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WHAT YOU NEED TO KNOW BEFORE YOU TAKE PROGYNOVA

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 Progynova, 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 to take Progynova. Be sure to: Ø go for regular breast screening and cervical smear tests, as recommended by your doctor. Ø regularly check your breasts for any changes such as dimpling of the skin, changes in the nipple, or any lumps you can see or feel. Do not take Progynova: 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 Progynova, Do not take Progynova • 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 vein 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 valerate or any of the other ingredients of this medicine (listed in section 6) 027_0 Page 3 of 10 • If you have been told to avoid lactose, that you have a rare hereditary condition called Lapp lactase deficiency or glucose-galactose malabsorption • If you have any reason to believe that you either are, or may be, pregnant, or if you are producing milk (lactating) and breast-feeding. (See also the ‘Pregnancy and breast-feeding’ section of this leaflet) Ø If any of the above conditions appear for the first time while taking Progynova, stop taking it at once and consult your doctor immediately. Warnings and precautions Talk to your doctor or pharmacist before taking Progynova 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 Progynova. If so, you should see your doctor more often for checkups: • 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 an oestrogen-sensitive cancer (such as 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 Progynova 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 Progynova’ 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 (thrombosis)’ Note: Progynova 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. 027_0 Page 4 of 10 HRT and cancer Excessive thickening of the lining of the womb (endometrial hyperplasia) and cancer of the lining of the womb (endometrial cancer) Taking 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). Taking a progestogen in addition to the oestrogen for at least 12 days of each 28 day cycle protects you from this extra risk. If you still have your womb, your doctor will prescribe a progestogen separately. If you have had your womb removed (a hysterectomy), discuss with your doctor whether you can safely take this product without a progestogen. If you’ve had your womb removed because of endometriosis, any endometrium left in your body may be at risk. So your doctor may prescribe HRT that includes a progestogen as well as an oestrogen. Compare In women who still have a womb and who are not taking HRT, on average, 5 in 1000 will be diagnosed with endometrial cancer between the ages of 50 and 65. For women, aged 50 to 65, who still have a womb and who take oestrogen-only HRT, between 10 and 60 women in 1000 will be diagnosed with endometrial cancer (i.e. between 5 and 55 extra cases), depending on the dose and how long it is taken. Breast cancer Evidence shows that taking combined oestrogen-progestogen or oestrogen-only hormone replacement therapy (HRT) increases the risk of breast cancer. The extra risk depends on how long you use HRT. The additional risk becomes clear within 3 years of use. After stopping HRT the extra risk will decrease with time, but the risk may persist for 10 years or more if you have used HRT for more than 5 years. Your risk of breast cancer is also higher: • if you have a close relative (mother, sister or grandmother) who has had breast cancer • if you are seriously overweight Compare Women aged 50 to 54 who are not taking HRT, on average, 13 to 17 in 1000 will be diagnosed with breast cancer over a 5-year period. For women aged 50 who start taking oestrogen-only HRT for 5 years, there will be 16-17 cases in 1000 users (i.e. an extra 0 to 3 cases). For women aged 50 who start taking oestrogen-progestogen HRT for 5 years, there will be 21 cases in 1000 users (i.e. an extra 4 to 8 cases). Women aged 50 to 59 who are not taking HRT, on average, 27 in 1000 will be diagnosed with breast cancer over a 10-year period. For women aged 50 who start taking oestrogen-only HRT for 10 years, there will be 34 cases in 1000 users (i.e. an extra 7 cases). For women aged 50 who start taking oestrogen-progestogen HRT for 10 years, there will be 48 cases in 1000 users (i.e. an extra 21 cases). Regularly check your breasts. See your doctor if you notice any changes in your breast such as: • dimpling of the skin • changes in the nipple • any lumps you can see or feel 027_0 Page 5 of 10 Additionally, you are advised to join mammography screening programs when offered to you. For mammogram screening, it is important that you inform the nurse/healthcare professional who is actually taking the x-ray that you use HRT, as this medication may increase the density of your breasts which may affect the outcome of the mammogram. Where the density of the breast is increased, mammography may not detect all lumps. Ovarian cancer Ovarian cancer (cancer of the ovaries) is rare – much rarer than breast cancer. It can be difficult to diagnose because there are often no obvious signs of the disease. The use of oestrogen-only or combined oestrogenprogestogen HRT has been associated with a slightly increased risk of ovarian cancer. The risk of ovarian cancer varies with age. For example, in women aged 50 to 54 who are not taking HRT, about 2 women in 2000 will be diagnosed with ovarian cancer over a 5-year period. For women who have been taking HRT for 5 years, there will be about 3 cases per 2000 users (i.e. about 1 extra case). Effects of HRT on heart or circulation Blood clots in a vein (thrombosis) The risk of blood clots in the veins (also called deep vein thrombosis, or DVT) is about 1.3 to 3–times higher in HRT users than non-users, especially during the first year of taking it. Blood clots can be serious, and if one travels to the lungs, it can cause chest pain, breathlessness, fainting or even death. This condition is called pulmonary