Estrofem

Estrofem Special Precautions

estradiol

Manufacturer:

Novo Nordisk

Distributor:

Firma Chun Cheong
/
DKSH
Full Prescribing Info
Special Precautions
Before taking Estrofem: Medical history and regular check-ups: The use of HRT carries risks which need to be considered when deciding whether to start taking it, or whether to carry on taking it.
The experience in treating women with a premature menopause (due to ovarian failure or surgery) is limited. If the patient has a premature menopause, the risks of using HRT may be different. Please talk to the doctor.
Before starting (or restarting) HRT, the doctor should ask about the patient's and her family's medical history. The doctor may decide to perform a physical examination. This may include an examination of the breasts and/or an internal examination, if necessary.
Once on Estrofem therapy, the patient should see the doctor for regular check-ups (at least once a year). At these check-ups, discuss with the doctor the benefits and risks of continuing with Estrofem.
Go for regular breast screening, as recommended by the doctor.
When to take special care with Estrofem: Tell the doctor if the patient has ever had any of the following problems, before starting the treatment, as these may return or become worse during treatment with Estrofem. If so, the patient should see the doctor more often for check-ups: fibroids inside the womb; growth of womb lining outside the womb (endometriosis) or a history of excessive growth of the womb lining (endometrial hyperplasia); increased risk of developing blood clots (see Blood clots in a vein (thrombosis) as follows); increased risk of getting an oestrogen-sensitive cancer (such as having a mother, sister or grandmother who has had breast cancer); high blood pressure; a liver disorder, such as a benign liver tumour; diabetes; gallstones; migraine or severe headaches; a disease of the immune system that affects many organs of the body (systemic lupus erythematosus, SLE); epilepsy; asthma; a disease affecting the eardrum and hearing (otosclerosis); a very high level of fat in the blood (triglycerides); fluid retention due to cardiac or kidney problems.
Stop taking Estrofem and see a doctor immediately: If the patient notices any of the following when taking HRT: any of the conditions mentioned in Contraindications; yellowing of the skin or the whites of the eyes (jaundice) as these may be signs of a liver disease; a large rise in the blood pressure (symptoms may be headache, tiredness, dizziness); migraine-like headaches which happen for the first time; if the patient becomes pregnant; if patient notices signs of a blood clot, such as painful swelling and redness of the legs, sudden chest pain, and difficulty in breathing.
For more information, see Blood clots in a vein (thrombosis).
Note: Estrofem is not a contraceptive. If it has been less than 12 months since the last menstrual period or if under 50 years old, the patient may still need to use additional contraception to prevent pregnancy. Talk to the doctor for advice.
HRT and cancer: Excessive thickening of the lining of the womb (endometrial hyperplasia) and cancer of the lining of the womb (endometrial cancer): Taking oestrogen-only HRT will increase the risk of excessive thickening of the lining of the womb (endometrial hyperplasia) and cancer of the womb lining (endometrial cancer).
Taking a progestagen in addition to the oestrogen for at least 12 days of each 28 day cycle protects from this extra risk. The doctor will prescribe a progestagen separately if the patient still has the womb. If the womb was removed (a hysterectomy), discuss with the doctor whether Estrofem can be safely taken without a progestagen.
Compare: In women who still have a womb and who are not taking HRT, on average, 5 in 1,000 will be diagnosed with endometrial cancer between the ages of 50 and 65.
For women aged 50 to 65 who still have a womb and who take oestrogen-only HRT, between 10 and 60 women in 1,000 will be diagnosed with endometrial cancer (i.e. between 5 and 55 extra cases), depending on the dose and for how long it is taken.
Unexpected bleeding: The patient will have a bleed once a month (so-called withdrawal bleed) while taking Estrofem. But, if the patient has unexpected bleeding or drops of blood (spotting) besides the monthly bleeding, which: carries on for more than the first 6 months, starts after the patient has been taking Estrofem more than 6 months, carries on after the patient has stopped taking Estrofem, see the doctor as soon as possible.
