Progesterone besins

Patient Information Leaflet

Warning! Keep this leaflet! Information on the immediate packaging is in a foreign language.
Progesterone Besins (Progestan)
200 mg, soft capsules
Progesterone (micronized)
Progesterone Besins and Progestan are different brand names of the same medicine.
Please read this 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 questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not give it to others. This medicine 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. This medicine is a progestagenic hormone therapy.
What it is used for
This medicine is used when 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) below normal. 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 (HRT) 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), 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 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 any contraceptive effect.
• Before starting hormone 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 blood clots (venous thrombosis) in the past,
• the patient has uterine bleeding.

Stop taking this medicine if:

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

If the patient misses a menstrual period during treatment, pregnancy must be ruled out.
During treatment, the endometrial lining may become excessively thickened (endometrial hyperplasia), or such 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
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 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 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, taken 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 who still have their uterus, estrogen therapy should not be used alone without combination treatment.
• 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.
It is best to take this medicine 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 you forget to take a dose, take it 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 missed dose.
Stopping treatment with 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 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
• 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 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 tired 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
• skin rash (which may be itchy)
• darkening or pigmentation of the skin (so-called chloasma, melasma)

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

• benign or malignant estrogen-dependent tumours, e.g. endometrial cancer
• venous thromboembolic events (venous thromboembolism) 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 times other than withdrawal bleeding.
Reporting of adverse reactions
If any adverse symptoms occur, including any adverse reactions not listed in this leaflet, please inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring of 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 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.
Do not store above 30°C. Do not freeze.
Store in the original packaging to protect from moisture.
Do not use this medicine if visible signs of deterioration are observed. 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 pack and other information

What Progesterone Besins contains

• The active substance is micronized progesterone. Each soft capsule contains 200 mg of progesterone.
• 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 packs containing 15, 30, 45 or 90 soft capsules for oral use, packed in blisters within a cardboard box.
• Progesterone Besins 200 mg are oval, slightly yellowish soft capsules.

For further information, please contact the marketing authorisation holder or parallel importer.
Marketing authorisation holder in France, the country of export:
Laboratoires Besins International
3, rue du Bourg L'Abbe
75003 Paris
France
Manufacturer:
Cyndea Pharma SL
Poligono Industrial Emiliano Revilla Sanz
Avenida De Agreda 31
Olvega 42110 (Soria)
Spain
Besins Manufacturing Belgium
128 Groot-Bijgaardenstraat
1620 Drogenbos
Belgium
Besins Manufacturing Espaňa
Polígono Industrial el Pitarco
Parcela 4
50450 Muel (Zaragoza)
Spain
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 France, the country of export: 34009 358 763 2 4
358 7632
362 0849
34009 362 084 9 0
362 0855
34009 362 085 5 1
362 0861
34009 362 086 1 2
Parallel import authorisation number: 61/22
This medicinal product is authorised in the European Economic Area member countries under the following names: