Lenzetto (Estradiol) 1.53mg transdermal spray solution 56 doses

The spray should be applied to the dry and healthy skin of the inner forearm. If that is not possible, it should be applied to the inner thigh.

Do not apply Lenzetto to the breasts or any area near the breasts.

How to apply Lenzetto

• Before a new applicator is used for the first time, the pump should be primed by spraying it three times with the cover on.
• Lenzetto is administered once daily, either as a monotherapy or as a continuous sequential treatment (when combined with a progestogen).

One metered-dose spray is administered once daily to the dry and healthy skin of the forearm as a starting dose. The dose may be increased to two metered-dose sprays daily to the forearm based on clinical response. Dose increase should be based on the degree of the woman's menopausal symptoms and should be made only after at least 4 weeks of continuous treatment with Lenzetto. The maximum daily dose is 3 metered-dose sprays (4.59 mg/day) to the forearm. Dose increase should be discussed with a doctor or pharmacist. For patients who have difficulty applying the prescribed dose to distinct, non-overlapping areas of the same forearm, Lenzetto may also be applied to sites on the alternate forearm, or to sites on the inner thigh.

Do not allow anyone else (especially children) or pets to come into contact with the skin area that has just been sprayed

Do not use Lenzetto:

• 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 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 (is inherited)
• If you are allergic to estradiol or any of the other ingredients of this medicine

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

Warnings and precautions
Talk to your doctor or pharmacist before using Lenzetto.

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 Lenzetto. 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 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 using Lenzetto and see a doctor immediately If you notice any of the following when using HRT:

• Any of the conditions mentioned in the “DO NOT use Lenzetto” 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