Utrogestan

Leaflet attached to the packaging: patient information

Warning! The leaflet should be kept. Information on the immediate packaging in a foreign language.

Utrogestan, 200 mg, vaginal soft capsules

Progesteronum

It is necessary to carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient.

• The leaflet should be kept so that it can be re-read if necessary.
• In case of any doubts, the doctor or pharmacist should be consulted.
• This medicine has been prescribed to a specific person. It should not be given to others. The medicine may harm another person, even if the symptoms of their illness are the same.
• If the patient experiences any side effects, including any side effects not listed in the leaflet, they should inform the doctor, pharmacist, or nurse. 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 (referred to as Utrogestan in this leaflet). Utrogestan contains a hormone called progesterone.

What Utrogestan is used for

Utrogestan can be used to support the chances of getting pregnant during in vitro fertilization (IVF) cycles or to prevent premature births during single pregnancies in some patients.

Maintenance of pregnancy

Utrogestan is intended for women who need additional doses of progesterone during assisted reproductive technology (ART) treatment.

2. Important information before using Utrogestan

When not to use Utrogestan:

• If the patient has been diagnosed with an allergy (hypersensitivity) to soy;
• If the patient is allergic to progesterone or any of the other ingredients of this medicine (listed in section 6);
• If the patient has severe liver disease;
• If the patient has bleeding from the genital tract of unknown cause;
• If the patient has breast or genital cancer;
• If the patient has venous thrombosis;
• If the patient has or has had blood clots in the veins (thrombosis), such as deep vein thrombosis or 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).

Warnings and precautions

Utrogestan should be used during the first 3 months of pregnancy. Before starting Utrogestan, the patient should discuss it with their doctor or pharmacist.
Utrogestan is not a contraceptive.
If the patient suspects that they may have had a miscarriage, they should talk to their doctor, as it may be necessary to stop using Utrogestan.

Children

Utrogestan is not intended for use in children.

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 over-the-counter medicines, including herbal medicines. This is because Utrogestan may affect the action of some other medicines. Also, some other medicines may 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 is intended for vaginal administration. Food and drink do not affect treatment.

Pregnancy, breastfeeding, and fertility

• Utrogestan is used to support pregnancy during infertility treatment. The method of using Utrogestan is described in section 3 "How to use Utrogestan".
• 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 there are any doubts, the doctor or pharmacist should be consulted.

• This medicine should be administered by inserting it deep into the vagina.
• The medicine should not be taken orally. However, accidental oral ingestion will not lead to harmful effects, but only reduce the chances of getting pregnant.

Recommended dose

Support during IVF cycles:

• Treatment starts on the day of embryo transfer.
• 200 mg of Utrogestan should be used daily, in the morning, at lunchtime, and before bedtime, as directed by the doctor.
• If laboratory tests indicate pregnancy, the same dosing schedule should be continued until the 7th-12th week of pregnancy, as directed by the doctor.

Prevention of premature births in some patients

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

Using more than the recommended dose of Utrogestan

In case of using more than the recommended dose of Utrogestan, 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 feeling tired.

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.
• A double dose should not be taken to make up for a missed dose.

4. Possible side effects

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

• vaginal discharge
• genital bleeding
• itching

Reporting side effects

If any side effects occur, including any side effects not listed in the leaflet, the patient should inform their doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of 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 side effects can 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.
• The medicine should not be used after the expiry date stated on the packaging. The expiry date refers to the last day of the month stated.
• There are no special precautions for storage.
• 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 of Utrogestan is progesterone. Each capsule contains 200 mg of progesterone.
• The other ingredients are purified 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 what the packaging contains

Utrogestan is an oval, yellowish soft capsule containing a white, oily suspension.
It is packaged in cardboard boxes containing PVC/Aluminum blisters with 14, 15, 21, 45, or 90 capsules.
For more detailed information, the patient should contact the marketing authorization holder or parallel importer.

Marketing authorization holder in the Netherlands, the country of export:

Besins Healthcare Netherlands B.V.
Oorsprongpark 12
3581 ET Utrecht
Netherlands

Manufacturer:

Cyndea Pharma, S.L.
Poligono Industrial Emiliano Revilla Sanz
Avenida de Agreda, 31
Ólvega 42110 (Soria), Spain

Parallel importer:

Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź

Repackaged by:

Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź
Netherlands marketing authorization number: RVG 123999

Parallel import authorization number: 6/22

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 200mg 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 200mg Capsules
Date of approval of the leaflet: 10.01.2022
[Information about the trademark]