Utrogestan

LEAFLET INCLUDED IN THE PACKAGING: INFORMATION FOR THE USER

Warning! Keep the leaflet, the information on the immediate packaging is in a foreign language!

Utrogestan,

200 mg, vaginal soft capsules

Progesteronum

You should carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if you need to.
• If you have any doubts, you should consult a 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 the patient experiences any side effects, including any side effects not listed in the leaflet, they should tell their 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 been diagnosed with an allergy (hypersensitivity) 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 genital cancer;
• If the patient has venous thrombosis;
• If the patient has had blood clots in the veins (thrombosis), such as deep vein thrombosis or pulmonary embolism;
• If the patient has had a cerebral hemorrhage;
• 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.

Utrogestan should not be used if any of the above situations apply to the patient. In case of doubt, the patient should discuss this with their 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 talk to her doctor, as it may be necessary to stop using Utrogestan. If the patient experiences vaginal bleeding, she should talk to her doctor.
If the patient is taking this medicine to maintain pregnancy during infertility treatment
Utrogestan should only be used during the first three months of pregnancy.
If the patient is taking this medicine to prevent preterm labor in singleton pregnancy
The doctor will discuss the risks and benefits of the available treatment options with the patient. The doctor and patient will decide together which treatment is most suitable.
If the patient is at risk of preterm labor, she may take Utrogestan from around the 20th to the 34th week of pregnancy. If the patient's water breaks while taking this medicine, she should contact her doctor immediately. This situation may pose a direct threat to the patient and her child.
In rare cases, use in the second and third trimester of pregnancy may lead to liver problems. If the patient experiences itching, which may be a sign of liver problems, she should contact her doctor.

Children

Utrogestan is not intended for use in children.

Diagnostic tests and monitoring

Before starting treatment and regularly during treatment, the doctor will perform a full medical examination.

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 medicines available without a prescription, including herbal medicines. This is because Utrogestan may affect the action of some other medicines. Some other medicines may also 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 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 the doctor has determined that the patient is 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 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 the patient has any doubts, they should consult their doctor or pharmacist.

• This medicine should be used by inserting it deep into the vagina.
• The medicine should not be taken orally. However, if it is accidentally taken orally, it will not cause harmful effects, but the chances of becoming pregnant may be lower.

Recommended dose

Support in in vitro fertilization (IVF) cycles:

• Treatment should start no later than the third day after egg retrieval.
• The patient should use 600 mg of Utrogestan daily, as directed by the doctor. One capsule should be inserted deep into the vagina in the morning, at noon, and before bedtime.
• If laboratory tests confirm that the patient is pregnant, the same dosing schedule should be continued for at least 7 weeks of pregnancy, but no longer than 12 weeks of pregnancy, as directed by the doctor.

Prevention of preterm labor in some patients

• The patient should 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 than the recommended dose of Utrogestan

If the patient uses too much Utrogestan, they should talk to their doctor or go to the hospital. They should take the packaging of the medicine with them.
The following disorders may occur: dizziness or fatigue.

Missing a dose of Utrogestan

• If the patient forgets to use a dose, they should use it as soon as possible. However, if it is almost time for the next dose, they should skip the missed dose.
• The patient should not use a double dose to make up for a missed dose.

Stopping Utrogestan treatment

Before stopping Utrogestan treatment, the patient should talk to their doctor, pharmacist, or nurse. If the patient stops using Utrogestan, the medicine will not help them become pregnant.
If the patient has any further questions about using this medicine, they should consult their doctor, pharmacist, or nurse.

4. Possible side effects

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

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

Within 1-3 hours after using the medicine, the patient may experience short-term fatigue or dizziness.

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in the leaflet, they should tell their doctor or pharmacist. Side effects can be reported directly to the Department of Pharmacovigilance 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 will 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 after EXP. The expiry date refers to the last day of the month stated.
• The medicine should be stored at a temperature below 25°C. Protect from light.
• The medicine should not be used if it appears to have changed.
• 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.
• 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 of Utrogestan is progesterone. Each capsule contains 200 mg of progesterone.
• The other ingredients are sunflower oil and soy lecithin. The other ingredients in the capsule shell are gelatin, glycerol, and titanium dioxide (E 171).

What Utrogestan looks like and contents of the packaging

Utrogestan is an oval, yellowish soft capsule containing a white, oily suspension.
It is packaged in cardboard boxes containing blisters of PVC/Al foil with 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 Greece, the country of export:

Faran S.A.
Ahaias 5 & Troizinias
145 64, N. Kifisia, Attica
Greece

Manufacturer:

Cyndea Pharma S.L.
Polígono Industrial Emiliano Revilla Sanz
Avenida de Ágreda 31
Olvega 42110 (Soria)
Spain
NextPharma Ploërmel
ZI de Camagnon
56800 Ploërmel
France

Parallel importer:

Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź

Repackaged by:

Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź

Marketing authorization number in Greece, the country of export:

131118/21/13-1-2022
88545/21-11-2013
30971/6-3-2020

Parallel import authorization number: 17/24

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 revision of the leaflet: 15.01.2024

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