The package insert of the medicine Fem 7

the package insert of the medicine Fem 7. Active principles Estradiol.

what For?

hormone replacement Therapy for the treatment of menopause symptoms, such as disorders vasomotor (sweating and hot flashes), vaginal atrophy, insomnia and irritability, emotional changes, urinary incontinence and atrophy urethral. Prevention and treatment of osteoporosis in women with fracture risk (early menopause, family history of osteoporosis, prolonged use of corticosteroids, large smokers, skeletal structure, small and fragile).Reduction of the increased risk of cardiovascular problems in postmenopausal women with coronary heart disease symptomatic.

Contraindications

When should I not use?

The use of Fem 7 is contraindicated in the following conditions:
pregnancy or suspicion of pregnancy;
lactation;
history or suspected breast cancer;
history or suspicion of neoplasia is estrogen-dependent;
genital bleeding abnormal undiagnosed;
liver disease, acute or chronic. Syndromes of the Rotor and Dubin Johnson (icterícias family chronic non-hemolytic);
a past history of liver disease in which the values of liver function tests have not returned to normal;
severe kidney disease.

The product should not be used as a contraceptive or a restorer of fertility.

Dosage

How to use?

FEM-7 should be applied once a week continuously, that is, each transdermal patch is replaced by a new one every seven days.

The treatment of Fem-7 must be started with a transdermal patch (releasing 50 mcg of estradiol in 24 hours). After a month, if necessary, the dose may be increased to two patches-transdermal. You should not use more than two adhesive transdermal patches by the week.

The patches should be applied in the regions of the body in which there is little bending of the skin during the movement. The preferred sites are the upper part of the buttocks, lower back and abdomen and hips. The region chosen must be clean, dry, degreased and integrates, without injury, cracks or irritations.

The product should not be applied on the breasts (or close to them), in areas of friction or bending (for example, in the waist), and in areas exposed to the sun. Should not be applied the patches always in the same place and it is recommended rotate the places of application.

After you open the sachet, remove the particles with protective disposable (avoiding to touch the adhesive) and apply immediately on the selected region. With the palm of your hand press the adhesive on the skin for at least 30 seconds, in order to enhance the grip.

The adhesive is not influenced by the bathroom, showers or swimming pools. If there is displacement partial or total adhesive, prior to 7 days, you should remove it and put another one.

older Patients
There are no warnings or special recommendations about the use of the product for older patients.

Side Effects

What are the evils that can cause me?

Were registered the following side effects with the use of the product:
Skin – erythema and irritation, transient on the application site, with or without a rash. These side effects are similar to those sometimes observed after occlusion of the skin with dressings. These reactions usually disappear two to three days after the removal of the adhesive product.

Urogenital – bleeding of escape.

Endocrine – breast tenderness.

Gastrointestinal – nausea, abdominal cramps, abdominal distension.

Neurological disorders – headache, migraine and, rarely, dizziness.

Cardiovascular disease – rarely: thrombophlebitis, exacerbation of varicose veins, increased blood pressure.

Various – cramping in the legs, not related to disease indication, usually transient, lasting about six weeks. (If the cramping
persist for longer you should reduce the dose of estrogen).

Rarely – edema and/or change in weight.

Warnings and Precautions

what should I know before using?

Before you start the treatment with estrogens, it is recommended that thorough medical examination of the patient, obtaining a family history. During the treatment, the patient should be subjected to clinical evaluations and gynaecological periodic.

Currently there is suggestive evidence of overall change in relative risk of breast cancer in post-menopausal women, receiving hormonal therapy of replacement. Treatments excess of five years require careful prior evaluation of the relationship risks/benefits.

The published studies do not indicate increased risk of disease thromboembolic (including myocardial infarction, stroke, and thrombophlebitis), in women, apparently normal, receiving hormonal replacement therapy at low doses is currently recommended.

however the treatment should be immediately discontinued in case of, over its lifetime, a phenomenon thromboembolic acute.

there is No evidence that contra-indicate estrogen replacement in patients with a history of thrombosis of the deep veins, elective surgery planned, pulmonary embolism, stroke or myocardial infarction, when these conditions are associated with the risk factors recognised, such as, immobilization (after birth or after injury) and postoperative (particularly after pelvic surgeries). In the absence of specific data, the product should be used with caution. The same procedure should be observed in patients with a history of endometriosis.

it Is recommended that the careful monitoring of patients with epilepsy, diabetes, hypertension, kidney disease and/or liver mild or moderate, benign disease of the breast, porphyria, otoesclerose, fibroids fibroids, pituitary tumors, and a significant family history of breast cancer.

If during the treatment arise, jaundice, headaches, migraine type, visual changes, thromboembolic phenomena or significant increase in blood pressure, the treatment should be stopped while investigating the causes.

The majority of the studies indicates that estrogen replacement therapy exerts a small effect on blood pressure. Some of them indicate that the use of estrogens may be associated with a small reduction in blood pressure.

in Addition, most of the studies on combined treatment indicate that the addition of progesterone has, also, reduced effect on blood pressure. Very rarely high blood pressure can occur idiosyncratic.

When administering estrogens to women with hypertension, it is needed constant supervision with assessments of blood pressure at regular intervals of time.

epidemiological Studies show that hormone replacement therapy for five or more years, reduces by more than 50% the frequency of fractures.

it Is, however, limited the existence of data proving the beneficial effects in the therapies over 10 years. It is required a careful assessment of the relationship risks/benefits in patients treated for periods longer than five and ten years. It is recommended that monitoring state annual bone of the patients who underwent long-term treatment.

There are reports that, in women with uterus intact, the administration isolated estrogen increased the risk of hyperplasia of the endometrium.

Therefore it is essential, in this type of patients, the addition of progestogen for at least 12 days in each cycle. FEM 7 is not an oral contraceptive or an agent, a restorer of fertility. If FEM-7 is administered to women with uterus intact, in the fertile period of their lives, it should be them recommended the use of contraceptive methods non-hormonal. The repeated occurrence of bleeding of exhaust should be investigated, including biopsy of the endometrium.

Overdose

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

Due to the mode of administration, it is unlikely to occur overdose of estradiol. If it is necessary to undo quickly the effect, simply remove it from the system. The signs of an overdose are generally, discomfort in the breasts, breakthrough bleeding (spotting, water retention or abdominal distention.