Crinone

PATIENT INFORMATION LEAFLET

Leaflet attached to the packaging: information for the user

Crinone, 80 mg/g, vaginal gel

Progesterone

Read the leaflet carefully before using the medicine, as it contains important information for the patient.

• Keep this leaflet, so you can read it again if you need to.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same as yours.
• If the patient experiences any side effects, including any not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is Crinone and what is it 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 packaging and other information

1. What is Crinone and what is it used for

Crinone contains the hormone progesterone. After the gel is inserted into the vagina, progesterone is slowly released into the bloodstream throughout the day.
Crinone is used to provide the patient with additional progesterone during medical fertility treatment. This is to help the patient become pregnant.
The patient may also be asked to continue using Crinone to maintain the 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 (a hereditary disorder of porphyrin metabolism in the blood);
• if the patient has or suspects they have breast or genital cancer;
• if the patient has ever had a blood clot associated with swelling of the veins (thrombophlebitis), blockage of blood vessels (thromboembolic disorders), or a stroke;
• if the patient is pregnant, but the fetus has died before birth (missed abortion). Do not use Crinone if any of the above situations apply to the patient. If in doubt, consult your doctor or pharmacist before using the medicine.

Warnings and precautions

Before starting treatment, consult your doctor if any of the following situations apply to the patient. The doctor may want to monitor the patient more closely during treatment:

• if the patient has liver or kidney problems;
• if the patient has heart disease or diabetes;
• if the patient has asthma;
• if the patient has epilepsy or frequent migraines;
• if the patient has ever had depression.

Tell your doctor if you experience any unexpected bleeding, so the doctor can diagnose the cause.

Children and adolescents

Crinone is not intended for use in children and adolescents.

Examinations and checks

Before using the medicine and periodically during treatment, it is necessary to undergo check-ups and tests, in particular:

• before using the medicine, the doctor will need to perform a cervical smear and examine the breasts and pelvic area;
• during treatment, the doctor will explain any abnormalities related to the uterus, such as thickening of the uterine lining (endometrial hyperplasia). The doctor will also monitor the patient for signs of blood clots in the blood vessels.

Crinone and other medicines

Do not use Crinone at the same time as other medicines inserted into the vagina.
Tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.

Pregnancy and breastfeeding

• Crinone is intended for use during medical fertility treatment. The patient may also be asked to continue using Crinone to maintain the pregnancy.
• It is not recommended to use Crinone during breastfeeding.

Driving and using machines

During treatment with Crinone, drowsiness may occur. In this case, do not drive or operate machinery. Drinking alcohol may increase drowsiness.

Crinone contains sorbic acid

Crinone contains sorbic acid. The medicine may cause local skin reactions (e.g., contact dermatitis). Local skin reactions may also occur on the genitals of the partner if the patient has intercourse during treatment with Crinone. This can be prevented by using condoms.

3. How to use Crinone

This medicine should always be used exactly as directed by your doctor. If you are unsure, consult your doctor or pharmacist.

Recommended dose

Starting from the day of embryo transfer, insert one Crinone applicator into the vagina every day, preferably in the morning. If the test results confirm that the patient is pregnant, the patient may be asked to continue using Crinone to maintain the pregnancy – for a total 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 is expected to remain in the applicator. This can be discarded, as the patient has received the full dose of the medicine.

Method of administration

This medicine is for vaginal use only, using the pre-filled applicator provided in the packaging.
Before using the applicator, read the following instructions carefully.

Description of the applicator

• 1. air chamber
• 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 the thumb and index finger, point the thin end of the applicator downwards and shake the applicator so that all the gel inside moves towards the thin end.

Opening the applicator

Holding the applicator by the flat part of the thick end, twist and remove the cap from the opposite, thin end. At this stage, do not press the air chamber on the thick end to avoid releasing the gel before use.

Inserting the applicator

Lean back or lie down with your knees slightly bent and apart. Carefully insert the applicator into the vagina as far as it will go, until your hand touches your body.
Press the air chamber on the thick end of the applicator firmly to release the gel from the applicator into the vagina.

After using the applicator

Discard the applicator, along with the small amount of gel remaining in it. Use each applicator only once.
The Crinone gel may remain in the vagina for several days. During this time, a beige or brown, grainy or white, cloudy discharge may appear. Do not worry about this.

Using more Crinone than recommended

It is unlikely that the patient will take too much medicine, as each applicator contains the correct dose.

Missing a dose of Crinone

Do not take a double dose to make up for a missed dose.
If a dose of Crinone is missed on one day, continue treatment with the usual single dose the next day.
If you have any further doubts about using this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, Crinone can cause side effects, although not everybody gets them.

Allergic reactions

If an allergic reaction occurs, stop using Crinone and consult your doctor immediately. This may include an itchy skin rash, swelling of the vulva, breasts, and face. The frequency of this side effect is not known.

Other side effects

Common(may affect up to 1 in 10 patients):

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

Remember

The Crinone gel may remain in the vagina for several days. During this time, a beige or brown, grainy or white, cloudy discharge may appear, which may cause irritation, pain, or swelling of the vagina, but do not worry about this.
If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist.

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Medicinal Product Monitoring, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
tel.: + 48 22 49 21 301
fax: + 48 22 49 21 309
website: https://smz.ezdrowie.gov.pl .
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of this medicine.

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 carton and blister pack.
Do not store above 25°C. Do not freeze.
Use each applicator only once. Discard the gel remaining in the applicator.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This 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 into the vagina.
• The other ingredients are: glycerol, liquid paraffin, hydrogenated palm oil glycerides, 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 off-white gel. It is provided in a single-dose applicator with a twist-off cap, in a protective foil pouch, in a cardboard carton.
Crinone is available in packs containing 6 or 15 single-dose applicators.
Not all pack sizes may be marketed.

Marketing authorization holder

Merck Sp. z o.o.
Al. Jerozolimskie 142B
02-305 Warsaw
Poland
Logo of the marketing authorization holder

Manufacturer

Catalent France Beinheim
74, rue Principale
Beinheim, 67930
France

This medicine is authorized in the Member States of the European Economic Area 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

Date of last revision of the leaflet: June 2024