Progesterone besins

Patient Information Leaflet

Warning! Keep this leaflet! The information on the immediate packaging 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 you.

• Keep this leaflet so that you can read it again if necessary.
• If you have any 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 others, even if their symptoms are the same.
• If you experience any adverse effects, including any not listed in this leaflet, inform your doctor or pharmacist. 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 in the body. It provides 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 recommend this medicine in the following situations:

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

b) Complete cessation of menstruation (menopause)
As add-back therapy in hormone replacement therapy (HRT) in postmenopausal women with 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 clot in a 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 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, the so-called "oestrogen", you should also check the patient information leaflet of that oestrogen medicine for conditions 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 the menopausal period (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 must 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 occur.

If the patient does not have a menstrual period during treatment, pregnancy should be ruled out.
During treatment, the endometrium (uterine lining) 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 treatment has ended, and persists, you should 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 any other medicines you are currently taking, have recently taken, or plan to take.
Some medicines may affect the action of Progesterone Besins:

• medicines known as barbiturates, previously used for sleep disorders or anxiety,
• antiepileptic drugs (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 you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, you should 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, you should consult your 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 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 you have been diagnosed with hypersensitivity to peanuts or soya.

3. How to use Progesterone Besins

This medicine should always be used exactly as directed by your doctor. 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 within the 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 hormone therapy

• 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 at bedtime for at least 12 to 14 days per month (during the last 2 weeks of each treatment cycle).
• This is 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.
It is best to take this medicine 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 sense of well-being, 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 your 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 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 they do not occur in everyone.
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 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 skin pigmentation or 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,
• blood clots in veins (venous thromboembolic disease) due to formation of 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 pigmentation (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 of the cycle)
The cycle may be shortened and bleeding may occur at times 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 or pharmacist. 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 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.
No special temperature storage requirements.
Store in the original packaging.
Do not use this medicine if you notice any visible signs of deterioration. Return the medicine to the 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 package and other information

What Progesterone Besins contains

• The active substance is micronized progesterone. Each capsule contains 200 mg of progesterone.
• Other components are: soybean 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 200 mg is available in packages containing 15, 45 or 90 soft capsules for oral use, packed in blisters and cardboard boxes.
• Progesterone Besins 200 mg consists of oval, slightly yellow soft capsules containing a white-tinged oily suspension.

For more detailed information, please contact the responsible party or the parallel importer.
Marketing Authorization 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
Poland
Repackaged by:
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Poland
Marketing Authorization Number in Belgium, country of export: BE 279386
Parallel Import Authorization Number: 405/22
This medicinal product is authorized for marketing in the European Economic Area member states under the following names:
Belgium Progesteron Besins 200 mg, soft capsules
Luxembourg Progestérone Besins 200 mg, capsules molles
Netherlands Progesteron Besins 200 mg, zachte capsules
Poland Progesterone Besins 200 mg, soft capsules
Germany Utrogest 200 mg, Weichkapseln