Probella

Leaflet attached to the packaging: patient information

Probella, 2 mg, tablets

Dienogest

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• This leaflet should be kept in case it needs to be read again.
• In case of any doubts, consult a doctor or pharmacist.
• This medicine has been prescribed to a specific person. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is Probella and what is it used for
• 2. Important information before taking Probella
• 3. How to take Probella
• 4. Possible side effects
• 5. How to store Probella
• 6. Contents of the packaging and other information

1. What is Probella and what is it used for

Probella is used to treat endometriosis (painful symptoms caused by abnormally located uterine lining). Probella contains a hormone, progestogen called dienogest.

2. Important information before taking Probella

When NOT to take Probella

• If there is a blood clot(thromboembolic disease) in the veins. This may occur, for example, in the blood vessels of the legs (deep vein thrombosis) or lungs (pulmonary embolism). See also "Probella and venous blood clots" below.
• If there is or has been a history of severe arterial disease, including cardiovascular disease, such as heart attackor strokeor heart diseasecausing reduced blood flow (angina pectoris). See also "Probella and arterial blood clots" below.
• If there is diabeteswith blood vessel damage.
• If there is or has been a history of severe liver disease(and liver function parameters have not returned to normal). Symptoms of liver disease may include yellowing of the skin and (or) itching all over the body.
• If there is or has been a history of benign or malignant liver tumor.
• If there is or has been a history of or suspected malignant hormone-dependent tumor, such as breast cancer or genital organ tumor.
• If there is unexplained vaginal bleeding.
• If there is known hypersensitivity (allergy)to dienogest or any of the other ingredients of this medicine (listed in section 6 and at the end of section 2).

If any of these conditions occur for the first time while taking Probella, the patient should stop taking it immediately and consult a doctor.

Warnings and precautions

While taking Probella, hormonal contraceptives must not be used in any form (pill, patch, intrauterine system). Probella is NOT a contraceptive. To prevent pregnancy, condoms or other non-hormonal contraceptives should be used. In some situations, special caution is required when taking Probella. Regular medical examinations may be necessary. The doctor should be informed if any of the following conditions apply to the patient. If:

• there has been a history of blood clot(venous thromboembolic disease) or a close family member has had a blood clot at a relatively young age;
• a close relative has breast cancer;
• there has been a history of depression;
• there is high blood pressureor high blood pressure develops while taking Probella;
• there is liver diseasewhile taking Probella. Symptoms may include yellowing of the skin, eyes, or itching all over the body. The doctor should be informed if such symptoms occurred during a previous pregnancy;
• there is diabetesor periodic diabetesduring a previous pregnancy;
• there has been a history of chloasma(yellow-brown spots on the skin, especially on the face). In such cases, excessive exposure to sunlight or ultraviolet radiation should be avoided;
• there is abdominal painwhile taking Probella.

While taking Probella, the chance of becoming pregnant is reduced, as Probella may affect ovulation. In the event of pregnancy while taking Probella, there is a slightly increased riskof ectopic pregnancy (the embryo develops outside the uterus). Before starting Probella, the doctor should be told if the patient has had an ectopic pregnancy or has tubal dysfunction.

Probella and severe uterine bleeding

Uterine bleeding, for example, in women with a disease in which the uterine lining (endometrium) grows into the muscular layer of the uterus, called adenomyosis, or benign uterine tumors, sometimes called uterine fibroids, may worsen while taking Probella. If the bleeding is heavy and prolonged, it may lead to a decrease in red blood cell count (anemia), which can be severe in some cases. In the event of anemia, the doctor should be consulted to determine if it is necessary to stop taking Probella.

Probella and changes in bleeding profile

In most women treated with Probella, changes in menstrual bleeding profile occur (see section 4, "Possible side effects").

Probella and venous blood clots

Some studies suggest that there may be a slight, statistically insignificant increase in the risk of blood clots in the legs (venous thromboembolic disease)associated with the use of progestogen-containing medications, such as Probella. Very rarely, blood clots can cause severe, permanent disability or even death. The risk of venous blood clotincreases:

• with age;
• if there is overweight;
• if the patient or a close family member has had a blood clot in the leg (thrombosis), lungs (pulmonary embolism), or other organ at a young age;
• if surgery is planned, a serious accident occurs, or immobilization lasts for a long time. It is essential to inform the doctor in advance about taking Probella, as treatment may need to be discontinued. The doctor will advise when to resume taking Probella. This is usually two weeks after recovery.

