Progesterone besins

Patient Information Leaflet

Warning! Keep this leaflet. The packaging information is in a foreign language!
Progesterone Besins (Progestan)
100 mg, soft capsules
Progesteronum
Progesterone Besins and Progestan are different brand names for the same medicine.
Please read this leaflet carefully before using the medicine, as it contains important information for the patient.

• 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 pass it on to others. It may harm someone else, even if their symptoms are the same.
• If you experience any adverse effects, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents

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

What Progesterone Besins is
This medicine contains progesterone, a natural female sex hormone produced by the body. This medicine works by regulating hormonal balance in the body. It provides progestagen hormone therapy.

What it is used for
This medicine is used when the patient has disorders caused by a lack of progesterone in the body. Your doctor may recommend this medicine in the following situations:

a) Progesterone deficiency
Low levels of progesterone produced by the ovaries (in the luteal phase). In this case, the medicine may be used to treat irregular menstrual cycles.

b) Complete cessation of menstruation (menopause)
As add-back therapy in hormone replacement therapy (HRT) in postmenopausal women who have an intact 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 tumour,

• if the patient has or is suspected of having a tumour of the breast or genital organs,

• if the patient has active venous thrombosis (blood clot in a vein), 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 inherited blood disorder called "porphyria".

• When using Progesterone Besins during the menopausal period in combination with another hormonal treatment, known as "estrogen", please also check the patient information leaflet of that estrogen medicine to see when that medicine should not be used.

Warnings and precautions
Before starting treatment with Progesterone Besins, discuss this with your doctor.

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

Tell your doctor if:

• the patient has had venous blood clots (venous thrombosis) in the past,
• the patient has uterine bleeding.

Discontinue taking this medicine if:

• any visual disturbances occur (e.g. loss of vision, double vision, pathological changes in retinal blood vessels),
• venous thromboembolic disease (venous thrombosis or embolism) occurs,
• severe headaches develop.

If the patient does not have a menstrual period during treatment, pregnancy should be ruled out.
During treatment, the endometrium (lining of the uterus) may become excessively thickened (endometrial hyperplasia), or existing hyperplasia may worsen.
If unexpected bleeding or spotting occurs during long-term treatment, at the end of treatment, or after treatment has ended and persists, consult your doctor.

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

Progesterone Besins and other medicines
Tell your doctor or pharmacist about all medicines currently used or recently used, as well as any medicines the patient plans to take.
Some medicines may affect the action of Progesterone Besins:

• medicines known as barbiturates, previously used 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).

Likewise, 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.

Taking Progesterone Besins with food and drink
This medicine should be taken independently of meals, preferably in the evening before bedtime.

Pregnancy, breastfeeding and fertility

If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult her doctor or pharmacist before using this medicine.

Pregnancy
If the patient is pregnant, suspects she may be pregnant, or is planning to become pregnant, she should consult her doctor before using this medicine or any other medicine.

Breastfeeding
Women who are breastfeeding should not use this medicine.
Before starting this medicine, discuss it with your doctor or pharmacist.

Fertility
This medicine may be used by women who have difficulty becoming pregnant. Therefore, this medicine has no harmful effect on fertility. Before starting this medicine, discuss it with your doctor or pharmacist.

Driving and using machines
Do not drive or operate machinery if drowsiness or dizziness occurs.

Progesterone Besins contains soya lecithin
This medicine contains soya lecithin (soya oil). Do not use if hypersensitivity to peanuts or soya has been diagnosed.

3. How to use Progesterone Besins

This medicine should always be used as directed by the physician. If in doubt, consult a doctor or pharmacist.
Progesterone Besins is available in the following doses: 100 mg, 200 mg.

Recommended dose for irregular menstrual bleeding

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

Recommended dose for menopausal hormone therapy

• In postmenopausal women with an intact uterus, estrogen therapy should not be used alone without concomitant treatment.
• Treatment should be supplemented with progesterone, administered as a single 200 mg dose before bedtime for at least 12 to 14 days per month (during the last 2 weeks of each treatment cycle).
• This should be followed by approximately one week without hormone therapy, during which withdrawal bleeding may occur.

