2. Before you take Estrofem®
Do not take Estrofem®
If any of the following apply to you. If you are not sure about any of the points below, talk to your doctor
before taking Estrofem®.
Do not take Estrofem®
- If you have or have ever had breast cancer, or if you are suspected of having it.
- If you have or have had cancer which is sensitive to oestrogens, such as cancer of the womb lining
(endometrium), or if you are suspected of having it.
- If you have any unexplained vaginal bleeding.
- If you have excessive thickening of the womb lining (endometrial hyperplasia) that is not being
- If you have or have ever had a blood clot in a vein (thrombosis), such as in the legs (deep venous
thrombosis) or the lungs (pulmonary embolism).
- If you have a blood clotting disorder (such as protein C, protein S, or antithrombin
- If you have or recently have had a disease caused by blood clots in the arteries, such as a heart attack,
stroke, or angina.
- If you have or have ever had a liver disease and your liver function tests have not returned to
- If you have a rare blood problem called ‘porphyria’ which is passed down in families
- If you are allergic (hypersensitive) to estradiol or any of the other ingredients of
Estrofem® (listed in section 6, Further information).
If any of the above conditions appear for the first time while taking Estrofem®, stop taking it at once and
consult your doctor immediately.
When to take special care with Estrofem®
Tell your doctor if you have ever had any of the following problems, before you start the treatment, as these may return
or become worse during treatment with Estrofem®. If so, you should see your doctor more often for check-ups:
- fibroids inside your womb
- growth of womb lining outside your womb (endometriosis) or a history of excessive growth of the womb lining
- increased risk of developing blood clots (see ‘Blood clots in a vein (thrombosis)’)
- increased risk of getting a oestrogen-sensitive cancer (such as having a mother, sister or grandmother who has had
- high blood pressure
- a liver disorder, such as a benign liver tumour
- migraine or severe headaches
- a disease of the immune system that affects many organs of the body (systemic lupus erythematosus, SLE)
- a disease affecting the eardrum and hearing (otosclerosis)
- a very high level of fat in your blood (triglycerides)
- fluid retention due to cardiac or kidney problems.
The use of HRT carries increased risk of getting gallstones.
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
The experience in treating women with a premature menopause (due to ovarian failure or surgery) is limited. If you have a
premature menopause the risks of using HRT may be different.
Please talk to your doctor.
Before you start (or restart) HRT, your doctor should ask about your own and your family’s medical history.
Your doctor may decide to perform a physical examination. This may include an examination of your breasts and/or an
internal examination, if necessary.
Once you have started on Estrofem® you should see your doctor for regular check-ups (at least once a
At these check-ups, discuss with your doctor the benefits and risks of continuing with Estrofem®.
Go for regular breast screening, as recommended by your doctor.
Stop taking Estrofem® and see a doctor immediately
If you notice any of the following when taking HRT:
- any of the conditions mentioned in the ‘DO NOT take Estrofem®’ section
- yellowing of your skin or the whites of your eyes (jaundice), general itching, abdominal (stomach) pain may be
signs of a liver disease
- a large rise in your blood pressure (symptoms may be headache, tiredness, dizziness)
- migraine-like headaches which happen for the first time
- intense long lasting headache, impaired vision or hearing, fainting, pronounced numbness or weakness in one side
of the body
- epileptic seizure happening for the first time
- if you become pregnant
- if you notice signs of a blood clot, such as:
- painful swelling and redness of the legs
- sudden chest pain
- 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 your last menstrual
period or you are under 50 years old, you may still need to use additional contraception to prevent pregnancy. Talk to your
doctor for advice.
HRT and cancer
Excessive thickening of the lining of the womb (endometrial hyperplasia) and cancer of the lining of the womb
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 progestogen in addition to the oestrogen for at least 12 days of each 28 day cycle protects you from this extra
risk. So your doctor will prescribe a progestogen separately if you still have your womb. If you have had your womb removed
(a hysterectomy), discuss with your doctor whether you can safely take this product without a progestogen.
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.
If you still have your uterus, you may have a bleed once a month (so-called withdrawal bleed) while taking
Estrofem® with a progestogen. But, if you have unexpected bleeding or drops of blood (spotting) besides your
monthly bleeding, which:
- carries on for more than the first 6 months
- starts after you have been taking Estrofem® more than 6 months
- carries on after you have stopped taking Estrofem®
see your doctor as soon as possible.
Evidence suggests that taking combined oestrogen-progestogen and possibly also oestrogen-only HRT increases the risk of
The risk is also increased if you have a later menopause. The extra risk depends on how long you take HRT.
The additional risk becomes clear within a few years. However, it returns to normal within a few years (at most 5) after
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.
Women aged 50 to 79 who are not taking HRT, on average, 9 to 14 in 1,000 will be diagnosed with breast cancer over a
For women aged 50 to 79 who are taking oestrogen-progestogen HRT over 5 years, there will be 13 to 20 cases in 1,000
users (i.e. 4 to 6 extra cases).
Regularly check your breasts.
See your doctor if you notice any changes such as:
- dimpling of the skin
- changes in the nipple
- any lumps you can see or feel.
Ovarian cancer is rare. A slightly increased risk of ovarian cancer has been reported in women taking HRT for at least 5
to 10 years.
Women aged 50 to 69 who are not taking HRT, on average, about 2 women in 1,000 will be diagnosed with ovarian cancer over
a 5-year period. For women who have been taking HRT for over 5 years, there will be between 2 and 3 cases per 1,000 users
(i.e. up to 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
You are more likely to get a blood clot in your veins as you get older and if any of the following applies to you.
