Progesterone Besins

Leaflet attached to the packaging: information for the patient

Warning! The leaflet should be kept. Information on the immediate packaging in a foreign language.

Progesterone Besins (Progestan), 100 mg, soft capsules

Progesterone
Progesterone Besins and Progestan are different trade names for the same drug.

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

• The leaflet should be kept so that it can be read again if necessary.
• In case of any doubts, the patient should consult a doctor or pharmacist.
• This drug has been prescribed to a specific person. It should not be given to others. The drug may harm another person, even if the symptoms of their illness are the same.
• If the patient experiences any adverse reactions, including any adverse reactions not listed in this leaflet, they should inform their doctor, pharmacist, or nurse. 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 drug contains progesterone, which is a natural female sex hormone produced by the body. The action of this drug is to regulate hormonal balance in the body. This drug is a progestogenic hormone therapy.

What is it used for

This drug is used if the patient has disorders caused by a lack of progesterone in the body. The doctor will recommend using this drug in the following situations:
a) Progesterone deficiency
The level of progesterone produced by the ovaries (in the luteal phase) is below normal. In this situation, the drug may be used to treat irregular menstrual 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 drug (listed in section 6),
• if the patient has vaginal bleeding of unknown cause,
• if the patient has severe liver dysfunction,
• 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 the veins (thrombophlebitis), 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.
• In the case of using Progesterone Besins during menopause in combination with other hormone therapy, so-called "estrogen", it is also necessary to check the information leaflet of that drug (estrogen) to see when not to use it.

Warnings and precautions

Before starting to take Progesterone Besins, the patient should discuss it with their doctor.

• This drug, when used as recommended, does not have a contraceptive effect.
• Before starting hormone replacement therapy during menopause (and later at regular annual intervals), the patient 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.

The patient should tell their doctor if:

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

The patient should stop taking this drug if:

• they experience any vision disorders (e.g. vision loss, double vision, pathological changes in the blood vessels of the retina),
• they have blood clots (thromboembolic disease) or thrombosis,
• they 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 prolonged treatment, at the end of treatment, or after stopping treatment, unexpected bleeding or spotting occurs, the patient should consult their doctor.

Children

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

Progesterone Besins and other drugs

The patient should tell their doctor or pharmacist about all drugs they are currently taking or have recently taken, as well as any drugs they plan to take.
Some drugs may affect the action of Progesterone Besins:

• drugs called barbiturates, used in the past for sleep disorders or anxiety treatment,
• drugs used for epilepsy (phenytoin, carbamazepine),
• certain antibiotics (ampicillin, tetracyclines, rifampicin),
• phenylbutazone (an anti-inflammatory drug),
• spironolactone (a diuretic),
• certain antifungal drugs (ketoconazole, griseofulvin).

Similarly, Progesterone Besins may affect the action of certain drugs used to treat diabetes.
Herbal products containing St. John's Wort (Hypericum perforatum) may weaken the action of Progesterone Besins.

Using Progesterone Besins with food and drink

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

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before using this drug.
Pregnancy
If the patient is pregnant, thinks they may be pregnant, or plans to become pregnant, they should consult their doctor before using this drug or any other drug.
Breastfeeding
Women who are breastfeeding should not use this drug.
Before starting to take this drug, the patient should discuss it with their doctor or pharmacist.
Fertility
This drug may be taken by women who have problems getting pregnant. Therefore, this drug does not have a harmful effect on fertility.
Before starting to take this drug, the patient should discuss it with their doctor or pharmacist.

Driving and using machines

The patient should not drive or operate machines if they experience drowsiness or dizziness.

Progesterone Besins contains soybean lecithin

The drug contains soybean lecithin (soybean oil). It should not be used in case of known hypersensitivity to peanuts or soy.

3. How to use Progesterone Besins

This drug should always be used as recommended by the doctor. In case of doubts, the patient should consult their doctor or pharmacist.
Progesterone Besins is available in doses of 100 mg and 200 mg.

Recommended dose in case of irregular menstrual bleeding

• The drug 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 other therapy.
• Treatment should be supplemented with progesterone taken in a single dose of 200 mg before bedtime for at least 12 to 14 days a month (during the last 2 weeks of each treatment sequence).
• Then, for about a week without replacement therapy, during which time 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 drug 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

The patient should immediately consult their doctor or pharmacist.
Overdose symptoms may occur, which include dizziness, fatigue, intense feelings of well-being, or painful menstruation. In such a case, the dose can be reduced. The patient should always consult their doctor first.

Missing a dose of Progesterone Besins

A missed dose of the drug should be taken as soon as possible after remembering. However, if it is almost time for the next dose, the missed dose should be skipped.
A double dose should not be taken to make up for a missed dose.

Stopping the use of Progesterone Besins

The doctor will inform the patient how long to use this drug. The patient should not stop treatment prematurely.
In case of any further doubts about using this drug, the patient should consult their doctor or pharmacist.

4. Possible side effects

Like all drugs, this drug can cause side effects, although not everybody gets them.

The patient should stop using this drug immediately if they experience:

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

The following side effects are common (occurring in up to 1 in 10 patients):

• headaches,
• changes in the menstrual cycle or bleeding at a different time than withdrawal bleeding. In such a case, the doctor may change the way the drug is taken.

The following side effects are uncommon (occurring in up to 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)
• skin itching, acne

The following side effects are rare (occurring in up to 1 in 1,000 patients):

• allergic reactions
• nausea

The following side effects are very rare (occurring in up to 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 progestogen:

• 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 lower limbs 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),
• likely 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 the patient experiences any side effects, including any side effects not listed in the leaflet, they should inform their doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the 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, more information can be collected on the safety of the drug.

5. How to store Progesterone Besins

The drug should be stored in a place that is out of sight and reach of children.
The drug should not be used after the expiration date stated on the packaging. The expiration date is the last day of the specified month.
The drug should not be stored at a temperature above 30°C. It should not be frozen. The drug should be stored in its original packaging to protect it from moisture.
The drug should not be used if visible signs of deterioration are observed. The drug should be returned to the pharmacist.
Drugs should not be thrown away into the sewage system or household waste containers. The patient should ask their pharmacist how to dispose of unused drugs. This will help protect the environment.

6. Contents of the packaging and other information

What Progesterone Besins contains

• The active substance of the drug is progesterone. One capsule contains 100 mg of progesterone in a soft capsule.
• The other ingredients are: soybean lecithin, sunflower oil, coating: titanium dioxide (E 171), gelatin, glycerol, purified water.

What Progesterone Besins looks like and what the packaging contains

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

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

Marketing authorization holder in France, the country of export:

Besins Healthcare France
3, Rue du Bourg l’Abbé 75003 Paris, France

Manufacturer:

Besins Manufacturing Belgium
128 Groot-Bijgaardenstraat
1620 Drogenbos
Belgium

Parallel importer:

Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź

Repackaged by:

Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź
Authorization number in France, the country of export:
34009 362 088 4 1
34009 358 113 8 7

Parallel import authorization number: 217/25

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

Date of leaflet approval: 25.06.2025

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