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CRINONE 8% VAGINAL GEL

Active substance(s): PROGESTERONE

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Package leaflet: Information for the user



Crinone® 8% Vaginal Gel



Progesterone
Read all of this leaflet carefully before you start using this
medicine because it contains important information for you.

Keep this leaflet. You may need to read it again.

If you have any further questions, ask your doctor or pharmacist
or nurse.

This medicine has been prescribed for you only. Do not pass it
onto others. It may harm them, even if their signs of illness are
the same as yours.

If you get any side effects talk to your doctor or pharmacist.
This includes any possible side effects not listed in this leaflet.
See section 4.
What is in this leaflet
1. What Crinone is and what it is used for
2. What you need to know before you use Crinone
3. How to use Crinone
4. Possible side effects
5. How to store Crinone
6. Contents of the pack and other information

1. What Crinone is and what it is used for
The full name of your medicine is Crinone 8% w/w vaginal gel. In this
leaflet the shorter name Crinone is used. Crinone contains a
hormone called progesterone. When the gel is inserted into your
vagina, the progesterone is slowly released into your bloodstream
throughout the day.
Crinone is used to give you extra progesterone in the treatment of
infertility due to incorrect levels of progesterone during the menstrual
cycle or when you are having an assisted fertility procedure. This is
to help you get pregnant. You may also be asked to continue using
Crinone to support your new pregnancy.
2.

What you need to know before you use Crinone

Do not use Crinone:

If you are allergic to the active substance or any of the other
ingredients of this medicine (listed in section 6).

If you have unexplained vaginal bleeding

If you have porphyria (an inability to break down certain
substances (porphyrins) in your blood that is passed down in
families)

If you have or think you might have cancer in your breasts or
genital organs

If you have ever had a blood clot due to swollen veins
(thrombophlebitis), a blocked blood vessel (thromboembolic
disorder) or a stroke

If you are pregnant but your baby has died inside of you
(missed abortion).
Do not use Crinone if any of the above apply to you.
If you are not sure, talk to your doctor or pharmacist before using
this medicine.

Before using this medicine, your doctor will need to do a smear
test and check your breasts and pelvic area.
During your treatment, your doctor will check for any problems
with your womb such as the lining getting thicker (endometrial
hyperplasia). They will also check for any signs of blood clots in
your blood vessels.

Other medicines and Crinone
Do not use Crinone at the same time as any other medicines that
are inserted into your vagina.
Tell your doctor or pharmacist if you are taking, or have recently
taken any other medicines, including medicines obtained without a
prescription.
Pregnancy and breast-feeding

Crinone is not normally used during pregnancy. However, if you
use Crinone to help you get pregnant, you may be asked to
continue using it to support your new pregnancy.

The use of Crinone during breast-feeding is not recommended.
Driving and using machines
You may feel very tired while using Crinone. If this happens, do not
drive or use machines. Drinking alcohol can make this tiredness
worse.
Crinone contains sorbic acid
Crinone contains sorbic acid. This may cause local skin reactions
such as contact dermatitis. These skin reactions might also occur on
your partner’s penis if you have sex while using Crinone. This may
be prevented by using condoms.
3. How to use Crinone
Always use Crinone exactly as your doctor has told you. Check with
your doctor or pharmacist if you are not sure.
Recommended dose
Insert the contents of one applicator of Crinone into your vagina
each day, starting after your doctor tells you that you have ovulated.
Or on the 18th-21st day of your menstrual cycle. (This first day of
your menstrual cycle is the day your period starts.)
When used during in-vitro fertilisation, from the day of the embryo
transfer, insert the contents of one applicator of Crinone into your
vagina each day, preferably in the morning. Once tests confirm that
you are pregnant, you may be asked to keep using Crinone to
support your new pregnancy – for a total of 30 days.
The applicator is designed in such a way that an exact amount of
gel (1.125g, containing 90mg progesterone) is delivered. It is
expected that a small amount of gel will be left in the applicator.
This can be thrown away as you will have received all of the
medicine that you need.
How to use
This medicine is only for use in your vagina using the pre-filled
applicator supplied in the pack.
Before using the applicator, please read all of the instructions
below.
What your applicator looks like

Warnings and precautions
Talk to your doctor or pharmacist before using Crinone if any of the
following apply to you. They may want to monitor you more closely
during treatment:






If you have liver or kidney problems
If you have heart problems or diabetes
If you have asthma
If you have epilepsy or often get migraines
If you have ever had depression.

