Dienogest stragen

Package leaflet: Information for the user

Dienogest Stragen, 2 mg, film-coated tablets
Dienogest
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, ask your doctor or pharmacist.
• This medicine has been prescribed for you personally. Do not pass it on to others. It may harm other people, even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of the leaflet

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

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

Dienogest Stragen is used in the treatment of endometriosis (painful symptoms caused by
abnormally located endometrial tissue). Dienogest Stragen contains a hormone,
a progestogen called dienogest.

2. Information before taking Dienogest Stragen

DO NOT TAKE Dienogest Stragen if:

• • you have blood clot (venous thromboembolic disease) in your veins. This may occur, for example, in blood vessels in the legs (deep vein thrombosis) or in the lungs (pulmonary embolism). See also “Dienogest Stragen and venous blood clots” below;
• • you have or have had in the past severe arterial disease, including cardiovascular disease such as heart attack, stroke, or heart disease causing reduced blood flow (angina pectoris). See also “Dienogest Stragen and arterial blood clots” below;
• • you have diabetes with blood vessel damage;
• • you have or have had in the past 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 of the whole body;
• • you have or have had in the past, or there is suspicion of benign or malignant liver tumour;
• • you have or have had in the past, or there is suspicion of a malignant hormone-dependent tumour, such as breast cancer or genital organ tumour;
• • you have unexplained vaginal bleeding;
• • you are allergic (hypersensitive) 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, you must stop taking the medicine immediately and consult your doctor.

Warnings and precautions

Before starting to take Dienogest Stragen, discuss this with your doctor or pharmacist.

While taking Dienogest Stragen, do not use hormonal contraceptives in any form (tablet, patch, vaginal ring).

Dienogest Stragen is NOT a contraceptive. To prevent pregnancy, you should use condoms or other non-hormonal contraceptive methods.

In certain situations, special caution is required when using Dienogest Stragen. Regular medical examinations may be necessary. Inform your doctor if any of the following conditions are present or have occurred in the past in the patient.

If:

• you have ever had blood clots (venous thromboembolic disease) in the past or a close family member had a blood clot at a relatively young age;
• a close relative has breast cancer;
• you have ever had depression;
• you have high blood pressure or high blood pressure develops during treatment with Dienogest Stragen;
• you develop liver disease while taking Dienogest Stragen. Symptoms may include yellowing of the skin or eyes or itching of the whole body. Inform your doctor if such symptoms occurred during a previous pregnancy;
• you have diabetes or had gestational diabetes during a previous pregnancy;
• you have ever had chloasma (brownish patches on the skin, especially on the face). In such a case, avoid prolonged sun exposure or ultraviolet radiation;
• you experience lower abdominal pain while taking Dienogest Stragen.

While taking Dienogest Stragen, the chance of becoming pregnant is reduced because Dienogest Stragen may affect ovulation.

If pregnancy occurs while taking Dienogest Stragen, there is a slightly increased risk of ectopic pregnancy (the embryo develops outside the uterus). Before starting treatment with Dienogest Stragen, inform your doctor if you have had an ectopic pregnancy in the past or have tubal function disorders.

Dienogest Stragen and severe uterine bleeding

Uterine bleeding, for example in women with a condition where the lining of the uterus (endometrium) grows into the muscular layer of the uterus, known as adenomyosis, or benign uterine tumours, sometimes called uterine fibroids, may worsen during treatment with Dienogest Stragen. If bleeding is heavy and persists for a long time, it may lead to a decrease in red blood cells (anaemia), which may be severe in some cases. If anaemia occurs, discuss with your doctor whether discontinuation of Dienogest Stragen is necessary.

Dienogest Stragen and changes in bleeding pattern

Most women treated with Dienogest Stragen experience changes in menstrual bleeding pattern (see section 4 “Possible side effects”).

