Cervidil

Patient Information Leaflet

Cervidil, 10 mg, vaginal insert
Dinoprostone
Please read this leaflet carefully before using this medicine, as it contains
important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, please ask your doctor or nurse.
• If you experience any side effects, including any not listed in this leaflet, please inform your doctor or nurse. See section 4.
• Cervidil should only be used under the supervision of an appropriately qualified specialist.

Contents of the leaflet:

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

1. What Cervidil is and what it is used for

Cervidil contains the active substance dinoprostone 10 mg and is used to help initiate the process of labour, provided that 37 weeks of pregnancy have been completed. Dinoprostone helps to ripen the cervix—the part of the birth canal known as the cervix uteri—to allow the baby to pass through. There may be several reasons why a woman might need assistance in starting this process. Please ask your doctor if you would like further information.

2. Important information before using Cervidil

When not to use Cervidil
Cervidil must not be administered:

• if the size of the baby's head may cause any problems during delivery
• if the baby is not positioned correctly in the uterus for vaginal delivery
• if the baby's health condition is unsatisfactory and (or) if the baby is at risk
• if the patient has previously undergone serious surgery or rupture of the cervix
• if the patient has untreated pelvic inflammatory disease (infection of the uterus, ovaries, fallopian tubes and (or) cervix)
• if the placenta covers the birth canal
• if the patient has had unexplained vaginal bleeding during the current pregnancy
• if the patient has previously undergone uterine surgery, including caesarean sections
• if the patient is allergic to dinoprostone or any of the other ingredients of this medicine (listed in section 6).

The doctor or nurse will not use Cervidil or will remove it if already applied:

• after the onset of labour
• if the patient requires administration of a drug, e.g. a drug containing oxytocin, to support progress in labour
• if contractions are too strong or prolonged
• if the baby is at risk
• if the patient experiences adverse reactions (see section 4. Possible side effects).

Experience with the use of Cervidil in patients with ruptured membranes is limited. If Cervidil has already been administered, the doctor or nurse will remove the medication when the membranes rupture or if their rupture is planned by the doctor or nurse.

Warnings and precautions
Before starting treatment with Cervidil, inform your doctor or nurse if any of the following apply to you:

• if the patient has or has ever had asthma (difficulty breathing) or glaucoma (eye disease)
• if the patient experienced overly strong or prolonged contractions in a previous pregnancy
• if the patient has a lung, liver or kidney disease
• if the patient is carrying more than one baby
• if the patient has had more than three full-term deliveries
• if the patient is taking a pain-relieving and (or) anti-inflammatory medicine containing non-steroidal anti-inflammatory drugs (also known as NSAIDs), e.g. aspirin
• if the patient is 35 years of age or older, if complications occurred during pregnancy such as diabetes, high blood pressure and low thyroid hormone levels (hypothyroidism), or if the pregnancy has lasted longer than 40 weeks due to increased risk of developing disseminated intravascular coagulation – a rare disorder affecting blood clotting.

Children and adolescents
The use of Cervidil in children and adolescents under 18 years of age has not been studied.

Cervidil with other medicines
Tell your doctor or nurse about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.
Cervidil may make the patient more sensitive to drugs belonging to the class of uterotonic agents used to enhance contractions. Concomitant administration of these drugs with Cervidil is not recommended.

Pregnancy and breastfeeding
Cervidil is used to facilitate the onset of labour at term. Cervidil should not be used at other stages of pregnancy. The use of Cervidil during breastfeeding has not been studied.
Cervidil may pass into breast milk, but it is believed that the amount and duration of passage are limited and should not interfere with breastfeeding. No effects have been observed in breastfed newborns.

Driving and using machines
Not applicable, as Cervidil is used exclusively in connection with childbirth.