Probella and arterial blood clots

There is limited evidence of a link between the use of progestogen-containing medications, such as Probella, and an increased risk of blood clots, for example, in the blood vessels of the heart (heart attack) or brain (stroke). In women with high blood pressure, the risk of stroke may be slightly increased when taking such medications as Probella. The risk of arterial blood clotincreases:

• in women who smoke - it is recommended to quit smoking when taking Probella, especially over the age of 35;
• if there is overweight;
• if a close family member has had a heart attack or stroke at a young age;
• if there is high blood pressure.

The doctor should be consulted before taking Probella.

Stop taking Probella and contact a doctor immediately if possible symptoms of a blood clot occur, such as:

• severe pain and (or) swelling of one leg;
• sudden severe chest pain that may also radiate to the left arm;
• sudden shortness of breath;
• sudden cough without an apparent cause;
• any unusual, severe, or prolonged headache or worsening of migraine;
• partial or complete blindness or double vision;
• difficulty speaking or inability to speak;
• dizziness or fainting;
• weakness, strange feeling, or numbness of any part of the body.

Probella and cancer

Currently available data do not clearly indicate whether Probella increases the risk of breast cancer or not. Breast cancer has been observed slightly more frequently in women taking hormones compared to women not taking hormones, but it is not known if this is caused by the treatment. For example, it may be due to the fact that more tumors are detected and detected earlier in women taking hormones, as they are more frequently examined by a doctor. The frequency of breast tumors decreases gradually after stopping hormonal treatment. It is essential to regularly examine the breastsand contact the doctor if any lump is felt. In rare cases, women taking hormones have reported benign liver tumors, and in even rarer cases, malignant liver tumors. The doctor should be contacted in case of severe abdominal pain.

Probella and osteoporosis Bone mineral density (BMD) changes

Taking Probella may affect bone strength in young people (12 to less than 18 years old). Therefore, if the patient is under 18 years old, the doctor will individually weigh the benefits and risks of taking Probella, considering possible risk factors for bone mass loss (osteoporosis). If the patient is taking Probella, they should take care of adequate calcium and vitamin D intake with their diet or supplements. If the patient has an increased risk of osteoporosis (bone weakness due to bone mineral loss), the doctor will carefully weigh the benefits and risks of treating with Probella, as Probella has a moderate estrogen-suppressing effect.

Probella and other medicines

The doctor should always be informed about currently taken medicines or herbal products. The doctor or dentist prescribing another medicine (or pharmacist) should also be told about taking Probella. Some medicines may affect the level of Probella in the blood and reduce its effectiveness or cause side effects. These include:

• medicines used for: epilepsy(e.g., phenytoin, barbiturates, primidone, carbamazepine, oxcarbazepine, topiramate, felbamate); tuberculosis(e.g., rifampicin); HIV and hepatitis C virus infections(so-called protease inhibitors and non-nucleoside reverse transcriptase inhibitors, such as ritonavir, nevirapine, efavirenz); fungal infections(griseofulvin, ketoconazole);
• St. John's Wort (Hypericum perforatum).

Before taking any medicine, consult a doctor or pharmacist.

Probella with food and drink

While taking Probella, the patient should avoid drinking grapefruit juice, as it may increase the level of Probella in the blood. This may increase the risk of side effects.

Lab tests

If a blood test is necessary, the doctor or laboratory staff should be told that the patient is taking Probella, as Probella may affect the results of some tests.

Pregnancy and breastfeeding

Probella must not be taken during pregnancy or breastfeeding.

Driving and using machines

No effect on the ability to drive and use machines has been observed in people taking Probella.

Probella contains lactose

If the patient has been diagnosed with intolerance to some sugars, they should contact their doctor before taking Probella.

Children and adolescents

Probella should not be taken by girls before their first menstrual period. Taking Probella may affect bone strength in young people (12 to less than 18 years old). Therefore, if the patient is under 18 years old, the doctor will individually weigh the benefits and risks of taking Probella, considering possible risk factors for bone mass loss (osteoporosis).

