Crinone

Package leaflet: Information for the user

Crinone, 80 mg/g, vaginal gel
Progesteronum
Please read the entire leaflet carefully before using this medicine, as it contains important information for you.

• Keep this leaflet for future reference.
• If you have any questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not share it with others. This medicine may harm other people, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Contents of the leaflet

1. What Crinone is and what it is used for
2. Important information 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 Crinone is and what it is used for

Crinone contains a hormone called progesterone. After the gel is inserted into the vagina, progesterone is slowly released into the bloodstream throughout the day.
Crinone is used to provide additional progesterone during assisted reproductive technology procedures. This helps the patient achieve pregnancy.
You may also be asked to continue using Crinone to support an established pregnancy.

2. Important information before using Crinone

When not to use Crinone

• if the patient is allergic to progesterone or any of the other ingredients of this medicine (listed in section 6);
• if the patient has unexplained vaginal bleeding;
• if the patient has porphyria (an inherited disorder impairing the breakdown of certain substances (porphyrins) in the blood);
• if the patient has or suspects she has a tumour of the breast or reproductive organs;
• if the patient has ever had a blood clot associated with vein swelling (venous thrombosis), blockage of blood vessels (thromboembolic disorder), or stroke;
• if the patient is pregnant but the baby has died before birth (missed abortion).

Do not use Crinone if any of the above situations apply to the patient. If in doubt, consult a doctor or pharmacist before using this medicine.

Warnings and precautions
Before starting treatment, talk to your doctor if any of the following situations apply to you. Your doctor may wish to monitor you more closely during treatment:

• if the patient has impaired liver or kidney function;
• if the patient has heart disease or diabetes;
• if the patient has asthma;
• if the patient has epilepsy or frequently suffers from migraines;
• if the patient has ever had depression.

Tell your doctor if any unexpected bleeding occurs, so that the cause can be diagnosed.

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

Examinations and monitoring
Before starting treatment and periodically during treatment, check-up visits and medical examinations are required, particularly:

• before treatment, the doctor must perform a cervical smear test and examine the breasts and the pelvic area;
• during treatment, the doctor will investigate any uterine abnormalities, such as thickening of the uterine lining (endometrial hyperplasia). The doctor will also monitor the patient for possible symptoms of blood clots in blood vessels.

Crinone and other medicines
Do not use Crinone at the same time as other medicines intended for vaginal use.
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines she plans to take.

Pregnancy and breastfeeding

• Crinone is intended for use during medically assisted reproduction procedures. The patient may also be advised to continue using the medicine to maintain pregnancy.
• Crinone is not recommended during breastfeeding.

Driving and operating machinery
Crinone may cause marked fatigue. If this occurs, the patient should not drive or operate machinery. Alcohol may worsen the feeling of fatigue.

Crinone contains sorbic acid
Crinone contains sorbic acid. This medicine may cause local skin reactions (e.g. contact dermatitis). Local skin reactions may also occur in the sexual partner’s genital area if intercourse takes place during treatment with Crinone. These reactions can be avoided by using condoms.

3. How to use Crinone

This medicine should always be used exactly as directed by the physician. In case of doubt, consult
your doctor or pharmacist.
Recommended dose
Starting on the day of embryo transfer, the contents of one Crinone applicator should be administered vaginally every day, preferably in the morning. If test results confirm that the patient is pregnant, she may be advised to continue using Crinone to maintain the pregnancy for a total period of 30 days.
The applicator is designed to deliver the exact amount of gel (1.125 g containing 90 mg of progesterone). A small amount of gel may remain in the applicator. This may be discarded, as the patient has already received the full required dose.
Method of administration
This medicine is intended for vaginal use only, using the pre-filled applicator supplied in the package.
Before using the applicator, please read the instructions below.

