Utrogestan

Leaflet attached to the packaging: patient information

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

Utrogestan

200mg, vaginal capsules, soft
Progesteronum

You should carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if you need to.
• If you have any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed to you specifically. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If you experience any side effects, including those not listed in the leaflet, you should tell your doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is Utrogestan and what is it used for
• 2. Important information before using Utrogestan
• 3. How to use Utrogestan
• 4. Possible side effects
• 5. How to store Utrogestan
• 6. Contents of the packaging and other information

1. What is Utrogestan and what is it 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 need additional doses of progesterone to maintain pregnancy during assisted reproductive technology (ART) treatment.

Prevention of preterm labor in singleton pregnancies

Utrogestan is intended for women who have had a preterm birth in the past and/or may have a problem with a part of the uterus known as a short cervix.

2. Important information before using Utrogestan

When not to use Utrogestan:

• If you are allergic (hypersensitive) to soy or peanuts;
• If you are allergic to progesterone or any of the other ingredients of this medicine (listed in section 6);
• If you have liver function disorders;
• If you have yellowing of the skin or eyes (jaundice);
• If you have vaginal bleeding of unknown cause;
• If you have breast cancer or cancer of the reproductive organs;
• If you have venous thrombosis;
• If you have had blood clots in the veins (thrombosis), such as deep vein thrombosis or pulmonary embolism;
• If you have had a stroke;
• If you have a rare blood disorder called porphyria, which is inherited;
• If you are pregnant, but the fetus has died (missed abortion);
• If your water has broken.

You should not use Utrogestan if any of the above situations apply to you. If you are in doubt, you should discuss this with your doctor or pharmacist before using Utrogestan.

Warnings and precautions

Utrogestan is not a contraceptive. If you think you may have had a miscarriage, you should talk to your doctor, as it may be necessary to stop using Utrogestan. If you experience vaginal bleeding, you should talk to your doctor. If you are taking this medicine to support pregnancy during infertility treatment
Utrogestan should only be used during the first 3 months of pregnancy. If you are taking this medicine to prevent preterm labor in a singleton pregnancy
Your doctor will discuss the risks and benefits of the available treatment options with you. You and your doctor will decide together which treatment is most suitable. If you are at risk of preterm labor, you may take Utrogestan from about the 20th to the 34th week of pregnancy. If your water breaks while taking this medicine, you should contact your doctor as soon as possible. This situation may pose a direct threat to you and your baby. In rare cases, use in the second and third trimester may lead to liver problems. If you experience itching, which may be a sign of liver problems, you should contact your doctor.

Children

Utrogestan is not intended for use in children.

Diagnostic tests and monitoring

Before starting treatment and regularly during treatment, your doctor will perform a full medical examination.

Utrogestan and other medicines

You should tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take. This includes medicines available without a prescription, including herbal medicines. This is because Utrogestan may affect the action of some other medicines. Some other medicines may also affect the action of Utrogestan. In particular, you should tell your doctor or pharmacist if you are taking any of the following medicines:

• Bromocriptine, used to treat disorders related to the pituitary gland or Parkinson's disease;
• Cyclosporine (used to weaken 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 inserted into the vagina. Food and drink do not affect treatment.

Pregnancy, breastfeeding, and fertility

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

Driving and using machines

Utrogestan has a negligible effect on driving and using machines.

Utrogestan contains soy lecithin

Women who are allergic to peanuts or soy should not use this medicine.

3. How to use Utrogestan

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

• This medicine should be inserted deep into the vagina.
• Do not take this medicine orally. Accidental oral intake will not cause harmful effects, but it may reduce the chances of becoming pregnant.

Recommended dose

Support in in vitro fertilization (IVF) cycles:

• Treatment starts no later than the third day after egg retrieval.
• You should use 600 mg of Utrogestan daily, as directed by your doctor. You should insert one capsule deep into the vagina in the morning, at noon, and before bedtime.
• If laboratory tests confirm that you are pregnant, you should continue with the same dosing schedule for at least 7 weeks of pregnancy, but no longer than 12 weeks of pregnancy, as directed by your doctor.