Inform your doctor if any of these situations apply to you:
- you are unable to walk for a long time because of major surgery, injury or illness (see also section 3, If you
need to have surgery)
- you are seriously overweight (BMI >30 kg/m2)
- you have any blood clotting problem that needs long-term treatment with a medicine used to prevent blood
- if any of your close relatives has ever had a blood clot in the leg, lung or another organ
- you have systemic lupus erythematosus (SLE)
- you have cancer.
For signs of a blood clot, see ‘Stop taking Estrofem® and see a doctor immediately’.
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-progestogen 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-progestogen 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
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.
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
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 your doctor for advice.
Using other medicines
Some medicines may interfere with the effects of Estrofem®. This might lead to irregular bleeding. This
applies to the following medicines:
- Medicines for epilepsy (such as phenobarbital, phenytoin and carbamazepin)
- Medicines for tuberculosis (such as rifampicin, rifabutin)
- Medicines for HIV infection (such as nevirapine, efavirenz, ritonavir and nelfinavir)
- Herbal remedies containing St John’s Wort (Hypericum perforatum).
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including
medicines obtained without a prescription, herbal medicines or other natural products.
Taking Estrofem® with food and drink
The tablets can be taken with or without food and drink.
Driving and using machines
Estrofem® has no known effect on the ability to drive or use machines.
Important information about some of the ingredients of Estrofem®:
Estrofem® contains lactose monohydrate. If you have an intolerance to some sugars, contact your doctor before
If you need a blood test, tell your doctor or the laboratory staff that you are taking Estrofem®, because this
medicine can affect the results of some tests.
Pregnancy and breast-feeding
Estrofem® is for use in post-menopausal women only. If you become pregnant, stop taking Estrofem®
and contact your doctor.
3. How to take Estrofem®
Always take Estrofem® exactly as your doctor has told you. You should check with your doctor or pharmacist if
you are unsure.
If your womb has been removed or if you have no vaginal bleeding and you are not taking other hormone therapy products,
you can start treatment on any convenient day.
Take one tablet once a day, at about the same time each day.
Once you have finished all the 28 tablets in the pack, start a new pack continuing the treatment without
For instructions on the use of the calendar pack, see “USER INSTRUCTIONS” at the end of the package leaflet.
Your doctor will aim to prescribe the lowest dose to treat your symptoms for as short as necessary. Talk to your doctor
if you think this dose is too strong or not strong enough.
If you have had your womb removed, your doctor will not prescribe a progestogen (another female hormone) in addition
unless you have had a condition called endometriosis (deposition of uterine tissue outside the womb).
If you have taken other HRT products until now, ask your doctor or pharmacist when you should start taking
If you take more Estrofem® than you should:
If you have taken more Estrofem® than you should, talk to a doctor or pharmacist. An overdose of
Estrofem® could make you feel sick or vomit.
If you forget to take Estrofem®:
If you forget to take your tablet at the usual time, take it within the next 12 hours. If more than 12 hours have gone
by, skip the missed dose and start again as normal the next day. Do not take a double dose to make up for a forgotten
tablet. Forgetting a dose may increase the likelihood of breakthrough bleeding and spotting if you still have your womb.
If you stop taking Estrofem®:
If you want to stop taking Estrofem®, talk to your doctor first. Your doctor will explain the effects of
stopping treatment and discuss other possibilities with you.
If you have any further questions on the use of this product ask your doctor or pharmacist.
If you need to have surgery:
If you are going to have surgery, tell the surgeon that you are taking Estrofem®. You may need to stop taking
Estrofem® about 4 to 6 weeks before the operation to reduce the risk of a blood clot (see section 2, Blood clots
in a vein). Ask your doctor when you can start taking Estrofem® again.
4. Possible side effects
The following diseases are reported more often in women using HRT compared to women not using HRT:
- breast cancer
- abnormal growth or cancer of the lining of the womb (endometrial hyperplasia or cancer)
- ovarian cancer
- blood clots in the veins of the legs or lungs (venous thromboembolism)
- heart disease
- probable memory loss if HRT is started over the age of 65
For more information about these side effects, see section 2.
The frequency of possible side effects listed below is defined using the following convention:
Very common (affects more than 1 user in 10)
Common (affects 1 to 10 users in 100)
Uncommon (affects 1 to 10 users in 1,000)
Rare (affects 1 to 10 users in 10,000)
Very rare (affects less than 1 user in 10,000)
Not known (frequency cannot be estimated from the available data).
Common side effects
- Abdominal (stomach) pain
- Feeling sick (nausea)
- Leg cramps
- Breast pain, breast tenderness or breast enlargement
- Oedema (retention of fluid)
- Weight increase.
Uncommon side effects
- Abnormal vision
- Blood clots in the veins (venous embolism)
- Heartburn (dyspepsia)
- Flatulence or bloating
- Itching or hives (urticaria).
Very rare side effects
- Irregular vaginal bleeding*
- Migraine, worse than before
- Insomnia (being unable to sleep)
- Changes in libido
- Vaginal infection caused by a fungus
- Deterioration of asthma
- Hair loss (alopecia)
- Increased blood pressure.
*If prescribed for women with an uterus
The following side effects have been reported with other HRT’s:
- Gall bladder disease
- Various skin disorders:
- Discoloration of the skin especially of the face or neck known as ‘pregnancy patches’ (chloasma)
- Painful reddish skin nodules (erythema nodosum)
- Rash with target-shaped reddening or sores (erythema multiforme).
Turn the inner disc to set the day of the week opposite the little plastic tab.
Break the plastic tab and tip out the first tablet.
On the next day simply move the transparent dial clockwise one space as indicated by the arrow. Tip out the next tablet.
Remember to take only one tablet once a day.