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CRINONE 8% W/W VAGINAL GEL

Active substance(s): PROGESTERONE

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Patient Information Leaflet

Crinone® 8% w/w Vaginal Gel
(progesterone)
The name of your medicine is Crinone 8% w/w Vaginal Gel, but
will be referred to as Crinone through the remainder of the
leaflet.
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 on to 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
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).

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 used 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. (The
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 (1.125 g, containing 90 mg 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

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.
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.

1. air tank
2. flat part of the thick end
3. thick end
4. thin end
5. 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.

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

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.
PP1/1433/V2

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

5. How to store Crinone
Keep out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on
the cartons and the wrapper.
Do not store above 25°C. Do not freeze.
Use each applicator only once. Any gel left in the applicator must
be thrown away.
Do not throw away any medicines via wastewater or household
waste. Ask your pharmacist how to throw away medicines you no
longer use. These measures will help protect the environment.
6. Contents of the pack and other information
What Crinone contains:
The active substance is progesterone.
Each single-use pre-filled applicator provides 1.125g of gel
containing 90mg progesterone.

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.

Also contains: sorbic acid, glycerine, light liquid paraffin,
hydrogenated palm oil glycerides, carbomer 974P, polycarbophil,
sodium hydroxide and purified water.
What Crinone looks like and contents of the pack:
Crinone is a smooth white to off-white gel. It is filled in singleuse, one-piece, white polyethylene vaginal applicators with twistoff caps, each sealed in a paper /aluminium / ionomer resin foil
wrapper.
Crinone is supplied in packs of 15 single-use applicators.
Manufactured by: Central Pharma (Contract Packaging) Ltd.,
Bedford, Bedfordshire, United Kingdom. Procured from within the
EU. Product Licence Holder: Quadrant Pharmaceuticals Ltd,
Lynstock House, Lynstock Way, Lostock, Bolton, BL6 4SA.
Repackaged by Maxearn Ltd, Bolton, BL6 4SA.
PL 20774/1433

Crinone 8% w/w Vaginal Gel

POM

Leaflet revision date: 28th September 2015
Crinone is a registered trademark of Merck KGaA

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.
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.

PP1/1433/V2

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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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