Prevention of preterm labor in some patients

• You should use 200 mg of Utrogestan daily, in the evening, before going to bed, from about the 20th to the 34th week of pregnancy.

Using more than the recommended dose of Utrogestan

If you use too much Utrogestan, you should talk to your doctor or go to the hospital. You should take the packaging with you. You may experience dizziness or fatigue.

Missing a dose of Utrogestan

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

Stopping Utrogestan

Before stopping Utrogestan, you should talk to your doctor, pharmacist, or nurse. If you stop using Utrogestan, it will not help you become pregnant. If you have any further questions about using this medicine, you should ask your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, Utrogestan can cause side effects, although not everybody gets them. Utrogestan may cause the following side effects:

• itching
• oily vaginal discharge
• vaginal bleeding
• burning sensation

Within 1-3 hours after using Utrogestan, you may experience short-term fatigue or dizziness.

Reporting side effects

If you experience any side effects, including those not listed in the leaflet, you should tell your doctor or pharmacist. You can report side effects directly to the Department of Drug Safety, 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 provide more information on the safety of this medicine.

5. How to store Utrogestan

• The medicine should be stored 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 month stated.
• Do not store above 25°C.
• Do not use this medicine if you notice any changes in its appearance.
• Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

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 soy lecithin. The other ingredients in the capsule shell are gelatin, glycerol, and titanium dioxide (E 171).

What Utrogestan looks like and contents of the packaging

Utrogestan is an oval, yellowish soft capsule containing a white, oily suspension. It is packaged in cardboard boxes containing blisters with 15, 30, 45, or 90 capsules. For more detailed information, you should contact the marketing authorization holder or the parallel importer.

Marketing authorization holder in Greece, the country of export:

Angelini Pharma Hellas Α.Β.Ε.Ε., 4 Roupel & 17 km Athens-Lamia Nat. Rd.
145 64 Nea Kifisia, Greece

Manufacturer:

Cyndea Pharma S.L., Polígono Industrial Emiliano Revilla Sanz
Avenida de Ágreda, 31, Olvega 42110 (Soria), Spain

Parallel importer:

InPharm Sp. z o.o., ul. Strumykowa 28/11, 03-138 Warsaw

Repackaged by:

InPharm Sp. z o.o. Services sp. k., ul. Chełmżyńska 249, 04-458 Warsaw
Greek marketing authorization number: 30971/6-3-2020

Parallel import authorization number: 423/22

This medicinal product is authorized in the Member States of the EEA under the following names:

Bulgaria: Utrogestan 200 mg vaginal capsules, soft
Croatia: Utrogestan 200 mg meke kapsule za rodnicu.
Czech Republic: Progesteron Besins 200 mg měkké tobolky
Estonia: Utrogestan 200 mg vaginaalpehmekapslid
Hungary: Utrogestan 200 mg lágy hüvelykapszula
Ireland: Utrogestan Vaginal 200 mg Capsules, soft
Latvia: Progesterone Besins 200 mg vaginālās mīkstās kapsulas
Lithuania: Progesterone Besins 200 mg makšties minkštosios kapsulės
Netherlands: Utrogestan 200 mg, zachte capsules voor vaginaal gebruik
Norway: Utrogestan 200 mg vaginalkapsler, myke
Poland: Utrogestan, 200 mg, kapsułki dopochwowe miękkie
Slovakia: Utrogestan 200 mg mäkké vaginálne kapsuly
Slovenia: Utrogestan 200 mg mehke vaginalne kapsule
Sweden: Utrogestan 200 mg mjuk Vaginalkapsel
United Kingdom: Utrogestan Vaginal 200 mg Capsules
Date of revision of the leaflet: 05.12.2022
[Information about the trademark]