D

Dinoges-EV

Rx

2 mg • Tablet

Dienogest + Estradiol Valerate • Nuvista Pharma PLC.

Therapeutic class: Drugs for menopausal symptoms: Hormone replacement therapy

🌐 বাংলায় দেখুন

Available as: 2 mg

More from Dinoges-EV

Other strengths and forms by Nuvista Pharma PLC.

Dinoges-EV 2 mg+2 mg Tablet

Indications & Uses

Dienogest + Estradiol Valerate is used for relief of post-menopausal symptoms linked to a drop in estrogen hormones, including hot flushes and vaginal dryness. It is also used for women who want menstrual bleeding to stop completely after it has kept coming back on and off because menopause is close. And it is meant for women whose menopausal symptoms get in the way of their normal daily activities.

Pharmacology

This medicine is an antiandrogenic gestagen, and it helps reduce and ease the menopausal symptoms that cause women distress. It is a Hormone Replacement Therapy (HRT) and contains two types of female hormones, an oestrogen and a progestogen. It is used in postmenopausal women who still have their uterus and whose last natural period was at least 12 months ago.

The two active components, estradiol valerate and dienogest, are combined to reduce the red flushes, vaginal dryness and irritation that women commonly have after menopause. Oestrogen serves numerous body processes. One of them is controlling the hormones released by the pituitary gland (the gonadotropins, luteinizing hormone and follicle-stimulating hormone), which rise after menopause. Oestrogen works by lowering the level of these hormones.

Dienogest is a progestin that works by binding to the progesterone receptor. It changes the secretory function of the endometrium and protects against endometrial proliferation. Together, these 2 substances prevent the return of menstrual bleeding, which usually happens with sequential Hormone Replacement Therapy.

Dosage Reference

Reference Information Only

Dosages shown are general references from official sources. Always consult your doctor or pharmacist for personalized dosing.

Adults:

Take one tablet a day, from the blister pack, at the same time each day. Each blister pack holds 28 days of tablets. The tablets are for oral use only, so swallow them whole with a little liquid.

Treatment is continuous. That means you start the next pack straight after finishing one, with no break in between.

If you forget a tablet, take it as soon as you can. If more than 24 hours have passed, you don't need to take an extra tablet. Forgetting several tablets may cause bleeding.

Side Effects

Women using HRT report the following diseases more often than women who don't use it: 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 probable memory loss if HRT is started over the age of 65. The most frequent side effects of Dienogest + Estradiol Valerate are unexpected menstruation-like bleeding, breast tenderness and breast pain. The bleeding happens during the first few months of treatment with this medicine. It is usually temporary and normally disappears with continued treatment. If it does not, contact your doctor. Common side effects (between 1 and 10 in every 100 patients are likely to get these): headache, migraine, dizziness, tiredness, anxiety, depressive mood, high blood pressure, worsening of high blood pressure, feeling sick, abdominal pain, diarrhoea, increase in gamma GT (an enzyme), thickening of the lining of the womb, inflammation of the genitals, swollen breasts, hot flushes, changes in body weight, thrush. Uncommon side effects (between 1 and 10 in every 1000 patients are likely to get these): sleeplessness, nervousness, inflammation of the veins, venous blood clot (leg pain), painful veins, constipation, swollen tummy (bloating), inflammation of the stomach, increased sweating, hair loss, different skin conditions such as exanthema, eczema and acne-like dermatitis acne, changes in vaginal secretions, lumpy breasts (fibrocystic disease), allergic reactions, fluid retention in the legs, altered blood fats, increase in blood sugar, change in sex drive, muscle cramps, anaemia. Rare side effects (between 1 and 10 in every 10,000 patients are likely to get these): depression, visual disorders, palpitations, indigestion, disturbances in liver enzymes, increase in the size of fibroids, increased appetite.

