Utrogestan

Leaflet attached to the packaging: patient information

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

Utrogestan(Utrogestan Vaginal)
200mg, vaginal soft capsules
Progesteronum
Utrogestan and Utrogestan Vaginal are different trade names for the same medicine.

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 a specific person. 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 side effects, including any side effects not listed in the leaflet, they should tell their 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 the patient has been diagnosed with an allergy (hypersensitivity) 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 jaundice (yellowing of the skin or eyes);
• If the patient has bleeding from the genital tract of unknown cause;
• If the patient has breast cancer or cancer of the genital tract;
• If the patient has venous thrombosis;
• If the patient has had blood clots in the veins (thrombosis), for example in the legs (deep vein thrombosis) or lungs (pulmonary embolism);
• If the patient has had a stroke;
• If the patient has a rare blood disorder called porphyria, which is inherited;
• If the patient is pregnant, but the fetus has died (missed abortion);
• If the patient's water has broken.

Do not use Utrogestan if any of the above situations apply to you. If in doubt, consult your doctor or pharmacist before using Utrogestan.

Warnings and precautions

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

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they 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, the patient should tell their doctor or pharmacist if they 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 the doctor has determined that the patient is 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

Patients who have been diagnosed with an allergy to peanuts or soy should not use this medicine.

3. How to use Utrogestan

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

• This medicine should be used by inserting it deeply into the vagina.
• Do not take this medicine orally. Accidental oral ingestion 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.
• 600 mg of Utrogestan should be used daily, as directed by the doctor. One capsule should be inserted deeply into the vagina in the morning, at noon, and before bedtime.
• If laboratory tests confirm that the patient is pregnant, the same dosing schedule should be continued for at least 7 weeks of pregnancy, but no longer than 12 weeks of pregnancy, as directed by the doctor.

Prevention of preterm labor in some patients

• 200 mg of Utrogestan should be used daily, in the evening, before bedtime, from about the 20th to the 34th week of pregnancy.

Using more than the recommended dose of Utrogestan

If too much Utrogestan is used, the patient should talk to their doctor or go to the hospital. The patient should take the packaging with them.
The following disorders may occur: dizziness or fatigue.

Missing a dose of Utrogestan

• If a dose is missed, it should be taken as soon as possible. However, if it is almost time for the next dose, the missed dose should be skipped.
• Do not take a double dose to make up for a missed dose.

Stopping Utrogestan treatment

Before stopping treatment, the patient should talk to their doctor, pharmacist, or nurse. If the patient stops using Utrogestan, the medicine will not help them become pregnant.
If the patient has any further questions about using this medicine, they should consult their doctor, pharmacist, or nurse.

4. Possible side effects

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

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

Within 1-3 hours after taking the medicine, the patient may experience short-term fatigue or dizziness.

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in the leaflet, they should tell their doctor or pharmacist. Side effects can be reported 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.
Reporting side effects will help gather more information on the safety of the 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.
• Store in the original packaging.
• Do not use this medicine if you notice any changes in its appearance.
• Medicines should not be disposed of via wastewater or household waste. The patient should ask their 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, titanium dioxide (E 171), and purified water.

What Utrogestan looks like and contents of the packaging

Utrogestan is an oval, off-white soft capsule.
It is packaged in cardboard boxes containing blisters with 15, 45, or 90 capsules.
For more detailed information, the patient should contact the marketing authorization holder or parallel importer.

Marketing authorization holder in Belgium, the country of export:

Besins Healthcare SA, Rue Washington 80, 1050 Ixelles, Belgium

Manufacturer:

Cyndea Pharma S.L., Polígono Industrial Emiliano Revilla Sanz, Avenida de Ágreda, 31, Olvega 42110 (Soria), Spain
Delpharm Drogenbos SA
Groot-Bijgaardenstraat, 128
1620 Drogenbos
Belgium

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
Belgian marketing authorization number:BE279377

Parallel import authorization number: 340/22

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 leaflet approval: 16.09.2022
[Information about the trademark]