If you are looking for information on other Elleste products, please see below:
Elleste Solo
First of all, thank you for choosing Numan. If your prescription request for Elleste Duet 1mg or 2mg Tablets has been accepted, or if you considering whether this treatment may be suitable for you, we'd like to help you learn how to use it to its best effect, and give you some important information before you start taking it.
What is it?
Elleste Duet is a sequential combined hormone replacement therapy (HRT). Each 28-day pack contains two types of tablets:
In Elleste Duet 1mg, this pack contains 16 white tablets (containing 1mg estradiol) and 12 pale green tablets (containing 1mg estradiol and 1mg norethisterone acetate, a synthetic progestogen).
In Elleste Duet 2mg, this pack contains 16 orange tablets (with 2mg estradiol) and 12 grey tablets (with 2mg estradiol and 1mg norethisterone acetate.
What is it used for?
Elleste Duet 1mg is used for the relief of menopausal symptoms in women who still have a uterus and are experiencing a menstrual cycle, however irregular. Elleste Duet 2mg is used for the relief of menopausal symptoms and is also licensed for the prevention of osteoporosis after menopause in women at high risk of fractures. It is suitable for women who require a higher dose of oestrogen for symptom control.
How long does it take to work?
Many women notice an improvement in their symptoms within a few weeks of starting treatment. However, it can sometimes take up to three months for your body to adjust and for you to feel the full benefits.
How do I use it?
For menopausal symptoms in women with a uterus: You should take one tablet orally each day, starting within 5 days of your period (or at any time if you no longer have periods), without a break between packs, at about the same time each day. If you are changing to Elleste Duet from a continuous Combined HRT preparation, you may start therapy at any time if you no longer have periods, or otherwise start on the first day of bleeding. Follow the arrows on the pack.
For Elleste-Duet 1mg:
Firstly, start with taking one white tablet a day for the first 16 days, followed by the pale green tablets for the next 12 days.
When you finish a pack, start the next one immediately without a break. This completes a 28-day cycle.
A monthly withdrawal bleed is expected towards the end of or after finishing the green tablets.
For Elleste-Duet 2mg:
Firstly, start with taking one orange tablet a day for the first 16 days, followed by the grey tablets for the next 12 days.
When you finish a pack, start the next one immediately without a break. This completes a 28-day cycle.
A monthly withdrawal bleed is expected towards the end of or after finishing the green tablets.
Missed dose: If you forget to take a dose, you should take the dose as soon as possible. If more than 12 hours have elapsed since your dose was due, it is recommended to continue with the next dose without taking the forgotten tablet. The likelihood of breakthrough bleeding or spotting may be increased with missed doses, however. Always take this medicine exactly as instructed, and check with your healthcare provider if you are not sure.
Special dosing requirements
The 1mg tablet dose of Elleste Duet is a standard starting dose for sequential HRT, though your clinician may adjust this dose over time depending on your response to treatment. The goal of HRT is always to use the lowest effective dose for the shortest duration necessary to manage your symptoms.
There are no special dosage requirements for elderly patients, though experience in treating women over 65 years is limited. This medicine is not for use in children.
Information on fertility, pregnancy and lactation
Pregnancy: Elleste Duet is not a contraceptive and is intended for use only in post-menopausal women. 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 healthcare provider for advice on this. If you become pregnant while taking it, you must stop treatment immediately and contact your healthcare provider.
Breastfeeding: Elleste Duet is not indicated during breastfeeding.
Other important safety information
The progestogen (norethisterone) in Elleste Duet is included to protect the womb lining from the effects of oestrogen, which is important if you have not had a hysterectomy or are taking any other progesterone treatment.
What are the associated risks with treatment?
Common side effects include headache, abdominal pain, back pain, and breast tenderness or pain. Irregular bleeding or spotting can occur, especially in the first few months. As an oral (systemic) form of HRT, Elleste Duet is associated with a small increased risk of blood clots (venous thromboembolism), stroke, and breast cancer. The risk of ovarian cancer may also be slightly increased. These risks are generally small and depend on factors like your age, medical history, and how long you take HRT for. For a full list of side effects, please see the Patient Information Leaflet provided with your medication and also linked at the bottom of this page.
What monitoring or follow-up is needed to continue taking treatment safely?
Your clinician will review your treatment after three months to check how you’re responding. After that, you should have a check-up at least once a year. These reviews will assess whether HRT is still right for you, make sure your symptoms are under control, ask about any side effects and vaginal bleeding, request a check of your weight and your blood pressure, and decide if you need further tests such as a bone density scan. You should also examine your breasts regularly, and make sure to attend all routine screening appointments such as mammograms and cervical screening, if applicable to you. If you have a premature menopause, the risks of using HRT may be different, which you should discuss with your clinician.
When to stop treatment
You should stop using Elleste Duet immediately and consult your doctor if you experience any of the following: signs of a blood clot (e.g. painful swelling in the leg), a swollen face, tongue and/or throat and/or difficulty swallowing or hives, together with difficulty breathing which are suggestive of an angioedema, jaundice (yellowing of the skin or eyes), a significant increase in your blood pressure, the new onset of a migraine-type headache, or if you become pregnant. When you and your clinician decide it is time to stop HRT, the dose is often reduced gradually to help prevent your menopausal symptoms from returning suddenly.
Conditions which need supervision
If any of the following conditions are present, have occurred previously, and/or have been aggravated during pregnancy or previous hormone treatment, you should be closely supervised, as these conditions may recur or be aggravated during treatment with Elleste Duet 1mg and 2mg Tablets, in particular:
Leiomyoma (uterine fibroids) or endometriosis
Risk factors for thromboembolic disorders
Risk factors for oestrogen dependent tumours, e.g. 1st degree heredity for breast cancer
Hypertension
Liver disorders (e.g. liver adenoma)
Diabetes mellitus with or without vascular involvement
Cholelithiasis
Migraine or (severe) headache
Systemic lupus erythematosus
A history of endometrial hyperplasia
Epilepsy
Asthma
Otosclerosis
Storage instructions
Do not store above 30°C. Store in the original package. Keep out of reach of children.
Further information:
If you have questions about your medication, wish to discuss alternative treatment plans, or need reassurance, our clinicians are available to provide expert advice and support. Just email us at [email protected].
Lastly, please read the Patient Information Leaflet linked below and included with your treatment for a full list of side effects, contraindications, and precautions.
