Product Details

What you need to know before you take Premarin

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 Premarin 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 Premarin. Go for regular breast screening, as recommended by your doctor. Do not take Premarin 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 Premarin. Do not take Premarin: ▪ If you are allergic (hypersensitive) to conjugated estrogens or any of the other ingredients of this medicine (listed in section 6). ▪ 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 estrogens such as cancer of the lining of the womb (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 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 previously had liver disease. ▪ If you have a rare blood problem called “porphyria” which is passed down in families (inherited). ▪ If you are pregnant, or you are breast-feeding. If any of the above conditions appear for the first time while taking Premarin, stop taking it at once and consult your doctor immediately. Warnings and precautions Talk to your doctor, pharmacist or nurse before taking Premarin 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 Premarin. 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 section 2 “Blood Clots in a vein (thrombosis)” for more detail) Page 3 of 11 • increased risk of getting estrogen-sensitive cancer (such as having a mother, sister or grandmother who has had breast cancer) (see section 2 “HRT and cancer”) • high blood pressure • heart disease • a liver disorder (e.g. a benign liver tumour) • kidney disease • fluid retention due to cardiac or kidney problems • diabetes • gallbladder disease or 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) • low blood calcium levels (hypocalcaemia) • a very high level of fat in your blood (triglycerides). Stop taking Premarin 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 Premarin” section • yellowing of the skin or the whites of your eyes (jaundice). These may be signs of a liver disease • 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 • have an allergic reaction, signs of which include a rash, itching, shortness of breath, difficulty in breathing and a swollen face • if you notice signs of a blood clot, such as: o painful swelling and redness of the legs o sudden chest pain o difficulty in breathing. For more information, see section titled “Blood Clots in a vein (thrombosis)” below. Premarin 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. HRT and cancer Excessive thickening of the lining of the womb (endometrial hyperplasia) and cancer of the lining of the womb (endometrial cancer) Taking estrogen-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 estrogen 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. Page 4 of 11 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 estrogen-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 for how long it is taken. Premarin 0.625 mg and 1.25 mg tablets contain a higher dose of estrogens than other estrogen-only HRT products. The risk of endometrium cancer when using Premarin 0.625 mg and 1.25 mg tablets together with a progestogen is not known. If you still have your womb, your doctor may prescribe a progestogen as well as estrogen. If so, these may be prescribed separately, or as a combined HRT product. If you have had your womb removed (a hysterectomy), your doctor will discuss with you whether you can safely take estrogen 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 estrogen. Your product, Premarin, is an estrogen-only product. Looking at women who still have a uterus 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 who take estrogen-only HRT, the number will be 2 to 12 times higher, depending on the dose and how long you take it. After stopping treatment risk may remain elevated for at least 10 years. In women with a uterus, use of estrogen-only HRT is not recommended because it increases the risk of endometrial cancer. Irregular bleeding If you get break-through bleeding or spotting, it’s usually nothing to worry about, especially during the first 3-6 months of taking HRT. But if the bleeding or spotting: ▪ carries on for more than the first 6 months ▪ starts after you’ve been taking Premarin for more than 6 months ▪ carries on even after you’ve stopped taking Premarin ➢ Make an appointment to see your doctor. It could be a sign that your endometrium has become thicker. Breast Cancer Women who have breast cancer, or have had breast cancer in the past, should not take HRT. Evidence shows that taking combined estrogen-progestogen or estrogen-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. Page 5 of 11 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 estrogen-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 are taking estrogen-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 estrogen-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 estrogen-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 such as: ▪ dimpling of the skin ▪ changes in the nipple ▪ any lumps you can see or feel Ovarian Cancer Ovarian cancer is rare – much rarer than