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CERVAGEM 1MG PESSARY

Active substance(s): GEMEPROST

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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 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

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.

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.

CROMinFOTO s.n.c.

GRAFICA - FOTOCOMPOSIZIONE

LEAFLET
TYPE OF MATERIAL:

MIN. FONT SIZE: CODE:
Via G. Tartini, 2 - 20158 - MILANO
Tel. 02.375787 • e-mail: crominfoto@tiscali.it

AZIENDA CERTIFICATA UNI EN ISO 9001:2008

8.5/9.5 pt. 89029190 4 a
VERSION:

89027065 315 x 210
OLD CODE:

DIMENSION mm:

89029190
(int. version 4)

CERVAGEM 1 MG
DESCRIPTION:

COUNTRY:

COLOURS N°:

1
REFLEX BLUE
COLOUR 1:

22 APR 2016

UK
LOGO VERSION:

//

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.

i

1. What Cervagem Pessary is
and what it is used for

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.

In this leaflet:

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.

- 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.

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.

Read all of this leaflet carefully
before you are given this medicine

Induction of abortion of second trimester pregnancies complicated by intrauterine
foetal death.

Is this leaflet hard to
see or read? Phone
0845 372 7101 for help

Therapeutic termination of pregnancy in patients in the second trimester of
gestation, in licensed institutions.

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.

Cervagem
1mg Pessary

PRESENTATION
White to yellowish-white spindle shaped vaginal pessaries each containing 1mg
GEMEPROST.

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.

Take special care with
Cervagem Pessary

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.

Do not use
Cervagem Pessary if:

2. What you need to know before
you use Cervagem Pessary

• 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.

• 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
pessaries.
Cervagem pessaries can be given in
one of the following ways in these
Turn
situations:
Over

3. How you will be given
Cervagem Pessary

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.

Taking or using other medicines

▲ 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

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

INFORMATION FOR THE USER

gemeprost


Cervagem 1mg Pessary

//

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.
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.
Aventis Pharma Ltd, One Onslow Street, Guildford, Surrey, GU1 4YS, UK
Manufactured by: SANOFI S.P.A., Loc. Valcanello, 03012 Anagni (FR), ITALY
89029190
Text issued: August 2015.

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.

89029190

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.
Loc. Valcanello
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 August 2015
©Sanofi, 2000 - 2015

22 APR 2016


Termination of pregnancy in the first
three months to make the operation
easier
• 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.

1
89027065 315 x 210
8.5/9.5 pt. 89029190 4 a

• 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

REFLEX BLUE
COLOUR 1:

COLOURS N°:

DIMENSION mm:

OLD CODE:

LOGO VERSION:

UK
CERVAGEM 1 MG
LEAFLET

VERSION:

MIN. FONT SIZE: CODE:

COUNTRY:

DESCRIPTION:

TYPE OF MATERIAL:

89029190
(int. version 4)
AZIENDA CERTIFICATA UNI EN ISO 9001:2008

GRAFICA - FOTOCOMPOSIZIONE

Via G. Tartini, 2 - 20158 - MILANO
Tel. 02.375787 • e-mail: crominfoto@tiscali.it

CROMinFOTO s.n.c.

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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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