Cautions & Contraindications

Warnings & Precautions

If you have ever had any of the following problems before you start treatment with Dienogest + Estradiol Valerate, they may return or become worse during treatment with this tablet. If so, you should see your doctor more often for check-ups: uterine fibroids, endometriosis, endometrial hyperplasia, an increased risk of developing blood clots, risk factors for estrogen-dependent tumours (for example 1st-degree heredity for breast cancer), high blood pressure, a liver disorder such as a benign liver tumour, diabetes, gallstones, migraine or severe headaches, systemic lupus erythematosus, epilepsy, asthma, otosclerosis, a very high level of fat in your blood (triglycerides), and fluid retention due to cardiac or kidney problems. In hereditary angioedema, products containing oestrogens may cause or worsen the symptoms. See your doctor immediately if you have symptoms of angioedema, such as a swollen face, tongue and/or throat, difficulty swallowing, or hives together with difficulty breathing. Stop taking this tablet and see a doctor immediately if you notice jaundice or a deterioration in liver function, a significant increase in blood pressure, a new onset of migraine-type headache, or pregnancy. The same applies if you notice signs of a blood clot, such as painful swelling and redness of the legs, sudden chest pain, or difficulty breathing. HRT and cancer: Taking oestrogen-only HRT increases the risk of excessive thickening of the lining of the womb (endometrial hyperplasia) and cancer of the womb lining (endometrial cancer). The progestogen in this tablet protects you from this extra risk. Irregular bleeding: You may have irregular bleeding or drops of blood (spotting) during the first 3 to 6 months of taking this tablet. However, the situation is different if the irregular bleeding carries on for more than the first 6 months. Breast cancer: Evidence suggests that combined oestrogen-progestogen HRT, and possibly also oestrogen-only HRT, increases the risk of breast cancer. This extra risk depends on how long you take HRT. It becomes clear within a few years, but it returns to normal within a few years (at most 5) after you stop treatment. Blood clots in a vein (thrombosis): The risk of blood clots in the veins is about 1.3 to 3 times higher in HRT users than in non-users, especially during the first year of taking it. Blood clots can be serious. If one travels to the lungs, it can cause chest pain, breathlessness, fainting or even death. Inform your doctor if any of these apply to you: you are unable to walk for a long time because of major surgery, injury or illness, you are seriously overweight (BMI >30 kg/m²), you have any blood clotting problem that needs long-term treatment with a medicine used to prevent blood clots, any of your close relatives has ever had a blood clot in the leg, lung or another organ, you have systemic lupus erythematosus (SLE), or you have cancer. Heart disease (heart attack): There is no evidence that HRT will prevent a heart attack. Women over the age of 60 years who use oestrogen-progestogen HRT are slightly more likely to develop heart disease than those not taking any HRT. Stroke: The risk of getting a stroke is about 1.5 times higher in HRT users than in non-users. The number of extra cases of stroke due to the use of HRT will increase with age.

Contraindications

Dienogest with estradiol valerate is contraindicated in known past or suspected breast cancer, known or suspected estrogen-dependent malignant tumors (e.g. endometrial cancer), undiagnosed genital bleeding, untreated endometrial hyperplasia, previous or current venous thromboembolism (deep venous thrombosis, pulmonary embolism), active or recent arterial thromboembolic disease (e.g. angina, myocardial infarction), known thrombophilic disorders (e.g. protein C, protein S, or antithrombin deficiency), acute liver disease, or a history of liver disease as long as liver function tests have failed to return to normal, porphyria, and hypersensitivity to the active substances or to any of the ingredients.

Pregnancy & Breastfeeding

Dienogest + Estradiol Valerate is meant for post-menopausal women only. If you become pregnant, stop taking it and contact your doctor. If you are breastfeeding, stop taking this tablet and contact your doctor too.

⚠️ Talk to your doctor before taking any medicine during pregnancy or while breastfeeding.

Overdose

Studies on acute toxicity show no acute toxicity risk is expected, even if someone accidentally takes a multiple of the therapeutic dose of Dienogest + Estradiol Valerate. An overdose may cause nausea and vomiting, and some women may have withdrawal bleeding. There is no specific antidote.

⚠️ In an emergency call 999 or go to the nearest hospital emergency department.

Storage

Store Dienogest + Estradiol Valerate below 30°C, away from light and moisture. Keep it out of the reach of children.

Drug Interactions

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Common questions about Dinoges-EV 2 mg

What is Dinoges-EV 2 mg Tablet?

Dinoges-EV 2 mg Tablet is a medicine that contains Dienogest + Estradiol Valerate. It is made by Nuvista Pharma PLC. It belongs to the Drugs for menopausal symptoms: Hormone replacement therapy group of medicines.

What is Dinoges-EV used for?

Dienogest + Estradiol Valerate is used for relief of post-menopausal symptoms linked to a drop in estrogen hormones, including hot flushes and vaginal dryness. It is also used for women who want menstrual bleeding to stop completely after it has kept coming back on and off because menopause is close.

What are the side effects of Dinoges-EV?

Women using HRT report the following diseases more often than women who don't use it: 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 probable memory loss if HRT is started over the age of 65. The most frequent side effects of Dienogest + Estradiol Valerate are unexpected menstruation-like bleeding, breast tenderness and breast pain.

Can I take Dinoges-EV during pregnancy or while breastfeeding?

Dienogest + Estradiol Valerate is meant for post-menopausal women only. If you become pregnant, stop taking it and contact your doctor. Talk to your doctor before taking any medicine during pregnancy or while breastfeeding.

What happens if I take too much Dinoges-EV?

Studies on acute toxicity show no acute toxicity risk is expected, even if someone accidentally takes a multiple of the therapeutic dose of Dienogest + Estradiol Valerate. An overdose may cause nausea and vomiting, and some women may have withdrawal bleeding. In an emergency call 999 or go to the nearest hospital emergency department.

How should I store Dinoges-EV?