Medicinal Products

DIVINA 2 mg / 10 mg

Generic drug of the therapeutic class: Gynecology
active ingredients: White tablet: Estradiol, Blue tablet: Estradiol, Medroxyprogesterone
laboratory: Orion Corporation

Compressed
Box of 1 Plate of 21
All forms

Indication

- Hormone Replacement Therapy (HRT) symptoms of estrogen deficiency in postmenopausal women.
- Prevention of postmenopausal osteoporosis in women with an increased risk of osteoporotic fracture and intolerance or contraindication to other treatments indicated for the prevention of osteoporosis.
- The experience of this treatment in women over 65 is limited.

Dosage DIVINA 2 mg / 10 mg Tablet Box of 1 Plate of 21

- Oral way:
This is a cyclical treatment.
The treatment regimen is as follows: take one tablet daily for 21 consecutive days in the following order:
. 1st to 11th day, 1 white tablet (estradiol),
. from day 12 to day 21, 1 blue tablet (estradiol and medroxyprogesterone acetate).
After a 7-day therapeutic stop, the following sequence will be taken under the same conditions.
- Haemorrhage deprivation may occur during the free treatment interval.
- If it is a prescription for a woman who is not taking HRT or a continuous combined HRT relay, treatment can be started any day.
On the other hand, if the pretreatment is a sequential HRT, the current treatment cycle must be completed before starting treatment with DIVINA, tablet.
- To start or continue treatment for the indication of postmenopausal symptoms, the minimum effective dose should be used for the shortest possible duration (see section on warnings and precautions for use).
- If you forget a tablet, it should be taken within 12 hours of the usual time of taking. Forgetting a tablet may promote the occurrence of spotting and bleeding.

Against indications

- known hypersensitivity to any of the active ingredients or to any of the excipients;
- known or suspected breast cancer or history of breast cancer;
- known or suspected estrogen-dependent malignant neoplasms (eg, endometrial cancer);
- undiagnosed genital haemorrhage;
- untreated endometrial hyperplasia;
- History of idiopathic venous thrombo-embolic accident or evolving thromboembolic event (deep vein thrombosis, pulmonary embolism);
- Recent or evolving arterial thromboembolic stroke (eg, angina, myocardial infarction);
- Acute liver disease or history of liver disease, until hepatic tests are normalized;
- Porphyria.
- Pregnancy: this medicine has no indication during pregnancy. The discovery of a pregnancy during treatment with DIVINA, tablet requires the immediate cessation of treatment. No clinical data of pregnancy exposed to DIVINA is available. Studies in animals have shown reproductive toxicity. The potential risks to the woman are not known. To date, most epidemiological studies have shown no teratogenic or foetotoxic effect in pregnant women inadvertently exposed to therapeutic doses of estrogens and progestins.
- Breast-feeding: This medicine has no indication during breastfeeding.
- Due to the presence of lactose, this drug is contraindicated in case of congenital galactosemia, glucose-galactose malabsorption syndrome or lactase deficiency.

