Elleste Duet tablets are a form of Hormone Replacement Therapy (HRT) designed to alleviate symptoms of menopause in women. Each tablet contains a combination of two hormones: estradiol, a form of oestrogen, and norethisterone, a progestogen. This combination helps manage symptoms like hot flushes, night sweats, mood swings, and vaginal dryness by replenishing hormone levels that naturally decline during menopause. Elleste Duet is also used to prevent osteoporosis in postmenopausal women at risk of fractures. The tablets are taken daily and are suitable for women who have not had a hysterectomy.
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What are Elleste Duet tablets?
Elleste Duet tablets are a type of Hormone Replacement Therapy (HRT) that combines two hormones: estradiol, a form of oestrogen, and norethisterone, a type of progestogen. These tablets are designed for women experiencing menopause, helping to alleviate symptoms such as hot flushes, night sweats, mood swings, and vaginal dryness by restoring hormone levels that decrease during this stage of life. Elleste Duet is also used to help prevent osteoporosis in postmenopausal women who are at risk of bone fractures. This medication is suitable for women who still have their womb and require both oestrogen and progestogen as part of their HRT regimen.
What are the active ingredients in Elleste Duet tablets?
The active ingredients contained in Elleste Duet are: Estradiol (as hemihydrate), norethisterone acetate (combined tablets only)
What are Elleste Duet tablets used for?
Elleste Duet is a type of Hormone Replacement Therapy (HRT) that contains two female hormones: an oestrogen (estradiol hemihydrate) and a progestogen (norethisterone acetate).
Elleste Duet is used for:
Relief of menopausal symptoms: During menopause, the body’s production of oestrogen decreases, leading to symptoms such as hot flushes, night sweats, and discomfort. Elleste Duet helps alleviate these symptoms when they significantly impact daily life.
Prevention of osteoporosis: Postmenopausal women are at increased risk of developing osteoporosis, a condition that weakens bones and makes them more prone to fractures. If you are at high risk of fractures and other treatments are not suitable, Elleste Duet 2 mg can be used to help prevent osteoporosis.
How do Elleste Duet tablets work?
Elleste Duet tablets work by supplementing the body with hormones that decrease during menopause.
Estradiol Hemihydrate (Oestrogen): This hormone helps to replace the oestrogen that the ovaries no longer produce after menopause. By restoring oestrogen levels, Elleste Duet helps relieve menopausal symptoms like hot flushes, night sweats, and vaginal dryness.
Norethisterone Acetate (Progestogen): This hormone is included to protect the lining of the womb (endometrium). If oestrogen is taken without progestogen, it can cause the lining of the womb to thicken, increasing the risk of endometrial cancer. Norethisterone balances the effects of oestrogen on the womb, reducing this risk.
Together, these hormones work to manage menopausal symptoms and reduce the risk of osteoporosis while maintaining the health of the womb lining.
How do you use Elleste Duet tablets?
Always take this medicine exactly as your doctor or pharmacist has instructed. If you are unsure, consult your doctor or pharmacist.
Your doctor will aim to prescribe the lowest effective dose to manage your symptoms for the shortest time necessary. If you feel the dose is too strong or too weak, speak to your doctor.
The Elleste Duet 1 mg pack contains 16 white tablets and 12 pale green tablets:
Start with the white tablets.
The Elleste Duet 2 mg pack contains 16 orange tablets and 12 grey tablets:
Start with the orange tablets.
If you are still having regular periods, begin on the first day of bleeding. If your periods are irregular or have stopped, you can start immediately.
Take one tablet each day, preferably at the same time each day.
Swallow the tablets whole with water.
Follow the arrows on the pack and take a tablet each day until the pack is finished.
Start a new strip the day after you finish the previous one.
To help you remember to take your tablets, use the provided stickers with the days of the week. For example, if starting on a Friday, use the sticker that begins with "Fri" and place it on the foil strip above the tablet where the start arrow is indicated.
Elleste Duet 1 mg: Begin with the white tablet marked by the start arrow.
Elleste Duet 2 mg: Begin with the orange tablet marked by the start arrow.
Changing from another type of HRT: If switching from another HRT, start Elleste Duet after finishing your current HRT pack. Follow any specific instructions your doctor provides, and if you have any doubts, consult your doctor.
Will I have periods? You will likely have a monthly bleed that may begin between day 21 of the pack and day 5 of the next pack. This pattern should remain consistent each month. Some women may not experience any bleeding. If you have irregular bleeding for more than a few months, inform your doctor.
If you need surgery: Inform your surgeon that you are taking Elleste Duet, as you may need to stop taking it 4 to 6 weeks before surgery to reduce the risk of blood clots. Ask your doctor when you can resume taking Elleste Duet.
If you forget to take Elleste Duet:
Take the missed tablet as soon as you remember and then continue as normal.
If you miss a tablet by more than 12 hours, skip it and take the next one at the regular time. Do not take a double dose. You may experience breakthrough bleeding or spotting.
If you take more Elleste Duet than you should: There should be no serious problems, but you may experience symptoms like breast tenderness, nausea, irregular periods, mood changes, tiredness, acne, or an increase in body and facial hair. If you are concerned, contact your doctor. Take the next tablet at the usual time.
If you have any further questions about using this medicine, consult your doctor or pharmacist.
Who should not use Elleste Duet tablets?
Medical History and Regular Check-Ups
Using HRT (Hormone Replacement Therapy) carries certain risks that need to be carefully evaluated when deciding whether to start or continue treatment. If you have experienced premature menopause (due to ovarian failure or surgery), the risks associated with HRT may be different, so it's important to discuss this with your doctor.
Before beginning (or resuming) HRT, your doctor will ask about your personal and family medical history. A physical examination, including a breast exam and possibly an internal examination, may also be recommended.
Once you start taking Elleste Duet, it's important to have regular check-ups with your doctor, at least once a year. During these visits, you should discuss the benefits and risks of continuing with Elleste Duet. Regular breast screenings should also be carried out as recommended by your doctor.
Do Not Take Elleste Duet
Do not take Elleste Duet if any of the following apply to you. If you are unsure about any of these points, consult your doctor before taking Elleste Duet:
You have or have ever had breast cancer, or it is suspected.
You have cancer that is sensitive to oestrogens, such as cancer of the womb lining (endometrium), or it is suspected.
You have any unexplained vaginal bleeding.
You have untreated excessive thickening of the womb lining (endometrial hyperplasia).
You have or have ever had a blood clot in a vein (thrombosis), such as in the legs (deep venous thrombosis) or lungs (pulmonary embolism).
You have a blood clotting disorder (such as protein C, protein S, or antithrombin deficiency).
You have or have recently had a disease caused by blood clots in the arteries, such as a heart attack, stroke, or angina.
You have or have ever had liver disease, and your liver function tests have not returned to normal.
You have a rare inherited blood disorder called “porphyria.”
You are allergic to estradiol hemihydrate, norethisterone acetate, or any of the other ingredients in this medicine.
If any of these conditions appear for the first time while taking Elleste Duet, stop taking it immediately and consult your doctor.
When to Take Special Care with Elleste Duet
Inform your doctor if you have had any of the following conditions before starting treatment, as they may return or worsen during treatment with Elleste Duet. If so, you may need more frequent check-ups:
Fibroids in 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 blood clots (see “Blood Clots in a Vein”).
Increased risk of oestrogen-sensitive cancer (e.g., if your mother, sister, or grandmother 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 affecting many organs (systemic lupus erythematosus, SLE).
Epilepsy.
Asthma.
A disease affecting the eardrum and hearing (otosclerosis).
Very high levels of fat in your blood (triglycerides).
Fluid retention due to heart or kidney problems.
Hereditary or acquired angioedema.
Stop Taking Elleste Duet and See a Doctor Immediately if You Notice:
Any of the conditions mentioned in the "Do Not Take Elleste Duet" section.
Yellowing of your skin or the whites of your eyes (jaundice), which may indicate liver disease.
Swelling of the face, tongue, and/or throat, or difficulty swallowing or breathing, which may suggest angioedema.
A significant increase in blood pressure (symptoms may include headache, tiredness, dizziness).
Migraine-like headaches occurring for the first time.
You become pregnant.
Signs of a blood clot, such as:
Painful swelling and redness in the legs.
Sudden chest pain.
Difficulty breathing.
For more information, see the section on "Blood Clots in a Vein."
Note: Elleste Duet is not a contraceptive. If it has been less than 12 months since your last menstrual period or if you are under 50 years old, you may still need to use additional contraception to prevent pregnancy. Consult your doctor for advice.
HRT and Cancer: FAQs
Endometrial Hyperplasia and Cancer of the Womb Lining
Taking oestrogen-only Hormone Replacement Therapy (HRT) increases the risk of excessive thickening of the womb lining (endometrial hyperplasia) and cancer of the womb lining (endometrial cancer).To reduce this risk, if you still have your womb, your doctor will prescribe a progestogen to be taken in addition to the oestrogen for at least 12 days of each 28-day cycle. If you have had a hysterectomy (your womb has been removed), discuss with your doctor whether it is safe to take oestrogen-only HRT without adding a progestogen.For women aged 50 to 65 who still have a womb and do not take HRT, about 5 in 1000 will develop endometrial cancer. However, in women of the same age who take oestrogen-only HRT, the number increases to between 10 and 60 in 1000, depending on the dose and duration of treatment.The specific risk of endometrial cancer when using more than 2 mg of Elleste Solo along with a progestogen is currently unknown.
What should I do if I experience unexpected bleeding while on HRT?
If you experience unexpected bleeding or spotting outside of your monthly withdrawal bleed while using Elleste Duet, especially if it:
Persists beyond the first 6 months,
Starts after more than 6 months of use,
Continues after you’ve stopped using Elleste Duet,
You should consult your doctor as soon as possible.
Does HRT increase the risk of breast cancer?
Yes, evidence shows that using combined estrogen-progestogen or estrogen-only HRT increases the risk of breast cancer. This extra risk becomes noticeable within 3 years of use and may persist for 10 years or more after stopping HRT, especially if used for more than 5 years.For example, in women aged 50 to 54 not using HRT, 13 to 17 in 1000 may be diagnosed with breast cancer over a 5-year period. For those on estrogen-only HRT, the risk increases to 16-17 in 1000, and for those on combined HRT, the risk rises to 21 in 1000.
How can I monitor for breast cancer while on HRT?
Regularly check your breasts for any changes such as dimpling of the skin, changes in the nipple, or any lumps you can see or feel. It’s also important to participate in mammography screening programs as advised by your doctor. When having a mammogram, inform the healthcare provider that you are using HRT, as it can increase breast density and affect the mammogram results.
Does HRT increase the risk of ovarian cancer?
There is a slightly increased risk of ovarian cancer with the use of both estrogen-only and combined estrogen-progestogen HRT. For women aged 50 to 54 who are not using HRT, about 2 in 2000 will be diagnosed with ovarian cancer over 5 years. This increases to about 3 in 2000 for women using HRT.
HRT and Circulation: FAQs
How does HRT affect the risk of blood clots?
The risk of blood clots in the veins (thrombosis) is 1.3 to 3 times higher in HRT users compared to non-users, particularly during the first year of use. Blood clots can be serious, especially if they travel to the lungs, potentially causing chest pain, breathlessness, fainting, or even death.In women in their 50s not using HRT, about 4 to 7 in 1000 might develop a blood clot over 5 years. This increases to 9 to 12 in 1000 for women using combined HRT, and to 5 to 8 in 1000 for those using estrogen-only HRT after a hysterectomy.
Does HRT affect heart disease risk?
HRT does not prevent heart attacks. Women over 60 using combined estrogen-progestogen HRT are slightly more likely to develop heart disease compared to non-users. However, for women who have had a hysterectomy and are using estrogen-only therapy, there is no increased risk of heart disease.
Does HRT increase the risk of stroke?
Yes, the risk of stroke is about 1.5 times higher in HRT users compared to non-users. For women in their 50s not using HRT, 8 in 1000 are expected to have a stroke over 5 years. This number increases to 11 in 1000 for those using HRT.
Other FAQs
Does HRT affect memory?
HRT does not prevent memory loss, and there is some evidence that starting HRT after age 65 may increase the risk of memory loss. Consult your doctor for advice.
What should I know about Elleste Duet and pregnancy?
Elleste Duet is intended for use in postmenopausal women only. If you become pregnant, stop using Elleste Duet and contact your doctor.
What are the side effects with Elleste Duet tablets?
Like all medicines, this medication can cause side effects, although not everyone experiences them. The following conditions are reported more frequently in women using HRT compared to those not using it:
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
Stroke
Possible memory loss if HRT is started after the age of 65
The following side effects have been associated with Elleste Duet, categorized by frequency:
Very common: May affect more than 1 in 10 people - headache, breast pain, breast tenderness, painful periods, issues with the menstrual cycle.
Common: May affect up to 1 in 10 people - feeling down, anxiety, mood changes, changes in sex drive, dizziness, difficulty sleeping, nausea, bloating, diarrhea, indigestion, stomach cramps, acne, rashes, itchiness, dry skin, back pain, pain in the extremities, breast enlargement, heavy periods, vaginal discharge, breakthrough bleeding, uterine spasms, vaginal infection, excessive thickening of the womb lining, pain, weakness, swelling of the ankles, feet, or fingers, weight gain.
Uncommon: May affect up to 1 in 100 people - migraine, vertigo, high blood pressure, varicose veins, vomiting, gallstones and gallbladder disease, skin discoloration, breast cancer, muscle cramps, increased levels of certain blood chemicals.
Rare: May affect up to 1 in 1,000 people - hypersensitivity, tingling or numbness, blood clot in a vein, vein inflammation, muscle weakness, growths in the womb (myoma, cysts, polyps).
Very rare: May affect up to 1 in 10,000 people - increased body and facial hair, yellowing of the skin.
Not known: Frequency cannot be estimated from available data - hair loss from the scalp.
Other side effects reported with other HRTs include:
Various skin disorders:
Discoloration of the skin, especially on the face or neck, known as "pregnancy patches" (chloasma)
Painful reddish skin nodules (erythema nodosum)
Rash with target-shaped reddening or sores (erythema multiforme)
Dry eyes and changes in tear film
If you experience any side effects, talk to your doctor, pharmacist, or nurse, including those not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at yellowcard.mhra.gov.ukor search for MHRA Yellow Card in the Google Play or Apple App Store. Reporting side effects can help provide more information on the safety of this medicine.
Do Elleste Duet tablets interact with other medicines?
Certain medications can interfere with the effectiveness of Elleste Duet, potentially leading to irregular bleeding. This includes:
Epilepsy medications (such as phenobarbital, phenytoin, and carbamazepine)
Tuberculosis medications (such as rifampicin and rifabutin)
HIV medications (such as nevirapine, efavirenz, ritonavir, telaprevir, and nelfinavir)
Herbal remedies containing St John’s Wort (Hypericum perforatum)
HRT can also affect how some other medicines work, including:
Lamotrigine (used for epilepsy), as it may increase the frequency of seizures
Hepatitis C virus (HCV) medications (such as combination regimens including ombitasvir/paritaprevir/ritonavir with or without dasabuvir, as well as regimens with glecaprevir/pibrentasvir). These may cause increases in liver enzyme levels (ALT) in women using CHCs containing ethinylestradiol. While Elleste Duet contains estradiol instead of ethinylestradiol, it is unknown whether a similar increase in ALT levels might occur when using Elleste Duet with these HCV treatments.
Always inform your doctor or pharmacist if you are currently taking or have recently taken any other medications, including those obtained without a prescription, herbal remedies, or natural products. Your doctor will provide appropriate guidance.
Elleste Duet tablets FAQs
What is Elleste Duet, and what is it used for?
Elleste Duet tablets are a form of hormone replacement therapy (HRT) that combines two female hormones: oestrogen (estradiol hemihydrate) and progestogen (norethisterone acetate). They are used to treat symptoms of menopause, such as hot flushes, night sweats, and vaginal dryness, which occur due to a decrease in oestrogen levels. Elleste Duet is also prescribed to prevent osteoporosis in postmenopausal women at an increased risk of fractures.
Who is Elleste Duet suitable for?
Elleste Duet is suitable for women experiencing menopausal symptoms who still have a menstrual cycle or have not had a hysterectomy. It is a cyclical HRT, meaning it mimics a regular menstrual cycle. The first 16 tablets in a pack contain only oestrogen, while the final 12 tablets contain both oestrogen and progestogen to induce a regular period and reduce the risk of endometrial cancer.
How does Elleste Duet work?
Elleste Duet works by supplementing the body with oestrogen and progestogen, which helps alleviate menopausal symptoms caused by a natural decline in hormone levels. The combination of hormones helps regulate the menstrual cycle in women who still have a uterus and reduces the risk of developing complications such as endometrial hyperplasia or cancer.
How should I take Elleste Duet?
Elleste Duet follows a 28-day cycle. If you still have regular periods, start taking the tablets on the first day of your period. If you do not have regular periods, you can start immediately. Take one tablet daily at the same time each day, following the arrows on the pack. Swallow the tablets whole with water, with or without food. Once you finish a pack, start a new one the next day.
What should I do if I miss a dose of Elleste Duet?
If you forget to take a tablet, take it as soon as you remember. However, if it has been more than 12 hours, skip the missed dose and take the next one at your regular time. Do not double the dose to make up for a missed tablet. Missing a dose may cause breakthrough bleeding or spotting.
What are the potential side effects of Elleste Duet?
Like all medications, Elleste Duet can cause side effects, though not everyone experiences them. Common side effects include:
Nausea
Headache
Breast tenderness
Mood changes
Weight gain
Acne
Back pain
Irregular vaginal bleeding
More serious side effects may include blood clots, stroke, or heart disease. If you notice symptoms such as leg pain, chest pain, sudden vision changes, or yellowing of the skin, seek medical attention immediately.
What precautions should I take while using Elleste Duet?
Elleste Duet is not suitable for everyone. Do not take it if you have a history of breast cancer, endometrial cancer, unexplained vaginal bleeding, blood clots, liver disease, or if you are allergic to any of its ingredients. Inform your doctor if you have conditions such as high blood pressure, diabetes, migraines, or a family history of breast cancer. Regular check-ups and breast screenings are recommended while using HRT.
Can Elleste Duet interact with other medications?
Yes, some medicines can interfere with the effectiveness of Elleste Duet, leading to irregular bleeding. These include:
Tell your doctor about any other medicines you are taking, including over-the-counter drugs and supplements.
What should I do if I experience side effects from Elleste Duet?
If you experience side effects, especially severe ones like chest pain, difficulty breathing, or signs of a stroke, stop taking Elleste Duet and seek medical attention immediately. For less severe side effects, consult your doctor or pharmacist for advice.
What are the alternatives to Elleste Duet?
If Elleste Duet is not suitable for you, other forms of HRT are available, including oestrogen-only HRT or different combined HRT formulations. Non-medicinal alternatives to manage menopausal symptoms include lifestyle changes, such as maintaining a healthy diet, exercising regularly, and using lubricants for vaginal dryness. Always discuss with your doctor the best treatment option for your needs.
