1 mg tablets
estriol
What Oestriol Aspen is and what it is used for
Oestriol Aspen is a drug used for Hormone Replacement Therapy ( HRT ). It contains the female sex hormone estriol, a so-called estrogen.
Oestriol Aspen is used to relieving menopausal symptoms such as dryness or irritation. The medical term for this is “vaginal atrophy”. It is caused by the amount of estrogen in the body decreasing, which occurs naturally after menopause (when menstruation ceases).
Oestriol Aspen works by replacing the estrogen that is normally produced in a woman’s ovaries. It can relieve genital problems and helps keep the genital mucosa elastic and resistant to both mechanical influences and infection.
Oestriol contained in Oestriol Aspen may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist, or other healthcare professionals if you have any further questions, and always follow their instructions.
Before using Oestriol Aspen
Medical background and regular check-ups
The use of HRT involves risks that must be taken into account when deciding to start treatment or continue an ongoing treatment.
Experience is limited for the treatment of women whose menstruation has stopped prematurely (when the ovaries have stopped working or the uterus has been removed). If you belong to that group, the risks of HRT may be different. Talk to your doctor.
Before starting treatment (or resuming treatment), your doctor will ask about your own, and your family’s, medical background. Your doctor may do a general medical and gynecological examination, which also includes the examination of your breasts.
Once you have started treatment, you should go for regular medical check-ups, at least once a year. During these check-ups, you should discuss with your doctor the benefits and risks of continued treatment.
Perform regular examinations of the breasts according to the doctor’s recommendations.
Do not take Oestriol Aspen
if any of the following apply to you. If you are not sure, talk to your doctor before taking Oestriol Aspen.
Do not take Oestriol Aspen:
- if you have or have had breast cancer or there is a suspicion that you may have it
- if you have or have had estrogen-dependent cancer , such as cancer of the uterine lining (endometrium) or if there is a suspicion of such cancer
- if you have unexpected genital bleeding that has not been investigated by a doctor
- if you have endometrial hyperplasia (severe thickening of the uterine lining) and are not being treated for it
- if you have or have had a blood clot in a vein (venous thromboembolism ), in your legs (deep vein thrombosis ) or in your lungs ( pulmonary embolism )
- if you have a coagulation disorder , a condition with an increased risk of blood clots (lack of protein C, protein S or antithrombin)
- if you have or have recently had any disease caused by a blood clot in the arteries , such as a heart attack , stroke or angina
- if you have or have had any liver disease and still have abnormal liver values
- if you have porphyria , a rare inherited blood disorder
- if you suffer from a rare hereditary problem of galactose intolerance, the Lapp lactase deficiency or glucose -galactose malabsorption . Therefore, if you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
- if you are allergic to estriol or any of the other ingredients of this medicine (listed in section 6).
If any of the above affects you the first time you use Oestriol Aspen, stop taking Oestriol Aspen and contact your doctor immediately.
Warnings and cautions
Talk to your doctor if you have or have had any of the following problems before starting treatment. They may recur or worsen during treatment with Oestriol Aspen. Should this occur, have more frequent check-ups with a doctor.
- if you have any disease affecting the lining of the uterus, as well as muscle knots ( fibroids ), endometriosis or have had endometrial hyperplasia (severe thickening of the uterine lining).
- if you have an increased risk of getting a blood clot (see below “Blood clots in a vein ( thrombosis )”)
- if a close relative has had breast cancer or other estrogen-dependent cancer
- high blood pressure
- liver disease eg liver adenoma (benign tumor )
- gallstone disease
- diabetes
- migraine or severe headache
- if you have systemic lupus erythematosus ( SLE ) – an autoimmune disease that affects many organs in the body
- epilepsy
- asthma
- otosclerosis (ossification of the middle ear leading to hearing loss)
- a very high level of blood fats ( triglycerides )
- fluid retention due to heart or kidney disease.
Tell your doctor if you have hepatitis C and are following a combination regimen of the medicines ombitasvir/paritaprevir/ritonavir, with or without dasabuvir. The use of a combination of these drugs with certain estrogen-containing products may cause elevated liver function tests (increase in liver enzyme ALT); The risk of this happening with Oestriol Aspen is currently unknown.