What the applicator looks like

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

Preparing the applicator
Holding the applicator by the thick end between thumb and forefinger, point the thin end downward and shake the applicator gently so that all the gel inside moves toward the thin end.
Opening the applicator
Holding the applicator by the flat part of the thick end, unscrew and remove the cap from the opposite, thin end. Do not press the air reservoir at the thick end at this stage, to prevent the gel from being expelled prematurely.
Inserting the applicator
Lean back or lie down with knees bent and slightly apart. Gently insert the applicator into the vagina deeply enough so that your hand touches the body.
Firmly press the air reservoir at the thick end of the applicator to release the gel from the applicator into the vagina.
After using the applicator
Dispose of the applicator, including the small amount of gel remaining inside. Each applicator should be used only once.
Crinone gel may remain in the vagina for several days. During this time, a beige or brownish, lumpy or white, cloudy discharge may occur. This is not a cause for concern.
Use of a higher than recommended dose of Crinone
It is unlikely that the patient would receive an overdose, as each applicator contains the correct dose of medicine.
Missed dose of Crinone
Do not use a double dose to make up for a missed dose.
If a dose of Crinone is missed on one day, continue treatment the next day with the usual single dose.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine may cause adverse reactions, although not everybody will experience them.
Allergic reactions
If an allergic reaction occurs, stop using Crinone and contact your doctor immediately.
For example, itchy skin rash, swelling of the vulva, breasts or face may occur. The likelihood of occurrence of an adverse reaction is unknown.
Other adverse reactions
Common (may affect up to 1 in 10 users):

• headache,
• drowsiness,
• stomach or intestinal pain or cramps,
• breast tenderness,
• intermenstrual bleeding (spotting),
• irritation or other mild reactions in the vagina or vaginal area.

Please note
Crinone gel may remain in the vagina for several days. During this time, a beige or brownish, lumpy or white, cloudy discharge may appear, which may cause irritation, pain or swelling of the vagina, but this is not a cause for concern.
If any adverse symptoms occur, including any adverse symptoms not listed in this leaflet, inform your doctor or pharmacist.
Reporting of adverse reactions
If any adverse symptoms occur, including any adverse symptoms not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
By reporting adverse reactions, additional information on the safety of the medicine can be collected.

5. How to store Crinone

Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the outer box and the immediate
packaging.
Do not store above 25°C. Do not freeze.
Each applicator should be used only once. Any gel remaining in the applicator should be discarded.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures will help protect the environment.

6. Contents of the packaging and other information

What Crinone contains

• The active substance is progesterone. Each applicator releases 1.125 g of vaginal gel containing 90 mg of progesterone.
• The other ingredients are: glycerol, liquid paraffin, hydrogenated glyceryl palmate, carbomer 974P, sorbic acid (E 200), polycarbophil, sodium hydroxide, and purified water.

What Crinone looks like and contents of the pack
Crinone is a smooth, white or almost white gel. It is contained in a single-dose applicator made of PE, with a twist-off cap, protected in a foil packaging made of Paper/Aluminium/Ionomer resin, and packed in a cardboard box.
Crinone is available in packs containing 6 or 15 single-dose applicators.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Merck Sp. z o.o.
Al. Jerozolimskie 142B
02-305 Warszawa
Poland

Logo of the Marketing Authorisation Holder

Manufacturer
Catalent France Beinheim
74, rue Principale
Beinheim, 67930
France

This medicinal product is authorised in the European Economic Area countries under the following names:
Bulgaria: Кринон 80 mg/g вагинален гeл
Croatia: Crinone 80 mg/g gel za rodnicu
Estonia: Crinone 80 mg/g vaginaalgeel
France: Crinone 80 mg/g gel vaginal
Germany: Crinone 8% Vaginalgel
Latvia: Crinone 80 mg/g vaginālais gels
Lithuania: Crinone 80 mg/g makšties gelis
Netherlands: Crinone 80 mg/g gel voor vaginaal gebruik
Poland: Crinone
Romania: Crinone 80 mg/g gel vaginal
Slovenia: Crinone 80 mg/g vaginalni gel