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CRINONE PROGESTERONE VAGINAL GEL 8%

Active substance(s): PROGESTERONE

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5. How to store Crinone

• if you have epilepsy or often get migraines

6. Contents of the pack and other information

• if you have ever had depression.

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.

Package Leaflet: Information for the user

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

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:
• 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.

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.

Crinone® 8% w/w
Vaginal Gel

Do not use Crinone:

Progesterone

• if you have unexplained vaginal bleeding

Do not use Crinone at the same time as any other
medicines that are inserted into your vagina.

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

Tell your doctor or pharmacist if you are taking, or have
recently taken any other medicines, including medicines
obtained without a prescription.

How to use

• if you have or think you might have cancer in your
breasts or genital organs

Pregnancy and breast-feeding

Before using the applicator, please read all of the instructions
below.

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.

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

• 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.
Warnings and precautions

1. What Crinone is and what it is used for

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:

2. What you need to know before you use Crinone

• if you have liver or kidney problems

3. How to use Crinone

• if you have heart problems or diabetes

4. Possible side effects

• if you have asthma

What is in this leaflet

Other medicines and Crinone

• 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.

This medicine is only for use in your vagina using the
pre-filled applicator supplied in the pack.

What your applicator looks like

• 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.

1. air tank

Crinone contains sorbic acid

2. flat part of the thick end

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. thick end
4. thin end
5. cap

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Getting your applicator ready

If you forget to use Crinone

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.

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.

Opening your applicator

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

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

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)

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.

• irritation or other mild reactions in or around your vagina.
Please note
Crinone gel can stay in your vagina for several days.

5. How to store Crinone
• Keep this medicine out of the sight and reach of children.

Bedford, MK41 OXZ

• 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.

This leaflet was last revised in March 2015

• 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 further information
What Crinone contains
• The active substance is progesterone. From each
applicator 1.125  g vaginal gel, containing 90  mg
progesterone, is delivered into the vagina.
• The other ingredients are 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 single-use, one-piece, white polyethylene vaginal
applicators with twist-off caps, each sealed in a paper
/aluminium / ionomer resin foil wrapper.
Crinone is supplied in packs of 6 or 15 single-use
applicators. Not all pack sizes may be marketed.

After using your applicator
Throw away the applicator, including the small amount
of gel that is left inside. Use each applicator only once.

Reporting side effects

Stanwell Road
Feltham

If you use more Crinone than you should

If you get any side effects, talk to your doctor or
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.

You are unlikely to use too much of this medicine as each
applicator contains the right amount.

By reporting side effects you can help provide more
information on the safety of this medicine.

Manufacturer

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.

United Kingdom

• Do not store above 25°C.

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.

Press the air tank at the thick end of the applicator firmly
to deliver the gel from the applicator into your vagina.

Caxton Road

Marketing Authorisation Holder
Merck Serono Ltd
Bedfont Cross

Middlesex
TW14 8NX
United Kingdom

Central Pharma (Contract Packaging) Ltd

40405100006TW839300

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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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