You should contact a doctor immediately and discontinue treatment if any of the following occur:
- any of the things mentioned in the section ‘Do not take Oestriol Aspen’
- if skin or whites of the eyes turn yellow (jaundice); it may be a symptom of liver disease
- if your blood pressure rises sharply (symptoms may include headache, fatigue or dizziness)
- if you are experiencing migraine-like headaches for the first time
- if you become pregnant
- if you get symptoms of a blood clot, such as
- painful swelling and redness of the legs
- sudden chest pain
- breathing difficulties
For further information, see below “Blood clots in a vein ( thrombosis )”.
Note: Oestriol Aspen is not a contraceptive. If it is less than 12 months since your last period, or if you are under 50, you may still need to use contraception to avoid pregnancy. Consult your doctor.
Hormone therapy and cancer
Severe thickening of the uterine lining ( endometrial hyperplasia ) and cancer of the uterine lining (endometrial cancer)
The use of HRT with estrogen alone increases the risk of severe thickening of the uterine lining and cancer of the uterine lining.
By taking progestogen as a supplement to estrogen for at least 12 days in each 28-day cycle, you are protected against this extra risk. The doctor will prescribe the progestogen if you have your uterus left. If your uterus has undergone surgery ( hysterectomy ), you should consult your doctor if you can take the medicine without a progestogen.
For women with the uterus left who do not take HRT, an average of 5 out of 1,000 women aged 50-65 will be diagnosed with endometrial cancer.
For women aged 50-65 who have the uterus left and who take HRT with estrogen alone, between 10 and 60 women out of 1,000 users will be diagnosed with endometrial cancer (ie between 5 and 55 extra cases), depending on dose one and how as long as it is taken.
Unexpected bleeding
During long-term treatment, the uterine lining should be checked at least once a year.
Gestagen supplementation may be considered. If a progestogen is added for at least 12-14 days of the cycle, you will have bleeding once a month (so-called dropout bleeding) when you take Oestriol Aspen.
But if you get unexpected bleeding or splashing bleeding in addition to your monthly bleeding, and these:
– lasts longer than 6 months
– starts after taking Oestriol Aspen for 6 months
– continue after you stop taking Oestriol Aspen
you should see a doctor as soon as possible.
Breast cancer
Data show that hormone replacement therapy ( HRT ) with a combination of estrogen-progestogen or with estrogen alone increases the risk of breast cancer. The increased risk depends on how long you use HRT. The increased risk is seen within 3 years. When treatment is stopped, the increased risk decreases over time, but it can persist for 10 years or more if you have used HRT for more than 5 years.
Comparison
Of 1,000 women aged 50 to 54 who do not take HRT, an average of 13 to 17 will be diagnosed with breast cancer over 5 years.
In women who are 50 years old and start taking HRT with estrogen alone for 5 years, 16-17 cases per 1,000 users (ie 0-3 extra cases) will occur.
In women who are 50 years old and start taking HRT with estrogen-progestogen for 5 years, there will be 21 cases per 1,000 users (ie 4-8 extra cases).
Among women aged 50–59 who do not use HRT, an average of 27 out of 1,000 will be diagnosed with breast cancer over 10 years.
In women who are 50 years old and start taking HRT with estrogen alone for 10 years, 34 cases per 1,000 users (ie 7 extra cases) will occur.
In women who are 50 years old and start taking HRT with estrogen-progestogen for 10 years, 48 cases per 1,000 users (ie 21 extra cases) will occur.
Check your breasts regularly. Contact a doctor if you notice changes such as:
indentations or pits
– changes in the nipple
nodules you can see or feel.
It is also recommended that you participate in a mammography examination when you are called to do so. At the mammogram, you must inform the nurse/healthcare professional who performs the examination that you are using HRT, as this medicine may increase the density of the breasts. An increased density in the breasts can make it more difficult to detect lumps on the mammography images.
It is not known whether Oestriol Aspen is associated with the same increased risk of breast cancer as other HRT medicines. If you are concerned about the risk of developing breast cancer, you should discuss the pros and cons of treatment with your doctor.