3. How to use Cervidil

Cervidil will be administered to the patient by trained medical personnel in a hospital or clinic equipped with monitoring devices for assessing the patient's and her baby's condition.
The doctor or nurse will insert one vaginal insert (vaginal pessary) into the patient's vagina near the cervix. The patient will not do this herself. Before insertion, the doctor or nurse may lubricate the vaginal insert with a small amount of lubricating gel. A retrieval thread of appropriate length will remain outside the vagina to facilitate removal of the vaginal insert when necessary.

The patient will lie down during this procedure and will be required to remain lying down for approximately 20–30 minutes after insertion of the Cervidil vaginal insert.

After insertion, the vaginal insert absorbs moisture, allowing for the slow release of dinoprostone.

While the vaginal insert remains in the vagina to assist in initiating labour, the patient will be monitored regularly, including for:

• cervical dilation,
• uterine contractions,
• labour pains and the baby's health condition.

Depending on the progress of labour, the doctor or nurse will decide how long Cervidil should remain in the vagina. Cervidil may remain in the vagina for up to 24 hours.

When removed, the vaginal insert will be 2–3 times larger than its original size and will be flexible.

Use of Cervidil for longer than recommended
If Cervidil is used for longer than recommended, it may lead to excessive uterine contractions or risk to the baby. In such cases, the Cervidil vaginal insert will be removed immediately.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although they do not occur in everyone.

Common: may affect up to 1 in 10 patients:

• Increased uterine contractions, with or without effect on the baby
• The baby's health may be affected and (or) the baby's heartbeat may be faster or slower than normal
• Change in the colour of the amniotic fluid

Uncommon: may affect up to 1 in 100 patients:

• Headache
• Low blood pressure
• The newborn has difficulty breathing immediately after birth
• The newborn has high levels of bilirubin, a breakdown product of red blood cells, which may cause yellowing of the skin and eyes
• Itching
• Excessive vaginal bleeding after childbirth
• The placenta separates from the uterine wall before the baby is born
• Reduced general condition of the newborn immediately after birth
• Slow progress of labour
• Inflammation of the membranes lining the inside of the uterus
• The mother's uterus does not contract after childbirth due to lack of normal uterine contractions
• Burning sensation in the genital area
• Fever

Frequency not known: frequency cannot be estimated from the available data:

• Fetal death, stillbirth and neonatal death; especially after severe events such as uterine rupture.
• Disseminated intravascular coagulation – a rare disorder affecting blood clotting. This may lead to blood clots forming and may increase the risk of bleeding.
• Amniotic fluid, which surrounds the baby during pregnancy, may enter the mother's bloodstream during delivery and block blood vessels, leading to a condition called amniotic fluid embolism, which may include symptoms such as: shortness of breath, low blood pressure, restlessness and chills; life-threatening blood clotting disorders, seizures, coma, bleeding and fluid in the lungs, threat to the fetus's life such as slow heart function.
• Hypersensitivity reactions and severe allergic reactions (anaphylactic reaction), which may include: difficulty breathing, shortness of breath, weak and rapid pulse, dizziness, itching, redness of the skin and rash.
• Abdominal pain
• Nausea
• Vomiting
• Diarrhoea
• Itching in the genital area
• Rupture of the uterine muscle

Reporting of adverse effects
If any adverse effects occur, including any not listed in this leaflet, inform your doctor or nurse. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Aleje Jerozolimskie 181C, 02-222 Warsaw
Tel: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse effects can also be reported to the marketing authorization holder.
Reporting adverse effects helps to provide more information on the safety of the medicine.

5. How to store Cervidil

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the foil sachet and cardboard box following the EXP label. The expiry date refers to the last day of the stated month. The batch number is indicated after the label (Lot).
Store in a freezer (from -10°C to -25°C). Store in the original packaging to protect from moisture.
Medicines must not be disposed of via the sewage system or household waste. After use, the doctor or nurse will dispose of the entire product as clinical waste. This will help protect the environment.

