined that the patient is at risk of preterm birth. Instructions for use of Utrogestan are described in section 3.
Breastfeeding women should not use Utrogestan.

Driving and operating machinery
Utrogestan has no or negligible influence on the ability to drive and operate machinery.

Utrogestan contains soya lecithin
Patients who have been diagnosed with hypersensitivity to peanuts or soy should not use this medicine.

3. How to use Utrogestan

This medicine should always be used exactly as directed by your doctor. If you are unsure, consult
your doctor or pharmacist.

This medicine should be administered by inserting it deeply into the vagina.
Do not take this medicine by mouth. Accidental oral intake will not cause harmful effects, but the chances of becoming pregnant may be reduced.

Recommended dose
Support in in vitro fertilization (IVF) cycles:

Treatment should begin no later than the third day after oocyte retrieval.
The recommended daily dose is 600 mg of Utrogestan, administered according to your doctor's instructions. One capsule should be inserted deeply into the vagina in the morning, at midday, and at bedtime.
If laboratory tests confirm that the patient is pregnant, this dosing regimen should be continued at least until week 7 of pregnancy, but no longer than until week 12 of pregnancy, as directed by the doctor.

Prevention of preterm birth in certain patients:

One capsule (200 mg) of Utrogestan should be administered daily by deep vaginal insertion in the evening before going to bed. This treatment may be used from approximately week 20 of pregnancy until week 34 of pregnancy.

Overdose of Utrogestan
If more than the recommended dose of Utrogestan has been used, consult your doctor or
go to the hospital. Bring the medicine package with you.
The following symptoms may occur: dizziness or feeling of fatigue.
Missed dose of Utrogestan

If you forget to use a dose, administer it as soon as possible. However, if it is almost time for the next dose, skip the missed dose.
Do not use a double dose to make up for a missed dose.

Stopping Utrogestan
Before stopping this medicine, speak to your doctor, pharmacist, or
nurse. If you stop using this medicine, it will no longer support your chance of becoming pregnant.
If you have any further questions about how to use this medicine, consult your doctor, pharmacist, or nurse.

4. Possible adverse reactions

Like any medicine, this medicine can cause adverse reactions, although not everyone experiences them.
The following adverse reactions may occur with this medicine:
Frequency unknown (frequency cannot be estimated from the available data):

itching
oily vaginal discharge
vaginal bleeding
burning sensation

Within 1–3 hours after taking the medicine, the patient may experience temporary fatigue or
dizziness.
Reporting of adverse reactions
If any adverse effects occur, including any adverse effects not listed in this leaflet, inform a doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring 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 enables better monitoring of the medicine's safety.

5. How to store Utrogestan

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the stated month. The abbreviation Lot indicates the batch number.
Store below 25°C. Protect from light.
Do not use this medicine if you notice any changes in its appearance.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.
Any unused medicinal product or waste material should be disposed of in accordance with local regulations.

6. Contents of the packaging and other information

What Utrogestan contains

The active substance is progesterone. Each capsule contains 200 mg of progesterone.
The other ingredients are sunflower oil and soybean lecithin. The other components contained in the capsule shell are gelatin, glycerol, and titanium dioxide (E 171).

What Utrogestan looks like and contents of the pack
Utrogestan is an oval, yellowish soft capsule containing a white, oily suspension.
It is packaged in cardboard boxes containing PVC/Al blisters with 15, 21, 45, or 90 capsules.
For more detailed information, please contact the marketing authorization holder or the parallel importer.
Marketing Authorization Holder in Greece, the country of export:
Faran S.A.
Ahaias 5 & Troizinias
145 64, N. Kifisia, Attica
Greece
Manufacturer:
Cyndea Pharma S.L.
Polígono Industrial Emiliano Revilla Sanz
Avenida de Ágreda 31
Olvega 42110 (Soria)
Spain
NextPharma Ploërmel
ZI de Camagnon
56800 Ploërmel
France
Parallel importer:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Repackaged in:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Marketing Authorization Numbers in Greece, the country of export:
131118/21/13-1-2022
88545/21-11-2013
30971/6-3-2020
Parallel Import Authorization Number: 17/24
This medicinal product is authorized for marketing in the EEA Member States under the following names:
Bulgaria: Утрогестан 200 mg вагинални капсули, меки
Croatia: Utrogestan 200 mg meke kapsule za rodnicu.
Czech Republic: Progesteron Besins 200 mg měkké tobolky
Denmark: Progestan
Estonia: Utrogestan 200 mg vaginaalpehmekapslid
Spain: Utrogestan Vaginal 200 mg Cápsula blanda
Ireland: Utrogestan Vaginal 200mg Capsules, soft
Iceland: Progestan 200 mg Mjúkt skeiðarhylki
Latvia: Progesterone Besins 200 mg vaginālās mīkstās kapsulas
Lithuania: Progesterone Besins 200 mg makšties minkštosios kapsulės
Malta: Utrogestan Vaginal 200mg Capsules, soft
Netherlands: Utrogestan 200 mg, zachte capsules voor vaginaal gebruik
Norway: Utrogestan 200 mg vaginalkapsler, myke
Poland: Utrogestan, 200 mg, kapsułki dopochwowe miękkie
Portugal: Utrogestan Vaginal 200 mg Cápsula mole
Slovakia: Utrogestan 200 mg mäkké vaginálne kapsuly
Slovenia: Utrogestan 200 mg mehke vaginalne kapsule
Sweden: Utrogestan 200 mg mjuk Vaginalkapsel
Hungary: Utrogestan 200 mg lágy hüvelykapszula
United Kingdom: Utrogestan Vaginal 200mg Capsules
Italy: Utrogestan Vaginale 200 mg Capsula molle