Ovarian cancer ( ovarian cancer )
Ovarian cancer is rare – much more rare than breast cancer. Use of HRT with estrogen alone or combined estrogen – progestogens has been associated with a slightly increased risk of ovarian cancer. The risk of ovarian cancer varies with age. The diagnosis of ovarian cancer will, for example, be made on about 2 women out of 2,000 between the ages of 50 and 54 who do not take HRT for 5 years. For women who have taken HRT for 5 years, there will be about 3 cases per 2,000 users (ie about 1 extra case). It is unclear whether long-term treatment with low-dose estrogens (eg Oestriol Aspen) poses a lower risk than other estrogen products.
How HRT affects the heart and blood circulation
Blood clots in a vein ( thrombosis )
The risk of blood clots in the veins is 1.3–3 times higher for women who take HRT than for those who do not, especially during the first year of treatment.
Blood clots can be serious. If a blood clot ends up in the lungs, it can cause chest pain, shortness of breath, collapse or even lead to death. It is not known whether Oestriol Aspen increases the risk in the same way as other HRT drugs.
You are more likely to get a blood clot in a vein if any of the following apply to you. Tell your doctor if any of the following apply to you:
- you have not been able to walk or stand for a long time due to a major operation, injury or illness (see also section 3, “If you need surgery”)
- you are severely overweight ( BMI over 30 kg / m 2 )
- you have a coagulation disorder that requires long-term treatment with drugs that prevent blood clots
- if a close relative has had a blood clot in the bone, lung or other organ
- you have SLE (systemic lupus erythematosus)
- you have cancer.
The symptoms of a blood clot are described in the section “You should contact a doctor immediately and stop the treatment”.
Comparison
For women in their 50s, who do not take HRT, for 5 years, an average of 4-7 out of 1,000 are expected to get a blood clot in a vein.
For women in their 50s who have taken HRT with estrogen-progestogen for more than 5 years, 9-12 out of 1,000 users are expected to get a blood clot in a vein (ie 5 extra cases)
For women in their 50s without a uterus who take estrogen alone for more than 5 years, 5-8 out of 1,000 users are expected to have a blood clot in a vein (ie 1 extra case).
Heart disease (heart attack)
There is no evidence that HRT prevents heart attacks.
For women over 60 who take HRT with estrogen-progestogen, the risk of developing heart disease is slightly higher than those who do not take HRT.
For women without a uterus who take estrogen alone, there is no increased risk of developing heart disease.
Stroke _
The risk of stroke is about 1.5 times higher for those who take HRT compared to those who do not. The risk of stroke is age-dependent, therefore the number of cases of stroke increases due to the use of HRT with increasing age.
Comparison
For women in their 50s who do not take HRT, an average of 8 out of 1,000 people are expected to have a stroke over 5 years.
For women in their 50s who have taken HRT for more than 5 years, 11 out of 1,000 users are expected to have a stroke (ie 3 extra cases)
Other conditions
Using HRT does not prevent memory loss. The risk of memory loss may be slightly higher in women who start using HRT after the age of 65. Consult your doctor.
Other medicines and Oestriol Aspen
Some medicines may affect the effect of Oestriol Aspen and, conversely, Oestriol Aspen may also affect the effectiveness of other medicines. This can lead to irregular bleeding. The following applies:
- antiepileptic drugs (eg phenobarbital, phenytoin and carbamazepine)
- drugs against tuberculosis (eg rifampicin, rifabutin)
- medicines for HIV infection (eg nevirapine , efavirenz, ritonavir, nelfinavir)
- herbal medicine containing St. John’s wort (Hypericum perforatum)
- or the following medicines: anti-inflammatory medicines ( cortisone ), muscle relaxants (succinylcholine or theophylline) or antibiotics (troleandomycin).
Tell your doctor if you have hepatitis C and are following a combination regimen of the medicines ombitasvir/paritaprevir/ritonavir, with or without dasabuvir. The use of a combination of these drugs with certain estrogen-containing products may cause elevated liver function tests (increase in liver enzyme ALT); The risk of this happening with Oestriol Aspen is currently unknown.
Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription and herbal remedies.
Results from blood test analyze
If you need to take a blood sample, tell your doctor, or the person taking the blood sample, that you are taking Oestriol Aspen as it may affect the results of some tests.
Use of Oestriol Aspen with food and drink
You can eat and drink as usual while using Oestriol Aspen.
