This is an X-PIL, which is a text only patient information leaflet, designed for people with sight problems.
Table of Contents
ESTROFEM® 2mg
film-coated tablets
Estradiol
Please read this leaflet carefully before you start to take your medicine. If you have any further questions about Estrofem® 2mg or are not sure about anything, please ask your doctor or pharmacist.
Estrofem® 2mg is supplied in a calendar pack containing 28 blue film-coated tablets.
Each Estrofem® 2mg tablet contains:
Estradiol 2mg (as hemihydrate).
The tablets are marked “NOVO 280”.
Film coating: Indigo Carmine E132, hypromellose, talc, titanium dioxide E171 and macrogol 400.
Excipients: Lactose monohydrate, maize starch, hydroxypropylcellulose, talc, magnesium stearate.
Estrofem® 2mg is a hormone preparation with estradiol, an oestrogen identical to the natural human oestrogen, for women who no longer produce enough oestrogen themselves.
Product Authorisation Holder and Manufacturer:
Estrofem® 2mg is hormone replacement therapy (HRT) used to:
Estrofem® 2mg may have been especially prescribed if you have had a hysterectomy (removal of the womb). If you have not had a hysterectomy (you still have your womb) then your doctor will usually also prescribe a progestogen (another type of hormone) to be taken with Estrofem® 2mg for 12-14 days every month or 28-day cycle.
around the time of the menopause, or after surgical removal of the ovaries.
If you have answered Yes to any of these questions you should not take Estrofem® 2mg.
As well as benefits, HRT has some risks which you need to consider when you’re deciding whether to take it, or whether to carry on taking it.
Medical check-ups
Before you start taking HRT, your doctor should ask you about your own and your family’s medical history. Your doctor may decide to examine your breasts and/or your abdomen, and may do an internal examination - but only if these examinations are necessary for you, or if you have any special concerns.
Once you’ve started on HRT, you should see your doctor for regular check-ups (at least every six to twelve months). At these check-ups, your doctor may discuss with you the benefits and risks of continuing to take HRT.
Be sure to:
Conditions which need supervision
Inform your doctor if you have or have had the following conditions as your doctor may want to follow you more closely. These conditions may, in rare cases, recur or be made worse during treatment with Estrofem® 2mg:
Endometrial cancer (cancer of the lining of the womb)
Taking oestrogen-only HRT for a long time can increase the risk of cancer of the lining of the womb (the endometrium). Taking a progestogen as well as the oestrogen helps to lower the extra risk.
If you still have your womb, your doctor will usually prescribe a progestogen as well as oestrogen. If so, these may be prescribed separately, or as a combined HRT product.
If you have had your womb removed (had a hysterectomy), your doctor will discuss with you whether you can safely take oestrogen without a progestogen.
If you’ve had your womb removed because of endometriosis, any endometrium left in your body may be at risk. So your doctor may prescribe HRT that includes a progestogen as well as an oestrogen
Your product, Estrofem® 2mg is an oestrogen-only product
Compare
Looking at women who still have a uterus and who are not taking HRT – on average 5 in 1000 will be diagnosed with endometrial cancer between the ages of 50 and 65.
For women who take oestrogen- only HRT, the number will be 2 to 12 times higher, depending on the dose and how long you take it.
The addition of a progestogen to oestrogen-only HRT substantially reduces the risk of endometrial cancer.
If you get breakthrough bleeding or spotting, it’s usually nothing to worry about, especially during the first few months of taking HRT.
But if the bleeding or spotting:
Breast cancer
Women who have breast cancer, or have had breast cancer in the past, should not take HRT.
Taking HRT slightly increases the risk of breast cancer; so does having a later menopause. The risk for a post-menopausal woman taking oestrogen-only HRT for 5 years is about the same as for a woman of the same age who’s still having periods over that time and not taking HRT. The risk for a woman who is taking oestrogen plus progestogen HRT is higher than for oestrogen-only HRT (but oestrogen plus progestogen HRT is beneficial for the endometrium, see ‘Endometrial cancer’ above).
For all kinds of HRT, the extra risk of breast cancer goes up the longer you take HRT, but returns to normal within about 5 years after stopping HRT.
Your risk of breast cancer is also higher:
If you have a family history of breast cancer you should use this medication with great caution.
Looking at women aged 50 who are not taking HRT - on average, about 32 in 1000 will be diagnosed with breast cancer by the time they reach the age of 65.
For women who start taking oestrogen-only HRT at age 50 and take it for 5 years, the figure will be between 33 and 34 in 1000 (i.e. an extra 1-2 cases).
If they take oestrogen-only HRT for 10 years, the figure will be 37 in 1000 (i.e. an extra 5 cases).
