Dienogest Stragen

Leaflet included in the packaging: patient information

Dienogest Stragen, 2 mg, coated tablets

Dienogest

It is necessary to carefully read the contents of the leaflet before taking the medicine, as it contains important information for the patient.

• It is necessary to keep this leaflet, so that it can be re-read if necessary.
• In case of any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed to a specific person. It should not be given to others. The medicine can harm another person, even if the symptoms of their illness are the same.
• If the patient experiences any undesirable symptoms, including any undesirable symptoms not mentioned in the leaflet, they should inform their doctor or pharmacist. See section 4.

Table of contents of the leaflet

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

1. What is Dienogest Stragen and what is it used for

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

2. Important information before taking Dienogest Stragen

DO NOT TAKE Dienogest Stragen if::

• there is a blood clot (thromboembolic disease) in the veins. It can occur, for example, in the blood vessels of the legs (deep vein thrombosis) or lungs (pulmonary embolism). See also "Dienogest Stragen and venous blood clots"below;
• there is or has been a history of severe arterial disease, including cardiovascular disease, such as heart attack or strokeor heart diseasecausing reduced blood flow (angina pectoris). See also "Dienogest Stragen and arterial blood clots"below;
• there is diabetes with vascular damage;
• 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) eyes;
• there is or has been a history of benign or malignant liver tumor;
• there is or has been a suspicion of malignanthormone-dependent tumor, such as breast cancer or genital tract tumor;
• there is unexplained vaginal bleeding;
• there is a known hypersensitivity(allergy) to dienogest or any of the other ingredients of this medicine (see section 6). If any of these conditions occur for the first time while taking Dienogest Stragen, the medicine should be stopped immediately and a doctor consulted.

Warnings and precautions

Before starting to take Dienogest Stragen, it is necessary to discuss it with a doctor or pharmacist.
While taking Dienogest Stragen, hormonal contraceptives should not be used in any form (pill, patch, intrauterine system).
Dienogest Stragen 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 Dienogest Stragen.
Regular medical examinations may be necessary. The doctor should be informed if any of the following conditions occur or have occurred in the patient.

• if there has ever been a blood clot(venous thromboembolic disease) or if a close relative has had a blood clot in the leg (thrombophlebitis), lungs (pulmonary embolism), or other organ at a relatively young age;
• if a close relative has breast cancer;
• if there has ever been depression;
• if there is high blood pressureor if high blood pressure develops while taking Dienogest Stragen;
• if liver disease occurs while taking Dienogest Stragen. Symptoms may include yellowing of the skin or eyes or itching all over the body. The doctor should be informed if such symptoms have occurred during a previous pregnancy;
• if there is diabetes or if diabetes occurred during a previous pregnancy;
• if there has ever been chloasma(yellow-brown spots on the skin, especially on the face). In such a case, it is necessary to avoid prolonged exposure to the sun or ultraviolet radiation;
• if there is abdominal painwhile taking Dienogest Stragen. While taking Dienogest Stragen, the chance of becoming pregnant is reduced, as Dienogest Stragen may affect ovulation. In the event of pregnancy while taking Dienogest Stragen, there is a slightly increased riskof ectopic pregnancy (the embryo develops outside the uterus). Before starting to take Dienogest Stragen, the doctor should be informed if the patient has ever had an ectopic pregnancy or if there are any disorders of tubal function.

Dienogest Stragen and heavy vaginal bleeding

Vaginal 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 uterine fibroids, sometimes called uterine myomas, may worsen while taking Dienogest Stragen. If the bleeding is heavy and prolonged, it can lead to a decrease in the number of red blood cells (anemia), which can be severe in some cases.
If anemia occurs, the doctor should be consulted about whether it is necessary to stop taking Dienogest Stragen.

Dienogest Stragen and changes in menstrual bleeding pattern

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

Dienogest Stragen and venous blood clots

Some studies suggest that there may be a slightly increased risk of venous blood clots(deep vein thrombosis) associated with the use of progestogen-only medicines like Dienogest Stragen. Very rarely, blood clots can cause severe, permanent disability or even death.
The risk of venous blood clotsincreases:

• with age;
• if there is overweight;
• if the patient or a close relative has had a blood clot in the leg (thrombophlebitis), lungs (pulmonary embolism), or other organ at a relatively 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 Dienogest Stragen, as it may be necessary to stop the treatment. The doctor will inform when to restart taking Dienogest Stragen. This time is usually two weeks after recovery.

