CRINONE 80 mg /G Gel

Зміст інструкції

1. CRINONE 80 mg/g vaginal gel
   1. What is Crinone and what is it used for
   2. What you need to know before using Crinone
   3. How to use Crinone
   4. Possible side effects
   5. How to store Crinone
   6. Contents of the pack and other information

CRINONE 80 mg/g vaginal gel

progesterone

Read this leaflet carefully before using this medicine as it contains important
information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you. Do not give it to other people, even if their symptoms are the same as yours, as it could be harmful.
• If any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

• 1. What Crinone is and what it is used for
• 2. What you need to know before using 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 is Crinone and what is it used for

Crinone contains a hormone called progesterone and belongs to the category of medicines called sex hormones (progestogens).
Crinone is indicated in adult women in cases of:

• infertility due to inadequate luteal phase (when the action or production of progesterone in the second phase of the menstrual cycle is not adequate)
• for use during assisted reproductive technology (in-vitro fertilization), when infertility is mainly due to problems with the fallopian tubes or the endometrium or to unknown causes, with normal ovulatory cycles.

2. What you need to know before using Crinone

Do not use Crinone

• if you are allergic to progesterone or to any of the other ingredients of this medicine (listed in section 6)
• if you have vaginal bleeding of unknown cause
• if you have suspected or confirmed cancer of the ovary, uterus or breast
• if you have blood clots in the veins (thrombophlebitis), blocked blood vessels (thromboembolic diseases), cerebral hemorrhage, or if you have risk factors for these conditions
• if you have an incomplete or missed miscarriage
• if you suffer from severe liver failure
• if you suffer from porphyria (inherited inability to break down certain substances in the blood, called porphyrins).

Warnings and precautions
Talk to your doctor before using Crinone.
Before treatment, a thorough examination of the breasts and pelvic organs should be performed.
Talk to your doctor before using Crinone if you are in any of the following circumstances, because the medicine
should be used with caution:

• if you suffer from endocrine problems (hormonal disorders)
• if you have liver problems (liver failure)
• if you have kidney problems (renal failure)
• if you have heart problems (heart failure)
• if you suffer from asthma
• if you suffer from epilepsy

In case of unexpected vaginal bleeding, inform your doctor so that the cause can be investigated.
If vision disturbances or symptoms related to the onset of possible thrombotic disorders occur during treatment, it is necessary to stop the treatment and undergo appropriate investigations.
In diabetics, progestogens may cause or worsen fluid retention and reduce glucose tolerance.

Children and adolescents
Crinone is not indicated for use in children and adolescents.

Other medicines and Crinone
Crinone should not be used in conjunction with other vaginal medications.
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
medicines.

Pregnancy and breastfeeding
Crinone can be used during the first trimester of pregnancy in cases of confirmed luteal insufficiency.
Crinone should not be used during breastfeeding because there may be traces of progesterone in breast milk.

Driving and operating machinery
Crinone does not impair the ability to drive and operate machinery.

Crinone contains sorbic acid (E200)
Sorbic acid contained in the vaginal gel may cause localized skin reactions (e.g. contact dermatitis).

3. How to use Crinone

Use this medicine following exactly the instructions of your doctor. If you have any doubts, consult your doctor or pharmacist.
For the treatment of infertility, the recommended dose is as follows:
one dose of Crinone (i.e. one applicator equal to 90 mg of progesterone) every day, starting after
the doctor has confirmed that ovulation has occurred or on the 18th-21st day of the cycle.
For use in in vitro fertilization, daily application of Crinone should continue until
placental autonomy in case of confirmed pregnancy.

How to use
Crinone must be applied directly into the vagina using the special sealed applicator. Wash your hands.
Remove the applicator from the sealed packaging, but do not tear the tab at this point.

• 1. Hold the applicator firmly by the thicker end (A).

Shake downwards like a thermometer so that the
contents move towards the thinner end (B).

• 2. Hold the applicator by the flat part of the thicker end and

rotate the tab at the thinner end (B) until it detaches and
throw it away. Be careful not to press the reservoir in the thicker part
at this point, to avoid leakage of gel before
use.

• 3. To insert the applicator, lie down or

sit with your knees bent. Gently insert the thinner end (B) of the applicator deeply
into the vagina.

• 4. Press firmly on the reservoir in the thicker end (A)

of the applicator to deposit the gel into the vagina. Remove
the applicator and discard it in a suitable container.

Special instructions for use at altitudes above 770 meters
Wash your hands. Remove the applicator from the sealed packaging, but do not tear the tab at this point.

• 1. Hold the applicator firmly at the reservoir in the thicker end (A). Using a sterile needle, make a hole in the flat part of the reservoir. This will serve to balance the pressure difference due to the altitude and ensure the delivery of the necessary amount of gel. Close the hole with your finger and shake downwards like a thermometer so that the contents move towards the thinner end (B).

Perform steps 2 and 3 as above.

• 4. Close the hole in the reservoir with your finger and press with

firmness on the reservoir in the thicker end (A) of the applicator
to deposit the gel into the vagina. Remove the applicator and
discard it in a suitable container.
Crinone coats the vaginal mucosa and provides a prolonged release of
progesterone.

Each applicator contains a quantity of gel greater than that actually released, as the remaining
part of the product remains adhered to the internal walls of the applicator. Any residual gel inside
the applicator is therefore to be considered normal.

If you use more Crinone than you should
It is not believed that cases of overdose can occur, as Crinone is administered via
single-dose applicator. However, in case of overdose, discontinue treatment with Crinone.

If you accidentally take too much Crinoneimmediately inform your doctor or
go to the nearest hospital.
If you forget to use Crinone
Do not take a double dose to make up for the missed dose.
If you forget to use Crinone for one day, continue with the normal dosage from the next day.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The majority of side effects detected in clinical studies could not be distinguished from the common
symptoms of early pregnancy. The following side effects have been reported in clinical studies, listed in order of
frequency:
Common (may affect up to 1 in 10 people):

• breast pain,
• dizziness.

Not known (frequency cannot be estimated from the available data):

• intermenstrual bleeding (spotting),
• vaginal irritation and other mild reactions at the application site, as well as hypersensitivity reactions that generally manifest as skin rash.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. You can also report side effects directly through the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse .
By reporting side effects you can help provide more information on the safety of this
medicine.

5. How to store Crinone

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after Exp.
The expiry date refers to the last day of that month.
Do not store at a temperature above 25°C. Do not freeze.
Do not use this medicine if you notice evident signs of deterioration of the packaging.
Do not scatter containers in the environment after use.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to eliminate the
medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Crinone contains

• The active ingredient is progesterone. Each single-dose applicator contains 90 mg of progesterone (equivalent to 8% w/w).
• The other ingredients are: glycerol, liquid paraffin, hydrogenated palm oil glycerides, carbopol 974P, sorbic acid (E200), polycarbophil, sodium hydroxide, purified water.

Description of the appearance of Crinone and contents of the pack
Crinone is a vaginal gel. Crinone is supplied in packs of 6 and 15 pre-filled single-dose applicators, each
individually sealed.
Each Crinone applicator contains 1.45 g of gel and releases 1.125 g of gel.
Not all pack sizes may be marketed.

Marketing authorisation holder and manufacturer
Marketing authorisation holder
Merck Serono S.p.A.
Via Casilina 125
00176 Rome

Manufacturer
Central Pharma (Contract Packaging) LTD.
Caxton Road, Bedford – United Kingdom
Millmount Healthcare Limited,
block-7, City North Business Campus
Stamullen, Co. Meath, K32 YD60
Ireland