Tell your doctor if you get any unexpected bleeding so that they can
investigate the cause of this.
Children and adolescents
Crinone is not for use in children or adolescents.
Tests and check ups
Check ups are required before you use this medicine and every so
often when you are using it. In particular:

1.
2.
3.
4.
5.

air tank
flat part of the thick end
thick end
thin end
cap

Getting your applicator ready
Grip the applicator by the thick end between your thumb and index
finger. Face the thin end of the applicator down to the ground and
shake the applicator down to move all the gel inside to the thin end.

Opening your applicator

Grip the applicator by the flat part of the thick end. Twist off and
remove the cap from the opposite thin end. To stop the gel from
flowing out before use, do not press the air tank at the thick end at
this stage.
Inserting your applicator

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side effects not listed in this leaflet. You can
also report side effects via the Yellow Card Scheme at
www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the
Google Play or Apple App Store. By reporting side effects, you can
help provide more information on the safety of this medicine.
5.







6.

How to store Crinone
Keep this medicine out of the sight and reach of children.
Do not store above 25°C. Do not freeze.
Do not use this medicine after the expiry date which is stated
on the cartons and the wrapper after ‘EXP’. The expiry date
refers to the last day of that month.
Do not use Crinone 8% if you notice visible damage.
Do not throw away any medicine via wastewater or household
waste. Ask your pharmacist how to throw away medicines you
no longer use. These measures will help protect the
environment.
Contents of the pack and further information

What Crinone contains



Lean back or lie down with your knees bent and spread apart.
Carefully insert the applicator well into your vagina, until your hand
touches your body.
Press the air tank at the thick end of the applicator firmly to deliver
the gel from the applicator into your vagina.
After using your applicator
Throw away the applicator, including the small amount of gel that is
left inside. Use each applicator only once.
Crinone gel can stay in your vagina for several days. You may get a
beige to brownish clumpy or cloudy white discharge during this time.
This is nothing to worry about.
If you use more Crinone than you should
You are unlikely to use too much of this medicine as each applicator
contains the right amount.
If you forget to use Crinone
Do not use a double dose to make up for a forgotten dose. If you
forget to use Crinone on one day, please continue as usual with a
single dose on the following day.
If you have any further questions on the use of this medicine ask
your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although
not everybody gets them.
Allergic reactions
If you get an allergic reaction stop taking Crinone and see a doctor
straight away. You may get for example an itchy skin rash. It is not
known how likely this side effect is.
Other side effects
Common (may affect up to 1 in 10 people):





headache
feeling very tired
stomach or gut (gastro-intestinal) cramps
breast tenderness

Uncommon (may affect up to 1 in 100 people) to very rare (may
affect up to 1 in 10,000 people):



bleeding between periods (spotting)
irritation or other mild reactions in or around your vagina.

Please note
Crinone gel can stay in your vagina for several days.
You may get a beige to brownish clumpy or cloudy white discharge
during this time. This discharge can cause irritation, pain or swelling
of the vagina but this is nothing to worry about.

The active substance is progesterone. From each applicator
1.125g vaginal gel, containing 90mg progesterone, is delivered
into the vagina.
The other ingredients are glycerol, light liquid paraffin,
hydrogenated palm oil, carbomer 974P, sorbic acid,
polycarbophil, sodium hydroxide and purified water.

What Crinone looks like and contents of the pack
The vaginal gel is filled into one piece of a white polyethylene
applicator for single use, with a twist off top closure intended for
intravaginal application. The applicator is wrapped and sealed in a
paper / aluminium / polyethylene film.
Applicants are packed in cardboard boxes containing 15 units.
Manufacturer
Central Pharma (Contract Packaging) Ltd, Bedford, Bedfordshire,
Great Britain
Procured within the E.U.
Re-packaged by Munro Wholesale Medical Supplies Ltd.,
3 Young Place, East Kilbride, G75 0TD.
Product Licence holder: Ecosse Pharmaceuticals Ltd.,
3 Young Place, East Kilbride, G75 0TD.
PL 10965/0583
POM
This leaflet was revised: 12/02/2018

If you are blind or partially sighted
and require this leaflet in a
different format, call 01355
574450 and ask for the
Regulatory Department.
E0583-1 – 03/15
Crinone® is the registered trademark of the Merck KGaA.