6. Contents of the pack and other information

What Cervidil contains

• The active substance is dinoprostone, also known as Prostaglandin E. Each vaginal therapeutic system contains 10 mg of dinoprostone, which is released at a rate of approximately 0.3 mg per hour over 24 hours. The other ingredients are:
• Hydrogel polymer containing: macrogol 8000, 1,2,6-hexanetriol, 4,4’-diisocyanate cyclohexylmethane, iron chloride
• Polyester thread

What Cervidil looks like and contents of the pack
The vaginal therapeutic system is a small, rectangular plastic insert placed in a knitted fabric applicator used for removing the insert from the vagina. The plastic insert is a hydrogel polymer that swells in the presence of moisture and releases dinoprostone. The applicator has a long tape that allows the physician or nurse to remove the insert from the vagina when necessary.
Each vaginal therapeutic system is individually enclosed in a sealed foil sachet made from laminated aluminium/polyethylene film and is packed in a cardboard box.
The pack contains 5 vaginal therapeutic systems.

Marketing Authorisation Holder
Ferring GmbH
Wittland 11
D-24109 Kiel
Germany

Manufacturers
Ferring GmbH
Wittland 11
D-24109 Kiel
Germany

This medicinal product is authorised in the European Economic Area countries and in the United Kingdom (Northern Ireland) under the following names:
Austria PROPESS 10 mg vaginales Freisetzungssystem
Belgium PROPESS 10 mg hulpmiddel voor vaginaal gebruik, PROPESS 10 mg système de diffusion, PROPESS 10 mg vaginales Wirkstofffreisetzungssystem
Bulgaria ПРОПЕС 10 mg вагинална лекарстводоставяща система / PROPESS 10 mg vaginal delivery system
Croatia Propess 10 mg sustav za isporuku u rodnicu
Cyprus Propess
Denmark Propess, vaginalindlæg
Estonia Propess
Finland Propess 10 mg depotlääkevalmiste, emättimeen
France PROPESS 10 mg, système de diffusion vaginale
Greece PROPESS 10 mg σύστημα ενδοκολπικής χορήγησης
Spain PROPESS 10 mg sistema de liberación vaginal
Netherlands Propess, vaginaal toedieningssysteem 10 mg
Ireland Propess 10 mg vaginal delivery system
Lithuania Propess
Luxembourg PROPESS 10 mg système de diffusion vaginale
Latvia Propess
Germany PROPESS 10 mg vaginales Freisetzungssystem
Norway Propess
Poland Cervidil
Portugal PROPESS 10 mg, Sistema de libertação vaginal
Czech Republic CERVIDIL
Romania PROPESS 10 mg/24 ore sistem cu cedare vaginală
Slovakia Cervidil 10 mg vaginálny inzert
Slovenia Propess 10 mg vaginalni dostavni sistem
Sweden Propess 10 mg vaginalinlägg
Hungary Propess 10mg hüvelyben alkalmazott gyógyszerleadó rendszer
United Kingdom PROPESS 10 mg vaginal delivery system
(Northern Ireland)
Italy PROPESS 10 mg – Dispositivo vaginale

Information intended exclusively for medical professionals:

INSTRUCTIONS FOR USE
Insertion

1. To remove Cervidil from its packaging, first tear the foil along the top edge of the pouch. Do not use scissors or sharp instruments to cut the foil, as this may damage the product. Grasp the applicator and gently remove the product from the pouch. Holding the vaginal insert system between the index and middle fingers, insert it into the vagina. If necessary, a small amount of water-soluble lubricant may be used.
2. Cervidil should be placed transversely, high in the posterior vaginal fornix.
3. Leave approximately 2 cm of the retrieval string protruding from the vagina to ensure easy removal of the vaginal insert system. The retrieval string may be shortened further if necessary.
4. The patient should remain lying down or sitting for 20–30 minutes after insertion to allow the insert to swell.

Removal
Cervidil can be quickly and easily removed by gently pulling the applicator's retrieval string.
After removal, ensure that the entire product (the vaginal insert system and applicator) has been removed from the vagina.