Skip to Content

UK Edition. Click here for US version.

MYSODELLE 200 MICROGRAMS VAGINAL DELIVERY SYSTEM

Active substance(s): MISOPROSTOL

View full screen / Print PDF » Download PDF ⇩
Transcript
Misoprostol

information for you.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your doctor or nurse.
- If you get any side effects, talk to your doctor or nurse. This includes any possible side effects not listed in this
See section 4.

NO TEXT IN THIS FIELD

NO TEXT IN THIS FIELD

Mysodelle® 200 micrograms vaginal delivery system

1. What Mysodelle is and what it is used for
2. What you need to know before you are given Mysodelle
3. How you are given Mysodelle
4. Possible side effects
5. How to store Mysodelle
6. Contents of the pack and other information
1. What Mysodelle is and what it is used for
Mysodelle contains the active substance misoprostol.
Mysodelle is used to help start the birth process from 36 weeks of
pregnancy.
Misoprostol belongs to a group of medicines called prostaglandins. Prostaglandins have two actions during labour. One is to
soften the mouth of the womb (cervix) so that the baby can more
easily be born through the vagina. The second is to cause contractions to start, which will help push the baby out of the womb
(uterus). There could be several reasons why you might need help
to start this process. Ask your doctor if you want more information.
2. What you need to know before you are given Mysodelle
Do not use Mysodelle:
- if you are allergic to misoprostol or any of the other ingredients
of this medicine (listed in section 6)
- if labour has started
- if your baby is not in good health and/ or is distressed
- if oxytocic drugs (medicines used to facilitate birth) and/or
other medicines to induce labour are being given (see
“Warnings and precautions” and “Other medicines and
Mysodelle” below)
- if you have had previous cervical or womb surgery including a
previous Caesarean birth for any earlier babies
- if you have any womb abnormality such as “heart-shaped”
uterus (bicornate uterus)
- if your placenta is covering the birth canal (placenta praevia) or
if you have had any unexplained vaginal bleeding after the 24th
week of this pregnancy
- if your baby is not in the correct position in the womb to be
born naturally (fetal malpresentation)
- if you have any signs or symptoms of
of the
waters that surround your baby (chorioamnionitis), unless
treatment has already been given
- if you are less than 36 weeks pregnant.
Warnings and precautions
Mysodelle should only be used under the supervision of an
appropriate specialist.
Your doctor or nurse will carefully monitor womb activity, status
of your baby and changes in the neck of the womb (cervix) when
Mysodelle is in place.
Mysodelle can cause strong womb stimulation if left in place
after onset of labour (see “If you use more Mysodelle than you
should” below).
In case the womb contractions are prolonged or strong or your
doctor or nurse is concerned for you or your baby, Mysodelle will
be removed. If the womb contractions continue after removal of
Mysodelle, tocolytic treatment may be given which will slow
down your contractions.
The effects of Mysodelle have not been studied in women with
severe pre-eclampsia (a condition where pregnant women suffer
from high blood pressure, protein in the urine and possibly other
complications).
Mysodelle has not been studied in women whose waters
have been broken for more than 48 hours prior to insertion of
Mysodelle. Please tell your doctor or if you think your waters
might have broken (premature rupture of your membranes).
If you have an infection (Group B Streptococcus) that requires
preventive antibiotic therapy, the antibiotic treatment may be
given to you at the same time as Mysodelle or earlier so that you
and your baby are treated before birth. If you know you have an
infection, please tell your doctor or nurse.
If your doctor
that treatment with oxytocin (medicine used
to facilitate birth) should be started, Mysodelle must be removed
by the doctor or nurse at least 30 minutes prior to oxytocin
adminstration (see “Do not use Mysodelle” above and “Other
medicines and Mysodelle” below).
A second dose of Mysodelle is not recommended, as the effects
of a second dose have not been studied.
An increased risk of disseminated intravascular coagulation (severe bleeding) after delivery has been described in patients whose
labour has been induced by any method.