Dienogest Stragen and arterial blood clots

There is limited evidence of a link between the use of progestogen-only medicines like Dienogest Stragen and an increased risk of arterial 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 due to the use of such medicines.
The risk of arterial blood clotsincreases:

• in women who smoke. It is strongly recommended to quit smoking when taking Dienogest Stragen, especially if the patient is over 35 years old;
• if the patient is overweight;
• if a close relative has had a heart attack or stroke at a young age;
• if there is high blood pressure.

The doctor should be consulted before taking Dienogest Stragen.

Stop taking Dienogest Stragen and consult a doctor immediately if any of the following symptoms of a blood clot occur:

• 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 obvious cause;
• any unusual, severe, or prolonged headache or worsening of migraine;
• partial or complete loss of vision or double vision;
• difficulty speaking or inability to speak;
• dizziness or fainting;
• weakness, strange feeling, or numbness of any part of the body.

Dienogest Stragen and cancer

Available data do not clearly indicate whether Dienogest Stragen increases the risk of breast cancer or not. Breast cancer has been observed slightly more frequently in women taking hormones compared to those not taking hormones, but it is not known if this is due to the treatment. For example, it may be because more tumors are detected and detected earlier in women taking hormones, as they are examined by a doctor more frequently. The frequency of breast cancer gradually decreases after stopping hormonal treatment. Regular breast examination is essential, and a doctor should be consulted if a lump is detected.
In rare cases, women taking hormones have been observed to have benign liver tumors, and in even rarer cases, malignant liver tumors. A doctor should be consulted if there is severe abdominal pain.

Dienogest Stragen and osteoporosis Bone mineral density (BMD) changes

Taking Dienogest Stragen may affect bone strength in young people (aged 12 to 18 years). Therefore, if the patient is under 18 years old, the doctor will individually weigh the benefits and risks of taking Dienogest Stragen, considering possible risk factors for bone loss (osteoporosis).

• If the patient takes Dienogest Stragen, they should ensure adequate calcium and vitamin D intake in their diet or as supplements to maintain bone health.

If the patient has an increased risk of osteoporosis (bone weakness due to loss of bone mineral substance), the doctor will carefully weigh the benefits and risks of treating with Dienogest Stragen, as Dienogest Stragen has a moderate suppressive effect on estrogen production (another type of female hormone) by the body.

Children and adolescents

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

Dienogest Stragen and other medicines

The doctor or pharmacist should be informed about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take. The doctor or pharmacist prescribing another medicine (or pharmacist) should also be informed about taking Dienogest Stragen.
Some medicines may affect the level of Dienogest Stragen in the blood and reduce its effectiveness or cause side effects.

• medicines used to treat the following diseases: epilepsy(e.g., phenytoin, barbiturates, primidone, carbamazepine, oxcarbazepine, topiramate, felbamate);

tuberculosis(e.g., rifampicin);
HIV and hepatitis C infections(so-called protease inhibitors and non-nucleoside reverse transcriptase inhibitors, such as ritonavir, nevirapine, efavirenz);
fungal infections(griseofulvin, ketoconazole);

• St. John's Wort.

Dienogest Stragen and grapefruit juice

While taking Dienogest Stragen, the patient should avoid drinking grapefruit juice, as it may increase the level of Dienogest Stragen in the blood. This may result in an increased risk of side effects.

Lab tests

If the patient needs to have a blood test, they should inform their doctor or laboratory staff that they are taking Dienogest Stragen, as Dienogest Stragen may affect the results of some tests.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant, breastfeeding, or thinks they may be pregnant, they should consult a doctor or pharmacist before taking this medicine.
Dienogest Stragen should 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 Dienogest Stragen.

3. How to take Dienogest Stragen

This medicine should always be taken exactly as prescribed by a doctor or pharmacist. In case of doubt, a doctor or pharmacist should be consulted.
The usual dose for adults is one tablet per day.
The following information applies to Dienogest Stragen if the doctor has not prescribed otherwise. The patient should follow the instructions below; otherwise, they will not get the full benefit of taking Dienogest Stragen.
Treatment with Dienogest Stragen can be started on any day of the natural cycle.
Adults: one tablet should be taken daily, preferably at the same time, if necessary, with a small amount of liquid. After finishing one pack, the next one should be started immediately, without interruption. The tablets should be continued even during menstrual bleeding days.

