Progesterone besins

Patient Information Leaflet

Caution! Please retain this leaflet. The packaging information is in a foreign language.
Progesterone Besins (Utrogestan 200 mg), 200 mg, soft capsules
Progesterone (micronized)
Progesterone Besins and Utrogestan 200 mg are different brand names for the same medicinal product.
Please read this leaflet carefully before using the medicine, as it contains important information for the patient.

• Please keep this leaflet, as you may need to read it again.
• If you have any further 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 reactions, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. 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. It is a form of progestogen hormone therapy.

What it is used for
This medicine is used in patients who have disorders caused by a deficiency of progesterone in the body. Your doctor may prescribe this medicine in the following situations:

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

b) Complete cessation of menstruation (menopause)
As add-back therapy in hormone replacement therapy (HRT) for 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 clots in the 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".
• If Progesterone Besins is used during menopause in combination with another hormonal treatment, the so-called "oestrogen", please also check the patient information leaflet of that medicine (oestrogen) for conditions 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 yearly 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 thrombosis (blood clots in the veins) in the past,
• the patient has uterine bleeding.

The patient should stop taking this medicine if:

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

If the patient misses a menstrual 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 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 the patient is currently taking or has recently taken, 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),
• 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 in the treatment of 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 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 this medicine, discuss this with your doctor or pharmacist.

Driving and operating machinery
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
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 monotherapy without concomitant treatment 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 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 should preferably be taken in the evening before bedtime. The second dose 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 feeling of well-being, or painful menstruation. In such a case, the dose may be reduced. Always consult your doctor beforehand.
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 a missed dose.
Stopping 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 effects

Like all medicines, this medicine may cause adverse effects, although not everyone experiences them.
Treatment with this medicine must be stopped immediately if the patient experiences:

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

The following adverse effects occur frequently (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 effects occur less frequently (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 effects occur rarely (in no more than 1 in 1000 patients):

• allergic reactions,
• nausea (feeling sick).

The following adverse effects occur very rarely (in no more than 1 in 10,000 patients):

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

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

• benign or malignant estrogen-dependent tumors, e.g. endometrial cancer,
• venous thromboembolism (blood clots in the 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 effects
If any adverse effects occur, including any adverse effects not listed in this leaflet, please inform your doctor, pharmacist or nurse. Adverse effects can be reported directly to the Department of Monitoring of Adverse Drug Reactions, 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 effects allows collection of further 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.
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 the sewage system or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the package and other information

What Progesterone Besins contains

• The active substance is progesterone in micronized form. One soft capsule contains 200 mg.
• The other ingredients 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 packages containing 15, 30, 45 or 90 soft capsules for oral use, packed in blisters and cardboard boxes.
• Progesterone Besins consists of oval, slightly yellow soft capsules containing a white-tinged oily suspension.

For further information, please contact the marketing authorisation holder or the 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
Besins Manufacturing España S.L.
Polígono Industrial el Pitarco
Parcela 4, Muel, 50450 Saragossa - 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
Belgium, country of export, marketing authorisation number: BE 279386
Parallel import authorisation number: 93/22
This medicinal product is authorised in the European Economic Area countries under the following names: