- estradiol hemihydrate
- norethisterone acetate
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: PL15142/0065.
Elleste Duet Conti
Package leaflet: Information for the user
Elleste DuetTM Conti Tablets
2 mg/1 mg film-coated tablets
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
What is in this leaflet
1. What Elleste Duet Conti Tablets are and what they are used for
2. What you need to know before you take Elleste Duet Conti Tablets
3. How to take Elleste Duet Conti Tablets
4. Possible side effects
5. How to store Elleste Duet Conti Tablets
6. Contents of the pack and other information
1. WHAT ELLESTE DUET CONTI TABLETS ARE AND WHAT THEY ARE USED FOR
Elleste Duet Conti Tablets are a Hormone Replacement Therapy (HRT). They contain two types of female hormones, an oestrogen (estradiol hemihydrate) and a progestogen (norethisterone acetate).
Elleste Duet Conti Tablets are used in postmenopausal women with at least one year since their last natural period.
Elleste Duet Conti Tablets are 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"). Elleste Duet Conti Tablets alleviate these symptoms after menopause. You will only be prescribed Elleste Duet Conti Tablets 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 Elleste Duet Conti Tablets to prevent osteoporosis after menopause.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE ELLESTE DUET CONTI TABLETS
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 Elleste Duet Conti Tablets 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 Elleste Duet Conti Tablets.
Go for regular breast screening, as recommended by your doctor.
Do not take Elleste Duet Conti Tablets
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 Elleste Duet Conti Tablets,
Do not take Elleste Duet Conti Tablets
If any of the above conditions appear for the first time while taking Elleste Duet Conti Tablets, stop taking them at once and consult your doctor immediately.
When to take special care with Elleste Duet Conti Tablets
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 Elleste Duet Conti Tablets. If so, you should see your doctor more often for check-ups:
Stop taking Elleste Duet Conti Tablets 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: Elleste Duet Conti Tablets are 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).
The progestogen in Elleste Duet Conti Tablets protects you from this extra risk.
You may have irregular bleeding or drops of blood (spotting) during the first 3-6 months of taking Elleste Duet Conti Tablets. However, if the irregular bleeding:
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.
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).
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 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, 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 Elleste Duet Conti Tablets 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).
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.
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).
Underactive thyroid gland
If you are having medicine for treatment of an underactive thyroid gland, your doctor will carry out tests while you are taking HRT, to ensure that your thyroid hormone levels remain acceptable.
If you have angioedema (a serious allergic reaction often involving swelling of the face, mouth and throat), oestrogens may make this worse.
Do not give this medicine to children.
Other medicines and Elleste Duet Conti Tablets
Some medicines may interfere with the effect of Elleste Duet Conti Tablets. This might lead to irregular bleeding. This applies to the following medicines:
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 Elleste Duet Conti Tablets, because this medicine can affect the results of some tests.
Pregnancy and breast-feeding
Elleste Duet Conti Tablets are for use in postmenopausal women only. If you become pregnant, stop taking Elleste Duet Conti Tablets and contact your doctor.
Driving and using machines
No effects on driving or using machinery have been observed for Elleste Duet Conti Tablets.
Elleste Duet Conti Tablets contain 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 ELLESTE DUET CONTI TABLETS
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
Your doctor will aim to prescribe the lowest possible dose to treat your symptoms for as short a time as necessary. Speak to your doctor if you think the dose is too strong or not strong enough.
If you are not taking any HRT
If you are not taking any HRT, you can start taking Elleste Duet Conti Tablets straightaway.
Changing from another type of HRT
If you are changing from another type of HRT, and you usually have a monthly bleed, start taking Elleste Duet Conti Tablets on the first day of bleeding.
If you do not have a monthly bleed, start taking Elleste Duet Conti Tablets on any convenient day.
If your doctor gives you instructions on changing from another type of HRT you should follow these instructions. If you have any doubts you should contact your doctor.
If you need to have surgery
If you are going to have surgery, tell the surgeon that you are taking Elleste Duet Conti Tablets. You may need to stop taking Elleste Duet Conti Tablets 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 Elleste Duet Conti Tablets again.
If you forget to take Elleste Duet Conti
Take the tablet as soon as you remember, and take the next one at the normal time.
If you have missed your tablet by more than 12 hours, dispose of this tablet safely and take the next one at the normal time. Do not take a double dose to make up for the forgotten tablet. You may experience some breakthrough bleeding or spotting.
If you take more Elleste Duet Conti than you should
There should be no problems, but you may experience breast tenderness, feel sick or actually be sick, have irregular periods, feel down, feel tired, develop acne or experience an increase in body and facial hair. If you are worried, contact your doctor. Take the usual tablet the following day.
If you have any further questions on the use of this medicine, 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 side effects have been associated with Elleste Duet Conti Tablets:
Frequencies are defined as follows:
Very common: may affect more than 1 in 10 people
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 1,000 people
Very rare: may affect up to 1 in 10,000 people
Not known: frequency cannot be estimated from the available data
Very common: headache, breast pain, breast tenderness, painful periods, problems with your menstrual cycle.
Common: feeling down, feeling anxious, mood changes, changes in sex drive, feeling dizzy, difficulty sleeping, feeling sick, bloating, diarrhoea, indigestion, stomach cramps, acne, rashes, itchiness, dry skin, back pain, pain in the extremities, breast enlargement, heavy periods, vaginal discharge, break-through bleeding, spasms (contractions) of the womb, vaginal infection, excessive thickening of the lining of the womb, pain, feeling of weakness, swelling of the ankles, feet and fingers, increase in weight.
Uncommon: migraine, a feeling of dizziness or “spinning”, high blood pressure, varicose veins, being sick, gallstones and gallbladder disease, change in colour of the skin, muscle cramps, breast cancer, increased levels of chemicals in the blood which may indicate disease.
Rare: hypersensitivity, tingling or numbness, blood clot in a vein, inflammation of a vein, muscle weakness, growths in the womb (myoma, cysts, polyps).
Very rare: increase in body and facial hair, yellowing of the skin.
Not known: loss of hair from the scalp.
The following side effects have been reported with other HRTs:
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
By reporting side effects, you can help provide more information on the safety of this medicine.
5. HOW TO STORE ELLESTE DUET CONTI TABLETS
Keep this medicine out of the sight and reach of children.
Do not store above 25°C. Store in the original package.
Do not use this medicine after the 'expiry date' which is stated on the carton after “EXP”. The expiry date refers to the last day of that month.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist to throw away medicines you no longer use. These measures will help protect the environment.
6. CONTENTS OF THE PACK AND OTHER INFORMATION
What Elleste Duet Conti Tablets contains
What Elleste Duet Conti Tablets look like and contents of the pack
Elleste Duet Conti Tablets are grey film-coated tablets with an embossing.
They are supplied in packs containing blister strips of 28 or 84 tablets.
Not all packs sizes may be marketed.
Marketing Authorisation Holder
This medicinal product is authorised in the Member States of the EEA under the following names:
Austria Parapanol kombi
UK Elleste Duet Conti Tablets
This leaflet was last revised in 02/2016.
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