breast cancer , but it is serious. It can be difficult to diagnose, because there are often no obvious signs of the disease. The use of estrogen-only or combined estrogen-progestogen 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 your 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 in 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, collapse 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 applies to you: ▪ you are seriously overweight (BMI>30 kg/m2 ) ▪ you have had a blood clot before ▪ if any of your close family has ever had a blood clot in the leg, lung or another organ ▪ you are pregnant or in your postpartum period ▪ you have any blood clotting problem that needs treatment with a medicine used to prevent blood clots ▪ you are unable to walk for a long time because of major surgery, injury or illness (see also “if you’re going to have surgery” below) ▪ you have a rare condition called SLE (systemic lupus erythematosus) ▪ you have cancer. Page 6 of 11 For signs of a blood clot, see section 2 Stop taking Premarin 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 have had their womb removed and have been taking estrogen-only HRT for over 5 years, there will be 5 to 8 cases in 1000 users (i.e. 1 extra case). If you’re going to have surgery, make sure your doctor knows about it or tell the surgeon that you are taking Premarin. You may need to stop taking Premarin about 4 to 6 weeks before the operation, to reduce the risk of a blood clot. Your doctor will tell you when you can start taking Premarin again. Heart Disease (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. There is no evidence that HRT will prevent a heart attack. For women who have had their womb removed and are taking estrogen-only therapy there is no increased risk of developing a heart disease. If you get: ▪ a pain in your chest that spreads to your arm or neck ➢ 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 having a stroke is about 1.5 times higher in HRT users than in non-users. The number of extra cases of stroke due to use of HRT will increase with age. More recent analysis of risk in women aged 50 to 59 years suggests no increased risk for women taking 0.625 mg Premarin tablets. 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, over a 5-year period, 8 in 1000 would be expected to have a stroke. For women in their 50s who are taking HRT, the figure would be 11 in 1000 users, over a five year period (i.e. an extra 3 cases). Page 7 of 11 If you get: ▪ unexplained migraine-type headaches, with or without disturbed vision ➢ See a doctor as soon as possible and do not take any more HRT until your doctor says you can. These headaches may be an early warning sign of a stroke. 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. Women with hypertriglyceridemia may experience large increases of their plasma triglycerides, which can lead to inflammation of the pancreas (pancreatitis). Symptoms of pancreatitis may include abdominal pain, abdominal swelling, fever and feeling or being sick. If you are taking thyroid hormone replacement therapy (e.g. thyroxine), your doctor may monitor your thyroid function more often when you start treatment. HRT may affect some medical tests. If you visit a hospital or clinic for any medical tests, you should tell the doctor concerned that you are taking HRT. Other medicines and Premarin Some medicines may interfere with the effect of Premarin. This might lead to irregular bleeding. Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription, herbal remedies or other natural products. In particular tell your doctor if you are taking: • an anticonvulsant (used to treat epilepsy e.g. phenobarbital, phenytoin, carbamazepine) • an anti-infective e.g. used to treat tuberculosis (rifampicin, rifabutin) or HIV (nevirapine, efavirenz, ritonavir and nelfinavir) • other antibiotics or antifungal medicines (e.g. erythromycin, clarithromycin, ketoconazole, itraconazole) • a herbal preparation such as St. John’s wort (Hypericum perforatum) • metyrapone (most commonly used in the treatment of Cushing’s syndrome) • cimetidine (used to treat stomach ulcers and reduce stomach acid) • dexamethasone (a corticosteroid) The way that Premarin works may be altered if other medicines are used at the same time. Premarin with food and drink Drinking grapefruit juice may affect the way that your medicine works. Laboratory tests If you need a blood test, tell your doctor or the laboratory staff that you are taking Premarin, because this medicine can affect the results of some tests. Pregnancy, breast-feeding and fertility If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. Driving and using machines Page 8 of 11 There is no evidence to suggest that taking Premarin will affect your ability to drive or to operate machinery. Premarin contains Lactose monohydrate, Sucrose and the colouring agent Sunset Yellow Lactose monohydrate and sucrose are sugars. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product. The colouring agent E110 (sunset yellow), that is used in the yellow tablets (1.25 mg), may cause allergic reactions.