Label: information for the user

Propess 10 milligrams vaginal delivery system

Dinoprostone

Read this label carefully before starting to use the medication, as it contains important information for you

-Keep this label, as you may need to read it again.

-If you have any questions, consult your doctor or pharmacist.

• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this label. See section 4.

-Propess should be administered by healthcare professionals under the supervision of a specialist.

1. What Propess is and how it is used

2. What you need to know before starting to use Propess

3. How to use Propess

4. Possible adverse effects

5. Storage of Propess

6. Contents of the package and additional information

Propess contains the active ingredient dinoprostone 10 mg and is used to help start the labor process, provided that 37 weeks of gestation have been completed. Dinoprostone dilates the cervix to allow the baby to be delivered. There are several reasons why assistance may be needed to start this process. Consult your doctor for more information.

No use Propess

Propess should not be used:

• if the head of your baby is too large and may cause any problems during delivery
• if your baby is not in the correct position inside the uterus for a normal delivery
• if your baby is not well or is suffering
• if you have had major surgery or a rupture of the cervix (uterus) previously
• if you have untreated inflammatory pelvic diseases (a uterine, ovarian, fallopian tube, and/or cervical infection)
• if the placenta blocks the birth canal
• if you have had vaginal bleeding during this pregnancy for unknown reasons
• if you have had a previous uterine operation, including a previous cesarean delivery
• if you are allergic (hypersensitive) to dinoprostone or any of the other components of Propess (listed in section 6)

Your doctor or midwife should not use Propess or, if they have already done so, should remove it:

• when labor has begun
• if they administer a medication, such as an oxytocic (uterine stimulant), to help progress labor
• if your contractions are very strong or prolonged
• if your baby begins to suffer

• if adverse effects appear (see 4. Possible adverse effects).

The experience with the use of Propess if the waters have broken is limited. Your doctor or midwife will remove it if you break your waters naturally or artificially.

Warnings and precautions

Please inform your doctor or midwife if any of the following occur:

• if you have or have had asthma (breathing difficulty) or glaucoma (an eye disease)
• if you have had strong or prolonged contractions in a previous pregnancy
• if you have any lung, liver, or kidney disease
• if you are carrying twins
• if you have given birth to more than three children
• if you are taking pain and/or anti-inflammatory medications that contain non-steroidal anti-inflammatory drugs (NSAIDs), such as aspirin
• if you are 35 years or older, if you have had complications during pregnancy such as diabetes, high blood pressure, and low thyroid hormone levels (hypothyroidism), or if the pregnancy exceeds 40 weeks, due to a higher risk of developing disseminated intravascular coagulation (DIC), a disease that affects blood coagulation.

Children and adolescents

Propess has not been investigated for use in girls and adolescents under 18 years old.

Use of Propess with other medications:

Please inform your doctor or pharmacist if you are using or have used recently other medications, including those obtained without a prescription. Propess may make you more sensitive to other medications belonging to the oxytocic group used to strengthen contractions. It is not recommended to administer these medications together with Propess.

Pregnancy and Lactation

Propess is used from the 38th week of gestation to help initiate the labor process. Propess should not be used in other stages of pregnancy.

Propess has not been investigated during lactation. Propess may be excreted in breast milk and colostrum, but it is expected that the level and duration will be very limited and will not interfere with breastfeeding. No effects have been observed in infants.

Driving and operating machinery

Not relevant since Propess should only be used in relation to delivery.

Propess will be administered by a trained healthcare professional in a hospital or clinic where facilities are available to monitor you and your baby.

The doctor or midwife will insert the vaginal release system into your vagina near the cervix. Do not attempt to do this yourself. Before applying Propess, the doctor or midwife will cover the vaginal release system with a small amount of gelatinous lubricant. Leave enough tape outside your vagina to facilitate the removal of the vaginal release system when necessary.

You must remain recumbent during the introduction of Propess and should remain in this position for 20-30 minutes.

After introduction, the vaginal release system absorbs moisture from the area, allowing dinoprostone to be released slowly.

Once the vaginal release system is in place to help initiate labor, your healthcare provider will monitor you periodically, including the following parameters:

• Cervical ripening
• Uterine contractions
• Labor pain and monitoring of your baby's health status

Your healthcare provider will decide how long you need to have Propess in place based on your progress. Propess can remain in place for a maximum of 24 hours.

When removing the product from your vagina, the vaginal release system will have expanded to 2-3 times its original size and will be flexible.

If you use more Propess than you should

If you have used Propess for longer than you should, there may be an increase in contractions or fetal distress. Propess, vaginal release system, should be removed immediately.

Like all medications, this medication may cause side effects, although not everyone will experience them.

Frequent: may affect up to 1 in 10 people

• Increased uterine contractions that may or may not affect the baby.
• The baby may experience distress and/orits heart rate may be faster or slower than normal.
• Decoloration of the amniotic fluid.

