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CERVAGEM 1MG PESSARY

Active substance(s): GEMEPROST / GEMEPROST

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INFORMATION FOR THE USER

Cervagem 1mg Pessary
gemeprost
Is this leaflet hard to
see or read?
Phone 0845 372 7101
for help
Read all of this leaflet carefully before
you are given this medicine
- Keep this leaflet. You may need to
read it again.
- If you have any further questions, ask
you doctor or nurse.
- If any of the side effects gets serious,
or if you notice any side effects not
listed in this leaflet, please tell your
doctor or nurse.
In this leaflet:
1. What Cervagem Pessary is and what it
is used for.
2. What you need to know before you
take Cervagem Pessary.
3. How you are given Cervagem Pessary
4. Possible side effects
5. How Cervagem Pessary is stored
6. Contents of the pack and other
information.

1. What Cervagem Pessary is
and what it is used for
Cervagem Pessary contains a
medicine called gemeprost.
This belongs to a group of
medicines called
prostaglandins. It works by making the
womb contract.Cervagem is normally
given to women in the following
situations:
• To make the operation to terminate a
pregnancy in the first three months
easier.
• To terminate a pregnancy between
the fourth and sixth month.
• To terminate a pregnancy between
the fourth and sixth month, if the
unborn baby (foetus) has already died.

i

2. What you need to know
before you use
Cervagem Pessary
Do not use
Cervagem Pessary if:
x You are allergic (hypersensitive) to
gemeprost or any of the other
ingredients of this medicine (See
section 6: Further information). Signs
of an allergic reaction include: a rash,
swallowing or breathing problems,
swelling of your lips, face, throat or
tongue.
x You are allergic or sensitive to
prostaglandin medicines such as
alprostadil, bimatoprost, latanoprost,
travoprost or misoprostol.
x You have or have had placenta previa
(light or heavy vaginal bleeding which
may be sudden, painless and
recurring). Your doctor should check
on this and may perform an
ultrasound scan.

x You have kidney problems.
x You have had an operation on your
womb, like a caesarean section.
Do not use this medicine if any of the
above apply to you. If you are not sure,
talk to your doctor or nurse before you
are given the first pessary.
Take special care with
Cervagem Pessary
Talk to your doctor or nurse before you
are given this medicine if:
▲ You have breathing problems.
▲ You have glaucoma (raised pressure in
the eye which affects your sight).
▲ You have any heart problems.
▲ You have dizziness, lightheadedness
or fainting. This may be due to low
blood pressure
▲ You have a rare genetic disease known
as sickle cell anaemia
▲ You have epilepsy
▲ You have unusual vaginal discharge,
pain when passing water or increased
need to pass water.
These may be signs of cervicitis
▲ You have vaginal pain, itching or
discharge. These may be signs of
vaginitis
▲ You have an illness where the level of
glucose in your blood is not controlled
properly (diabetes mellitus)
▲ You have a problem with your blood
clotting
Taking or using other
medicines
Please tell your doctor or
nurse if you are taking or have recently
taken any other medicines, including
medicines obtained without prescription.
This includes medicines you can buy
without prescription, including herbal
medicines. This is because Cervagem can
affect the way some other medicines
work. Also some medicines can affect the
way Cervagem works.
In particular, tell your doctor you are
taking any of the following.
Medicines used to speed up labour such
as oxytocin. This can increase the effect of
Cervagem.

3. How you will be given
Cervagem Pessary
• Cervagem pessaries will be given to
you by a doctor or nurse.
• The pessaries are inserted into your
vagina.
• The number of pessaries given to you
will depend on the reason for its use.
The doctor or nurse will keep
an eye on you while you are
being treated with Cervagem
Turn
Over
pessaries.



Cervagem
1mg Pessary

maximum of 5 administrations. If abortion is not
established after 5 pessaries, a second course of
treatment may be instituted starting 24 hours
after the initial commencement of treatment.
If abortion is not well established after 10
pessaries, a further course of CERVAGEM
treatment is not recommended and alternative
means should be employed to effect uterine
emptying

gemeprost
Store below minus 10°C (-10°C)
in the original pack

3. Intrauterine foetal death in the
second trimester of gestation.
One pessary to be inserted into the posterior
vaginal fornix at 3-hourly intervals up to a
maximum of 5 administrations.
Elderly: Not applicable.
Children: Not applicable.

PRESENTATION
White to yellowish-white spindle shaped vaginal
pessaries each containing 1mg
GEMEPROST.
INDICATIONS
Softening and dilatation of the cervix uteri prior
to trans-cervical intrauterine operative
procedures in pregnant patients in the first
trimester of gestation.
Therapeutic termination of pregnancy in patients
in the second trimester of gestation, in licensed
institutions.
Induction of abortion of second trimester
pregnancies complicated by intrauterine foetal
death.

