Utrogestan

Patient Information Leaflet

Caution! Keep this leaflet. The information on the immediate packaging is in a foreign language.
Utrogestan (Utrogestan Vaginal), 200 mg, soft vaginal capsules
Progesteronum
Utrogestan and Utrogestan Vaginal are different trade names for the same medicine.
Please read this leaflet carefully before using the medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm others, even if their symptoms are the same.
• If you experience any adverse effects, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. 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

Supporting pregnancy during fertility treatment
Utrogestan is intended for women who require additional progesterone to support pregnancy during assisted reproductive technology (ART) procedures.

Prevention of preterm birth in women with singleton pregnancies
Utrogestan is intended for women who have previously delivered prematurely and/or who have a short cervix.

2. Important information before using Utrogestan

When not to use Utrogestan:

• If the patient has been diagnosed with 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 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 currently has or has previously had blood clots in the veins (venous thrombosis), for example in the legs (deep vein thrombosis) or lungs (pulmonary embolism);
• If the patient has previously had a haemorrhagic stroke;
• 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 "waters have broken" (ruptured membranes).

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 she may have had a miscarriage, she should speak with her doctor, as use of Utrogestan must then be discontinued.
If the patient experiences vaginal bleeding, she should consult 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 associated with available treatment options. The doctor and patient will jointly decide on the most appropriate treatment.
If the patient is at risk of preterm birth, she may take Utrogestan from approximately week 20 to week 34 of pregnancy. If the patient's waters break while taking this medicine, she must contact her doctor immediately. This situation may pose an immediate risk to the patient and her baby.
In rare cases, 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 and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking, has recently taken, or plans to take, including over-the-counter medicines and herbal supplements. This is because Utrogestan may affect the action of certain other medicines, and some other medicines may affect how Utrogestan works.
In particular, inform the 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 should be 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 of Utrogestan 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 have been diagnosed with hypersensitivity to peanuts or soy should not use this medicine.

3. How to use Utrogestan

This medicine should always be used exactly as prescribed by your doctor. If in doubt, 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 is not harmful, but the chance of becoming pregnant may be reduced.

Recommended dose
Support during 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, as prescribed by your doctor. One capsule should be inserted deeply into the vagina in the morning, at noon, and at bedtime.
• 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 not beyond week 12, as directed by the doctor.

Prevention of preterm birth in certain patients

• One capsule (200 mg) of Utrogestan should be inserted deeply into the vagina every evening before going to bed. This treatment may be used from approximately week 20 of pregnancy up to week 34 of pregnancy.

Use of more than the recommended dose of Utrogestan
If more than the recommended dose of Utrogestan has been used, speak to your doctor or go to the hospital immediately. Take the medicine package with you.
The following symptoms may occur: dizziness or feeling of fatigue.

Missed dose of Utrogestan

• If you forget to use a dose, take 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 missed dose.

Stopping treatment with Utrogestan
Before stopping treatment with this medicine, consult your doctor, pharmacist, or nurse. If you stop using this medicine, it may not support your chance of becoming pregnant.
For any further questions about the use of this medicine, consult your doctor, pharmacist, or nurse.

4. Possible adverse effects

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

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

Within 1-3 hours after taking the medicine, the patient may experience temporary fatigue or
dizziness.
Reporting of adverse effects
If any adverse effects occur, including any adverse effects not listed in the leaflet, inform your doctor, pharmacist or nurse. Adverse effects 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
By reporting adverse effects, additional information on the safety of the medicine can be collected.

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 helps protect the environment.
• Any unused medicinal product or waste material should be disposed of in accordance with local regulations.

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 soybean lecithin. The other components of 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 packed in cardboard boxes containing blisters with 15 or 45 capsules.
For further information, please contact the marketing authorisation holder or the parallel importer.
Marketing authorisation holder in Belgium, the country of export:
Besins Healthcare SA
Rue Washington 80
1050 Brussels
Belgium
Manufacturer:
Cyndea Pharma, S.L.
Polígono Industrial Emiliano Revilla Sanz
Avenida de Ágreda, 31
Olvega 42110 (Soria), Spain
Besins Manufacturing España S.L.
Polígono Industrial el Pitarco
Parcela 4, Muel, 50450 Zaragoza – Spain
Parallel importer:
Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź
Repackaged in:
Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź
Belgium, country of export, marketing authorisation number: BE 279377
Parallel import authorisation number: 210/22
This medicinal product is authorised for sale in the EEA Member States 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, soft vaginal capsules
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