3. How to take Probella

Probella should always be taken as directed by the doctor. In case of doubts, the doctor or pharmacist should be consulted again. The usual dose for adults is one tablet per day. The following information applies to Probella if the doctor has not prescribed otherwise. The instructions below should be followed; otherwise, the patient will not get the full benefits of taking Probella. Treatment with Probella can be started on any day of the natural cycle. Adults: One tablet should be taken daily, preferably at the same time, with a small amount of liquid if necessary. After finishing the packaging, the next one should be started without a break. Tablets should be continued even during menstrual bleeding days.

Taking more Probella than recommended

There are no reports of serious harmful effects after taking too many Probella tablets at once. However, in case of doubts, the doctor should be consulted.

Missing a dose of Probella or vomiting or diarrhea

The effect of Probella will be less effective if a tablet is missed. If one or more tablets are missed, only one tablet should be taken as soon as possible, and the next tablet should be taken at the usual time the next day. If vomiting occurs within 3-4 hours after taking Probella or severe diarrhea occurs, there is a risk that the active substance of the tablet will not be absorbed by the body. The situation is almost the same as if the tablets were missed. After vomiting or diarrhea within 3-4 hours after taking Probella, the next tablet should be taken as soon as possible. A double dose should not be taken to make up for the missed tablet.

Stopping Probella

If the patient stops taking Probella, their previous endometriosis symptoms may return.

4. Possible side effects

Like all medicines, Probella can cause side effects, although not everybody gets them. Such effects are more common during the first few months after starting Probella and usually disappear with continued use. Changes in bleeding profile, such as spotting, irregular bleeding, or menstrual period may not occur at all, may also occur.

Common (occurring in 1 to 10 out of 100 patients)

• weight gain
• low mood, sleep problems, nervousness, loss of interest in sex, or mood changes
• headache or migraine
• nausea, abdominal pain, bloating, abdominal distension, or vomiting
• acne or hair loss
• back pain
• breast discomfort, ovarian cyst, or hot flashes
• uterine or vaginal bleeding, including spotting
• weakness or irritability

Uncommon (occurring in 1 to 10 out of 1,000 patients)

• anemia
• weight loss or increased appetite
• anxiety, depression, or sudden mood changes
• autonomic nervous system imbalance (controls subconscious body functions, e.g., sweating) or attention disorders
• dry eyes
• tinnitus
• non-specific circulation problems or palpitations
• low blood pressure
• shortness of breath
• diarrhea, constipation, abdominal discomfort, gastritis, or gingivitis
• dry skin, excessive sweating, severe itching all over the body, hirsutism, nail fragility, dandruff, skin inflammation, abnormal hair growth, hypersensitivity to light, or pigmentation problems
• bone pain, muscle cramps, pain, or feeling of heaviness in the arms and hands or legs and feet
• urinary tract infection
• vaginal thrush, vaginal dryness, discharge, pelvic pain, atrophic vaginitis with discharge (atrophic vulvovaginitis), or breast lump or lumps
• edema due to fluid retention

Additional side effects in adolescents (12 to less than 18 years old): bone density loss.

Reporting side effects

If any side effects occur, including any not listed in this leaflet, the doctor or pharmacist should be told. Side effects can be reported directly to the Department of Drug Adverse Reaction Monitoring 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 Side effects can also be reported to the marketing authorization holder. By reporting side effects, more information can be gathered on the safety of the medicine.

5. How to store Probella

Store in the original packaging to protect from light. The medicine should be stored out of sight and reach of children. Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the specified month. The entry on the packaging after the EXP abbreviation indicates the expiry date, and after the Lot abbreviation, it indicates the batch number. Medicines should not be disposed of via wastewater or household waste. The pharmacist should be asked how to dispose of medicines that are no longer used. This will help protect the environment.

6. Contents of the packaging and other information

What Probella contains

• The active substance is dienogest. Each tablet contains 2 mg of dienogest.
• The other ingredients are: lactose monohydrate, cornstarch, povidone (K30), magnesium stearate.

What Probella looks like and what the packaging contains

Probella tablets are round, white tablets with a diameter of 5 mm. The tablets are supplied in a blister pack containing 28 tablets. The boxes contain one, three, or six blisters with 28 tablets (calendar packaging).

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Polpharma S.A. ul. Pelplińska 19, 83-200 Starogard Gdański tel.: +48 22 364 61 01

Manufacturer

Laboratorios León Farma, S.A. C/ La Vallina s/n, Poligono Industrial Navatejera 24193-León Spain Date of last update of the leaflet:May 2024