CONTRAINDICATIONS
CERVAGEM should not be administered to women
with known hypersensitivity to prostaglandins or
to women with renal function disturbances.
CERVAGEM is also contraindicated in women
experiencing uterine fragility related to uterine
scarring, and in placenta previa.
CERVAGEM pessaries should not be used for the
induction of labour or cervical softening at term
as foetal effects have not been ascertained.
PRECAUTIONS
CERVAGEM should be used with caution in
patients with obstructive airways disease, those
with cardiovascular insufficiency, elevated
intraocular pressure, cervicitis or vaginitis.
Serious, potentially fatal, cardiovascular accidents
(myocardial infarction and/or spasm of the
coronary arteries and severe hypotension) have
been reported with protaglandins including
CERVAGEM.
Cardiac and vascular parameters should be
monitored by taking regular measurements of
the patients pulse and blood pressure.
Coagulopathy may occur following intrauterine
foetal death and should be monitored and
managed actively according to current standard
clinical practice.

ADMINISTRATION AND DOSAGE
Before administration, the pessary should be
allowed to warm to room temperature for 30
minutes, away from direct heat and sunlight, in
the unopened foil sachet.
1. Softening and dilatation of the cervix
in the first trimester of gestation.
Adults: One pessary to be inserted into the
posterior vaginal fornix 3 hours before surgery.
2. Therapeutic termination of pregnancy
in the second trimester of gestation.
Adults: One pessary to be inserted into the
posterior vaginal fornix at 3-hourly intervals to a

Via G. Tartini, 2 - 2 0 15 8 - M I L A N O

CROMinFOTO s.n.c. Tel. 02.375787 • e-mail: crominfoto@tiscali.it
GRAFICA - FOTOCOMPOSIZIONE

TYPE OF MATERIAL:

AZIENDA CERTIFICATA UNI EN ISO 9001:2008

DESCRIPTION:

8 /9.5 pt. 89031609

VERSION: OLD CODE :

2 a 89029190

08 MAR 2017

COUNTRY:

LEAFLET FOLDED CERVAGEM 1 MG
MIN. FONT SIZE: CODE:

89031609
(int. version 2)

LOGO VERSION:

//

U.K.
DIMENSIONS mm:

125 x 420 (125 x 26,25)

COLOURS N°:

1

COLOUR 1:

REFLEX BLUE

Cervagem pessaries can be given in one
of the following ways in these situations:
Termination of pregnancy in the first
three months to make the operation
easier
• One pessary inserted three hours
before the operation.
• If the operation is delayed for more
than three hours, you will be kept
under observation. This is because
termination may occur anyway.
• If you start to bleed, tell the doctor or
nurse.
Termination of pregnancy between the
fourth and sixth month
• One pessary inserted every three
hours.
• Up to 5 pessaries are normally given.
• Sometimes you may need up to five
more pessaries.
• If the termination has not happened
by this time, your doctor or nurse will
use another method to finish the
termination.
Termination of a pregnancy between
the fourth and sixth month, if the
unborn baby (foetus) has already died
• One pessary will be inserted every
three hours.
• Up to 5 pessaries are normally given
to you.
After the treatment, the doctor or nurse
will check to make sure the termination
has been completed properly.
It is important to keep your appointment
if you are due a follow-up examination
after this treatment.

4. Possible side effects
Like all medicines, Cervagem
Pessary can cause side effects,
although not everybody gets
them.
Very rare allergic reactions that can
occur with prostaglandins such as
Cervagem
You could notice the following signs of an
allergic reaction:
• Flushing, fainting, fever and chills
• Itching and redness all over your body
• Tight chest and difficulty in breathing
• Back pain
If you think that Cervagem is causing an
allergic reaction, tell your doctor straight
away.
Very rare side effects
• Splitting or tearing of the womb. This
usually happens in women who have
had several children or a previous
operation on the womb (such as a
caesarian section).
• Heart and circulation problems.
Other side effects
If you have any of the following side
effects, do not worry. However if they are
troublesome, talk to your doctor or nurse.
These side effects usually last for a short
time.
• Bleeding from your vagina and mild
pain in your womb (like period pain)
• Feeling sick (nausea) and being sick
(vomiting)
• Diarrhoea
• Headache and flushing
• Muscle weakness and backache

• Feeling dizzy, light headed and faint
• High temperature and chills
(shivering)
• Difficulty in breathing
• Very fast and uneven heartbeat
(palpitations)
• Fall in blood pressure
• Chest pain or in some cases with
tightness, crushing or squeezing
pressure on the chest and may radiate
to the neck, shoulder or arms
(coronary spasm)
• Heart attack
Reporting of side effects
If you get any side effects, talk to your
doctor, pharmacist or nurse. This includes
any possible side effects not listed in this
leaflet. You can also report side effects
directly via the Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard
By reporting side effects you can help
provide more information on the safety
of this medicine.

5. How to store
Cervagem Pessary
• Keep this medicine in a safe place
where children cannot see or reach
them
• Store below minus 10°C in a freezer
• Do not use Cervagem Pessary after the
expiry date stated on the box and the
foil pouches. The expiry date refers to
the last day of that month.
• Before use, each pessary should be
allowed to warm up to room
temperature
Medicines should not be disposed of via
wastewater or household waste. Ask your
doctor or nurse how to dispose of
medicines no longer required. These
measures will help to protect the
environment.

