Oestrogel Pump-Pack
1. What Oestrogel is and what it is used for
2. What you need to know before you use Oestrogel
PACKAGE LEAFLET: INFORMATION FOR THE USER OESTROGEL® PUMP PACK
(estradiol)
The full name of your medicine is Oestrogel Pump Pack. It is called Oestrogel in this leaflet.
Read all of this leaflet carefully before you start using this medicine because it contains important information for you.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.
What is in this leaflet:
1. What Oestrogel is and what it is used for
2. What you need to know before you use Oestrogel
3. How to use Oestrogel
4. Possible side effects
5. How to store Oestrogel
6. Contents of the pack and other information
Oestrogel is a Hormone Replacement Therapy (HRT). It contains the female hormone oestrogen.
Oestrogel is used in postmenopausal women with at least 6 months since their last natural period.
Oestrogel is used for:
Relief of symptoms occurring after menopause
During the menopause, the amount of the oestrogen produced by a woman's body drops.
This can cause symptoms such as hot face, neck and chest (hot flushes). Oestrogel alleviates these symptoms after menopause. You will only be prescribed Oestrogel if your symptoms seriously hinder your daily life.
Prevention of osteoporosis
After the menopause some women may develop fragile bones (osteoporosis). You should discuss all available options with your doctor.
If you are at an increased risk of fractures due to osteoporosis and other medicines are not suitable for you, you can use Oestrogel to prevent osteoporosis after menopause.
How Oestrogel works
Oestrogel works by replacing the oestrogen in your body. This is so that you have a similar amount of oestrogen as before your menopause.
Medical history and regular check-ups
The use of HRT carries risks which need to be considered when deciding whether to start using it, or whether to carry on using it.
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 will ask you 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 Oestrogel you should see your doctor for regular check-ups (at least once a year). At these check-ups, discuss with your doctor the benefits and risks of continuing with Oestrogel.
Go for regular breast screening, as recommended by your doctor.
Do not use Oestrogel
If any of the following applies to you. If you are not sure about any of the points below, talk to your doctor before using Oestrogel.
Do not use Oestrogel:
• If you have or have ever had breast cancer, or if you are suspected of having it,
• If you have cancer which is sensitive to oestrogen, 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 treated,
• If you have or have ever had blood clots in a vein (thrombosis), such as in the legs (deep venous thrombosis) or lungs (pulmonary embolism),
• If you have a blood clotting disorder (such as protein C, protein S, or antithrombin deficiency),
• 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 normal,
• If you have a rare blood problem called “porphyria” which is passed down in families (inherited),
• If you are allergic to estradiol or any other ingredients of this medicine (listed in section 6).
If any of the above conditions appear for the first time while using Oestrogel,
stop using it at once and consult your doctor immediately.
Warnings and precautions
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
Oestrogel. If so, you should see your doctor more often for check-ups:
• fibrosis inside your womb,
• growth of womb lining outside your 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)”),
• increased risk of getting a 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 tumor,
• 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 your blood (triglycerides),
• fluid retention due to heart or kidney problems.
Stop using Oestrogel and see a doctor immediately If you notice any of the following when taking HRT:
• any of the conditions mentioned in the 'Do not use Oestrogel' section
• yellowing of your skin or the whites of your eyes (jaundice). These 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
• 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: Oestrogel is not a contraceptive. If it is 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. Speak 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 (endometrial cancer)
Using 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).
Using 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 using HRT, on average, 5 in 1000 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 1000 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.
Irregular bleeding
You may have irregular bleeding or drops of blood (spotting) during the first 3-6 months of using Oestrogel. However, if the irregular bleeding:
• carries on for more than the first 6 months
• starts after you have been using Oestrogel for more than 6 months
• carries on after you have stopped using Oestrogel see your doctor as soon as possible.
Breast cancer
Evidence suggests that using combined oestrogen-progestogen and possibly also oestrogen-only HRT increases the risk of breast cancer. 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 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 1000 will be diagnosed with breast cancer over a 5-year period. For women aged 50 to 79 who are taking oestrogen-progestogen HRT over 5 years, there will be 13 to 23 cases in 1000 users (i.e. an extra 4 to 6 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
Ovarian cancer is rare. A slightly increased risk of ovarian cancer has been reported in women using HRT for at least 5 to 10 years.
Women aged 50 to 69 who are not using HRT, on average about 2 women in 1000 will be diagnosed with ovarian cancer over a 5-year period. For women who have been using HRT for 5 years, there will be between 2 and 3 cases per 1000 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 using it.
Blood clots can be serious, and if one travels to the lungs, it can cause chest pain, breathlessness, fainting or even death.
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 applies 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 clots
• 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 using Oestrogel and see a doctor immediately”.
Compare
Looking at women in their 50s who are not using HRT, on average, over a 5 -year period, 4 to 7 in 1000 would be expected to get a blood clot in a vein. For women in their 50s who have been using oestrogen-progestogen HRT for over 5 years, there will be 9 to 12 cases in 1000 users (i.e.an extra 5 cases).
For women in their 50s who have had their womb removed and have been using oestrogen-only HRT for over 5 years, there will be 5 to 8 cases in 1000 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 using any HRT. For women who have had their womb removed and are using 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 using HRT, on average, 8 in 1000 would be expected to have a stroke over a 5-year period. For women in their 50s who are using HRT, there will be 11 cases in 1000 users, over 5 years (i.e. an extra 3 cases).
