Bula do remedy Repogen

the package insert of the medicine Repogen. Active principles Medroxyprogesterone and Conjugated Estrogens. Sale under medical prescription.

what For?

vasomotor Symptoms of menopause; vaginitis atrophic and urethritis atrophic; osteoporosis; hipoestrogenismo.

Contraindications

When should I not use?

Cancer of the breast or of the genital organs, diagnosed or suspected. Neoplasia is estrogen-dependent, diagnosed or suspected. Pregnancy is diagnosed or suspected. Genital bleeding abnormal of undetermined causes. History or presence of thrombophlebitis, or thromboembolic disorders or apoplexy of the brain. Miscarriage and retained. Disease or liver dysfunction. Hypersensitivity to the components of the medicine.

Dosage

How to use?

·· you Should use the lowest dose that controls the symptoms.

· The administration may be initiated at any time if the patient presents with amenorrhea of two months or more. If the patient still menstruates, the administration should be started on the fifth day of the menstrual cycle.

· once the progestogens are administered to protect against the changes hiperplásicas of the endometrium, patients histerectomizadas do not require progestogens.

recommended Doses:
·· REPOGEN: THE administration can be continuous or cyclic :
. Vaginitis artrófica due to deficiency estrogen and symptoms
vasomotor menopause: 0,625 – to 1.25 mg per day.

. Osteoporosis: 0.625 mg per day.

. Protection cardiovascular: 0.625 mg to 1.25 mg per day.

. Hipoestrogenismo: 0,625 – to 1.25 mg per day.

·· REPOGEN CYCLE : one tablet daily, using the indication of the case-calendar, starting with the more tablets clear – containing 0.625 mg of estrogens – and, after the 14th day of the cycle, passing to the tablets more dark, which contain the estrogen and the progestogen until the end of the cycle.

·· REPOGEN CONTI : one tablet daily, with no breaks.

Side Effects

What are the evils that can cause me?

The adverse reactions observed in the treatment with the association of estrogens and progestogens were: thrombophlebitis, pulmonary embolism, cerebral thrombosis, thrombosis retinal, changes of the menstrual flow, intermenstrual bleeding, dysmenorrhea, amenorrhea, increase in size of fibroids fibroids, cervical erosions, vaginal candidiasis, hypersensitivity of the breasts, mammary secretion, nausea, vomiting, abdominal cramps, abdominal distension, jaundice, urticaria, erythema multiforme, chloasma, erythema nodosum, alopecia, hirsutism, intolerance to contact lenses, dizziness, migraine, headaches, depression, edema, changes in libido, fatigue and hypertension.

Warnings and Precautions

what should I know before using?

·· Before you start treatment, and periodically, one should have special attention to the breasts, pelvic organs, abdomen and blood pressure.

· The patients with uterus intact should be examined periodically for signs of hyperplasia or endometrial cancer.

· Some patients may develop manifestations undesirable by the stimulation of estrogen excess, such as abnormal uterine bleeding or excessive, mastodynia etc. You should adopt diagnostic measures appropriate, including biopsy-endometrial, to exclude the possibility of malignant disease in case of bleeding abnormal genital recurring.

· Under the use of estrogens, pedunculated fibroids may increase in size.

· there is No evidence that estrogens are effective in the symptoms of the nerve or in the depression associated with vasomotor symptoms. Estrogens should not be used in the treatment of these conditions.

· The estrogen should be discontinued at least four weeks prior to surgeries associated with the risk increasing of thromboembolism, or during periods of prolonged immobilization.

As the Repogen, the Repogen Cycle and the Repogen Conti can cause some degree of fluid retention, conditions which may be adversely influenced by this effect, such as asthma, epilepsy, migraine, cardiac dysfunction, or renal failure, require carefully note. Estrogens and progestogens may be poorly metabolized in patients with liver dysfunction. Therefore, should be administered with caution in such patients.

A decrease in glucose tolerance has been observed in a small percentage of patients in the combined therapy of estrogens-progestogens whose mechanism is not yet fully known. For this reason, patients with diabetes should be carefully monitored while receiving therapy with progestogens.

The prolonged use of estrogens may change the metabolism of calcium and phosphorus. Estrogens should be used with caution in patients with metabolic bone disease.

An increased risk of cholelithiasis bile has been described in postmenopausal women receiving estrogens.

Repogen, Repogen Cycle and Repogen Conti are not contraceptives and should not be used as such. Women weather still with the potential to become pregnant should be advised to use effective non-hormonal contraceptives.

in Case of partial or complete loss of vision, diplopia, or migraine, the medication should be discontinued and the doctor should be informed. If it is determined papilledema or lesions in the retinal vascular, the treatment should be stopped.

Patients on prolonged treatment should be re-evaluated every six months at least.

Usage in Pregnancy:
Estrogens and progestogens should not be used during pregnancy.

The treatment estrogenic during pregnancy is associated with increased risk of congenital malformations in the reproductive organs of fetuses and increased risk of adenose vaginal, cervical dysplasia and cancer vaginal in the female. If the patient is exposed to AMP (acetate medroxyprogesterone) during the first four months of pregnancy, or if you become pregnant while using this product, you should be notified of the potential risks to the fetus.

Carcinogenesis, Mutagênese
There are no conclusive evidence that estrogens increase the risk of breast cancer in postmenopausal women. Some studies report an increased risk of breast cancer with the use of very prolonged estrogen. Women receiving therapy estrogen must be submitted to the examination of the breasts regularly and properly educated to carry out self-examination in the intervals between the queries.

Use during Lactation:
Is not established if Repogen, Repogen Cycle and Repogen Conti are excreted in breast milk. Considering the possible adverse reactions in infants due to estrogen, its use during lactation is not recommended.

Overdose

what to do if someone use a larger amount than is recommended?

there have been reported serious adverse effects after the ingestion by children of high-dose oral contraceptives containing estrogens. the overdose can cause nausea, and bleeding may occur by suppression. it is reasonable to assume that the general procedures of gastric lavage and general treatment of the support should be employed.