Utrogestan

Package leaflet: Information for the patient

Warning! Keep this leaflet! Information on the immediate packaging in a foreign language.
Utrogestan (Utrogestan 200 mg), 200 mg, vaginal soft capsules
Progesteronum
Utrogestan and Utrogestan 200 mg are different trade names for the same medicine.
Please read the entire 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 you experience any adverse effects, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents of the leaflet

1. What Utrogestan is and what it is used for
2. What you need to know before using Utrogestan
3. How to use Utrogestan
4. Possible side effects
5. How to store Utrogestan
6. 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
Supporting pregnancy during infertility treatment
Utrogestan is intended for women who require additional doses of progesterone to support pregnancy during treatment as part of an assisted reproductive technology (ART) programme.
Prevention of preterm birth in women with singleton pregnancies
Utrogestan is intended for women who have previously delivered prematurely and/or who have a short cervix.

2. Important information before using Utrogestan

When not to use Utrogestan:

• If the patient has a known hypersensitivity to soya 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 impaired liver function;
• If the patient has jaundice (yellowing of the skin or eyes);
• If the patient has unexplained vaginal bleeding;
• 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), for example in the legs (deep vein thrombosis) or lungs (pulmonary embolism);
• If the patient has previously experienced a haemorrhagic stroke;
• 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 membranes have ruptured ("water has broken").

Utrogestan should not be used if any of the above conditions apply to the patient.
If in doubt, consult 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 her doctor, as treatment with Utrogestan must then be discontinued.
If the patient experiences vaginal bleeding, she should speak to her doctor.
If the patient is using this medicine to support pregnancy during infertility treatment
Utrogestan should only be used 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 delivery, she may use Utrogestan from approximately week 20 to week 34 of pregnancy. If the patient's membranes rupture while taking this medicine, she must contact her doctor immediately. 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 sign 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, has recently taken, or plans to take. This includes over-the-counter medicines, including herbal medicines. This is because Utrogestan may affect the action of certain other medicines. Likewise, certain other medicines may affect how Utrogestan works.
In particular, inform the doctor or pharmacist if the patient is taking any of the following medicines:

• 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 as an adjunct to support pregnancy during infertility treatment or when 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 are allergic to peanuts or soya should not use this medicine.

3. How to use Utrogestan

This medicine should always be used exactly as prescribed by your doctor. If in doubt, consult
your doctor or pharmacist.

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

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

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

Prevention of preterm birth in certain patients:

• One capsule (200 mg) of Utrogestan should be administered daily, deeply into the vagina, in the evening before going to bed. This medicine can be used from approximately week 20 of pregnancy until week 34 of pregnancy.

Use of more than the recommended dose of Utrogestan
If an excessive 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 administer a dose, administer it as soon as possible. However, if it is almost time for the next dose, skip the missed dose.
• Do not administer a double dose to make up for the missed dose.

Stopping use of Utrogestan
Before stopping use of this medicine, consult your doctor, pharmacist, or nurse. If the patient stops using this medicine, it will not support pregnancy.
If you have any further questions about the use of this medicine, consult your doctor, pharmacist, or nurse.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
This medicine may cause the following adverse reactions:
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 not listed in this leaflet, inform your 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, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl.
Reporting adverse reactions enables better assessment 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. The expiry date refers to the last day of the specified month.
• There are no special storage instructions.
• 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 in use. This will help protect the environment.
• Any unused medicinal product or waste material must be disposed of in accordance with local regulations.

6. Contents of the pack 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 soya lecithin. The other components contained in the capsule shell are gelatin, glycerol, titanium dioxide (E 171), and purified water.

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/Aluminium blisters with 15, 21, 45 or 90 capsules.
For more detailed information, please contact the marketing authorisation holder or the parallel importer.
Marketing authorisation holder in France, the country of export:
Laboratoires Besins International, 3, rue du Bourg l’Abbe, 75003 Paris, France
Manufacturer:
Cyndea Pharma SL
Poligono Industrial Emiliano Revilla Sanz
Avenida de Agreda 31
42110 Olvega (Soria), Spain
Besins Manufacturing Belgium SA
128 Groot-Bijgaardenstraat
1620 Drogenbos
Belgium
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 France, the country of export: 34009 358 768 4 3
Parallel import authorisation number: 216/24
This medicinal product is authorised for sale 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