For women who start taking oestrogen plus progestogen HRT at age 50 and take it for 5 years, the figure will be 38 in 1000 (i.e. an extra 6 cases).
If they take oestrogen plus progestogen HRT for 10 years, the figure will be 51 in 1000 (i.e. an extra 19 cases).
If you notice any changes in your breasts such as:
Ovarian cancer
Ovarian cancer (cancer of the ovaries) is very rare, but it is serious. It can be difficult to diagnose, because there are often no obvious signs of the disease.
Some studies have indicated that taking oestrogen-only HRT for more than 5 years may increase the risk of ovarian cancer. It is not yet known whether other kinds of HRT increase the risk in the same way.
Blood clots
HRT may increase the risk of blood clots in the veins (also called deep vein thrombosis or DVT), especially during the first year of taking it. If a clot travels to the lungs, it can cause breathlessness, chest pain, collapse or even death. This condition is called pulmonary embolism, or PE.
DVT and PE are examples of a condition called venous thromboembolism, or VTE.
You are more likely to get a blood clot:
If any of these things applies to you, talk to your doctor to see if you should take HRT.
Looking at women in their 50s who are not taking HRT – on average, over a 5-year period, 3 in 1000 would be expected to get a blood clot.
For women in their 50s who are taking HRT, the figure would be 7 in 1000.
Looking at women in their 60s who are not taking HRT – on average, over a 5-year period, 8 in 1000 would be expected to get a blood clot.
For women in their 60s who are taking HRT, the figure would be 17 in 1000.
If you get:
If you’re going to have surgery, make sure your doctor knows about it. You may need to stop taking HRT about 4 to 6 weeks before the operation, to reduce the risk of a blood clot. Your doctor will tell you when you can start taking HRT again.
Heart disease
HRT is not recommended for women who have heart disease, or have had heart disease recently. If you have ever had heart disease, talk to your doctor to see if you should be taking HRT.
HRT will not help to prevent heart disease.
Studies with one type of HRT (containing conjugated oestrogen plus the progestogen MPA) have shown that women may be slightly more likely to get heart disease during the first year of taking the medication. For other types of HRT, the risk is likely to be similar, although this is not yet certain.
Stroke
Recent research suggests that HRT slightly increases the risk of having a stroke. Other things that can increase the risk of stroke include:
If you are worried about any of these things, or if you have had a stroke in the past, talk to your doctor to see if you should take HRT.
Looking at women in their 50s who are not taking HRT - on average, over a 5-year period, 3 in 1000 would be expected to have a stroke.
For women in their 50s who are taking HRT, the figure would be 4 in 1000.
Looking at women in their 60s who are not taking HRT - on average, over a 5-year period, 11 in 1000 would be expected to have a stroke.
For women in their 60s who are taking HRT, the figure would be 15 in 1000.
Other conditions
There is no evidence that HRT will prevent memory loss. In one study of women who started using combined conjugated equine oestrogen (CEE) and medroxyprogesterone acetate (MPA) HRT after the age of 65, a small increase in the risk of dementia was observed. It is not known whether this applies to younger post-menopausal women or other HRT products.
If you need a blood test tell the doctor that you are taking Estrofem® 2mg since oestrogen can affect the results of certain tests.
Contraception
It is important to note that Estrofem® 2mg is not an oral contraceptive. If you are taking non-hormonal contraceptive precautions when you start Estrofem® 2mg, you should continue to do so until your doctor tells you that contraceptive precautions are no longer required. If you have been taking a hormonal contraceptive (i.e the “pill” or depot injections) you must change to a non-hormonal form of contraception before starting Estrofem® 2mg.
If your doctor has already told you that you no longer need to take contraceptive precautions you need not do so whilst taking Estrofem® 2mg.
Pregnancy and breast-feeding
Do not take Estrofem® 2mg if you are pregnant or breast-feeding.
Using other medicines
Other medicines may influence the effects of Estrofem® 2mg or Estrofem® 2mg may influence the effects of other medicines. Inform your doctor or pharmacist if you are taking or have recently taken any other medicine even those not prescribed. In particular:
Estrofem® 2mg is an oestrogen-only preparation. The tablets are taken orally, once a day, every day without pause. The lowest effective dose that gives you symptom relief should be used for the shortest duration when treating menopausal symptoms. You should only continue treatment as long as the benefit in alleviation of symptoms outweighs the risks.
When Do You Start?
If you still have an intact womb:
Your doctor will probably prescribe progestogen tablets for you to take in addition to Estrofem® 2mg. Take these as directed by your doctor.
If you are still having periods, take the first Estrofem® 2mg tablet on the 5th day of your period.
If you do not have periods, or they are irregular, you may start on any day that is convenient.