There is no experience with the use of Mysodelle to start the birth
process in women who are pregnant with more than one baby and
there is no experience with the use of Mysodelle in women who
have had more than 3 previous babies delivered vaginally after 24
weeks of pregnancy.
Mysodelle is only used if you have a medical reason for needing
help to start the birth process.
Other medicines and Mysodelle
Tell your doctor or nurse if you are using, have recently used or
might use any other medicines. Some other medicines may
ence the effect of Mysodelle.
Mysodelle must not be given at the same time as oxytocic drugs
(medicines used to facilitate birth) and/or other medicines to help
start labour (see “Do not use Mysodelle” and “Warnings and
precautions” above).
Pregnancy and breast-feeding
Mysodelle is used to help start labour from week 36 of the
pregnancy. Mysodelle should not be used at other phases of
pregnancy.
Misoprostol acid may be excreted in colostrum (the
excreted
by the breasts for the
3 – 4 days after delivery) and breast
milk, but the level and duration is expected to be very limited and
should not hinder breast-feeding.
Fertility
Fertility will not be affected by use of Mysodelle to help start the
birth process from 36 weeks of pregnancy.
Mysodelle contains Butylated hydroxyanisole
Mysodelle contains butylated hydroxyanisole which is used as an
antioxidant that preserves the product. It is only present in trace
amounts. Butylated hydroxyanisole can cause skin reactions (e.g.
contact dermatitis), or irritation to the eyes and mucous membranes.
3. How you are given Mysodelle
The recommended dose is one Mysodelle vaginal delivery system
which contains 200 micrograms of misoprostol. The active
ingredient, misoprostol, is released at an average rate of approximately 7 micrograms per hour over a 24 hour period.
Your doctor or nurse will place one Mysodelle in your vagina
next to the neck of your womb (cervix). You will not do this
yourself. Your doctor or nurse may coat Mysodelle with a small
amount of lubricating jelly before putting it in place. Mysodelle
can easily be pulled out by the doctor or nurse when it is time to
remove it.
You will be lying down during this procedure and you will
have to stay that way for about 30 minutes after insertion of
Mysodelle.
Once placed in the vagina, Mysodelle takes up moisture and
slowly releases misoprostol.
When using the toilet, please use caution to avoid removing
Mysodelle by mistake. Tell the doctor or nurse if Mysodelle falls
out at any time.
The doctor or nurse will decide how long Mysodelle will be kept
in place, depending on your progress. Mysodelle can be left in
place for up to 24 hours.
Your doctor or nurse will remove Mysodelle
- when labour starts
- if your contractions are too strong or prolonged
- if your baby becomes distressed
- if 24 hours have elapsed since insertion
If Mysodelle falls out, it will not be replaced.
On removal of the product from the vagina, Mysodelle will have
swollen to 2-3 times of its original size and be flexible.
Use in children and adolescents
Mysodelle has not been studied in pregnant women less than 18
years of age.

4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Common: may affect up to 1 in 10 people:
• The unborn baby’s heart rate changes during
labour which may be a reason for concern (foetal
heart rate disorder)
• The mother’s womb contracts too frequently and
the unborn baby’s heart rate may be affected
which may be a reason for concern (abnormal
labour affecting foetus)
• The baby has a bowel movement in the womb
which may be a reason for concern (meconium in
amniotic fluid)
• The mother’s womb contracts too frequently which
may be a reason for concern (uterine contractions
abnormal).

Uncommon: may affect up to 1 in 100 people:
• Brain effects in the baby due to not enough oxygen
(hypoxic-ischaemic encephalopathy)
• The baby has
breathing immediately after birth
(neonatal respiratory depression; neonatal respiratory distress
syndrome; transient tachypnoea of the newborn)
• Nausea
• Vomiting
• Rash
• Unexpected bleeding from the vagina before delivery
(antepartum haemorrhage)
• Increased acidity in the baby’s blood (foetal acidosis)
• Excessive vaginal bleeding after birth (postpartum
haemorrhage)
• The placenta separates from the wall of the womb before the
birth of the baby (premature separation of placenta)
• A contraction that lasts too long and may be a reason for
concern (uterine hypertonus)
• Itching of the genital area (pruritus genital)
• Overall newborn condition depressed at birth (Apgar score
low)
• Increase in blood pressure
• Tearing of the womb (uterine rupture).
Reporting of side effects
If you get any side effects, talk to your doctor or nurse. This
includes any side effects not listed in this
You can also
report side effects directly (see details below). By reporting side
effects you can help provide more information on the safety of
this medicine.
United Kingdom
Yellow Card Scheme
Website: www.mhra.gov.uk/yellowcard
Ireland
Pharmacovigilance Section
Irish Medicines Board
Kevin O’Malley House
Earlsfort Centre
Earlsfort Terrace
IRL - Dublin 2
Tel: +353 1 6764971
Fax: +353 1 6762517
Website: www.imb.ie
e-mail: imbpharmacovigilance@imb.ie

What Mysodelle looks like and contents of
the pack
Mysodelle contains a reservoir of 200 micrograms misoprostol. Mysodelle is a small
rectangular shaped piece of plastic contained
in a cloth mesh retrieval system. The plastic
is a hydrogel polymer which swells in the
presence of moisture to release a controlled
amount of misoprostol. The retrieval system
has a long tape which allows the doctor or
nurse to remove it when they need to.

