Talk to your doctor before taking this medicine, if you:

• are allergic to estradiol or any of the other ingredients of this medicine
• have or have ever had breast cancer
• have cancer, which is sensitive to oestrogens, such as cancer of the womb lining (endometrium)
• have any unexplained vaginal bleeding
• need to have surgery
• have ever had a blood clot in a vein (thrombosis) such as in the legs (deep vein thrombosis) or the lungs (pulmonary embolism)
• have a blood clotting disorder (such as protein C, protein S, or antithrombin deficiency)
• have or recently have had a disease caused by blood clots in the arteries, such as a heart attack, stroke or angina
• have or have ever had a liver or kidney disease
• have a rare blood problem called porphyria which is passed down in families (inherited)
• have fibroids inside your womb
• have growth of womb lining outside your womb (endometriosis) or a history of excessive growth of the womb lining (endometrial hyperplasia)
• increased risk of getting an oestrogen-sensitive cancer high blood pressure
• have diabetes
• suffer from gallstones
• have a disease of the immune system that affects many organs of the body (systemic lupus erythematosus, SLE)
• suffer from epilepsy
• have a very high level of fat in your blood (triglycerides)

• If you are pregnant or breast-feeding, think you may be pregnant or planning to have baby, ask your doctor for advice before taking this medicine

• VALEST is not for use in adolescents or children

• No effects on ability to drive and use machines have been observed in users of VALEST

• breast or ovarian cancer
• abnormal growth or cancer of the lining of the womb (endometrial hyperplasia or cancer)
• blood clots in the veins of the legs or lungs (venous thromboembolism)
• heart disease
• stroke
• vaginal bleeding at unexpected times (breakthrough bleeding and spotting)
• breast pain, tenderness or enlargement, breast discharge painful periods, changes in vaginal secretions, pre-menstrual symptoms, increased size of fibroids in the womb, thrush, changes to the neck of the womb
• indigestion, a feeling of being bloated, passing wind, feeling or being sick, abdominal pain, gall bladder disease
• skin rashes or discolouration, itching, eczema, acne, unusual hair loss or hair growth, increased skin pigment especially on the face some rare skin problems
• headache, migraine, dizziness, anxiety or depressive symptoms, fatigue
• fast or irregular heartbeat (palpitations), high blood pressure, inflammation of veins usually in the legs
• fluid retention leading to swelling of parts of the body
• changes in body weight and sex drive, increased appetite
• muscle cramps, leg pains
• nose bleeds, visual disturbances, discomfort with contact lenses, allergic-type reactions, a worsening of glucose tolerance, bladder inflammation, rare disorders (porphyria, chorea)

NA

NA

NA

NA

HRT and cancer

• Excessive thickening of the lining of the womb (endometrial hyperplasia) and cancer of the lining of the womb (endometrial cancer)
• Using oestrogen-only HRT will increase the risk of excessive thickening of the lining of the womb (endometrial hyperplasia) and cancer of the womb lining (endometrial cancer)
• Using a progestogen in addition to the oestrogen for at least 12 days of each 28 day cycle protects you from this extra risk. So your doctor will prescribe a progestogen separately if you still have your womb. If you have had your womb removed (a hysterectomy)
• Discuss with your doctor whether you can safely take this product without a progestogen

Irregular bleeding

You may have irregular bleeding or drops of blood (spotting) during the first 3-6 months of using VALEST. However, if the irregular bleeding:

• carries on for more than the first 6 months
• starts after you have been using this medicine for more than 6 months
• carries on after you have stopped using this medicine

Breast cancer

• HRT increases the risk of breast cancer
• For women who have had their womb removed and who are using oestrogen-only HRT for 5 years, little or no increase in breast cancer
• Regularly check your breasts. See your doctor if you notice any changes such as: dimpling of the skin, hanges in the nipple,lumps you can see or feel
• you are advised to take mammography screening test as this medication may increase the density of your breasts where the density of the breast is increased, mammography may not detect all lumps

Ovarian cancer

The use of oestrogen-only or combined oestrogen-progestogen HRT has been associated with a slightly increased risk of ovarian cancer

• Keep this medicine out of reach of children
• Do not use this medicine after the expiry date
• Store at room temperature (15-25C)