Breast cancer: Evidence suggests that taking combined oestrogen-progestagen and possibly also oestrogen-only HRT increases the risk of breast cancer. The extra risk depends on how long the patient takes HRT. The additional risk becomes clear within a few years. However, it returns to normal within a few years (at most 5) after stopping treatment.
For women who have had their womb removed and who are using oestrogen-only HRT for 5 years, little or no increase in breast cancer risk is shown.
Compare: Women aged 50 to 79 who are not taking HRT, on average, 9 to 17 in 1,000 will be diagnosed with breast cancer over a 5-year period. For women aged 50 to 79 who are taking oestrogen-progestagen HRT over 5 years, there will be 13 to 23 cases in 1,000 users (i.e. 4 to 6 extra cases).
Regularly check the breasts. See the doctor if the patient notices any changes such as: dimpling of the skin, changes in the nipple, any lumps the patient can see or feel.
Ovarian cancer: Ovarian cancer is rare - much rarer than breast cancer. The use of oestrogen-only or combined oestrogen-progestagen HRT has been associated with a slightly increased risk of ovarian cancer. The risk of ovarian cancer varies with age. For example, in women aged 50 to 54 who are not taking HRT, about 2 women in 2,000 will be diagnosed with ovarian cancer over a 5-year period. For women who have been taking HRT for 5 years, there will be about 3 cases per 2,000 users (i.e. about 1 extra case).
Effect of HRT on heart and circulation: Blood clots in a vein (thrombosis): The risk of blood clots in the veins is about 1.3- to 3-times higher in HRT users than in non-users, especially during the first year of taking it.
Blood clots can be serious, and if one travels to the lungs, it can cause chest pain, breathlessness, fainting or even death.
The patient is more likely to get a blood clot in the veins as she gets older and if any of the following applies. Inform the doctor if any of these situations applies: the patient is unable to walk for a long time because of major surgery, injury or illness (see Dosage & Administration); the patient is seriously overweight (BMI >30 kg/m2); the patient has any blood clotting problem that needs long-term treatment with a medicine used to prevent blood clots; if any of the close relatives has ever had a blood clot in the leg, lung or another organ; the patient has systemic lupus erythematosus (SLE); the patient has cancer.
For signs of a blood clot, see Stop taking Estrofem and see a doctor immediately as previously mentioned.
Compare: Looking at women in their 50s who are not taking HRT, on average, over a 5-year period, 4 to 7 in 1,000 would be expected to get a blood clot in a vein.
For women in their 50s who have been taking oestrogen-progestagen HRT for over 5 years, there will be 9 to 12 cases in 1,000 users (i.e. 5 extra cases).
For women in their 50s who have had their womb removed and have been taking oestrogen-only HRT for over 5 years, there will be 5 to 8 cases in 1,000 users (i.e. 1 extra case).
Heart disease (heart attack): There is no evidence that HRT will prevent a heart attack.
Women over the age of 60 years who use oestrogen-progestagen HRT are slightly more likely to develop heart disease than those not taking any HRT.
For women who have had their womb removed and are taking oestrogen-only therapy there is no increased risk of developing a heart disease.
Stroke: The risk of getting stroke is about 1.5-times higher in HRT users than in non-users. The number of extra cases of stroke due to use of HRT will increase with age.
Compare: Looking at women in their 50s who are not taking HRT, on average, 8 in 1,000 would be expected to have a stroke over a 5-year period. For women in their 50s who are taking HRT, there will be 11 cases in 1,000 users, over 5 years (i.e. 3 extra cases).
Other conditions: HRT will not prevent memory loss. There is some evidence of a higher risk of memory loss in women who start using HRT after the age of 65. Talk to the doctor for advice.
Important information about some of the ingredients of Estrofem: Estrofem contains lactose monohydrate. If the patient has an intolerance to some sugars, contact the doctor before taking Estrofem.
Laboratory tests: If the patient needs a blood test, tell the doctor or the laboratory staff that Estrofem is being taken, because this medicine can affect the results of some tests.
Driving and using machines: Estrofem has no known effect on the ability to drive or use machines.
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