NO TEXT IN THIS FIELD

NO TEXT IN THIS FIELD

If you use more Mysodelle than you should
If Mysodelle is left in place after onset of active
labour it may lead to increasing contractions or the
baby may become distressed. Mysodelle will then be
removed immediately by your doctor or nurse.

1 x 200 micrograms vaginal delivery system
5 x 200 micrograms vaginal delivery system
5 x 200 micrograms vaginal delivery system
(multipack).
Each vaginal delivery system is contained
within an individual foil sachet produced
from an aluminium foil laminated strip containing a desiccant and packed in a carton.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Ferring Pharmaceuticals Ltd.
Drayton Hall, Church Road, West Drayton, UB7 7PS, (UK)
PL 03194/0112
Ferring Ireland Ltd.
United Drug House, Magna Drive, Magna Business Park,
Citywest Road, Dublin 24, Ireland
PA 1009/025/001
Manufacturer
Ferring Controlled Therapeutics Limited
1 Redwood Place, Peel Park Campus, East Kilbride
Scotland, G74 5PB

This medicinal product is authorised in the Member States of
the EEA under the following names:
Misodel: Austria, Bulgaria, Cyprus, Czech Republic, Denmark,
Finland, France, Germany, Greece, Hungary, Iceland,
Latvia, Lithuania, Malta, Netherlands, Norway, Poland,
Portugal, Romania, Slovakia, Spain and Sweden.
Mysodelle: Belgium, Estonia, Ireland, Italy, Luxemburg, Slovenia,
and UK.
This leaflet was last revised in 10/2013.
Mysodelle, FERRING and the FERRING Logo are
trade marks of Ferring B.V. © 2013 Ferring B.V.

The following information is intended for healthcare professionals only.
Mysodelle is supplied in an individual aluminium foil sachet.
There is a “tear mark” on one side of the foil sachet. Open the
package along the tear mark across the top of the sachet. Do not
use scissors or other sharp objects which may cut the retrieval
system.
Place Mysodelle high in the posterior vaginal fornix (Figure a).
To ensure that Mysodelle remains in situ, it should be turned 90o
so that it lies transversely in the posterior fornix of the vagina
(Figure b). Water-soluble lubricants may be used to aid insertion
when necessary.

5. How to store Mysodelle
Keep this medicine out of the sight and reach of children.
Store in a freezer (-10 to -25°C). No thawing is required prior to
use.
Do not use this medicine after the expiry date which is stated on
the foil and the carton after EXP. The expiry date refers to the last
day of that month.
Do not throw away any medicines via wastewater or household
waste. Your doctor or nurse should throw away or dispose of
medicines you no longer use. These measures will help to protect
the environment.
6. Contents of the pack and other information
What Mysodelle contains
- The active substance is misoprostol.
Each vaginal delivery system contains 200 micrograms of
misoprostol and releases misoprostol at a mean rate of
approximately 7 micrograms/hour over 24 hours.
- The other excipients are:
Cross-linked hydrogel polymer (comprised of macrogol,
1,2,6- hexanetriol and dicyclohexyl-methane-4,4’-diisocyanate)
butylated hydroxyanisole
polyester retrieval system (knitted polyester yarn)

Figure a.

Figure b.

Figure c.

After Mysodelle has been inserted, the withdrawal tape may be
cut with scissors always ensuring there is
tape outside
the vagina to allow removal.
The patient is to remain in bed for 30 minutes after insertion,
but may be ambulatory thereafter. Take care not to inadvertently
remove Mysodelle during toileting and vaginal examinations.
Mysodelle is removed by gently pulling the tail of the retrieval
system (Figure c).
The vaginal delivery system should NEVER be removed from the
retrieval system.
Mysodelle is a controlled release formulation that swells in the
presence of moisture, causing drug release to occur. During insertion, Mysodelle will swell to 2-3 times its original size and be
pliable. After removal, ensure that the entire product (insert and
retrieval system) has been removed from the vagina.

Expand view ⇕

Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

Hide