Prepidil

Package Leaflet: Information for the User

Prepidil 500 μg/3 g, cervical gel
Dinoprostonum

Read the package leaflet carefully before using the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, or if any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

Table of Contents of the Leaflet:

• 1. What is Prepidil and what is it used for
• 2. Important information before using Prepidil
• 3. How to use Prepidil
• 4. Possible side effects
• 5. How to store Prepidil
• 6. Contents of the pack and other information

1. What is Prepidil and what is it used for

Prepidil is used to help induce labor at term when this is necessary for obstetric or medical reasons. Dinoproston is a prostaglandin with a luteolytic effect. Prostaglandins can stimulate the contraction of smooth muscle organs and modulate the response of these organs to hormonal stimuli.

2. Important information before using Prepidil

When not to use Prepidil:

• if you are allergic to prostaglandins or any of the other ingredients of this medicine (listed in section 6).
• if you have contraindications to the use of drugs that stimulate uterine contractions or for which prolonged uterine contractions are not recommended, for example in the following cases:
• high-order multiple pregnancy (six or more reported pregnancies),
• delayed engagement of the fetal head,
• previous uterine surgery, such as cesarean section or hysterectomy,
• cephalopelvic disproportion,
• acute obstetric conditions in which the benefit-to-risk ratio for the fetus or mother favors surgical intervention,
• fetal presentation other than cephalic,
• clinical suspicion of early fetal distress based on fetal heart rate monitoring,
• infection of the lower genital tract,
• undiagnosed vaginal discharge and/or abnormal vaginal bleeding during pregnancy,
• difficult and/or traumatic delivery in history,
• presenting part above the pelvic inlet,
• active heart, lung, kidney, or liver disease,
• placenta previa.

Warnings and precautions

Prepidil should only be used in hospitals and clinics with specialized obstetric units and only when 24-hour medical care is ensured. Before and during its administration, careful monitoring of uterine contractions, fetal status, and cervical characteristics (dilation, effacement, and dilation) is necessary to detect any adverse reactions, such as excessive uterine stimulation, prolonged uterine contractions, or fetal distress. In patients with a history of uterine hypertonus or hypercontractility, the doctor should recommend continuous monitoring of contractions and maternal and fetal status. Caution is required when administering Prepidil to patients with circulatory, hepatic, or renal disorders, asthma, glaucoma (or increased intraocular pressure), epilepsy, hypertension, ruptured membranes, or multiple pregnancy. In the event of prolonged strong contractions, the risk of uterine rupture should always be considered. Before using Prepidil, the cervicovaginal proportions should be carefully evaluated. Treatment of patients with excessive uterine tone or hypercontractility, or those with concerns about fetal heart rate, should aim to maintain good maternal and fetal status. As with all substances with an effect similar to oxytocin, in the event of excessive activity or abnormal uterine pain, the possibility of uterine rupture should be considered. A consequence of uterine rupture may be the entry of fetal tissue into the maternal circulation, which can lead to an anaphylactoid reaction. The use of exogenous prostaglandins may enhance the response to oxytocin. Prepidil gel should not be applied above the internal cervical os, as excessive uterine stimulation has been observed with extra-amniotic administration.

Other medicines and Prepidil

Prostaglandins enhance the effect of oxytocin on the uterus, so they should not be administered simultaneously. If these drugs are used sequentially, close monitoring of the patient is recommended. The recommended time interval between intravenous oxytocin administration and Prepidil use is 6 to 12 hours. You should tell your doctor about any alcohol consumption and all medicines you are currently taking or have recently taken, as well as any medicines you plan to take. You should consult your doctor about the possibility of using Prepidil and other medicines simultaneously.

Using Prepidil in patients with renal or hepatic impairment

Patients with severe renal or hepatic disease associated with metabolic disorders should be closely monitored.

Prepidil with food and drink

You should inform your doctor about any alcohol consumption.

Pregnancy and breastfeeding

Prepidil is used only in pregnancy to help induce labor.

3. How to use Prepidil

Prepidil is intended for use only under the supervision of a doctor in hospitals and clinics equipped with facilities for monitoring the patient and her child. The dose and frequency of administration are determined by the doctor. In case of doubts, you should consult your doctor. (See Information intended for healthcare professionals only).

