Menopause considerably diminishes the estrogens production in the ovary, estradiol constitutes a hormonal replacement therapy in the treatment of symptoms due to an estrogens deficiency (it prevents the vasomotor symptoms and the genital-urinary atrophy)

Therapeutic indications:

Estrogens deficiency therapy of vasomotor symptoms or vulvar/vaginal atrophy associated with menopause.

 Posology and Administration:
Apply the gel on a wide skin territory: Shoulders, arms, lower part of thighs, abdomen, back and neck, avoiding breasts and the vaginal zone. Before dressing, allow the gel to dry for 5 minutes, without massaging or rubbing.

Posology.

The normal dose is 1 or 2 puff of gel per day (1.25 or 2.5 g, respectively)

In more severe cases 5 g. may be applied in one daily dose.

The treatment is cyclical, one daily application for 3 weeks, rest for one week then restart the cycle (or 25 days per calendar month).

During 10 days of the cycle it is convenient to add a progestogen (days 12 to 21).

An efficient posology may vary from one patient to another due to the individual pharmacokinetics, or according to the post-menopause residual production of estrogens.

Posology may eventually re-adapt after the 2° or 3° cycle, depending on the following clinical signs:

Dose in excess: 
Breasts painful tension.
Anxiety, nervousness, agressiveness.
Leukorrhea, chloasma and polymenorrhea.
In these cases the dose may be applied every 2 days.
 
Insufficient dose:
Flushes.
Depression.
Asthenia.

In these cases the dose may be doubled

CAUTIONS

Before taking this medication, risks and benefits which its use bear, must be carefully considered; those must be discussed between you and your physician. You must mainly consider the following aspects:
Allergies: Inform your physician if you have or have ever had any unusual or allergic reaction to estrogens. Equally inform him/her if you are allergic to any other substance such as food, preservers or colorants.
Pregnancy: The use of estrogens during pregnancy or immediately after giving birth is not recommended. Reach pregnancy or being pregnant is improbable its occurrence in menopause period.
Breast feeding: It is not recommended the use of this medication by wet nurse.  Estrogens are spread to breast milk and its effects in the fed child are unknown.
The elderly population: This medication has been assayed in the elderly women and has not produced problems or different adverse effects than presented in young women. When estrogens are used in women after menopause, may increase the uterine cancer risk. The unusual vaginal bleeding apparition may be a sign of warning to this type of cancer; inform your physician if you suffer from any kind of vaginal bleeding of unknown cause.
Before starting the GINODERM use, your physician will check your pelvic organs, breasts and blood pressure among other organs; probably your physician will regularly repeat these exams. While taking GINODERM, consult your physician at least twice a year, to assure that this medication does not cause undesirable effects.
The use of estrogens in some patients may cause gum hardening, inflammation or bleeding. Brush and clean your teeth with dental floss, in a regular and careful way; to massage the gums may help to prevent. Consult your dentist regularly to keep healthy your gums.
Changes in your menstrual cycle may be produced or bleeding points during the first three months of using. If your menstrual periods have stopped, they may resume again. Do not stop taking this medication. Ask your physician if bleeding continues for an unusual time; if your period does not start within 45 days of your last period, or if you think you are pregnant.
Inform to the physician that you are under estradiol therapy before taking any laboratory exam; some of them may be affected for the use of this medication.
Estrogens have been associated to men breast carcinoma; they must have regularly breast exams.

SPECIAL WARNINGS

1. It has been informed that the use of estrogens alone, without progestagen, the risk of endometrial cancer increases from 4.5 to 13.9 times.
   Morphologic and biochemical studies of the womb, suggest that it is necessary medroxyprogesterone for 12 to 14 days, to produce the maxim maturing and eliminate any hyperplastic change.
2. Breast cancer
   The majority of the studies have not showed an increase in breast cancer, however, a moderate increase has been established (1.3 to 2.0%).
3. Cardiovascular diseases
   Big doses of estrogens, similar to the ones used in prostate and breast cancer, showed that they increase the risk of myocardial infarction, embolisms and thrombophlebitis in men.
4. Raise of blood pressure
   Estrogens may produce a blood pressure raise; this is variable, depending on the idiosyncrasy of the person.
5. Hypercalcemia
   Estrogens administration may produce severe hypercalcemia in patients with breast cancer and metastasis.
   Drug must be suspended if this is produced.

CONTRAINDICATIONS:

• High blood pressure, angina or heart disease.
• Brain hemorrhage (an apoplexy attack)
• Hemorrhagic problems
• Breast cancer, uterine cancer or any cancer related to hormones.
• Any hepatic disease or have jaundice backgrounds (yellow skin or eyes) caused by the use of hormones.
• Abnormal vaginal bleeding which have not been diagnosed
• Migraine (severe headache)
• Asthma
• High cholesterol or triglyceride levels in the blood.
• Convulsions or epilepsy
• Pregnancy or breast feeding.
• Depression
• Uterine Fibroid

INTERACTIONS:
Ginoderm effect may be modified by its administration with other medications (Interactions). You must inform your physician of all medications that you are taking before using Ginoderm, especially if it is about:
Other drugs that have not been indicated here, they also may act in reciprocity with estradiol.
Talk to your physician or pharmacist before taking any prescription or not prescribed medications.
Do not take any medication without consulting your physician.

ADVERSE REACTIONS:
If you feel any of the following serious side effects, stop taking estradiol and seek for emergency medical care:
An allergic reaction (breathe difficulty, throat narrowing; lips, tongue or face swelling; or nettle rash), blood clot (pain, blushing, one leg or one hand swelling, respiratory failure, chest pain, headache, blur vision or confusion), a lump in the breast, or liver damage (yellowing of skin or eyes, nauseas, abdominal pain or discomfort, unusual bleeding or bruises, severe fatigue).
Other undesirable effects;

•  Endometrial cancer increases and breast cancer
•  Cardiovascular diseases
•  Raise of blood pressure
•  Hypercalcemia

UNDESIRABLE EFFECTS:
It is probable that other side effects of lesser seriousness occur. Keep taking GINODERM and call your physician if you feel loss of appetite, nausea or vomiting, breast swelling or sensitivity, acne or changes in the skin color, loss of sexual appetite, headaches, migraines or dizziness, liquid retention (hands, feet or ankles swelling), problems wearing contact lens, depression, changes in menstrual cycle or bleeding points. Visit your physician regularly and immediately notify him of any unusual vaginal hemorrhage.

Other side effects may also occur and have not been pointed out here. Consult your physician about any side effect that seems unusual or especially that worry you about.

OVERDOSE:
Any medication taken in excess may cause serious consequences. If you suspect any overdose, immediately seek for medical care.
Overdose symptoms include nausea, vomiting and menstrual bleeding.

STORAGE CONDITIONS:
Keep in its original package, in a fresh and dry place, away from the light and out of the reach of children.
Store below 300C
Do not use this medication after the best before date indicated on the package.

Manufactured by Laboratorios Recalcine S.A., Santiago, Chile

Imported by Sinensix Pharma (Thailand) Co., Ltd. Bangkok, Thailand