Utrogestan

Leaflet attached to the packaging: patient information

Utrogestan, 200 mg, vaginal soft capsules

progesterone

Read the leaflet carefully before using the medicine, as it contains important information for the patient.

• Keep this leaflet, so you can read it again if you need to.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed specifically for you. 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, 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 is Utrogestan 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 have a short cervix.

2. Important information before using Utrogestan

When not to use Utrogestan:

• If the patient has a known hypersensitivity (allergy) 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 vaginal bleeding of unknown cause;
• If the patient has breast cancer or cancer of the reproductive organs;
• If the patient has a history of blood clots;
• If the patient has had blood clots in the past (thrombosis), for example in the legs (deep vein thrombosis) or lungs (pulmonary embolism)

(pulmonary embolism);

• If the patient has had a stroke in the past;
• 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 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, 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
Your doctor and you will decide together which treatment is most suitable for you.
If you are at risk of preterm labor, you may take Utrogestan from around the 20th to the 34th week of pregnancy. If your water breaks while taking this medicine, you should 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, 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

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 way some other medicines work. Some other medicines may also 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 the 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

Patients who are allergic to peanuts or soy 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 orally. If you accidentally take it orally, it will not cause harm, but it may reduce your chances of getting pregnant.

Recommended dose

Support in in vitro fertilization (IVF) cycles:

• Treatment starts 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 labor in some patients

• Insert one capsule (200 mg) of Utrogestan deep into the vagina every evening, before going to bed. This medicine can be used from around 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 about using this medicine, 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:
Frequency not known (frequency cannot be estimated from the available data):

• 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, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Pharmacovigilance, 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
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather 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 after EXP. The expiry date refers to the last day of the month.
  The batch number is indicated by the abbreviation Lot.
• This medicine does not require any special storage precautions.
• Do not use this medicine if you notice any changes 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.
• Any unused medicinal product or waste material should be disposed of in accordance with local requirements.

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 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 contents of the pack

Utrogestan is an oval, yellowish soft capsule containing a white, oily suspension.
It is packaged in cardboard boxes containing blisters of PVC/Aluminum foil with 15, 21, 45, or 90 capsules.
Not all pack sizes may be marketed.

Marketing authorization holder

Besins Healthcare Ireland Limited
Plaza 4, Level 4 Custom House Plaza
Harbourmaster Place, IFSC
Dublin 1, D01 A9N3
Ireland

Manufacturer

Cyndea Pharma, S.L.
Poligono Industrial Emiliano Revilla Sanz
Avenida de Agreda, 31
Ólvega 42110 Soria
Spain
or
BESINS MANUFACTURING ESPAŇA S.L.
Poligono industrial el Pitarco, Parcela 4,
Muel
50450 Zaragoza
Spain

This medicinal product is authorized in the Member States of the EEA 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

Date of last revision of the leaflet: 09/2024