Progesterone Besins

Leaflet accompanying the packaging: patient information

Warning! Keep the leaflet! Information on the immediate packaging in a foreign language.

Progesterone Besins(Utrogestan 100 mg)

100 mg, soft capsules

Progesterone (micronized)
Progesterone Besins and Utrogestan 100 mg are different trade names for the same drug.

You should carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient.

• You should keep this leaflet so that you can read it again if necessary
• In case of any doubts, you should consult a 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.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is Progesterone Besins and what is it used for
• 2. Important information before using Progesterone Besins
• 3. How to use Progesterone Besins
• 4. Possible side effects
• 5. How to store Progesterone Besins
• 6. Contents of the packaging and other information

1. What is Progesterone Besins and what is it used for

What is Progesterone Besins

The medicine contains progesterone, which is a natural female sex hormone produced by the body. The action of this medicine is to regulate hormonal balance in the body. This medicine is a progestagen hormone therapy.

What is it used for

This medicine is used if the patient has disorders caused by a lack of progesterone in the body. The doctor will recommend using this medicine in the following situations:
a) Progesterone deficiency
The concentration of progesterone produced by the ovaries (in the luteal phase) is below normal. In this situation, this medicine may be used to treat irregular periods.
b) Complete cessation of menstruation (menopause)
Supplementary treatment in hormone replacement therapy in women during menopause with a preserved uterus.

2. Important information before using Progesterone Besins

When not to use Progesterone Besins:

• if the patient is allergic to progesterone or any of the other ingredients of this medicine (listed in section 6),
• if the patient has vaginal bleeding of unknown cause,
• if the patient has severe liver function disorders,
• if the patient has a liver tumor,
• if the patient has or is suspected of having breast or genital cancer,
• if the patient has active blood clots in a vein (thromboembolism), e.g. in the legs (deep vein thrombosis) or lungs (pulmonary embolism), or if the patient has had such blood clots in the past,
• if the patient has bleeding into the brain,
• if the patient has a rare blood disease called "porphyria", which is inherited.
• If Progesterone Besins is used during menopause in combination with another hormone treatment, so-called "estrogen", you should also check the package leaflet of that medicine (estrogen) to see when not to use it.

Warnings and precautions

Before starting to take Progesterone Besins, you should discuss it with your doctor.

• This medicine used as directed does not have a contraceptive effect.
• Before starting hormone replacement therapy during menopause (and later at regular annual intervals), you should consult a doctor who will perform a breast and pelvic examination.
• If treatment with Progesterone Besins is started too early in the month, especially before the 15th day of the cycle, the cycle may be shortened or bleeding may occur.

You should tell your doctor if:

• you have had blood clots in the veins (venous thrombosis) in the past,
• you have uterine bleeding.

You should stop taking this medicine if:

• you experience any vision disturbances (e.g. vision loss, double vision, vascular changes in the retina),
• you have blood clots (thromboembolic disease),
• you have severe headaches.

If the patient experiences a lack of menstruation during treatment, they should make sure they are not pregnant.
During treatment, the uterine lining may start to grow excessively (endometrial hyperplasia) or this growth may worsen.
If during long-term treatment, at the end of treatment or after stopping treatment, unexpected bleeding or spotting occurs, which persists, you should consult a doctor.

Children

The efficacy and safety of using Progesterone Besins in children have not been established.

Progesterone Besins and other medicines

You should 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.
Some medicines may affect the action of Progesterone Besins:

• barbiturates, used in the past for sleep disorders or to treat anxiety,
• medicines used for epilepsy (phenytoin, carbamazepine),
• certain antibiotics (ampicillin, tetracyclines, rifampicin),
• phenylbutazone (an anti-inflammatory medicine),
• spironolactone (a diuretic),
• certain antifungal medicines (ketoconazole, griseofulvin).
• Similarly, Progesterone Besins may affect the action of certain medicines used to treat diabetes.

Herbal products containing St. John's Wort ( Hypericum perforatum) may reduce the effectiveness of Progesterone Besins.

Using Progesterone Besins with food and drink

The medicine should be taken regardless of meals, preferably in the evening before bedtime.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, you should consult your doctor or pharmacist before using this medicine.
Pregnancy
If you are pregnant, think you may be pregnant, or plan to become pregnant, you should consult your doctor before using this medicine or any other medicine.
Breastfeeding
Women who are breastfeeding should not use this medicine.
Before starting to take this medicine, you should discuss it with your doctor or pharmacist.
Fertility
This medicine may be taken by women who have problems getting pregnant. Therefore, this medicine does not have any harmful effect on fertility.
Before starting to take this medicine, you should discuss it with your doctor or pharmacist.

Driving and using machines

You should not drive or operate machinery if you experience drowsiness or dizziness.

Progesterone Besins contains soya lecithin

The medicine contains soya lecithin (soya oil). Do not use if you are hypersensitive to peanuts or soya.

3. How to use Progesterone Besins

This medicine should always be used as directed by your doctor. If you are unsure, you should consult your doctor or pharmacist.
Progesterone Besins is available in strengths of 100 mg and 200 mg.

Recommended dose for irregular menstrual bleeding

• The medicine should be taken for 10 days in the cycle, usually from the 17th to the 26th day inclusive.
• The dose usually ranges from 200 to 300 mg of progesterone per day, taken in 1 or 2 divided doses, i.e. 200 mg in the evening before bedtime and 100 mg in the morning of the next day, if necessary.