Rare: may affect up to 1 in 100

• Headache
• Decreased blood pressure
• The baby has difficultyesbreathing immediately after birth
• The baby has high levels of bilirubin in the blood, a waste product of red blood cells, which can cause yellowing of the skin and eyes.
• Itching
• Heavy vaginal bleeding after delivery
• The placenta separates from the uterine wall before the baby is born
• Decreased general condition of the newborn immediately after birth
• Prolonged labor process
• Inflammation of the membranes that line the inside of the uterus
• The uterus of the mother does not contract after delivery due to a lack of normal uterine contractions
• Burning sensation in the genital area
• Fever

Unknown frequency: the frequency cannot be estimated based on available data:

• Fetal death, stillbirth, and neonatal death (neonatal death); especially after severe events such as uterine rupture.
• Disseminated Intravascular Coagulation (DIC); a rare disease that affects blood coagulation causing clots and increasing the risk of bleeding after delivery.
• The fluid surrounding the baby during pregnancy can penetrate the mother's circulatory system during delivery and cause a condition called anaphylactoid syndrome of pregnancy, which may include symptoms such as: shortness of breath, low blood pressure, anxiety, and chills, problems that put life at risk with blood coagulation, seizures, coma, bleeding, and fluid in the lungs, fetal distress of the type low heart rate .
• Severe allergic reactions, including respiratory difficulties, shortness of breath, weak or rapid pulse, dizziness, itching, skin redness, and severe hives.
• Abdominal pain
• Nausea
• Vomiting
• Diarrhea
• Swelling of the genital area
• Uterine rupture

Reporting of adverse effects:

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is possible adverse effects that do not appear in this prospectus. You can also report them directly through the Spanish System of Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication

Keep out of sight and reach of children.

Do not use Propess after the expiration date shown on the packaging and the aluminum foil wrapper. The expiration date is the last day of the month indicated.

Store in a freezer (-10 to -25°C). Store in the original packaging to protect it from moisture.

Medicines should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the packaging and medicines you no longer need. This will help protect the environment.

Composition of Propess :

• The active ingredient is dinoprostona, commonly known as prostaglandin E 2. Each vaginal delivery system contains 10 milligrams of dinoprostona, which is released at approximately 0.3 milligrams per hour for 24 hours.
• The other components are: reticulated macrogol polymer (hydrogel) and polyester thread.

Appearance of the product and contents of the package

The vaginal delivery system is a small rectangular piece of plastic in a reticulated extraction system.

The plastic piece is a hydrogel polymer that swells in the presence of moisture, releasing the dinoprostona.

The extraction system has a long tape that allows the doctor or midwife to extract it when necessary.

Each vaginal delivery system is presented in an individual aluminum foil package made from a laminated aluminum strip and packaged in a container.

Container containing 5 vaginal delivery systems.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization:

FERRING S.A.U.

C/ del Arquitecto Sánchez Arcas nº 3, 1º

28040 Madrid, ESPAÑA.

Responsible for manufacturing:

Ferring GmbH

Wittland 11

24109 Kiel

Germany

This medicine is authorized in the member states of the European Economic Area and in the United Kingdom (Northern Ireland) with the following names:

Austria, PROPESS 10 mg vaginal delivery systems

Belgium, PROPESS 10 mg vaginal delivery system, PROPESS 10 mg vaginal delivery system, PROPESS 10 mg vaginal delivery system

Bulgaria, ????????? 10 mg ????????????????? ??????????? / PROPESS 10 mg vaginal delivery system

Croatia, Propess 10 mg vaginal delivery system

Cyprus, Propess

Czechia, CERVIDIL

Denmark, Propess, vaginal device

Estonia, Propess

Finland, Propess 10 mg vaginal delivery system, emättimeen

France, PROPESS 10 mg vaginal delivery system

Germany, PROPESS 10 mg vaginal delivery system

Greece, PROPESS 10 mg ??????????? ???????????

Hungary, Propess 10mg hüvelyben alkalmazott gyógyszerleadó rendszer

Ireland, Propess 10 mg vaginal delivery system

Italy, PROPESS 10 mg – Vaginal device

Latvia, Propess

Lithuania, Propess

Luxembourg, PROPESS 10 mg vaginal delivery system

Netherlands, Propess, vaginal delivery system 10 mg

Norway, Propess

Poland, Cervidil

Portugal, PROPESS 10 mg, vaginal delivery system

Romania, PROPESS 10 mg/24 ore vaginal delivery system

Slovakia, Cervidil 10 mg vaginal device

Slovenia, Propess 10mg vaginal delivery system

Spain, PROPESS 10 mg vaginal delivery system

Sweden, Propess 10 mg vaginal device

United Kingdom (Northern Ireland), PROPESS 10mg vaginal delivery system

Last review date of this leaflet: September 2021.

----------------------------------------------------------------------------------------------------------------------

The following information is intended only for medical professionals or healthcare professionals:

INSTRUCTIONS FOR USE

Application

Extraction

Propess can be quickly and easily removed by gently pulling on the tape. After removal, check that the complete product (vaginal delivery system and extraction system) has been removed from the vagina.