Divina side effects

THE FOLLOWING SIDE EFFECTS HAVE BEEN OBSERVED DURING A SUBSTITUTED HORMONE TREATMENT OF MENOPAUSE (CLINICAL STUDIES) :
- disorders of the nervous system:
. Common : Headache
. Uncommon : Dizziness. Migraine.
. Rare : Aggravation of epilepsy.
- Metabolism and nutrition disorders:
Rare : Glucose intolerance.
- Vascular disorders:
. Uncommon : Venous thromboembolic disease.
. Rare : Hypertension.
- Disorders of the reproductive organs and the breast:
. Common : Tension / breast pain. Breast hypertrophy. Dysmenorrhea. Menorrhagia. Breakthrough bleeding. Leucorrhoea.
. Uncommon : Benign breast tumor Increase in size of a uterine leiomyoma. Vaginitis / vaginal candidiasis.
. Rare : Galactorrhea.
- Hepatobiliary disorders:
Rare : Anomaly of liver function tests.
- Skin and subcutaneous tissue disorders:
. Uncommon : Pruritus.
. Rare : Discoloration of the skin. Acne.
- General disorders and anomalies at the site of administration:
. Frequent : Weight change (increase or decrease) Fluid retention with peripheral edema.
. Uncommon : Asthenia.
. Rare : Anaphylactic reaction (in women with a history of allergic reaction).
- Psychiatric disorders:
. Uncommon : Depression. Mood disorders.
. Rare : Modification of the libido.
- Gastrointestinal disorders:
. Common : Nausea Abdominal pain.
. Uncommon : Flatulence. Vomiting.
BREAST CANCER :
- The results of a large number of epidemiological studies and a randomized placebo-controlled study, the WHI study, show that the overall risk of breast cancer increases with the duration of HRT use in women taking or having recently took a HRT.
- For estrogens alone, the relative risks (RR) estimated after a new analysis of 51 epidemiological studies (of which more than 80% used an estrogen alone) and MWS are similar, ie 1 (95% CI: 1.21-1.49) and 1.30 (95% CI: 1.21-1.40).
- For the combination of estrogen and progestogen, several epidemiological studies have shown that the overall risk of breast cancer is higher than for estrogen alone.
- The MWS shows that, compared to women who have never used HRT, the use of different estrogen / progestin combinations is at risk for breast cancer (RR = 2.00, 95% CI: 1.88-2, 12) higher than that of estrogen alone (RR = 1.30, 95% CI: 1.21-1.40) or tibolone (RR = 1.45, 95% CI: 1.25-1.68).
In the WHI study, this relative risk is estimated at 1.24 (95% CI: 1.01-1.54) for all women treated for 5.6 years with an estrogen / progestin combination (EEC + MPA). compared to placebo.
The absolute risks calculated from the results of the MWS and WHI studies are presented below:
- The MWS, taking into account the average incidence of breast cancer in developed countries, estimates that:
. out of 1000 non-users of HRT, about 32 will develop breast cancer between 50 and 64 years of age.
. out of 1000 women taking or having recently taken HRT, the number of additional cases would be:
For users of estrogen alone:
. Between 0 and 3 cases (best estimate = 1.5) for 5 years of use,
. Between 3 and 7 cases (best estimate = 5) for 10 years of use.
For users of estrogen / progestin combinations:
. Between 5 and 7 cases (best estimate = 6) for 5 years of use,
. Between 18 and 20 cases (best estimate = 19) for 10 years of use.
- The WHI study estimates that at the end of 5.6 years of follow-up of women aged 50 to 79, the number of additional cases of invasive breast cancer attributable to the use of an estrogen / progestin combination (EEC + MPA) is 8 cases per 10, 000 women-years.
- The calculations made from the data of the study allow to estimate that:
. For 1000 women in the placebo group:
Approximately 16 cases of invasive breast cancer will be diagnosed in 5 years of follow-up.
. For 1000 women using an estrogen / progestin combination (EEC + MPA), the number of additional cases would be:
Between 0 and 9 (best estimate = 4) for 5 years of use.
- The number of additional cases of breast cancer is almost identical among users regardless of the age of onset of treatment (between 45 and 65 years) (see section on warnings and precautions for use).
CANCER OF THE ENDOMETER :
- In non-hysterectomized women treated with estrogen alone, the risk of hyperplasia or endometrial cancer increases with duration of treatment.
- According to data from epidemiological studies, the best estimate of risk between the ages of 50 and 65 is about 5 diagnoses of endometrial cancer in 1000 women not using HRT.
- Under estrogen alone, the risk of endometrial cancer is multiplied by 2 to 12 compared to non-users, depending on the duration of use and the dose of estrogen used. The combined use of a progestin with estrogen lowers the risk significantly.
THE FOLLOWING SIDE EFFECTS, CONSIDERED AS CLASS EFFECTS, ARE REPORTED IN THE ADMINISTRATION OF ESTROPROGESTATIVE TREATMENT :
- benign or malignant estrogen-dependent tumors, such as endometrial cancer;
. venous thrombo-embolic disease (ie: pelvic deep vein thrombosis or lower extremities, pulmonary embolism), more common in women on HRT than non-users. For further information, see sections contraindications and warnings and precautions for use ;
- myocardial infarction and stroke;
- biliary diseases;
- cutaneous and subcutaneous disorders: chloasma, erythema multiforme, erythema nodosum; vascular purpura;
- probable dementia (see Warnings and precautions for use section).

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