Progesterone besins

Package leaflet: Information for the patient

Warning! Keep this leaflet. The information on the immediate packaging is in a foreign language.
Progesterone Besins (Utrogestan), 100 mg, soft capsules
Progesteronum
Progesterone Besins and Utrogestan are different trade names for the same medicinal product.
Please read this leaflet carefully before using the medicine, as 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, pharmacist, or nurse.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm someone else, even if their symptoms are the same.
• If the patient experiences any adverse reactions, including any not listed in this leaflet, inform the doctor, pharmacist, or nurse. See section 4.

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
This medicine contains progesterone, which is a natural female sex hormone produced by the body. This medicine works by regulating hormonal balance in the body. This medicine provides progestogenic hormone 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 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 case, this medicine may be used to treat irregular menstruation.
b) Complete cessation of menstruation (menopause)
Add-on treatment in hormone replacement therapy in postmenopausal women who still have their 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 the 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 menopause in combination with another hormonal treatment, the so-called "oestrogen", you should also check the patient information leaflet of that oestrogen medicine to see when that medicine should not be used.

Warnings and precautions
Before starting to take 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 yearly 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 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.

You should stop taking this medicine if:

• any visual disturbances occur (e.g. visual field defects, double vision, retinal vascular lesions),
• venous thromboembolism (venous thromboembolic disease) occurs,
• severe headaches occur. If the patient misses a period during treatment, pregnancy should be ruled out.

During treatment, the endometrium (lining of the uterus) may begin to grow excessively (endometrial hyperplasia) or existing hyperplasia may worsen.
If unexpected bleeding or spotting occurs during long-term treatment, at the end of treatment, or after stopping treatment, 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, have recently taken, or 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).

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 can 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 baby, 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 to take this medicine, discuss this with your doctor or pharmacist.

Fertility
This medicine may be taken by women who have difficulty becoming pregnant. Therefore, this medicine has no harmful effect on fertility.
Before starting to take this medicine, discuss this 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 are known to be hypersensitive to peanuts or soya.

3. How to use Progesterone Besins

This medicine should always be used exactly as prescribed by the doctor. In case of doubt, consult
your doctor or pharmacist.
Progesterone Besins is available in 100 mg and 200 mg doses.
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.
• The 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 replacement 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.
This medicine is best taken in the evening before bedtime. The second dose should be taken
the next morning.
Use of a higher than recommended dose of Progesterone Besins
Consult your doctor or pharmacist immediately.
Symptoms of overdose may include dizziness, fatigue, intense feeling of well-being, or painful menstruation. In such cases, the dose may be reduced. Always consult your doctor first.
Missed dose of Progesterone Besins
If a dose is missed, take it 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 a missed dose.
Stopping treatment with Progesterone Besins
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 all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
You must stop using 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,
• visual 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 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 pigmentation or skin discoloration (so-called chloasma, pregnancy mask).

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) due to venous thrombosis in the 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 pigmentation (chloasma), various skin disorders with formation of blisters and nodules (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 reactions occur, including any not listed in this leaflet, inform your doctor, pharmacist or nurse. Adverse reactions can be reported directly to the Department of Monitoring of 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 allows the collection of further information on the safety of the medicine's use.

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 packaging. The expiry date refers to the last day of the stated month.
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 a pharmacist.
Medicines must not be disposed of via wastewater or household waste. Ask a pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the packaging 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: soy lecithin, purified 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 packages containing 30 or 90 soft capsules for oral use, packed in blisters and cardboard boxes.
• Progesterone Besins consists of round, slightly yellow soft capsules containing a white, oily suspension.

For further information, please contact the responsible party or parallel importer.
Marketing Authorisation Holder in the Czech Republic, country of export:
Laboratoires Besins International
3, Rue du Bourg l’Abbé 75003 Paris, France
Manufacturer:
Cyndea Pharma, S.L.
Poligono Industrial Emiliano Revilla Sanz
Avenida de Ágreda 31, 42110 Ólvega (Soria)
Spain
Parallel importer:
Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź
Repackaged in:
Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź
Marketing Authorisation number in the Czech Republic, country of export: 56/056/97-C
Parallel import authorisation number: 155/25
This medicinal product is authorised for supply in the European Economic Area under the following names: