- estradiol hemihydrate
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 can be viewed in PDF format using the link above.
The text only version may be available from RNIB in large print, Braille or audio CD. For further information call RNIB Medicine Leaflet Line on 0800 198 5000. The product code(s) for this leaflet is: PL46302/0052.
PATIENT INFORMATION LEAFLET
Zumenon® 1mg film-coated tablets
Read all of this leaflet carefully before you start using this medicine.
In this leaflet:
1. What Zumenon is and what it is used for
2. Before you use Zumenon
3. How to use Zumenon
4. Possible side effects
5. How to store Zumenon
6. Further information
1. WHAT ZUMENON IS AND WHAT IT IS USED FOR
Zumenon is a Hormone Replacement Therapy (HRT). It contains the female hormone oestrogen. Zumenon is used in postmenopausal women with at least 6 months since their last natural period and women switching from standard (cyclic or sequential) HRT on the advice of their doctor.
Zumenon 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”). Zumenon alleviates these symptoms after menopause. You will only be prescribed Zumenon if your symptoms seriously hinder your daily life.
2. BEFORE YOU TAKE ZUMENON
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 taking 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 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 Zumenon 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 Zumenon.
Go for regular breast screening, as recommended by your doctor.
Do not take Zumenon
If any of the following applies to you. If you are not sure about any of the points below, talk to your doctor before taking Zumenon,
Do not take Zumenon
If any of the above conditions appear for the first time while taking Zumenon, stop taking it at once and consult your doctor immediately.
When to take special care with Zumenon
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 Zumenon. If so, you should see your doctor more often for check-ups:
Stop taking Zumenon 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: Zumenon 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)
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 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.
You will have a bleed once a month (so-called withdrawal bleed) while taking Zumenon. But, if you have unexpected bleeding or drops of blood (spotting) besides your monthly bleeding, which:
see your doctor as soon as possible
Evidence suggests that taking 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. 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).
Ovarian cancer is rare - much rarer than breast cancer. The use of oestrogen-only or combined oestrogen-progestagen 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, on average about 2 women in 2000 will be diagnosed with ovarian cancer over a 5-year period. For women who have been taking 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 taking 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 taking Zumenon 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 1000 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 1000 users (i.e. an extra 5 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 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 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 heart disease.
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 1000 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 1000 users, over 5 years (i.e. an extra 3 cases).
Using other medicines
Some medicines may interfere with the effect of Zumenon. This might lead to irregular bleeding. This applies to the following medicines:
Problems due to high levels of the following medicines may occur when you take Zumenon so careful drug monitoring and dose decrease may become necessary:
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.
If you need a blood test, tell your doctor or the laboratory staff that you are taking Zumenon, because this medicine can affect the results of some tests.
Pregnancy and breast-feeding
Zumenon is for use in peri and postmenopausal women only. If you become pregnant, stop taking Zumenon and contact your doctor.
Important information about some of the ingredients of Zumenon
Zumenon tablets contain milk sugar (lactose). If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
3. HOW TO TAKE ZUMENON
Always take Zumenon exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.
Take one tablet every day, without a break between packs. Swallow the tablet with water, with or without food.
In women with a uterus, a progestagen should normally be added to Zumenon for 12 - 14 days of each month. If you are having regular periods you should start taking Zumenon on day one of bleeding.
If you are not having regular periods and are not taking any other HRT preparations, or you are switching from a combined continuous HRT product, you can start taking Zumenon on any convenient day.
If you are currently using a ‘cyclic’ or ‘sequential’ HRT preparation (which involves taking an oestrogen tablet or patch for part of the month, followed by both oestrogen and progestagen tablet or patch for up to 14 days) start taking Zumenon the day after you finish the pack i.e. at the end of the progestagen phase.
Your doctor will aim to prescribe the lowest dose to treat your symptom for as short as necessary. Speak to your doctor if you think this dose is too strong or not strong enough.
You may experience some irregular bleeding or light bleeding (spotting) during your first few months of taking Zumenon. If the bleeding is troublesome, or continues beyond the first few months of treatment you should discuss this with your doctor.
If you take more Zumenon than you should
Nausea (feeling sick), vomiting, sleepiness, dizziness and withdrawal bleeding may occur. No treatment is necessary, but if you are worried contact your doctor for advice.
If you forget to take Zumenon
Take the missed tablet as soon as you remember. If it is more than 12 hours since you took the last one, take the next dose without taking the forgotten tablet. Do not take a double dose. Bleeding or spotting may occur if you miss a dose.
If you need to have surgery
If you are going to have surgery, tell the surgeon that you are taking Zumenon. You may need to stop taking Zumenon 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 Zumenon again.
If you stop taking Zumenon
Do not stop taking Zumenon without first talking to your doctor.
If you have any further questions on the use of this product, ask your doctor or pharmacist
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:
For more information about these side effects, see Section 2.
The following serious side effects may occur during treatment with Zumenon:
If any of these side effects occur you should stop treatment immediately and contact your doctor.
The following side effects may occur during treatment:
Common (in less than 1 in 10, but more than 1 in 100 patients treated):
Uncommon (in less than 1 in 100, but more than 1 in 1,000 patients treated):
Rare (in less than 1 in 1,000, but more than 1 in 10,000 patients treated):
Very rare (in less than 1 in 10,000 patients treated, not known (cannot be estimated from the available data)):
If unscheduled bleeding occurs after some time on HRT, you should contact your doctor. If unscheduled bleeding continues after stopping HRT, it may be necessary to perform tests to exclude disease of the endometrium (the lining of the uterus).
Changes can occur in the levels of certain proteins and hormones in the blood. The action of the hormones in the body is not affected. You should tell your doctor that you are taking HRT if you are to have a blood test.
The following side effects have been reported in association with estradiol treatment (frequency unknown):
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. 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.
By reporting side effects you can help provide more information on the safety of this medicine.
5. HOW TO STORE ZUMENON
Keep out of the reach and sight of children.
This medicinal product does not require any special storage conditions.
Do not use Zumenon after the “use before” date which is stated on the pack. The “use before” date refers to the last day of that month.
Medicines 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.
6. FURTHER INFORMATION
What Zumenon contains
Each tablet contains 1 mg oestradiol hemihydrate.
The other ingredients in the tablet core are:
The other ingredients in the film coating are:
What Zumenon looks like and contents of the pack
White round film-coated tablets.
The inscription on the tablets is 379 on one side.
The tablets are packed in a PVC film with a covering aluminium foil.
The blister strips contain 28 film-coated tablets. There are 84 tablets in each carton.
Marketing Authorisation Holder
This leaflet was last revised in June 2018.
20 Station Close, Potters Bar, Hertfordshire, EN6 1TL, UK
+44 (0)1707 853000
+44 (0)1707 853 000