Package leaflet: Information for the patient

Warning! Keep this leaflet. Information on the immediate packaging in a foreign language.
Utrogestan, 200 mg, soft vaginal capsules
Progesterone
Please read carefully all the information in this leaflet before using this medicine, as it contains
important information for the patient.

Keep this leaflet so that you can read it again if necessary.
If you have any doubts, 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 other people, even if their symptoms are the same.
If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor, pharmacist or nurse. See section 4.

Table of contents of the leaflet

What Utrogestan is and what it is used for
Important information before using Utrogestan
How to use Utrogestan
Possible side effects
How to store Utrogestan
Contents of the pack and other information

1. What Utrogestan is and what it is used for

The name of this medicine is Utrogestan (referred to as Utrogestan in this leaflet). Utrogestan contains a hormone called progesterone.
What Utrogestan is used for
Utrogestan may be used to support the chance of becoming pregnant during in vitro fertilization (IVF) cycles or to help prevent preterm birth in singleton pregnancies in certain patients.
Maintenance of pregnancy
Utrogestan is intended for women who require additional doses of progesterone during assisted reproductive technology (ART) treatment.

2. Important information before using Utrogestan

When not to use Utrogestan:

If the patient has been diagnosed with soy allergy (hypersensitivity);
If the patient is allergic to progesterone or any of the other ingredients of this medicine (listed in section 6);
If the patient has severe liver disease;
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 (vein inflammation with blood clot);
If the patient currently has or has had in the past venous thrombosis, for example deep vein thrombosis in the legs or pulmonary embolism;
If the patient has had cerebral haemorrhage;
If the patient has a rare inherited blood disorder called "porphyria";
If the patient is pregnant, but the fetus has died (missed miscarriage).

Warnings and precautions
Utrogestan should be used during the first three months of pregnancy. Before starting treatment with Utrogestan, discuss this with your doctor or pharmacist.
Utrogestan is not a contraceptive.
If the patient suspects that a miscarriage may have occurred, she should consult her doctor, as treatment with Utrogestan must then be discontinued.

Children
Utrogestan is not intended for use in children.

Utrogestan and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any 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, inform 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 intended for vaginal administration. Food and drink do not affect treatment.

Pregnancy, breastfeeding and fertility

Utrogestan is used to support pregnancy during infertility treatment. Instructions for use are described in section 3 "How to use Utrogestan".
Breastfeeding women should not use Utrogestan.

Driving and operating machinery
Utrogestan has negligible influence on the ability to drive and operate machinery.

Utrogestan contains soybean lecithin
Patients who have been diagnosed with peanut or soy allergy should not use this medicine.

3. How to use Utrogestan

This medicine should always be used 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.
This medicine must not be taken orally. However, accidental oral intake does not lead to harmful effects, but only reduces the chances of becoming pregnant.

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

Treatment should begin on the day of embryo transfer.
The recommended daily dose is 200 mg of Utrogestan, administered in the morning, at lunchtime, and in the evening before bedtime, as directed by your doctor.
If laboratory tests confirm pregnancy, continue the same dosing regimen until the 7th to 12th week of pregnancy, as advised by your doctor.

Prevention of preterm birth in certain patients:

The recommended daily dose is 200 mg of Utrogestan, administered every evening before bedtime, starting at approximately week 20 of pregnancy until week 34 of pregnancy.

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

Missed dose of Utrogestan

If you forget to use a dose, administer 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.

4. Possible adverse reactions

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

vaginal discharge
vaginal bleeding
itching

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in the leaflet, inform a doctor, pharmacist or nurse. 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 helps to provide more information on the safety of the 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 stated month.
There are no special storage instructions.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer 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: purified sunflower oil and soybean lecithin. The other ingredients 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, yellowish soft capsule containing a white, oily suspension.
It is packaged in cardboard boxes containing PVC/Aluminium blisters with 14, 15, 21, 45, or 90 capsules.
For more detailed information, please contact the marketing authorisation holder or the parallel importer.
Marketing authorisation holder in the Netherlands, the country of export:
Besins Healthcare Netherlands B.V.
Oorsprongpark 12
3581 ET Utrecht
The Netherlands
Manufacturer:
Cyndea Pharma, S.L.
Poligono Industrial Emiliano Revilla Sanz
Avenida de Agreda, 31
Ólvega 42110 (Soria), 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
Marketing authorisation number in the Netherlands, the country of export: RVG 123999
Parallel import authorisation number: 6/22
This medicinal product is authorised for sale in the EEA countries 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