Utrogestan

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
Progesteronum
Please read all of this leaflet carefully before using this medicine because it contains important information for you.

• Keep this leaflet so that you can read it again if necessary.
• 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. It 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 or pharmacist. See section 4.

Table of contents of the leaflet

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
Support 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) programme.
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 liver function disorders;
• If the patient has jaundice (yellowing of the skin or eyes);
• If the patient has unexplained vaginal bleeding;
• 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 thromboembolism), for example in the legs (deep vein thrombosis) or lungs (pulmonary embolism);
• If the patient has previously experienced 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 membranes have ruptured ("water has broken").

Do not use Utrogestan if any of the above situations apply to the patient.
If in doubt, discuss with a doctor or pharmacist before using Utrogestan.

Warnings and precautions

Utrogestan is not a contraceptive.

If the patient suspects she may have had a miscarriage, she should speak to her doctor, as treatment with 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 single pregnancy

The doctor will discuss with the patient the risks and benefits of the 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 membranes rupture while taking this medicine, she must contact her doctor immediately. Such a 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 symptom 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 the doctor or pharmacist about all medicines the patient is currently taking, has recently taken, or plans to take, including over-the-counter medicines, including herbal medicines. This is because Utrogestan may affect the action of some 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 is administered vaginally. Food and drink do not affect treatment.

Pregnancy, breastfeeding and fertility

• Utrogestan is used as an adjunct 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 operating machinery

Utrogestan has no or negligible influence on the ability to drive and operate 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 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 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 begin no later than the third day after oocyte retrieval.
• The recommended daily dose is 600 mg of Utrogestan, administered according to your doctor's instructions. Insert one capsule deeply into the vagina in the morning, at midday, and at bedtime.
• If laboratory tests confirm that the patient is pregnant, continue the same dosing regimen until at least week 7 of pregnancy, but no longer than until week 12 of pregnancy, as directed by your doctor.

Prevention of preterm birth in certain patients:

• The recommended dose is 200 mg of Utrogestan administered daily in the evening before bedtime, from approximately week 20 of pregnancy until week 34 of pregnancy.

Taking more Utrogestan than recommended
If you have used more Utrogestan than recommended, speak to your doctor or go to the hospital.
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 forgotten dose.

Stopping Utrogestan
Before stopping this medicine, talk to your doctor, pharmacist, or nurse. If you stop using this medicine, it may 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
• vaginal bleeding
• burning sensation

Within 1–3 hours after taking the medicine, the patient may experience temporary fatigue or dizziness.
Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform a doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring of Adverse Drug Reactions 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 adverse reactions enables further information on the safety of this medicine to 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.
• Do not store above 25°C.
• 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 required. This will help protect the environment.

6. Contents of the package 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 ingredients contained in the capsule shell are gelatin, glycerol, and titanium dioxide (E 171).

What Utrogestan looks like and contents of the pack
Utrogestan is oval, yellowish soft capsules containing a white, oily suspension.
It is packed in cardboard boxes containing blisters with 15, 30, 45, or 90 capsules.
For further information, please contact the Marketing Authorisation Holder or the Parallel Importer.
Marketing Authorisation Holder in Greece, the country of export:
Angelini Pharma Hellas Α.Β.Ε.Ε., 4 Roupel & 17 km Athens-Lamia Nat. Rd.
145 64 Nea Kifisia, Greece
Manufacturer:
Cyndea Pharma S.L., Polígono Industrial Emiliano Revilla Sanz
Avenida de Ágreda, 31, Olvega 42110 (Soria), Spain
Parallel Importer:
InPharm Sp. z o.o., ul. Strumykowa 28/11, 03-138 Warsaw, Poland
Repackaged in:
InPharm Sp. z o.o. Services sp. k., ul. Chełmżyńska 249, 04-458 Warsaw, Poland
Marketing Authorisation Number in Greece, the country of export: 30971/6-3-2020
Parallel Import Authorisation Number: 423/22
This medicinal product is authorised 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