How to take the capsules
The capsules should be swallowed with a small amount of water.
The capsules should not be taken with food.
It is best to take this medicine in the evening before bedtime. The second dose should be taken the next morning.

Overdose of Progesterone Besins
Seek immediate advice from a doctor or pharmacist.
Symptoms of overdose may include dizziness, fatigue, intense sense of well-being, or painful menstruation. In such cases, the dose may be reduced. Always consult a doctor beforehand.

Missed dose of Progesterone Besins
If a dose is missed, take it as soon as remembered. However, if it is almost time for the next dose, skip the missed dose. Do not take a double dose to make up for a missed dose.

Stopping treatment with Progesterone Besins
The doctor will inform the patient how long this medicine should be used. Do not stop treatment prematurely.
If there are any further doubts regarding the use of this medicine, consult a doctor or pharmacist.

4. Possible adverse reactions

Like any medicine, this medicine may cause adverse reactions, although not everyone experiences them.
You must stop taking this medicine immediately if the patient experiences:

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

The following adverse reactions are common (occurring in no more than 1 in 10 patients):

• headaches
• changes in the menstrual cycle or bleeding at times other than withdrawal bleeding. In such cases, the doctor may change the way the medicine is taken.

The following adverse reactions are uncommon (occurring in no more than 1 in 100 patients):

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

The following adverse reactions are rare (occurring in no more than 1 in 1,000 patients):

• allergic reactions
• nausea (feeling sick)

The following adverse reactions are very rare (occurring in no more than 1 in 10,000 patients):

• depression
• rash (which may be itchy)
• dark skin pigmentation or discoloration (so-called chloasma, pregnancy mask)

Additional adverse reactions reported with hormone replacement therapy containing estrogen and progestagen:

• benign or malignant estrogen-dependent tumor, e.g. endometrial cancer,
• venous thromboembolic events (venous thromboembolic disease) due to blood clots (thrombosis) in deep veins of the legs or pelvis, as well as pulmonary embolism 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 skin discoloration (chloasma), various skin disorders with blister and nodule formation (erythema multiforme, erythema nodosum, vasculitic purpura),
• possibly dementia.

If the treatment sequence is started too early in the cycle (especially before day 15 of the cycle)
The cycle may be shortened and bleeding may occur at a time other than withdrawal bleeding.

Reporting of adverse reactions
If any adverse symptoms occur, including any adverse symptoms not listed in this leaflet, the patient should inform a doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring of Adverse Drug Reactions at 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
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Progesterone Besins

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the stated month. The abbreviation "Lot" means batch number.
Do not store above 30°C.
Do not freeze.
Store in the original packaging to protect from moisture.
Do not use this medicine if you notice any visible signs of deterioration. Return the medicine to the pharmacist.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This helps protect the environment.

6. Contents of the pack and other information

What Progesterone Besins contains

• The active substance is progesterone. Each capsule contains 100 mg of progesterone in a soft capsule.
• The other ingredients are: soya lecithin, sunflower oil, titanium dioxide (E 171), gelatine, glycerol, purified water.

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, packed in PVC/Aluminium blisters in a cardboard box.
• Progesterone Besins 100 mg consists of round, slightly yellow soft capsules containing a white to off-white oily suspension.

For further information, please contact the marketing authorisation holder or the parallel importer.
Marketing authorisation holder in France, the country of export:
Besins Healthcare France
3 rue du Bourg l’Abbé
75003 Paris
France
Manufacturer:
Cyndea Pharma SL
Polígono Industrial Emiliano Revilla Sanz
Avenida de Ágreda, 31
42110 Ólvega (Soria)
Spain
Besins Manufacturing Belgium
128 Groot-Bijgaardenstraat
1620 Drogenbos
Belgium
Besins Manufacturing España
Poligono Industrial El Pitarco
Parcela 4
50450 Muel (Zaragoza)
Spain
Parallel importer:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Repackaged in:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Number of marketing authorisation in France, the country of export: 34009 362 088 4 1
362 088-4
34009 358 113 8 7
358 113-8
Parallel import authorisation number: 361/24
This medicinal product is authorised in the European Economic Area countries under the following names: