This is indicated for the relief of

• post-menopausal symptoms associated with decreased estrogen levels, including hot flushes and vaginal dryness.
• It is also indicated for women who desire complete cessation of menstrual bleeding after intermittent recurrence due to impending menopause.
• It may be used in women whose menopausal symptoms significantly interfere with normal daily activities.

This is classified as an antiandrogenic gestagen and is used as a Hormone Replacement Therapy (HRT). It contains two female hormones: an estrogen and a progestogen. It is intended for use in postmenopausal women who have had at least 12 months since their last natural menstruation and still have an intact uterus. The active components, estradiol valerate and dienogest, work together to reduce menopausal symptoms such as hot flushes, vaginal dryness, and irritation.

Estrogen regulates various body functions, including controlling pituitary hormone secretion (such as gonadotropins, luteinizing hormone, and follicle-stimulating hormone), which are elevated after menopause. By reducing these hormone levels, estrogen helps alleviate postmenopausal symptoms. Dienogest is a progestin that binds to progesterone receptors. It transforms endometrial secretory function and protects against endometrial proliferation. Together, these components help prevent the recurrence of menstrual bleeding, which may occur with sequential hormone replacement therapy.

One tablet should be taken daily at the same time blister packet. blister packet. Each blister pack contains tablets for 28 days of treatment. This is for oral use only. The tablets are to be swallowed whole with some liquid. Treatment is continuous, which means that the next pack follows immediately without a break. The tablets should preferably be taken at the same time every day. In case a tablet is forgotten it should be taken as soon as possible. If more than 24 hours have elapsed no extra tablet needs to be taken. If several tablets are forgotten, bleeding may occur.

Some medicines can affect the action of this tablet. This may result in irregular bleeding. This includes the following medicines:

• Medicines for epilepsy (e.g. phenobarbital, phenytoin, carbamazepine)
• Medicines for tuberculosis (e.g. rifampicin, rifabutin)
• Medicines for HIV infection (e.g. nevirapine, efavirenz, ritonavir, nelfinavir)
• Herbal products containing St. John’s wort (Hypericum perforatum)

This medicine should not be used in the following conditions:

• Known or suspected breast cancer
• Known or suspected estrogen-dependent cancers (e.g. endometrial cancer)
• Unexplained genital bleeding
• Untreated endometrial hyperplasia
• Previous or current venous thromboembolism (e.g. deep vein thrombosis, pulmonary embolism)
• Active or recent arterial thromboembolic disease (e.g. angina, myocardial infarction)
• Known blood clotting disorders (e.g. protein C, protein S, or antithrombin deficiency)
• Acute liver disease or history of liver disease with abnormal liver tests
• Porphyria
• Hypersensitivity to active substances or any ingredients

The following conditions have been reported more frequently in women using HRT compared to those not using HRT: breast cancer, abnormal growth or cancer of the lining of the womb (endometrial hyperplasia or cancer), ovarian cancer, blood clots in the veins of the legs or lungs (venous thromboembolism), heart disease, stroke, and possible memory loss when HRT is started after the age of 65.

Most frequent side effects: unexpected menstruation-like bleeding, breast tenderness, breast pain.
Unexpected menstruation-like bleeding may occur during the first few months of treatment. It is usually temporary and generally resolves with continued therapy. If it persists, consult your doctor.

Common side effects (affecting 1 to 10 in 100 patients):

• Headache, migraine, dizziness
• Tiredness, anxiety, depressive mood
• High blood pressure or worsening of existing high blood pressure
• Nausea, abdominal pain, diarrhoea
• Increased gamma GT (liver enzyme), Thickening of the womb lining, Inflammation of the genitals
• Breast swelling, Hot flushes
• Changes in body weight
• Thrush (fungal infection)

Uncommon side effects (affecting 1 to 10 in 1,000 patients):

• Sleeplessness, nervousness
• Vein inflammation, venous blood clot (leg pain), painful veins
• Constipation, bloating
• Increased sweating, hair loss, Skin reactions (rash, eczema, acne-like dermatitis)
• Changes in vaginal discharge
• Lumpy breasts (fibrocystic changes), Allergic reactions
• Fluid retention in legs,Changes in blood fats
• Increased blood sugar,Changes in sex drive
• Muscle cramps
• Anaemia

Rare side effects (affecting 1 to 10 in 10,000 patients): depression, visual disturbances, palpitations, indigestion, liver enzyme abnormalities, enlargement of fibroids, and increased appetite.

This medicine is intended for use in post-menopausal women only. If pregnancy occurs, stop taking this medicine and consult your doctor immediately. If you are a breastfeeding mother, discontinue use and contact your doctor.

If you have ever experienced any of the following conditions before starting treatment, they may reappear or worsen during therapy. In such cases, regular medical check-ups are advised:

Uterine fibroids, endometriosis, endometrial hyperplasia, increased risk of blood clots, risk factors for estrogen-dependent tumours (e.g. first-degree family history of breast cancer), high blood pressure, liver disorders (such as benign liver tumours), diabetes, gallstones, migraine or severe headaches, systemic lupus erythematosus, epilepsy, asthma, otosclerosis, very high blood triglycerides, fluid retention due to heart or kidney problems, hereditary angioedema (which may be triggered or worsened by estrogen-containing products).

Seek immediate medical attention if you develop symptoms of angioedema such as swelling of the face, tongue, or throat, difficulty swallowing, or hives with breathing difficulty.

Stop taking this medicine and consult a doctor immediately if you experience: Jaundice or worsening liver function, significant increase in blood pressure, new onset migraine-type headache, or pregnancy. Also seek urgent help if signs of blood clots occur, such as painful swelling and redness in the legs, sudden chest pain, or shortness of breath.

HRT and Cancer Excessive thickening of the uterine lining (endometrial hyperplasia) and endometrial cancer may occur. Estrogen-only HRT increases this risk, but the progestogen in this medicine helps reduce it.

Irregular Bleeding Irregular bleeding or spotting may occur during the first 3–6 months of treatment. If it continues beyond 6 months, consult your doctor.

Breast Cancer Combined estrogen-progestogen and possibly estrogen-only HRT may increase the risk of breast cancer. The risk depends on duration of use and appears within a few years of treatment. It returns to normal within a few years (up to 5 years) after stopping therapy.

Blood Clots (Thrombosis)

• HRT users have a 1.3 to 3 times higher risk of blood clots in veins, especially during the first year. These can be serious or life-threatening if they reach the lungs.
• Inform your doctor if you: are immobile due to surgery, injury, or illness; are severely overweight (BMI >30 kg/m²); have a clotting disorder requiring long-term anticoagulant therapy; have a family history of blood clots; have systemic lupus erythematosus; or have cancer.

Heart Disease (Heart Attack) There is no evidence that HRT prevents heart attacks. Women over 60 using estrogen-progestogen HRT may have a slightly increased risk of heart disease compared to non-users.

Stroke HRT users have about a 1.5 times higher risk of stroke than non-users. The risk increases with age.

Acute toxicity studies show that even large accidental doses are unlikely to cause serious toxicity. Overdose may lead to nausea, vomiting, and withdrawal bleeding in some women. There is no specific antidote.

Medicines for menopausal symptoms: Hormone Replacement Therapy (HRT), female sex hormones.

Store below 30°C, protect from light and moisture. Keep out of reach of children.