Progesterone Besins

Package Leaflet: Information for the Patient

Progesterone Besins, 100 mg Soft Capsules

Progesterone Besins, 200 mg Soft Capsules

Progesterone (micronized)

Read the package leaflet carefully before taking 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.
• 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 Progesterone Besins and what is it used for
• 2. Important information before taking Progesterone Besins
• 3. How to take Progesterone Besins
• 4. Possible side effects
• 5. How to store Progesterone Besins
• 6. Contents of the pack 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 progestogenic 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 taking 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 menstrual periods.
b) Complete cessation of menstruation (menopause)
Supplementary treatment in hormone replacement therapy for women in menopause with a preserved uterus.

2. Important information before taking Progesterone Besins

When not to take 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 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.
• 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 take it.

Warnings and precautions

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

• This medicine, when taken as recommended, does not have a contraceptive effect.
• Before starting hormone replacement therapy during menopause (and later at regular annual intervals), you should consult your 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.

Tell your doctor if:

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

Stop taking this medicine if:

• you experience any vision disturbances (e.g. limited vision, double vision, pathological changes in the blood vessels of the retina),
• you have blood clots (thromboembolic disease) or thrombosis,
• you have severe headaches.

If the patient experiences a lack of menstruation during treatment, they should ensure they are not pregnant.
The endometrium may start to grow excessively (endometrial hyperplasia) or this growth may worsen during treatment.
If, during prolonged treatment, at the end of treatment, or after stopping treatment, unexpected bleeding or spotting occurs and persists, consult your doctor.

Children

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

Progesterone Besins and other medicines

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 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 effect of Progesterone Besins.

Taking 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, consult your doctor or pharmacist before taking this medicine.
Pregnancy
If you are pregnant, think you may be pregnant, or plan to become pregnant, consult your doctor before taking this medicine or any other medicine.
Breastfeeding
Women who are breastfeeding should not take this medicine.
Before starting to take this medicine, 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, discuss it with your doctor or pharmacist.

Driving and using machines

Do not drive or operate machinery if you experience drowsiness or dizziness.

Progesterone Besins contains soybean lecithin

The medicine contains soybean lecithin (soybean oil). Do not take if you are hypersensitive to peanuts or soy.

3. How to take Progesterone Besins

This medicine should always be taken exactly as your doctor has told you. If you are unsure, consult your doctor or pharmacist.

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, 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 time withdrawal bleeding may occur.

How to take the capsules

Swallow the capsules with a small amount of water.
Do not take the capsules with food.
This medicine is best taken in the evening before bedtime. The second dose should be taken the next morning.

What to do if you take more Progesterone Besins than you should

Consult your doctor or pharmacist immediately.
Overdose symptoms may occur, including dizziness, fatigue, intense feeling of well-being, or painful menstruation. In such a case, the dose can be reduced. Always consult your doctor first.

What to do if you miss a dose of Progesterone Besins

Take the missed dose as soon as you remember. However, if it is almost time for the next dose, skip the missed dose.
Do not take a double dose to make up for the missed dose.

What to do if you stop taking Progesterone Besins

Your doctor will tell you how long to take this medicine. Do not stop treatment prematurely.
If you have any further doubts about taking this medicine, consult your doctor or pharmacist.

4. Possible side effects

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

Stop taking 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 times other 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 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 legs or pelvis, as well as pulmonary embolism, which occur more frequently in women taking hormone replacement therapy than in women who do not take 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 time other than withdrawal bleeding.

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 Drug Safety Monitoring 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
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Progesterone Besins

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton after "EXP". The expiry date refers to the last day of the month.
The batch number is indicated by "Lot".
Do not store above 30°C.
Do not freeze.
Store in the original package to protect from moisture.
Do not use this medicine if you notice visible signs of deterioration. Return the medicine to your pharmacist.
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 pack and other information

What Progesterone Besins contains

• The active substance is progesterone in micronized form. One capsule contains 100 mg or 200 mg in a soft capsule.
• The other ingredients are: soybean lecithin, purified sunflower oil, titanium dioxide (E171), gelatin, glycerol.

What Progesterone Besins looks like and contents of the pack

• Progesterone Besins, 100 mg is available in packs of 30 or 90 soft capsules for oral use, packaged in blisters and cardboard boxes.
• Progesterone Besins, 200 mg is available in packs containing 15, 30, 45, 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 oily suspension.
• Progesterone Besins, 200 mg are oval, slightly yellow soft capsules containing a white oily suspension.
• Not all pack sizes may be marketed.

Marketing authorization holder

Besins Healthcare S.A.
Rue Washington 80
1050 Ixelles
Belgium

Manufacturer

Cyndea Pharma S.L.
Polígono Industrial Emiliano Revilla Sanz
Avenida de Ágreda, 31
42110 Ólvega (Soria)
Spain
or
Besins Manufacturing España S.L.
Polígono industrial el Pitarco,
Parcela 4, Muel,
50450 Zaragoza
Spain

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

Date of last revision of the leaflet: 10/2024