Dienogest Stragen and venous blood clots

Some studies suggest a slight, statistically non-significant increased risk of blood clots in the legs (venous thromboembolic disease) associated with the use of medicines containing progestogens, such as Dienogest Stragen. Very rarely, blood clots may cause serious, permanent disability or even lead to death.

The risk of venous blood clot increases:

• • with age;
• • if you are overweight;
• • if you or a close relative had a blood clot in the leg (thrombosis), lungs (pulmonary embolism), or another organ at a young age;
• • if surgery is planned, a serious accident has occurred, or prolonged immobilisation is present. It is important to inform your doctor in advance about taking Dienogest Stragen, as treatment may need to be discontinued. Your doctor will advise when to restart taking Dienogest Stragen. Usually, this is two weeks after recovery.

Dienogest Stragen and arterial blood clots

There is limited evidence of an association between the use of medicines containing progestogens, such as Dienogest Stragen, and an increased risk of arterial blood clots, for example in blood vessels of the heart (heart attack) or brain (stroke). In women with hypertension, the risk of stroke may be slightly increased due to the use of such medicines.

The risk of arterial blood clot increases:

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

Consult your doctor before taking Dienogest Stragen.

You must stop taking Dienogest Stragen and contact your doctor immediately if you notice possible symptoms of blood clots, such as:

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

Dienogest Stragen and cancer

Current available data do not clearly indicate whether Dienogest Stragen increases or does not increase the risk of breast cancer. Breast cancer has been observed slightly more frequently in women taking hormones compared to women not taking hormones, but it is not known whether this is caused by the treatment. For example, it may result from the fact that more tumours are detected and detected earlier in women taking hormones because they are examined more frequently by a doctor. The incidence of breast tumours gradually decreases after stopping hormonal treatment. Regular breast examination is important, and you should contact your doctor if you feel a lump.

In rare cases, benign liver tumours have been observed in women taking hormones, and even more rarely, malignant liver tumours. Contact your doctor if you experience extremely severe abdominal pain.

Dienogest Stragen and osteoporosis

Changes in bone mineral density (BMD)

The use of Dienogest Stragen may affect bone strength in adolescents (aged 12 to below 18 years). Therefore, if the patient is under 18 years of age, the doctor will individually assess the benefits and risks of using Dienogest Stragen, taking into account possible risk factors for bone mass loss (osteoporosis).

If you are taking Dienogest Stragen, for bone health, you should ensure adequate intake of calcium and vitamin D in your diet or as supplements.

If you have an increased risk of developing osteoporosis (weakening of bones due to loss of bone minerals), your doctor will carefully assess the benefits and risks of treatment with Dienogest Stragen, as Dienogest Stragen shows a moderate suppressive effect on the body's production of oestrogen (another type of female hormone).

Children and adolescents

Dienogest Stragen must not be used in girls before their first menstrual period. The use of Dienogest Stragen may affect bone strength in adolescents (aged 12 to below 18 years). Therefore, if the patient is under 18 years of age, the doctor will individually assess the benefits and risks of using Dienogest Stragen, taking into account possible risk factors for bone mass loss (osteopor游戏副本

3. How to take Dienogest Stragen

This medicine should always be taken as directed by your doctor or pharmacist. If in doubt,
consult your doctor or pharmacist.
The usual dose for adults is 1 tablet per day.
The following information applies to Dienogest Stragen unless otherwise instructed by your doctor.
Please follow these instructions carefully; otherwise, the patient may not achieve the full benefit
of taking Dienogest Stragen.
Treatment with Dienogest Stragen may be started on any day of the natural cycle.
Adults: take one tablet daily, preferably at the same time each day, with a small amount of liquid if needed.
After finishing one pack, start the next pack immediately without any break. Continue taking the tablets
even during days with menstrual bleeding.

Taking more Dienogest Stragen than recommended
There are no reports of serious harmful effects following a single intake of an excessive number of Dienogest Stragen tablets.
However, if in doubt, contact your doctor.