Pregnancy and breastfeeding
Oestriol Aspen is intended for women whose menstruation has stopped. If you become pregnant, stop taking Oestriol Aspen and consult a doctor.
Oestriol Aspen should not be used if you are pregnant.
Oestriol Aspen should not be used if you are breastfeeding.
Driving and using machines
No effects on the ability to drive and use machines have been observed.
Important information about some of the ingredients of Oestriol Aspen
Oestriol Aspen tablets contain lactose monohydrates. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
How to use Oestriol Aspen
Your doctor will strive to give you the lowest dose, which will give you symptom relief, and you should use Oestriol Aspen for the shortest possible time. Talk to your doctor if you do not get any relief from the symptoms, or feel that the dose is too high.
Initial treatment: 2-3 mg daily in a single dose for 2-3 weeks.
Maintenance treatment:
The usual dose is 1-2 mg daily (1 to 2 tablets).
Swallow the tablets with water or other beverage. You should take the entire daily dose at about the same time each day.
If you use more Oestriol Aspen than you should
If you have ingested too much medicine or if, for example, a child has accidentally ingested the medicine, contact a doctor or hospital for risk assessment and advice.
If you forget to take Oestriol Aspen
If you forget to take a dose, take it as soon as it is discovered unless more than 12 hours have passed since your regular tablet was taken. In the latter case, skip the missed dose one and take the next dose at the usual time instead.
Do not take a double dose to make up for a forgotten dose.
If you need surgery
If you are going to have surgery, tell your surgeon that you are taking Oestriol Aspen. You may need to stop taking Oestriol Aspen for 4 to 6 weeks before surgery to avoid the risk of blood clots (see section 2, “Blood clots in a vein ( thrombosis )”). Ask your doctor when it is appropriate to start taking Oestriol Aspen again.
Possible side effects
Like all medicines, Oestriol Aspen can cause side effects, although not everybody gets them. The side effects of Oestriol Aspen are usually mild and transient. They may also be due to a too high dose.
The following diseases are more common in women who take HRT than those who do not:
- breast cancer
- severe thickening of the uterine lining ( endometrial hyperplasia ) or cancer of the uterine lining (endometrial cancer)
- ovarian cancer ( ovarian cancer )
- blood clots in veins in bones or lungs (venous thromboembolism )
- heart disease
- stroke _
- probable memory loss, if treatment with HRT is started after the age of 65.
See section 2 for more information on these side effects.
Depending on the dose and the patient’s sensitivity, Oestriol Aspen may cause the following side effects (frequency may not be calculated from the available data):
– swelling and feeling of tension in the breasts
– minor bleeding from the abdomen
– nausea
– fluid accumulation in the body, such as swollen ankles or feet.
– flu-like symptoms.
In most patients, these side effects disappear after the first weeks of treatment. Contact your doctor if vaginal bleeding occurs or if any side effects get worse or persist.
The following side effects have been reported with other HRTs:
- gallbladder disease
- various skin diseases:
- dark skin spots, especially on the face and neck, so-called “pregnancy spots” (chloasma)
- painful reddish-purple bumps on the skin (erythema nodosum)
- annular redness or sore rash (erythema multiforme).
How to store Oestriol Aspen
Keep out of sight and reach of children.
No special storage instructions.
Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiration date is the last day of the specified month.
The medicine should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
Other information
Content declaration
The active substance in Oestriol Aspen tablets is estriol.
The other ingredients are amylopectin, magnesium stearate, potato starch, and lactose monohydrate (86 mg).
What the medicine looks like and contents of the pack
The tablets are white, round, flat, with break marks and beveled edges. The tablets are marked with the code “DG” above the notch and “7” below.
Oestriol Aspen 1 mg is available in packs of 90 tablets (pressure pack).
Marketing Authorization Holder and Manufacturer
Marketing Authorisation Holder:
Aspen Pharma Trading Limited, 3016 Lake Drive, Citywest Business Campus, Dublin 24, Ireland. Tel: +46 856 642 572
Manufacturer:
Cyndea Pharma, Polígono Industrial Emiliano Revilla Sanz, Avendia de Ágreda, 31 42110 Ólvega (Soria), Spain