Utrogestan

Package Leaflet: Information for the Patient

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

Utrogestan (Utrogestan Vaginal), 200 mg, Vaginal Soft Capsules

Progesterone
Utrogestan and Utrogestan Vaginal are different trade names for the same medicine.

Before Using Utrogestan, Read the Leaflet Carefully

• Keep this leaflet, you may need to read it again.
• In case of any doubts, consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in the leaflet, tell your 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. 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 Birth in Women with 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 peanuts or soya;
• If you are allergic to progesterone or any of the other ingredients of this medicine (listed in section 6);
• If you have liver problems;
• 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 blood clots;
• If you have had blood clots in the veins (thrombosis), for example in the legs (deep vein thrombosis) or lungs (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 have a missed abortion (the fetus has died).
• If your water has broken.

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

Warnings and Precautions

Utrogestan is not a contraceptive.
If you think you may have had a miscarriage, talk to your doctor, as you may need to stop using Utrogestan.
If you experience vaginal bleeding, 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 birth 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 for you.
If you are at risk of preterm birth, you may take Utrogestan from about the 20th to the 34th week of pregnancy. If your water breaks while taking this medicine, you must contact your doctor immediately. This situation may pose a direct threat to you and your baby.
In rare cases, using Utrogestan in the second and third trimester may lead to liver problems. If you experience itching, which may be a sign of liver problems, 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

Tell your doctor or pharmacist about all medicines you are taking, or have recently taken, and those you plan to take, including those obtained without a prescription, including herbal medicines. This is because Utrogestan may affect the way some other medicines work. Also, some other medicines may affect the way Utrogestan works.
In particular, 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, Breast-feeding, and Fertility

• Utrogestan is used to support pregnancy during infertility treatment or if your doctor has determined that you are at risk of preterm birth. Instructions for using Utrogestan are described in section 3.
• Women who are breast-feeding should not use Utrogestan.

Driving and Using Machines

Utrogestan has a negligible effect on driving and using machines.

Utrogestan Contains Soya Lecithin

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

3. How to Use Utrogestan

Always use this medicine exactly as your doctor has told you. If you are unsure, consult your doctor or pharmacist.

• This medicine should be inserted deep into the vagina.
• Do not take this medicine by mouth. If you accidentally take it by mouth, it will not harm you, but it may reduce your chances of getting pregnant.

Recommended Dose

Support in IVF cycles

• Treatment should start no later than the third day after egg retrieval.
• Use 600 mg of Utrogestan daily, as directed by your doctor. Insert one capsule deep into the vagina in the morning, at noon, and before bedtime.
• If laboratory tests confirm that you are pregnant, 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 birth in some patients

• 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 Utrogestan Than Recommended

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

Missing a Dose of Utrogestan

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

Stopping Utrogestan

Before stopping Utrogestan, talk to your doctor, pharmacist, or nurse. If you stop using Utrogestan, it will not help you get pregnant.
If you have any further questions on the use of this product, 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 temporary dizziness or fatigue.

Reporting Side Effects

If you experience any side effects, including those not listed in the leaflet, tell your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Medicinal Product Monitoring, Urząd Rejestracji Produktów Leczniczych, Wyrobów Medycznych i Produktów Biobójczych, 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

• Keep this medicine out of the 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 change in its appearance.
• Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. 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 soya 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 Pack

Utrogestan is oval, yellowish soft capsules containing a white, oily suspension.
It is packaged in cardboard boxes containing blisters of 15 or 45 capsules.
For more detailed information, consult the marketing authorization holder or parallel importer.

Marketing Authorization Holder in Belgium, the Country of Export:

Besins Healthcare SA
Avenue Louise 287
1050 Brussels, Belgium

Manufacturer:

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

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
Belgian authorization number: BE 279377

Parallel Import Authorization Number: 210/22

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 Revision of the Leaflet: 17.05.2022
[Information about the trademark]