Besins Manufacturing Belgium SA

OESTROGEL (Estradiol, Oestradiol), 0.6mg/g, 80 gram/flacon

EUR35
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Description

Description

OESTROGEL (Estradiol, Oestradiol) contains the Estradiol as an active ingredient which is chemically and biologically identical to endogenous human estradiol. It has an estrogenic effect on the main target organs: the ovaries, endometrium, vaginal epithelium, mammary glands, urethra, hypothalamus, pituitary and liver. Similar to the action of endogenous estrogens in the follicular phase of the menstrual cycle. It compensates for estrogen deficiency in women during menopause and reduces the severity of menopausal disorders, including "hot flashes", increased sweating at night, atrophic changes in the urinary tract (atrophic vulvovaginitis, dyspareunia, urinary incontinence) and psycho-emotional disorders. The clinical efficacy of Oestrogel in the treatment of menopause symptoms is comparable to that when taking estrogen orally.

USES

  • Treat Symptoms of Menopause
  • Primary and Secondary Amenorrhea
  • Hypomenorrhea, Oligomenorrhea, Dysmenorrhea
  • Mucous Inflammation of The Vagina
  • Infertility

GUARANTEE & EXPIRY DATE
Original from the Belgian Besins Manufacturing Belgium SA.
All packs are air tight sealed and expire up to 12.2021.

DESCRIPTION
Oestrogel is also taken for the prevention of bone loss associated with natural menopause or after ovary removal surgery. Oestrogel can be used before pregnancy planning. The gel helps to improve the condition of the endometrium, due to which favorable conditions are created in the woman’s body for conception. For pregnancy planning the gel is necessary as a drug that increases the level of estradiol.

PACKAGING
OESTROGEL comes in the form of gel, 0.6 mg per 1 gram of gel, 80 grams of gel in the dispencer flacon.
Active ingredient: Estradiol hemihydrate 0.6 mg per 1 gram of gel.
Excipients: Carbomer (Carbopol 980) - 5.0 mg, trolamine (triethanolamine) - 5.0 mg, ethanol - 400 mg, purified water q.s. up to 1 gram.

DOSAGE
OESTROGEL is prescribed externally, continuously or cyclically. Dose and duration of therapy is set individually.

Typically, the initial dose of the drug is 2.5 g of gel once per day, which corresponds to 1.5 mg of estradiol. In most patients, this dose is effective in alleviating the symptoms of menopause. If, after one month of therapy, efficacy is not achieved, an increase in the daily dose of the drug to a maximum of 5 g of gel is possible, which corresponds to 3 mg of estradiol.

To start and continue treatment for the symptoms of menopause, a minimum effective dose should be applied over a minimum period of time.

For the prevention of osteoporosis in postmenopausal women, the minimum effective dose in most patients is 2.5 g once per day.

One click on the pump-dispenser is equal to 1.25 g of gel (which corresponds to 0.75 mg of estradiol), equal to half of the daily dose.

Use of the drug Oestrogel without the addition of a progestogen is possible only in patients with a uterus removed. Patients with an intact uterus during treatment with Oestrogel are recommended to take Gestagen.

During the menopausal transition period, treatment should be carried out for at least 3 weeks in a row, then a break of 1 week should follow, at the same time, Gestagen is administered orally during the last 12-14 days of the month.

In the period of perimenopause, treatment can be carried out from day 1 to day 25 of the month simultaneously with oral administration of progestogen. During a week break, menstrual bleeding may occur due to a decrease in the content of sex hormones. It is recommended to use only those gestagens, the use of which is allowed simultaneously with estrogen.

In the period of postmenopausal treatment with estrogen in combination with gestagens is carried out continuously.

Long-term estrogen monotherapy is indicated in women after hysterectomy. In women who have undergone hysterectomy, the addition of progestogen in the absence of a history of endometriosis is not recommended.

Depending on the clinical symptoms, after 2-3 cycles of treatment, the dose is adjusted:

  • When symptoms of hyperestrogenemia appear, such as a feeling of tension in the mammary glands, a feeling of fullness in the abdomen and pelvis, anxiety, nervousness, aggressiveness, a dose reduction is necessary.
  • With the symptoms of hypoestrogenism, such as persistent "hot flashes", vaginal mucosa dryness, headache, sleep disorders, asthenia, tendency to depression, the dose should be increased.

The gel is applied by patients independently, in the morning or in the evening, with a thin layer on clean, dry skin of the abdomen, lumbar region, shoulders or forearms until completely absorbed. The area of ​​application should be at least 2 square palms.

Do not massage the place of application of the gel. Avoid contact with the gel on the mammary glands and the mucous membrane of the vulva and vagina.

Application is considered correct and effective if the gel is absorbed completely within 2-3 minutes.

If the sticky consistency persists for more than 5 minutes after application, it means that the surface of the skin is too small.

Oestrogel does not stain. Hands should be washed immediately after applying the gel.

SIDE EFFECTS AND PRECAUTIONS
On the part of the immune system: rarely - anaphylactic reactions (in women with a history of allergic reactions).

On the part of metabolism and nutrition: rarely - impaired glucose tolerance.

Mental disorders: infrequently - depression, mood swings; rarely a change in libido.

On the part of the nervous system: often - headache; infrequently - migraine, dizziness; rarely exacerbation of epilepsy.

Since the cardiovascular system: infrequently - venous thromboembolism; rarely - increased blood pressure.

On the part of the gastrointestinal tract: often - nausea, abdominal pain; infrequently - flatulence, vomiting.

On the part of the liver and biliary tract: rarely - a deviation from the norm indicators of functional liver samples.

On the part of the skin and subcutaneous tissues: infrequently - itchy skin; rarely - skin discoloration, acne.

On the part of the genital organs and the mammary gland: often - edema of the mammary glands, pain in the mammary glands, enlargement of the mammary glands, dysmenorrhea, menorrhagia, metrorrhagia, leukorrhea, endometrial hyperplasia; infrequently - benign tumors of the mammary glands, an increase in the size of the uterus, uterine myoma, vaginitis, candidal vaginitis; rarely - galactorrhea.

Other: often - change in body weight (decrease or increase), fluid retention with peripheral edema; infrequently - asthenia.

STORAGE
Store in dry place at room temperature. Do not exceed storage temperature higher than 25 degrees Celcius. Keep away from direct sunlight. Keep locked and away from children.

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