4. Possible side effects

Like all medicines, Prepidil can cause side effects, although not everybody gets them. The frequency and severity of side effects of Prepidil are dose-dependent and, to some extent, also dependent on the route of administration. During the use of Prepidil, the following side effects have been observed:
In the mother:

• hypersensitivity reactions (e.g., anaphylactic reaction, anaphylactic shock, anaphylactoid reaction),
• abnormal uterine contractions (occurring with increased frequency, increased intensity, and prolonged duration) with or without changes in fetal heart rate,
• hypertension,
• cardiac arrest,
• uterine rupture,
• nausea, vomiting, and diarrhea,
• pulmonary embolism/amniotic fluid embolism,
• short wheezes heard over the lungs,
• bronchospasm/asthma,
• dyspnea,
• feeling of chest compression,
• cough,
• back pain,
• placental abruption,
• sudden cervical dilation,
• fever,
• feeling of heat, pain, irritation in the vagina,
• rash. In patients, there may be an increase in body temperature and white blood cell count; these symptoms resolve after the end of treatment.

In the fetus/newborn:

• fetal distress/fetal heart rate abnormalities during or after treatment with Prepidil,
• premature birth,
• fetal death, stillbirth, neonatal death; especially after severe side effects, such as uterine rupture,
• neonatal assessment score less than 7 points on the Apgar scale,
• fetal acidosis.

As with any other intravaginally administered drug, there is a risk of local infections following extra-amniotic administration of Prepidil. In the event of an infection, appropriate treatment should be initiated. Other side effects not listed above may occur with the use of Prepidil.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, you should inform your doctor. Side effects can be reported directly to the Department of Drug Safety, 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. Side effects can also be reported to the marketing authorization holder or its representative. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Prepidil

Store in a refrigerator (2°C - 8°C).
Keep out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton after EXP. The expiry date refers to the last day of that month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

What Prepidil contains

• The active substance is dinoproston (dinoprostonum).
• The other ingredients are colloidal silicon dioxide, glycerol triacetate.

What Prepidil looks like and contents of the pack

3 g of gel in a plastic syringe placed in a sterile pack and a plastic catheter placed in a sterile pack, in a cardboard box.

Marketing authorization holder:

Pfizer Europe MA EEIG, Boulevard de la Plaine 17, 1050 Bruxelles, Belgium

Manufacturer:

Pfizer Manufacturing Belgium NV, Rijksweg 12, 2870 Puurs-Sint-Amands, Belgium
To obtain more detailed information about this medicine, you should contact the representative of the marketing authorization holder:
Pfizer Polska Sp. z o.o.
tel. 22 335 61 00

Date of last revision of the leaflet: 08/2024

Information intended for healthcare professionals only:

To administer the medicine correctly, the patient should be in a supine position and have a vaginal speculum in place. The entire contents of the syringe (500 μg dinoproston = 3 g Prepidil) should be injected in a sterile manner into the cervical canal using the plastic catheter provided with the pack. Prepidil should not be administered above the internal cervical os. After administration of the gel, the patient should remain in a supine position for at least 15 minutes to minimize gel leakage. The contents of the syringe are intended for use in a single patient only. Do not attempt to administer a small amount of gel remaining in the plastic catheter. Avoid contact of the medicine with the skin and wash your hands after application. After use, the syringe, plastic catheter, and any unused parts of the pack should be disposed of in accordance with local regulations. INSTRUCTIONS FOR USE OF THE SYRINGE Remove the sterile plastic catheter and sterile syringe from the outer packaging.

• 1. Remove the protective cap (the cap will serve as an extension of the plunger).
• 2. Insert the cap into the syringe.
• 3. Firmly attach the free end of the sterile, plastic catheter to the end of the syringe. Proper attachment of the end will be confirmed by a clicking sound. Then, begin administering the gel.

In case of overdose of Prepidil

Prepidil is available only in single-dose packs, so symptoms of overdose may occur only in patients with hypersensitivity to the medicine. Symptoms of overdose may include: excessive uterine stimulation or abnormal, intense, or frequent uterine contractions, which may lead to fetal distress. In case of overdose, symptomatic treatment should be used. If prolonged excessive uterine stimulation and/or fetal distress occur after discontinuation of Prepidil, administration of a beta-mimetic agent may be beneficial. If symptomatic treatment is ineffective, immediate delivery is indicated.

Explanation of symbols on the catheter packaging

STERILE ENDOCERVICAL CATHETER – sterile catheter for the cervix

Medical device

Single sterile barrier system, sterilized by radiation

For single use only

Do not re-sterilize

Do not use if packaging is damaged

Expiration date of the catheter

Batch number of the catheter

Manufacturer of the catheter