If your womb has been removed:
You may start taking Estrofem® 2mg on any day that is convenient. You do not need to take progestogen tablets unless your womb was removed because of endometriosis (see under ‘Endometrial cancer (cancer of the lining of the womb)’ above).
How to Use the Calendar Dial Pack:
Estrofem® 2mg tablets are contained in a convenient calendar dial pack which helps you to take the tablets correctly. Take 1 tablet a day, preferably at the same time each day, until all 28 tablets have been taken. Swallow the tablet with a glass of water.
You can always tell whether you have taken your tablets as directed by looking at the day on the calendar pack. Please find illustrations telling you how to use the calendar pack at the beginning of this package insert. When you have finished each pack, start the next pack immediately, repeating the instructions.
Estrofem® 2mg therapy can be stopped at any time. If your womb is intact, a period will often follow.
If you forget to take Estrofem® 2mg
If you forget to take a tablet at the usual time, take it as soon as possible. If you do not take the forgotten tablet before the usual time the day after, throw away the forgotten tablet and continue treatment as usual. Forgetting a dose may increase the likelihood of breakthrough bleeding and spotting if you still have your womb.
If you use more Estrofem® 2mg than you should
If you have taken more Estrofem® 2mg tablets than you should, talk to a doctor or pharmacist.
An overdose of Estrofem® 2mg could make you feel sick or vomit.
Bleeding with Estrofem® 2mg
If you have had a hysterectomy you will not have any bleeding with Estrofem® 2mg.
If you have not had a hysterectomy and you take progestogen every month in addition to Estrofem® 2mg, this will probably cause you to have a regular bleed towards or just after the end of the progestogen tablets.
In all likelihood, your doctor will usually give you Estrofem® 2mg for no longer than 1 year at a time because it is important that your treatment is reviewed regularly.
Ask your doctor about scheduling your consultations.
To eliminate menopausal symptoms, your doctor may recommend that you continue therapy for 2 to 3 years or longer.
If, for some reason, you want to stop taking Estrofem® 2mg, discuss the decision with your doctor. You have a right to understand the consequences of your decision and discuss alternative health options that may be better suited to you.
Like all medicines, Estrofem® 2mg can have side effects.
The following side effects may occur during your Estrofem® 2mg treatment:
Common (>1% and < 10% - less than 1 per 10 but more than 1 per 100)
Depression
Headache
Abdominal pain and nausea (feeling sick)
Leg cramps
Breast tenderness, breast enlargement and breast pain
Oedema (fluid retention)
Weight increase.
Uncommon (>0.1% and < 1% - less than 1 per 100 but more than 1 per 1000)
Abnormal vision
Blood clots in the veins
Indigestion, vomiting, flatulence (wind) and bloating
Gallstones
Rash or hives.
The following side effects have been reported to be associated with Estrofem® or other oestrogen treatment:
Irregular vaginal bleeding*
Deterioration of migraine
Dizziness
Diarrhoea
Hair loss
Increased blood pressure
Risk of developing endometrial hyperplasia and endometrial cancer* (see also section “Endometrial cancer (cancer of the lining of the womb)”)
Increase in size of uterine fibroids
Deterioration of asthma
Heart attack and congestive heart disease
Gallbladder disease
Chloasma, erythema multiforme, erythema nodosum and vasular purpura (skin diseases).
Vaginal infection
Insomnia
Epilepsy
Changes in sexual desire
Breast cancer (see under ‘Breast cancer’ above)
Dementia (see under ‘Other conditions’ above).
* In women who have not had a hysterectomy
If you notice any side effects, including any not mentioned in this leaflet, please inform your doctor or pharmacist.
Store in the original package in order to protect from light and moisture. Do not store above 25°C.
Do not refrigerate or freeze.
Keep out of reach and sight of children.
Do not use the product after the expiry date marked on the label of the calendar dial pack and on the carton.
Product Authorisation Number: PA 218/50/1
Date of Preparation: July 2010
Further Information is available to the medical and allied professions from:
Estrofem® is a trademark owned by Novo Nordisk FemCare AG, Switzerland
© 2010
Novo Nordisk A/S
1. SET THE DAY REMINDER
Turn the inner disc to set the day of the week opposite the little plastic tab.
2. HOW TO TAKE THE FIRST TABLET
Break the plastic tab and tip out the first tablet.
3. EVERY DAY
Simply move the transparent dial clockwise one space as indicated by the arrow.
Tip out the next tablet.
The transparent dial can only be turned after the tablet in the opening has been removed.
See further instructions in the section “How Do You Take Estrofem® 2mg?”
8-2822-11-001-1
Link to this document from your website:http://www.medicines.ie/medicine/14563/XPIL/Estrofem+2mg/