Utrogestan

Patient Information Leaflet

Warning! Keep this leaflet! The outer packaging contains information in a foreign language.
Utrogestan (Utrogestan Vaginal)
200 mg, soft vaginal capsules
Progesterone
Utrogestan and Utrogestan Vaginal are different brand names of the same medicine.
Please read this leaflet carefully before using the medicine, as it contains important
information for the patient.

• Keep this leaflet to be able to read it again if necessary.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm someone else, even if their symptoms are the same.
• If you experience any adverse effects, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of Contents

1. What Utrogestan is and what it is 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 pack and other information

1. What Utrogestan is and what it is 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 require additional doses of progesterone to support pregnancy during treatment as part of an assisted reproductive technology (ART) program.
Prevention of preterm birth in women with singleton pregnancies
Utrogestan is intended for women who have previously delivered prematurely and/or who 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 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 impaired liver function;
• If the patient has yellowing of the skin or eyes (jaundice);
• If the patient has vaginal bleeding of unknown cause;
• If the patient has cancer of the breast or genital organs;
• If the patient has thrombophlebitis (inflammation of a vein due to a blood clot);
• If the patient has or has had venous thromboembolism, for example in the legs (deep vein thrombosis) or lungs (pulmonary embolism);
• If the patient has had a stroke in the past;
• If the patient has a rare inherited blood disorder called "porphyria";
• If the patient is pregnant but the fetus has died (missed miscarriage);
• If the patient's membranes have ruptured ("water has broken").

Do not use Utrogestan if any of the above situations apply to the patient.
If in doubt, discuss this with a doctor or pharmacist before using Utrogestan.
Warnings and precautions
Utrogestan is not a contraceptive.
If the patient suspects that a miscarriage may have occurred, she should consult a doctor,
as treatment with Utrogestan must then be discontinued.
If the patient experiences vaginal bleeding, she should speak with her doctor.
If the patient is using this medicine to support pregnancy during infertility treatment
Utrogestan should be used only during the first 3 months of pregnancy.
If the patient is using this medicine to prevent preterm birth in a singleton pregnancy
The doctor will discuss with the patient the risks and benefits of the available treatment options.
The doctor and the patient will jointly decide on the most appropriate treatment.
If the patient is at risk of preterm birth, she may use Utrogestan from approximately week 20 to week 34 of pregnancy.
If the patient's membranes rupture while using this medicine, she must contact her doctor immediately.
This situation may pose an immediate risk to the patient and her baby.
Rarely, use during the second and third trimesters of pregnancy may lead to liver problems.
If the patient develops itching, which may be a sign of liver problems, she should contact her 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 with other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, including medicines she plans to take. This includes over-the-counter medicines, including herbal medicines. This is because Utrogestan may affect the action of certain other medicines. Likewise, certain other medicines may affect how Utrogestan works.
In particular, tell your doctor or pharmacist if the patient is taking any of the following medicines:

• Bromocriptine, used to treat disorders related to the pituitary gland or Parkinson's disease;
• Cyclosporine (used to suppress 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 administered vaginally. Food and drink do not affect treatment.
Pregnancy, breastfeeding and fertility

• Utrogestan is used to support pregnancy during infertility treatment or when the doctor has determined that the patient is at risk of preterm birth. Instructions for use are described in section 3.
• Breastfeeding women should not use Utrogestan.

Driving and using machines
Utrogestan has negligible influence on the ability to drive and use machinery.
Utrogestan contains soya lecithin
Patients who are allergic to peanuts or soya should not use this medicine.

3. How to use Utrogestan

This medicine should always be used exactly as your doctor has told you. If you are not sure,
please consult your doctor or pharmacist.

• This medicine should be administered by inserting it deeply into the vagina.
• Do not take this medicine by mouth. Accidental oral intake will not cause harmful effects, but the chances of becoming pregnant may be reduced.

Recommended dose
Support in in vitro fertilization (IVF) cycles:

• Treatment should start no later than the third day after oocyte retrieval.
• The recommended daily dose is 600 mg of Utrogestan, administered as one capsule inserted deeply into the vagina in the morning, at noon, and at bedtime, as directed by your doctor.
• If laboratory tests confirm that the patient is pregnant, the same dosing regimen should be continued for at least up to week 7 of pregnancy, but no longer than until week 12 of pregnancy, as advised by your doctor.

Prevention of preterm birth in certain patients:

• 200 mg of Utrogestan should be administered daily in the evening before going to sleep, from approximately week 20 of pregnancy until week 34 of pregnancy.

Use of a higher than recommended dose of Utrogestan
If you have used more Utrogestan than you should, talk to your doctor or go to a hospital.
Bring the medicine pack with you.
The following symptoms may occur: dizziness or feeling tired.

Missed dose of Utrogestan

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

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

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
This medicine may cause the following adverse reactions:
Frequency unknown (frequency cannot be determined from available data):

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

Within 1 to 3 hours after taking the medicine, the patient may experience transient fatigue or dizziness.
Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, phone: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl.
Reporting adverse reactions enables the collection of additional information on the safety of this medicine.

5. How to store Utrogestan

• Keep this medicine 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 stated month.
• Store in the original packaging.
• Do not use this medicine if you notice any changes in its appearance.
• Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the pack 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 soybean lecithin. The other components contained 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 capsule in off-white color. It is packaged in cardboard boxes containing blisters with 15, 45, or 90 capsules. For more detailed information, please contact the marketing authorization holder or the 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

Marketing Authorization Number in Belgium, the country of export: BE279377
Parallel Import Authorization Number: 340/22

This medicinal product is authorized for sale in the EEA Member States 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