Package leaflet: Information for the user
Progesterone 8% Vaginal Gel

Tests and check ups
Check ups are required before you use this medicine and every so
often when you are using it. In particular:

Read all of this leaflet carefully before you start using this
medicine because it contains important information for you.












Keep this leaflet. You may need to read it again.
If you have any further questions, ask your doctor or pharmacist
or nurse.
This medicine has been prescribed for you only. Do not pass it
onto others. It may harm them, even if their signs of illness are
the same as yours.
If you get any side effects talk to your doctor or pharmacist.
This includes any possible side effects not listed in this leaflet.
See section 4.

What is in this leaflet
1.
2.
3.
4.
5.
6.

What Progesterone is and what it is used for
What you need to know before you use Progesterone
How to use Progesterone
Possible side effects
How to store Progesterone
Contents of the pack and other information

1.

What Progesterone is and what it is used for

The full name of your medicine is progesterone 8% w/w vaginal gel.
In this leaflet the shorter name progesterone is used. Progesterone
contains a hormone called progesterone. When the gel is inserted
into your vagina, the progesterone is slowly released into your
bloodstream throughout the day.
Progesterone is used to give you extra progesterone in the treatment
of infertility due to incorrect levels of progesterone during the
menstrual cycle or when you are having an assisted fertility
procedure. This is to help you get pregnant. You may also be asked
to continue using progesterone to support your new pregnancy.
2.

What you need to know before you use progesterone

Do not use progesterone:









If you are allergic to the active substance or any of the other
ingredients of this medicine (listed in section 6).
If you have unexplained vaginal bleeding
If you have porphyria (an inability to break down certain
substances (porphyrins) in your blood that is passed down in
families)
If you have or think you might have cancer in your breasts or
genital organs
If you have ever had a blood clot due to swollen veins
(thrombophlebitis), a blocked blood vessel (thromboembolic
disorder) or a stroke
If you are pregnant but your baby has died inside of you
(missed abortion).

Do not use progesterone if any of the above apply to you.
If you are not sure, talk to your doctor or pharmacist before using
this medicine.
Warnings and precautions
Talk to your doctor or pharmacist before using progesterone if any of
the following apply to you. They may want to monitor you more
closely during treatment:






If you have liver or kidney problems
If you have heart problems or diabetes
If you have asthma
If you have epilepsy or often get migraines
If you have ever had depression.

Tell your doctor if you get any unexpected bleeding so that they can
investigate the cause of this.
Children and adolescents
Progesterone is not for use in children or adolescents.

Before using this medicine, your doctor will need to do a smear
test and check your breasts and pelvic area.
During your treatment, your doctor will check for any problems
with your womb such as the lining getting thicker (endometrial
hyperplasia). They will also check for any signs of blood clots in
your blood vessels.

Other medicines and Progesterone
Do not use progesterone at the same time as any other medicines
that are inserted into your vagina.
Tell your doctor or pharmacist if you are taking, or have recently
taken any other medicines, including medicines obtained without a
prescription.
Pregnancy and breast-feeding




Progesterone is not normally used during pregnancy. However,
if you use progesterone to help you get pregnant, you may be
asked to continue using it to support your new pregnancy.
The use of progesterone during breast-feeding is not
recommended.

Driving and using machines
You may feel very tired while using progesterone. If this happens, do
not drive or use machines. Drinking alcohol can make this tiredness
worse.
Progesterone contains sorbic acid
Progesterone contains sorbic acid. This may cause local skin
reactions such as contact dermatitis. These skin reactions might also
occur on your partner’s penis if you have sex while using
progesterone. This may be prevented by using condoms.
3.

How to use Progesterone

Always use progesterone exactly as your doctor has told you.
Check with your doctor or pharmacist if you are not sure.
Recommended dose
Insert the contents of one applicator of progesterone into your
vagina each day, starting after your doctor tells you that you have
ovulated. Or on the 18th-21st day of your menstrual cycle. (This first
day of your menstrual cycle is the day your period starts.)
When used during in-vitro fertilisation, from the day of the embryo
transfer, insert the contents of one applicator of progesterone into
your vagina each day, preferably in the morning. Once tests confirm
that you are pregnant, you may be asked to keep using
progesterone to support your new pregnancy – for a total of 30
days.
The applicator is designed in such a way that an exact amount of
gel (1.125g, containing 90mg progesterone) is delivered. It is
expected that a small amount of gel will be left in the applicator.
This can be thrown away as you will have received all of the
medicine that you need.
How to use
This medicine is only for use in your vagina using the pre-filled
applicator supplied in the pack.
Before using the applicator, please read all of the instructions
below.
What your applicator looks like

