PREPIDIL 0,5 МГ/3 Г Вагинальный гель

Содержание инструкции

1. Prepidil 0.5 mg/3 g endocervical gel
   1. What is Prepidil and what is it used for
   2. What you need to know before Prepidil is given to you
   3. How to administer Prepidil
   4. Possible side effects
   5. How to store Prepidil
   6. Contents of the pack and other information

Prepidil 0.5 mg/3 g endocervical gel

dinoprostone

Read this leaflet carefully before this medicine is administered as 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 any side effects occur, including those not listed in this leaflet, ask 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 to administer 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 contains the active ingredient dinoprostone, which belongs to a group of medicines called
oxytocics. Dinoprostone is a medicine similar to prostaglandin E2, a substance produced
naturally by the body when labour begins.
Prepidil is used to soften and dilate the cervix when it is necessary to induce
labour.

2. What you need to know before Prepidil is given to you

Prepidil will 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 had previous 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 had complicated deliveries;
• if you have previously had six or more full-term deliveries;
• if the baby is in an unfavourable position for delivery;
• if you have had bleeding or vaginal discharge of unknown origin during pregnancy;
• if the baby's heart rate is irregular;
• if the risk/benefit ratio for you and the baby is in favour of surgical intervention.

Warnings and precautions
Talk to your doctor or nurse before you are given Prepidil if:

• you have heart or blood circulation problems;
• you have liver or kidney problems;
• you have asthma;
• you suffer from glaucoma, i.e. high pressure inside the eye;
• you are about to have more than one baby
• your waters have broken
• you are 35 years of age or older, have had complications during pregnancy or your pregnancy has lasted more than 40 weeks. Prepidil will be given to you with caution because there is a greater risk of blood clot formation in blood vessels after delivery.

Before and during the administration of Prepidil, the doctor will carefully monitor the activity of the uterus, the
baby's heartbeat, the dilation and thinning of the cervix, to verify
the effectiveness of the medicine and prevent or minimize possible side effects.
Tell your doctor or nurse if you experience very intense uterine pain, as this could be
a symptom of a rupture of the uterine wall.
Following the administration of Prepidil, it is possible that, for unknown reasons, an
involuntary interruption of pregnancy may occur and that some of the fluid surrounding the fetus (amniotic
fluid) enters your bloodstream, triggering a severe and potentially
fatal allergic reaction (Pregnancy Anaphylactoid Syndrome).

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

Pregnancy and breastfeeding
Prepidil will only be given to you in the final stages of pregnancy to induce labour.
After delivery you can 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 you and your baby, under the supervision of experienced physicians.
Prepidil will be administered into the cervical canal of the uterus using a special applicator. After
administration, you must remain lying down for at least 10-15 minutes to prevent leakage of the
medicine from the cervical canal.
The recommended dose is 0.5 mg, corresponding to the entire contents of a prefilled syringe. In case of
insufficient effect, the dose may be repeated every 6 hours. The maximum recommended daily dose is
1.5 mg.

If you are given too much Prepidil
If you are given too much Prepidil, you may experience an excessive increase
in the intensity of labor pains and uterine contractions. The doctor and healthcare personnel will intervene
to reduce these undesirable 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 everybody gets them.

Side effects in the mother:

• allergic or anaphylactic reactions, including anaphylactic shock
• nausea and/or vomiting
• diarrhea
• back pain
• increased frequency, intensity or duration of contractions
• laceration of the uterine wall
• postpartum hemorrhage
• feeling of heat in the vagina
• fever
• formation of blood clots in blood vessels (after delivery)

Side effects in the baby:

• (frequency not known: the frequency cannot be defined based on available data): fetal death, delivery of a stillborn fetus and neonatal death (neonatal mortality), especially following serious events such as uterine laceration
• alteration of the fetal heart rate during labor and fetal distress
• reduction of the function of some organs of the newborn after birth.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, please tell your
doctor or pharmacist. You can also report side effects directly through 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 sight and reach of children.
Do not use this medicine after the expiry date which is stated on the pack 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.
Store in the original package to protect the medicine from light.
Do not dispose of any medicine in wastewater or household waste. This will help to protect
the environment.

6. Contents of the pack and other information

What Prepidil contains

• The active substance is dinoprostone. A pre-filled syringe contains 0.5 mg of dinoprostone.
• The other ingredients 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 pre-filled syringe in polyethylene containing 3 g
of gel + 1 applicator.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Pfizer Italia S.r.l.
via Isonzo, 71
04100 Latina

Manufacturer
PFIZER MANUFACTURING BELGIUM N.V.
Rijksweg 12
2870 Puurs
Belgium
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The following information is intended exclusively for doctors or healthcare professionals:
Instructions for assembling the syringe and administration

• 1. Remove the protective cap (which will serve as an extension for the plunger)
• 2. Insert the protective cap into the syringe
• 3. Firmly insert the applicator onto the syringe
• 4. Administer the contents of the syringe by slow extrusion into the cervical canal just before the internal cervical os. After administration of the gel, the patient should remain in a supine position for 10-15 minutes to prevent leakage of the medicine from the cervical canal.

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