Recommended dose for menopause treatment

• In women during menopause with a preserved uterus, it is not recommended to use estrogen alone without combination with another treatment.
• Treatment should be supplemented with progesterone taken in a single dose of 200 mg before bedtime for at least 12 to 14 days per month (during the last 2 weeks of each treatment sequence).
• Then, for about a week without replacement therapy, during which withdrawal bleeding may occur.

How to take the capsules

The capsules should be swallowed, washed down with a small amount of water.
The capsules should not be taken with food.
This medicine is best taken in the evening before bedtime. The second dose should be taken the next morning.

Using a higher dose of Progesterone Besins than recommended

You should consult your doctor or pharmacist immediately.
Overdose symptoms may occur, which include dizziness, fatigue, intense feeling of well-being, or painful periods. In such a case, the dose can be reduced. You should always consult your doctor first.

Missing a dose of Progesterone Besins

A missed dose should be taken as soon as you remember. However, if it is almost time for the next dose, you should skip the missed dose.
You should not take a double dose to make up for a missed dose.

Stopping treatment with Progesterone Besins

Your doctor will inform you how long to use this medicine. You should not stop treatment prematurely.
If you have any further doubts about using this medicine, you should consult your doctor or pharmacist.

4. Possible side effects

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

You should stop using this medicine immediately if you experience:

• stroke, blood clots, or internal bleeding into the brain
• blood clots in the veins of the legs or pelvis
• sudden severe headache
• vision disturbances
• yellowing of the skin or whites of the eyes (jaundice)

The following side effects are common (occurring in less than 1 in 10 patients):

• headaches,
• changes in menstrual cycle or bleeding at a different time than withdrawal bleeding. In such a case, your doctor may change the way you take the medicine.

The following side effects are uncommon (occurring in less than 1 in 100 patients):

• changes in the breasts, breasts may become tender
• feeling of fatigue or dizziness
• nausea (vomiting), diarrhea, constipation
• yellowing of the skin or whites of the eyes (jaundice)
• itching of the skin, acne

The following side effects are rare (occurring in less than 1 in 1000 patients):

• allergic reactions
• nausea (nausea)

The following side effects are very rare (occurring in less than 1 in 10,000 patients):

• depression
• rash (which may be itchy)
• darkening or discoloration of the skin (chloasma, pregnancy mask)

Additional side effects reported in connection with hormone replacement therapy containing estrogen and progestagen:

• estrogen-dependent benign or malignant tumor, e.g. endometrial cancer,
• blood clots in the veins (venous thromboembolic disease) due to the occurrence of blood clots (thrombosis) in the deep veins of the legs or pelvis, as well as pulmonary embolism, which occur more frequently in women using hormone replacement therapy than in women who do not use it,
• heart attack (myocardial infarction) and stroke,
• gallbladder disorders,
• brownish discoloration of the skin (chloasma), various skin disorders with blistering and nodules (erythema multiforme, nodular erythema, vascular purpura),
• possibly dementia.

If the treatment sequence is started too early in the month (especially before the 15th day of the cycle)

15. day of the cycle

The cycle may be shortened and bleeding may occur at a different time than withdrawal bleeding.

Reporting side effects

If you experience any side effects, including any side effects not listed in the leaflet, you should tell your doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, 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.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Progesterone Besins

The medicine should be stored out of sight and reach of children.
You should not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the month.
There are no special storage temperature recommendations.
Store in the original packaging.
You should not use this medicine if you notice visible signs of deterioration. The medicine should be returned to the pharmacist.
Medicines should not be disposed of via wastewater or household waste. You should 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 Progesterone Besins contains

• The active substance of the medicine is micronized progesterone. One capsule contains 100 mg of progesterone.
• The other ingredients are: soya lecithin, sunflower oil; capsule: titanium dioxide (E 171), gelatin, glycerol, purified water.

What Progesterone Besins looks like and what the packaging contains

• Progesterone Besins is available in packs of 30 or 90 soft capsules for oral use, packaged in blisters and cardboard boxes.
• Progesterone Besins, 100 mg, are round, slightly yellow soft capsules, containing a white suspension.

For more detailed information, you should contact the marketing authorization holder or parallel importer.

Marketing authorization holder in Belgium, the country of export:

Besins Healthcare SA
Rue Washington 80
1050 Ixelles
Belgium

Manufacturer:

CYNDEA PHARMA S.L.
Polígono Industrial Emiliano Revilla Sanz
Avenida de Ágreda, 31
42110 Olvega (Soria)
Spain
DELPHARM DROGENBOS SA
Groot-Bijgaardenstraat, 128
1620 Drogenbos
Belgium

Parallel importer:

InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw

Repackaged by:

InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Marketing authorization number in Belgium, the country of export:BE 117923

Parallel import authorization number: 400/22

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Belgium
Progesteron Besins 100 mg, capsule molles
Luxembourg
Progestérone Besins 100 mg, capsule molles
Netherlands
Progesteron Besins 100 mg, zacht capsules
Poland
Progesterone Besins 100 mg, soft capsules
Germany
Utrogest 100 mg, Weichkapseln
Date of revision of the leaflet: 07.11.2022
[Information about the trademark]