Progesterone besins

Patient Information Leaflet

Progesterone Besins, 100 mg soft capsules
Progesterone Besins, 200 mg soft capsules
Progesterone (micronized)
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for you.

• Keep this leaflet, as you may need to read it again
• If you have any further questions, please ask your doctor or pharmacist
• This medicine has been prescribed for you personally. Do not pass it on to others. It may harm someone else even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, please inform your doctor or pharmacist. See section 4.

Contents of the leaflet

1. What Progesterone Besins is and what it is used for
2. What you need to know before using Progesterone Besins
3. How to use 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. The action of this medicine is to regulate hormonal balance in the body. This medicine provides progestogenic hormone therapy.
What it is used for
This medicine is used when you have disorders caused by a lack 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, this medicine may be used to treat irregular menstrual periods.
b) Complete cessation of menstruation (menopause)
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 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, a 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, please 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 blood clots (venous thrombosis) in the past,
• the patient has uterine bleeding.

You should stop taking this medicine if:

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

If the patient does not have a menstrual 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 the patient is currently taking, has recently taken, or 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).

Similarly, 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 taken by women who have difficulty becoming pregnant. Therefore, this medicine does not have any 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 hypersensitivity to peanuts or soya has been diagnosed.

3. How to use Progesterone Besins

This medicine should always be used as directed by your doctor. 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, taken in one or two 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 postmenopausal women with an intact uterus, estrogen therapy alone (unopposed estrogen) 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 is followed by a period of approximately one week without hormone replacement therapy, during which withdrawal bleeding may occur.

How to take the capsules
Swallow the capsules 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 prescribed
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 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 the 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 advise you on how long to continue treatment. 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 using 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)
• 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 thromboembolic disease (blood clots in the veins), including deep vein thrombosis in 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, erythema nodosum, vasculitic purpura),
• possibly 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 symptoms occur, including any adverse symptoms not listed in this leaflet, 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
Adverse reactions can also be reported to the marketing authorisation holder.
Reporting adverse reactions helps 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" indicates the 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 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 progesterone in micronized form. One capsule contains 100 mg or 200 mg of micronized progesterone in a soft capsule.
• The other ingredients are: soya lecithin, purified sunflower oil, titanium dioxide (E171), gelatin, glycerol.

What Progesterone Besins looks like and contents of the pack

• Progesterone Besins 100 mg is available in packs containing 30 or 90 soft capsules for oral use, packed in blisters and cardboard boxes.
• Progesterone Besins 200 mg is available in packs containing 15, 30, 45 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.
• Progesterone Besins 200 mg are oval, slightly yellow soft capsules containing a white-tinged oily suspension.
• Not all pack sizes may be marketed.

Marketing Authorisation Holder
Besins Healthcare S.A.
80 Rue Washington
1050 Ixelles
Belgium
Manufacturer
Cyndea Pharma S.L.
Polígono Industrial Emiliano Revilla Sanz
Avenida de Ágreda, 31
42110 Ólvega (Soria)
Spain
or
Besins Manufacturing España S.L.
Polígono industrial el Pitarco,
Parcela 4, Muel,
50450 Zaragoza
Spain
This medicinal product is authorised in the European Economic Area countries under the following names: