Active ingredient
- estradiol
Legal Category
POM: Prescription only medicine
POM: Prescription only medicine
The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine. It is written for patients and gives information about taking or using a medicine. It is possible that the leaflet in your medicine pack may differ from this version because it may have been updated since your medicine was packaged.
Below is a text only representation of the Patient Information Leaflet. The original leaflet can be viewed using the link above.
The text only version may be available in large print, Braille or audio CD. For further information call emc accessibility on 0800 198 5000. The product code(s) for this leaflet is: PL28397/0002.
Oestrogel Pump-Pack 750 micrograms/actuation Gel
Package Leaflet: Information for the User
OESTROGEL® PUMP-PACK 750 MICROGRAMS/ACTUATION GEL
ESTRADIOL
Read all of this leaflet carefully before you start using this medicine because it contains important information for you.
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
1. What Oestrogel is and what it is used for
The full name of your medicine is Oestrogel Pump-Pack 750 micrograms/actuation gel. It is called Oestrogel in this leaflet.
Oestrogel is a Hormone Replacement Therapy (HRT). It contains the female hormone oestrogen. Oestrogel is used in postmenopausal women.
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.
2. What you need to know before you use Oestrogel
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 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:
Stop using Oestrogel and see a doctor immediately
If you notice any of the following when taking HRT:
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.
Unexpected bleeding
You will have a bleed once a month (so-called withdrawal bleed) while taking Oestrogel. But, if you have unexpected bleeding or drops of blood (spotting) besides your monthly bleeding, which:
see your doctor as soon as possible.
Breast cancer
Evidence shows that using combined oestrogen-progestogen or oestrogen-only hormone replacement therapy (HRT) increases the risk of breast cancer. The extra risk depends on how long you use HRT. The additional risk becomes clear within 3 years of use. After stopping HRT the extra risk will decrease with time, but the risk may persist for 10 years or more if you have used HRT for more than 5 years.
Compare
Women aged 50 to 54 who are not taking HRT, on average, 13 to 17 in 1000 will be diagnosed with breast cancer over a 5-year period.
For women aged 50 who start taking oestrogen-only HRT for 5 years, there will be 16-17 cases in 1000 users (i.e. an extra 0 to 3 cases).
For women aged 50 who start taking oestrogen-progestogen HRT for 5 years, there will be 21cases in 1000 users (i.e. an extra 4 to 8 cases).
Women aged 50 to 59 who are not taking HRT, on average, 27 in 1000 will be diagnosed with breast cancer over a 10-year period.
For women aged 50 who start taking oestrogen-only HRT for 10 years, there will be 34 cases in 1000 users (i.e. an extra 7 cases)
For women aged 50 who start taking oestrogen-progestogen HRT for 10 years, there will be 48 cases in 1000 users (i.e. an extra 21 cases).
Additionally, you are advised to join mammography screening programs when offered to you. For mammogram screening, it is important that you inform the nurse/healthcare professional who is actually taking the x-ray that you use HRT, as this medication may increase the density of your breasts which may affect the outcome of the mammogram.Where the density of the breast is increased, mammography may not detect all lumps.
Ovarian cancer
Ovarian cancer is rare - much rarer than breast cancer. The use of oestrogen-only or combined oestrogen-progestogen 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 2000 will be diagnosed with ovarian cancer over a 5-year period. For women who have been using HRT for 5 years, there will be about 3 cases per 2000 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 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:
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).
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. Speak to your doctor for advice.
Other medicines and Oestrogel
Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines including medicines obtained without a prescription, herbal medicines or natural products.
Some medicines may interfere with the effect of Oestrogel. This might lead to irregular bleeding. This applies to the following medicines:
Laboratory tests
If you need a blood test, tell your doctor or the laboratory staff that you are using Oestrogel, because this medicine can affect the result of some tests.
Pregnancy and breast-feeding
Oestrogel is for use in postmenopausal women only. If you become pregnant, stop using Oestrogel and contact your doctor.
3. How to use Oestrogel
Always use Oestrogel exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
Using this medicine
Your doctor will aim to prescribe the lowest dose to treat your symptoms for as short as necessary. Speak to your doctor if you think this dose is too strong or not strong enough.
Preparing your new Pump Pack
Before using your new Pump Pack for the first time, you need to prepare it for use as follows:
How much to use and when to use
How to apply the gel
1. Make sure that your hands and the skin where you are going to apply the gel are clean, dry and unbroken.
2. Remove the canister cap to reveal the plunger.
3. Hold the Oestrogel Pump Pack in one hand and place your other hand under the spout, ready to collect the gel.
4. Push the plunger down firmly. This will dispense one measure of the gel.
5. Apply the gel to either:
or
6. Do not apply on or near the breasts, or near the genital area.
7. Spread the gel over a large area of skin on each shoulder, outer arm or mid-inner thigh.
8. If your doctor has prescribed 2 measures of gel, spread 1 measure over each outer arm and shoulder, or each mid-inner thigh. If 4 measures of gel have been prescribed, spread 2 measures over each outer arm and shoulder or each mid-inner thigh. (See steps 4-8).
9. Replace the cap.
10. Leave to dry for 5 minutes before covering with clothes.
11. Wash hands with soap and water after applying the gel.
If you believe Oestrogel has been transferred to another person (man or child):
Wash the area of skin onto which may have been affected immediately with soap and water.
How you know when your Pump Pack is empty
If you use more Oestrogel than you should
The effects of overdosing are generally: breast tenderness, nausea and vaginal bleeding. These symptoms disappear when treatment is stopped or the dose is reduced. In case of the accidental using of an excessive dose of the medicine tell your doctor immediately.
If you forget to use Oestrogel
If you forget a dose you may have breakthrough bleeding or spotting.
If you need to have surgery
If you are going to have surgery, tell the surgeon that you are using Oestrogel. You may need to stop using Oestrogel 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 using Oestrogel again.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
The following diseases are reported more often in women using HRT compared to women not using HRT:
The following side effects have been reported since Oestrogel came on to the market:
Frequency not known (cannot be estimated from the available data):
During clinical trials, the following side effects have also been observed:
Frequency not known (cannot be estimated from the available data)
Side effects observed with HRT products used in menopause are reported below:
Common (may affect up to 1 in 10 people):
Uncommon (may affect up to 1 in 100 people):
Rare (may affect up to 1 in 1000 people):
The following side effects have been reported with other HRTs:
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist.
United Kingdom
This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
Ireland
You can also report side effects directly via
By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store Oestrogel
6. Contents of the pack and other information
What Oestrogel Pump Pack contains
What Oestrogel Pump Pack looks like and contents of the pack
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Ireland Marketing Authorisation Holder
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This leaflet was last revised in March 2022
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