1.
2.
3.
4.
5.

air tank
flat part of the thick end
thick end
thin end
cap

Getting your applicator ready
Grip the applicator by the thick end between your thumb and index
finger. Face the thin end of the applicator down to the ground and
shake the applicator down to move all the gel inside to the thin end.
Opening your applicator

Uncommon (may affect up to 1 in 100 people) to very rare (may
affect up to 1 in 10,000 people):



bleeding between periods (spotting)
irritation or other mild reactions in or around your vagina.

Please note
Progesterone gel can stay in your vagina for several days.
You may get a beige to brownish clumpy or cloudy white discharge
during this time. This discharge can cause irritation, pain or swelling
of the vagina but this is nothing to worry about.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side effects not listed in this leaflet. You can
also report side effects via the Yellow Card Scheme at
www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the
Google Play or Apple App Store. By reporting side effects, you can
help provide more information on the safety of this medicine.

Grip the applicator by the flat part of the thick end. Twist off and
remove the cap from the opposite thin end. To stop the gel from
flowing out before use, do not press the air tank at the thick end at
this stage.
Inserting your applicator

5.







6.

How to store Progesterone
Keep this medicine out of the sight and reach of children.
Do not store above 25°C. Do not freeze.
Do not use this medicine after the expiry date which is stated
on the cartons and the wrapper after ‘EXP’. The expiry date
refers to the last day of that month.
Do not use Progesterone 8% if you notice visible damage.
Do not throw away any medicine via wastewater or household
waste. Ask your pharmacist how to throw away medicines you
no longer use. These measures will help protect the
environment.
Contents of the pack and further information

What Progesterone contains


Lean back or lie down with your knees bent and spread apart.
Carefully insert the applicator well into your vagina, until your hand
touches your body.
Press the air tank at the thick end of the applicator firmly to deliver
the gel from the applicator into your vagina.
After using your applicator
Throw away the applicator, including the small amount of gel that is
left inside. Use each applicator only once.
Progesterone gel can stay in your vagina for several days. You may
get a beige to brownish clumpy or cloudy white discharge during this
time. This is nothing to worry about.
If you use more Progesterone than you should
You are unlikely to use too much of this medicine as each applicator
contains the right amount.
If you forget to use Progesterone
Do not use a double dose to make up for a forgotten dose. If you
forget to use Progesterone on one day, please continue as usual
with a single dose on the following day.
If you have any further questions on the use of this medicine ask
your doctor or pharmacist.
4.

Possible side effects

Like all medicines, this medicine can cause side effects, although
not everybody gets them.
Allergic reactions
If you get an allergic reaction stop taking Progesterone and see a
doctor straight away. You may get for example an itchy skin rash. It
is not known how likely this side effect is.
Other side effects
Common (may affect up to 1 in 10 people):





headache
feeling very tired
stomach or gut (gastro-intestinal) cramps
breast tenderness



The active substance is progesterone. From each applicator
1.125g vaginal gel, containing 90mg progesterone, is delivered
into the vagina.
The other ingredients are glycerol, light liquid paraffin,
hydrogenated palm oil, carbomer 974P, sorbic acid,
polycarbophil, sodium hydroxide and purified water.

What Progesterone looks like and contents of the pack
The vaginal gel is filled into one piece of a white polyethylene
applicator for single use, with a twist off top closure intended for
intravaginal application. The applicator is wrapped and sealed in a
paper / aluminium / polyethylene film.
Applicants are packed in cardboard boxes containing 15 units.
Manufacturer
Central Pharma (Contract Packaging) Ltd, Bedford, Bedfordshire,
Great Britain
Procured within the E.U.
Re-packaged by Munro Wholesale Medical Supplies Ltd.,
3 Young Place, East Kilbride, G75 0TD.
Product Licence holder: Ecosse Pharmaceuticals Ltd.,
3 Young Place, East Kilbride, G75 0TD.
PL 10965/0583
POM
This leaflet was revised: 12/02/2018

If you are blind or partially sighted
and require this leaflet in a
different format, call 01355
574450 and ask for the
Regulatory Department.
E0583-1(P) – 03/15

+ Expand Transcript

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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