Missed dose or occurrence of vomiting or diarrhoea
The effectiveness of Dienogest Stragen may be reduced if a tablet is missed.
If one or more tablets are missed, take one tablet as soon as possible and continue taking one tablet daily at the usual time.
Do not take a double dose to make up for the missed tablet.

If vomiting occurs within 3–4 hours after taking Dienogest Stragen, or if severe diarrhoea occurs,
there is a risk that the active substance may not be fully absorbed by the body.
These situations are similar to missing a tablet.
After vomiting or diarrhoea occurring within 3–4 hours of taking Dienogest Stragen,
take another tablet as soon as possible.

Stopping treatment with Dienogest Stragen
If the patient stops taking Dienogest Stragen, previous symptoms of endometriosis may return.
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.
These reactions are more common during the first few months after starting Dienogest Stragen and usually subside with continued use. Bleeding pattern changes may also occur, such as spotting, irregular bleeding, or absence of menstruation.

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

• increased body weight;
• low mood, sleep problems, nervousness, loss of interest in sex, or mood changes;
• headache or migraine;
• nausea, abdominal pain, flatulence, bloating, or vomiting;
• acne or hair loss;
• back pain;
• breast discomfort, ovarian cyst, or hot flushes;
• uterine and (or) vaginal bleeding, including spotting;
• fatigue or irritability.

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

• anaemia;
• weight loss or increased appetite;
• anxiety, depression, or sudden mood changes;
• autonomic nervous system imbalance (controls unconscious body functions, e.g. sweating) or attention disturbances;
• dry eye;
• tinnitus;
• non-specific circulatory problems or palpitations;
• low blood pressure;
• dyspnoea;
• diarrhoea, constipation, abdominal discomfort, gastritis, enteritis, gingivitis;
• dry skin, excessive sweating, severe generalized itching, development of male-pattern hair growth (hirsutism), brittle nails, dandruff, skin inflammation, abnormal hair growth, photosensitivity reaction, or pigmentation disorders;
• bone pain, muscle cramps, pain and (or) heaviness in arms and hands or legs and feet;
• urinary tract infection;
• vaginal candidiasis, genital dryness, vaginal discharge, pelvic pain, atrophic genital inflammation with discharge (atrophic vaginitis and vulvitis), or breast lump(s);
• fluid retention leading to oedema.

Additional adverse reactions in adolescents (aged 12 to under 18 years): loss of bone density.

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department for Monitoring Adverse Drug Reactions, 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 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 Dienogest Stragen

No special precautions for storage of the medicinal product are required.
The medicine should be stored out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after the abbreviation
"EXP". The expiry date refers to the last day of the stated month. The batch number is
indicated on the packaging after the abbreviation "Lot".
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 Dienogest Stragen contains
The active substance is dienogest. Each tablet contains 2 mg of dienogest.
The other ingredients are:
Tablet core: microcrystalline cellulose, pregelatinized starch (maize), crospovidone (type A),
povidone (K-25), colloidal anhydrous silica, magnesium stearate.
Tablet coating: AquaPolish white: hypromellose, hydroxypropylcellulose, talc, cottonseed oil,
hydrogenated, titanium dioxide (E 171).

What Dienogest Stragen looks like and contents of the pack
Dienogest Stragen is a white, round, film-coated tablet with a diameter of 7.1 mm and a height of 3.4 mm.
14 white film-coated tablets are packed in a blister made of PVC (250 µm) and aluminium (20 µm), which perforates when the tablet is pushed out of the packaging.
Two blisters, each containing 14 tablets, are packed into a moisture-protective sachet made of PET/aluminium/PE.
One or three sachets are placed in a cardboard box.
Pack sizes: 28 and 84 film-coated tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Stragen Nordic A/S
Industrivej 24F
3550 Slangerup
Denmark
Tel.: +45 48108810
E-mail: [email protected]

Manufacturer:
Haupt Pharma Münster GmbH
Schleebrüggenkamp 15
48159 Münster
Germany