Oestrogel

The active substance is: 17 β estradiol.
One ruler delivers 2.5 g of gel, i.e. 1.5 mg estradiol.
Gel for cutaneous application, 80 g tube.
Excipients/Inactive Ingredients: The other ingredients are: carbomer (carbopol), trolamine, ethanol, purified water.

ATC Classification: G03CA03 ESTROGENS (genito urinary system and sex hormones).
This medicine contains a natural estrogen.

Hormone replacement therapy (HRT) for estrogen deficiency symptoms in postmenopausal women or ovariectomized woman: vasomotor disorders (hot flashes, night sweats), genitourinary trophic disorders (vulvovaginal atrophy, dyspareunia, urinary incontinence) and psychological disorders (sleep disorders, asthenia).
Prevention of osteoporosis in postmenopausal women at high risk of fracture who are intolerant of, or contraindicated to, drugs approved for osteoporosis prevention.

For the treatment of postmenopausal symptoms, the minimum effective dose of 1.25 g gel per day (=0.75 mg of estradiol) should be recommended for 21 to 28 days per month. As the dose varies according to the needs, the average dose is 2.5 g of gel per day. Prevention of osteoporosis, the minimum effective dose is 2.5 g of estrogen gel once daily for most patients.

If the patient uses more OESTROGEL than she should: The effects of overdosage are usually a sensation of tension in the breast, swelling of the abdomen, anxiety, irritability.
Those signs disappear when the treatment is stopped or when the dose is reduced.
Consult the doctor if such symptoms appear during treatment.

Hypersensitivity to the active substance or to any of the excipients.
Known or suspected breast cancer or history of breast cancer. Known or suspected estrogen-dependent malignancies (e.g. endometrial cancer). Vaginal bleeding of unknown etiology. Untreated endometrial hyperplasia. Previous or ongoing idiopathic venous thromboembolism (deep vein thrombosis, pulmonary embolism). Known thrombophilic abnormalities (e.g. protein C, protein S or antithrombin deficiency). Recent or ongoing arterial thromboembolic disease (e.g. angina, myocardial infarction). Acute liver disease or history of liver disease, as long as liver function tests remain abnormal. Porphyria. Known or suspected pregnancy.

BEFORE USING OESTROGEL: Report to the doctor any previous illness or illness occurring during the course of treatment, particularly: If the patient has had a cerebro vascular accident (related to a haemorrhage or a blood clot).
If the patient suffers from vascular disorders (particularly ocular of the retina).
If the patient has suffered from itching during previous pregnancy.
If there is medical history of breast cancer in the family.
In all these situations, treatment of the menopause is not contraindicated but requires particular monitoring.
This medicine should not generally be used, except if the doctor permits, in the following cases: Recent inflammation of a vein with formation of a blood clot or recent obliteration of a pulmonary vessels.
Certain cardiac diseases.
Take special care with OESTROGEL: The doctor may associate another hormone treatment (progestogen) for at least the last 12 days of treatment with OESTROGEL.
A periodic medical examination of breasts should be carried out in some cases (particularly in cases of known breast nodule or cyst).
A medical examination is necessary before and periodically during the course of treatment.
The patient will undergo strict medical control if she suffers from overweight, severe diabetes, high blood pressure, endometriosis (characterised by the presence of uterine mucus other than in the uterus), kidney failure or hepatic disorders, epilepsy, asthma, lupus (severe affection of the skin), pituitary tumour (gland of the brain), porphyria (hereditary disease), otospongiosis (disorder of the ear leading to loss of hearing).
If the symptoms persist despite treatment, consult the doctor.
Warn the doctor if the patient is bedridden or scheduled to undergo surgery.
Follow the recommendations of the doctor particularly with regards to the progestogen therapy generally associated with this treatment.

Pregnancy and breast feeding: This medicinal product has no indication during pregnancy.
Clinically speaking, the results of numerous epidemiological studies to date have not shown any risk of malformation at the start of pregnancy with estrogens administered alone or in association.
Consequently, the late diagnoses of pregnancy during exposure to estrogens (or estroprogestogens) does not necessitate its interruption. In case of accidental ingestion during pregnancy: stop treatment and talk to the doctor.
Lactation: not applicable.

Headache, dizziness, nausea, abdominal pain, breast swelling/pain, alopecia, pruritus, weight change, water retention with peripheral oedema, vaginitis, dysmenorrhea, menorrhagia, endometrial hyperplasia, anaphylactic reaction.

Concomitant use w/ skin medication which alters skin barrier or function (e.g., sodium lauryl sulphate, benzalkonium or benzothonium chloride, astringents, sunscreens salicylic acid, lactic acid) should be avoided. The metabolism of estrogens may be increased by concomitant use of substances known to induce drug-metabolising enzymes, specifically cytochrome P450 enzymes, such as anticonvulsants (e.g., phenobarbital, phenytoin, carbamazepine) and anti-infectives (e.g., rifampicin, rifabutin, nevirapine, efavirenz). Ritonavir and nelfinavir, although known as strong enzyme inhibitors, by contrast exhibit inducing properties when used concomitantly with steroid hormones. Herbal medicine preparations containing St. John's wort (Hypericum perforatum) may induce the metabolism of estrogens.

There are no special storage instructions.
In the case or visible signs of deterioration, return the medicine to the pharmacist.

Oestrogens, Progesterones & Related Synthetic Drugs

G03CA03 - estradiol ; Belongs to the class of natural and semisynthetic estrogens used in estrogenic hormone preparations.

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