Progesterone besins

Package leaflet: Information for the user

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

• Keep this leaflet, so that you can read it again if necessary.
• If you have any doubts, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm other people, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor, pharmacist or nurse. See section 4.

Table of contents of the leaflet

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
The medicine contains progesterone, which is a natural female sex hormone produced by the body. This medicine acts by regulating hormonal balance in the body. It provides hormonal progestagen therapy.
What it is used for
This medicine is used if the patient has disorders caused by a lack of progesterone in the body. Your doctor may 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 case, this medicine may be used to treat irregular menstruation.
b) Complete cessation of menstruation (menopause)
As supplementary treatment in hormone replacement therapy in postmenopausal women who still have their uterus.

2. Important information before taking Progesterone Besins

When not to take Progesterone Besins:

• if you are allergic to progesterone or to any of the other ingredients of this medicine (listed in section 6),
• if you have vaginal bleeding of unknown cause,
• if you have severe liver function disorders,
• if you have a liver tumour,
• if you have or are suspected of having a tumour of the breast or genital organs,
• if you have active venous thrombosis (blood clot in a vein), e.g. in the legs (deep vein thrombosis) or in the lungs (pulmonary embolism), or if you have had such blood clots in the past,
• if you have cerebral haemorrhage,
• if you have a rare inherited blood disorder called "porphyria".
• If Progesterone Besins is used during menopause in combination with another hormonal treatment, known as "estrogen", you should also check the patient information leaflet of that estrogen medicine to see when it should not be used.

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

• This medicine, when used as directed, does not have contraceptive effects.
• Before starting hormone therapy during menopause (and subsequently at regular annual intervals), you should 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 menstrual cycle, especially before day 15, the cycle may be shortened or breakthrough bleeding may occur.

Tell your doctor if:

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

Stop taking this medicine if you experience:

• any visual disturbances (e.g. loss of vision, double vision, retinal vascular lesions),
• blood clots (venous thromboembolic or thrombotic disease),
• severe headaches.

If you do not have a menstrual period during treatment, you should confirm whether you are pregnant.
During treatment, the endometrium (uterine lining) 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 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:

• medicines called barbiturates, previously used for sleep disorders or anxiety,
• medicines used for epilepsy (phenytoin, carbamazepine),
• some antibiotics (ampicillin, tetracyclines, rifampicin),
• phenylbutazone (an anti-inflammatory medicine),
• spironolactone (a diuretic),
• some 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.
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 you are pregnant or breastfeeding, think you may be pregnant or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.
Pregnancy
If you are pregnant, think you may be pregnant, or are planning to become pregnant, consult your 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 taken by women who have difficulty becoming pregnant. Therefore, this medicine does not have any 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 you have been diagnosed with hypersensitivity to peanuts or soya.

3. How to use Progesterone Besins

This medicine should always be used as directed by the physician. In case of doubt, consult your
doctor or pharmacist.
Progesterone Besins is available in 100 mg and 200 mg strengths.
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 treatment

• 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 a break of approximately one week without hormone replacement therapy, during which withdrawal bleeding may occur.

How to take the capsules
The capsules should be swallowed 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, if prescribed, should be taken the next morning.
Taking more Progesterone Besins than recommended
Seek immediate advice from your 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 your doctor beforehand.
Missing a dose of Progesterone Besins
If you forget to take a dose, take it as soon as you remember. However, if it is almost time for your next dose, skip the missed dose.
Do not take a double dose to make up for a missed dose.
Stopping Progesterone Besins treatment
Your doctor will inform you how long you should continue taking this medicine. Do not stop treatment prematurely.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like any medicine, this medicine can 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
• vision disturbances
• yellowing of the skin or whites of the eyes (jaundice)

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

• 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 women):

• breast changes, breasts may become tender
• feeling tired or dizzy
• 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 women):

• allergic reactions
• nausea (feeling sick)

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

• depression
• rash (which may be itchy)
• darkening or pigmentation of the skin (so-called chloasma, melasma)

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

• benign or malignant estrogen-dependent tumours, e.g. endometrial cancer,
• venous thromboembolism (blood clots in veins), including deep vein thrombosis in the legs or pelvis, and 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),
• probable 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 reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor, pharmacist or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions 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
Reporting adverse reactions helps to provide more information on the safety of this medicine.

5. How to store Progesterone Besins

Keep the medicine out of the 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.
No special temperature storage conditions are required. Store in the original packaging.
Do not use this medicine if you notice any visible signs of deterioration. Return the medicine to a pharmacist.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the pack and other information

What Progesterone Besins contains

• The active substance is micronized progesterone. Each capsule contains 100 mg of progesterone in a soft capsule.
• Other components are: soy lecithin, sunflower oil, capsule shell: titanium dioxide (E 171), gelatin, glycerol, purified water.

What Progesterone Besins looks like and contents of the pack

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

For further information, please contact the responsible party or parallel importer.
Marketing Authorisation Holder in Belgium, country of export:
Besins Healthcare SA
Rue Washington 80, 1050 Ixelles, Belgium
Manufacturer:
Cyndea Pharma, S.L.
Poligono Industrial Emiliano Revilla Sanz
Avenida de Agreda, 31
Ólvega 42110 (Soria), Spain
Parallel importer:
Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź, Poland
Repackaged in:
Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź, Poland
Marketing Authorisation number in Belgium, country of export: BE 117923
Parallel import authorisation number: 92/22
This medicinal product is authorised for marketing in the Member States of the European
Economic Area under the following names: