Prepidil

Package leaflet: Information for the user

Prepidil 0.5 mg/3 g endocervical gel

dinoprostone
Please read this leaflet carefully before this medicine is administered to you because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or nurse.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or nurse. See section 4.

Contents of this leaflet:

1. What Prepidil is and what it is used for
2. What you need to know before Prepidil is administered
3. How Prepidil is administered
4. Possible side effects
5. How to store Prepidil
6. Contents of the pack and other information

1. What Prepidil is and what it is used for

Prepidil contains the active substance dinoprostone, which belongs to a group of medicines called
oxytocics. Dinoprostone is a medicine similar to prostaglandin E2, a substance naturally produced
by the body when labour begins.
Prepidil is used to soften and dilate the cervix (cervix) when induction of labour is necessary.

2. What you need to know before Prepidil is administered

Prepidil must not be given to you

• if you are allergic to dinoprostone, to prostaglandins, or to any of the other ingredients of this medicine (listed in section 6);
• if you have previously undergone surgery on the uterus (caesarean section or surgical incision of the uterus);
• if the baby’s head is too large in relation to your pelvis;
• if you have previously experienced complicated deliveries;
• if you have already had six or more full-term deliveries;
• if the baby is in an unfavourable position for delivery;
• if you have experienced vaginal bleeding or discharge of unknown origin during pregnancy;
• if the baby’s heart rate is irregular;
• if, for you and your baby, the risk/benefit ratio favours surgical intervention.

Warnings and precautions
Please consult your doctor or nurse before Prepidil is administered if:

• you have heart or circulatory problems;
• you have liver or kidney problems;
• you have asthma;
• you suffer from glaucoma, i.e. high pressure within the eye;
• you are expecting more than one baby;
• your waters have broken;
• you are aged 35 years or older, have experienced complications during pregnancy, or your pregnancy has lasted longer than 40 weeks. Prepidil will be administered with caution because there is an increased risk of blood clot formation in blood vessels after delivery.

Before and during administration of Prepidil, your doctor will carefully monitor uterine activity, the baby’s heartbeat, and cervical dilation and thinning, to assess the effectiveness of the medicine and to prevent or minimize possible adverse effects.
Inform your doctor or nurse if you experience severe uterine pain, as this may be a sign of uterine wall rupture.
After administration of Prepidil, for unknown reasons, an involuntary termination of pregnancy may occur, and some of the fluid surrounding the fetus (amniotic fluid) may enter your bloodstream, triggering a severe and potentially fatal allergic-type reaction (Amniotic Fluid Embolism Syndrome).

Other medicines and Prepidil
Inform your doctor or nurse if you are taking, have recently taken, or might take any other medicine.
Prepidil increases the effects of oxytocin, a medicine used to induce labour and strengthen uterine contractions. Therefore, if you require both of these medicines, your doctor will know how to administer them.
Beta-mimetic medicines, used for asthma and certain heart conditions, reduce the effects of Prepidil.

Pregnancy and breastfeeding
Prepidil will only be administered during the late stages of pregnancy to induce labour.
After delivery, you may breastfeed normally.

3. How to administer Prepidil

Prepidil will be administered to you exclusively by qualified personnel in a hospital or clinic where equipment is available to monitor both you and your baby, under the supervision of experienced physicians.
Prepidil will be administered into the cervical canal of the uterus using a specific applicator. After administration, you must remain lying down for at least 10–15 minutes to prevent the medicine from leaking out of the cervical canal.
The recommended dose is 0.5 mg, corresponding to the entire contents of one pre-filled syringe. If the effect is insufficient, the dose may be repeated every 6 hours. The maximum recommended daily dose is 1.5 mg.
If you are given more Prepidil than you should have been
If you are given more Prepidil than you should have, you may experience an excessive increase in the intensity of labour pains and uterine contractions. Your doctor and healthcare staff will take action to reduce these unwanted effects.
If you have any doubts about the use of this medicine, consult your doctor or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them.
Side effects in the mother:

• allergic or anaphylactic reactions, including anaphylactic shock
• nausea and/or vomiting
• diarrhoea
• back pain
• increased frequency, intensity, or duration of contractions
• uterine wall rupture
• postpartum haemorrhage
• sensation of warmth in the vagina
• fever
• formation of blood clots in blood vessels (after childbirth)

Side effects in the baby:

• (frequency not known: frequency cannot be estimated based on available data): fetal death, delivery of a stillborn baby, and death of the newborn (neonatal death), particularly following serious events such as uterine rupture
• changes in the fetal heartbeat during labour and fetal distress
• reduced function of certain organs in the newborn after birth.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at: https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Prepidil

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and on the syringe after
"Exp.". The expiry date refers to the last day of that month.
Store in a refrigerator (2°C–8°C). Do not freeze.
Keep in the original packaging to protect the medicine from light.
Do not dispose of any medicine via wastewater or household waste. This will help protect the environment.

6. Package contents and other information

What Prepidil contains

• The active substance is dinoprostone. One pre-filled syringe contains 0.5 mg of dinoprostone.
• The other components are: anhydrous colloidal silica and triacetin.

Description of the appearance of Prepidil and contents of the pack
Prepidil is available in packs containing 1 single-use polyethylene pre-filled syringe with 3 g of gel + 1 applicator.

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
Pfizer Italia S.r.l.
via Isonzo, 71
04100 Latina
Manufacturer
PFIZER MANUFACTURING BELGIUM N.V.
Rijksweg 12
2870 Puurs
Belgium

The following information is intended exclusively for physicians or healthcare professionals:
Instructions for assembling the syringe and administration

1. Remove the protective cap (which will be used as a plunger extension)
2. Insert the protective cap into the syringe
3. Firmly attach the applicator to the syringe
4. Administer the contents of the syringe by slow extrusion into the cervical canal, close to the internal uterine orifice. After administration of the gel, the patient should remain in the supine position for 10–15 minutes to avoid leakage of the medicinal product from the cervical canal.

IMPORTANT
Use only the applicator provided.
Do not administer any gel remaining in the applicator.