Progesterone besins

Package leaflet: Information for the user

Warning! Keep this leaflet, information on the immediate packaging is in a foreign language!
Progesterone Besins (Progestan)
200 mg, soft capsules
Progesteronum
Progesterone Besins and Progestan are different trade names of the same medicine.
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for the patient.

• Keep this leaflet so that you can read it again if necessary.
• 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. This medicine may harm other people, even if their symptoms are the same.
• If the patient experiences any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. 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 acts by regulating hormonal balance in the body. This medicine 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
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 breast or genital organ tumour,

• if the patient has active venous thrombosis (blood clots), 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 menopause in combination with another hormonal treatment, the so-called "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 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 annual 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 thrombosis (blood clots in veins) in the past,
• the patient has uterine bleeding.

Stop taking this medicine if:

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

If the patient misses a period during treatment, pregnancy should be ruled out.
During treatment, the endometrial lining may 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 or have recently taken, as well as any medicines you 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),
• 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 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 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 does not have any 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 are hypersensitive 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.
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 should not be used as unopposed monotherapy.
• 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
Consult your doctor or pharmacist immediately.
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 remembered. 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.
Discontinuation of Progesterone Besins
Your doctor will inform you how long this medicine should be used. Do not discontinue treatment prematurely.
If you have any further doubts regarding 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.
This medicine must be stopped 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 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 tired or dizzy
• 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)
• darkening or pigmentation of the skin (so-called chloasma, melasma)

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 the veins) due to formation of blood clots (thrombosis) in deep leg or pelvic veins, 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)
The cycle may be shortened and bleeding may occur at times other than withdrawal bleeding.

Reporting of adverse reactions
If any adverse effects occur, including any adverse effects not listed in this leaflet, please inform your doctor or pharmacist. 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, 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 this 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 carton after "EXP". The expiry date refers to the last day of the stated month. The abbreviation "Lot" means batch number.
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 should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the pack and other information

What Progesterone Besins contains

• The active substance is progesterone. One soft capsule contains 200 mg of progesterone.
• Other ingredients are: sunflower oil, soybean lecithin. Capsule shell: gelatin, glycerol, titanium dioxide (E 171), purified water.

What Progesterone Besins looks like and contents of the pack

• Progesterone Besins 200 mg is available in packs containing 15, 30, 45, 60 or 90 soft capsules intended for oral use, packed in blisters and cardboard boxes.
• Progesterone Besins 200 mg is oval, slightly yellow soft capsules containing a white-tinged oily suspension.

For more detailed information, please contact the marketing authorisation holder or the parallel importer.
Marketing authorisation holder in France, the country of export:
Besins Healthcare France
3 rue du Bourg l’Abbé
75003 Paris
France
Manufacturer
Besins Manufacturing Belgium SA
128 Groot-Bijgaardemstraat
1620 Drogenbos
Belgium
Cyndea Pharma SL
Poligono Industrial Emiliano Revilla Sanz
Avenida de Agreda 31
42110 (Soria)
Spain
Parallel importer:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Repackaged in:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Marketing authorisation numbers in France, the country of export: 34009 362 084 9 0
362 084-9
34009 362 085 5 1
362 085-5
34009 358 763 2 4
358 763-2
34009 362 086 1 2
362 086-1
Parallel import authorisation number: 298/24
This medicinal product is authorised in the European Economic Area member states under the following names: