Medicinal Products

AVADENE 2 mg / 0.05 mg

Generic drug of the therapeutic class: Gynecology
Active ingredients: Yellow tablet:, Estradiol, Red-brown tablet:, Estradiol, Gestodene
laboratory: Schering SA

Coated tablet
Box of 28
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.
(See also warnings and precautions for use).
- The experience of this treatment in women over 65 is limited.

Dosage AVADENE 2 mg / 0.05 mg Film-coated tablet Box of 28

Oral way.
Continuous sequential processing.
Avadene 2 mg / 0.050 mg is a continuous, sequential combination of estrogen and progestin. Estrogen is administered throughout the cycle. The progestin is sequentially associated for 12 days of the cycle.
The therapeutic scheme is as follows:
Take one tablet daily for 28 consecutive days in the following order:
. from the 1st to the 16th day, a yellow tablet (estradiol);
. from the 17th to the 28th day, a red-brown tablet (associating estradiol and gestodene).
At the end of the 28 days, continue treatment directly with the next pack of 28 tablets, without interruption of treatment between the platelets.
The tablets should be swallowed whole with a little liquid. They can be taken during or outside meals, preferably always at the same time.
As a rule, treatment of climacteric symptoms should be started with Avadene 1 mg / 0.025 mg. If, after a few weeks of treatment, the symptoms are not satisfactorily controlled, the treatment may be replaced by Avadene 2 mg / 0.050 mg.
The prevention of postmenopausal osteoporosis in women at increased risk of osteoporotic fracture should take into account expected dose-dependent bone mass outcomes (see section 5.1) and individual tolerability of treatment. .
If this is a first-time prescription for women who have never taken HRT or if it is a relay of a continuous combined HRT, treatment can be started any day of the day. cycle.
On the other hand, if it is a relay of a sequential THS, the treatment must be started the day after the end of the previous treatment.
To start or continue treatment for the indication of post-menopausal symptoms, the minimum effective dose should be used for the shortest possible duration (see section on warnings and precautions for use).
- Missing one tablet : if you forget a tablet, it should be taken within 12 to 24 hours after the usual time of taking. If treatment is interrupted for a longer period, irregular bleeding may occur.
- Populations at risk : see sections contraindications and warnings and precautions for use .
- Elderly : There are few clinical data on the treatment of older women.

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 venous thrombo-embolic 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: Avadene 2 mg / 0.050 mg has no indication during pregnancy. The discovery of pregnancy during treatment with Avadene 2 mg / 0.050 mg requires the immediate cessation of treatment. Clinical data on a limited number of exposed pregnancies show no adverse effects of gestodene on the fetus. To date, most epidemiological studies have shown no teratogenic or foetotoxic effect in pregnant women inadvertently exposed to combinations of estrogens and progestins.
- Breast-feeding: Avadene 2 mg / 0.050 mg has no indication during breastfeeding.
Due to the presence of lactose, this drug is contraindicated in cases of congenital galactosemia, glucose-galactose malabsorption syndrome or lactase deficiency.

Avadene side effects

Adverse reactions that may occur during treatment with Avadene 2 mg / 0.050 mg are described below. The data below (HARTS Body System and Dictionary Term) presents the adverse effects according to their frequency of appearance. These frequencies are based on the number of adverse events reported in 10 Phase III clinical trials (1542 patients) that are considered to be related to the use of Avadene 2 mg / 0.050 mg. The most common side effects were mastodynia (10%).
- Genital system:
. Frequent> 1/100 <1/10 : Cystic fibrosis of the breast, dysmenorrhea, menorrhagia, spotting, menstrual disorders, leucorrhea, breast tenderness.
. Uncommon> 1/1000 <1/100 : benign breast tumor, uterine polyp, exacerbation of uterine fibroids, endometriosis, vaginal candidiasis, increased breast volume.
- Gastrointestinal system:
. Frequent> 1/100 <1/10 : abdominal pain, abdominal swelling.
. Uncommon> 1/1000 <1/100 : vomiting, constipation, diarrhea.
- The nervous system :
. Frequent> 1/100 <1/10 : headache.
. Uncommon> 1/1000 <1/100 : stroke, migraine, vertigo.
- Muscular and skeletal system:
. Frequent> 1/100 <1/10 : muscle cramps, pain in the limbs.
. Uncommon> 1/1000 <1/100 : arthralgia.
- Psychiatric:
Frequent> 1/100 <1/10 : nervousness, depression.
- Vascular system :
Uncommon> 1/1000 <1/100 : superficial or deep vein thrombosis, thrombophlebitis, arterial hypertension, angina.
- General system:
Uncommon> 1/1000 <1/100 : peripheral edema, weight gain, asthenia, increased appetite.
- Skin and subcutaneous tissues:
Uncommon> 1/1000 <1/100 : acne, skin rash, pruritus, alopecia, seborrhea.
- Hepatobiliary system:
Uncommon> 1/1000 <1/100 : lithiasis of the bile duct, abnormal liver function tests.
- 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 (RRs) estimated from a new analysis of 51 epidemiological studies (of which more than 80% used estrogen alone) and MWS are similar, ie 1, (95% CI: 1.21-1.49) and 1.30 (95% CI: 1.21-1.40).
For combined hormonal combinations, 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 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 the ages of 50 and 64;
. 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 (CEE + MPA) is 8 cases per 10, 000 women-years.
Calculations based on the study data suggest 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 at which treatment is started (between 45 and 65 years of age) (see section on warnings and precautions for use).
- Endometrial cancer :
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 ages 50 and 65 is about 5 endometrial cancer diagnoses 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 undesirable effects are reported during the administration of estrogen / progestogen treatment (class effects):
. benign or malignant estrogen-dependent tumors: endometrial cancer;
. venous thromboembolic disease (deep vein thrombosis of the pelvis 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;
. likely dementia (see Warnings and Precautions section).

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