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)
100 mg, soft capsules
Progesterone (micronized)
Progesterone Besins and Utrogestan 100 mg 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 for future reference
• If you have any doubts, 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 others, even if their symptoms are identical.
• If you experience any adverse reactions, including those not listed in this leaflet, inform your doctor or pharmacist. 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 acts by regulating hormonal balance in the body. This product provides progestagenic hormone therapy.
What it is used for
This medicine is used if the patient has disorders caused by a deficiency 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)
As an add-back 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 clots in veins), e.g. in the legs (deep vein thrombosis) or lungs (pulmonary embolism), or if the patient has previously experienced such venous blood clots,
• 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", please also check the patient information leaflet of that oestrogen 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 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 previously experienced venous blood clots (venous thrombosis),
• the patient has uterine bleeding.

Discontinue use of this medicine if:

• any visual disturbances occur (e.g. loss of vision, double vision, retinal vascular lesions),
• venous thromboembolism (venous thrombosis or embolism) 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 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 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),
• 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 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 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 the patient has a known hypersensitivity to peanuts or soya.

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.
Progesterone Besins is available in strengths of 100 mg and 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 treatment

• In menopausal women with an intact uterus, unopposed estrogen monotherapy 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.

Use of a higher than recommended dose of Progesterone Besins
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.

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 advise you on how long to continue treatment. Do not discontinue 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 can cause adverse effects, 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 effects 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 effects are not common (occurring in no more than 1 in 100 patients):

• 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 effects are rare (occurring in no more than 1 in 1,000 patients):

• allergic reactions
• nausea (feeling sick)

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

• depression
• rash (which may be itchy)
• dark skin discoloration or pigmentation (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 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 not using it,
• heart attack (myocardial infarction) and stroke,
• gallbladder disorders,
• brownish skin discoloration (chloasma), various skin disorders with formation of blisters and nodules (erythema multiforme, erythema nodosum, vasculitic purpura),
• probable dementia.

If the treatment sequence is started too early in the cycle (especially before day 15)
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 not listed in this leaflet, inform your doctor or pharmacist. Adverse effects 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, tel.: +48 22 4921301, fax: +48 22 4921309, website: https://smz.ezdrowie.gov.pl.
Reporting adverse effects helps provide more information on the safety of using this medicine.

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.
There are no special temperature storage requirements.
Store in the original packaging.
Do not use this medicine if visible signs of deterioration are observed. 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. This will help protect the environment.

6. Contents of the packaging and other information

What Progesterone Besins contains

• The active substance is micronized progesterone. Each capsule contains 100 mg of progesterone.
• 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 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-tinged oily suspension.

For further information, please contact the marketing authorisation holder 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.
Polígono Industrial Emiliano Revilla Sanz
Avenida de Ágreda, 31
42110 Olvega (Soria)
Spain
DELPHARM DROGENBOS SA
Groot-Bijgaardenstraat, 128
1620 Drogenbos
Belgium
Parallel importer:
InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw
Repackaged in:
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Marketing authorisation number in Belgium, country of export: BE 117923
Parallel import licence number: 400/22
This medicinal product is authorised in the European Economic Area countries under the following names:
Belgium Progesteron Besins 100 mg, capsule molles
Luxembourg Progestérone Besins 100 mg, capsule molles
Netherlands Progesteron Besins 100 mg, zacht capsules
Poland Progesterone Besins 100 mg, soft capsules
Germany Utrogest 100 mg, Weichkapseln