Progesterone besins

Package leaflet: Information for the patient

Warning! Keep the leaflet. The information on the immediate packaging is in a foreign language.
Progesterone Besins (Utrogestan 100 mg), 100 mg, soft capsules
Progesterone (micronized)
Progesterone Besins and Utrogestan 100 mg are different trade names for the same medicinal product.
Please read the 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 or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. The 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, tell 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
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. It provides progestagenic 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
Low levels of progesterone produced by the ovaries (in the luteal phase). In this case, this medicine may be used to treat irregular menstruation.
b) Complete cessation of menstruation (menopause)
As an add-on treatment in hormone replacement therapy in postmenopausal women who have a 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 clots in veins), 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 cerebral haemorrhage,

• 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 "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 therapy during the menopausal period (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.

You must stop taking this medicine if:

• any visual disturbances occur (e.g. loss of vision, double vision, retinal vascular lesions),
• venous thrombosis (venous thromboembolic disease or thrombosis) occurs,
• severe headaches develop.

If the patient does not have a menstrual period during treatment, pregnancy should be ruled out.
During treatment, the endometrium (uterine lining) may undergo excessive growth (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 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
The 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 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 as directed by the physician. In case of doubt, consult your doctor or pharmacist.

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 menopausal women with an intact uterus, estrogen therapy alone (unopposed) is not recommended.
• 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.
Do not take the capsules with food.
This medicine should preferably be taken in the evening before bedtime. The second dose should be taken the next morning.

Taking more Progesterone Besins than recommended
Consult your doctor or pharmacist immediately.
Symptoms of overdose may include dizziness, fatigue, intense drowsiness, or painful menstruation. In such cases, the dose may be reduced. Always consult your doctor beforehand.

If you forget to take 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 a forgotten dose.

Stopping Progesterone Besins
Your doctor will inform you how long you should continue this treatment. Do not stop treatment prematurely.
If you have any further doubts about the use of this medicine, consult your 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,
• 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 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 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),
• dark skin pigmentation or discoloration (chloasma, pregnancy mask).

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

• benign or malignant estrogen-dependent tumours, e.g. endometrial cancer,
• venous thromboembolic events (venous thromboembolic disease) due to blood clots (thrombosis) in deep veins of 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 formation of blisters and nodules (erythema multiforme, nodular erythema, 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 different time than withdrawal bleeding.

Reporting of adverse reactions
If any adverse symptoms occur, including any adverse reactions not listed in this leaflet, you should inform your doctor, pharmacist, or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, phone +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 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.
Store below 30°C. Do not store in the refrigerator. Keep in the original packaging to protect from light.
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 sewage systems or household waste. Ask a pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the pack and other information

What Progesterone Besins contains

• The active substance is micronized progesterone. One 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 100 mg is available in packs of 30 or 90 soft capsules for oral use, packed in blisters and cardboard boxes.
• Progesterone Besins 100 mg are round, slightly yellow soft capsules containing a white to off-white oily suspension.

For more detailed information, please contact the marketing authorisation holder or the parallel importer.
Marketing authorisation holder in the Netherlands, country of export:
Besins Healthcare Netherlands B.V.
Servaasbolwerk 14
3512NK Utrecht
The Netherlands
Manufacturer:
Cyndea Pharma S.L.
Polígono Industrial Emiliano Revilla Sanz
Avenida de Ágreda 31
Olvega 42110 (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 Netherlands, country of export: RVG 11473
Parallel import licence number: 40/25
This medicinal product is authorised in the Member States of the European Economic Area under the following names: