Elleste Duet

Elleste Duet is a Hormone Replacement Therapy (HRT) for oestrogen deficiency symptoms in post- and peri-menopausal women it is available in two strengths: Elleste Duet 1 mg (containing 1 mg estradiol and 1 mg norethisterone acetate) and Elleste Duet 2 mg (containing 2 mg estradiol and 1 mg norethisterone acetate).

Elleste Duet is used for relief of symptoms occurring after menopause. During the menopause, the amount of oestrogen produced by a woman’s body drops. This can cause symptoms such as hot face, neck and chest (“hot flushes”). Elleste Duet alleviates these symptoms after menopause.

Elleste Duet are continuous sequential hormone replacement therapies. This kind of treatment is beneficial for patients with a womb/uterus who may still have regular/irregular periods. Most women will experience regular periods whilst taking Elleste Duet.

Please Note: Elleste Duet 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. Do not use a hormonal contraceptive while using HRT.

The Elleste Duet 1 mg pack contains 16 white tablets and 12 pale green tablets. You must start with the white tablets.

The Elleste Duet 2 mg pack contains 16 orange tablets and 12 grey tablets. You must start with the orange tablets.

If you are still having regular periods, start on the first day of bleeding. If you are not having regular periods you can start straight away.

The lowest effective dose for the shortest duration should be used.

Directions: One white/orange tablet to be taken daily for the first 16 days, followed by one pale green/grey tablet for the next 12 days. A new cycle should then begin without any break.

• Take one tablet each day. You can take the tablet at a time of the day that suits you but it is best to take it at about the same time each day.
• Swallow the tablets whole, with some water.
• Follow the direction of the arrows on the pack and take a tablet each day until the pack is empty.
• When you finish your first foil strip, start a new strip on the next day. Remember to put a fresh sticker on your new foil strip.

To help you remember to take your tablets, we have included stickers in the pack with the days of the week marked on them. For example, if you are starting the tablets on a Friday, use the sticker which starts with ‘Fri’. Stick this at the top of the foil strip on the side where you can see the tablets.

If you are taking

• Elleste Duet 1 mg, the first day should be above the white tablet which has the start arrow next to it.
• Elleste Duet 2 mg, the first day should be above the orange tablet which has the start arrow next to it.

You will probably have a monthly bleed. This may start any time between day 21 of the pack to day 5 of the next pack. This pattern will usually be the same from month to month. Some women may have no bleeds. In the first few months you may get irregular bleeding. However, if this carries on you should tell your doctor.

If you forget to take Elleste Duet 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.

Like all medicines, this medicine can cause side effects, although not everybody gets them. The following side effects have been associated with Elleste Duet:

Very common (may affect more than 1 in 10): headache, breast pain, breast tenderness, painful periods, problems with your menstrual cycle.

Common (may affect up to 1 in 10) : 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 or fingers, increase in weight.

The list above isn’t exhaustive. If you experience serious side effects or side effects lasting longer than 3 months then you should consult your doctor immediately.

Make sure you read the patient information leaflet for a full list of side effects, cautions and contraindications. You should only take HRT once you have understood all the warnings and precautions as HRT may increase your chances of getting certain cancers or cardiovascular disease. If you are concerned discuss this with your doctor or The Family Chemist clinician.

Do not take Elleste Duet:

• If you have or have ever had breast cancer, or if you are suspected of having it
• If you have cancer which is sensitive to oestrogens, such as cancer of the womb lining (endometrium), or if you are suspected of having it
• If you have any unexplained vaginal bleeding
• If you have excessive thickening of the womb lining (endometrial hyperplasia) that is not being treated
• If you have or have ever had a blood clot in a vein (thrombosis), such as in the legs (deep venous thrombosis) or the lungs (pulmonary embolism)
• If you have a blood clotting disorder (such as protein C, protein S, or antithrombin deficiency)
• If you have or recently have had a disease caused by blood clots in the arteries, such as a heart attack, stroke or angina
• If you have or have ever had a liver disease and your liver function tests have not returned to normal
• If you have a rare blood problem called “porphyria” which is passed down in families (inherited)
• If you are allergic to estradiol hemihydrate or norethisterone acetate or any of the other ingredients of this medicine.

If any of the above conditions appear for the first time while taking Elleste Duet, stop taking it at once and consult your doctor immediately.

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. If so, you should see your doctor more often for check-ups:

• fibroids inside 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 developing blood clots (see “Blood clots in a vein (thrombosis)”)
• increased risk of getting a oestrogen-sensitive cancer (such as having a mother, sister or grandmother who has had breast cancer)
• high blood pressure.
• a liver disorder, such as a benign liver tumour
• diabetes
• gallstones
• migraine or severe headaches
• a disease of the immune system that affects many organs of the body (systemic lupus erythematosus, SLE)
• epilepsy
• asthma
• a disease affecting the eardrum and hearing (otosclerosis)
• a very high level of fat in your blood (triglycerides)
• fluid retention due to cardiac or kidney problems
• hereditary and acquired angioedema

If you notice any of the following when taking HRT:

• any of the conditions mentioned in the ‘DO NOT take Elleste Duet’ section
• yellowing of your skin or the whites of your eyes (jaundice). These may be signs of a liver disease
• swollen face, tongue and/or throat and/or difficulty swallowing or hives, together with difficulty breathing which are suggestive of an angioedema
• a large rise in your blood pressure (symptoms may be headache, tiredness, dizziness)
• migraine-like headaches which happen for the first time
• if you become pregnant
• if you notice signs of a blood clot, such as:
  • painful swelling and redness of the legs
  • sudden chest pain
  • difficulty in breathing

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