embolism, or PE. DVT and PE are examples of a condition called venous thromboembolism, or VTE. You are more likely to get a blood clot in your veins as you get older and if any of the following applies to you. Inform your doctor if any of these situations apply to you: • you are unable to walk for a long time because of major surgery, injury or illness (see also section 3, “If you need to have surgery”) • you are seriously overweight (BMI >30 kg/m2 ) • you have any blood clotting problem that needs long-term treatment with a medicine used to prevent blood clots • any of your close relatives has ever had a blood clot in the leg, lung or any other organ • you have had one or more miscarriages • you have systemic lupus erythematosus (SLE) • you have cancer For signs of a blood clot, see “Stop taking Progynova and see a doctor immediately”. Compare Looking at women in their 50s who are not taking HRT, on average, over a 5-year period, 4 to 7 in 1000 would be expected to get a blood clot in a vein. For women in their 50s who are taking oestrogen-progestogen HRT, for over 5 years, there will be 9 – 12 cases in 1000 (i.e. an extra 5 cases). For women in their 50s who have had their womb removed and have been taking oestrogen-only HRT for over 5 years, there will be 5 to 8 cases in 1000 users (i.e. 1 extra case). Heart disease (heart attack) There is no evidence that HRT will prevent a heart attack. HRT is not recommended for women who have heart disease, or have had heart disease recently. If you have ever had heart disease, talk to your doctor to see if you should be taking HRT. Women over the age of 60 years who use oestrogen-progestogen HRT are slightly more likely to develop heart disease than those not taking any HRT. For women who have had their womb removed and are taking oestrogen-only therapy there is no increased risk of developing a heart disease. 027_0 Page 6 of 10 If you get: • a pain in your chest that spreads to your arm or neck Ø See a doctor as soon as possible and do not take any more HRT until your doctor says you can. This pain could be a sign of heart disease. Stroke The risk of getting a stroke is about 1.5–times higher in HRT users than in non–users. The number of extra cases of stroke due to HRT use will increase with age. Other things that can increase the risk of stroke include: • high blood pressure • smoking • drinking too much alcohol • an irregular heartbeat If you are worried about any of these things, or if you have had a stroke in the past, talk to your doctor to see if you should take HRT. Compare Looking at women in their 50s who are not taking HRT, on average, 8 in 1000 would be expected to have a stroke over a 5-year period. For women in their 50s who are taking HRT, there will be 11 cases in 1000 users, over 5 years (i.e. an extra 3 cases). Other conditions • HRT will not prevent memory loss. There is some evidence of a higher risk of memory loss in women who start using HRT after the age of 65. Speak to your doctor for advice. • If you have heart or kidney problems, your doctor should examine you carefully as oestrogens may cause fluid retention resulting in swelling. • If you have pre-existing elevated triglycerides (a type of blood fat) your doctor should monitor you closely during oestrogen replacement therapy or HRT. Rare cases of large increases of plasma triglycerides (hypertriglyceridemia) leading to inflammation of the pancreas (pancreatitis) have been reported with oestrogen replacement therapy. • If you have a tendency to develop blotchy brown patches (chloasma) on the face you should avoid exposure to the sun or ultraviolet light whilst using Progynova. • Your doctor will monitor you carefully if you have terminal kidney insufficiency as the blood levels of the active substances in Progynova will probably increase Other medicines and Progynova Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. Some medicines may interfere with the effect of Progynova. This might lead to irregular bleeding. This applies to the following medicines: • Medicines for epilepsy (such as barbiturates, phenytoin, primidone,carbamazepine and possibly oxcarbazepine, topiramate and felbamate) • Medicines for tuberculosis (such as rifampicin, rifabutin) • Medicines for HIV and Hepatitis C Virus infections (so-called protease inhibitors and nonnucleoside reverse transcriptase inhibitors such as nevirapine, efavirenz, ritonavir and nelfinavir) • Herbal remedies containing St. John’s wort (Hypericum perforatum) • Medicines for Hepatitis C virus (HCV) (such as combination regimen ombitasvir/paritaprevir/ritonavir with or without dasabuvir as well as regimen glecaprevir/pibrentasvir) may cause increases in liver function blood test results (increase in ALT liver enzyme) in women using CHCs (combined hormonal contraceptives) containing ethinylestradiol. Progynova contains estradiol instead of ethinylestradiol. It is not known whether 027_0 Page 7 of 10 an increase in ALT liver enzyme can occur when using Progynova with this HCV combination regimen. Your doctor will advise you • Medicines for treatment of fungal infections (such as griseofulvin, fluconazole, itraconazole, ketoconazole and voriconazole) • Medicines for treatment of bacterial infections (such as clarithromycin and erythromycin) • Medicines for treatment of certain heart diseases, high blood pressure (such as verapamil and diltiazem) • Grapefruit juice Laboratory tests If you need a blood test, tell your doctor or the laboratory staff that you are taking Progynova, because this medicine can affect the results of some tests. Pregnancy and breast-feeding Progynova is for use in post-menopausal women only. Do not take if you are pregnant or breast-feeding. If you become pregnant, stop taking Progynova immediately and contact your doctor. Driving and using machines No effects on ability to drive and use machines have been observed in users of Progynova. Progynova contains lactose monohydrate and sucrose Progynova contains lactose and sucrose (types of sugar). If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.