AA Medical
Full Prescribing Info
17-β estradiol.
One graduated dose corresponds to 2.5 g of gel, the equivalent of 1.5 mg of oestradiol.
Excipients/Inactive Ingredients: The other constituents are: carbomer, trolamine, ethanol, purified water.
ATC classification: G03CA03.
OESTROGENS - (G: genital-urinary system and sex hormones).
This medicine contains a natural oestrogen.
It is prescribed: For the treatment of problems due to a deficiency in oestrogens linked to the menopause. It is hormone replacement therapy or HRT.
For the prevention of post-menopausal osteoporosis for women with an increased risk of fracture and showing either an intolerance or a contraindication to other treatments employed in the prevention of osteoporosis. The choice of this treatment should be discussed with the doctor.
Experience of this treatment in women above 65 years of age is limited.
Dosage/Direction for Use
DOSAGE: The oestradiol gel is presented in a tube.
Each graduated measure delivers 2.5 g of gel, containing 1.5 mg of oestradiol.
The average dose is 1 graduated measure per day, during 24 to 28 days per month.
The doctor will prescribe OESTROGEL according to a scheme adapted to the patient's case.
Bleeding resembling menstrual bleeding can occur during the period of discontinuation. This bleeding is normal and is not abundant.
If irregular or over-abundant bleeding occurs, consult the doctor.
If the patient has the impression the effect of OESTROGEL is too strong or too weak, consult the doctor or pharmacist.
STEPS TO TAKE IN THE CASE WHERE ONE OR MORE DOSES HAVE BEEN OMITTED: If the patient forgets to use OESTROGEL: if the patient has forgotten to apply the gel on the planned day, do it as quickly as possible and return to the therapeutic schedule as initially intended.
Do not take a double dose to compensate for the single dose that the patient has forgotten to take.
If the patient has not been treated for several days in a row, irregular bleeding may occur.
If the patient has any doubts, consult the doctor.
RISK OF WITHDRAWAL SYMPTOMS: When the treatment is ended, signs of a deficit in oestrogen linked to the menopause could reappear.
Application of the gel is made over a large surface of clean skin (on the arms, upper part of the bottom, lower part of the abdomen, lumbar region, upper part of the thighs, etc.).
The gel should not be applied to the breasts or the mucous membranes.
A massage is useful but it is recommended to let it dry for about 2 minutes first before putting on clothing. The gel does not leave marks.
It is recommended to wash hands after applying the gel.
FREQUENCY AND MOMENT AT WHICH THE MEDICINE SHOULD BE ADMINISTERED: The application can take place either in the evening or in the morning.
DURATION OF TREATMENT: According to the doctor's indications.
The signs of an overdose are usually a feeling of pain in the breasts, abdominal swelling, flatulence, irritability. No specific treatment is required. These signs disappear when the dose is reduced.
If these symptoms persist, consult the doctor.
OESTROGEL SHOULD NOT BE USED in the following cases: history or a current venous or arterial thrombo-embolic diseases (phlebitis, pulmonary embolism, angina pectoris, myocardial infarction, cerebral vascular incidents); breast cancer, uterine or any other oestrogen-dependent cancer; endometrial hyperplasia (excessive development of the uterine mucous membrane); undiagnosed vaginal bleeding; certain liver illnesses; known allergies to one of its constituents; porphyria (hereditary disease).
Special Precautions
A medical examination is required before and periodically in the course of treatment. At regular intervals (at least once a year), the doctor will invite the patient to discuss the benefits and risks associated with hormone replacement therapy in order to evaluate whether the patient should continue or stop the treatment.
The doctor will carry out regular clinical examination of the breasts, especially in cases involving history of breast cancer in the family or if the patient has cysts or lumps in the breasts. The doctor could also decide to prescribe a mammography. Inform the doctor if the patient notices a modification in the breasts during treatment.
Women who use a hormone replacement therapy have an increased risk of developing a thrombo-embolic disease, a breast cancer or uterine cancer and perhaps a cardiovascular incident or a cerebral vascular problem.
With women who still have their uterus, a progestogen treatment will be added during at least 12 days in the cycle.
Inform the doctor of any disease occurring during treatment. In the following situations, treatment of the menopause is not contraindicated but requires special attention: hypertension, diabetes, endometriosis (an infection characterized by the presence of uterine mucous outside the uterus), uterine fibroma, hepatic or biliary problems, epilepsy, migraines or severe head-aches, renal or cardiac otospongiosis (an infection of the ear leading to a loss of hearing).
Contact the doctor immediately in the case of the appearance of one of the following: allergic reactions (breathing difficulties, thoracic oppression, generalized eruption such as urticaria, itching); jaundice (of the eyes and skin); significant increase in arterial tension; significant increase in blood pressure; unusual pain in the legs, weakness in the limbs; chest pains, irregular pulse, sudden breathlessness; loss of consciousness, confusion, unusually severe headaches, vertigo, visual problems, slowness or loss of speech; pregnancy; lumps in the breasts.
Inform the doctor if the patient has to remain in bed or if the patient has to undergo a surgical operation.
If the symptoms of oestrogen deficiency linked to the menopause persist in spite of the treatment, tell the doctor.
If abundant bleeding occurs, consult the doctor.
Use In Pregnancy & Lactation
This medicine should not be taken during pregnancy or when breast-feeding.
If the patient discovers that she is pregnant when taking this medicine, stop the treatment and consult the doctor.
Discovery of pregnancy exposed accidentally to this medicine does not justify a termination (of pregnancy).
Ask the doctor's or pharmacist's advice before taking another medicine.
Side Effects
LIKE ALL ACTIVE PRODUCTS, THIS MEDICINE CAN, IN CERTAIN INDIVIDUALS, PRODUCE SOME MORE OR LESS UNCOMFORTABLE EFFECTS: breast tension; genital bleedings; abdominal pain and swelling; nausea; headaches; painful periods; vaginal discharge.
Rarely observed: vomiting; changes in the hepatic function (liver), an icterus (jaundice), an infection of the biliary vesicle; libido disorders; skin disorders.
If the patient notices undesirable side-effects not mentioned in these instructions, inform the doctor or pharmacist.
Drug Interactions
Tell the doctor or pharmacist if the patient takes or has recently taken another medicines, especially an anticonvulsant, anti-tuberculosis or treatment for AIDS such as: carbamazepine, oxcarbazepine, phenobarbital, phenytoin, rifabutin, rifampicin, ritonavir, nelfinavir, nevirapine, efavirenz or preparations based on plants containing St. John's wort (Hypericum perforatum), even when it is a medicine obtained without a prescription.
There are no particular storage recommendations.
Do not exceed the use-by date noted on the external packaging.
In the case of visible signs of deterioration, return the medicine to the pharmacist.
MIMS Class
Oestrogens, Progesterones & Related Synthetic Drugs
ATC Classification
G03CA03 - estradiol ; Belongs to the class of natural and semisynthetic estrogens used in estrogenic hormone preparations.
Gel 0.06% x 80 g.
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