Taking more than the recommended dose of Dienogest Stragen

There are no reports of serious harmful effects after accidentally taking too many Dienogest Stragen tablets. However, in case of doubt, a doctor should be consulted.

Missing a dose of Dienogest Stragen or vomiting or diarrhea

The effectiveness of Dienogest Stragen will be reduced if a tablet is missed.
If one or more tablets are missed, the patient should take only one tablet as soon as possible and continue taking the tablets at the same time the next day.
If vomiting occurs within 3-4 hours after taking Dienogest Stragen or if there is severe diarrhea, there is a risk that the active substance of the tablet will not be absorbed by the body. These situations are similar to missing a tablet.
After vomiting or diarrhea occurring within 3-4 hours after taking Dienogest Stragen, the patient should take the next tablet as soon as possible.
A double dose should not be taken to make up for the missed tablet.

Stopping Dienogest Stragen

If the patient stops taking Dienogest Stragen, their previous endometriosis symptoms may return.
In case of any further doubts about taking this medicine, a doctor or pharmacist should be consulted.

4. Possible side effects

Like all medicines, Dienogest Stragen can cause side effects, although not everybody gets them.
Such effects are more common during the first few months after starting to take Dienogest Stragen and usually disappear with continued treatment. Changes in menstrual bleeding pattern, such as spotting, irregular bleeding, or amenorrhea, 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, gas, bloating, or vomiting;
• hair loss or hair thinning;
• back pain;
• discomfort in the breast area, ovarian cyst, or hot flashes;
• vaginal or uterine bleeding, including spotting;
• weakness or irritability.

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

• anemia;
• weight loss or increased appetite;
• lethargy, depression, or sudden mood changes;
• imbalance of the autonomic nervous system (controls involuntary body functions, e.g., sweating) or attention disorders;
• dry eye;
• tinnitus;
• non-specific circulation problems or palpitations;
• low blood pressure;
• shortness of breath;
• diarrhea, constipation, abdominal discomfort, gastritis, enteritis, or tonsillitis;
• dry skin, excessive sweating, severe itching all over the body, hirsutism (male-type hair growth), nail fragility, hair loss, skin rash, abnormal pigmentation, or photosensitivity;
• bone pain, muscle cramps, pain, or feeling of heaviness in the arms and hands or legs and feet;
• urinary tract infection;
• vaginal candidiasis, dryness of the genital area, discharge, pelvic pain, atrophic vaginitis with discharge (atrophic vulvovaginitis), or breast lump or lumps;
• swelling due to fluid retention.

Additional side effects in adolescents (aged 12 to 18 years): loss of bone density.

Reporting side effects

If any side effects occur, including any side effects not mentioned in the leaflet, the doctor or pharmacist should be informed. Side effects can be reported directly to the Department of Post-Marketing Surveillance of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181 C, PL-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.
Reporting side effects helps to gather more information on the safety of the medicine.

5. How to store Dienogest Stragen

There are no special precautions for storing the medicine.
The medicine should be stored out of sight and reach of children.
The medicine should not be used after the expiry date stated on the packaging after "EXP". The expiry date refers to the last day of the month stated.
The batch number is stated on the packaging after "Lot".
Medicines should not be disposed of via wastewater or household waste. A pharmacist should be asked how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Dienogest Stragen contains

The active substance of the medicine is dienogest. Each tablet contains 2 mg of dienogest.
The other ingredients are:
Tablet core: microcrystalline cellulose, maize starch, crospovidone (type A), povidone (K-25), colloidal anhydrous silica, magnesium stearate
Tablet coating: AquaPolish white: hypromellose, hydroxypropylcellulose, talc, hydrogenated cottonseed oil, titanium dioxide (E 171).

What Dienogest Stragen looks like and contents of the pack

Dienogest Stragen is a white, round, coated tablet with a diameter of 7.1 mm and a height of 3.4 mm.
14 white coated tablets are packaged in a PVC (250 µm) and aluminum (20 µm) blister, which is perforated when the tablet is pressed out of the packaging.
Two blisters containing 14 tablets are packaged in a PET/Aluminum/PE pouch that protects the tablets from moisture.
The carton box contains one or three pouches.
Pack sizes: 28 and 84 coated tablets
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Stragen Nordic A/S
Helsingørsgade 8C
3400 Hillerød
Denmark
Tel.: +45 48108810
Email: [email protected]

Manufacturer:

Haupt Pharma Münster GmbH
Schleebrüggenkamp 15
48159 Münster
Germany

Date of last revision of the leaflet: 2021-09-18