6. Contents of the pack and
other information
What Cervagem Pessary contains
• The active substance is gemeprost.
• The other ingredients are Witepsol S
52 and dehydrated ethanol.
What Cervagem Pessary looks like and
contents of the pack
The pessary is a bullet-shaped waxy solid,
2-3 centimetres long and it comes in
boxes of 5 pessaries.
Marketing Authorisation Holder and
Manufacturer
Marketing Authorisation Holder
Sanofi
One Onslow Street
Guildford
Surrey, GU1 4YS, UK
Tel: 0845 372 7101
email:uk-medicalinformation@sanofi.com
Manufacturer
Sanofi S.p.A.
Via Valcanello 4
03012 Anagni (FR)
ITALY
This leaflet does not contain all the
information about your medicine. If you
have any questions or are not sure about
anything, ask your doctor or pharmacist.
This leaflet was last revised in
Feb 2017
©Sanofi, 2000 - 2017

89031609


Patients with the following diseases have not
been studied: ulcerative colitis, diabetes mellitus,
sickle-cell anaemia, epilepsy, disorders of blood
coagulation, cardiovascular or pulmonary
disease.
If it is necessary to postpone surgery for much
beyond the recommended 3 hour interval,
patients should be kept under observation as
there is a possibility that spontaneous abortion
may occur.
Adequate follow-up of the procedure is essential
to ensure that the termination process has been
completed as the embryopathic effects of
CERVAGEM have not been determined. CERVAGEM
pessaries should not be used for the induction of
labour or cervical softening at term as foetal
effects have not been ascertained.
INTERACTIONS
Oxytocin and other labour inducers or
accelerators can potentiate the action of
CERVAGEM.
SIDE-EFFECTS
Vaginal bleeding and mild uterine pain, similar
to menstrual pain, may occur in the interval
between the administration of the pessary and
surgery, especially if this interval is prolonged
beyond the recommended 3 hours. Nausea,
vomiting, loose stools or diarrhoea may occur but
are rarely severe enough to require treatment.
However, standard anti-emetic or anti-diarrhoeal
agents may be administered if required. Other
reported side-effects include headache, muscle
weakness, dizziness, flushing, chills, backache,
dyspnoea, chest pain, palpitations and mild
pyrexia.
Uterine rupture has been reported on rare
occasions, most commonly in multiparous
women with a history of uterine surgery.
Anaphylactic reactions have not occurred with
CERVAGEM but such reactions have very rarely
been noted with other prostaglandins.

In very rare cases, severe hypotension and
coronary spasms with subsequent myocardial
infarctions have been reported.
Reporting of side effects
If you get any side effects, talk to your doctor,
pharmacist or nurse. This includes any possible
side effects not listed in this leaflet. You can also
report side effects directly via the Yellow Card
Scheme at: www.mhra.gov.uk/yellowcard
By reporting side effects you can help provide
more information on the safety of this medicine.
OVERDOSAGE
The toxic dose of CERVAGEM in women has not
been established. Cumulative dosage of 10mg in
24 hours has been well tolerated. In animals the
acute toxic effects are similar to those of
prostaglandin E1 and include depression of the
CNS and relaxation of the smooth muscle,
leading to hypotension. Clinically valuable signs
of impending toxicity are likely to be sedation,
tremor, convulsion, dyspnoea, abdominal pain
and diarrhoea, which may be bloody, palpitations
or bradycardia. Treatment should be
symptomatic. A vaginal douche may be of value
depending on the elapsed time since insertion of
the pessary.
PHARMACEUTICAL PRECAUTIONS
Store below minus 10°C (-10°C) in the original
pack. Temperature cycling should be avoided.
Once the foil sachet has been opened, any
pessary not used within 12 hours should be
destroyed.
Sanofi, One Onslow Street,
Guildford, Surrey, GU1 4YS, UK
Manufactured by: SANOFI S.p.A.,
Via Valcanello 4, 03012 Anagni (FR), ITALY
Text issued: Feb 2017

89031609

Via G. Tartini, 2 - 2 0 15 8 - M I L A N O

CROMinFOTO s.n.c. Tel. 02.375787 • e-mail: crominfoto@tiscali.it
GRAFICA - FOTOCOMPOSIZIONE

TYPE OF MATERIAL:

AZIENDA CERTIFICATA UNI EN ISO 9001:2008

DESCRIPTION:

8 /9.5 pt. 89031609

VERSION: OLD CODE :

2 a 89029190

08 MAR 2017

COUNTRY:

LEAFLET FOLDED CERVAGEM 1 MG
MIN. FONT SIZE: CODE:

89031609
(int. version 2)

LOGO VERSION:

//

U.K.
DIMENSIONS mm:

125 x 420 (125 x 26,25)

COLOURS N°:

1

COLOUR 1:

REFLEX BLUE

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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.

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