Elleste Solo
(estradiol)

Elleste Solo 1 mg Tablets are white film-coated tablets with an embossing.

Elleste Solo 2 mg Tablets are orange film-coated tablets with an embossing.

They are supplied in packs containing blister strips.

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 Solo 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 Solo. Go for regular breast screening, as recommended by your doctor.

Do not take Elleste Solo 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 Solo.

Do not take Elleste Solo

• 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 any of the other ingredients of this medicine (see ‘What it contains’ section above)

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

When to take special care with Elleste Solo

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 Solo. 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” section below)
• increased risk of getting an 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

Stop taking Elleste Solo and see a doctor immediately

If you notice any of the following when taking HRT:

• any of the conditions mentioned in the ‘DO NOT take Elleste Solo’ 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.
  For more information, see ‘Blood clots in a vein’ section below

Note: Elleste Solo 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.